H.Amdt. 71House111th Congress (2009-2011)
An amendment in the nature of a substitute printed in part B of House Report 111-72 to create a Tobacco Harm Reduction Center under the Department of HHS to regulate all tobacco products and establishes a regulatory scheme to provide for tobacco prevention, education, and cessation programs.
Sponsored by 
Rep. Steve Buyer (R-IN)
Rep. Steve Buyer (R-IN)Submitted April 1, 2009
Description
Amendment in the nature of a substitute sought to insert a complete new text with provisions that create a Tobacco Harm Reduction Center under the Department of HHS to regulate all tobacco products and establish a regulatory scheme to provide for tobacco prevention, education and cessation programs.
Legislative Activity
Stay on top of the latest movement without scrolling through every action
Not Used
Latest Action
Amendment failed by House: On agreeing to the Buyer amendment (A002) Failed by recorded vote: 142 - 284 (Roll no. 185).
April 2, 2009 • 11:32 AM
View full timeline
Not Used
Amendment failed by House: On agreeing to the Buyer amendment (A002) Failed by recorded vote: 142 - 284 (Roll no. 185).
April 2, 2009 • 11:32 AM
Floor
Roll call votes on amendments in House
April 2, 2009 • 11:32 AM
Floor
House amendment not agreed to: On agreeing to the Buyer amendment (A002) Failed by recorded vote: 142 - 284 (Roll no. 185).
April 2, 2009 • 11:32 AM
Floor
The previous question was ordered on the bill, as amended, and the Buyer amendment thereto, pursuant to the rule. (consideration: CR H4412-4413)
April 2, 2009 • 11:16 AM
Floor
On agreeing to the Buyer amendment (A002) Failed by recorded vote: 142 - 284 (Roll no. 185).
April 2, 2009 • 11:32 AM
Floor
House amendment offered
April 1, 2009
Not Used
House amendment offered/reported by : Amendment (A002) in the nature of a substitute offered by Mr. Buyer.(consideration: CR H4344-4368; text: CR H4344-4365)
April 1, 2009 • 8:12 PM
Floor
Amendment (A002) in the nature of a substitute offered by Mr. Buyer. (consideration: CR H4344-4368; text: CR H4344-4365)
April 1, 2009 • 8:12 PM
Votes
1 roll call on this amendment
Text
Offered
FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT
Mr. WAXMAN. Mr. Speaker, pursuant to House Resolution 307, I call up
the bill (H.R. 1256) to protect the public health by providing the Food
and Drug Administration with certain authority to regulate tobacco
products, and ask for its immediate consideration.
The Clerk read the title of the bill.
The SPEAKER pro tempore. Pursuant to House Resolution 307, the
amendment printed in part A of House Report 111-72 is adopted, and the
bill, as amended, is considered read.
The text of the bill, as amended, is as follows:
H.R. 1256
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Family
Smoking Prevention and Tobacco Control Act''.
(b) Table of Contents.--The table of contents of this Act
is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.
Sec. 5. Severability.
TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION
Sec. 101. Amendment of Federal Food, Drug, and Cosmetic Act.
Sec. 102. Final rule.
Sec. 103. Conforming and other amendments to general provisions.
Sec. 104. Study on raising the minimum age to purchase tobacco
products.
Sec. 105. Enforcement action plan for advertising and promotion
restrictions.
TITLE II--TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT
DISCLOSURE
Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Authority to revise cigarette warning label statements.
Sec. 203. State regulation of cigarette advertising and promotion.
Sec. 204. Smokeless tobacco labels and advertising warnings.
Sec. 205. Authority to revise smokeless tobacco product warning label
statements.
Sec. 206. Tar, nicotine, and other smoke constituent disclosure to the
public.
TITLE III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS
Sec. 301. Labeling, recordkeeping, records inspection.
Sec. 302. Study and report.
SEC. 2. FINDINGS.
The Congress finds the following:
(1) The use of tobacco products by the Nation's children is
a pediatric disease of considerable proportions that results
in new generations of tobacco-dependent children and adults.
(2) A consensus exists within the scientific and medical
communities that tobacco products are inherently dangerous
and cause cancer, heart disease, and other serious adverse
health effects.
(3) Nicotine is an addictive drug.
(4) Virtually all new users of tobacco products are under
the minimum legal age to purchase such products.
(5) Tobacco advertising and marketing contribute
significantly to the use of nicotine-containing tobacco
products by adolescents.
(6) Because past efforts to restrict advertising and
marketing of tobacco products have failed adequately to curb
tobacco use by adolescents, comprehensive restrictions on the
sale, promotion, and distribution of such products are
needed.
(7) Federal and State governments have lacked the legal and
regulatory authority and resources they need to address
comprehensively the public health and societal problems
caused by the use of tobacco products.
(8) Federal and State public health officials, the public
health community, and the public at large recognize that the
tobacco industry should be subject to ongoing oversight.
(9) Under article I, section 8 of the Constitution, the
Congress is vested with the responsibility for regulating
interstate commerce and commerce with Indian tribes.
(10) The sale, distribution, marketing, advertising, and
use of tobacco products are activities in and substantially
affecting interstate commerce because they are sold,
marketed, advertised, and distributed in interstate commerce
on a nationwide basis, and have a substantial effect on the
Nation's economy.
(11) The sale, distribution, marketing, advertising, and
use of such products substantially affect interstate commerce
through the health care and other costs attributable to the
use of tobacco products.
(12) It is in the public interest for Congress to enact
legislation that provides the Food and Drug Administration
with the authority to regulate tobacco products and the
advertising and promotion of such products. The benefits to
the American people from enacting such legislation would be
significant in human and economic terms.
(13) Tobacco use is the foremost preventable cause of
premature death in America. It causes over 400,000 deaths in
the United States each year, and approximately 8,600,000
Americans have chronic illnesses related to smoking.
(14) Reducing the use of tobacco by minors by 50 percent
would prevent well over 10,000,000 of today's children from
becoming regular, daily smokers, saving over 3,000,000 of
them from premature death due to tobacco-induced disease.
Such a reduction in youth smoking would also result in
approximately $75,000,000,000 in savings attributable to
reduced health care costs.
(15) Advertising, marketing, and promotion of tobacco
products have been especially directed to attract young
persons to use tobacco products, and these efforts have
resulted in increased use of such products by youth. Past
efforts to oversee these activities have not been successful
in adequately preventing such increased use.
(16) In 2005, the cigarette manufacturers spent more than
$13,000,000,000 to attract new users, retain current users,
increase current consumption, and generate favorable long-
term attitudes toward smoking and tobacco use.
(17) Tobacco product advertising often misleadingly
portrays the use of tobacco as socially acceptable and
healthful to minors.
(18) Tobacco product advertising is regularly seen by
persons under the age of 18, and persons under the age of 18
are regularly exposed to tobacco product promotional efforts.
(19) Through advertisements during and sponsorship of
sporting events, tobacco has become strongly associated with
sports and has become portrayed as an integral part of sports
and the healthy lifestyle associated with rigorous sporting
activity.
(20) Children are exposed to substantial and unavoidable
tobacco advertising that leads to favorable beliefs about
tobacco use, plays a role in leading young people to
overestimate the prevalence of tobacco use, and increases the
number of young people who begin to use tobacco.
(21) The use of tobacco products in motion pictures and
other mass media glamorizes its use for young people and
encourages them to use tobacco products.
[[Page H4319]]
(22) Tobacco advertising expands the size of the tobacco
market by increasing consumption of tobacco products
including tobacco use by young people.
(23) Children are more influenced by tobacco marketing than
adults: more than 80 percent of youth smoke three heavily
marketed brands, while only 54 percent of adults, 26 and
older, smoke these same brands.
(24) Tobacco company documents indicate that young people
are an important and often crucial segment of the tobacco
market. Children, who tend to be more price sensitive than
adults, are influenced by advertising and promotion practices
that result in drastically reduced cigarette prices.
(25) Comprehensive advertising restrictions will have a
positive effect on the smoking rates of young people.
(26) Restrictions on advertising are necessary to prevent
unrestricted tobacco advertising from undermining legislation
prohibiting access to young people and providing for
education about tobacco use.
(27) International experience shows that advertising
regulations that are stringent and comprehensive have a
greater impact on overall tobacco use and young people's use
than weaker or less comprehensive ones.
(28) Text only requirements, although not as stringent as a
ban, will help reduce underage use of tobacco products while
preserving the informational function of advertising.
(29) It is in the public interest for Congress to adopt
legislation to address the public health crisis created by
actions of the tobacco industry.
(30) The final regulations promulgated by the Secretary of
Health and Human Services in the August 28, 1996, issue of
the Federal Register (61 Fed. Reg. 44615-44618) for inclusion
as part 897 of title 21, Code of Federal Regulations, are
consistent with the first amendment to the United States
Constitution and with the standards set forth in the
amendments made by this subtitle for the regulation of
tobacco products by the Food and Drug Administration, and the
restriction on the sale and distribution of, including access
to and the advertising and promotion of, tobacco products
contained in such regulations are substantially related to
accomplishing the public health goals of this Act.
(31) The regulations described in paragraph (30) will
directly and materially advance the Federal Government's
substantial interest in reducing the number of children and
adolescents who use cigarettes and smokeless tobacco and in
preventing the life-threatening health consequences
associated with tobacco use. An overwhelming majority of
Americans who use tobacco products begin using such products
while they are minors and become addicted to the nicotine in
those products before reaching the age of 18. Tobacco
advertising and promotion play a crucial role in the decision
of these minors to begin using tobacco products. Less
restrictive and less comprehensive approaches have not and
will not be effective in reducing the problems addressed by
such regulations. The reasonable restrictions on the
advertising and promotion of tobacco products contained in
such regulations will lead to a significant decrease in the
number of minors using and becoming addicted to those
products.
(32) The regulations described in paragraph (30) impose no
more extensive restrictions on communication by tobacco
manufacturers and sellers than are necessary to reduce the
number of children and adolescents who use cigarettes and
smokeless tobacco and to prevent the life-threatening health
consequences associated with tobacco use. Such regulations
are narrowly tailored to restrict those advertising and
promotional practices which are most likely to be seen or
heard by youth and most likely to entice them into tobacco
use, while affording tobacco manufacturers and sellers ample
opportunity to convey information about their products to
adult consumers.
(33) Tobacco dependence is a chronic disease, one that
typically requires repeated interventions to achieve long-
term or permanent abstinence.
(34) Because the only known safe alternative to smoking is
cessation, interventions should target all smokers to help
them quit completely.
(35) Tobacco products have been used to facilitate and
finance criminal activities both domestically and
internationally. Illicit trade of tobacco products has been
linked to organized crime and terrorist groups.
(36) It is essential that the Food and Drug Administration
review products sold or distributed for use to reduce risks
or exposures associated with tobacco products and that it be
empowered to review any advertising and labeling for such
products. It is also essential that manufacturers, prior to
marketing such products, be required to demonstrate that such
products will meet a series of rigorous criteria, and will
benefit the health of the population as a whole, taking into
account both users of tobacco products and persons who do not
currently use tobacco products.
(37) Unless tobacco products that purport to reduce the
risks to the public of tobacco use actually reduce such
risks, those products can cause substantial harm to the
public health to the extent that the individuals, who would
otherwise not consume tobacco products or would consume such
products less, use tobacco products purporting to reduce
risk. Those who use products sold or distributed as modified
risk products that do not in fact reduce risk, rather than
quitting or reducing their use of tobacco products, have a
substantially increased likelihood of suffering disability
and premature death. The costs to society of the widespread
use of products sold or distributed as modified risk products
that do not in fact reduce risk or that increase risk include
thousands of unnecessary deaths and injuries and huge costs
to our health care system.
(38) As the National Cancer Institute has found, many
smokers mistakenly believe that ``low tar'' and ``light''
cigarettes cause fewer health problems than other cigarettes.
As the National Cancer Institute has also found, mistaken
beliefs about the health consequences of smoking ``low tar''
and ``light'' cigarettes can reduce the motivation to quit
smoking entirely and thereby lead to disease and death.
(39) Recent studies have demonstrated that there has been
no reduction in risk on a population-wide basis from ``low
tar'' and ``light'' cigarettes, and such products may
actually increase the risk of tobacco use.
(40) The dangers of products sold or distributed as
modified risk tobacco products that do not in fact reduce
risk are so high that there is a compelling governmental
interest in ensuring that statements about modified risk
tobacco products are complete, accurate, and relate to the
overall disease risk of the product.
(41) As the Federal Trade Commission has found, consumers
have misinterpreted advertisements in which one product is
claimed to be less harmful than a comparable product, even in
the presence of disclosures and advisories intended to
provide clarification.
(42) Permitting manufacturers to make unsubstantiated
statements concerning modified risk tobacco products, whether
express or implied, even if accompanied by disclaimers would
be detrimental to the public health.
(43) The only way to effectively protect the public health
from the dangers of unsubstantiated modified risk tobacco
products is to empower the Food and Drug Administration to
require that products that tobacco manufacturers sold or
distributed for risk reduction be reviewed in advance of
marketing, and to require that the evidence relied on to
support claims be fully verified.
(44) The Food and Drug Administration is a regulatory
agency with the scientific expertise to identify harmful
substances in products to which consumers are exposed, to
design standards to limit exposure to those substances, to
evaluate scientific studies supporting claims about the
safety of products, and to evaluate the impact of labels,
labeling, and advertising on consumer behavior in order to
reduce the risk of harm and promote understanding of the
impact of the product on health. In connection with its
mandate to promote health and reduce the risk of harm, the
Food and Drug Administration routinely makes decisions about
whether and how products may be marketed in the United
States.
(45) The Federal Trade Commission was created to protect
consumers from unfair or deceptive acts or practices, and to
regulate unfair methods of competition. Its focus is on those
marketplace practices that deceive or mislead consumers, and
those that give some competitors an unfair advantage. Its
mission is to regulate activities in the marketplace. Neither
the Federal Trade Commission nor any other Federal agency
except the Food and Drug Administration possesses the
scientific expertise needed to implement effectively all
provisions of the Family Smoking Prevention and Tobacco
Control Act.
(46) If manufacturers state or imply in communications
directed to consumers through the media or through a label,
labeling, or advertising, that a tobacco product is approved
or inspected by the Food and Drug Administration or complies
with Food and Drug Administration standards, consumers are
likely to be confused and misled. Depending upon the
particular language used and its context, such a statement
could result in consumers being misled into believing that
the product is endorsed by the Food and Drug Administration
for use or in consumers being misled about the harmfulness of
the product because of such regulation, inspection, approval,
or compliance.
(47) In August 2006 a United States district court judge
found that the major United States cigarette companies
continue to target and market to youth. USA v. Philip Morris,
USA, Inc., et al. (Civil Action No. 99-2496 (GK), August 17,
2006).
(48) In August 2006 a United States district court judge
found that the major United States cigarette companies
dramatically increased their advertising and promotional
spending in ways that encourage youth to start smoking
subsequent to the signing of the Master Settlement Agreement
in 1998. USA v. Philip Morris, USA, Inc., et al. (Civil
Action No. 99-2496 (GK), August 17, 2006).
(49) In August 2006 a United States district court judge
found that the major United States cigarette companies have
designed their cigarettes to precisely control nicotine
delivery levels and provide doses of nicotine sufficient to
create and sustain addiction while also concealing much of
their nicotine-related research. USA v. Philip Morris, USA,
Inc., et al. (Civil Action No. 99-2496 (GK), August 17,
2006).
SEC. 3. PURPOSE.
The purposes of this Act are--
(1) to provide authority to the Food and Drug
Administration to regulate tobacco products under the Federal
Food, Drug, and
[[Page H4320]]
Cosmetic Act (21 U.S.C. 301 et seq.), by recognizing it as
the primary Federal regulatory authority with respect to the
manufacture, marketing, and distribution of tobacco products
as provided for in this Act;
(2) to ensure that the Food and Drug Administration has the
authority to address issues of particular concern to public
health officials, especially the use of tobacco by young
people and dependence on tobacco;
(3) to authorize the Food and Drug Administration to set
national standards controlling the manufacture of tobacco
products and the identity, public disclosure, and amount of
ingredients used in such products;
(4) to provide new and flexible enforcement authority to
ensure that there is effective oversight of the tobacco
industry's efforts to develop, introduce, and promote less
harmful tobacco products;
(5) to vest the Food and Drug Administration with the
authority to regulate the levels of tar, nicotine, and other
harmful components of tobacco products;
(6) in order to ensure that consumers are better informed,
to require tobacco product manufacturers to disclose research
which has not previously been made available, as well as
research generated in the future, relating to the health and
dependency effects or safety of tobacco products;
(7) to continue to permit the sale of tobacco products to
adults in conjunction with measures to ensure that they are
not sold or accessible to underage purchasers;
(8) to impose appropriate regulatory controls on the
tobacco industry;
(9) to promote cessation to reduce disease risk and the
social costs associated with tobacco-related diseases; and
(10) to strengthen legislation against illicit trade in
tobacco products.
SEC. 4. SCOPE AND EFFECT.
(a) Intended Effect.--Nothing in this Act (or an amendment
made by this Act) shall be construed to--
(1) establish a precedent with regard to any other
industry, situation, circumstance, or legal action; or
(2) affect any action pending in Federal, State, or Tribal
court, or any agreement, consent decree, or contract of any
kind.
(b) Agricultural Activities.--The provisions of this Act
(or an amendment made by this Act) which authorize the
Secretary to take certain actions with regard to tobacco and
tobacco products shall not be construed to affect any
authority of the Secretary of Agriculture under existing law
regarding the growing, cultivation, or curing of raw tobacco.
(c) Revenue Activities.--The provisions of this Act (or an
amendment made by this Act) which authorize the Secretary to
take certain actions with regard to tobacco products shall
not be construed to affect any authority of the Secretary of
the Treasury under chapter 52 of the Internal Revenue Code of
1986.
SEC. 5. SEVERABILITY.
If any provision of this Act, the amendments made by this
Act, or the application of any provision of this Act to any
person or circumstance is held to be invalid, the remainder
of this Act, the amendments made by this Act, and the
application of the provisions of this Act to any other person
or circumstance shall not be affected and shall continue to
be enforced to the fullest extent possible.
TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION
SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) Definition of Tobacco Products.--Section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is
amended by adding at the end the following:
``(rr)(1) The term `tobacco product' means any product made
or derived from tobacco that is intended for human
consumption, including any component, part, or accessory of a
tobacco product (except for raw materials other than tobacco
used in manufacturing a component, part, or accessory of a
tobacco product).
``(2) The term `tobacco product' does not mean an article
that is a drug under subsection (g)(1), a device under
subsection (h), or a combination product described in section
503(g).
``(3) The products described in paragraph (2) shall be
subject to chapter V of this Act.
``(4) A tobacco product shall not be marketed in
combination with any other article or product regulated under
this Act (including a drug, biologic, food, cosmetic, medical
device, or a dietary supplement).''.
(b) FDA Authority Over Tobacco Products.--The Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
(1) by redesignating chapter IX as chapter X;
(2) by redesignating sections 901 through 910 as sections
1001 through 1010; and
(3) by inserting after chapter VIII the following:
``CHAPTER IX--TOBACCO PRODUCTS
``SEC. 900. DEFINITIONS.
``In this chapter:
``(1) Additive.--The term `additive' means any substance
the intended use of which results or may reasonably be
expected to result, directly or indirectly, in its becoming a
component or otherwise affecting the characteristic of any
tobacco product (including any substances intended for use as
a flavoring or coloring or in producing, manufacturing,
packing, processing, preparing, treating, packaging,
transporting, or holding), except that such term does not
include tobacco or a pesticide chemical residue in or on raw
tobacco or a pesticide chemical.
``(2) Brand.--The term `brand' means a variety of tobacco
product distinguished by the tobacco used, tar content,
nicotine content, flavoring used, size, filtration,
packaging, logo, registered trademark, brand name,
identifiable pattern of colors, or any combination of such
attributes.
``(3) Cigarette.--The term `cigarette'--
``(A) means a product that--
``(i) is a tobacco product; and
``(ii) meets the definition of the term `cigarette' in
section 3(1) of the Federal Cigarette Labeling and
Advertising Act; and
``(B) includes tobacco, in any form, that is functional in
the product, which, because of its appearance, the type of
tobacco used in the filler, or its packaging and labeling, is
likely to be offered to, or purchased by, consumers as a
cigarette or as roll-your-own tobacco.
``(4) Cigarette tobacco.--The term `cigarette tobacco'
means any product that consists of loose tobacco that is
intended for use by consumers in a cigarette. Unless
otherwise stated, the requirements applicable to cigarettes
under this chapter shall also apply to cigarette tobacco.
``(5) Commerce.--The term `commerce' has the meaning given
that term by section 3(2) of the Federal Cigarette Labeling
and Advertising Act.
``(6) Counterfeit tobacco product.--The term `counterfeit
tobacco product' means a tobacco product (or the container or
labeling of such a product) that, without authorization,
bears the trademark, trade name, or other identifying mark,
imprint, or device, or any likeness thereof, of a tobacco
product listed in a registration under section 905(i)(1).
``(7) Distributor.--The term `distributor' as regards a
tobacco product means any person who furthers the
distribution of a tobacco product, whether domestic or
imported, at any point from the original place of manufacture
to the person who sells or distributes the product to
individuals for personal consumption. Common carriers are not
considered distributors for purposes of this chapter.
``(8) Illicit trade.--The term `illicit trade' means any
practice or conduct prohibited by law which relates to
production, shipment, receipt, possession, distribution,
sale, or purchase of tobacco products including any practice
or conduct intended to facilitate such activity.
``(9) Indian country.--The term `Indian country' has the
meaning given such term in section 1151 of title 18, United
States Code.
``(10) Indian tribe.--The term `Indian tribe' has the
meaning given such term in section 4(e) of the Indian Self-
Determination and Education Assistance Act.
``(11) Little cigar.--The term `little cigar' means a
product that--
``(A) is a tobacco product; and
``(B) meets the definition of the term `little cigar' in
section 3(7) of the Federal Cigarette Labeling and
Advertising Act.
``(12) Nicotine.--The term `nicotine' means the chemical
substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or
C[10]H[14]N[2], including any salt or complex of nicotine.
``(13) Package.--The term `package' means a pack, box,
carton, or container of any kind or, if no other container,
any wrapping (including cellophane), in which a tobacco
product is offered for sale, sold, or otherwise distributed
to consumers.
``(14) Retailer.--The term `retailer' means any person,
government, or entity who sells tobacco products to
individuals for personal consumption, or who operates a
facility where self-service displays of tobacco products are
permitted.
``(15) Roll-your-own tobacco.--The term `roll-your-own
tobacco' means any tobacco product which, because of its
appearance, type, packaging, or labeling, is suitable for use
and likely to be offered to, or purchased by, consumers as
tobacco for making cigarettes.
``(16) Small tobacco product manufacturer.--The term `small
tobacco product manufacturer' means a tobacco product
manufacturer that employs fewer than 350 employees. For
purposes of determining the number of employees of a
manufacturer under the preceding sentence, the employees of a
manufacturer are deemed to include the employees of each
entity that controls, is controlled by, or is under common
control with such manufacturer.
``(17) Smoke constituent.--The term `smoke constituent'
means any chemical or chemical compound in mainstream or
sidestream tobacco smoke that either transfers from any
component of the cigarette to the smoke or that is formed by
the combustion or heating of tobacco, additives, or other
component of the tobacco product.
``(18) Smokeless tobacco.--The term `smokeless tobacco'
means any tobacco product that consists of cut, ground,
powdered, or leaf tobacco and that is intended to be placed
in the oral or nasal cavity.
``(19) State; territory.--The terms `State' and `Territory'
shall have the meanings given to such terms in section 201.
``(20) Tobacco product manufacturer.--The term `tobacco
product manufacturer' means any person, including any
repacker or relabeler, who--
``(A) manufactures, fabricates, assembles, processes, or
labels a tobacco product; or
``(B) imports a finished tobacco product for sale or
distribution in the United States.
``(21) Tobacco warehouse.--
[[Page H4321]]
``(A) Subject to subparagraphs (B) and (C), the term
`tobacco warehouse' includes any person--
``(i) who--
``(I) removes foreign material from tobacco leaf through
nothing other than a mechanical process;
``(II) humidifies tobacco leaf with nothing other than
potable water in the form of steam or mist; or
``(III) de-stems, dries, and packs tobacco leaf for storage
and shipment;
``(ii) who performs no other actions with respect to
tobacco leaf; and
``(iii) who provides to any manufacturer to whom the person
sells tobacco all information related to the person's actions
described in clause (i) that is necessary for compliance with
this Act.
``(B) The term `tobacco warehouse' excludes any person
who--
``(i) reconstitutes tobacco leaf;
``(ii) is a manufacturer, distributor, or retailer of a
tobacco product; or
``(iii) applies any chemical, additive, or substance to the
tobacco leaf other than potable water in the form of steam or
mist.
``(C) The definition of the term `tobacco warehouse' in
subparagraph (A) shall not apply to the extent to which the
Secretary determines, through rulemaking, that regulation
under this chapter of the actions described in such
subparagraph is appropriate for the protection of the public
health.
``(22) United states.--The term `United States' means the
50 States of the United States of America and the District of
Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin
Islands, American Samoa, Wake Island, Midway Islands, Kingman
Reef, Johnston Atoll, the Northern Mariana Islands, and any
other trust territory or possession of the United States.
``SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.
``(a) In General.--Tobacco products, including modified
risk tobacco products for which an order has been issued in
accordance with section 911, shall be regulated by the
Secretary under this chapter and shall not be subject to the
provisions of chapter V.
``(b) Applicability.--This chapter shall apply to all
cigarettes, cigarette tobacco, roll-your-own tobacco, and
smokeless tobacco and to any other tobacco products that the
Secretary by regulation deems to be subject to this chapter.
``(c) Scope.--
``(1) In general.--Nothing in this chapter, or any policy
issued or regulation promulgated thereunder, or in sections
101(a), 102, or 103 of title I, title II, or title III of the
Family Smoking Prevention and Tobacco Control Act, shall be
construed to affect, expand, or limit the Secretary's
authority over (including the authority to determine whether
products may be regulated), or the regulation of, products
under this Act that are not tobacco products under chapter V
or any other chapter.
``(2) Limitation of authority.--
``(A) In general.--The provisions of this chapter shall not
apply to tobacco leaf that is not in the possession of a
manufacturer of tobacco products, or to the producers of
tobacco leaf, including tobacco growers, tobacco warehouses,
and tobacco grower cooperatives, nor shall any employee of
the Food and Drug Administration have any authority to enter
onto a farm owned by a producer of tobacco leaf without the
written consent of such producer.
``(B) Exception.--Notwithstanding subparagraph (A), if a
producer of tobacco leaf is also a tobacco product
manufacturer or controlled by a tobacco product manufacturer,
the producer shall be subject to this chapter in the
producer's capacity as a manufacturer. The exception in this
subparagraph shall not apply to a producer of tobacco leaf
who grows tobacco under a contract with a tobacco product
manufacturer and who is not otherwise engaged in the
manufacturing process.
``(C) Rule of construction.--Nothing in this chapter shall
be construed to grant the Secretary authority to promulgate
regulations on any matter that involves the production of
tobacco leaf or a producer thereof, other than activities by
a manufacturer affecting production.
``(d) Rulemaking Procedures.--Each rulemaking under this
chapter shall be in accordance with chapter 5 of title 5,
United States Code. This subsection shall not be construed to
affect the rulemaking provisions of section 102(a) of the
Family Smoking Prevention and Tobacco Control Act.
``(e) Center for Tobacco Products.--Not later than 90 days
after the date of enactment of the Family Smoking Prevention
and Tobacco Control Act, the Secretary shall establish within
the Food and Drug Administration the Center for Tobacco
Products, which shall report to the Commissioner of Food and
Drugs in the same manner as the other agency centers within
the Food and Drug Administration. The Center shall be
responsible for the implementation of this chapter and
related matters assigned by the Commissioner.
``(f) Office To Assist Small Tobacco Product
Manufacturers.--The Secretary shall establish within the Food
and Drug Administration an identifiable office to provide
technical and other nonfinancial assistance to small tobacco
product manufacturers to assist them in complying with the
requirements of this Act.
``(g) Consultation Prior to Rulemaking.--Prior to
promulgating rules under this chapter, the Secretary shall
endeavor to consult with other Federal agencies as
appropriate.
``SEC. 902. ADULTERATED TOBACCO PRODUCTS.
``A tobacco product shall be deemed to be adulterated if--
``(1) it consists in whole or in part of any filthy,
putrid, or decomposed substance, or is otherwise contaminated
by any added poisonous or added deleterious substance that
may render the product injurious to health;
``(2) it has been prepared, packed, or held under
insanitary conditions whereby it may have been contaminated
with filth, or whereby it may have been rendered injurious to
health;
``(3) its package is composed, in whole or in part, of any
poisonous or deleterious substance which may render the
contents injurious to health;
``(4) the manufacturer or importer of the tobacco product
fails to pay a user fee assessed to such manufacturer or
importer pursuant to section 919 by the date specified in
section 919 or by the 30th day after final agency action on a
resolution of any dispute as to the amount of such fee;
``(5) it is, or purports to be or is represented as, a
tobacco product which is subject to a tobacco product
standard established under section 907 unless such tobacco
product is in all respects in conformity with such standard;
``(6)(A) it is required by section 910(a) to have premarket
review and does not have an order in effect under section
910(c)(1)(A)(i); or
``(B) it is in violation of an order under section
910(c)(1)(A);
``(7) the methods used in, or the facilities or controls
used for, its manufacture, packing, or storage are not in
conformity with applicable requirements under section
906(e)(1) or an applicable condition prescribed by an order
under section 906(e)(2); or
``(8) it is in violation of section 911.
``SEC. 903. MISBRANDED TOBACCO PRODUCTS.
``(a) In General.--A tobacco product shall be deemed to be
misbranded--
``(1) if its labeling is false or misleading in any
particular;
``(2) if in package form unless it bears a label
containing--
``(A) the name and place of business of the tobacco product
manufacturer, packer, or distributor;
``(B) an accurate statement of the quantity of the contents
in terms of weight, measure, or numerical count;
``(C) an accurate statement of the percentage of the
tobacco used in the product that is domestically grown
tobacco and the percentage that is foreign grown tobacco; and
``(D) the statement required under section 920(a),
except that under subparagraph (B) reasonable variations
shall be permitted, and exemptions as to small packages shall
be established, by regulations prescribed by the Secretary;
``(3) if any word, statement, or other information required
by or under authority of this chapter to appear on the label
or labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements, or
designs in the labeling) and in such terms as to render it
likely to be read and understood by the ordinary individual
under customary conditions of purchase and use;
``(4) if it has an established name, unless its label
bears, to the exclusion of any other nonproprietary name, its
established name prominently printed in type as required by
the Secretary by regulation;
``(5) if the Secretary has issued regulations requiring
that its labeling bear adequate directions for use, or
adequate warnings against use by children, that are necessary
for the protection of users unless its labeling conforms in
all respects to such regulations;
``(6) if it was manufactured, prepared, propagated,
compounded, or processed in an establishment not duly
registered under section 905(b), 905(c), 905(d), or 905(h),
if it was not included in a list required by section 905(i),
if a notice or other information respecting it was not
provided as required by such section or section 905(j), or if
it does not bear such symbols from the uniform system for
identification of tobacco products prescribed under section
905(e) as the Secretary by regulation requires;
``(7) if, in the case of any tobacco product distributed or
offered for sale in any State--
``(A) its advertising is false or misleading in any
particular; or
``(B) it is sold or distributed in violation of regulations
prescribed under section 906(d);
``(8) unless, in the case of any tobacco product
distributed or offered for sale in any State, the
manufacturer, packer, or distributor thereof includes in all
advertisements and other descriptive printed matter issued or
caused to be issued by the manufacturer, packer, or
distributor with respect to that tobacco product--
``(A) a true statement of the tobacco product's established
name as described in paragraph (4), printed prominently; and
``(B) a brief statement of--
``(i) the uses of the tobacco product and relevant
warnings, precautions, side effects, and contraindications;
and
``(ii) in the case of specific tobacco products made
subject to a finding by the Secretary after notice and
opportunity for comment that such action is appropriate to
protect the public health, a full description of the
components of such tobacco product or the formula showing
quantitatively each ingredient of such tobacco product to the
extent required in regulations which shall be
[[Page H4322]]
issued by the Secretary after an opportunity for a hearing;
``(9) if it is a tobacco product subject to a tobacco
product standard established under section 907, unless it
bears such labeling as may be prescribed in such tobacco
product standard; or
``(10) if there was a failure or refusal--
``(A) to comply with any requirement prescribed under
section 904 or 908; or
``(B) to furnish any material or information required under
section 909.
``(b) Prior Approval of Label Statements.--The Secretary
may, by regulation, require prior approval of statements made
on the label of a tobacco product. No regulation issued under
this subsection may require prior approval by the Secretary
of the content of any advertisement, except for modified risk
tobacco products as provided in section 911. No advertisement
of a tobacco product published after the date of enactment of
the Family Smoking Prevention and Tobacco Control Act shall,
with respect to the language of label statements as
prescribed under section 4 of the Federal Cigarette Labeling
and Advertising Act and section 3 of the Comprehensive
Smokeless Tobacco Health Education Act of 1986 or the
regulations issued under such sections, be subject to the
provisions of sections 12 through 15 of the Federal Trade
Commission Act.
``SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE
SECRETARY.
``(a) Requirement.--Each tobacco product manufacturer or
importer, or agents thereof, shall submit to the Secretary
the following information:
``(1) Not later than 6 months after the date of enactment
of the Family Smoking Prevention and Tobacco Control Act, a
listing of all ingredients, including tobacco, substances,
compounds, and additives that are, as of such date, added by
the manufacturer to the tobacco, paper, filter, or other part
of each tobacco product by brand and by quantity in each
brand and subbrand.
``(2) A description of the content, delivery, and form of
nicotine in each tobacco product measured in milligrams of
nicotine in accordance with regulations promulgated by the
Secretary in accordance with section 4(e) of the Federal
Cigarette Labeling and Advertising Act.
``(3) Beginning 3 years after the date of enactment of the
Family Smoking Prevention and Tobacco Control Act, a listing
of all constituents, including smoke constituents as
applicable, identified by the Secretary as harmful or
potentially harmful to health in each tobacco product, and as
applicable in the smoke of each tobacco product, by brand and
by quantity in each brand and subbrand. Effective beginning 3
years after such date of enactment, the manufacturer,
importer, or agent shall comply with regulations promulgated
under section 915 in reporting information under this
paragraph, where applicable.
``(4) Beginning 6 months after the date of enactment of the
Family Smoking Prevention and Tobacco Control Act, all
documents developed after such date of enactment that relate
to health, toxicological, behavioral, or physiologic effects
of current or future tobacco products, their constituents
(including smoke constituents), ingredients, components, and
additives.
``(b) Data Submission.--At the request of the Secretary,
each tobacco product manufacturer or importer of tobacco
products, or agents thereof, shall submit the following:
``(1) Any or all documents (including underlying scientific
information) relating to research activities, and research
findings, conducted, supported, or possessed by the
manufacturer (or agents thereof) on the health,
toxicological, behavioral, or physiologic effects of tobacco
products and their constituents (including smoke
constituents), ingredients, components, and additives.
``(2) Any or all documents (including underlying scientific
information) relating to research activities, and research
findings, conducted, supported, or possessed by the
manufacturer (or agents thereof) that relate to the issue of
whether a reduction in risk to health from tobacco products
can occur upon the employment of technology available or
known to the manufacturer.
``(3) Any or all documents (including underlying scientific
or financial information) relating to marketing research
involving the use of tobacco products or marketing practices
and the effectiveness of such practices used by tobacco
manufacturers and distributors.
An importer of a tobacco product not manufactured in the
United States shall supply the information required of a
tobacco product manufacturer under this subsection.
``(c) Time for Submission.--
``(1) In general.--At least 90 days prior to the delivery
for introduction into interstate commerce of a tobacco
product not on the market on the date of enactment of the
Family Smoking Prevention and Tobacco Control Act, the
manufacturer of such product shall provide the information
required under subsection (a).
``(2) Disclosure of additive.--If at any time a tobacco
product manufacturer adds to its tobacco products a new
tobacco additive or increases the quantity of an existing
tobacco additive, the manufacturer shall, except as provided
in paragraph (3), at least 90 days prior to such action so
advise the Secretary in writing.
``(3) Disclosure of other actions.--If at any time a
tobacco product manufacturer eliminates or decreases an
existing additive, or adds or increases an additive that has
by regulation been designated by the Secretary as an additive
that is not a human or animal carcinogen, or otherwise
harmful to health under intended conditions of use, the
manufacturer shall within 60 days of such action so advise
the Secretary in writing.
``(d) Data List.--
``(1) In general.--Not later than 3 years after the date of
enactment of the Family Smoking Prevention and Tobacco
Control Act, and annually thereafter, the Secretary shall
publish in a format that is understandable and not misleading
to a lay person, and place on public display (in a manner
determined by the Secretary) the list established under
subsection (e).
``(2) Consumer research.--The Secretary shall conduct
periodic consumer research to ensure that the list published
under paragraph (1) is not misleading to lay persons. Not
later than 5 years after the date of enactment of the Family
Smoking Prevention and Tobacco Control Act, the Secretary
shall submit to the appropriate committees of Congress a
report on the results of such research, together with
recommendations on whether such publication should be
continued or modified.
``(e) Data Collection.--Not later than 24 months after the
date of enactment of the Family Smoking Prevention and
Tobacco Control Act, the Secretary shall establish, and
periodically revise as appropriate, a list of harmful and
potentially harmful constituents, including smoke
constituents, to health in each tobacco product by brand and
by quantity in each brand and subbrand. The Secretary shall
publish a public notice requesting the submission by
interested persons of scientific and other information
concerning the harmful and potentially harmful constituents
in tobacco products and tobacco smoke.
``SEC. 905. ANNUAL REGISTRATION.
``(a) Definitions.--In this section:
``(1) Manufacture, preparation, compounding, or
processing.--The term `manufacture, preparation, compounding,
or processing' shall include repackaging or otherwise
changing the container, wrapper, or labeling of any tobacco
product package in furtherance of the distribution of the
tobacco product from the original place of manufacture to the
person who makes final delivery or sale to the ultimate
consumer or user.
``(2) Name.--The term `name' shall include in the case of a
partnership the name of each partner and, in the case of a
corporation, the name of each corporate officer and director,
and the State of incorporation.
``(b) Registration by Owners and Operators.--On or before
December 31 of each year, every person who owns or operates
any establishment in any State engaged in the manufacture,
preparation, compounding, or processing of a tobacco product
or tobacco products shall register with the Secretary the
name, places of business, and all such establishments of that
person. If enactment of the Family Smoking Prevention and
Tobacco Control Act occurs in the second half of the calendar
year, the Secretary shall designate a date no later than 6
months into the subsequent calendar year by which
registration pursuant to this subsection shall occur.
``(c) Registration by New Owners and Operators.--Every
person upon first engaging in the manufacture, preparation,
compounding, or processing of a tobacco product or tobacco
products in any establishment owned or operated in any State
by that person shall immediately register with the Secretary
that person's name, place of business, and such
establishment.
``(d) Registration of Added Establishments.--Every person
required to register under subsection (b) or (c) shall
immediately register with the Secretary any additional
establishment which that person owns or operates in any State
and in which that person begins the manufacture, preparation,
compounding, or processing of a tobacco product or tobacco
products.
``(e) Uniform Product Identification System.--The Secretary
may by regulation prescribe a uniform system for the
identification of tobacco products and may require that
persons who are required to list such tobacco products under
subsection (i) shall list such tobacco products in accordance
with such system.
``(f) Public Access to Registration Information.--The
Secretary shall make available for inspection, to any person
so requesting, any registration filed under this section.
``(g) Biennial Inspection of Registered Establishments.--
Every establishment registered with the Secretary under this
section shall be subject to inspection under section 704 or
subsection (h), and every such establishment engaged in the
manufacture, compounding, or processing of a tobacco product
or tobacco products shall be so inspected by 1 or more
officers or employees duly designated by the Secretary at
least once in the 2-year period beginning with the date of
registration of such establishment under this section and at
least once in every successive 2-year period thereafter.
``(h) Registration by Foreign Establishments.--Any
establishment within any foreign country engaged in the
manufacture, preparation, compounding, or processing of a
tobacco product or tobacco products, shall register under
this section under regulations promulgated by the Secretary.
Such regulations shall require such establishment to provide
the information required by subsection (i) and shall include
provisions for registration of any such establishment upon
condition that adequate and effective means
[[Page H4323]]
are available, by arrangement with the government of such
foreign country or otherwise, to enable the Secretary to
determine from time to time whether tobacco products
manufactured, prepared, compounded, or processed in such
establishment, if imported or offered for import into the
United States, shall be refused admission on any of the
grounds set forth in section 801(a).
``(i) Registration Information.--
``(1) Product list.--Every person who registers with the
Secretary under subsection (b), (c), (d), or (h) shall, at
the time of registration under any such subsection, file with
the Secretary a list of all tobacco products which are being
manufactured, prepared, compounded, or processed by that
person for commercial distribution and which have not been
included in any list of tobacco products filed by that person
with the Secretary under this paragraph or paragraph (2)
before such time of registration. Such list shall be prepared
in such form and manner as the Secretary may prescribe and
shall be accompanied by--
``(A) in the case of a tobacco product contained in the
applicable list with respect to which a tobacco product
standard has been established under section 907 or which is
subject to section 910, a reference to the authority for the
marketing of such tobacco product and a copy of all labeling
for such tobacco product;
``(B) in the case of any other tobacco product contained in
an applicable list, a copy of all consumer information and
other labeling for such tobacco product, a representative
sampling of advertisements for such tobacco product, and,
upon request made by the Secretary for good cause, a copy of
all advertisements for a particular tobacco product; and
``(C) if the registrant filing a list has determined that a
tobacco product contained in such list is not subject to a
tobacco product standard established under section 907, a
brief statement of the basis upon which the registrant made
such determination if the Secretary requests such a statement
with respect to that particular tobacco product.
``(2) Consultation with respect to forms.--The Secretary
shall consult with the Secretary of the Treasury in
developing the forms to be used for registration under this
section to minimize the burden on those persons required to
register with both the Secretary and the Tax and Trade Bureau
of the Department of the Treasury.
``(3) Biannual report of any change in product list.--Each
person who registers with the Secretary under this section
shall report to the Secretary once during the month of June
of each year and once during the month of December of each
year the following:
``(A) A list of each tobacco product introduced by the
registrant for commercial distribution which has not been
included in any list previously filed by that person with the
Secretary under this subparagraph or paragraph (1). A list
under this subparagraph shall list a tobacco product by its
established name and shall be accompanied by the other
information required by paragraph (1).
``(B) If since the date the registrant last made a report
under this paragraph that person has discontinued the
manufacture, preparation, compounding, or processing for
commercial distribution of a tobacco product included in a
list filed under subparagraph (A) or paragraph (1), notice of
such discontinuance, the date of such discontinuance, and the
identity of its established name.
``(C) If since the date the registrant reported under
subparagraph (B) a notice of discontinuance that person has
resumed the manufacture, preparation, compounding, or
processing for commercial distribution of the tobacco product
with respect to which such notice of discontinuance was
reported, notice of such resumption, the date of such
resumption, the identity of such tobacco product by
established name, and other information required by paragraph
(1), unless the registrant has previously reported such
resumption to the Secretary under this subparagraph.
``(D) Any material change in any information previously
submitted under this paragraph or paragraph (1).
``(j) Report Preceding Introduction of Certain
Substantially Equivalent Products Into Interstate Commerce.--
``(1) In general.--Each person who is required to register
under this section and who proposes to begin the introduction
or delivery for introduction into interstate commerce for
commercial distribution of a tobacco product intended for
human use that was not commercially marketed (other than for
test marketing) in the United States as of February 15, 2007,
shall, at least 90 days prior to making such introduction or
delivery, report to the Secretary (in such form and manner as
the Secretary shall prescribe)--
``(A) the basis for such person's determination that--
``(i) the tobacco product is substantially equivalent,
within the meaning of section 910, to a tobacco product
commercially marketed (other than for test marketing) in the
United States as of February 15, 2007, or to a tobacco
product that the Secretary has previously determined,
pursuant to subsection (a)(3) of section 910, is
substantially equivalent and that is in compliance with the
requirements of this Act; or
``(ii) the tobacco product is modified within the meaning
of paragraph (3), the modifications are to a product that is
commercially marketed and in compliance with the requirements
of this Act, and all of the modifications are covered by
exemptions granted by the Secretary pursuant to paragraph
(3); and
``(B) action taken by such person to comply with the
requirements under section 907 that are applicable to the
tobacco product.
``(2) Application to certain post-february 15, 2007,
products.--A report under this subsection for a tobacco
product that was first introduced or delivered for
introduction into interstate commerce for commercial
distribution in the United States after February 15, 2007,
and prior to the date that is 21 months after the date of
enactment of the Family Smoking Prevention and Tobacco
Control Act shall be submitted to the Secretary not later
than 21 months after such date of enactment.
``(3) Exemptions.--
``(A) In general.--The Secretary may exempt from the
requirements of this subsection relating to the demonstration
that a tobacco product is substantially equivalent within the
meaning of section 910, tobacco products that are modified by
adding or deleting a tobacco additive, or increasing or
decreasing the quantity of an existing tobacco additive, if
the Secretary determines that--
``(i) such modification would be a minor modification of a
tobacco product that can be sold under this Act;
``(ii) a report under this subsection is not necessary to
ensure that permitting the tobacco product to be marketed
would be appropriate for protection of the public health; and
``(iii) an exemption is otherwise appropriate.
``(B) Regulations.--Not later than 15 months after the date
of enactment of the Family Smoking Prevention and Tobacco
Control Act, the Secretary shall issue regulations to
implement this paragraph.
``SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO
PRODUCTS.
``(a) In General.--Any requirement established by or under
section 902, 903, 905, or 909 applicable to a tobacco product
shall apply to such tobacco product until the applicability
of the requirement to the tobacco product has been changed by
action taken under section 907, section 910, section 911, or
subsection (d) of this section, and any requirement
established by or under section 902, 903, 905, or 909 which
is inconsistent with a requirement imposed on such tobacco
product under section 907, section 910, section 911, or
subsection (d) of this section shall not apply to such
tobacco product.
``(b) Information on Public Access and Comment.--Each
notice of proposed rulemaking or other notification under
section 907, 908, 909, 910, or 911 or under this section, any
other notice which is published in the Federal Register with
respect to any other action taken under any such section and
which states the reasons for such action, and each
publication of findings required to be made in connection
with rulemaking under any such section shall set forth--
``(1) the manner in which interested persons may examine
data and other information on which the notice or findings is
based; and
``(2) the period within which interested persons may
present their comments on the notice or findings (including
the need therefore) orally or in writing, which period shall
be at least 60 days but may not exceed 90 days unless the
time is extended by the Secretary by a notice published in
the Federal Register stating good cause therefore.
``(c) Limited Confidentiality of Information.--Any
information reported to or otherwise obtained by the
Secretary or the Secretary's representative under section
903, 904, 907, 908, 909, 910, 911, or 704, or under
subsection (e) or (f) of this section, which is exempt from
disclosure under subsection (a) of section 552 of title 5,
United States Code, by reason of subsection (b)(4) of that
section shall be considered confidential and shall not be
disclosed, except that the information may be disclosed to
other officers or employees concerned with carrying out this
chapter, or when relevant in any proceeding under this
chapter.
``(d) Restrictions.--
``(1) In general.--The Secretary may by regulation require
restrictions on the sale and distribution of a tobacco
product, including restrictions on the access to, and the
advertising and promotion of, the tobacco product, if the
Secretary determines that such regulation would be
appropriate for the protection of the public health. The
Secretary may by regulation impose restrictions on the
advertising and promotion of a tobacco product consistent
with and to full extent permitted by the first amendment to
the Constitution. The finding as to whether such regulation
would be appropriate for the protection of the public health
shall be determined with respect to the risks and benefits to
the population as a whole, including users and nonusers of
the tobacco product, and taking into account--
``(A) the increased or decreased likelihood that existing
users of tobacco products will stop using such products; and
``(B) the increased or decreased likelihood that those who
do not use tobacco products will start using such products.
No such regulation may require that the sale or distribution
of a tobacco product be limited to the written or oral
authorization of a practitioner licensed by law to prescribe
medical products.
``(2) Label statements.--The label of a tobacco product
shall bear such appropriate statements of the restrictions
required by a
[[Page H4324]]
regulation under subsection (a) as the Secretary may in such
regulation prescribe.
``(3) Limitations.--
``(A) In general.--No restrictions under paragraph (1)
may--
``(i) prohibit the sale of any tobacco product in face-to-
face transactions by a specific category of retail outlets;
or
``(ii) establish a minimum age of sale of tobacco products
to any person older than 18 years of age.
``(B) Matchbooks.--For purposes of any regulations issued
by the Secretary, matchbooks of conventional size containing
not more than 20 paper matches, and which are customarily
given away for free with the purchase of tobacco products,
shall be considered as adult-written publications which shall
be permitted to contain advertising. Notwithstanding the
preceding sentence, if the Secretary finds that such
treatment of matchbooks is not appropriate for the protection
of the public health, the Secretary may determine by
regulation that matchbooks shall not be considered adult-
written publications.
``(4) Remote sales.--
``(A) In general.--The Secretary shall--
``(i) within 18 months after the date of enactment of the
Family Smoking Prevention and Tobacco Control Act, promulgate
regulations regarding the sale and distribution of tobacco
products that occur through means other than a direct, face-
to-face exchange between a retailer and a consumer in order
to prevent the sale and distribution of tobacco products to
individuals who have not attained the minimum age established
by applicable law for the purchase of such products,
including requirements for age verification; and
``(ii) within 2 years after such date of enactment, issue
regulations to address the promotion and marketing of tobacco
products that are sold or distributed through means other
than a direct, face-to-face exchange between a retailer and a
consumer in order to protect individuals who have not
attained the minimum age established by applicable law for
the purchase of such products.
``(B) Relation to other authority.--Nothing in this
paragraph limits the authority of the Secretary to take
additional actions under the other paragraphs of this
subsection.
``(e) Good Manufacturing Practice Requirements.--
``(1) Methods, facilities, and controls to conform.--
``(A) In general.--In applying manufacturing restrictions
to tobacco, the Secretary shall, in accordance with
subparagraph (B), prescribe regulations (which may differ
based on the type of tobacco product involved) requiring that
the methods used in, and the facilities and controls used
for, the manufacture, preproduction design validation
(including a process to assess the performance of a tobacco
product), packing, and storage of a tobacco product conform
to current good manufacturing practice, or hazard analysis
and critical control point methodology, as prescribed in such
regulations to assure that the public health is protected and
that the tobacco product is in compliance with this chapter.
Such regulations may provide for the testing of raw tobacco
for pesticide chemical residues regardless of whether a
tolerance for such chemical residues has been established.
``(B) Requirements.--The Secretary shall--
``(i) before promulgating any regulation under subparagraph
(A), afford the Tobacco Products Scientific Advisory
Committee an opportunity to submit recommendations with
respect to the regulation proposed to be promulgated;
``(ii) before promulgating any regulation under
subparagraph (A), afford opportunity for an oral hearing;
``(iii) provide the Tobacco Products Scientific Advisory
Committee a reasonable time to make its recommendation with
respect to proposed regulations under subparagraph (A);
``(iv) in establishing the effective date of a regulation
promulgated under this subsection, take into account the
differences in the manner in which the different types of
tobacco products have historically been produced, the
financial resources of the different tobacco product
manufacturers, and the state of their existing manufacturing
facilities, and shall provide for a reasonable period of time
for such manufacturers to conform to good manufacturing
practices; and
``(v) not require any small tobacco product manufacturer to
comply with a regulation under subparagraph (A) for at least
4 years following the effective date established by the
Secretary for such regulation.
``(2) Exemptions; variances.--
``(A) Petition.--Any person subject to any requirement
prescribed under paragraph (1) may petition the Secretary for
a permanent or temporary exemption or variance from such
requirement. Such a petition shall be submitted to the
Secretary in such form and manner as the Secretary shall
prescribe and shall--
``(i) in the case of a petition for an exemption from a
requirement, set forth the basis for the petitioner's
determination that compliance with the requirement is not
required to assure that the tobacco product will be in
compliance with this chapter;
``(ii) in the case of a petition for a variance from a
requirement, set forth the methods proposed to be used in,
and the facilities and controls proposed to be used for, the
manufacture, packing, and storage of the tobacco product in
lieu of the methods, facilities, and controls prescribed by
the requirement; and
``(iii) contain such other information as the Secretary
shall prescribe.
``(B) Referral to the tobacco products scientific advisory
committee.--The Secretary may refer to the Tobacco Products
Scientific Advisory Committee any petition submitted under
subparagraph (A). The Tobacco Products Scientific Advisory
Committee shall report its recommendations to the Secretary
with respect to a petition referred to it within 60 days
after the date of the petition's referral. Within 60 days
after--
``(i) the date the petition was submitted to the Secretary
under subparagraph (A); or
``(ii) the day after the petition was referred to the
Tobacco Products Scientific Advisory Committee,
whichever occurs later, the Secretary shall by order either
deny the petition or approve it.
``(C) Approval.--The Secretary may approve--
``(i) a petition for an exemption for a tobacco product
from a requirement if the Secretary determines that
compliance with such requirement is not required to assure
that the tobacco product will be in compliance with this
chapter; and
``(ii) a petition for a variance for a tobacco product from
a requirement if the Secretary determines that the methods to
be used in, and the facilities and controls to be used for,
the manufacture, packing, and storage of the tobacco product
in lieu of the methods, facilities, and controls prescribed
by the requirement are sufficient to assure that the tobacco
product will be in compliance with this chapter.
``(D) Conditions.--An order of the Secretary approving a
petition for a variance shall prescribe such conditions
respecting the methods used in, and the facilities and
controls used for, the manufacture, packing, and storage of
the tobacco product to be granted the variance under the
petition as may be necessary to assure that the tobacco
product will be in compliance with this chapter.
``(E) Hearing.--After the issuance of an order under
subparagraph (B) respecting a petition, the petitioner shall
have an opportunity for an informal hearing on such order.
``(3) Compliance.--Compliance with requirements under this
subsection shall not be required before the end of the 3-year
period following the date of enactment of the Family Smoking
Prevention and Tobacco Control Act.
``(f) Research and Development.--The Secretary may enter
into contracts for research, testing, and demonstrations
respecting tobacco products and may obtain tobacco products
for research, testing, and demonstration purposes.
``SEC. 907. TOBACCO PRODUCT STANDARDS.
``(a) In General.--
``(1) Special rules.--
``(A) Special rule for cigarettes.--Beginning 3 months
after the date of enactment of the Family Smoking Prevention
and Tobacco Control Act, a cigarette or any of its component
parts (including the tobacco, filter, or paper) shall not
contain, as a constituent (including a smoke constituent) or
additive, an artificial or natural flavor (other than tobacco
or menthol) or an herb or spice, including strawberry, grape,
orange, clove, cinnamon, pineapple, vanilla, coconut,
licorice, cocoa, chocolate, cherry, or coffee, that is a
characterizing flavor of the tobacco product or tobacco
smoke. Nothing in this subparagraph shall be construed to
limit the Secretary's authority to take action under this
section or other sections of this Act applicable to menthol
or any artificial or natural flavor, herb, or spice not
specified in this subparagraph.
``(B) Additional special rule.--Beginning 2 years after the
date of enactment of the Family Smoking Prevention and
Tobacco Control Act, a tobacco product manufacturer shall not
use tobacco, including foreign grown tobacco, that contains a
pesticide chemical residue that is at a level greater than is
specified by any tolerance applicable under Federal law to
domestically grown tobacco.
``(2) Revision of tobacco product standards.--The Secretary
may revise the tobacco product standards in paragraph (1) in
accordance with subsection (c).
``(3) Tobacco product standards.--
``(A) In general.--The Secretary may adopt tobacco product
standards in addition to those in paragraph (1) if the
Secretary finds that a tobacco product standard is
appropriate for the protection of the public health.
``(B) Determinations.--
``(i) Considerations.--In making a finding described in
subparagraph (A), the Secretary shall consider scientific
evidence concerning--
``(I) the risks and benefits to the population as a whole,
including users and nonusers of tobacco products, of the
proposed standard;
``(II) the increased or decreased likelihood that existing
users of tobacco products will stop using such products; and
``(III) the increased or decreased likelihood that those
who do not use tobacco products will start using such
products.
``(ii) Additional considerations.--In the event that the
Secretary makes a determination, set forth in a proposed
tobacco product
[[Page H4325]]
standard in a proposed rule, that it is appropriate for the
protection of public health to require the reduction or
elimination of an additive, constituent (including a smoke
constituent), or other component of a tobacco product because
the Secretary has found that the additive, constituent, or
other component is or may be harmful, any party objecting to
the proposed standard on the ground that the proposed
standard will not reduce or eliminate the risk of illness or
injury may provide for the Secretary's consideration
scientific evidence that demonstrates that the proposed
standard will not reduce or eliminate the risk of illness or
injury.
``(4) Content of tobacco product standards.--A tobacco
product standard established under this section for a tobacco
product--
``(A) shall include provisions that are appropriate for the
protection of the public health, including provisions, where
appropriate--
``(i) for nicotine yields of the product;
``(ii) for the reduction or elimination of other
constituents, including smoke constituents, or harmful
components of the product; or
``(iii) relating to any other requirement under
subparagraph (B);
``(B) shall, where appropriate for the protection of the
public health, include--
``(i) provisions respecting the construction, components,
ingredients, additives, constituents, including smoke
constituents, and properties of the tobacco product;
``(ii) provisions for the testing (on a sample basis or, if
necessary, on an individual basis) of the tobacco product;
``(iii) provisions for the measurement of the tobacco
product characteristics of the tobacco product;
``(iv) provisions requiring that the results of each or of
certain of the tests of the tobacco product required to be
made under clause (ii) show that the tobacco product is in
conformity with the portions of the standard for which the
test or tests were required; and
``(v) a provision requiring that the sale and distribution
of the tobacco product be restricted but only to the extent
that the sale and distribution of a tobacco product may be
restricted under a regulation under section 906(d);
``(C) shall, where appropriate, require the use and
prescribe the form and content of labeling for the proper use
of the tobacco product; and
``(D) shall require tobacco products containing foreign-
grown tobacco to meet the same standards applicable to
tobacco products containing domestically grown tobacco.
``(5) Periodic reevaluation of tobacco product standards.--
The Secretary shall provide for periodic evaluation of
tobacco product standards established under this section to
determine whether such standards should be changed to reflect
new medical, scientific, or other technological data. The
Secretary may provide for testing under paragraph (4)(B) by
any person.
``(6) Involvement of other agencies; informed persons.--In
carrying out duties under this section, the Secretary shall
endeavor to--
``(A) use personnel, facilities, and other technical
support available in other Federal agencies;
``(B) consult with other Federal agencies concerned with
standard setting and other nationally or internationally
recognized standard-setting entities; and
``(C) invite appropriate participation, through joint or
other conferences, workshops, or other means, by informed
persons representative of scientific, professional, industry,
agricultural, or consumer organizations who in the
Secretary's judgment can make a significant contribution.
``(b) Considerations by Secretary.--
``(1) Technical achievability.--The Secretary shall
consider information submitted in connection with a proposed
standard regarding the technical achievability of compliance
with such standard.
``(2) Other considerations.--The Secretary shall consider
all other information submitted in connection with a proposed
standard, including information concerning the countervailing
effects of the tobacco product standard on the health of
adolescent tobacco users, adult tobacco users, or nontobacco
users, such as the creation of a significant demand for
contraband or other tobacco products that do not meet the
requirements of this chapter and the significance of such
demand.
``(c) Proposed Standards.--
``(1) In general.--The Secretary shall publish in the
Federal Register a notice of proposed rulemaking for the
establishment, amendment, or revocation of any tobacco
product standard.
``(2) Requirements of notice.--A notice of proposed
rulemaking for the establishment or amendment of a tobacco
product standard for a tobacco product shall--
``(A) set forth a finding with supporting justification
that the tobacco product standard is appropriate for the
protection of the public health;
``(B) invite interested persons to submit a draft or
proposed tobacco product standard for consideration by the
Secretary;
``(C) invite interested persons to submit comments on
structuring the standard so that it does not advantage
foreign-grown tobacco over domestically grown tobacco; and
``(D) invite the Secretary of Agriculture to provide any
information or analysis which the Secretary of Agriculture
believes is relevant to the proposed tobacco product
standard.
``(3) Finding.--A notice of proposed rulemaking for the
revocation of a tobacco product standard shall set forth a
finding with supporting justification that the tobacco
product standard is no longer appropriate for the protection
of the public health.
``(4) Comment.--The Secretary shall provide for a comment
period of not less than 60 days.
``(d) Promulgation.--
``(1) In general.--After the expiration of the period for
comment on a notice of proposed rulemaking published under
subsection (c) respecting a tobacco product standard and
after consideration of comments submitted under subsections
(b) and (c) and any report from the Tobacco Products
Scientific Advisory Committee, the Secretary shall--
``(A) if the Secretary determines that the standard would
be appropriate for the protection of the public health,
promulgate a regulation establishing a tobacco product
standard and publish in the Federal Register findings on the
matters referred to in subsection (c); or
``(B) publish a notice terminating the proceeding for the
development of the standard together with the reasons for
such termination.
``(2) Effective date.--A regulation establishing a tobacco
product standard shall set forth the date or dates upon which
the standard shall take effect, but no such regulation may
take effect before 1 year after the date of its publication
unless the Secretary determines that an earlier effective
date is necessary for the protection of the public health.
Such date or dates shall be established so as to minimize,
consistent with the public health, economic loss to, and
disruption or dislocation of, domestic and international
trade. In establishing such effective date or dates, the
Secretary shall consider information submitted in connection
with a proposed product standard by interested parties,
including manufacturers and tobacco growers, regarding the
technical achievability of compliance with the standard, and
including information concerning the existence of patents
that make it impossible to comply in the timeframe envisioned
in the proposed standard. If the Secretary determines, based
on the Secretary's evaluation of submitted comments, that a
product standard can be met only by manufacturers requiring
substantial changes to the methods of farming the
domestically grown tobacco used by the manufacturer, the
effective date of that product standard shall be not less
than 2 years after the date of publication of the final
regulation establishing the standard.
``(3) Limitation on power granted to the food and drug
administration.--Because of the importance of a decision of
the Secretary to issue a regulation--
``(A) banning all cigarettes, all smokeless tobacco
products, all little cigars, all cigars other than little
cigars, all pipe tobacco, or all roll-your-own tobacco
products; or
``(B) requiring the reduction of nicotine yields of a
tobacco product to zero,
the Secretary is prohibited from taking such actions under
this Act.
``(4) Amendment; revocation.--
``(A) Authority.--The Secretary, upon the Secretary's own
initiative or upon petition of an interested person, may by a
regulation, promulgated in accordance with the requirements
of subsection (c) and paragraph (2), amend or revoke a
tobacco product standard.
``(B) Effective date.--The Secretary may declare a proposed
amendment of a tobacco product standard to be effective on
and after its publication in the Federal Register and until
the effective date of any final action taken on such
amendment if the Secretary determines that making it so
effective is in the public interest.
``(5) Referral to advisory committee.--
``(A) In general.--The Secretary may refer a proposed
regulation for the establishment, amendment, or revocation of
a tobacco product standard to the Tobacco Products Scientific
Advisory Committee for a report and recommendation with
respect to any matter involved in the proposed regulation
which requires the exercise of scientific judgment.
``(B) Initiation of referral.--The Secretary may make a
referral under this paragraph--
``(i) on the Secretary's own initiative; or
``(ii) upon the request of an interested person that--
``(I) demonstrates good cause for the referral; and
``(II) is made before the expiration of the period for
submission of comments on the proposed regulation.
``(C) Provision of data.--If a proposed regulation is
referred under this paragraph to the Tobacco Products
Scientific Advisory Committee, the Secretary shall provide
the Advisory Committee with the data and information on which
such proposed regulation is based.
``(D) Report and recommendation.--The Tobacco Products
Scientific Advisory Committee shall, within 60 days after the
referral of a proposed regulation under this paragraph and
after independent study of the data and information furnished
to it by the Secretary and other data and information before
it, submit to the Secretary a report and recommendation
respecting such regulation, together with all underlying data
and information and a statement of the reason or basis for
the recommendation.
[[Page H4326]]
``(E) Public availability.--The Secretary shall make a copy
of each report and recommendation under subparagraph (D)
publicly available.
``(e) Menthol Cigarettes.--
``(1) Referral; considerations.--Immediately upon the
establishment of the Tobacco Products Scientific Advisory
Committee under section 917(a), the Secretary shall refer to
the Committee for report and recommendation, under section
917(c)(4), the issue of the impact of the use of menthol in
cigarettes on the public health, including such use among
children, African Americans, Hispanics, and other racial and
ethnic minorities. In its review, the Tobacco Products
Scientific Advisory Committee shall address the
considerations listed in subsections (a)(3)(B)(i) and (b).
``(2) Report and recommendation.--Not later than 1 year
after its establishment, the Tobacco Product Scientific
Advisory Committee shall submit to the Secretary the report
and recommendations required pursuant to paragraph (1).
``(3) Rule of construction.--Nothing in this subsection
shall be construed to limit the Secretary's authority to take
action under this section or other sections of this Act
applicable to menthol.
``SEC. 908. NOTIFICATION AND OTHER REMEDIES.
``(a) Notification.--If the Secretary determines that--
``(1) a tobacco product which is introduced or delivered
for introduction into interstate commerce for commercial
distribution presents an unreasonable risk of substantial
harm to the public health; and
``(2) notification under this subsection is necessary to
eliminate the unreasonable risk of such harm and no more
practicable means is available under the provisions of this
chapter (other than this section) to eliminate such risk,
the Secretary may issue such order as may be necessary to
assure that adequate notification is provided in an
appropriate form, by the persons and means best suited under
the circumstances involved, to all persons who should
properly receive such notification in order to eliminate such
risk. The Secretary may order notification by any appropriate
means, including public service announcements. Before issuing
an order under this subsection, the Secretary shall consult
with the persons who are to give notice under the order.
``(b) No Exemption From Other Liability.--Compliance with
an order issued under this section shall not relieve any
person from liability under Federal or State law. In awarding
damages for economic loss in an action brought for the
enforcement of any such liability, the value to the plaintiff
in such action of any remedy provided under such order shall
be taken into account.
``(c) Recall Authority.--
``(1) In general.--If the Secretary finds that there is a
reasonable probability that a tobacco product contains a
manufacturing or other defect not ordinarily contained in
tobacco products on the market that would cause serious,
adverse health consequences or death, the Secretary shall
issue an order requiring the appropriate person (including
the manufacturers, importers, distributors, or retailers of
the tobacco product) to immediately cease distribution of
such tobacco product. The order shall provide the person
subject to the order with an opportunity for an informal
hearing, to be held not later than 10 days after the date of
the issuance of the order, on the actions required by the
order and on whether the order should be amended to require a
recall of such tobacco product. If, after providing an
opportunity for such a hearing, the Secretary determines that
inadequate grounds exist to support the actions required by
the order, the Secretary shall vacate the order.
``(2) Amendment of order to require recall.--
``(A) In general.--If, after providing an opportunity for
an informal hearing under paragraph (1), the Secretary
determines that the order should be amended to include a
recall of the tobacco product with respect to which the order
was issued, the Secretary shall, except as provided in
subparagraph (B), amend the order to require a recall. The
Secretary shall specify a timetable in which the tobacco
product recall will occur and shall require periodic reports
to the Secretary describing the progress of the recall.
``(B) Notice.--An amended order under subparagraph (A)--
``(i) shall not include recall of a tobacco product from
individuals; and
``(ii) shall provide for notice to persons subject to the
risks associated with the use of such tobacco product.
In providing the notice required by clause (ii), the
Secretary may use the assistance of retailers and other
persons who distributed such tobacco product. If a
significant number of such persons cannot be identified, the
Secretary shall notify such persons under section 705(b).
``(3) Remedy not exclusive.--The remedy provided by this
subsection shall be in addition to remedies provided by
subsection (a).
``SEC. 909. RECORDS AND REPORTS ON TOBACCO PRODUCTS.
``(a) In General.--Every person who is a tobacco product
manufacturer or importer of a tobacco product shall establish
and maintain such records, make such reports, and provide
such information, as the Secretary may by regulation
reasonably require to assure that such tobacco product is not
adulterated or misbranded and to otherwise protect public
health. Regulations prescribed under the preceding sentence--
``(1) may require a tobacco product manufacturer or
importer to report to the Secretary whenever the manufacturer
or importer receives or otherwise becomes aware of
information that reasonably suggests that one of its marketed
tobacco products may have caused or contributed to a serious
unexpected adverse experience associated with the use of the
product or any significant increase in the frequency of a
serious, expected adverse product experience;
``(2) shall require reporting of other significant adverse
tobacco product experiences as determined by the Secretary to
be necessary to be reported;
``(3) shall not impose requirements unduly burdensome to a
tobacco product manufacturer or importer, taking into account
the cost of complying with such requirements and the need for
the protection of the public health and the implementation of
this chapter;
``(4) when prescribing the procedure for making requests
for reports or information, shall require that each request
made under such regulations for submission of a report or
information to the Secretary state the reason or purpose for
such request and identify to the fullest extent practicable
such report or information;
``(5) when requiring submission of a report or information
to the Secretary, shall state the reason or purpose for the
submission of such report or information and identify to the
fullest extent practicable such report or information; and
``(6) may not require that the identity of any patient or
user be disclosed in records, reports, or information
required under this subsection unless required for the
medical welfare of an individual, to determine risks to
public health of a tobacco product, or to verify a record,
report, or information submitted under this chapter.
In prescribing regulations under this subsection, the
Secretary shall have due regard for the professional ethics
of the medical profession and the interests of patients. The
prohibitions of paragraph (6) continue to apply to records,
reports, and information concerning any individual who has
been a patient, irrespective of whether or when he ceases to
be a patient.
``(b) Reports of Removals and Corrections.--
``(1) In general.--Except as provided in paragraph (2), the
Secretary shall by regulation require a tobacco product
manufacturer or importer of a tobacco product to report
promptly to the Secretary any corrective action taken or
removal from the market of a tobacco product undertaken by
such manufacturer or importer if the removal or correction
was undertaken--
``(A) to reduce a risk to health posed by the tobacco
product; or
``(B) to remedy a violation of this chapter caused by the
tobacco product which may present a risk to health.
A tobacco product manufacturer or importer of a tobacco
product who undertakes a corrective action or removal from
the market of a tobacco product which is not required to be
reported under this subsection shall keep a record of such
correction or removal.
``(2) Exception.--No report of the corrective action or
removal of a tobacco product may be required under paragraph
(1) if a report of the corrective action or removal is
required and has been submitted under subsection (a).
``SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TOBACCO
PRODUCTS.
``(a) In General.--
``(1) New tobacco product defined.--For purposes of this
section the term `new tobacco product' means--
``(A) any tobacco product (including those products in test
markets) that was not commercially marketed in the United
States as of February 15, 2007; or
``(B) any modification (including a change in design, any
component, any part, or any constituent, including a smoke
constituent, or in the content, delivery or form of nicotine,
or any other additive or ingredient) of a tobacco product
where the modified product was commercially marketed in the
United States after February 15, 2007.
``(2) Premarket review required.--
``(A) New products.--An order under subsection (c)(1)(A)(i)
for a new tobacco product is required unless--
``(i) the manufacturer has submitted a report under section
905(j); and the Secretary has issued an order that the
tobacco product--
``(I) is substantially equivalent to a tobacco product
commercially marketed (other than for test marketing) in the
United States as of February 15, 2007; and
``(II) is in compliance with the requirements of this Act;
or
``(ii) the tobacco product is exempt from the requirements
of section 905(j) pursuant to a regulation issued under
section 905(j)(3).
``(B) Application to certain post-february 15, 2007,
products.--Subparagraph (A) shall not apply to a tobacco
product--
``(i) that was first introduced or delivered for
introduction into interstate commerce for commercial
distribution in the United States after February 15, 2007,
and prior to the date that is 21 months after the date of
enactment of the Family Smoking Prevention and Tobacco
Control Act; and
``(ii) for which a report was submitted under section
905(j) within such 21-month period,
[[Page H4327]]
except that subparagraph (A) shall apply to the tobacco
product if the Secretary issues an order that the tobacco
product is not substantially equivalent.
``(3) Substantially equivalent defined.--
``(A) In general.--In this section and section 905(j), the
term `substantially equivalent' or `substantial equivalence'
means, with respect to the tobacco product being compared to
the predicate tobacco product, that the Secretary by order
has found that the tobacco product--
``(i) has the same characteristics as the predicate tobacco
product; or
``(ii) has different characteristics and the information
submitted contains information, including clinical data if
deemed necessary by the Secretary, that demonstrates that it
is not appropriate to regulate the product under this section
because the product does not raise different questions of
public health.
``(B) Characteristics.--In subparagraph (A), the term
`characteristics' means the materials, ingredients, design,
composition, heating source, or other features of a tobacco
product.
``(C) Limitation.--A tobacco product may not be found to be
substantially equivalent to a predicate tobacco product that
has been removed from the market at the initiative of the
Secretary or that has been determined by a judicial order to
be misbranded or adulterated.
``(4) Health information.--
``(A) Summary.--As part of a submission under section
905(j) respecting a tobacco product, the person required to
file a premarket notification under such section shall
provide an adequate summary of any health information related
to the tobacco product or state that such information will be
made available upon request by any person.
``(B) Required information.--Any summary under subparagraph
(A) respecting a tobacco product shall contain detailed
information regarding data concerning adverse health effects
and shall be made available to the public by the Secretary
within 30 days of the issuance of a determination that such
tobacco product is substantially equivalent to another
tobacco product.
``(b) Application.--
``(1) Contents.--An application under this section shall
contain--
``(A) full reports of all information, published or known
to, or which should reasonably be known to, the applicant,
concerning investigations which have been made to show the
health risks of such tobacco product and whether such tobacco
product presents less risk than other tobacco products;
``(B) a full statement of the components, ingredients,
additives, and properties, and of the principle or principles
of operation, of such tobacco product;
``(C) a full description of the methods used in, and the
facilities and controls used for, the manufacture,
processing, and, when relevant, packing and installation of,
such tobacco product;
``(D) an identifying reference to any tobacco product
standard under section 907 which would be applicable to any
aspect of such tobacco product, and either adequate
information to show that such aspect of such tobacco product
fully meets such tobacco product standard or adequate
information to justify any deviation from such standard;
``(E) such samples of such tobacco product and of
components thereof as the Secretary may reasonably require;
``(F) specimens of the labeling proposed to be used for
such tobacco product; and
``(G) such other information relevant to the subject matter
of the application as the Secretary may require.
``(2) Referral to tobacco products scientific advisory
committee.--Upon receipt of an application meeting the
requirements set forth in paragraph (1), the Secretary--
``(A) may, on the Secretary's own initiative; or
``(B) may, upon the request of an applicant,
refer such application to the Tobacco Products Scientific
Advisory Committee for reference and for submission (within
such period as the Secretary may establish) of a report and
recommendation respecting the application, together with all
underlying data and the reasons or basis for the
recommendation.
``(c) Action on Application.--
``(1) Deadline.--
``(A) In general.--As promptly as possible, but in no event
later than 180 days after the receipt of an application under
subsection (b), the Secretary, after considering the report
and recommendation submitted under subsection (b)(2), shall--
``(i) issue an order that the new product may be introduced
or delivered for introduction into interstate commerce if the
Secretary finds that none of the grounds specified in
paragraph (2) of this subsection applies; or
``(ii) issue an order that the new product may not be
introduced or delivered for introduction into interstate
commerce if the Secretary finds (and sets forth the basis for
such finding as part of or accompanying such denial) that 1
or more grounds for denial specified in paragraph (2) of this
subsection apply.
``(B) Restrictions on sale and distribution.--An order
under subparagraph (A)(i) may require that the sale and
distribution of the tobacco product be restricted but only to
the extent that the sale and distribution of a tobacco
product may be restricted under a regulation under section
906(d).
``(2) Denial of application.--The Secretary shall deny an
application submitted under subsection (b) if, upon the basis
of the information submitted to the Secretary as part of the
application and any other information before the Secretary
with respect to such tobacco product, the Secretary finds
that--
``(A) there is a lack of a showing that permitting such
tobacco product to be marketed would be appropriate for the
protection of the public health;
``(B) the methods used in, or the facilities or controls
used for, the manufacture, processing, or packing of such
tobacco product do not conform to the requirements of section
906(e);
``(C) based on a fair evaluation of all material facts, the
proposed labeling is false or misleading in any particular;
or
``(D) such tobacco product is not shown to conform in all
respects to a tobacco product standard in effect under
section 907, and there is a lack of adequate information to
justify the deviation from such standard.
``(3) Denial information.--Any denial of an application
shall, insofar as the Secretary determines to be practicable,
be accompanied by a statement informing the applicant of the
measures required to remove such application from deniable
form (which measures may include further research by the
applicant in accordance with 1 or more protocols prescribed
by the Secretary).
``(4) Basis for finding.--For purposes of this section, the
finding as to whether the marketing of a tobacco product for
which an application has been submitted is appropriate for
the protection of the public health shall be determined with
respect to the risks and benefits to the population as a
whole, including users and nonusers of the tobacco product,
and taking into account--
``(A) the increased or decreased likelihood that existing
users of tobacco products will stop using such products; and
``(B) the increased or decreased likelihood that those who
do not use tobacco products will start using such products.
``(5) Basis for action.--
``(A) Investigations.--For purposes of paragraph (2)(A),
whether permitting a tobacco product to be marketed would be
appropriate for the protection of the public health shall,
when appropriate, be determined on the basis of well-
controlled investigations, which may include 1 or more
clinical investigations by experts qualified by training and
experience to evaluate the tobacco product.
``(B) Other evidence.--If the Secretary determines that
there exists valid scientific evidence (other than evidence
derived from investigations described in subparagraph (A))
which is sufficient to evaluate the tobacco product, the
Secretary may authorize that the determination for purposes
of paragraph (2)(A) be made on the basis of such evidence.
``(d) Withdrawal and Temporary Suspension.--
``(1) In general.--The Secretary shall, upon obtaining,
where appropriate, advice on scientific matters from the
Tobacco Products Scientific Advisory Committee, and after due
notice and opportunity for informal hearing for a tobacco
product for which an order was issued under subsection
(c)(1)(A)(i), issue an order withdrawing the order if the
Secretary finds--
``(A) that the continued marketing of such tobacco product
no longer is appropriate for the protection of the public
health;
``(B) that the application contained or was accompanied by
an untrue statement of a material fact;
``(C) that the applicant--
``(i) has failed to establish a system for maintaining
records, or has repeatedly or deliberately failed to maintain
records or to make reports, required by an applicable
regulation under section 909;
``(ii) has refused to permit access to, or copying or
verification of, such records as required by section 704; or
``(iii) has not complied with the requirements of section
905;
``(D) on the basis of new information before the Secretary
with respect to such tobacco product, evaluated together with
the evidence before the Secretary when the application was
reviewed, that the methods used in, or the facilities and
controls used for, the manufacture, processing, packing, or
installation of such tobacco product do not conform with the
requirements of section 906(e) and were not brought into
conformity with such requirements within a reasonable time
after receipt of written notice from the Secretary of
nonconformity;
``(E) on the basis of new information before the Secretary,
evaluated together with the evidence before the Secretary
when the application was reviewed, that the labeling of such
tobacco product, based on a fair evaluation of all material
facts, is false or misleading in any particular and was not
corrected within a reasonable time after receipt of written
notice from the Secretary of such fact; or
``(F) on the basis of new information before the Secretary,
evaluated together with the evidence before the Secretary
when such order was issued, that such tobacco product is not
shown to conform in all respects to a tobacco product
standard which is in effect under section 907, compliance
with which was a condition to the issuance of an order
relating to the application, and that there is a lack of
adequate information to justify the deviation from such
standard.
``(2) Appeal.--The holder of an application subject to an
order issued under paragraph (1) withdrawing an order issued
pursuant to
[[Page H4328]]
subsection (c)(1)(A)(i) may, by petition filed on or before
the 30th day after the date upon which such holder receives
notice of such withdrawal, obtain review thereof in
accordance with section 912.
``(3) Temporary suspension.--If, after providing an
opportunity for an informal hearing, the Secretary determines
there is reasonable probability that the continuation of
distribution of a tobacco product under an order would cause
serious, adverse health consequences or death, that is
greater than ordinarily caused by tobacco products on the
market, the Secretary shall by order temporarily suspend the
authority of the manufacturer to market the product. If the
Secretary issues such an order, the Secretary shall proceed
expeditiously under paragraph (1) to withdraw such
application.
``(e) Service of Order.--An order issued by the Secretary
under this section shall be served--
``(1) in person by any officer or employee of the
department designated by the Secretary; or
``(2) by mailing the order by registered mail or certified
mail addressed to the applicant at the applicant's last known
address in the records of the Secretary.
``(f) Records.--
``(1) Additional information.--In the case of any tobacco
product for which an order issued pursuant to subsection
(c)(1)(A)(i) for an application filed under subsection (b) is
in effect, the applicant shall establish and maintain such
records, and make such reports to the Secretary, as the
Secretary may by regulation, or by order with respect to such
application, prescribe on the basis of a finding that such
records and reports are necessary in order to enable the
Secretary to determine, or facilitate a determination of,
whether there is or may be grounds for withdrawing or
temporarily suspending such order.
``(2) Access to records.--Each person required under this
section to maintain records, and each person in charge of
custody thereof, shall, upon request of an officer or
employee designated by the Secretary, permit such officer or
employee at all reasonable times to have access to and copy
and verify such records.
``(g) Investigational Tobacco Product Exemption for
Investigational Use.--The Secretary may exempt tobacco
products intended for investigational use from the provisions
of this chapter under such conditions as the Secretary may by
regulation prescribe.
``SEC. 911. MODIFIED RISK TOBACCO PRODUCTS.
``(a) In General.--No person may introduce or deliver for
introduction into interstate commerce any modified risk
tobacco product unless an order issued pursuant to subsection
(g) is effective with respect to such product.
``(b) Definitions.--In this section:
``(1) Modified risk tobacco product.--The term `modified
risk tobacco product' means any tobacco product that is sold
or distributed for use to reduce harm or the risk of tobacco-
related disease associated with commercially marketed tobacco
products.
``(2) Sold or distributed.--
``(A) In general.--With respect to a tobacco product, the
term `sold or distributed for use to reduce harm or the risk
of tobacco-related disease associated with commercially
marketed tobacco products' means a tobacco product--
``(i) the label, labeling, or advertising of which
represents explicitly or implicitly that--
``(I) the tobacco product presents a lower risk of tobacco-
related disease or is less harmful than one or more other
commercially marketed tobacco products;
``(II) the tobacco product or its smoke contains a reduced
level of a substance or presents a reduced exposure to a
substance; or
``(III) the tobacco product or its smoke does not contain
or is free of a substance;
``(ii) the label, labeling, or advertising of which uses
the descriptors `light', `mild', or `low' or similar
descriptors; or
``(iii) the tobacco product manufacturer of which has taken
any action directed to consumers through the media or
otherwise, other than by means of the tobacco product's
label, labeling, or advertising, after the date of enactment
of the Family Smoking Prevention and Tobacco Control Act,
respecting the product that would be reasonably expected to
result in consumers believing that the tobacco product or its
smoke may present a lower risk of disease or is less harmful
than one or more commercially marketed tobacco products, or
presents a reduced exposure to, or does not contain or is
free of, a substance or substances.
``(B) Limitation.--No tobacco product shall be considered
to be `sold or distributed for use to reduce harm or the risk
of tobacco-related disease associated with commercially
marketed tobacco products', except as described in
subparagraph (A).
``(C) Smokeless tobacco product.--No smokeless tobacco
product shall be considered to be `sold or distributed for
use to reduce harm or the risk of tobacco-related disease
associated with commercially marketed tobacco products'
solely because its label, labeling, or advertising uses the
following phrases to describe such product and its use:
`smokeless tobacco', `smokeless tobacco product', `not
consumed by smoking', `does not produce smoke', `smokefree',
`smoke-free', `without smoke', `no smoke', or `not smoke'.
``(3) Effective date.--The provisions of paragraph
(2)(A)(ii) shall take effect 12 months after the date of
enactment of the Family Smoking Prevention and Tobacco
Control Act for those products whose label, labeling, or
advertising contains the terms described in such paragraph on
such date of enactment. The effective date shall be with
respect to the date of manufacture, provided that, in any
case, beginning 30 days after such effective date, a
manufacturer shall not introduce into the domestic commerce
of the United States any product, irrespective of the date of
manufacture, that is not in conformance with paragraph
(2)(A)(ii).
``(c) Tobacco Dependence Products.--A product that is
intended to be used for the treatment of tobacco dependence,
including smoking cessation, is not a modified risk tobacco
product under this section if it has been approved as a drug
or device by the Food and Drug Administration and is subject
to the requirements of chapter V.
``(d) Filing.--Any person may file with the Secretary an
application for a modified risk tobacco product. Such
application shall include--
``(1) a description of the proposed product and any
proposed advertising and labeling;
``(2) the conditions for using the product;
``(3) the formulation of the product;
``(4) sample product labels and labeling;
``(5) all documents (including underlying scientific
information) relating to research findings conducted,
supported, or possessed by the tobacco product manufacturer
relating to the effect of the product on tobacco-related
diseases and health-related conditions, including information
both favorable and unfavorable to the ability of the product
to reduce risk or exposure and relating to human health;
``(6) data and information on how consumers actually use
the tobacco product; and
``(7) such other information as the Secretary may require.
``(e) Public Availability.--The Secretary shall make the
application described in subsection (d) publicly available
(except matters in the application which are trade secrets or
otherwise confidential, commercial information) and shall
request comments by interested persons on the information
contained in the application and on the label, labeling, and
advertising accompanying such application.
``(f) Advisory Committee.--
``(1) In general.--The Secretary shall refer to the Tobacco
Products Scientific Advisory Committee any application
submitted under this section.
``(2) Recommendations.--Not later than 60 days after the
date an application is referred to the Tobacco Products
Scientific Advisory Committee under paragraph (1), the
Advisory Committee shall report its recommendations on the
application to the Secretary.
``(g) Marketing.--
``(1) Modified risk products.--Except as provided in
paragraph (2), the Secretary shall, with respect to an
application submitted under this section, issue an order that
a modified risk product may be commercially marketed only if
the Secretary determines that the applicant has demonstrated
that such product, as it is actually used by consumers,
will--
``(A) significantly reduce harm and the risk of tobacco-
related disease to individual tobacco users; and
``(B) benefit the health of the population as a whole
taking into account both users of tobacco products and
persons who do not currently use tobacco products.
``(2) Special rule for certain products.--
``(A) In general.--The Secretary may issue an order that a
tobacco product may be introduced or delivered for
introduction into interstate commerce, pursuant to an
application under this section, with respect to a tobacco
product that may not be commercially marketed under paragraph
(1) if the Secretary makes the findings required under this
paragraph and determines that the applicant has demonstrated
that--
``(i) such order would be appropriate to promote the public
health;
``(ii) any aspect of the label, labeling, and advertising
for such product that would cause the tobacco product to be a
modified risk tobacco product under subsection (b) is limited
to an explicit or implicit representation that such tobacco
product or its smoke does not contain or is free of a
substance or contains a reduced level of a substance, or
presents a reduced exposure to a substance in tobacco smoke;
``(iii) scientific evidence is not available and, using the
best available scientific methods, cannot be made available
without conducting long-term epidemiological studies for an
application to meet the standards set forth in paragraph (1);
and
``(iv) the scientific evidence that is available without
conducting long-term epidemiological studies demonstrates
that a measurable and substantial reduction in morbidity or
mortality among individual tobacco users is reasonably likely
in subsequent studies.
``(B) Additional findings required.--To issue an order
under subparagraph (A) the Secretary must also find that the
applicant has demonstrated that--
``(i) the magnitude of the overall reductions in exposure
to the substance or substances which are the subject of the
application is substantial, such substance or substances are
harmful, and the product as actually used exposes consumers
to the specified reduced level of the substance or
substances;
``(ii) the product as actually used by consumers will not
expose them to higher levels of other harmful substances
compared to the
[[Page H4329]]
similar types of tobacco products then on the market unless
such increases are minimal and the reasonably likely overall
impact of use of the product remains a substantial and
measurable reduction in overall morbidity and mortality among
individual tobacco users;
``(iii) testing of actual consumer perception shows that,
as the applicant proposes to label and market the product,
consumers will not be misled into believing that the
product--
``(I) is or has been demonstrated to be less harmful; or
``(II) presents or has been demonstrated to present less of
a risk of disease than 1 or more other commercially marketed
tobacco products; and
``(iv) issuance of an order with respect to the application
is expected to benefit the health of the population as a
whole taking into account both users of tobacco products and
persons who do not currently use tobacco products.
``(C) Conditions of marketing.--
``(i) In general.--Applications subject to an order under
this paragraph shall be limited to a term of not more than 5
years, but may be renewed upon a finding by the Secretary
that the requirements of this paragraph continue to be
satisfied based on the filing of a new application.
``(ii) Agreements by applicant.--An order under this
paragraph shall be conditioned on the applicant's agreement
to conduct postmarket surveillance and studies and to submit
to the Secretary the results of such surveillance and studies
to determine the impact of the order on consumer perception,
behavior, and health and to enable the Secretary to review
the accuracy of the determinations upon which the order was
based in accordance with a protocol approved by the
Secretary.
``(iii) Annual submission.--The results of such postmarket
surveillance and studies described in clause (ii) shall be
submitted annually.
``(3) Basis.--The determinations under paragraphs (1) and
(2) shall be based on--
``(A) the scientific evidence submitted by the applicant;
and
``(B) scientific evidence and other information that is
made available to the Secretary.
``(4) Benefit to health of individuals and of population as
a whole.--In making the determinations under paragraphs (1)
and (2), the Secretary shall take into account--
``(A) the relative health risks to individuals of the
tobacco product that is the subject of the application;
``(B) the increased or decreased likelihood that existing
users of tobacco products who would otherwise stop using such
products will switch to the tobacco product that is the
subject of the application;
``(C) the increased or decreased likelihood that persons
who do not use tobacco products will start using the tobacco
product that is the subject of the application;
``(D) the risks and benefits to persons from the use of the
tobacco product that is the subject of the application as
compared to the use of products for smoking cessation
approved under chapter V to treat nicotine dependence; and
``(E) comments, data, and information submitted by
interested persons.
``(h) Additional Conditions for Marketing.--
``(1) Modified risk products.--The Secretary shall require
for the marketing of a product under this section that any
advertising or labeling concerning modified risk products
enable the public to comprehend the information concerning
modified risk and to understand the relative significance of
such information in the context of total health and in
relation to all of the diseases and health-related conditions
associated with the use of tobacco products.
``(2) Comparative claims.--
``(A) In general.--The Secretary may require for the
marketing of a product under this subsection that a claim
comparing a tobacco product to 1 or more other commercially
marketed tobacco products shall compare the tobacco product
to a commercially marketed tobacco product that is
representative of that type of tobacco product on the market
(for example the average value of the top 3 brands of an
established regular tobacco product).
``(B) Quantitative comparisons.--The Secretary may also
require, for purposes of subparagraph (A), that the percent
(or fraction) of change and identity of the reference tobacco
product and a quantitative comparison of the amount of the
substance claimed to be reduced shall be stated in immediate
proximity to the most prominent claim.
``(3) Label disclosure.--
``(A) In general.--The Secretary may require the disclosure
on the label of other substances in the tobacco product, or
substances that may be produced by the consumption of that
tobacco product, that may affect a disease or health-related
condition or may increase the risk of other diseases or
health-related conditions associated with the use of tobacco
products.
``(B) Conditions of use.--If the conditions of use of the
tobacco product may affect the risk of the product to human
health, the Secretary may require the labeling of conditions
of use.
``(4) Time.--An order issued under subsection (g)(1) shall
be effective for a specified period of time.
``(5) Advertising.--The Secretary may require, with respect
to a product for which an applicant obtained an order under
subsection (g)(1), that the product comply with requirements
relating to advertising and promotion of the tobacco product.
``(i) Postmarket Surveillance and Studies.--
``(1) In general.--The Secretary shall require, with
respect to a product for which an applicant obtained an order
under subsection (g)(1), that the applicant conduct
postmarket surveillance and studies for such a tobacco
product to determine the impact of the order issuance on
consumer perception, behavior, and health, to enable the
Secretary to review the accuracy of the determinations upon
which the order was based, and to provide information that
the Secretary determines is otherwise necessary regarding the
use or health risks involving the tobacco product. The
results of postmarket surveillance and studies shall be
submitted to the Secretary on an annual basis.
``(2) Surveillance protocol.--Each applicant required to
conduct a surveillance of a tobacco product under paragraph
(1) shall, within 30 days after receiving notice that the
applicant is required to conduct such surveillance, submit,
for the approval of the Secretary, a protocol for the
required surveillance. The Secretary, within 60 days of the
receipt of such protocol, shall determine if the principal
investigator proposed to be used in the surveillance has
sufficient qualifications and experience to conduct such
surveillance and if such protocol will result in collection
of the data or other information designated by the Secretary
as necessary to protect the public health.
``(j) Withdrawal of Authorization.--The Secretary, after an
opportunity for an informal hearing, shall withdraw an order
under subsection (g) if the Secretary determines that--
``(1) the applicant, based on new information, can no
longer make the demonstrations required under subsection (g),
or the Secretary can no longer make the determinations
required under subsection (g);
``(2) the application failed to include material
information or included any untrue statement of material
fact;
``(3) any explicit or implicit representation that the
product reduces risk or exposure is no longer valid,
including if--
``(A) a tobacco product standard is established pursuant to
section 907;
``(B) an action is taken that affects the risks presented
by other commercially marketed tobacco products that were
compared to the product that is the subject of the
application; or
``(C) any postmarket surveillance or studies reveal that
the order is no longer consistent with the protection of the
public health;
``(4) the applicant failed to conduct or submit the
postmarket surveillance and studies required under subsection
(g)(2)(C)(ii) or subsection (i); or
``(5) the applicant failed to meet a condition imposed
under subsection (h).
``(k) Chapter IV or V.--A product for which the Secretary
has issued an order pursuant to subsection (g) shall not be
subject to chapter IV or V.
``(l) Implementing Regulations or Guidance.--
``(1) Scientific evidence.--Not later than 2 years after
the date of enactment of the Family Smoking Prevention and
Tobacco Control Act, the Secretary shall issue regulations or
guidance (or any combination thereof) on the scientific
evidence required for assessment and ongoing review of
modified risk tobacco products. Such regulations or guidance
shall--
``(A) to the extent that adequate scientific evidence
exists, establish minimum standards for scientific studies
needed prior to issuing an order under subsection (g) to show
that a substantial reduction in morbidity or mortality among
individual tobacco users occurs for products described in
subsection (g)(1) or is reasonably likely for products
described in subsection (g)(2);
``(B) include validated biomarkers, intermediate clinical
endpoints, and other feasible outcome measures, as
appropriate;
``(C) establish minimum standards for postmarket studies,
that shall include regular and long-term assessments of
health outcomes and mortality, intermediate clinical
endpoints, consumer perception of harm reduction, and the
impact on quitting behavior and new use of tobacco products,
as appropriate;
``(D) establish minimum standards for required postmarket
surveillance, including ongoing assessments of consumer
perception;
``(E) require that data from the required studies and
surveillance be made available to the Secretary prior to the
decision on renewal of a modified risk tobacco product; and
``(F) establish a reasonable timetable for the Secretary to
review an application under this section.
``(2) Consultation.--The regulations or guidance issued
under paragraph (1) shall be developed in consultation with
the Institute of Medicine, and with the input of other
appropriate scientific and medical experts, on the design and
conduct of such studies and surveillance.
``(3) Revision.--The regulations or guidance under
paragraph (1) shall be revised on a regular basis as new
scientific information becomes available.
``(4) New tobacco products.--Not later than 2 years after
the date of enactment of the Family Smoking Prevention and
Tobacco Control Act, the Secretary shall issue
[[Page H4330]]
a regulation or guidance that permits the filing of a single
application for any tobacco product that is a new tobacco
product under section 910 and which the applicant seeks to
commercially market under this section.
``(m) Distributors.--Except as provided in this section, no
distributor may take any action, after the date of enactment
of the Family Smoking Prevention and Tobacco Control Act,
with respect to a tobacco product that would reasonably be
expected to result in consumers believing that the tobacco
product or its smoke may present a lower risk of disease or
is less harmful than one or more commercially marketed
tobacco products, or presents a reduced exposure to, or does
not contain or is free of, a substance or substances.
``SEC. 912. JUDICIAL REVIEW.
``(a) Right To Review.--
``(1) In general.--Not later than 30 days after--
``(A) the promulgation of a regulation under section 907
establishing, amending, or revoking a tobacco product
standard; or
``(B) a denial of an application under section 910(c),
any person adversely affected by such regulation or denial
may file a petition for judicial review of such regulation or
denial with the United States Court of Appeals for the
District of Columbia or for the circuit in which such person
resides or has their principal place of business.
``(2) Requirements.--
``(A) Copy of petition.--A copy of the petition filed under
paragraph (1) shall be transmitted by the clerk of the court
involved to the Secretary.
``(B) Record of proceedings.--On receipt of a petition
under subparagraph (A), the Secretary shall file in the court
in which such petition was filed--
``(i) the record of the proceedings on which the regulation
or order was based; and
``(ii) a statement of the reasons for the issuance of such
a regulation or order.
``(C) Definition of record.--In this section, the term
`record' means--
``(i) all notices and other matter published in the Federal
Register with respect to the regulation or order reviewed;
``(ii) all information submitted to the Secretary with
respect to such regulation or order;
``(iii) proceedings of any panel or advisory committee with
respect to such regulation or order;
``(iv) any hearing held with respect to such regulation or
order; and
``(v) any other information identified by the Secretary, in
the administrative proceeding held with respect to such
regulation or order, as being relevant to such regulation or
order.
``(b) Standard of Review.--Upon the filing of the petition
under subsection (a) for judicial review of a regulation or
order, the court shall have jurisdiction to review the
regulation or order in accordance with chapter 7 of title 5,
United States Code, and to grant appropriate relief,
including interim relief, as provided for in such chapter. A
regulation or denial described in subsection (a) shall be
reviewed in accordance with section 706(2)(A) of title 5,
United States Code.
``(c) Finality of Judgment.--The judgment of the court
affirming or setting aside, in whole or in part, any
regulation or order shall be final, subject to review by the
Supreme Court of the United States upon certiorari or
certification, as provided in section 1254 of title 28,
United States Code.
``(d) Other Remedies.--The remedies provided for in this
section shall be in addition to, and not in lieu of, any
other remedies provided by law.
``(e) Regulations and Orders Must Recite Basis in Record.--
To facilitate judicial review, a regulation or order issued
under section 906, 907, 908, 909, 910, or 916 shall contain a
statement of the reasons for the issuance of such regulation
or order in the record of the proceedings held in connection
with its issuance.
``SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS.
``The Secretary shall issue regulations to require that
retail establishments for which the predominant business is
the sale of tobacco products comply with any advertising
restrictions applicable to retail establishments accessible
to individuals under the age of 18.
``SEC. 914. JURISDICTION OF AND COORDINATION WITH THE FEDERAL
TRADE COMMISSION.
``(a) Jurisdiction.--
``(1) In general.--Except where expressly provided in this
chapter, nothing in this chapter shall be construed as
limiting or diminishing the authority of the Federal Trade
Commission to enforce the laws under its jurisdiction with
respect to the advertising, sale, or distribution of tobacco
products.
``(2) Enforcement.--Any advertising that violates this
chapter or a provision of the regulations referred to in
section 102 of the Family Smoking Prevention and Tobacco
Control Act, is an unfair or deceptive act or practice under
section 5(a) of the Federal Trade Commission Act and shall be
considered a violation of a rule promulgated under section 18
of that Act.
``(b) Coordination.--With respect to the requirements of
section 4 of the Federal Cigarette Labeling and Advertising
Act and section 3 of the Comprehensive Smokeless Tobacco
Health Education Act of 1986--
``(1) the Chairman of the Federal Trade Commission shall
coordinate with the Secretary concerning the enforcement of
such Act as such enforcement relates to unfair or deceptive
acts or practices in the advertising of cigarettes or
smokeless tobacco; and
``(2) the Secretary shall consult with the Chairman of such
Commission in revising the label statements and requirements
under such sections.
``SEC. 915. REGULATION REQUIREMENT.
``(a) Testing, Reporting, and Disclosure.--Not later than
36 months after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act, the Secretary shall
promulgate regulations under this Act that meet the
requirements of subsection (b).
``(b) Contents of Rules.--The regulations promulgated under
subsection (a)--
``(1) shall require testing and reporting of tobacco
product constituents, ingredients, and additives, including
smoke constituents, by brand and subbrand that the Secretary
determines should be tested to protect the public health,
provided that, for purposes of the testing requirements of
this paragraph, tobacco products manufactured and sold by a
single tobacco product manufacturer that are identical in all
respects except the labels, packaging design, logo, trade
dress, trademark, brand name, or any combination thereof,
shall be considered as a single brand; and
``(2) may require that tobacco product manufacturers,
packagers, or importers make disclosures relating to the
results of the testing of tar and nicotine through labels or
advertising or other appropriate means, and make disclosures
regarding the results of the testing of other constituents,
including smoke constituents, ingredients, or additives, that
the Secretary determines should be disclosed to the public to
protect the public health and will not mislead consumers
about the risk of tobacco-related disease.
``(c) Authority.--The Secretary shall have the authority
under this chapter to conduct or to require the testing,
reporting, or disclosure of tobacco product constituents,
including smoke constituents.
``(d) Small Tobacco Product Manufacturers.--
``(1) First compliance date.--The initial regulations
promulgated under subsection (a) shall not impose
requirements on small tobacco product manufacturers before
the later of--
``(A) the end of the 2-year period following the final
promulgation of such regulations; and
``(B) the initial date set by the Secretary for compliance
with such regulations by manufacturers that are not small
tobacco product manufacturers.
``(2) Testing and reporting initial compliance period.--
``(A) 4-year period.--The initial regulations promulgated
under subsection (a) shall give each small tobacco product
manufacturer a 4-year period over which to conduct testing
and reporting for all of its tobacco products. Subject to
paragraph (1), the end of the first year of such 4-year
period shall coincide with the initial date of compliance
under this section set by the Secretary with respect to
manufacturers that are not small tobacco product
manufacturers or the end of the 2-year period following the
final promulgation of such regulations, as described in
paragraph (1)(A). A small tobacco product manufacturer shall
be required--
``(i) to conduct such testing and reporting for 25 percent
of its tobacco products during each year of such 4-year
period; and
``(ii) to conduct such testing and reporting for its
largest-selling tobacco products (as determined by the
Secretary) before its other tobacco products, or in such
other order of priority as determined by the Secretary.
``(B) Case-by-case delay.--Notwithstanding subparagraph
(A), the Secretary may, on a case-by-case basis, delay the
date by which an individual small tobacco product
manufacturer must conduct testing and reporting for its
tobacco products under this section based upon a showing of
undue hardship to such manufacturer. Notwithstanding the
preceding sentence, the Secretary shall not extend the
deadline for a small tobacco product manufacturer to conduct
testing and reporting for all of its tobacco products beyond
a total of 5 years after the initial date of compliance under
this section set by the Secretary with respect to
manufacturers that are not small tobacco product
manufacturers.
``(3) Subsequent and additional testing and reporting.--The
regulations promulgated under subsection (a) shall provide
that, with respect to any subsequent or additional testing
and reporting of tobacco products required under this
section, such testing and reporting by a small tobacco
product manufacturer shall be conducted in accordance with
the timeframes described in paragraph (2)(A), except that, in
the case of a new product, or if there has been a
modification described in section 910(a)(1)(B) of any product
of a small tobacco product manufacturer since the last
testing and reporting required under this section, the
Secretary shall require that any subsequent or additional
testing and reporting be conducted in accordance with the
same timeframe applicable to manufacturers that are not small
tobacco product manufacturers.
``(4) Joint laboratory testing services.--The Secretary
shall allow any 2 or more small tobacco product manufacturers
to join together to purchase laboratory testing services
required by this section on a group basis in order to ensure
that such manufacturers
[[Page H4331]]
receive access to, and fair pricing of, such testing
services.
``(e) Extensions for Limited Laboratory Capacity.--
``(1) In general.--The regulations promulgated under
subsection (a) shall provide that a small tobacco product
manufacturer shall not be considered to be in violation of
this section before the deadline applicable under paragraphs
(3) and (4), if--
``(A) the tobacco products of such manufacturer are in
compliance with all other requirements of this chapter; and
``(B) the conditions described in paragraph (2) are met.
``(2) Conditions.--Notwithstanding the requirements of this
section, the Secretary may delay the date by which a small
tobacco product manufacturer must be in compliance with the
testing and reporting required by this section until such
time as the testing is reported if, not later than 90 days
before the deadline for reporting in accordance with this
section, a small tobacco product manufacturer provides
evidence to the Secretary demonstrating that--
``(A) the manufacturer has submitted the required products
for testing to a laboratory and has done so sufficiently in
advance of the deadline to create a reasonable expectation of
completion by the deadline;
``(B) the products currently are awaiting testing by the
laboratory; and
``(C) neither that laboratory nor any other laboratory is
able to complete testing by the deadline at customary,
nonexpedited testing fees.
``(3) Extension.--The Secretary, taking into account the
laboratory testing capacity that is available to tobacco
product manufacturers, shall review and verify the evidence
submitted by a small tobacco product manufacturer in
accordance with paragraph (2). If the Secretary finds that
the conditions described in such paragraph are met, the
Secretary shall notify the small tobacco product manufacturer
that the manufacturer shall not be considered to be in
violation of the testing and reporting requirements of this
section until the testing is reported or until 1 year after
the reporting deadline has passed, whichever occurs sooner.
If, however, the Secretary has not made a finding before the
reporting deadline, the manufacturer shall not be considered
to be in violation of such requirements until the Secretary
finds that the conditions described in paragraph (2) have not
been met, or until 1 year after the reporting deadline,
whichever occurs sooner.
``(4) Additional extension.--In addition to the time that
may be provided under paragraph (3), the Secretary may
provide further extensions of time, in increments of no more
than 1 year, for required testing and reporting to occur if
the Secretary determines, based on evidence properly and
timely submitted by a small tobacco product manufacturer in
accordance with paragraph (2), that a lack of available
laboratory capacity prevents the manufacturer from completing
the required testing during the period described in paragraph
(3).
``(f) Rule of Construction.--Nothing in subsection (d) or
(e) shall be construed to authorize the extension of any
deadline, or to otherwise affect any timeframe, under any
provision of this Act or the Family Smoking Prevention and
Tobacco Control Act other than this section.
``SEC. 916. PRESERVATION OF STATE AND LOCAL AUTHORITY.
``(a) In General.--
``(1) Preservation.--Except as provided in paragraph
(2)(A), nothing in this chapter, or rules promulgated under
this chapter, shall be construed to limit the authority of a
Federal agency (including the Armed Forces), a State or
political subdivision of a State, or the government of an
Indian tribe to enact, adopt, promulgate, and enforce any
law, rule, regulation, or other measure with respect to
tobacco products that is in addition to, or more stringent
than, requirements established under this chapter, including
a law, rule, regulation, or other measure relating to or
prohibiting the sale, distribution, possession, exposure to,
access to, advertising and promotion of, or use of tobacco
products by individuals of any age, information reporting to
the State, or measures relating to fire safety standards for
tobacco products. No provision of this chapter shall limit or
otherwise affect any State, Tribal, or local taxation of
tobacco products.
``(2) Preemption of certain state and local requirements.--
``(A) In general.--No State or political subdivision of a
State may establish or continue in effect with respect to a
tobacco product any requirement which is different from, or
in addition to, any requirement under the provisions of this
chapter relating to tobacco product standards, premarket
review, adulteration, misbranding, labeling, registration,
good manufacturing standards, or modified risk tobacco
products.
``(B) Exception.--Subparagraph (A) does not apply to
requirements relating to the sale, distribution, possession,
information reporting to the State, exposure to, access to,
the advertising and promotion of, or use of, tobacco products
by individuals of any age, or relating to fire safety
standards for tobacco products. Information disclosed to a
State under subparagraph (A) that is exempt from disclosure
under section 552(b)(4) of title 5, United States Code, shall
be treated as a trade secret and confidential information by
the State.
``(b) Rule of Construction Regarding Product Liability.--No
provision of this chapter relating to a tobacco product shall
be construed to modify or otherwise affect any action or the
liability of any person under the product liability law of
any State.
``SEC. 917. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.
``(a) Establishment.--Not later than 6 months after the
date of enactment of the Family Smoking Prevention and
Tobacco Control Act, the Secretary shall establish a 12-
member advisory committee, to be known as the Tobacco
Products Scientific Advisory Committee (in this section
referred to as the `Advisory Committee').
``(b) Membership.--
``(1) In general.--
``(A) Members.--The Secretary shall appoint as members of
the Tobacco Products Scientific Advisory Committee
individuals who are technically qualified by training and
experience in medicine, medical ethics, science, or
technology involving the manufacture, evaluation, or use of
tobacco products, who are of appropriately diversified
professional backgrounds. The committee shall be composed
of--
``(i) 7 individuals who are physicians, dentists,
scientists, or health care professionals practicing in the
area of oncology, pulmonology, cardiology, toxicology,
pharmacology, addiction, or any other relevant specialty;
``(ii) 1 individual who is an officer or employee of a
State or local government or of the Federal Government;
``(iii) 1 individual as a representative of the general
public;
``(iv) 1 individual as a representative of the interests of
the tobacco manufacturing industry;
``(v) 1 individual as a representative of the interests of
the small business tobacco manufacturing industry, which
position may be filled on a rotating, sequential basis by
representatives of different small business tobacco
manufacturers based on areas of expertise relevant to the
topics being considered by the Advisory Committee; and
``(vi) 1 individual as a representative of the interests of
the tobacco growers.
``(B) Nonvoting members.--The members of the committee
appointed under clauses (iv), (v), and (vi) of subparagraph
(A) shall serve as consultants to those described in clauses
(i) through (iii) of subparagraph (A) and shall be nonvoting
representatives.
``(C) Conflicts of interest.--No members of the committee,
other than members appointed pursuant to clauses (iv), (v),
and (vi) of subparagraph (A) shall, during the member's
tenure on the committee or for the 18-month period prior to
becoming such a member, receive any salary, grants, or other
payments or support from any business that manufactures,
distributes, markets, or sells cigarettes or other tobacco
products.
``(2) Limitation.--The Secretary may not appoint to the
Advisory Committee any individual who is in the regular full-
time employ of the Food and Drug Administration or any agency
responsible for the enforcement of this Act. The Secretary
may appoint Federal officials as ex officio members.
``(3) Chairperson.--The Secretary shall designate 1 of the
members appointed under clauses (i), (ii), and (iii) of
paragraph (1)(A) to serve as chairperson.
``(c) Duties.--The Tobacco Products Scientific Advisory
Committee shall provide advice, information, and
recommendations to the Secretary--
``(1) as provided in this chapter;
``(2) on the effects of the alteration of the nicotine
yields from tobacco products;
``(3) on whether there is a threshold level below which
nicotine yields do not produce dependence on the tobacco
product involved; and
``(4) on its review of other safety, dependence, or health
issues relating to tobacco products as requested by the
Secretary.
``(d) Compensation; Support; FACA.--
``(1) Compensation and travel.--Members of the Advisory
Committee who are not officers or employees of the United
States, while attending conferences or meetings of the
committee or otherwise engaged in its business, shall be
entitled to receive compensation at rates to be fixed by the
Secretary, which may not exceed the daily equivalent of the
rate in effect under the Senior Executive Schedule under
section 5382 of title 5, United States Code, for each day
(including travel time) they are so engaged; and while so
serving away from their homes or regular places of business
each member may be allowed travel expenses, including per
diem in lieu of subsistence, as authorized by section 5703 of
title 5, United States Code, for persons in the Government
service employed intermittently.
``(2) Administrative support.--The Secretary shall furnish
the Advisory Committee clerical and other assistance.
``(3) Nonapplication of faca.--Section 14 of the Federal
Advisory Committee Act does not apply to the Advisory
Committee.
``(e) Proceedings of Advisory Panels and Committees.--The
Advisory Committee shall make and maintain a transcript of
any proceeding of the panel or committee. Each such panel and
committee shall delete from any transcript made under this
subsection information which is exempt from disclosure under
section 552(b) of title 5, United States Code.
``SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE.
``(a) In General.--The Secretary shall--
[[Page H4332]]
``(1) at the request of the applicant, consider designating
products for smoking cessation, including nicotine
replacement products as fast track research and approval
products within the meaning of section 506;
``(2) consider approving the extended use of nicotine
replacement products (such as nicotine patches, nicotine gum,
and nicotine lozenges) for the treatment of tobacco
dependence; and
``(3) review and consider the evidence for additional
indications for nicotine replacement products, such as for
craving relief or relapse prevention.
``(b) Report on Innovative Products.--
``(1) In general.--Not later than 3 years after the date of
enactment of the Family Smoking Prevention and Tobacco
Control Act, the Secretary, after consultation with
recognized scientific, medical, and public health experts
(including both Federal agencies and nongovernmental
entities, the Institute of Medicine of the National Academy
of Sciences, and the Society for Research on Nicotine and
Tobacco), shall submit to the Congress a report that examines
how best to regulate, promote, and encourage the development
of innovative products and treatments (including nicotine-
based and non-nicotine-based products and treatments) to
better achieve, in a manner that best protects and promotes
the public health--
``(A) total abstinence from tobacco use;
``(B) reductions in consumption of tobacco; and
``(C) reductions in the harm associated with continued
tobacco use.
``(2) Recommendations.--The report under paragraph (1)
shall include the recommendations of the Secretary on how the
Food and Drug Administration should coordinate and facilitate
the exchange of information on such innovative products and
treatments among relevant offices and centers within the
Administration and within the National Institutes of Health,
the Centers for Disease Control and Prevention, and other
relevant agencies.
``SEC. 919. USER FEES.
``(a) Establishment of Quarterly Fee.--Beginning on the
date of enactment of the Family Smoking Prevention and
Tobacco Control Act, the Secretary shall in accordance with
this section assess user fees on, and collect such fees from,
each manufacturer and importer of tobacco products subject to
this chapter. The fees shall be assessed and collected with
respect to each quarter of each fiscal year, and the total
amount assessed and collected for a fiscal year shall be the
amount specified in subsection (b)(1) for such year, subject
to subsection (c).
``(b) Assessment of User Fee.--
``(1) Amount of assessment.--The total amount of user fees
authorized to be assessed and collected under subsection (a)
for a fiscal year is the following, as applicable to the
fiscal year involved:
``(A) For fiscal year 2009, $85,000,000 (subject to
subsection (e)).
``(B) For fiscal year 2010, $235,000,000.
``(C) For fiscal year 2011, $450,000,000.
``(D) For fiscal year 2012, $477,000,000.
``(E) For fiscal year 2013, $505,000,000.
``(F) For fiscal year 2014, $534,000,000.
``(G) For fiscal year 2015, $566,000,000.
``(H) For fiscal year 2016, $599,000,000.
``(I) For fiscal year 2017, $635,000,000.
``(J) For fiscal year 2018, $672,000,000.
``(K) For fiscal year 2019 and each subsequent fiscal year,
$712,000,000.
``(2) Allocations of assessment by class of tobacco
products.--
``(A) In general.--The total user fees assessed and
collected under subsection (a) each fiscal year with respect
to each class of tobacco products shall be an amount that is
equal to the applicable percentage of each class for the
fiscal year multiplied by the amount specified in paragraph
(1) for the fiscal year.
``(B) Applicable percentage.--
``(i) In general.--For purposes of subparagraph (A), the
applicable percentage for a fiscal year for each of the
following classes of tobacco products shall be determined in
accordance with clause (ii):
``(I) Cigarettes.
``(II) Cigars, including small cigars and cigars other than
small cigars.
``(III) Snuff.
``(IV) Chewing tobacco.
``(V) Pipe tobacco.
``(VI) Roll-your-own tobacco.
``(ii) Allocations.--The applicable percentage of each
class of tobacco product described in clause (i) for a fiscal
year shall be the percentage determined under section 625(c)
of Public Law 108-357 for each such class of product for such
fiscal year.
``(iii) Requirement of regulations.--Notwithstanding clause
(ii), no user fees shall be assessed on a class of tobacco
products unless such class of tobacco products is listed in
section 901(b) or is deemed by the Secretary in a regulation
under section 901(b) to be subject to this chapter.
``(iv) Reallocations.--In the case of a class of tobacco
products that is not listed in section 901(b) or deemed by
the Secretary in a regulation under section 901(b) to be
subject to this chapter, the amount of user fees that would
otherwise be assessed to such class of tobacco products shall
be reallocated to the classes of tobacco products that are
subject to this chapter in the same manner and based on the
same relative percentages otherwise determined under clause
(ii).
``(3) Determination of user fee by company.--
``(A) In general.--The total user fee to be paid by each
manufacturer or importer of a particular class of tobacco
products shall be determined for each quarter by
multiplying--
``(i) such manufacturer's or importer's percentage share as
determined under paragraph (4); by
``(ii) the portion of the user fee amount for the current
quarter to be assessed on all manufacturers and importers of
such class of tobacco products as determined under paragraph
(2).
``(B) No fee in excess of percentage share.--No
manufacturer or importer of tobacco products shall be
required to pay a user fee in excess of the percentage share
of such manufacturer or importer.
``(4) Allocation of assessment within each class of tobacco
product.--The percentage share of each manufacturer or
importer of a particular class of tobacco products of the
total user fee to be paid by all manufacturers or importers
of that class of tobacco products shall be the percentage
determined for purposes of allocations under subsections (e)
through (h) of section 625 of Public Law 108-357.
``(5) Allocation for cigars.--Notwithstanding paragraph
(4), if a user fee assessment is imposed on cigars, the
percentage share of each manufacturer or importer of cigars
shall be based on the excise taxes paid by such manufacturer
or importer during the prior fiscal year.
``(6) Timing of assessment.--The Secretary shall notify
each manufacturer and importer of tobacco products subject to
this section of the amount of the quarterly assessment
imposed on such manufacturer or importer under this
subsection for each quarter of each fiscal year. Such
notifications shall occur not later than 30 days prior to the
end of the quarter for which such assessment is made, and
payments of all assessments shall be made by the last day of
the quarter involved.
``(7) Memorandum of understanding.--
``(A) In general.--The Secretary shall request the
appropriate Federal agency to enter into a memorandum of
understanding that provides for the regular and timely
transfer from the head of such agency to the Secretary of the
information described in paragraphs (2)(B)(ii) and (4) and
all necessary information regarding all tobacco product
manufacturers and importers required to pay user fees. The
Secretary shall maintain all disclosure restrictions
established by the head of such agency regarding the
information provided under the memorandum of understanding.
``(B) Assurances.--Beginning not later than fiscal year
2015, and for each subsequent fiscal year, the Secretary
shall ensure that the Food and Drug Administration is able to
determine the applicable percentages described in paragraph
(2) and the percentage shares described in paragraph (4). The
Secretary may carry out this subparagraph by entering into a
contract with the head of the Federal agency referred to in
subparagraph (A) to continue to provide the necessary
information.
``(c) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in
appropriations Acts. Such fees are authorized to remain
available until expended. Such sums as may be necessary may
be transferred from the Food and Drug Administration salaries
and expenses appropriation account without fiscal year
limitation to such appropriation account for salaries and
expenses with such fiscal year limitation.
``(2) Availability.--
``(A) In general.--Fees appropriated under paragraph (3)
are available only for the purpose of paying the costs of the
activities of the Food and Drug Administration related to the
regulation of tobacco products under this chapter and the
Family Smoking Prevention and Tobacco Control Act. No fees
collected under subsection (a) may be used for any other
costs.
``(B) Prohibition against use of other funds.--
``(i) In general.--Except as provided in clause (ii), fees
collected under subsection (a) are the only funds authorized
to be made available for the purpose described in
subparagraph (A).
``(ii) Startup costs.--Clause (i) does not apply until the
date on which the Secretary has collected fees under
subsection (a) for 2 fiscal year quarters. Until such date,
other amounts available to the Food and Drug Administration
(excluding fees collected under subsection (a)) are
authorized to be made available to pay the costs described in
subparagraph (A), provided that such amounts are reimbursed
through fees collected under subsection (a).
``(3) Authorization of appropriations.--For fiscal year
2009 and each subsequent fiscal year, there is authorized to
be appropriated for fees under this section an amount equal
to the amount specified in subsection (b)(1) for the fiscal
year.
``(d) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall
be treated as a claim of the United States Government subject
to subchapter II of chapter 37 of title 31, United States
Code.
``(e) Applicability to Fiscal Year 2009.--If the date of
enactment of the Family Smoking Prevention and Tobacco
Control
[[Page H4333]]
Act occurs during fiscal year 2009, the following applies,
subject to subsection (c):
``(1) The Secretary shall determine the fees that would
apply for a single quarter of such fiscal year according to
the application of subsection (b) to the amount specified in
paragraph (1)(A) of such subsection (referred to in this
subsection as the `quarterly fee amounts').
``(2) For the quarter in which such date of enactment
occurs, the amount of fees assessed shall be a pro rata
amount, determined according to the number of days remaining
in the quarter (including such date of enactment) and
according to the daily equivalent of the quarterly fee
amounts. Fees assessed under the preceding sentence shall not
be collected until the next quarter.
``(3) For the quarter following the quarter to which
paragraph (2) applies, the full quarterly fee amounts shall
be assessed and collected, in addition to collection of the
pro rata fees assessed under paragraph (2).''.
SEC. 102. FINAL RULE.
(a) Cigarettes and Smokeless Tobacco.--
(1) In general.--On the first day of publication of the
Federal Register that is 180 days or more after the date of
enactment of this Act, the Secretary of Health and Human
Services shall publish in the Federal Register a final rule
regarding cigarettes and smokeless tobacco, which--
(A) is deemed to be issued under chapter 9 of the Federal
Food, Drug, and Cosmetic Act, as added by section 101 of this
Act; and
(B) shall be deemed to be in compliance with all applicable
provisions of chapter 5 of title 5, United States Code, and
all other provisions of law relating to rulemaking
procedures.
(2) Contents of rule.--Except as provided in this
subsection, the final rule published under paragraph (1),
shall be identical in its provisions to part 897 of the
regulations promulgated by the Secretary of Health and Human
Services in the August 28, 1996, issue of the Federal
Register (61 Fed. Reg., 44615-44618). Such rule shall--
(A) provide for the designation of jurisdictional authority
that is in accordance with this subsection in accordance with
this Act and the amendments made by this Act;
(B) strike Subpart C--Labels and section 897.32(c);
(C) strike paragraphs (a), (b), and (i) of section 897.3
and insert definitions of the terms ``cigarette'',
``cigarette tobacco,'', and ``smokeless tobacco'' as defined
in section 900 of the Federal Food, Drug, and Cosmetic Act;
(D) insert ``or roll-your-own paper'' in section 897.34(a)
after ``other than cigarettes or smokeless tobacco'';
(E) become effective on the date that is 1 year after the
date of enactment of this Act; and
(F) amend paragraph (d) of section 897.16 to read as
follows:
``(d)(1) Except as provided in subparagraph (2), no
manufacturer, distributor, or retailer may distribute or
cause to be distributed any free samples of cigarettes,
smokeless tobacco, or other tobacco products (as such term is
defined in section 201 of the Federal Food, Drug, and
Cosmetic Act).
``(2)(A) Subparagraph (1) does not prohibit a manufacturer,
distributor, or retailer from distributing or causing to be
distributed free samples of smokeless tobacco in a qualified
adult-only facility.
``(B) This subparagraph does not affect the authority of a
State or local government to prohibit or otherwise restrict
the distribution of free samples of smokeless tobacco.
``(C) For purposes of this paragraph, the term `qualified
adult-only facility' means a facility or restricted area
that--
``(i) requires each person present to provide to a law
enforcement officer (whether on or off duty) or to a security
guard licensed by a governmental entity government-issued
identification showing a photograph and at least the minimum
age established by applicable law for the purchase of
smokeless tobacco;
``(ii) does not sell, serve, or distribute alcohol;
``(iii) is not located adjacent to or immediately across
from (in any direction) a space that is used primarily for
youth-oriented marketing, promotional, or other activities;
``(iv) is a temporary structure constructed, designated,
and operated as a distinct enclosed area for the purpose of
distributing free samples of smokeless tobacco in accordance
with this subparagraph; and
``(v) is enclosed by a barrier that--
``(I) is constructed of, or covered with, an opaque
material (except for entrances and exits);
``(II) extends from no more than 12 inches above the ground
or floor (which area at the bottom of the barrier must be
covered with material that restricts visibility but may allow
airflow) to at least 8 feet above the ground or floor (or to
the ceiling); and
``(III) prevents persons outside the qualified adult-only
facility from seeing into the qualified adult-only facility,
unless they make unreasonable efforts to do so; and
``(vi) does not display on its exterior--
``(I) any tobacco product advertising;
``(II) a brand name other than in conjunction with words
for an area or enclosure to identify an adult-only facility;
or
``(III) any combination of words that would imply to a
reasonable observer that the manufacturer, distributor, or
retailer has a sponsorship that would violate section
897.34(c).
``(D) Distribution of samples of smokeless tobacco under
this subparagraph permitted to be taken out of the qualified
adult-only facility shall be limited to 1 package per adult
consumer containing no more than 0.53 ounces (15 grams) of
smokeless tobacco. If such package of smokeless tobacco
contains individual portions of smokeless tobacco, the
individual portions of smokeless tobacco shall not exceed 8
individual portions and the collective weight of such
individual portions shall not exceed 0.53 ounces (15 grams).
Any manufacturer, distributor, or retailer who distributes or
causes to be distributed free samples also shall take
reasonable steps to ensure that the above amounts are limited
to one such package per adult consumer per day.
``(3) Notwithstanding subparagraph (2), no manufacturer,
distributor, or retailer may distribute or cause to be
distributed any free samples of smokeless tobacco--
``(A) to a sports team or entertainment group; or
``(B) at any football, basketball, baseball, soccer, or
hockey event or any other sporting or entertainment event
determined by the Secretary to be covered by this
subparagraph.
``(4) The Secretary shall implement a program to ensure
compliance with this paragraph and submit a report to the
Congress on such compliance not later than 18 months after
the date of enactment of the Family Smoking Prevention and
Tobacco Control Act.
``(5) Nothing in this paragraph shall be construed to
authorize any person to distribute or cause to be distributed
any sample of a tobacco product to any individual who has not
attained the minimum age established by applicable law for
the purchase of such product.''.
(3) Amendments to rule.--Prior to making amendments to the
rule published under paragraph (1), the Secretary shall
promulgate a proposed rule in accordance with chapter 5 of
title 5, United States Code.
(4) Rule of construction.--Except as provided in paragraph
(3), nothing in this section shall be construed to limit the
authority of the Secretary to amend, in accordance with
chapter 5 of title 5, United States Code, the regulation
promulgated pursuant to this section, including the
provisions of such regulation relating to distribution of
free samples.
(5) Enforcement of retail sale provisions.--The Secretary
of Health and Human Services shall ensure that the provisions
of this Act, the amendments made by this Act, and the
implementing regulations (including such provisions,
amendments, and regulations relating to the retail sale of
tobacco products) are enforced with respect to the United
States and Indian tribes.
(6) Qualified adult-only facility.--A qualified adult-only
facility (as such term is defined in section 897.16(d) of the
final rule published under paragraph (1)) that is also a
retailer and that commits a violation as a retailer shall not
be subject to the limitations in section 103(q) and shall be
subject to penalties applicable to a qualified adult-only
facility.
(7) Congressional review provisions.--Section 801 of title
5, United States Code, shall not apply to the final rule
published under paragraph (1).
(b) Limitation on Advisory Opinions.--As of the date of
enactment of this Act, the following documents issued by the
Food and Drug Administration shall not constitute advisory
opinions under section 10.85(d)(1) of title 21, Code of
Federal Regulations, except as they apply to tobacco
products, and shall not be cited by the Secretary of Health
and Human Services or the Food and Drug Administration as
binding precedent:
(1) The preamble to the proposed rule in the document
titled ``Regulations Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco Products to Protect Children
and Adolescents'' (60 Fed. Reg. 41314-41372 (August 11,
1995)).
(2) The document titled ``Nicotine in Cigarettes and
Smokeless Tobacco Products is a Drug and These Products Are
Nicotine Delivery Devices Under the Federal Food, Drug, and
Cosmetic Act'' (60 Fed. Reg. 41453-41787 (August 11, 1995)).
(3) The preamble to the final rule in the document titled
``Regulations Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco to Protect Children and
Adolescents'' (61 Fed. Reg. 44396-44615 (August 28, 1996)).
(4) The document titled ``Nicotine in Cigarettes and
Smokeless Tobacco is a Drug and These Products are Nicotine
Delivery Devices Under the Federal Food, Drug, and Cosmetic
Act; Jurisdictional Determination'' (61 Fed. Reg. 44619-45318
(August 28, 1996)).
SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GENERAL
PROVISIONS.
(a) Amendment of Federal Food, Drug, and Cosmetic Act.--
Except as otherwise expressly provided, whenever in this
section an amendment is expressed in terms of an amendment
to, or repeal of, a section or other provision, the reference
is to a section or other provision of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.).
(b) Section 301.--Section 301 (21 U.S.C. 331) is amended--
(1) in subsection (a), by inserting ``tobacco product,''
after ``device,'';
(2) in subsection (b), by inserting ``tobacco product,''
after ``device,'';
(3) in subsection (c), by inserting ``tobacco product,''
after ``device,'';
(4) in subsection (e)--
(A) by striking the period after ``572(i)''; and
[[Page H4334]]
(B) by striking ``or 761 or the refusal to permit access
to'' and inserting ``761, 909, or 920 or the refusal to
permit access to'';
(5) in subsection (g), by inserting ``tobacco product,''
after ``device,'';
(6) in subsection (h), by inserting ``tobacco product,''
after ``device,'';
(7) in subsection (j)--
(A) by striking the period after ``573''; and
(B) by striking ``708, or 721'' and inserting ``708, 721,
904, 905, 906, 907, 908, 909, or 920(b)'';
(8) in subsection (k), by inserting ``tobacco product,''
after ``device,'';
(9) by striking subsection (p) and inserting the following:
``(p) The failure to register in accordance with section
510 or 905, the failure to provide any information required
by section 510(j), 510(k), 905(i), or 905(j), or the failure
to provide a notice required by section 510(j)(2) or
905(i)(3).'';
(10) by striking subsection (q)(1) and inserting the
following:
``(q)(1) The failure or refusal--
``(A) to comply with any requirement prescribed under
section 518, 520(g), 903(b), 907, 908, or 916;
``(B) to furnish any notification or other material or
information required by or under section 519, 520(g), 904,
909, or 920; or
``(C) to comply with a requirement under section 522 or
913.'';
(11) in subsection (q)(2), by striking ``device,'' and
inserting ``device or tobacco product,'';
(12) in subsection (r), by inserting ``or tobacco product''
after the term ``device'' each time that such term appears;
and
(13) by adding at the end the following:
``(oo) The sale of tobacco products in violation of a no-
tobacco-sale order issued under section 303(f).
``(pp) The introduction or delivery for introduction into
interstate commerce of a tobacco product in violation of
section 911.
``(qq)(1) Forging, counterfeiting, simulating, or falsely
representing, or without proper authority using any mark,
stamp (including tax stamp), tag, label, or other
identification device upon any tobacco product or container
or labeling thereof so as to render such tobacco product a
counterfeit tobacco product.
``(2) Making, selling, disposing of, or keeping in
possession, control, or custody, or concealing any punch,
die, plate, stone, or other item that is designed to print,
imprint, or reproduce the trademark, trade name, or other
identifying mark, imprint, or device of another or any
likeness of any of the foregoing upon any tobacco product or
container or labeling thereof so as to render such tobacco
product a counterfeit tobacco product.
``(3) The doing of any act that causes a tobacco product to
be a counterfeit tobacco product, or the sale or dispensing,
or the holding for sale or dispensing, of a counterfeit
tobacco product.
``(rr) The charitable distribution of tobacco products.
``(ss) The failure of a manufacturer or distributor to
notify the Attorney General and the Secretary of the Treasury
of their knowledge of tobacco products used in illicit trade.
``(tt) With respect to a tobacco product, any statement
directed to consumers through the media or through the label,
labeling, or advertising that would reasonably be expected to
result in consumers believing that the product is regulated,
inspected or approved by the Food and Drug Administration, or
that the product complies with the requirements of the Food
and Drug Administration, including a statement or implication
in the label, labeling, or advertising of such product, and
that could result in consumers believing that the product is
endorsed for use by the Food and Drug Administration or in
consumers being misled about the harmfulness of the product
because of such regulation, inspection, or compliance.''.
(c) Section 303.--Section 303(f) (21 U.S.C. 333(f)) is
amended--
(1) in paragraph (1)(A), by inserting ``or tobacco
products'' after the term ``devices'' each place such term
appears;
(2) in paragraph (5)--
(A) in subparagraph (A)--
(i) by striking ``assessed'' the first time it appears and
inserting ``assessed, or a no-tobacco-sale order may be
imposed,''; and
(ii) by striking ``penalty'' the second time it appears and
inserting ``penalty, or upon whom a no-tobacco-sale order is
to be imposed,'';
(B) in subparagraph (B)--
(i) by inserting after ``penalty,'' the following: ``or the
period to be covered by a no-tobacco-sale order,''; and
(ii) by adding at the end the following: ``A no-tobacco-
sale order permanently prohibiting an individual retail
outlet from selling tobacco products shall include provisions
that allow the outlet, after a specified period of time, to
request that the Secretary compromise, modify, or terminate
the order.''; and
(C) by adding at the end the following:
``(D) The Secretary may compromise, modify, or terminate,
with or without conditions, any no-tobacco-sale order.'';
(3) in paragraph (6)--
(A) by inserting ``or the imposition of a no-tobacco-sale
order'' after the term ``penalty'' each place such term
appears; and
(B) by striking ``issued.'' and inserting ``issued, or on
which the no-tobacco-sale order was imposed, as the case may
be.''; and
(4) by adding at the end the following:
``(8) If the Secretary finds that a person has committed
repeated violations of restrictions promulgated under section
906(d) at a particular retail outlet then the Secretary may
impose a no-tobacco-sale order on that person prohibiting the
sale of tobacco products in that outlet. A no-tobacco-sale
order may be imposed with a civil penalty under paragraph
(1). Prior to the entry of a no-sale order under this
paragraph, a person shall be entitled to a hearing pursuant
to the procedures established through regulations of the Food
and Drug Administration for assessing civil money penalties,
including at a retailer's request a hearing by telephone, or
at the nearest regional or field office of the Food and Drug
Administration, or at a Federal, State, or county facility
within 100 miles from the location of the retail outlet, if
such a facility is available.''.
(d) Section 304.--Section 304 (21 U.S.C. 334) is amended--
(1) in subsection (a)(2)--
(A) by striking ``and'' before ``(D)''; and
(B) by striking ``device.'' and inserting the following:
``device, and (E) Any adulterated or misbranded tobacco
product.'';
(2) in subsection (d)(1), by inserting ``tobacco product,''
after ``device,'';
(3) in subsection (g)(1), by inserting ``or tobacco
product'' after the term ``device'' each place such term
appears; and
(4) in subsection (g)(2)(A), by inserting ``or tobacco
product'' after ``device''.
(e) Section 505.--Section 505(n)(2) (21 U.S.C. 355(n)(2))
is amended by striking ``section 904'' and inserting
``section 1004''.
(f) Section 523.--Section 523(b)(2)(D) (21 U.S.C.
360m(b)(2)(D)) is amended by striking ``section 903(g)'' and
inserting ``section 1003(g)''.
(g) Section 702.--Section 702(a)(1) (U.S.C. 372(a)(1)) is
amended--
(1) by striking ``(a)(1)'' and inserting ``(a)(1)(A)''; and
(2) by adding at the end the following:
``(B)(i) For a tobacco product, to the extent feasible, the
Secretary shall contract with the States in accordance with
this paragraph to carry out inspections of retailers within
that State in connection with the enforcement of this Act.
``(ii) The Secretary shall not enter into any contract
under clause (i) with the government of any of the several
States to exercise enforcement authority under this Act on
Indian country without the express written consent of the
Indian tribe involved.''.
(h) Section 703.--Section 703 (21 U.S.C. 373) is amended--
(1) by inserting ``tobacco product,'' after the term
``device,'' each place such term appears; and
(2) by inserting ``tobacco products,'' after the term
``devices,'' each place such term appears.
(i) Section 704.--Section 704 (21 U.S.C. 374) is amended--
(1) in subsection (a)(1)--
(A) by striking ``devices, or cosmetics'' each place it
appears and inserting ``devices, tobacco products, or
cosmetics'';
(B) by striking ``or restricted devices'' each place it
appears and inserting ``restricted devices, or tobacco
products'';
(C) by striking ``and devices and subject to'' and all that
follows through ``other drugs or devices'' and inserting
``devices, and tobacco products and subject to reporting and
inspection under regulations lawfully issued pursuant to
section 505(i) or (k), section 519, section 520(g), or
chapter IX and data relating to other drugs, devices, or
tobacco products'';
(2) in subsection (b), by inserting ``tobacco product,''
after ``device,''; and
(3) in subsection (g)(13), by striking ``section 903(g)''
and inserting ``section 1003(g)''.
(j) Section 705.--Section 705(b) (21 U.S.C. 375(b)) is
amended by inserting ``tobacco products,'' after
``devices,''.
(k) Section 709.--Section 709 (21 U.S.C. 379a) is amended
by inserting ``tobacco product,'' after ``device,''.
(l) Section 801.--Section 801 (21 U.S.C. 381) is amended--
(1) in subsection (a)--
(A) by inserting ``tobacco products,'' after the term
``devices,'' ;
(B) by inserting ``or section 905(h)'' after ``section
510''; and
(C) by striking the term ``drugs or devices'' each time
such term appears and inserting ``drugs, devices, or tobacco
products'';
(2) in subsection (e)(1)--
(A) by inserting ``tobacco product'' after ``drug,
device,''; and
(B) by inserting ``, and a tobacco product intended for
export shall not be deemed to be in violation of section
906(e), 907, 911, or 920(a),'' before ``if it--'';
(3) by adding at the end the following:
``(p)(1) Not later than 36 months after the date of
enactment of the Family Smoking Prevention and Tobacco
Control Act, and annually thereafter, the Secretary shall
submit to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives, a report
regarding--
``(A) the nature, extent, and destination of United States
tobacco product exports that do not conform to tobacco
product standards established pursuant to this Act;
``(B) the public health implications of such exports,
including any evidence of a negative public health impact;
and
``(C) recommendations or assessments of policy alternatives
available to Congress and the executive branch to reduce any
negative public health impact caused by such exports.
``(2) The Secretary is authorized to establish appropriate
information disclosure requirements to carry out this
subsection.''.
[[Page H4335]]
(m) Section 1003.--Section 1003(d)(2)(C) (as redesignated
by section 101(b)) is amended--
(1) by striking ``and'' after ``cosmetics,''; and
(2) inserting ``, and tobacco products'' after ``devices''.
(n) Section 1009.--Section 1009(b) (as redesignated by
section 101(b)) is amended by striking ``section 908'' and
inserting ``section 1008''.
(o) Section 409 of the Federal Meat Inspection Act.--
Section 409(a) of the Federal Meat Inspection Act (21 U.S.C.
679(a)) is amended by striking ``section 902(b)'' and
inserting ``section 1002(b)''.
(p) Rule of Construction.--Nothing in this section is
intended or shall be construed to expand, contract, or
otherwise modify or amend the existing limitations on State
government authority over tribal restricted fee or trust
lands.
(q) Guidance and Effective Dates.--
(1) In general.--The Secretary of Health and Human Services
shall issue guidance--
(A) defining the term ``repeated violation'', as used in
section 303(f)(8) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 333(f)(8)) as amended by subsection (c), as
including at least 5 violations of particular requirements
over a 36-month period at a particular retail outlet that
constitute a repeated violation and providing for civil
penalties in accordance with paragraph (2);
(B) providing for timely and effective notice by certified
or registered mail or personal delivery to the retailer of
each alleged violation at a particular retail outlet prior to
conducting a followup compliance check, such notice to be
sent to the location specified on the retailer's registration
or to the retailer's registered agent if the retailer has
provider such agent information to the Food and Drug
Administration prior to the violation;
(C) providing for a hearing pursuant to the procedures
established through regulations of the Food and Drug
Administration for assessing civil money penalties, including
at a retailer's request a hearing by telephone or at the
nearest regional or field office of the Food and Drug
Administration, and providing for an expedited procedure for
the administrative appeal of an alleged violation;
(D) providing that a person may not be charged with a
violation at a particular retail outlet unless the Secretary
has provided notice to the retailer of all previous
violations at that outlet;
(E) establishing that civil money penalties for multiple
violations shall increase from one violation to the next
violation pursuant to paragraph (2) within the time periods
provided for in such paragraph;
(F) providing that good faith reliance on the presentation
of a false government-issued photographic identification that
contains a date of birth does not constitute a violation of
any minimum age requirement for the sale of tobacco products
if the retailer has taken effective steps to prevent such
violations, including--
(i) adopting and enforcing a written policy against sales
to minors;
(ii) informing its employees of all applicable laws;
(iii) establishing disciplinary sanctions for employee
noncompliance; and
(iv) requiring its employees to verify age by way of
photographic identification or electronic scanning device;
and
(G) providing for the Secretary, in determining whether to
impose a no-tobacco-sale order and in determining whether to
compromise, modify, or terminate such an order, to consider
whether the retailer has taken effective steps to prevent
violations of the minimum age requirements for the sale of
tobacco products, including the steps listed in subparagraph
(F).
(2) Penalties for violations.--
(A) In general.--The amount of the civil penalty to be
applied for violations of restrictions promulgated under
section 906(d), as described in paragraph (1), shall be as
follows:
(i) With respect to a retailer with an approved training
program, the amount of the civil penalty shall not exceed--
(I) in the case of the first violation, $0.00 together with
the issuance of a warning letter to the retailer;
(II) in the case of a second violation within a 12-month
period, $250;
(III) in the case of a third violation within a 24-month
period, $500;
(IV) in the case of a fourth violation within a 24-month
period, $2,000;
(V) in the case of a fifth violation within a 36-month
period, $5,000; and
(VI) in the case of a sixth or subsequent violation within
a 48-month period, $10,000 as determined by the Secretary on
a case-by-case basis.
(ii) With respect to a retailer that does not have an
approved training program, the amount of the civil penalty
shall not exceed--
(I) in the case of the first violation, $250;
(II) in the case of a second violation within a 12-month
period, $500;
(III) in the case of a third violation within a 24-month
period, $1,000;
(IV) in the case of a fourth violation within a 24-month
period, $2,000;
(V) in the case of a fifth violation within a 36-month
period, $5,000; and
(VI) in the case of a sixth or subsequent violation within
a 48-month period, $10,000 as determined by the Secretary on
a case-by-case basis.
(B) Training program.--For purposes of subparagraph (A),
the term ``approved training program'' means a training
program that complies with standards developed by the Food
and Drug Administration for such programs.
(C) Consideration of state penalties.--The Secretary shall
coordinate with the States in enforcing the provisions of
this Act and, for purposes of mitigating a civil penalty to
be applied for a violation by a retailer of any restriction
promulgated under section 906(d), shall consider the amount
of any penalties paid by the retailer to a State for the same
violation.
(3) General effective date.--The amendments made by
paragraphs (2), (3), and (4) of subsection (c) shall take
effect upon the issuance of guidance described in paragraph
(1) of this subsection.
(4) Special effective date.--The amendment made by
subsection (c)(1) shall take effect on the date of enactment
of this Act.
(5) Package label requirements.--The package label
requirements of paragraphs (2), (3), and (4) of section
903(a) of the Federal Food, Drug, and Cosmetic Act (as
amended by this Act) shall take effect on the date that is 12
months after the date of enactment of this Act. The effective
date shall be with respect to the date of manufacture,
provided that, in any case, beginning 30 days after such
effective date, a manufacturer shall not introduce into the
domestic commerce of the United States any product,
irrespective of the date of manufacture, that is not in
conformance with section 903(a)(2), (3), and (4) and section
920(a) of the Federal Food, Drug, and Cosmetic Act.
(6) Advertising requirements.--The advertising requirements
of section 903(a)(8) of the Federal Food, Drug, and Cosmetic
Act (as amended by this Act) shall take effect on the date
that is 12 months after the date of enactment of this Act.
SEC. 104. STUDY ON RAISING THE MINIMUM AGE TO PURCHASE
TOBACCO PRODUCTS.
The Secretary of Health and Human Services shall--
(1) convene an expert panel to conduct a study on the
public health implications of raising the minimum age to
purchase tobacco products; and
(2) not later than 5 years after the date of enactment of
this Act, submit a report to the Congress on the results of
such study.
SEC. 105. ENFORCEMENT ACTION PLAN FOR ADVERTISING AND
PROMOTION RESTRICTIONS.
(a) Action Plan.--
(1) Development.--Not later than 6 months after the date of
enactment of this Act, the Secretary of Health and Human
Services (in this section referred to as the ``Secretary'')
shall develop and publish an action plan to enforce
restrictions adopted pursuant to section 906 of the Federal
Food, Drug, and Cosmetic Act, as added by section 101(b) of
this Act, or pursuant to section 102(a) of this Act, on
promotion and advertising of menthol and other cigarettes to
youth.
(2) Consultation.--The action plan required by paragraph
(1) shall be developed in consultation with public health
organizations and other stakeholders with demonstrated
expertise and experience in serving minority communities.
(3) Priority.--The action plan required by paragraph (1)
shall include provisions designed to ensure enforcement of
the restrictions described in paragraph (1) in minority
communities.
(b) State and Local Activities.--
(1) Information on authority.--Not later than 3 months
after the date of enactment of this Act, the Secretary shall
inform State, local, and tribal governments of the authority
provided to such entities under section 5(c) of the Federal
Cigarette Labeling and Advertising Act, as added by section
203 of this Act, or preserved by such entities under section
916 of the Federal Food, Drug, and Cosmetic Act, as added by
section 101(b) of this Act.
(2) Community assistance.--At the request of communities
seeking assistance to prevent underage tobacco use, the
Secretary shall provide such assistance, including assistance
with strategies to address the prevention of underage tobacco
use in communities with a disproportionate use of menthol
cigarettes by minors.
TITLE II--TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT
DISCLOSURE
SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS.
(a) Amendment.--Section 4 of the Federal Cigarette Labeling
and Advertising Act (15 U.S.C. 1333) is amended to read as
follows:
``SEC. 4. LABELING.
``(a) Label Requirements.--
``(1) In general.--It shall be unlawful for any person to
manufacture, package, sell, offer to sell, distribute, or
import for sale or distribution within the United States any
cigarettes the package of which fails to bear, in accordance
with the requirements of this section, one of the following
labels:
``WARNING: Cigarettes are addictive.
``WARNING: Tobacco smoke can harm your children.
``WARNING: Cigarettes cause fatal lung disease.
``WARNING: Cigarettes cause cancer.
``WARNING: Cigarettes cause strokes and heart disease.
``WARNING: Smoking during pregnancy can harm your baby.
``WARNING: Smoking can kill you.
``WARNING: Tobacco smoke causes fatal lung disease in
nonsmokers.
[[Page H4336]]
``WARNING: Quitting smoking now greatly reduces serious
risks to your health.
``(2) Placement; typography; etc.--Each label statement
required by paragraph (1) shall be located in the upper
portion of the front and rear panels of the package, directly
on the package underneath the cellophane or other clear
wrapping. Each label statement shall comprise at least the
top 30 percent of the front and rear panels of the package.
The word `WARNING' shall appear in capital letters and all
text shall be in conspicuous and legible 17-point type,
unless the text of the label statement would occupy more than
70 percent of such area, in which case the text may be in a
smaller conspicuous and legible type size, provided that at
least 60 percent of such area is occupied by required text.
The text shall be black on a white background, or white on a
black background, in a manner that contrasts, by typography,
layout, or color, with all other printed material on the
package, in an alternating fashion under the plan submitted
under subsection (c).
``(3) Does not apply to foreign distribution.--The
provisions of this subsection do not apply to a tobacco
product manufacturer or distributor of cigarettes which does
not manufacture, package, or import cigarettes for sale or
distribution within the United States.
``(4) Applicability to retailers.--A retailer of cigarettes
shall not be in violation of this subsection for packaging
that--
``(A) contains a warning label;
``(B) is supplied to the retailer by a license- or permit-
holding tobacco product manufacturer, importer, or
distributor; and
``(C) is not altered by the retailer in a way that is
material to the requirements of this subsection.
``(b) Advertising Requirements.--
``(1) In general.--It shall be unlawful for any tobacco
product manufacturer, importer, distributor, or retailer of
cigarettes to advertise or cause to be advertised within the
United States any cigarette unless its advertising bears, in
accordance with the requirements of this section, one of the
labels specified in subsection (a).
``(2) Typography, etc.--Each label statement required by
subsection (a) in cigarette advertising shall comply with the
standards set forth in this paragraph. For press and poster
advertisements, each such statement and (where applicable)
any required statement relating to tar, nicotine, or other
constituent (including a smoke constituent) yield shall
comprise at least 20 percent of the area of the advertisement
and shall appear in a conspicuous and prominent format and
location at the top of each advertisement within the trim
area. The Secretary may revise the required type sizes in
such area in such manner as the Secretary determines
appropriate. The word `WARNING' shall appear in capital
letters, and each label statement shall appear in conspicuous
and legible type. The text of the label statement shall be
black if the background is white and white if the background
is black, under the plan submitted under subsection (c). The
label statements shall be enclosed by a rectangular border
that is the same color as the letters of the statements and
that is the width of the first downstroke of the capital `W'
of the word `WARNING' in the label statements. The text of
such label statements shall be in a typeface pro rata to the
following requirements: 45-point type for a whole-page
broadsheet newspaper advertisement; 39-point type for a half-
page broadsheet newspaper advertisement; 39-point type for a
whole-page tabloid newspaper advertisement; 27-point type for
a half-page tabloid newspaper advertisement; 31.5-point type
for a double page spread magazine or whole-page magazine
advertisement; 22.5-point type for a 28 centimeter by 3
column advertisement; and 15-point type for a 20 centimeter
by 2 column advertisement. The label statements shall be in
English, except that--
``(A) in the case of an advertisement that appears in a
newspaper, magazine, periodical, or other publication that is
not in English, the statements shall appear in the
predominant language of the publication; and
``(B) in the case of any other advertisement that is not in
English, the statements shall appear in the same language as
that principally used in the advertisement.
``(3) Matchbooks.--Notwithstanding paragraph (2), for
matchbooks (defined as containing not more than 20 matches)
customarily given away with the purchase of tobacco products,
each label statement required by subsection (a) may be
printed on the inside cover of the matchbook.
``(4) Adjustment by secretary.--The Secretary may, through
a rulemaking under section 553 of title 5, United States
Code, adjust the format and type sizes for the label
statements required by this section; the text, format, and
type sizes of any required tar, nicotine yield, or other
constituent (including smoke constituent) disclosures; or the
text, format, and type sizes for any other disclosures
required under the Federal Food, Drug, and Cosmetic Act. The
text of any such label statements or disclosures shall be
required to appear only within the 20 percent area of
cigarette advertisements provided by paragraph (2). The
Secretary shall promulgate regulations which provide for
adjustments in the format and type sizes of any text required
to appear in such area to ensure that the total text required
to appear by law will fit within such area.
``(c) Marketing Requirements.--
``(1) Random display.--The label statements specified in
subsection (a)(1) shall be randomly displayed in each 12-
month period, in as equal a number of times as is possible on
each brand of the product and be randomly distributed in all
areas of the United States in which the product is marketed
in accordance with a plan submitted by the tobacco product
manufacturer, importer, distributor, or retailer and approved
by the Secretary.
``(2) Rotation.--The label statements specified in
subsection (a)(1) shall be rotated quarterly in alternating
sequence in advertisements for each brand of cigarettes in
accordance with a plan submitted by the tobacco product
manufacturer, importer, distributor, or retailer to, and
approved by, the Secretary.
``(3) Review.--The Secretary shall review each plan
submitted under paragraph (2) and approve it if the plan--
``(A) will provide for the equal distribution and display
on packaging and the rotation required in advertising under
this subsection; and
``(B) assures that all of the labels required under this
section will be displayed by the tobacco product
manufacturer, importer, distributor, or retailer at the same
time.
``(4) Applicability to retailers.--This subsection and
subsection (b) apply to a retailer only if that retailer is
responsible for or directs the label statements required
under this section except that this paragraph shall not
relieve a retailer of liability if the retailer displays, in
a location open to the public, an advertisement that does not
contain a warning label or has been altered by the retailer
in a way that is material to the requirements of this
subsection and subsection (b).''.
(b) Effective Date.--The amendment made by subsection (a)
shall take effect 12 months after the date of enactment of
this Act. Such effective date shall be with respect to the
date of manufacture, provided that, in any case, beginning 30
days after such effective date, a manufacturer shall not
introduce into the domestic commerce of the United States any
product, irrespective of the date of manufacture, that is not
in conformance with section 4 of the Federal Cigarette
Labeling and Advertising Act (15 U.S.C. 1333), as amended by
subsection (a).
SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING LABEL
STATEMENTS.
(a) Preemption.--Section 5(a) of the Federal Cigarette
Labeling and Advertising Act (15 U.S.C. 1334(a)) is amended
by striking ``No'' and inserting ``Except to the extent the
Secretary requires additional or different statements on any
cigarette package by a regulation, by an order, by a
standard, by an authorization to market a product, or by a
condition of marketing a product, pursuant to the Family
Smoking Prevention and Tobacco Control Act (and the
amendments made by that Act), or as required under section
903(a)(2) or section 920(a) of the Federal Food, Drug, and
Cosmetic Act, no''.
(b) Change in Required Statements.--Section 4 of the
Federal Cigarette Labeling and Advertising Act (15 U.S.C.
1333), as amended by section 201, is further amended by
adding at the end the following:
``(d) Change in Required Statements.--The Secretary may, by
a rulemaking conducted under section 553 of title 5, United
States Code, adjust the format, type size, and text of any of
the label requirements, require color graphics to accompany
the text, increase the required label area from 30 percent up
to 50 percent of the front and rear panels of the package, or
establish the format, type size, and text of any other
disclosures required under the Federal Food, Drug, and
Cosmetic Act, if the Secretary finds that such a change would
promote greater public understanding of the risks associated
with the use of tobacco products.''.
SEC. 203. STATE REGULATION OF CIGARETTE ADVERTISING AND
PROMOTION.
Section 5 of the Federal Cigarette Labeling and Advertising
Act (15 U.S.C. 1334) is amended by adding at the end the
following:
``(c) Exception.--Notwithstanding subsection (b), a State
or locality may enact statutes and promulgate regulations,
based on smoking and health, that take effect after the
effective date of the Family Smoking Prevention and Tobacco
Control Act, imposing specific bans or restrictions on the
time, place, and manner, but not content, of the advertising
or promotion of any cigarettes.''.
SEC. 204. SMOKELESS TOBACCO LABELS AND ADVERTISING WARNINGS.
(a) Amendment.--Section 3 of the Comprehensive Smokeless
Tobacco Health Education Act of 1986 (15 U.S.C. 4402) is
amended to read as follows:
``SEC. 3. SMOKELESS TOBACCO WARNING.
``(a) General Rule.--
``(1) It shall be unlawful for any person to manufacture,
package, sell, offer to sell, distribute, or import for sale
or distribution within the United States any smokeless
tobacco product unless the product package bears, in
accordance with the requirements of this Act, one of the
following labels:
``WARNING: This product can cause mouth cancer.
``WARNING: This product can cause gum disease and tooth
loss.
``WARNING: This product is not a safe alternative to
cigarettes.
``WARNING: Smokeless tobacco is addictive.
``(2) Each label statement required by paragraph (1) shall
be--
``(A) located on the 2 principal display panels of the
package, and each label statement shall comprise at least 30
percent of each such display panel; and
[[Page H4337]]
``(B) in 17-point conspicuous and legible type and in black
text on a white background, or white text on a black
background, in a manner that contrasts by typography, layout,
or color, with all other printed material on the package, in
an alternating fashion under the plan submitted under
subsection (b)(3), except that if the text of a label
statement would occupy more than 70 percent of the area
specified by subparagraph (A), such text may appear in a
smaller type size, so long as at least 60 percent of such
warning area is occupied by the label statement.
``(3) The label statements required by paragraph (1) shall
be introduced by each tobacco product manufacturer, packager,
importer, distributor, or retailer of smokeless tobacco
products concurrently into the distribution chain of such
products.
``(4) The provisions of this subsection do not apply to a
tobacco product manufacturer or distributor of any smokeless
tobacco product that does not manufacture, package, or import
smokeless tobacco products for sale or distribution within
the United States.
``(5) A retailer of smokeless tobacco products shall not be
in violation of this subsection for packaging that--
``(A) contains a warning label;
``(B) is supplied to the retailer by a license- or permit-
holding tobacco product manufacturer, importer, or
distributor; and
``(C) is not altered by the retailer in a way that is
material to the requirements of this subsection.
``(b) Required Labels.--
``(1) It shall be unlawful for any tobacco product
manufacturer, packager, importer, distributor, or retailer of
smokeless tobacco products to advertise or cause to be
advertised within the United States any smokeless tobacco
product unless its advertising bears, in accordance with the
requirements of this section, one of the labels specified in
subsection (a).
``(2)(A) Each label statement required by subsection (a) in
smokeless tobacco advertising shall comply with the standards
set forth in this paragraph.
``(B) For press and poster advertisements, each such
statement and (where applicable) any required statement
relating to tar, nicotine, or other constituent yield shall
comprise at least 20 percent of the area of the
advertisement.
``(C) The word `WARNING' shall appear in capital letters,
and each label statement shall appear in conspicuous and
legible type.
``(D) The text of the label statement shall be black on a
white background, or white on a black background, in an
alternating fashion under the plan submitted under paragraph
(3).
``(E) The label statements shall be enclosed by a
rectangular border that is the same color as the letters of
the statements and that is the width of the first downstroke
of the capital `W' of the word `WARNING' in the label
statements.
``(F) The text of such label statements shall be in a
typeface pro rata to the following requirements: 45-point
type for a whole-page broadsheet newspaper advertisement; 39-
point type for a half-page broadsheet newspaper
advertisement; 39-point type for a whole-page tabloid
newspaper advertisement; 27-point type for a half-page
tabloid newspaper advertisement; 31.5-point type for a double
page spread magazine or whole-page magazine advertisement;
22.5-point type for a 28 centimeter by 3 column
advertisement; and 15-point type for a 20 centimeter by 2
column advertisement.
``(G) The label statements shall be in English, except
that--
``(i) in the case of an advertisement that appears in a
newspaper, magazine, periodical, or other publication that is
not in English, the statements shall appear in the
predominant language of the publication; and
``(ii) in the case of any other advertisement that is not
in English, the statements shall appear in the same language
as that principally used in the advertisement.
``(3)(A) The label statements specified in subsection
(a)(1) shall be randomly displayed in each 12-month period,
in as equal a number of times as is possible on each brand of
the product and be randomly distributed in all areas of the
United States in which the product is marketed in accordance
with a plan submitted by the tobacco product manufacturer,
importer, distributor, or retailer and approved by the
Secretary.
``(B) The label statements specified in subsection (a)(1)
shall be rotated quarterly in alternating sequence in
advertisements for each brand of smokeless tobacco product in
accordance with a plan submitted by the tobacco product
manufacturer, importer, distributor, or retailer to, and
approved by, the Secretary.
``(C) The Secretary shall review each plan submitted under
subparagraphs (A) and (B) and approve it if the plan--
``(i) will provide for the equal distribution and display
on packaging and the rotation required in advertising under
this subsection; and
``(ii) assures that all of the labels required under this
section will be displayed by the tobacco product
manufacturer, importer, distributor, or retailer at the same
time.
``(D) This paragraph applies to a retailer only if that
retailer is responsible for or directs the label statements
under this section, unless the retailer displays, in a
location open to the public, an advertisement that does not
contain a warning label or has been altered by the retailer
in a way that is material to the requirements of this
subsection.
``(4) The Secretary may, through a rulemaking under section
553 of title 5, United States Code, adjust the format and
type sizes for the label statements required by this section;
the text, format, and type sizes of any required tar,
nicotine yield, or other constituent disclosures; or the
text, format, and type sizes for any other disclosures
required under the Federal Food, Drug, and Cosmetic Act. The
text of any such label statements or disclosures shall be
required to appear only within the 20 percent area of
advertisements provided by paragraph (2). The Secretary shall
promulgate regulations which provide for adjustments in the
format and type sizes of any text required to appear in such
area to ensure that the total text required to appear by law
will fit within such area.
``(c) Television and Radio Advertising.--It is unlawful to
advertise smokeless tobacco on any medium of electronic
communications subject to the jurisdiction of the Federal
Communications Commission.''.
(b) Effective Date.--The amendment made by subsection (a)
shall take effect 12 months after the date of enactment of
this Act. Such effective date shall be with respect to the
date of manufacture, provided that, in any case, beginning 30
days after such effective date, a manufacturer shall not
introduce into the domestic commerce of the United States any
product, irrespective of the date of manufacture, that is not
in conformance with section 3 of the Comprehensive Smokeless
Tobacco Health Education Act of 1986 (15 U.S.C. 4402), as
amended by subsection (a)
SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT
WARNING LABEL STATEMENTS.
(a) In General.--Section 3 of the Comprehensive Smokeless
Tobacco Health Education Act of 1986 (15 U.S.C. 4402), as
amended by section 204, is further amended by adding at the
end the following:
``(d) Authority To Revise Warning Label Statements.--The
Secretary may, by a rulemaking conducted under section 553 of
title 5, United States Code, adjust the format, type size,
and text of any of the label requirements, require color
graphics to accompany the text, increase the required label
area from 30 percent up to 50 percent of the front and rear
panels of the package, or establish the format, type size,
and text of any other disclosures required under the Federal
Food, Drug, and Cosmetic Act, if the Secretary finds that
such a change would promote greater public understanding of
the risks associated with the use of smokeless tobacco
products.''.
(b) Preemption.--Section 7(a) of the Comprehensive
Smokeless Tobacco Health Education Act of 1986 (15 U.S.C.
4406(a)) is amended by striking ``No'' and inserting ``Except
as provided in the Family Smoking Prevention and Tobacco
Control Act (and the amendments made by that Act), no''.
SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT
DISCLOSURE TO THE PUBLIC.
Section 4 of the Federal Cigarette Labeling and Advertising
Act (15 U.S.C. 1333), as amended by sections 201 and 202, is
further amended by adding at the end the following:
``(e) Tar, Nicotine, and Other Smoke Constituent
Disclosure.--
``(1) In general.--The Secretary shall, by a rulemaking
conducted under section 553 of title 5, United States Code,
determine (in the Secretary's sole discretion) whether
cigarette and other tobacco product manufacturers shall be
required to include in the area of each cigarette
advertisement specified by subsection (b) of this section, or
on the package label, or both, the tar and nicotine yields of
the advertised or packaged brand. Any such disclosure shall
be in accordance with the methodology established under such
regulations, shall conform to the type size requirements of
subsection (b) of this section, and shall appear within the
area specified in subsection (b) of this section.
``(2) Resolution of differences.--Any differences between
the requirements established by the Secretary under paragraph
(1) and tar and nicotine yield reporting requirements
established by the Federal Trade Commission shall be resolved
by a memorandum of understanding between the Secretary and
the Federal Trade Commission.
``(3) Cigarette and other tobacco product constituents.--In
addition to the disclosures required by paragraph (1), the
Secretary may, under a rulemaking conducted under section 553
of title 5, United States Code, prescribe disclosure
requirements regarding the level of any cigarette or other
tobacco product constituent including any smoke constituent.
Any such disclosure may be required if the Secretary
determines that disclosure would be of benefit to the public
health, or otherwise would increase consumer awareness of the
health consequences of the use of tobacco products, except
that no such prescribed disclosure shall be required on the
face of any cigarette package or advertisement. Nothing in
this section shall prohibit the Secretary from requiring such
prescribed disclosure through a cigarette or other tobacco
product package or advertisement insert, or by any other
means under the Federal Food, Drug, and Cosmetic Act.
``(4) Retailers.--This subsection applies to a retailer
only if that retailer is responsible
[[Page H4338]]
for or directs the label statements required under this
section.''.
TITLE III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS
SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPECTION.
Chapter IX of the Federal Food, Drug, and Cosmetic Act, as
added by section 101, is further amended by adding at the end
the following:
``SEC. 920. LABELING, RECORDKEEPING, RECORDS INSPECTION.
``(a) Origin Labeling.--
``(1) Requirement.--Beginning 1 year after the date of
enactment of the Family Smoking Prevention and Tobacco
Control Act, the label, packaging, and shipping containers of
tobacco products for introduction or delivery for
introduction into interstate commerce in the United States
shall bear the statement `sale only allowed in the United
States'.
``(2) Effective date.--The effective date specified in
paragraph (1) shall be with respect to the date of
manufacture, provided that, in any case, beginning 30 days
after such effective date, a manufacturer shall not introduce
into the domestic commerce of the United States any product,
irrespective of the date of manufacture, that is not in
conformance with such paragraph.
``(b) Regulations Concerning Recordkeeping for Tracking and
Tracing.--
``(1) In general.--The Secretary shall promulgate
regulations regarding the establishment and maintenance of
records by any person who manufactures, processes,
transports, distributes, receives, packages, holds, exports,
or imports tobacco products.
``(2) Inspection.--In promulgating the regulations
described in paragraph (1), the Secretary shall consider
which records are needed for inspection to monitor the
movement of tobacco products from the point of manufacture
through distribution to retail outlets to assist in
investigating potential illicit trade, smuggling, or
counterfeiting of tobacco products.
``(3) Codes.--The Secretary may require codes on the labels
of tobacco products or other designs or devices for the
purpose of tracking or tracing the tobacco product through
the distribution system.
``(4) Size of business.--The Secretary shall take into
account the size of a business in promulgating regulations
under this section.
``(5) Recordkeeping by retailers.--The Secretary shall not
require any retailer to maintain records relating to
individual purchasers of tobacco products for personal
consumption.
``(c) Records Inspection.--If the Secretary has a
reasonable belief that a tobacco product is part of an
illicit trade or smuggling or is a counterfeit product, each
person who manufactures, processes, transports, distributes,
receives, holds, packages, exports, or imports tobacco
products shall, at the request of an officer or employee duly
designated by the Secretary, permit such officer or employee,
at reasonable times and within reasonable limits and in a
reasonable manner, upon the presentation of appropriate
credentials and a written notice to such person, to have
access to and copy all records (including financial records)
relating to such article that are needed to assist the
Secretary in investigating potential illicit trade,
smuggling, or counterfeiting of tobacco products. The
Secretary shall not authorize an officer or employee of the
government of any of the several States to exercise authority
under the preceding sentence on Indian country without the
express written consent of the Indian tribe involved.
``(d) Knowledge of Illegal Transaction.--
``(1) Notification.--If the manufacturer or distributor of
a tobacco product has knowledge which reasonably supports the
conclusion that a tobacco product manufactured or distributed
by such manufacturer or distributor that has left the control
of such person may be or has been--
``(A) imported, exported, distributed, or offered for sale
in interstate commerce by a person without paying duties or
taxes required by law; or
``(B) imported, exported, distributed, or diverted for
possible illicit marketing,
the manufacturer or distributor shall promptly notify the
Attorney General and the Secretary of the Treasury of such
knowledge.
``(2) Knowledge defined.--For purposes of this subsection,
the term `knowledge' as applied to a manufacturer or
distributor means--
``(A) the actual knowledge that the manufacturer or
distributor had; or
``(B) the knowledge which a reasonable person would have
had under like circumstances or which would have been
obtained upon the exercise of due care.
``(e) Consultation.--In carrying out this section, the
Secretary shall consult with the Attorney General of the
United States and the Secretary of the Treasury, as
appropriate.''.
SEC. 302. STUDY AND REPORT.
(a) Study.--The Comptroller General of the United States
shall conduct a study of cross-border trade in tobacco
products to--
(1) collect data on cross-border trade in tobacco products,
including illicit trade and trade of counterfeit tobacco
products and make recommendations on the monitoring of such
trade;
(2) collect data on cross-border advertising (any
advertising intended to be broadcast, transmitted, or
distributed from the United States to another country) of
tobacco products and make recommendations on how to prevent
or eliminate, and what technologies could help facilitate the
elimination of, cross-border advertising; and
(3) collect data on the health effects (particularly with
respect to individuals under 18 years of age) resulting from
cross-border trade in tobacco products, including the health
effects resulting from--
(A) the illicit trade of tobacco products and the trade of
counterfeit tobacco products; and
(B) the differing tax rates applicable to tobacco products.
(b) Report.--Not later than 18 months after the date of
enactment of this Act, the Comptroller General of the United
States shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives a report on the
study described in subsection (a).
(c) Definition.--In this section:
(1) The term ``cross-border trade'' means trade across a
border of the United States, a State or Territory, or Indian
country.
(2) The term ``Indian country'' has the meaning given to
such term in section 1151 of title 18, United States Code.
(3) The terms ``State'' and ``Territory'' have the meanings
given to those terms in section 201 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321).
The SPEAKER pro tempore. After 1 hour of debate on the bill, as
amended, it shall be in order to consider the amendment in the nature
of a substitute printed in part B of the report, if ordered by the
gentleman from Indiana (Mr. Buyer) or his designee, which shall be in
order without intervention of any point of order, shall be considered
read, and shall be debatable for 30 minutes equally divided and
controlled by the proponent and an opponent.
The gentleman from California (Mr. Waxman) and the gentleman from
Indiana (Mr. Buyer) each will control 30 minutes.
The Chair recognizes the gentleman from California.
Mr. WAXMAN. Mr. Speaker, I yield myself such time as I may consume in
debating this legislation.
Mr. Speaker, and my colleagues, we have come to what I hope will be
an historic occasion, and that is finally doing something about the
harm that tobacco does to thousands and thousands of Americans who die
each year, and to stop the attempt to get our children to smoke. But it
has taken us far too long to get to this point.
In 1994, the tobacco executives stood up before my subcommittee, they
raised their hand, and they said they were going to tell the truth.
They swore under oath, though, that nicotine was not addictive. They
also said cigarettes were not harmful. They also said they didn't
manipulate nicotine. They also said that they would never target kids.
And, it turned out, they were not telling us the truth.
In 1996, the Food and Drug Administration tried to regulate tobacco
products, but the Supreme Court told them that they needed Congress to
give them specific legal authority. Now, 13 years later, here we are
finally giving FDA that authority to regulate the leading preventable
cause of death in America.
Every one of us has seen the devastating effects of tobacco through
losing someone we love, watching others grow sick, or even feeling the
grip of addiction firsthand. Worst of all is watching our children and
grandchildren be targeted as the next wave of casualties.
Regulating tobacco is the single most important thing we can do right
now to curb this deadly toll, and FDA is the only agency with the right
combination of scientific expertise, regulatory experience, and public
health mission to oversee these products effectively.
This legislation will direct the Food and Drug Administration to end
the marketing and sales of tobacco to kids; to prevent manufacturers
from calling cigarettes ``light'' or ``less dangerous'' when in fact
they are not; and to require changes to what is in cigarettes, like
toxic ingredients such as formaldehyde, benzene, radioactive elements,
and other deadly chemicals.
{time} 1930
Some have objected that this bill is too big a challenge for an
already overburdened FDA. But it is clear to me that FDA's recent
struggles are primarily a result of years of chronic underfunding. This
does not mean that FDA, with strong and committed leadership, cannot
take on the critical role of protecting the country against the harms
of tobacco. It simply means that when we give the agency this new
responsibility, we also must give it the
[[Page H4339]]
resources necessary to do the job and to do it well.
We have ensured that this will happen. The tobacco program will be
fully funded through a new user fee paid for by the industry. That
money will go exclusively to the new tobacco center and will be enough
for FDA to handle this task well. Furthermore, by doing so, we will
ensure that the new tobacco program will have no impact on other
missions at the Food And Drug Administration.
In short, we have everything we need to take this historic step: A
comprehensive and flexible set of new authorities and full, certain
funding. All we need now is the political will to do the right thing.
The breadth of support for this bill, from the AARP to the American
Academy of Pediatrics, from the Southern Baptist Convention to the
Islamic Society of North America, shows just how critical this issue is
to all Americans. It is also supported by the American Lung
Association, the American Heart Association and the American Cancer
Society, the groups that are best situated to understand the damage
caused by tobacco.
I also want to note that we have worked hard to accommodate specific
concerns that we have heard about this bill. In committee consideration
of the bill last year, we made changes to ensure fairness and
flexibility for convenience stores, tobacco growers and small
manufacturers, and we worked with the minority to incorporate their
suggestions. We also worked with members of the Congressional Black
Caucus to ensure that menthol cigarettes will be an early focus of the
agency's attention and the agency has the authority to deal with these
and other products.
I want to thank my colleague, Todd Platts, for his strong leadership
and dedication to working on this legislation, as well as John Dingell
and Frank Pallone for their diligent work in moving this bill forward
over the years. I also want to thank Ed Towns, Stephen Lynch and Ike
Skelton, all of whom were critical in getting us to this point. Each of
these individuals has made this possible and produced a great victory
for all Americans, especially our children.
I urge the passage of this legislation.
I reserve the balance of my time.
Mr. BUYER. I yield myself such time as I may consume.
I would note that the gentleman read a list of individuals that
supports his bill. But what he left off the list and the prior speaker
under the rule, the gentleman from Colorado, was very critical of the
tobacco companies. But Altria supports the Waxman bill. Now what is
interesting about this is I would ask the gentleman from Colorado, he
was so critical of tobacco, but obviously he didn't know that a tobacco
company was supporting the Waxman bill.
I truly believe in my heart, since I had written Altria, and they
have sent me a letter here in response to the substitute, H.R. 1261, I
truly believe that had they not endorsed the Waxman bill 8 years ago
that they would be endorsing this bill. And the reason I say that, I
just find it in my heart, they let me know in their bill dated to me by
the chairman and chief executive of Altria, he says, ``We specifically
support H.R. 1266 and supported its predecessor bills for more than 8
years.'' That is the Waxman bill. But he goes on further in his letter,
and he says, ``Your letter seeks our input on several aspects of
tobacco regulation. You recently introduced H.R. 1261, including harm
reduction, product design standards and the appropriate public health
standard for tobacco regulation. Before addressing these topics more
specifically,'' and they do that in the letter, he said, ``I want to
commend your thoughtful leadership on the topic of comprehensive
tobacco regulation. Your focus on H.R. 1261 on harm reduction
strategies will, we believe, encourage further meaningful conversation
about how Federal regulators should exercise authority over tobacco
products. We especially appreciate the focus you are bringing in the
public policy debate in an important principle that regulation should
ensure and certainly not discourage adult consumers access to accurate,
objective and non-misleading information about the relative risks of
all tobacco products. We have consistently expressed our view that it
would be wrong for the Federal regulatory framework to deny adult
tobacco consumers access to information about potential benefits to
products that could ultimately reduce the harm caused by smoking.''
Now that is the harm-reduction strategy that we have incorporated in
this bipartisan bill. And so I wanted to bring that to everyone's
attention that this harm-reduction strategy is extremely important. We
should not have this abstinence approach that is in the Waxman bill.
Now this was an approach that was drafted many, many years ago, and a
lot of things have taken place since Mr. Waxman drafted this bill. And
he is not taking these things into account. I respect the gentleman. I
respect his efforts. I respect his tenacity and his persistence. And
hopefully we will have a meeting of the minds one day, and we can
incorporate both of our dual-tracked efforts here to move people to
stop smoking.
The supporters of the Waxman bill, as I noted from some of the
speakers, they claim that it is designed to protect children from the
dangers of smoking. But H.R. 1256 does not include any provision that
actually protects minors from tobacco use. The American Association of
Public Health Physicians wrote on March 3, 2009, ``The current bill,
the bill which is before us and being debated, referred to as the
Waxman bill, H.R. 1256, in its current form would ensure current levels
of tobacco-related deaths while doing nothing of significance to reduce
the number of teens who would initiate tobacco use with no bill at
all.''
You see, those of whom are supporting the substitute, we support
steps to require the States to use more of their Master Settlement
Agreement funds to combat underage smoking and promote smoking
cessation while also strengthening the Synar amendment which prevents
the underage purchasing of cigarettes. Unfortunately, H.R. 1256 does
not contain these important public health provisions.
With that, I reserve the balance of my time.
Mr. WAXMAN. Mr. Speaker, I yield to the gentleman from North Carolina
(Mr. Etheridge).
Mr. ETHERIDGE. I thank the gentleman. I would like to engage the
chairman in a colloquy to address the issue of FDA and tobacco farmers.
I represent one of the largest tobacco-producing districts in the
Nation, so naturally I have a lot of farmers who are very concerned
about how they might be affected by this legislation.
Mr. Chairman, my question to you is, does this bill in any way
authorize the FDA to regulate tobacco farms?
Mr. WAXMAN. I thank you for the question, Mr. Etheridge. This is an
important question, especially for those who represent tobacco-growing
districts. There has been some confusion about this point, so let me be
clear. It is not the intent of this bill to allow FDA on the farm. The
bill gives FDA the authority to regulate tobacco products but not
tobacco leaf.
Mr. ETHERIDGE. I thank you for that.
And does the bill specifically state that FDA's regulatory authority
would only apply to manufactured tobacco products and not the
traditional production and harvest methods on the farm?
Mr. WAXMAN. The gentleman is correct.
Mr. ETHERIDGE. I thank the chairman.
Mr. Waxman, I thank you for that, and I thank you for the
clarification that this is a bill intended to protect our children and
not to regulate tobacco farmers. Tobacco is a critical crop in North
Carolina's economy and has been for a long time. I look forward to
continuing to working with you to help North Carolina farmers preserve
their jobs and their livelihood.
Mr. WAXMAN. I reserve the balance of my time.
Mr. BUYER. I yield myself such time as I may consume.
The gentleman just spoke about his concern with regard to product
standards. It is one of the chief concerns in the Waxman bill. The
provisions on product standards allow the FDA to impose any
requirements or prohibitions it sees fit, except that it may not ban
the product or reduce nicotine delivery to zero. FDA need not consider
the cost or feasibility of imposing a standard. FDA does have to
consider
[[Page H4340]]
the possibility of a black market, but can impose a standard even if it
will lead to the creation or expansion of a black market. That should
concern everyone with regard to illicit trade.
The Waxman bill also prevents communication about significant
differences among levels of risk presented by different types of
tobacco products, and it clamps down on any effects to develop and
market modified-risk tobacco products. Modified-risk tobacco products
are defined as any existing or new product that bears a claim or where
the manufacturer conveys to consumers through media or otherwise that:
It presents a lower risk or is less harmful than other tobacco
products; has a reduced level of substance or reduced exposure to a
substance; is free of or does not contain a substance; or uses the
descriptor ``light,'' ``mild'' or ``low'' or a similar descriptor.
Approval of a modified-risk product requires under the Waxman bill
that the product will significantly reduce harm and the risk of disease
to the individual users and that approval benefits the health of the
population as a whole. You see, this is a two-tier standard and is
almost impossible or nearly impossible to satisfy. So I completely
understand why the gentleman came to the floor concerned about product
standards. So if you want to embrace a harm-reduction strategy to
migrate people from smoking down the continuum of risk to eventually
quitting, the Waxman bill does not permit that. We don't permit the
innovation of science to drive people to lower-risk products. And that
is what the substitute tries to do.
With that, I will yield to the gentleman, the ranking Republican,
Lamar Smith of Texas, such time as he may consume.
Mr. SMITH of Texas. Mr. Speaker, I thank my colleague from Indiana
for yielding me time.
Mr. Speaker, H.R. 1256 directs the Secretary of HHS to promulgate an
interim final rule that is identical to the FDA's 1996 rule, which
legal experts from across the political spectrum have stated would
violate the first amendment.
While these experts' views should carry great weight, even more
persuasive is the fact that the U.S. Supreme Court also has weighed in
on various provisions of the rule, finding them unconstitutional. In
Lorillard Tobacco v. Reilly, the U.S. Supreme Court struck down a
Massachusetts statute that was similar in many ways to the FDA's
proposed rule. The statute banned outdoor ads within 1,000 feet of
schools, parks and playgrounds and also restricted point-of-sale
advertising for tobacco products.
The Court held that this regulation ran afoul of the test established
in the Central Hudson case, which defines the protection afforded
commercial speech under the first amendment, as it was not sufficiently
narrowly tailored and would have disparate impacts from community to
community.
The Court then noted that since the Massachusetts statute was based
on the FDA's rule, the FDA rule would have similar constitutional
problems. As Justice Sandra Day O'Connor wrote for the court, ``The
uniformly broad sweep of the geographical limitation demonstrates a
lack of tailoring.''
Additionally, the proposed rule in H.R. 1256 would require ads to use
only black text on a white background. The U.S. Supreme Court found a
similar provision unconstitutional in Zauderer v. Office of
Disciplinary Counsel. In that case, dealing with advertising for legal
services, the Court held that the use of colors and illustrations in
ads is entitled to the same first amendment protections given verbal
commercial speech.
Justice Byron White, in his opinion for the Court, wrote that
pictures and illustrations in ads cannot be banned ``simply on the
strength of the general argument that the visual content of
advertisements may, under some circumstances, be deceptive or
manipulative.''
So there are numerous speech restrictions in this legislation that
raise serious first amendment concerns. This will create a swarm of
lawsuits that will only divert us from trying to develop more effective
approaches to tobacco use in the United States.
To include speech restrictions that a broad range of legal experts
have stated are almost certain to be unconstitutional fatally taints
this bill.
{time} 1945
I know the bill is well-intentioned, but I hope my colleagues will
support the alternative offered by the gentleman from Indiana (Mr.
Buyer).
Mr. BUYER. I reserve the balance of my time.
Mr. WAXMAN. I am including in the Record an exchange of letters on
H.R. 1256 between the chairman of the Committee on the Judiciary and
myself.
Committee on the Judiciary,
Washington, DC, March 24, 2009.
Hon. Henry A. Waxman,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Chairman Waxman: This is to advise you that, as a
result of your having worked with us to appropriately craft
provisions in H.R. 1256, the ``Family Smoking Prevention and
Tobacco Control Act,'' that fall within the rule X
jurisdiction of the Committee on the Judiciary, we are able
to agree to discharging our committee from further
consideration of the bill in order that it may proceed
without delay to the House floor for consideration.
The Judiciary Committee takes this action with the
understanding that by foregoing further consideration of H.R.
1256 at this time, we do not waive any jurisdiction over
subject matter contained in this or similar legislation. We
also reserve the right to seek appointment of an appropriate
number of conferees to any House-Senate conference involving
this important legislation, and request your support if such
a request is made.
I would appreciate your including this letter in the
Congressional Record during consideration of the bill on the
House floor. Thank you for your attention to this request,
and for the cooperative relationship between our two
committees.
Sincerely,
John Conyers, Jr.,
Chairman.
____
Congress of the United States,
Committee on Energy and Commerce,
Washington, DC, March 25, 2009.
Hon. John Conyers,
Chairman, Committee on the Judiciary,
Washington, DC.
Dear Chairman Conyers: Thank you for your letter regarding
H.R. 1256, the ``Family Smoking Prevention and Tobacco
Control Act.'' The letter noted that certain provisions of
the bill are within the jurisdiction of the Committee on the
Judiciary under rule X of the Rules of the House.
The Committee on Energy and Commerce recognizes the
jurisdictional interest of the Committee on the Judiciary in
these provisions. We further appreciate your agreement to
forgo action on the bill, and I concur that the agreement
does not in any way prejudice the Committee on the Judiciary
with respect to the appointment of conferees or its
jurisdictional prerogatives on this bill or similar
legislation in the future.
I will include our letters in the Congressional Record
during consideration of the bill on the House floor. Again I
appreciate your cooperation regarding this important
legislation.
Sincerely,
Henry A. Waxman
I reserve the balance of my time.
Mr. BUYER. I would yield now 3 minutes to Dr. Gingrey, the gentleman
from Georgia.
Mr. GINGREY of Georgia. Mr. Speaker, I thank the gentleman for
yielding. And I certainly want to pay tribute to Chairman Waxman in
regard to the work that he has done over these many years, 10, at
least, in regard to trying to help our society rid themselves of,
really, the scourge of smoking cigarettes and many health care problems
that that leads to. I don't think that there's any question in
anybody's mind about that. And certainly the Surgeon General's warning,
very profound, clear warning on a package of cigarettes, should bring
their attention to that every time they light up, whether we're talking
about young adults or at any age group. And leading to lung cancer and
chronic obstructive pulmonary disease, maybe better known as emphysema.
So I commend Chairman Waxman very much. I think his heart is in the
right place, and what he's trying to do is very credible.
But I do feel that Representative Buyer, from Indiana, and his
substitute amendment, will be presented shortly. I really feel, Mr.
Speaker, that this is very likely a better way. And so I do rise in
strong support of the Buyer amendment in the nature of a substitute.
Despite decades of intense efforts to eradicate the practice, still
more than 40 million American adults continue to smoke cigarettes, and
that is likely to remain the case, unfortunately, for decades to come.
All tobacco products are harmful, but the health risks associated
with cigarettes are significantly greater than those associated with
the use of smoke-
[[Page H4341]]
free tobacco and nicotine-only products.
So, given these facts, an increasing number of public health experts
advocate adopting a tobacco ``harm-reduction'' approach like that
proposed in the Buyer amendment that will lower the health risks
associated with using tobacco or nicotine.
A growing body of science shows that smokers who switch to smokeless
tobacco products can significantly decrease their risk of tobacco-
related illness and death.
A World Health Organization Study Group wrote last year that:
``Smokeless tobacco products do not cause the lung diseases causally
associated with the use of combusted tobacco products such as
cigarettes, pipes and cigars.''
Scientific studies show that even the risk for cancers of the mouth
and the throat are higher for smokers than for those who use tobacco
products that do not burn. Year after year, this body has considered
tobacco regulation that fails to recognize the significant progress
that can be achieved by adding this harm-reduction component to
tobacco-control efforts.
An article last year, Mr. Speaker, in the Journal of Health Care Law
and Policy correctly concluded that, and this is a quote, ``Ignoring
harm reduction is simply not a viable option as there is no question
that it is possible to provide massively less toxic alternative
products.''
The SPEAKER pro tempore. The time of the gentleman has expired.
Mr. BUYER. I yield to the gentleman of Georgia an additional minute.
Mr. GINGREY of Georgia. Mr. Speaker, a 2007 article in the
International Journal of Drug Policy noted that ``A pragmatic, public
health approach to tobacco control would recognize a continuum of risk
and encourage nicotine users to move themselves down the risk spectrum
by choosing safer alternatives to smoking, without demanding
abstinence.''
The Buyer amendment presents us with the opportunity to institute
that type of pragmatic approach. It offers a stringent regime under
which harm-reduction strategies can augment and leverage continued
efforts to prevent tobacco use, and to encourage current smokers to
quit.
So, as a physician who deeply cares about the health and the welfare
of our citizens, I urge you, my colleagues on both sides of the aisle,
to adopt the amendment as our Nation's best option for fighting the
disease and the death caused by tobacco in the 21st century.
Mr. BUYER. I reserve my time.
Mr. WAXMAN. Mr. Speaker, I have no further requests for time.
Although some Members may join us shortly, I ask the gentleman how many
other speakers he wishes to call on before we close the debate.
Mr. BUYER. We have two speakers that I'm aware of that are on their
way.
Mr. WAXMAN. I'll reserve my time and let you go forward. I see there
are some of your Members there if they're going to speak on the bill.
Mr. BUYER. To the gentleman's question, you wanted to know how many
more speakers do I have. I was not prepared that you would not have
speakers in support of your bill, so I thought that we'd be going back
and forth, so I have Members coming from their offices to the floor.
But I would be more than happy to take some of my time.
May I ask, Mr. Speaker--actually, we're on your time, I guess, at the
moment. I guess, on your time. May I ask how much time both of us may
have remaining?
The SPEAKER pro tempore. The gentleman from Indiana has 16 minutes
remaining. The gentleman from California has 23\1/2\ minutes remaining.
Mr. WAXMAN. We're going to reserve the balance of our time.
Mr. BUYER. I yield myself such time as I may consume.
We've had a discussion here on the floor, Mr. Speaker, with regard to
other concerns over the Food and Drug Administration and its ability to
regulate tobacco products, products that will never qualify as safe and
effective, and could have significant negative impacts on all
Americans.
Congress has spent a great deal of time investigating the ways in
which the FDA has been unable to fulfill its core mission. Burdening
the FDA with additional responsibilities outside the agency's expertise
and core missions at this time will have dire consequences for the
American people and the FDA's ability to ensure the safety and efficacy
of our Nation's food, drugs and medical devices.
H.R. 1256 allows the FDA to divert resources from its core mission,
including funds from food safety inspections and drugs and devices
approvals to fund the startup costs of a newer tobacco center. At a
time when FDA is struggling to perform many of its core functions,
diversion of its limited resources will negatively impact the safety of
the American public.
Now, in a bipartisan manner, we share the concerns of many in the
public health community that effectively giving FDA's stamp of approval
on cigarettes will improperly lead people to believe that these
products are safe, and they really aren't. So there actually could be
this perception, when people see that the FDA has approved it, there
could be this public perception that there's an FDA approval of a
particular nicotine delivery device.
Now, what we seek to do is to turn this over to a different agency,
whereby we can learn about the different relative risks among that
continuum of risk, so that people can make, then, informed decisions
and choices relative to the use of tobacco products.
Now, I agree with the American Association of Public Health
Physicians, which wrote on March 3, 2009, in regard to H.R. 1256, ``The
current bill, in its current form, would assure current levels of
tobacco-related deaths, while doing nothing of significance to reduce
the number of teens who would initiate tobacco use with no bill at
all.''
Now, I read that earlier, but it's so important I had to read it
again. Now, Congressman McIntyre and I have authored this bipartisan
alternative to establish the Tobacco Harm Reduction Center under the
Department of Health and Human Services. The alternative is based on
public health policies that acknowledge a continuum of risk among all
tobacco products, and referenced scientific literature which shows that
smokeless tobacco products are 90 to even 99 percent less hazardous
than cigarettes in their risks of causing tobacco-related illnesses and
death.
Now, why wouldn't we embrace that as a form of public policy?
Unlike H.R. 1256, the alternative substitute would have insured adult
tobacco users are given complete, accurate and truthful information
about the risks and relative risks of all tobacco products so that they
can make informed health decisions, while providing incentives to
develop reduced-risk tobacco products.
See, that's really one of the chief concerns I have about Mr.
Waxman's legislation is that when he creates a two-tier product
standard with the implementation of new products, how can we ever
migrate people to a lesser-harm nicotine delivery device in our efforts
to get them to quit? That's why we have this position by Mr. Waxman,
either you smoke or you die. And that's not what we should be
embracing.
The alternative substitute, which Members will have a chance to vote
on, strengthens prevention against minors' tobacco use, ensures that
States properly fund anti-tobacco education and smoking-cessation
programs, and protects American jobs.
Now, this alternative legislation will significantly improve the
public health, while also protecting the already overburdened FDA from
new responsibilities that take away from its ability to protect, once
again, our Nation's food and drug supply.
In 2001 the Institute of Medicine noted, ``The potential for
reduction in morbidity and mortality that could result from the use of
less toxic products by those who do not stop using tobacco, justifies
the inclusion of harm reduction as a component in a broad program of
tobacco control.'' That was my appeal to Chairman Waxman as to why the
harm reduction strategy should be endorsed.
You see, if enacted, H.R. 1256, Mr. Waxman's bill, significantly
curtails, if not entirely eliminates, incentives for manufacturers to
develop and market products that reduce exposure to tobacco toxic
substances. In order to obtain approval of a modified risk product, an
applicant must demonstrate that the marketing and the labeling of the
product will not mislead consumers into believing that the product is
or
[[Page H4342]]
has been demonstrated to be less harmful than current products.
Further, it has to be demonstrated that the product reduces risk for
both the individual and for the population as a whole. This is the two-
tiered standard I keep referring to. It is unlikely that such a
standard could ever be proven. You see, that is what is so clever about
Mr. Waxman's legislation. He puts in a standard that can never be
achieved. And if you want to move people down a continuum of risk and
improve public health, it cannot be done under Mr. Waxman's approach.
Now, those of us that support the substitute are concerned that such
disincentives will effectively freeze the current tobacco market and
prevent innovation that could lead to significantly less harmful
tobacco products and improve the Nation's health. That is the exact
position that Altria took in their letter to me.
Mr. Speaker, H.R. 1256 directs the Secretary of HHS to promulgate an
interim final rule that is identical to the FDA's 1996 rule, which
legal experts from across the political spectrum have stated would
violate the First Amendment. While these experts' views should carry
great weight, even more dispositive is the fact that the U.S. Supreme
Court has also weighed in on various provisions of the rule, finding
them unconstitutional.
In Lorillard Tobacco Co. v. Reilly, the U.S. Supreme Court struck
down a Massachusetts statute that was similar in many ways to the FDA's
proposed rule. The statute banned outdoor ads within 1,000 feet of
schools, parks and playgrounds and also restricted point-of-sale
advertising for tobacco products. The Court held that this regulation
ran afoul of the test established in the Central Hudson case, which
defines the protection afforded commercial speech under the First
Amendment, as it was not sufficiently narrowly tailored, and would have
disparate impacts from community to community.
The Court then noted that since the Massachusetts statute was based
on the FDA's rule, the FDA rule would have similar unconstitutional
effects on a nationwide basis. As Justice Sandra Day O'Connor wrote for
the Court, ``the uniformly broad sweep of the geographical limitation
demonstrates a lack of tailoring.''
Additionally, the proposed rule in H.R. 1256 would require ads to use
only black text on a white background. Again, the U.S. Supreme Court
found a similar provision unconstitutional in Zauderer v. Office of
Disciplinary Counsel. In that case, dealing with advertising for legal
services, the Court held that the use of colors and illustrations in
ads are entitled to the same First Amendment protections given verbal
commercial speech. Justice Byron White, in his opinion for the Court,
wrote that pictures and illustrations in ads cannot be banned ``simply
on the strength of the general argument that the visual content of
advertisements may, under some circumstances, be deceptive or
manipulative.''
There are numerous other speech restrictions in this legislation that
raise serious First Amendment issues and will create a swarm of
lawsuits that will only divert us from trying to develop more effective
approaches to tobacco use in the United States. To put forward speech
restrictions that a broad range of experts have stated are almost
certain to be struck down would be highly counterproductive, and the
only winners in this effort will be the litigants' constitutional
lawyers rather than the American public.
I reserve the balance of my time.
{time} 2000
Mr. WAXMAN. Mr. Speaker, I am ready to move on to the Buyer
substitute, and if the gentleman from Indiana is ready to yield back
his time, I will yield back my time, and we can go to the substitute,
itself.
Mr. BUYER. You would not rob me of the opportunity to put my chart on
display, would you, Mr. Chairman?
Mr. WAXMAN. I wouldn't deny you any opportunity to make any points or
to show any charts.
Mr. BUYER. Thank you.
Mr. WAXMAN. Is the gentleman ready to offer his amendment?
Mr. BUYER. I am prepared to show a chart on my debate time.
Mr. WAXMAN. Oh. Well then, I'll reserve the balance of my time.
Mr. BUYER. I thank the gentleman.
How much time do I have, Mr. Speaker?
The SPEAKER pro tempore. The gentleman has 9\1/2\ minutes remaining.
Mr. BUYER. I yield 3 minutes to the gentleman from Texas, Dr.
Burgess.
Mr. BURGESS. I thank the gentleman for yielding.
This bill is certainly a misplaced priority. Mr. Speaker, I lost both
parents to tobacco-related illness. I know of the seriousness of this
illness. I saw it virtually every day in the 25 years I practiced
medicine. Tobacco is a scourge upon our society.
It is for Congress to meet then. In the bill in front of us this
evening, the Food and Drug Administration, a Federal agency that right
now is essentially a beleaguered agency that cannot do what we require
it to do with regulating food and drugs, is now going to be given a
completely new mission.
The mission of the Food and Drug Administration is to ensure that we
have drugs that are safe and effective. Tobacco, when used as directed,
kills 400,000 people a year. Tobacco certainly could be regarded as
effective when used as directed, but it could never be regarded as
safe.
Last night, in the Rules Committee, I attempted to offer an amendment
which would have allowed the Food and Drug Administration to at least
require that a cigarette be manufactured that contains zero milligrams
of nicotine. In fact, there is explicit language in the bill that
prohibits the Food and Drug Administration from requiring a zero-
milligram nicotine cigarette. Why is this important?
Well, I told the Rules Committee last night that this was essentially
the anti-hypocrisy amendment. If we were serious about what we were
trying to do for public health, we would allow the Food and Drug
Administration to eliminate nicotine in the cigarette because, after
all, a tobacco cigarette is a drug-delivery device. Its sole purpose is
to deliver nicotine to the user. In fact, if you do not have nicotine
with its addictive powers, cigarette smoking is, itself, so unpleasant
that no one would willingly smoke a cigarette. They do so to satisfy
the addiction to nicotine.
In some of Chairman Waxman's hearings that he did in the last decade,
he had tobacco executives admit that they manipulated levels of
nicotine. Why? Because the nicotine is required to addict a smoker so
he will continue to smoke. Eliminate the nicotine, and you have
eliminated the smoking as a habit. As a consequence, the enormous
public health debt that we're piling up in treating smoking-related
illnesses suddenly becomes a much more realistic figure.
I, frankly, do not understand why we would have a bill on the floor
to allow the Food and Drug Administration to regulate tobacco usage
when we will not allow them to have the one tool that would actually do
some good in this legislation, which is to allow the Food and Drug
Administration to require a zero-milligram nicotine cigarette.
In other words, we're going to allow nicotine to continue to be in
cigarettes, allow the level to continue to be manipulated and continue
to allow the youth of this country to be addicted to this pernicious
habit. If we were really serious, if it weren't just the fact that
we're addicted to tobacco money, we would allow the FDA the ability to
exclude nicotine from cigarette products.
Mr. WAXMAN. Mr. Speaker, we have put in this bill that the FDA has
the power to lower the levels of nicotine to a level that would be
appropriate for the protection of the public health. We did not allow
the FDA, under the legislation, to eliminate nicotine from cigarettes
because we're all aware that, if cigarettes were not permitted to
contain nicotine at all, that would be tantamount to an outright ban on
cigarettes. I would not like to see people smoking cigarettes at all,
but I'm not for prohibition, and therefore, we did not give the FDA
that power to ban cigarettes in effect.
Now, it's odd to find that we're criticized for not doing enough and
then are criticized for doing too much. You can't have it both ways. I
think the FDA is in the position to regulate. We ought to give them
that power, and that's why I would urge support for the legislation.
At this time, I would like to yield 5 minutes to the gentleman from
Pennsylvania (Mr. Platts), and if he needs more time, I'll yield more
to him.
Mr. PLATTS. Mr. Speaker, I rise in support of H.R. 1256, the Family
Smoking Prevention and Tobacco Control Act. My good friend and former
colleague, Congressman Tom Davis, helped to champion this effort with
Chairman Waxman for many years. With Congressman Davis' retirement last
year, I'm honored to have taken
[[Page H4343]]
his place as the lead Republican sponsor of this important legislation
and to have the privilege of working with Chairman Waxman and his staff
on this important effort.
Mr. Speaker, tobacco is one of the deadliest consumer products on the
market today. It kills over 400,000 Americans every year. Yet it is one
of the least regulated of all consumer products. In other words, while
the FDA has the authority to regulate seemingly harmless products such
as lipstick, hair spray and shaving cream, to name just three, the FDA
does not have the authority it needs to regulate one of the deadliest,
if not the deadliest, products available for sale to our citizens. It
is long past time when tobacco products should be subject to serious
regulation to protect the public's health. This bill would finally
accomplish this important goal.
First, this legislation would ensure that tobacco products are not
advertised to or sold to children. Addiction to tobacco begins almost
universally in childhood and in adolescence. Every day, almost 4,000
children try their first cigarette, and over 1,000 become daily
smokers. Tobacco companies have long taken advantage of this
vulnerability by promoting their products through such tactics as
cartoon advertisements, free tobacco-themed merchandise that appeals to
kids and through sponsorships of sports and entertainment events.
With health care costs spiraling out of control every year, the cost
of treating these smokers later in life is fast becoming prohibitively
expensive. Prohibiting advertising to children would go a long way in
preventing young people in America from starting to smoke, and it would
save billions of dollars and countless lives in the years to come.
Second, this legislation would require that tobacco products marketed
as safer than other tobacco products are, in fact, demonstrated to be
safer. The history of low-tar cigarettes illustrates the grave danger
to public health caused by fooling consumers into believing
unsubstantiated claims that one kind of cigarette is safer than
another. Millions of Americans switched to low-tar cigarettes,
believing they were reducing their risk of lung cancer. Many were
convinced to switch instead of to quit. It was not until decades later
that we learned through the deaths of those smoking low-tar cigarettes
that low-tar cigarettes were just as dangerous as full-tar cigarettes.
Under this legislation, we will not have to wait for the deaths of
millions of more Americans to learn whether a so-called ``safer''
cigarette is what it claims to be.
This bill does not ban tobacco products. H.R. 1256 would allow the
FDA to scientifically evaluate the health benefits and risks posed by
ingredients in cigarettes, and it would take steps to reduce the harm
caused by tobacco products. This legislation preserves an adult's
choice to smoke. Even though I don't believe we want anyone to, it
preserves that choice, and we make sure that those tobacco products
that are marketed as safe alternatives to cigarettes are, in fact,
scientifically proven to be safer.
Finally, I understand that some individuals have concerns with
placing such authority under the FDA. I think it's important to note
that the FDA already regulates products that people use to help quit
smoking, such as nicotine gums and patches. In addition, this
legislation does provide an entirely separate funding stream for the
FDA's regulation of tobacco products to ensure that other important
efforts carried out by this agency are not diminished.
I hope my colleagues will join me in supporting the Family Smoking
Prevention and Tobacco Control Act.
For the record, I believe there was reference that the reason we're
not completely banning it is because of the influence of tobacco funds
in campaigns. If I understand that correctly, I want to be on the
record as one who doesn't accept any political action committee funds,
including tobacco funds, and I've not received any such funds. Never
have. Never will. This is about doing right for American citizens. It's
about the health of our citizens. It's especially about the health of
our children.
Vote ``yes'' and oppose this substitute. Support the underlying bill.
Mr. BUYER. I want to thank both gentlemen--Mr. Platts and the
chairman--for his bill. As I've said, I complimented you earlier about
your persistence and about your tenacity, about your drive and your
sincerity. I don't question it at all. I have a different approach on
how we can improve public policy, and this has been a good debate. I
want to thank the chairman for allowing this debate to occur. It was a
healthy debate at the committee during the markup. I think it's a
healthy debate for us to have.
Over 100 countries around the world are struggling with how they
answer these public health questions on how to deal with individuals
who become addicted to nicotine. When you look at this approach of,
``Well, let's just quit. Stop smoking and just quit,'' I just take a
simple look at this. I say there are 45 million smokers, and then there
are 2 million who are trying to stop smoking. Yet there's only a 7
percent success rate. Something is not working. To me, that's a rate of
failure.
So that's why Mr. McIntyre and I came up with a different approach.
We came up with a harm-reduction approach, and what we seek to do is to
put our arms around everything. Not only are we trying to accomplish
some of the similar goals of Mr. Waxman and Mr. Platts and of others
who support Mr. Waxman's approach, but we wanted to include everything.
We could include abstinence. We could include cessation programs and
prevention and education. We seek to do that because we have a harm-
reduction strategy to do that, and we want to move people down a
continuum of risk.
When you look at the 45 million smokers, 85 percent of them are
smoking light or ultralight cigarettes. Now, the reason they do that is
they make a subconscious decision that somehow it's a healthier or a
safer cigarette. The reality is it's not. It's not.
So Mr. Platts is absolutely correct, but what we seek to do in the
substitute is we want to regulate tobacco. That's what Mr. McIntyre and
I seek to do. We want to regulate tobacco. We don't want to do it under
the FDA. We want to do it in a harm-reduction center, and we want the
tobacco companies to come forward. We'll regulate that tobacco, but we
want to migrate smokers into other forms of products. I'm going to talk
about that in greater detail on the substitute.
At this point, Mr. Waxman, I don't have any other speakers, so we can
proceed to the substitute.
Mr. DINGELL. Mr. Speaker, I rise in strong support of H.R. 1256, the
Family Smoking Prevention and Tobacco Control Act. This historic
legislation will grant the Food and Drug Administration the authority
to regulate tobacco products. Aside from a few technical changes, H.R.
1256 is identical to the legislation Chairman Waxman and I worked hard
together to pass in the House last year.
This legislation is long overdue:
In 1957, Surgeon General Leroy Burney declared the causal link
between smoking and lung cancer.
In 1964, Surgeon General Luther Terry's Report proclaimed that
cigarette smoking is a health hazard of sufficient importance in the
United States to warrant appropriate remedial action.
Today, fifty-two years after the cancer link was established, forty-
five years after the call for remedial action, we are finally poised to
regulate this lethal product.
H.R. 1256 creates a fully-funded separate tobacco center at FDA to
regulate tobacco products. The FDA is the appropriate scientific and
regulatory agency to provide this oversight. Through a user fee on
tobacco products, FDA will have the resources to implement this
legislation and the legislation segregates the tobacco center and its
funding from other FDA programs.
The FDA needs more resources and greater authority to meet its other
obligations with respect to food, drugs, devices and cosmetics. My
colleagues, Mr. Pallone and Mr. Stupak, and I have introduced
legislation to address this need. To my colleagues who are concerned
with FDA's lack of resources, I invite you to join us in this effort.
Each year, tobacco use kills more than 400,000 people. The American
people need assurance that their food and medical products are safe.
But they also need meaningful oversight of tobacco products. This
Congress can deliver both.
I urge my colleagues to vote in favor of H.R. 1256.
Mr. VAN HOLLEN. Madam Speaker, as an original cosponsor, I rise in
strong support of the bipartisan Family Smoking Prevention and Tobacco
Control Act. I want to thank Chairman Waxman and so many others for
their
[[Page H4344]]
leadership in bringing this legislation to the floor after so many
years and so many battles. This is an important day for the American
people.
Granting the Food and Drug Administration authority to regulate
tobacco products is long overdue and is a critical step in the
protection of the public's health. As we know, the FDA has the power to
regulate and oversee all sorts of products that are sold today. Many
products that they regulate are not addictive. Yet we do not have the
FDA's regulatory authority when it came to the very addictive products
of tobacco and nicotine.
Because of the lack of regulatory authority on tobacco products, the
FDA has been sidelined and the result is that the big tobacco companies
have taken advantage of that opportunity and exploited it by marketing
their deadly products to young people. For far too long, the tobacco
companies have been targeting our kids, deceiving all of us about the
harmful effects of their products and manipulating the ingredients in
their products--all to ensure that their profit levels remained high.
In order for them to continue to make their profits, they had to
continue getting one generation after another hooked on tobacco
products.
Let's make sure that future generations of young people do not get
addicted. Addiction to tobacco products has had a huge cost to our
society in terms of lives and money with over 400,000 American deaths
every year. We have a chance today to put an end to that cycle.
In my home State of Maryland, I am very proud of the steps we have
taken to curb the effects of tobacco use. We increased the tobacco tax
and youth smoking has declined. We also passed a comprehensive
smokefree indoor air law in 2007. But we can't have every State
fighting alone to have a successful national program to curb tobacco
use. We need one entity that has this power to help protect the
American people, especially the young people of our country, from the
deadly effects of tobacco products.
Mr. Speaker, this bill is a crucial step in protecting the health and
well-being of our constituents from the deadly effects of tobacco use.
It will save lives and money. I urge my colleagues to join me in a yes
vote on this much-needed legislation.
Mr. LUCAS. Mr. Speaker, I am appalled at the blatant disregard for
the public policy process. What kind of trick is being played out on
the American people when half of H.R. 1256--the half that pays for FDA
legislation--comes on suspension of the rules and the other half, the
part that burdens American companies with more taxes and regulation,
comes under a closed rule?
This bill gives FDA broad statutory authority to regulate the
manufacturing, distribution, advertising, promotion, sale, and use of
cigarettes and smokeless tobacco. And, it will ultimately result in FDA
being on the farm micromanaging our farmers.
FDA has clearly proven it is severely overburdened with its current
authority. Just look to the recent examples of salmonella found in
peanut and pistachio products. Why would we give a huge new expansion
of authority to an agency that has proven it can't handle the load it
has? Can you honestly tell the American people to have confidence in
the FDA to protect them?
How will this new authority be paid for? New taxes, of course. The
bill taxes companies and importers to pay for the cost of regulation.
The bill sets the amount of the assessments each year, which will
increase to $712 million per year.
Also, this bill calls for using funds from the Thrift Savings Plan.
Do we really want to use the savings portion of the bill to pay for
more Washington bureaucracy?
Tobacco producers, small convenience stores, and tobacco
warehouseman, which are the backbones of commerce across poor and rural
districts, will be put out of business under this bill.
And, farmers--beware--FDA will come directly on your farm and tell
you how to operate. Producers will bear the brunt of this legislation.
FDA will tell producers what type of seeds they can plant, the methods
in which they cultivate those seeds, the records they must keep and on
and on and on.
I ask for a ``no'' vote on this classic tax and regulate bill.
Mr. BUYER. I yield back the balance of my time.
Mr. WAXMAN. Mr. Speaker, I also yield back my time.
The SPEAKER pro tempore. All time for debate on the bill has expired.
Amendment Offered by Mr. Buyer
Mr. BUYER. Mr. Speaker, I have an amendment at the desk.
The SPEAKER pro tempore. The Clerk will designate the amendment.
The text of the amendment is as follows:
Amendment in the nature of a substitute printed in part B
of House Report 111-72 offered by Mr. Buyer:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Youth
Prevention and Tobacco Harm Reduction Act''.
(b) Table of Contents.--The table of contents of this Act
is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.
Sec. 5. Severability.
Sec. 6. Effective date.
TITLE I--AUTHORITY OF THE TOBACCO HARM REDUCTION CENTER
Sec. 100. Definitions.
Sec. 101. Center authority over tobacco products.
Sec. 102. Exclusion of other regulatory programs.
Sec. 103. Existing Federal statutes maintained.
Sec. 104. Proceedings in the name of the United States; subpoenas;
preemption of State and local law; no private right of
action.
Sec. 105. Illicit trade.
Sec. 106. Adulterated tobacco products.
Sec. 107. Misbranded tobacco products.
Sec. 108. Submission of health information to the Administrator.
Sec. 109. Registration and listing.
Sec. 110. General provisions respecting control of tobacco products.
Sec. 111. Smoking article standards.
Sec. 112. Notification and other remedies.
Sec. 113. Records and reports on tobacco products.
Sec. 114. Application for review of certain smoking articles.
Sec. 115. Modified risk tobacco products.
Sec. 116. Judicial review.
Sec. 117. Jurisdiction of and coordination with the Federal Trade
Commission.
Sec. 118. Regulation requirement.
Sec. 119. Preservation of State and local authority.
Sec. 120. Tobacco Products Scientific Advisory Committee.
Sec. 121. Drug products used to treat tobacco dependence.
Sec. 122. Advertising and marketing of tobacco products.
TITLE II--TOBACCO PRODUCTS WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT
DISCLOSURE
Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Smokeless tobacco labels and advertising warnings.
TITLE III--PUBIC DISCLOSURES BY TOBACCO PRODUCTS MANUFACTURERS
Sec. 301. Disclosures on packages of tobacco products.
Sec. 302. Disclosures on packages of smokeless tobacco.
Sec. 303. Public disclosure of ingredients.
TITLE IV--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS
Sec. 401. Study and report on illicit trade.
Sec. 402. Amendment to section 1926 of the Public Health Service Act.
Sec. 403. Establishment of rankings.
TITLE V--ENFORCEMENT PROVISIONS
Sec. 501. Prohibited acts.
Sec. 502. Injunction proceedings.
Sec. 503. Penalties.
Sec. 504. Seizure.
Sec. 505. Report of minor violations.
Sec. 506. Inspection.
Sec. 507. Effect of compliance.
Sec. 508. Imports.
Sec. 509. Tobacco products for export.
TITLE VI--MISCELLANEOUS PROVISIONS
Sec. 601. Use of payments under the master settlement agreement and
individual State settlement agreements.
Sec. 602. Preemption of State Laws Implementing Fire Safety Standard
for Cigarettes.
Sec. 603. Inspection by the alcohol and tobacco tax trade bureau of
records of certain cigarette and smokeless tobacco
sellers.
Sec. 604. Severability.
TITLE VII--TOBACCO GROWER PROTECTION
Sec. 701. Tobacco grower protection.
SEC. 2. FINDINGS.
The Congress finds the following:
(1) Cigarette smoking is a leading cause of preventable
deaths in the United States. Cigarette smoking significantly
increases the risk of developing lung cancer, heart disease,
chronic bronchitis, emphysema and other serious diseases with
adverse health conditions.
(2) The risk for serious diseases is significantly affected
by the type of tobacco product and the frequency, duration
and manner of use.
(3) No tobacco product has been shown to be safe and
without risks. The health risks associated with cigarettes
are significantly greater than those associated with the use
of smoke-free tobacco and nicotine products.
(4) Nicotine in tobacco products is addictive but is not
considered a significant threat to health.
(5) It is the smoke inhaled from burning tobacco which
poses the most significant risk of serious diseases.
(6) Quitting cigarette smoking significantly reduces the
risk for serious diseases.
(7) Adult tobacco consumers have a right to be fully and
accurately informed about the risks of serious diseases, the
significant
[[Page H4345]]
differences in the comparative risks of different tobacco and
nicotine-based products, and the benefits of quitting. This
information should be based on sound science.
(8) Governments, public health officials, tobacco
manufacturers and others share a responsibility to provide
adult tobacco consumers with accurate information about the
various health risks and comparative risks associated with
the use of different tobacco and nicotine products.
(9) Tobacco products should be regulated in a manner that
is designed to achieve significant and measurable reductions
in the morbidity and mortality associated with tobacco use.
Regulations should enhance the information available to adult
consumers to permit them to make informed choices, and
encourage the development of tobacco and nicotine products
with lower risks than cigarettes currently sold in the United
States.
(10) The form of regulation should be based on the risks
and comparative risks of tobacco and nicotine products and
their respective product categories.
(11) The regulation of marketing of tobacco products should
be consistent with constitutional protections and enhance an
adult consumer's ability to make an informed choice by
providing accurate information on the risks and comparative
risks of tobacco products.
(12) Reducing the diseases and deaths associated with the
use of cigarettes serves public health goals and is in the
best interest of consumers and society. Harm reduction should
be the critical element of any comprehensive public policy
surrounding the health consequences of tobacco use.
(13) Significant reductions in the harm associated with the
use of cigarettes can be achieved by providing accurate
information regarding the comparative risks of tobacco
products to adult tobacco consumers, thereby encouraging
smokers to migrate to the use of smoke-free tobacco and
nicotine products, and by developing new smoke-free tobacco
and nicotine products and other actions.
(14) Governments, public health officials, manufacturers,
tobacco producers and consumers should support the
development, production, and commercial introduction of
tobacco leaf, and tobacco and nicotine-based products that
are scientifically shown to reduce the risks associated with
the use of existing tobacco products, particularly
cigarettes.
(15) Adult tobacco consumers should have access to a range
of commercially viable tobacco and nicotine-based products.
(16) There is substantial scientific evidence that selected
smokeless tobacco products can satisfy the nicotine addiction
of inveterate smokers while eliminating most, if not all,
risk of pulmonary and cardiovascular complications of smoking
and while reducing the risk of cancer by more than 95
percent.
(17) Transitioning smokers to selected smokeless tobacco
products will eliminate environmental tobacco smoke and fire-
related hazards.
(18) Current ``abstain, quit, or die'' tobacco control
policies in the United States may have reached their maximum
possible public health benefit because of the large number of
cigarette smokers either unwilling or unable to discontinue
their addiction to nicotine.
(19) There is evidence that harm reduction works and can be
accomplished in a way that will not increase initiation or
impede smoking cessation.
(20) Health-related agencies and organizations, both within
the United States and abroad have already gone on record
endorsing Harm Reduction as an approach to further reducing
tobacco related illness and death.
(21) Current Federal policy requires tobacco product
labeling that leaves the incorrect impression that all
tobacco product present equal risk.
SEC. 3. PURPOSE.
The purposes of this Act are--
(1) to provide authority to the Tobacco Harm Reduction
Center by recognizing it as the primary Federal regulatory
authority with respect to tobacco products as provided for in
this Act;
(2) to ensure that the Center has the authority to address
issues of particular concern to public health officials,
especially the use of tobacco by young people and dependence
on tobacco;
(3) to authorize the Center to set national standards
controlling the manufacture of tobacco products and the
identity, public disclosure, and amount of ingredients used
in such products;
(4) to provide new and flexible enforcement authority to
ensure that there is effective oversight of the tobacco
industry's efforts to develop, introduce, and promote less
harmful tobacco products;
(5) to vest the Center with the authority to regulate the
levels of tar, nicotine, and other harmful components of
tobacco products;
(6) to ensure that consumers are better informed regarding
the relative risks for death and disease between categories
of tobacco products;
(7) to continue to allow the sale of tobacco products to
adults in conjunction with measures to ensure that they are
not sold or accessible to underage purchasers;
(8) to impose appropriate regulatory controls on the
tobacco industry;
(9) to promote prevention, cessation, and harm reduction
policies and regulations to reduce disease risk and the
social costs associated with tobacco-related diseases;
(10) to provide authority to the Department of Health and
Human Services to regulate tobacco products;
(11) to establish national policies that effectively reduce
disease and death associated with cigarette smoking and other
tobacco use;
(12) to establish national policies that encourage
prevention, cessation, and harm reduction measures regarding
the use of tobacco products;
(13) to encourage current cigarette smokers who will not
quit to use noncombustible tobacco or nicotine products that
have significantly less risk than cigarettes;
(14) to establish national policies that accurately and
consistently inform adult tobacco consumers of significant
differences in risk between respective tobacco products;
(15) to establish national policies that encourage and
assist the development and awareness of noncombustible
tobacco and nicotine products;
(16) to coordinate national and State prevention,
cessation, and harm reduction programs;
(17) to impose measures to ensure tobacco products are not
sold or accessible to underage purchasers; and
(18) to strengthen Federal and State legislation to prevent
illicit trade in tobacco products.
SEC. 4. SCOPE AND EFFECT.
(a) Intended Effect.--Nothing in this Act (or an amendment
made by this Act) shall be construed to--
(1) establish a precedent with regard to any other
industry, situation, circumstance, or legal action;
(2) affect any action pending in Federal, State, or Tribal
court, or any agreement, consent decree, or contract of any
kind; or
(3) be applicable to tobacco products or component parts
manufactured in the United States for export.
(b) Agricultural Activities.--The provisions of this Act
(or an amendment made by this Act) which authorize the
Administrator to take certain actions with regard to tobacco
and tobacco products shall not be construed to affect any
authority of the Secretary of Agriculture under existing law
regarding the growing, cultivation, or curing of raw tobacco.
(c) Revenue Activities.--The provisions of this Act (or an
amendment made by this Act) which authorize the Administrator
to take certain actions with regard to tobacco products shall
not be construed to affect any authority of the Secretary of
the Treasury under chapter 52 of the Internal Revenue Code of
1986.
SEC. 5. SEVERABILITY.
If any provision of this Act, the amendments made by this
Act, or the application of any provision of this Act to any
person or circumstance is held to be invalid, the remainder
of this Act, the amendments made by this Act, and the
application of the provisions of this Act to any other person
or circumstance shall not be affected and shall continue to
be enforced to the fullest extent possible.
SEC. 6. EFFECTIVE DATE.
Except as otherwise specifically provided, the effective
date of this Act shall be the date of its enactment.
TITLE I--AUTHORITY OF THE TOBACCO HARM REDUCTION CENTER
SEC. 100. DEFINITIONS.
In this Act:
(1) The term ``Administrator'' means the chief executive of
the Tobacco Harm Reduction Center.
(2) The term ``adult'' means any individual who has
attained the minimum age under applicable State law to be an
individual to whom tobacco products may lawfully be sold.
(3) The term ``adult-only facility'' means a facility or
restricted area, whether open-air or enclosed, where the
operator ensures, or has a reasonable basis to believe, that
no youth is present. A facility or restricted area need not
be permanently restricted to adults in order to constitute an
adult-only facility, if the operator ensures, or has a
reasonable basis to believe, that no youth is present during
any period of operation as an adult-only facility.
(4) The term ``affiliate'' means a person that directly or
indirectly owns or controls, is owned or controlled by, or is
under common ownership or control with, another person. The
terms ``owns,'' ``is owned'', and ``ownership'' refer to
ownership of an equity interest, or the equivalent thereof,
of 50 percent or more.
(5) The term ``annual report'' means a tobacco product
manufacturer's annual report to the Center, which provides
ingredient information and nicotine yield ratings for each
brand style that tobacco product manufacturer manufactures
for commercial distribution domestically.
(6) The term ``brand name'' means a brand name of a tobacco
product distributed or sold domestically, alone, or in
conjunction with any other word, trademark, logo, symbol,
motto, selling message, recognizable pattern of colors, or
any other indicium of product identification identical or
similar to, or identifiable with, those used for any domestic
brand of tobacco product. The term shall not include the
corporate name of any tobacco product manufacturer that does
not, after the effective date of this Act, sell a brand style
of tobacco product in the United States that includes such
corporate name.
(7) The term ``brand style'' means a tobacco product having
a brand name, and distinguished by the selection of the
tobacco,
[[Page H4346]]
ingredients, structural materials, format, configuration,
size, package, product descriptor, amount of tobacco, or
yield of ``tar'' or nicotine.
(8) The term ``Center'' means the Tobacco Harm Reduction
Center.
(9) The term ``cigar'' has the meaning assigned that term
by the Alcohol and Tobacco Tax and Trade Bureau in section
40.11 of title 27, Code of Federal Regulations.
(10) The term ``cigarette'' means--
(A) any roll of tobacco wrapped in paper or in any
substance not containing tobacco; or
(B) any roll of tobacco wrapped in any substance containing
tobacco which, because of the appearance of the roll of
tobacco, the type of tobacco used in the filler, or its
package or labeling, is likely to be offered to, or purchased
by, consumers as a cigarette described in paragraph (1).
(11) The term ``competent and reliable scientific
evidence'' means evidence based on tests, analyses, research,
or studies, conducted and evaluated in an objective manner by
individuals qualified to do so, using procedures generally
accepted in the relevant scientific disciplines to yield
accurate and reliable results.
(12) The term ``distributor'' means any person who furthers
the distribution of tobacco products, whether domestic or
imported, at any point from the original place of manufacture
to the person who sells or distributes the tobacco product to
individuals for personal consumption. Common carriers,
retailers, and those engaged solely in advertising are not
considered distributors for purposes of this Act.
(13) The terms ``domestic'' and ``domestically'' mean
within the United States, including activities within the
United States involving advertising, marketing, distribution,
or sale of tobacco products that are intended for consumption
within the United States.
(14) The term ``illicit tobacco product'' means any tobacco
product intended for use by consumers in the United States--
(A) as to which not all applicable duties or taxes have
been paid in full;
(B) that has been stolen, smuggled, or is otherwise
contraband;
(C) that is counterfeit; or
(D) that has or had a label, labeling, or packaging
stating, or that stated, that the product is or was for
export only, or that it is or was at any time restricted by
section 5704 of title 26, United States Code.
(15) The term ``illicit trade'' means any transfer,
distribution, or sale in interstate commerce of any illicit
tobacco product.
(16) The term ``immediate container'' does not include
package liners.
(17) The term ``Indian tribe'' has the meaning assigned
that term in section 4(e) of the Indian Self Determination
and Education Assistance Act.
(18) The term ``ingredient'' means tobacco and any
substance added to tobacco to have an effect in the final
tobacco product or when the final tobacco product is used by
a consumer.
(19) The term ``International Organization for
Standardization (ISO) testing regimen'' means the methods for
measuring cigarette smoke yields, as set forth in the most
recent version of ISO 3308, entitled ``Routine analytical
cigarette-smoking machine--Definition of standard
conditions''; ISO 4387, entitled ``Cigarettes--Determination
of total and nicotine-free dry particulate matter using a
routine analytical smoking machine''; ISO 10315, entitled
``Cigarettes--Determination of nicotine in smoke
condensates--Gas-chromatographic method''; ISO 10362-1,
entitled ``Cigarettes--Determination of water in smoke
condensates--Part 1: Gas-chromatographic method''; and ISO
8454, entitled ``Cigarettes--Determination of carbon monoxide
in the vapour phase of cigarette smoke--NDIR method''. A
cigarette that does not burn down in accordance with the
testing regimen standards may be measured under the same puff
regimen using the number of puffs that such a cigarette
delivers before it extinguishes, plus an additional three
puffs, or with such other modifications as the Administrator
may approve.
(20) The term ``interstate commerce'' means all trade,
traffic, or other commerce--
(A) within the District of Columbia, or any territory or
possession of the United States;
(B) between any point in a State and any point outside
thereof;
(C) between points within the same State through any place
outside such State; or
(D) over which the United States has jurisdiction.
(21) The term ``label'' means a display of written,
printed, or graphic matter upon or applied securely to the
immediate container of a tobacco product.
(22) The term ``labeling'' means all labels and other
written, printed, or graphic matter (1) upon or applied
securely to any tobacco product or any of its containers or
wrappers, or (2) accompanying a tobacco product.
(23) The term ``little cigar'' has the meaning assigned
that term by the Alcohol and Tobacco Tax and Trade Bureau in
section 40.11 of title 27, Code of Federal Regulations.
(24) The term ``loose tobacco'' means any form of tobacco,
alone or in combination with any other ingredient or
material, that, because of its appearance, form, type,
packaging, or labeling, is suitable for use and likely to be
offered to, or purchased by, consumers as tobacco for making
or assembling cigarettes, incorporation into pipes, or
otherwise used by consumers to make any tobacco product.
(25) The term ``manufacture'' means to design, manufacture,
fabricate, assemble, process, package, or repackage, label,
or relabel, import, or hold or store in a commercial
quantity, but does not include--
(A) the growing, curing, de-stemming, or aging of tobacco;
or
(B) the holding, storing or transporting of a tobacco
product by a common carrier for hire, a public warehouse, a
testing laboratory, a distributor, or a retailer.
(26) The term ``nicotine-containing product'' means a
product, other than a tobacco product, that contains added
nicotine, whether or not in the form of a salt or solvate,
that has been--
(A) synthetically produced, or
(B) obtained from tobacco or other source of nicotine.
(27) The term ``package'' means a pack, box, carton, pouch,
or container of any kind in which a tobacco product or
tobacco products are offered for sale, sold, or otherwise
distributed to consumers. The term ``package'' does not
include an outer container used solely for shipping one or
more packages of a tobacco product or tobacco products.
(28) The term ``person'' means any individual, partnership,
corporation, committee, association, organization or group of
persons, or other legal or business entity.
(29) The term ``proof of age'' means a driver's license or
other form of identification that is issued by a governmental
authority and includes a photograph and a date of birth of
the individual.
(30) The term ``raw tobacco'' means tobacco in a form that
is received by a tobacco product manufacturer as an
agricultural commodity, whether in a form that is natural,
stem, or leaf, cured or aged, or as parts or pieces, but not
in a reconstituted form, extracted pulp form, or extract
form.
(31) The term ``reduced-exposure claim'' means a statement
in advertising or labeling intended for one or more consumers
of tobacco products, that a tobacco product provides a
reduced exposure of users of that tobacco product to one or
more toxicants, as compared to an appropriate reference
tobacco product or category of tobacco products. A statement
or representation that a tobacco product or the tobacco in a
tobacco product contains ``no additives'' or is ``natural''
or that uses a substantially similar term is not a reduced-
exposure claim if the advertising or labeling that contains
such statement or representation also contains the disclosure
required by section 108(h) of this Act.
(32) The term ``reduced-risk claim'' means a statement in
advertising or labeling intended for one or more consumers of
smoking articles, that a smoking article provides to users of
that product a reduced risk of morbidity or mortality
resulting from one or more chronic diseases or serious
adverse health conditions associated with tobacco use, as
compared to an appropriate reference smoking article or
category of smoking articles, even if it is not stated,
represented, or implied that all health risks associated with
using that smoking article have been reduced or eliminated. A
statement or representation that a smoking article or the
tobacco in a smoking article contains ``no additives,'' or is
``natural,'' or that uses a substantially similar term is not
a reduced-risk claim if the advertising or labeling that
contains such statement or representation also contains the
disclosure required by section 108(h).
(33) The term ``retailer'' means any person that--
(A) sells tobacco products to individuals for personal
consumption; or
(B) operates a facility where the sale of tobacco products
to individuals for personal consumption is permitted.
(34) The term ``small business'' means a tobacco product
manufacturer that--
(A) has 150 or fewer employees; and
(B) during the 3-year period prior to the current calendar
year, had an average annual gross revenue from tobacco
products that did not exceed $40,000,000.
(35) The term ``smokeless tobacco product'' means any form
of finely cut, ground, powdered, reconstituted, processed or
shaped tobacco, leaf tobacco, or stem tobacco, whether or not
combined with any other ingredient, whether or not in extract
or extracted form, and whether or not incorporated within any
carrier or construct, that is intended to be placed in the
oral or nasal cavity, including dry snuff, moist snuff, and
chewing tobacco.
(36) The term ``smoking article'' means any tobacco-
containing article that is intended, when used by a consumer,
to be burned or otherwise to employ heat to produce a vapor,
aerosol or smoke that--
(A) incorporates components of tobacco or derived from
tobacco; and
(B) is intended to be inhaled by the user.
(37) The term ``State'' means any State of the United
States and, except as otherwise specifically provided,
includes any Indian tribe or tribal organization, the
District of Columbia, the Commonwealth of Puerto Rico, Guam,
the Virgin Islands, American Samoa, Wake Island, Midway
Island, Kingman Reef, Johnston Atoll, the Northern Marianas,
and any other trust territory or possession of the United
States.
(38) The term ``tar'' means nicotine-free dry particulate
matter as defined in ISO 4387, entitled ``Cigarettes--
Determination of total and nicotine-free dry particulate
matter using a routine analytical smoking machine''.
[[Page H4347]]
(39) The term ``tobacco'' means a tobacco plant or any part
of a harvested tobacco plant intended for use in the
production of a tobacco product, including leaf, lamina,
stem, or stalk, whether in green, cured, or aged form,
whether in raw, treated, or processed form, and whether or
not combined with other materials, including any by-product,
extract, extracted pulp material, or any other material
(other than purified nicotine) derived from a tobacco plant
or any component thereof, and including strip, filler, stem,
powder, and granulated, blended, or reconstituted forms of
tobacco.
(40) The term ``tobacco product'' means--
(A) the singular of ``tobacco products'' as defined in
section 5702(c) of the Internal Revenue Code of 1986;
(B) any other product that contains tobacco as a principal
ingredient and that, because of its appearance, type, or the
tobacco used in the product, or its packaging and labeling,
is likely to be offered to, or purchased by, consumers as a
tobacco product as described in subparagraph (A); and
(C) any form of tobacco or any construct incorporating
tobacco, intended for human consumption, whether by--
(i) placement in the oral or nasal cavity;
(ii) inhalation of vapor, aerosol, or smoke; or
(iii) any other means.
(41) The term ``tobacco product category'' means a type of
tobacco product characterized by its composition, components,
and intended use, and includes tobacco products classified as
cigarettes, loose tobacco for roll-your-own tobacco products,
little cigars, cigars, pipe tobacco, moist snuff, dry snuff,
chewing tobacco, and other forms of tobacco products (which
are treated in this Act collectively as a single category).
(42) The term ``tobacco product communication'' means any
means, medium, or manner for providing information relating
to any tobacco product, including face-to-face interaction,
mailings by postal service or courier to an individual who is
an addressee, and electronic mail to an individual who is an
addressee.
(43) The term ``tobacco product manufacturer'' means an
entity that directly--
(A) manufactures anywhere a tobacco product that is
intended to be distributed commercially in the United States,
including a tobacco product intended to be distributed
commercially in the United States through an importer;
(B) is the first purchaser for resale in the United States
of tobacco products manufactured outside the United States
for distribution commercially in the United States; or
(C) is a successor or assign of any of the foregoing.
(44) The term ``toxicant'' means a chemical or physical
agent that produces an adverse biological effect.
(45) The term ``tribal organization'' has the meaning
assigned that term in section 4(1) of the Indian Self
Determination and Education Assistance Act.
(46) The term ``United States'' means the several States,
as defined in this Act.
(47) The term ``youth'' means any individual who in not an
adult.
SEC. 101. CENTER AUTHORITY OVER TOBACCO PRODUCTS.
(a) In General.--Tobacco products, including modified risk
tobacco products for which an order has been issued in
accordance with section 117, shall be regulated by the
Administrator under this Act.
(b) Applicability.--This Act shall apply to all cigarettes,
cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco and to any other tobacco products that the
Administrator by regulation deems to be subject to this Act.
(c) Center.--The Secretary of Health and Human Services
shall establish within the Department of Health and Human
Services the Tobacco Harm Reduction Center. The head of the
Center shall be an Administrator, who shall assume the
statutory authority conferred by this Act, perform the
functions that relate to the subject matter of this Act, and
have the authority to promulgate regulations for the
efficient enforcement of this Act. In promulgating any
regulations under such authority, in whole or in part or any
regulation that is likely to have an annual effect on the
economy of $50,000,000 or more or have a material adverse
effect on adult users of tobacco products, tobacco product
manufacturers, distributors, or retailers, the Administrator
shall--
(1) determine the technological and economic ability of
parties that would be required to comply with the regulation
to comply with it;
(2) consider experience gained under any relevantly similar
regulations at the Federal or State level;
(3) determine the reasonableness of the relationship
between the costs of complying with such regulation and the
public health benefits to be achieved by such regulation;
(4) determine the reasonable likelihood of measurable and
substantial reductions in morbidity and mortality among
individual tobacco users;
(5) determine the impact to United States tobacco producers
and farm operations;
(6) determine the impact on the availability and use of
tobacco products by minors; and
(7) determine the impact on illicit trade of tobacco
products.
(d) Limitation of Authority.--
(1) In general.--The provisions of this Act shall not apply
to tobacco leaf that is not in the possession of a
manufacturer of tobacco products, or to the producers of
tobacco leaf, including tobacco growers, tobacco warehouses,
and tobacco grower cooperatives, nor shall any employee of
the Center have any authority to enter onto a farm owned by a
producer of tobacco leaf without the written consent of such
producer.
(2) Exception.--Notwithstanding paragraph (1), if a
producer of tobacco leaf is also a tobacco product
manufacturer or controlled by a tobacco product manufacturer,
the producer shall be subject to this Act in the producer's
capacity as a manufacturer. The exception in this
subparagraph shall not apply to a producer of tobacco leaf
who grows tobacco under a contract with a tobacco product
manufacturer and who is not otherwise engaged in the
manufacturing process.
(3) Rule of construction.--Nothing in this Act shall be
construed to grant the Administrator authority to promulgate
regulations on any matter that involves the production of
tobacco leaf or a producer thereof.
(e) Rulemaking Procedures.--Each rulemaking under this Act
shall be in accordance with chapter 5 of title 5, United
States Code.
(f) Consultation Prior to Rulemaking.--Prior to
promulgating rules under this Act, the Administrator shall
endeavor to consult with other Federal agencies as
appropriate.
SEC. 102. EXCLUSION OF OTHER REGULATORY PROGRAMS.
(a) Exclusion of Tobacco Products and Nicotine-Containing
Products From the Federal Food, Drug, and Cosmetic Act.--No
tobacco product and no nicotine-containing product shall be
regulated as a food, drug, or device in accordance with
section 201 (f), (g) or (h) or Chapter IV or V of the Federal
Food, Drug, and Cosmetic Act, except that any tobacco product
commercially distributed domestically and any nicotine-
containing product commercially distributed domestically
shall be subject to Chapter V of the Federal Food, Drug, and
Cosmetic Act if the manufacturer or a distributor of such
product markets it with an explicit claim that the product is
intended for use in the cure, mitigation, treatment, or
prevention of disease in man or other animals, within the
meaning of section 201(g)(1)(C) or section 201(h)(2) of that
Act.
(b) Limitation on Effect of This Act.--Nothing in this Act
shall be construed to--
(1) establish a precedent with regard to any other
industry, situation, circumstance, or legal action; or
(2) affect any action pending in any Federal, State, or
Tribal court, or any agreement, consent decree, or contract
of any kind.
(c) Exclusions From Authority of Administrator.--The
authority granted to the Administrator under this Act shall
not apply to--
(1) raw tobacco that is not in the possession or control of
a tobacco product manufacturer;
(2) raw tobacco that is grown for a tobacco product
manufacturer by a grower, and that is in the possession of
that grower or of a person that is not a tobacco product
manufacturer and is within the scope of subparagraphs (A)
through(F) of paragraph (3); or
(3) the activities, materials, facilities, or practices of
persons that are not tobacco product manufacturers and that
are--
(A) producers of raw tobacco, including tobacco growers;
(B) tobacco warehouses, and other persons that receive raw
tobacco from growers;
(C) tobacco grower cooperatives;
(D) persons that cure raw tobacco;
(E) persons that process raw tobacco; and
(F) persons that store raw tobacco for aging.
If a producer of raw tobacco is also a tobacco product
manufacturer, an affiliate of a tobacco product manufacturer,
or a person producing raw tobacco for a tobacco product
manufacturer, then that producer shall be subject to this Act
only to the extent of that producer's capacity as a tobacco
product manufacturer.
SEC. 103. EXISTING FEDERAL STATUTES MAINTAINED.
Except as amended or repealed by this Act, all Federal
statutes in effect as of the effective date of this Act that
regulate tobacco, tobacco products, or tobacco product
manufacturers shall remain in full force and effect. Such
statutes include, without limitation--
(1) the Federal Cigarette Labeling and Advertising Act,
sections 1331-1340 of title 15, United States Code, except
that section 1335 of title 15, United States Code, is
repealed;
(2) the Comprehensive Smokeless Tobacco Health Education
Act of 1986, sections 4401-4408 of title 15, United States
Code, except that section 4402(f) of title 15, United States
Code, is repealed;
(3) section 300x-26 of title 42, United States Code; and
(4) those statutes authorizing regulation of tobacco,
tobacco products, or tobacco product manufacturers by the
Federal Trade Commission, the Department of Agriculture, the
Environmental Protection Agency, the Internal Revenue
Service, and the Alcohol and Tobacco Tax and Trade Bureau of
the Department of the Treasury.
SEC. 104. PROCEEDINGS IN THE NAME OF THE UNITED STATES;
SUBPOENAS; PREEMPTION OF STATE AND LOCAL LAW;
NO PRIVATE RIGHT OF ACTION.
In furtherance of this Act:
(1) All proceedings for the enforcement, or to restrain
violations, of this Act shall be by
[[Page H4348]]
and in the name of the United States. Subpoenas for witnesses
who are required to attend a court of the United States, in
any district, may run into any other district in any
proceeding under this section. No State, or political
subdivision thereof, may proceed or intervene in any Federal
or State court under this Act or under any regulation
promulgated under it, or allege any violation thereof except
a violation by the Administrator. Nothing in this Act shall
be construed to create a right of action by any private
person for any violation of any provision of this Act or of
any regulation promulgated under it.
(2) With respect to any subject matter addressed by this
Act or by any regulation promulgated under it, no requirement
or prohibition shall be imposed under State or local law upon
any tobacco product manufacturer or distributor.
(3) Paragraph (2) shall not apply to any requirement or
prohibition imposed under State or local law before the date
of introduction of the bill that was enacted as this Act.
SEC. 105. ILLICIT TRADE.
The Administrator shall not promulgate any regulation or
take any other action that has the effect of--
(1) increasing illicit trade involving tobacco or any
tobacco product, or
(2) making affected tobacco products unacceptable to a
substantial number of then current users of such products,
thereby creating a substantial risk that such users will
resort to illicit tobacco products, or tobacco products that
are otherwise noncompliant or unlawful.
SEC. 106. ADULTERATED TOBACCO PRODUCTS.
A tobacco product shall be deemed to be adulterated--
(1) if it bears or contains any poisonous or deleterious
substance other than--
(A) tobacco;
(B) a substance naturally present in tobacco;
(C) a pesticide or fungicide chemical residue in or on
tobacco if such pesticide or fungicide chemical is registered
by the Environmental Protection Agency for use on tobacco in
the United States; or
(D) in the case of imported tobacco, a residue of a
pesticide or fungicide chemical that--
(i) is approved for use in the country of origin of the
tobacco; and
(ii) has not been banned, and the registration of which has
not been canceled, by the Environmental Protection Agency for
use on tobacco in the United States) that may render it
injurious to health; but, in case the substance is not an
added substance, such tobacco product shall not be considered
adulterated under this subsection if the quantity of such
substance in such tobacco product does not ordinarily render
it injurious to health;
(2) if there is significant scientific agreement that, as a
result of the tobacco it contains, the tobacco product
presents a risk to human health that is materially higher
than the risk presented by--
(A) such product on the effective date of this Act; or
(B) if such product was not distributed commercially
domestically on that date, by comparable tobacco products of
the same style and within the same category that were
commercially distributed domestically on that date;
(3) if it has been prepared, packed, or held under
unsanitary conditions whereby it may have become contaminated
with filth;
(4) if its package is composed, in whole or in part, of any
poisonous or deleterious substance that may render the
contents injurious to health; or
(5) if its ``tar'' yield is in violation of section 111.
SEC. 107. MISBRANDED TOBACCO PRODUCTS.
A tobacco product shall be deemed to be misbranded--
(1) if its labeling is false or misleading in any
particular;
(2) if in package form unless it bears a label containing--
(A) an identification of the type of product it is, by the
common or usual name of such type of product;
(B) an accurate statement of the quantity of the contents
in the package in terms of weight, measure, or numerical
count, except that reasonable variations shall be permitted,
and exemptions as to small packages shall be established by
regulations promulgated by the Administrator;
(C) the name and place of business of the tobacco product
manufacturer, packer, or distributor; and
(D) the information required by section 201(c) and (e) or
section 202(c) and (e), as applicable;
(3) if any word, statement, or other information required
by or under authority of this Act to appear on the label,
labeling, or advertising is not prominently placed thereon
with such conspicuousness (as compared with other words,
statements, or designs on the label, labeling, or
advertising, as applicable) and in such terms as to render it
reasonably likely to be read and understood by the ordinary
individual under customary conditions of purchase and use;
(4) if any word, statement, or other information is
required by or under this Act to appear on the label, unless
such word, statement, or other information also appears on
the outside container or wrapper, if any, of the retail
package of such tobacco product, or is easily legible through
the outside container or wrapper;
(5) if it was manufactured, prepared, or processed in an
establishment not duly registered under section 109, if it
was not included in a list required by section 109, or if a
notice or other information respecting it was not provided as
required by section 109;
(6) if its packaging, labeling, or advertising is in
violation of this Act or of an applicable regulation
promulgated in accordance with this Act;
(7) if it contains tobacco or another ingredient as to
which a required disclosure under this Act was not made;
(8) if it is labeled or advertised, or the tobacco
contained in it is advertised, as--
(A) containing ``no additives,'' or any substantially
similar term, unless the labeling or advertising, as
applicable, also contains, clearly and prominently, the
following disclosure: ``No additives in our tobacco does NOT
mean safer.''; or
(B) being ``natural,'' or any substantially similar term,
unless the labeling or advertising, as applicable, also
contains, clearly and prominently, the following disclosure:
``Natural does NOT mean safer.'';
(9) if in its labeling or advertising a term descriptive of
the tobacco in the tobacco product is used otherwise than in
accordance with a sanction or approval granted by a Federal
agency;
(10) if with respect to such tobacco product a disclosure
required by section 603 was not made;
(11) if with respect to such tobacco product a
certification required by section 803 was not submitted or is
materially false or misleading; or
(12) if its manufacturer or distributor made with respect
to it a claim prohibited by section 115.
SEC. 108. SUBMISSION OF HEALTH INFORMATION TO THE
ADMINISTRATOR.
(a) Requirement.--Each tobacco product manufacturer or
importer, or agents thereof, shall submit to the
Administrator the following information:
(1) Not later than 18 months after the date of enactment of
the Act, a listing of all ingredients, including tobacco,
substances, compounds, and additives that are, as of such
date, added by the manufacturer to the tobacco, paper,
filter, or other part of each tobacco product by brand and by
quantity in each brand and brand style.
(2) A description of the content, delivery, and form of
nicotine in each tobacco product measured in milligrams of
nicotine in accordance with regulations promulgated by the
Administrator in accordance with section 4(e) of the Federal
Cigarette Labeling and Advertising Act.
(3) Beginning 4 years after the date of enactment of this
Act, a listing of all constituents, including smoke
constituents as applicable, identified by the Administrator
as harmful to health in each tobacco product, and as
applicable in the smoke of each tobacco product, by brand and
by quantity in each brand and subbrand.
(b) Data Submission.--At the request of the Administrator,
each tobacco product manufacturer or importer of tobacco
products, or agents thereof, shall submit the following:
(1) Any or all documents (including underlying scientific
information) relating to research activities, and research
findings, conducted, supported, or possessed by the
manufacturer (or agents thereof) on the health,
toxicological, or physiologic effects of tobacco products and
their constituents (including smoke constituents),
ingredients, components, and additives.
(2) Any or all documents (including underlying scientific
information) relating to research activities, and research
findings, conducted, supported, or possessed by the
manufacturer (or agents thereof) that relate to the issue of
whether a significant reduction in risk to health from
tobacco products can occur upon the employment of technology
available to the manufacturer.
An importer of a tobacco product not manufactured in the
United States shall supply the information required of a
tobacco product manufacturer under this subsection.
(c) Data List.--
(1) In general.--Not later than 4 years after the date of
enactment of the Act, and annually thereafter, the
Administrator shall publish in a format that is
understandable and not misleading to a lay person, and place
on public display (in a manner determined by the
Administrator) the list established under subsection (d).
(2) Consumer research.--The Administrator shall conduct
periodic consumer research to ensure that the list published
under paragraph (1) is not misleading to lay persons. Not
later than 5 years after the date of enactment of the Act,
the Administrator shall submit to the appropriate committees
of Congress a report on the results of such research,
together with recommendations on whether such publication
should be continued or modified.
(d) Data Collection.--Not later than 36 months after the
date of enactment of this Act, the Administrator shall
establish, and periodically revise as appropriate, a list of
harmful constituents, including smoke constituents, to health
in each tobacco product by brand and by quantity in each
brand and subbrand.
SEC. 109. REGISTRATION AND LISTING.
(a) Definitions.--As used in this section:
(1) The term ``manufacture, preparation, or processing''
shall include repackaging or
[[Page H4349]]
otherwise changing the container, wrapper, or label of any
tobacco product package other than the carton in furtherance
of the distribution of the tobacco product from the original
place of manufacture to the person that makes final delivery
or sale to the ultimate consumer or user, but shall not
include the addition of a tax marking or other marking
required by law to an already packaged tobacco product.
(2) The term ``name'' shall include in the case of a
partnership the name of the general partner and, in the case
of a privately held corporation, the name of the chief
executive officer of the corporation and the State of
incorporation.
(b) Annual Registration.--Commencing one year after
enactment, on or before December 31 of each year, every
person that owns or operates any establishment in any State
engaged in the manufacture, preparation, or processing of a
tobacco product or products for commercial distribution
domestically shall register with the Administrator its name,
places of business, and all such establishments.
(c) New Producers.--Every person upon first engaging, for
commercial distribution domestically, in the manufacture,
preparation, or processing of a tobacco product or products
in any establishment that it owns or operates in any State
shall immediately register with the Administrator its name,
places of business, and such establishment.
(d) Registration of Foreign Establishments.--
(1) Commencing one year after enactment of this Act, on or
before December 31 of each year, the person that, within any
foreign country, owns or operates any establishment engaged
in the manufacture, preparation, or processing of a tobacco
product that is imported or offered for import into the
United States shall, through electronic means or other means
permitted by the Administrator, register with the
Administrator the name and place of business of each such
establishment, the name of the United States agent for the
establishment, and the name of each importer of such tobacco
product in the United States that is known to such person.
(2) Such person also shall provide the information required
by subsection (j), including sales made by mail, or through
the Internet, or other electronic means.
(3) The Administrator is authorized to enter into
cooperative arrangements with officials of foreign countries
to ensure that adequate and effective means are available for
purposes of determining, from time to time, whether tobacco
products manufactured, prepared, or processed by an
establishment described in paragraph (1), if imported or
offered for import into the United States, shall be refused
admission on any of the grounds set forth in section 708.
(e) Additional Establishments.--Every person duly
registered in accordance with the foregoing subsections of
this section shall immediately register with the
Administrator any additional establishment that it owns or
operates and in which it begins the manufacture, preparation,
or processing of a tobacco product or products for commercial
distribution domestically or for import into the United
States.
(f) Exclusions From Application of This Section.--The
foregoing subsections of this section shall not apply to--
(1) persons that manufacture, prepare, or process tobacco
products solely for use in research, teaching, chemical or
biological analysis, or export; or
(2) such other classes of persons as the Administrator may
by regulation exempt from the application of this section
upon a finding that registration by such classes of persons
in accordance with this section is not necessary for the
protection of the public health.
(g) Inspection of Premises.--Every establishment registered
with the Administrator pursuant to this section shall be
subject to inspection pursuant to section 706; and every such
establishment engaged in the manufacture, preparation, or
processing of a tobacco product or products shall be so
inspected by one or more officers or employees duly
designated by the Administrator at least once in the two-year
period beginning with the date of registration of such
establishment pursuant to this section and at least once in
every successive two-year period thereafter, except that
inspection of establishments outside the United States may be
conducted by other personnel pursuant to a cooperative
arrangement under subsection (d)(3).
(h) Filing of Lists of Tobacco Products Manufactured,
Prepared, or Processed by Registrants; Statements;
Accompanying Disclosures.--
(1) Every person that registers with the Administrator
under subsection (b), (c), (d), or (e) shall, at the time of
registration under any such subsection, file with the
Administrator a list of all brand styles (with each brand
style in each list listed by the common or usual name of the
tobacco product category to which it belongs and by any
proprietary name) that are being manufactured, prepared, or
processed by such person for commercial distribution
domestically or for import into the United States, and that
such person has not included in any list of tobacco products
filed by such person with the Administrator under this
paragraph or paragraph (2) before such time of registration.
Such list shall be prepared in such form and manner as the
Administrator may prescribe, and shall be accompanied by the
label for each such brand style and a representative sampling
of any other labeling and advertising for each;
(2) Each person that registers with the Administrator under
this section shall report to the Administrator each August
for the preceding six-month period from January through June,
and each February for the preceding six-month period form
July through December, following information:
(A) A list of each brand style introduced by the registrant
for commercial distribution domestically or for import into
the United States that has not been included in any list
previously filed by such registrant with the Administrator
under this subparagraph or paragraph (1). A list under this
subparagraph shall list a brand style by the common or usual
name of the tobacco product category to which it belongs and
by any proprietary name, and shall be accompanied by the
other information required by paragraph (1).
(B) If since the date the registrant last made a report
under this paragraph (or if such registrant has not
previously made a report under this paragraph, since the
effective date of this Act) such registrant has discontinued
the manufacture, preparation, or processing for commercial
distribution domestically or for import into the United
States of a brand style included in a list filed by such
registrant under subparagraph (A) or paragraph (1), notice of
such discontinuance, the date of such discontinuance, and the
identity (by the common or usual name of the tobacco product
category to which it belongs and by any proprietary name) of
such tobacco product.
(C) If, since the date the registrant reported pursuant to
subparagraph (B) a notice of discontinuance of a tobacco
product, the registrant has resumed the manufacture,
preparation, or processing for commercial distribution
domestically or for import into the United States of that
brand style, notice of such resumption, the date of such
resumption, the identity of such brand style (by the common
or usual name of the tobacco product category to which it
belongs and by any proprietary name), and the other
information required by paragraph (1), unless the registrant
has previously reported such resumption to the Administrator
pursuant to this subparagraph.
(D) Any material change in any information previously
submitted pursuant to this paragraph (2) or paragraph (1).
(i) Electronic Registration.--Registrations under
subsections (b), (c), (d), and (e) (including the submission
of updated information) shall be submitted to the
Administrator by electronic means, unless the Administrator
grants a request for waiver of such requirement because use
of electronic means is not reasonable for the person
requesting such waiver.
SEC. 110. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO
PRODUCTS.
(a) In General.--Any requirement established by or under
section 106, 107, or 113 applicable to a tobacco product
shall apply to such tobacco product until the applicability
of the requirement to the tobacco product has been changed by
action taken under section 111, section 114, section 115, or
subsection (d) of this section, and any requirement
established by or under section 106, 107, or 113 which is
inconsistent with a requirement imposed on such tobacco
product under section 111, section 114, section 115, or
subsection (d) of this section shall not apply to such
tobacco product.
(b) Information on Public Access and Comment.--Each notice
of proposed rulemaking or other notification under section
111, 112, 113, 114, or 115 or under this section, any other
notice which is published in the Federal Register with
respect to any other action taken under any such section and
which states the reasons for such action, and each
publication of findings required to be made in connection
with rulemaking under any such section shall set forth--
(1) the manner in which interested persons may examine data
and other information on which the notice or findings is
based; and
(2) the period within which interested persons may present
their comments on the notice or findings (including the need
therefore) orally or in writing, which period shall be at
least 60 days but may not exceed 90 days unless the time is
extended by the Administrator by a notice published in the
Federal Register stating good cause therefore.
(c) Limited Confidentiality of Information.--Any
information reported to or otherwise obtained by the
Administrator or the Administrator's representative under
section 107, 108, 111, 112, 113, 114, 115, or 504, or under
subsection (e) or (f) of this section, which is exempt from
disclosure under subsection (a) of section 552 of title 5,
United States Code, by reason of subsection (b)(4) of that
section shall be considered confidential and shall not be
disclosed, except that the information may be disclosed to
other officers or employees concerned with carrying out this
Act, or when relevant in any proceeding under this Act.
(d) Restrictions.--
(1) In general.--The Administrator may issue regulations,
consistent with this Act, regarding tobacco products if the
Administrator determines that such regulation would be
appropriate for the protection of the public health. The
finding as to whether such regulation would be appropriate
for the protection of the public health shall be determined
with respect to the risks and benefits to the users of the
tobacco product, and taking into account that the standard is
reasonably likely to result in measurable and substantial
reductions in morbidly and mortality among individual tobacco
users.
[[Page H4350]]
(2) Label statements.--The label of a tobacco product shall
bear such appropriate statements of the restrictions required
by a regulation under subsection (a) as the Administrator may
in such regulation prescribe.
(e) Good Manufacturing Practice Requirements.--
(1) Methods, facilities, and controls to conform.--
(A) In general.--In applying manufacturing restrictions to
tobacco, the Administrator shall, in accordance with
subparagraph (B), prescribe regulations (which may differ
based on the type of tobacco product involved) requiring that
the methods used in, and the facilities and controls used
for, the manufacture, preproduction design validation
(including a process to assess the performance of a tobacco
product), packing, and storage of a tobacco product conform
to current good manufacturing practice, or hazard analysis
and critical control point methodology, as prescribed in such
regulations to assure that the public health is protected and
that the tobacco product is in compliance with this Act. Such
regulations may provide for the testing of raw tobacco for
pesticide chemical residues after a tolerance for such
chemical residues has been established.
(B) Requirements.--The Administrator shall--
(i) before promulgating any regulation under subparagraph
(A), afford the Tobacco Products Scientific Advisory
Committee an opportunity to submit recommendations with
respect to the regulation proposed to be promulgated;
(ii) before promulgating any regulation under subparagraph
(A), afford opportunity for an oral hearing;
(iii) provide the Tobacco Products Scientific Advisory
Committee a reasonable time to make its recommendation with
respect to proposed regulations under subparagraph (A); and
(iv) in establishing the effective date of a regulation
promulgated under this subsection, take into account the
differences in the manner in which the different types of
tobacco products have historically been produced, the
financial resources of the different tobacco product
manufacturers, and the state of their existing manufacturing
facilities, and shall provide for a reasonable period of time
for such manufacturers to conform to good manufacturing
practices but no earlier than four years from date of
enactment.
(C) Additional special rule.--A tobacco product
manufactured in or imported into the United States shall not
contain foreign-grown flue-cured or burley tobacco that--
(i) was knowingly grown or processed using a pesticide
chemical that is not approved under applicable Federal law
for use in domestic tobacco farming and processing; or
(ii) in the case of a pesticide chemical that is so
approved, was grown or processed using the pesticide chemical
in a manner inconsistent with the approved labeling for use
of the pesticide chemical in domestic tobacco farming and
processing.
(D) Exclusion.--Subparagraph (C)(ii) shall not apply to
tobacco products manufactured with foreign-grown flue-cured
or burley tobacco so long as that foreign grown tobacco was
either--
(i) in the inventory of a manufacturer prior to the
effective date, or
(ii) planted by the farmer prior to the effective date of
this Act and utilized by the manufacturer no later than 3
years after the effective date.
(E) Setting of maximum residue limits.--The Administrator
shall adopt the following pesticide residue standards:
Pesticide residue standards
The maximum concentration of residues of the following
pesticides allowed in flue-cured or burley tobacco, expressed
as parts by weight of the residue per one million parts by
weight of the tobacco (PPM) are:
CHLORDANE.....3.0
DIBROMOCHLOROPROPANE (DBCP).....1.0
DICAMBA (Temporary).... 5.0
ENDRIN....0.1
ETHYLENE DIBROMIDE (EDB)....0.1
FORMOTHION.....0.5
HEXACHLOROBENZENE (HCB)....0.1
METHOXYCHLOR.....0.1
TOXAPHENE.....0.3
2,4-D (Temporary).....5.0
2,4,5-T.....0.1
Sum of ALDRIN and DIELDRIN.....0.1
Sum of CYPERMETHRIN and PERMETHRIN (Temporary).....3.0
Sum of DDT, TDE (DDD), and DDE .....0.4
Sum of HEPTACHLOR and HEPTACHLOR EPOXIDE.....0.1
(F) Maximum residue limits.--The Administrator shall adopt
regulations within one year of the effective date of this Act
to establish maximum residue limits for pesticides identified
under subparagraph (E) but not included in the table of such
subparagraph to account for the fact that weather and
agronomic conditions will cause pesticides identified in
subparagraph (E) to be detected in foreign-grown tobacco even
where the farmer has not knowingly added such pesticide.
(2) Exemptions; variances.--
(A) Petition.--Any person subject to any requirement
prescribed under paragraph (1) may petition the Administrator
for a permanent or temporary exemption or variance from such
requirement. Such a petition shall be submitted to the
Administrator in such form and manner as the Administrator
shall prescribe and shall--
(i) in the case of a petition for an exemption from a
requirement, set forth the basis for the petitioner's
determination that compliance with the requirement is not
required to assure that the tobacco product will be in
compliance with this Act;
(ii) in the case of a petition for a variance from a
requirement, set forth the methods proposed to be used in,
and the facilities and controls proposed to be used for, the
manufacture, packing, and storage of the tobacco product in
lieu of the methods, facilities, and controls prescribed by
the requirement; and
(iii) contain such other information as the Administrator
shall prescribe.
(B) Referral to the tobacco products scientific advisory
committee.--The Administrator may refer to the Tobacco
Products Scientific Advisory Committee any petition submitted
under subparagraph (A). The Tobacco Products Scientific
Advisory Committee shall report its recommendations to the
Administrator with respect to a petition referred to it
within 60 days after the date of the petition's referral.
Within 60 days after--
(i) the date the petition was submitted to the
Administrator under subparagraph (A); or
(ii) the day after the petition was referred to the Tobacco
Products Scientific Advisory Committee,
whichever occurs later, the Administrator shall by order
either deny the petition or approve it.
(C) Approval.--The Administrator may approve--
(i) a petition for an exemption for a tobacco product from
a requirement if the Administrator determines that compliance
with such requirement is not required to assure that the
tobacco product will be in compliance with this Act; and
(ii) a petition for a variance for a tobacco product from a
requirement if the Administrator determines that the methods
to be used in, and the facilities and controls to be used
for, the manufacture, packing, and storage of the tobacco
product in lieu of the methods, facilities, and controls
prescribed by the requirement are sufficient to assure that
the tobacco product will be in compliance with this Act.
(D) Conditions.--An order of the Administrator approving a
petition for a variance shall prescribe such conditions
respecting the methods used in, and the facilities and
controls used for, the manufacture, packing, and storage of
the tobacco product to be granted the variance under the
petition as may be necessary to assure that the tobacco
product will be in compliance with this Act.
(E) Hearing.--After the issuance of an order under
subparagraph (B) respecting a petition, the petitioner shall
have an opportunity for an informal hearing on such order.
(3) Compliance.--Compliance with requirements under this
subsection shall not be required before the end of the 3-year
period following the date of enactment of this Act.
(f) Research and Development.--The Administrator may enter
into contracts for research, testing, and demonstrations
respecting tobacco products and may obtain tobacco products
for research, testing, and demonstration purposes.
SEC. 111. SMOKING ARTICLE STANDARDS.
(a) In General.--
(1) Restrictions on descriptors used in marketing of
cigarettes.--
(A) In general.--Except as provided in subparagraph (B), no
person shall use, with respect to any cigarette brand style
commercially distributed domestically, on the portion of the
package of such cigarette brand style that customarily is
visible to consumers before purchase, or in advertising of
such cigarette brand style any of the following as a
descriptor of any cigarette brand style--
(i) the name of any candy or fruit;
(ii) the word ``candy,'' ``citrus,'' ``cream,'' ``fruit,''
``sugar,'' ``sweet,'' ``tangy,'' or ``tart,''; or
(iii) any extension or variation of any of the words
``candy,'' ``citrus,'' ``cream,'' ``fruit,'' ``sugar,''
``sweet,'' ``tangy,'' or ``tart,'' including but not limited
to ``creamy,'' or ``fruity.''
(B) Limitation.--Subparagraph (A) shall not apply to the
use of the following words or to any extension or variation
of any of them: ``coffee,'' ``mint,'' and ``menthol''.
(C) Scented materials.--No person shall use, in the
advertising or labeling of any cigarette commercially
distributed domestically, any scented materials, except in an
adult-only facility.
(D) Definitions.--In this section:
(i) The term ``candy'' means a confection made from sugar
or sugar substitute, including any confection identified
generically or by brand, and shall include the words
``cacao,'' ``chocolate,'' ``cinnamon,'' ``cocoa,'' ``honey,''
``licorice,'' ``maple,'' ``mocha,'' and ``vanilla.''
(ii) The term ``fruit'' means any fruit identified by
generic name, type, or variety, including but not limited to
``apple,'' ``banana,'' ``cherry,'' and ``orange.'' The term
``fruit'' does not include words that identify seeds, nuts or
peppers, or types or varieties thereof or words that are
extensions or variations of such words.
(2) Smoking article standards.--
(A) In general.--The Administrator may adopt smoking
article standards in addition to those in paragraph (1) if
the Administrator finds that a smoking article standard is
appropriate for the protection of the public health.
[[Page H4351]]
(B) Determinations.--
(i) Considerations.--In making a finding described in
subparagraph (A), the Administrator shall consider scientific
evidence concerning--
(I) the risks and benefits to the users of smoking articles
of the proposed standard; and
(II) that the standard is reasonably likely to result in
measurable and substantial reductions in morbidity and
mortality among individual tobacco users.
(ii) Additional considerations.--In the event that the
Administrator makes a determination, set forth in a proposed
smoking article standard in a proposed rule, that it is
appropriate for the protection of public health to require
the reduction or elimination of an additive, constituent
(including a smoke constituent), or other component of a
smoking article because the Administrator has found that the
additive, constituent, or other component is harmful, any
party objecting to the proposed standard on the ground that
the proposed standard will not reduce or eliminate the risk
of illness or injury may provide for the Administrator's
consideration scientific evidence that demonstrates that the
proposed standard will not reduce or eliminate the risk of
illness or injury.
(3) Content of smoking article standards.--A smoking
article standard established under this section for a smoking
article--
(A) may include provisions that are appropriate for the
protection of the public health, including provisions, where
appropriate--
(i) for ``tar'' and nicotine yields of the product;
(ii) for the reduction of other constituents, including
smoke constituents, or harmful components of the product; or
(iii) relating to any other requirement under subparagraph
(B); and
(B) may, where appropriate for the protection of the public
health, include--
(i) provisions respecting the construction, components,
ingredients, additives, constituents, including smoke
constituents, and properties of the smoking article;
(ii) provisions for the testing (on a sample basis or, if
necessary, on an individual basis) of the smoking article;
(iii) provisions for the measurement of the smoking article
characteristics of the smoking article; and
(iv) provisions requiring that the results of each or of
certain of the tests of the smoking article required to be
made under clause (ii) show that the smoking article is in
conformity with the portions of the standard for which the
test or tests were required.
(4) Periodic reevaluation of smoking article standards.--
The Administrator may provide for periodic evaluation of
smoking article standards established under this section to
determine whether such standards should be changed to reflect
new medical, scientific, or other technological data.
(5) Cigarette ``tar'' limits.--
(A) No increase in ``tar'' yields.--No cigarette
manufacturer shall distribute for sale domestically a brand
style of cigarettes that generates a ``tar'' yield greater
than the ``tar'' yield of that brand style of cigarettes on
the date of introduction of this Act, as determined by the
ISO smoking regimen and its associated tolerances. The
``tar'' tolerances for cigarettes with ISO ``tar'' yields in
the range of 1 to 20 milligrams per cigarette, based on
variations arising from sampling procedure, test method, and
sampled product, itself, are the greater of plus or minus--
(i) 15 percent; or
(ii) 1 milligram per cigarette.
(B) Limit on new cigarettes.--After the effective date of
this Act, no cigarette manufacturer shall manufacture for
commercial distribution domestically a brand style of
cigarettes that both--
(i) was not in commercial distribution domestically on the
effective date of this Act, and
(ii) generates a ``tar'' yield of greater than 20
milligrams per cigarette as determined by the ISO smoking
regimen and its associated tolerances.
(C) Limit on all cigarettes.--After December 31, 2010, no
cigarette manufacturer shall manufacture for commercial
distribution domestically a brand style of cigarettes that
generates a ``tar'' yield greater than 20 milligrams per
cigarette as determined by the ISO smoking regimen and its
associated tolerances.
(D) Review by administrator.--After the effective date of
this Act, the Administrator shall evaluate the available
scientific evidence addressing the potential relationship
between historical ``tar'' yield values and risk of harm to
smokers. If upon a review of that evidence, and after
consultation with technical experts of the Tobacco Harm
Reduction Center and the Centers for Disease Control and
Prevention and notice and an opportunity for public comment,
the Administrator determines, that a reduction in ``tar''
yield may reasonably be expected to provide a meaningful
reduction of the risk or risks of harm to smokers, the
Administrator shall issue an order that--
(i) provides that no cigarette manufacturer shall
manufacture for commercial distribution domestically a
cigarette that generates a ``tar'' yield that exceeds 14
milligrams as determined by the ISO smoking regimen and its
associated tolerances; and
(ii) provides a reasonable time for manufacturers to come
into compliance with such prohibition.
(6) Involvement of other agencies; informed persons.--In
carrying out duties under this section, the Administrator
shall endeavor to--
(A) use personnel, facilities, and other technical support
available in other Federal agencies;
(B) consult with other Federal agencies concerned with
standard setting and other nationally or internationally
recognized standard-setting entities; and
(C) invite appropriate participation, through joint or
other conferences, workshops, or other means, by informed
persons representative of scientific, professional, industry,
agricultural, or consumer organizations who in the
Administrator's judgment can make a significant contribution.
(b) Considerations by Administrator.--
(1) Technical achievability.--The Administrator shall
consider information submitted in connection with a proposed
standard regarding the technical achievability of compliance
with such standard.
(2) Other considerations.--The Administrator shall consider
all other information submitted in connection with a proposed
standard, such as the creation of a significant demand for
contraband or other tobacco products that do not meet the
requirements of this Act and the significance of such demand.
(c) Proposed Standards.--
(1) In general.--The Administrator shall publish in the
Federal Register a notice of proposed rulemaking for the
establishment, amendment, or revocation of any smoking
article standard.
(2) Requirements of notice.--A notice of proposed
rulemaking for the establishment or amendment of a smoking
article standard shall--
(A) set forth a finding with supporting justification that
the smoking article standard is appropriate for the
protection of the public health;
(B) invite interested persons to submit a draft or proposed
smoking article standard for consideration by the
Administrator;
(C) invite interested persons to submit comments on
structuring the standard so that it does not advantage
foreign-grown tobacco over domestically grown tobacco; and
(D) invite the Secretary of Agriculture to provide any
information or analysis which the Secretary of Agriculture
believes is relevant to the proposed smoking article
standard.
(3) Finding.--A notice of proposed rulemaking for the
revocation of a smoking article standard shall set forth a
finding with supporting justification that the smoking
article standard is no longer appropriate for the protection
of the public health.
(4) Comment.--The Administrator shall provide for a comment
period of not less than 90 days.
(d) Promulgation.--
(1) In general.--After the expiration of the period for
comment on a notice of proposed rulemaking published under
subsection (c) respecting a standard and after consideration
of comments submitted under subsections (b) and (c) and any
report from the Tobacco Products Scientific Advisory
Committee, if the Administrator determines that the standard
would be appropriate for the protection of the public health,
the Administrator shall--
(A) promulgate a regulation establishing a smoking article
standard and publish in the Federal Register findings on the
matters referred to in subsection (c); or
(B) publish a notice terminating the proceeding for the
development of the standard together with the reasons for
such termination.
(2) Effective date.--A regulation establishing a smoking
article standard shall set forth the date or dates upon which
the standard shall take effect, but no such regulation may
take effect before 1 year after the date of its publication
unless the Administrator determines that an earlier effective
date is necessary for the protection of the public health.
Such date or dates shall be established so as to minimize,
consistent with the public health, economic loss to, and
disruption or dislocation of, domestic and international
trade. In establishing such effective date or dates, the
Administrator shall consider information submitted in
connection with a proposed product standard by interested
parties, including manufacturers and tobacco growers,
regarding the technical achievability of compliance with the
standard, and including information concerning the existence
of patents that make it impossible to comply in the timeframe
envisioned in the proposed standard.
(3) Limitation on power granted.--Because of the importance
of a decision of the Administrator to issue a regulation--
(A) banning cigarettes, smokeless smoking articles, little
cigars, cigars other than little cigars, pipe tobacco, or
roll-your-own smoking articles;
(B) requiring the reduction of ``tar'' or nicotine yields
of a smoking article to zero;
(C) prohibiting the sale of any smoking article in face-to-
face transactions by a specific category of retail outlets;
(D) establishing a minimum age of sale of smoking articles
to any person older than 18 years of age; or
(E) requiring that the sale or distribution of a smoking
article be limited to the written or oral authorization of a
practitioner licensed by law to prescribe medical products,
the Administrator is prohibited from taking such actions
under this Act.
[[Page H4352]]
(4) Matchbooks.--For purposes of any regulations issued by
the Administrator under this Act, matchbooks of conventional
size containing not more than 20 paper matches, and which are
customarily given away for free with the purchase of smoking
articles, shall be considered as adult-written publications
which shall be permitted to contain advertising.
(5) Amendment; revocation.--
(A) Authority.--The Administrator, upon the Administrator's
own initiative or upon petition of an interested person, may
by a regulation, promulgated in accordance with the
requirements of subsection (c) and paragraph (2), amend or
revoke a smoking article standard.
(B) Effective date.--The Administrator may declare a
proposed amendment of a smoking article standard to be
effective on and after its publication in the Federal
Register and until the effective date of any final action
taken on such amendment if the Administrator determines that
making it so effective is in the public interest.
(6) Referral to advisory committee.--
(A) In general.--The Administrator shall refer a proposed
regulation for the establishment, amendment, or revocation of
a smoking article standard to the Tobacco Products Scientific
Advisory Committee for a report and recommendation with
respect to any matter involved in the proposed regulation
which requires the exercise of scientific judgment.
(B) Initiation of referral.--The Administrator shall make a
referral under this paragraph--
(i) on the Administrator's own initiative; or
(ii) upon the request of an interested person that--
(I) demonstrates good cause for the referral; and
(II) is made before the expiration of the period for
submission of comments on the proposed regulation.
(C) Provision of data.--If a proposed regulation is
referred under this paragraph to the Tobacco Products
Scientific Advisory Committee, the Administrator shall
provide the Advisory Committee with the data and information
on which such proposed regulation is based.
(D) Report and recommendation.--The Tobacco Products
Scientific Advisory Committee shall, within 90 days after the
referral of a proposed regulation under this paragraph and
after independent study of the data and information furnished
to it by the Administrator and other data and information
before it, submit to the Administrator a report and
recommendation respecting such regulation, together with all
underlying data and information and a statement of the reason
or basis for the recommendation.
(E) Public availability.--The Administrator shall make a
copy of each report and recommendation under subparagraph (D)
publicly available.
SEC. 112. NOTIFICATION AND OTHER REMEDIES.
(a) Notification.--If the Administrator determines that--
(1) a tobacco product which is introduced or delivered for
introduction into interstate commerce for commercial
distribution presents an unreasonable risk of substantial
harm materially above the risk for death and disease of
tobacco products currently in interstate commerce, to the
public health; and
(2) notification under this subsection is necessary to
eliminate the unreasonable risk of such harm and no more
practicable means is available under the provisions of this
Act (other than this section) to eliminate such risk,
the Administrator may issue such order as may be necessary to
assure that adequate notification is provided in an
appropriate form, by the persons and means best suited under
the circumstances involved, to all persons who should
properly receive such notification in order to eliminate such
risk. The Administrator may order notification by any
appropriate means, including public service announcements.
Before issuing an order under this subsection, the
Administrator shall consult with the persons who are to give
notice under the order.
(b) No Exemption From Other Liability.--Compliance with an
order issued under this section shall not relieve any person
from liability under Federal or State law. In awarding
damages for economic loss in an action brought for the
enforcement of any such liability, the value to the plaintiff
in such action of any remedy provided under such order shall
be taken into account.
(c) Recall Authority.--
(1) In general.--If the Administrator finds that there is a
reasonable probability that a tobacco product contains a
manufacturing or other defect not ordinarily contained in
tobacco products on the market that would cause serious,
acute adverse health consequences or death, the Administrator
shall issue an order requiring the appropriate person
(including the manufacturers, importers, distributors, or
retailers of the tobacco product) to immediately cease
distribution of such tobacco product. The order shall provide
the person subject to the order with an opportunity for an
informal hearing, to be held not later than 10 days after the
date of the issuance of the order, on the actions required by
the order and on whether the order should be amended to
require a recall of such tobacco product. If, after providing
an opportunity for such a hearing, the Administrator
determines that inadequate grounds exist to support the
actions required by the order, the Administrator shall vacate
the order.
(2) Amendment of order to require recall.--
(A) In general.--If, after providing an opportunity for an
informal hearing under paragraph (1), the Administrator
determines that the order should be amended to include a
recall of the tobacco product with respect to which the order
was issued, the Administrator shall, except as provided in
subparagraph (B), amend the order to require a recall. The
Administrator shall specify a timetable in which the tobacco
product recall will occur and shall require periodic reports
to the Administrator describing the progress of the recall.
(B) Notice.--An amended order under subparagraph (A)--
(i) shall not include recall of a tobacco product from
individuals; and
(ii) shall provide for notice to persons subject to the
risks associated with the use of such tobacco product.
In providing the notice required by clause (ii), the
Administrator may use the assistance of retailers and other
persons who distributed such tobacco product. If a
significant number of such persons cannot be identified, the
Administrator shall notify such persons under section 705(b).
(3) Remedy not exclusive.--The remedy provided by this
subsection shall be in addition to remedies provided by
subsection (a).
SEC. 113. RECORDS AND REPORTS ON TOBACCO PRODUCTS.
Every person who is a tobacco product manufacturer or
importer of a tobacco product shall establish and maintain
such records, make such reports, and provide such
information, as the Administrator may by regulation
reasonably require to assure that such tobacco product is not
adulterated or misbranded.
SEC. 114. APPLICATION FOR REVIEW OF CERTAIN SMOKING ARTICLES.
(a) In General.--
(1) New smoking article defined.--For purposes of this
section the term ``new smoking article'' means--
(A) any smoking article that was not commercially marketed
in the United States as of the date of enactment of this Act;
and
(B) any smoking article that incorporates a significant
modification (including changes in design, component, part,
or constituent, including a smoke constituent, or in the
content, delivery or form of nicotine, or other additive or
ingredient) of a smoking article where the modified product
was commercially marketed in the United States after the date
of enactment of this Act.
(2) Premarket review required.--
(A) New products.--An order under subsection (c)(1)(A) for
a new smoking article is required unless the product--
(i) is substantially equivalent to a smoking article
commercially marketed in the United States as of date of
enactment of this Act; and
(ii) is in compliance with the requirements of this Act.
(B) Consumer testing.--This section shall not apply to
smoking articles that are provided to adult tobacco consumers
for purposes of consumer testing. For purposes of this
section, the term ``consumer testing'' means an assessment of
smoking articles that is conducted by or under the control
and direction of a manufacturer for the purpose of evaluating
consumer acceptance of such smoking articles, utilizing only
the quantity of cigarettes that is reasonably necessary for
such assessment
(3) Substantially equivalent defined.--
(A) In general.--In this section, the term ``substantially
equivalent'' or ``substantial equivalence'' means, with
respect to the smoking article being compared to the
predicate smoking article, that the Administrator by order
has found that the smoking article--
(i) has the same general characteristics as the predicate
smoking article; or
(ii) has different characteristics and the information
submitted contains information, including clinical data if
deemed necessary by the Administrator, that demonstrates that
it is not appropriate to regulate the product under this
section because the product does not raise different
questions of public health for the consumer of the product.
(B) Characteristics.--In subparagraph (A), the term
``characteristics'' means the materials, ingredients, design,
composition, heating source, or other features of a smoking
article.
(C) Limitation.--A smoking article may not be found to be
substantially equivalent to a predicate smoking article that
has been removed from the market at the initiative of the
Administrator or that has been determined by a judicial order
to be misbranded or adulterated.
(4) Health information.--As part of a submission respecting
a smoking article, the person required to file a premarket
notification shall provide an adequate summary of any health
information related to the smoking article or state that such
information will be made available upon request by any
person.
(b) Application.--
(1) Contents.--An application under this section shall
contain--
(A) full reports of all information, published or known to,
or which should reasonably be known to, the applicant,
concerning investigations which have been made to show the
health risks of such smoking article and whether such smoking
article presents less risk than other smoking articles;
[[Page H4353]]
(B) a full statement of the components, ingredients,
additives, and properties, and of the principle or principles
of operation, of such smoking article;
(C) a full description of the methods used in, and the
facilities and controls used for, the manufacture,
processing, and, when relevant, packing and installation of,
such smoking article;
(D) an identifying reference to any smoking article
standard under section 111 which would be applicable to any
aspect of such smoking article, and either adequate
information to show that such aspect of such smoking article
fully meets such smoking article standard or adequate
information to justify any deviation from such standard;
(E) such samples of such smoking article and of components
thereof as the Administrator may reasonably require;
(F) specimens of the labeling proposed to be used for such
smoking article; and
(G) such other information relevant to the subject matter
of the application as the Administrator may require.
(2) Referral to tobacco products scientific advisory
committee.--Upon receipt of an application meeting the
requirements set forth in paragraph (1), the Administrator--
(A) may, on the Administrator's own initiative; or
(B) may, upon the request of an applicant,
refer such application to the Tobacco Products Scientific
Advisory Committee for reference and for submission (within
such period as the Administrator may establish) of a report
and recommendation respecting the application, together with
all underlying data and the reasons or basis for the
recommendation.
(c) Action on Application.--
(1) Deadline.--As promptly as possible, but in no event
later than 90 days after the receipt of an application under
subsection (b), the Administrator, after considering the
report and recommendation submitted under subsection (b)(2),
shall--
(A) issue an order that the new product may be introduced
or delivered for introduction into interstate commerce if the
Administrator finds that none of the grounds specified in
paragraph (2) of this subsection applies; or
(B) issue an order that the new product may not be
introduced or delivered for introduction into interstate
commerce if the Administrator finds (and sets forth the basis
for such finding as part of or accompanying such denial) that
1 or more grounds for denial specified in paragraph (2) of
this subsection apply.
(2) Denial of application.--The Administrator shall deny an
application submitted under subsection (b) if, upon the basis
of the information submitted to the Administrator as part of
the application and any other information before the
Administrator with respect to such smoking article, the
Administrator finds that--
(A) there is a lack of a showing that permitting such
smoking article to be marketed would be appropriate for the
protection of the public health;
(B) the methods used in, or the facilities or controls used
for, the manufacture, processing, or packing of such smoking
article do not conform to the requirements of section 110(e);
(C) based on a fair evaluation of all material facts, the
proposed labeling is false or misleading in any particular;
or
(D) such smoking article is not shown to conform to a
smoking article standard in effect under section 111, and
there is a lack of adequate information to justify the
deviation from such standard.
(3) Denial information.--Any denial of an application
shall, insofar as the Administrator determines to be
practicable, be accompanied by a statement informing the
applicant of the measures required to remove such application
from deniable form (which measures may include further
research by the applicant in accordance with 1 or more
protocols prescribed by the Administrator).
(4) Basis for finding.--For purposes of this section, the
finding as to whether the commercial introduction of a
smoking article for which an application has been submitted
is appropriate for the protection of the public health shall
be determined with respect to the risks and benefits to the
users of the smoking article, and taking into account whether
such commercial introduction is reasonably likely to increase
the morbidly and mortality among individual tobacco users.
(d) Withdrawal and Temporary Suspension.--
(1) In general.--The Administrator shall, upon obtaining,
where appropriate, advice on scientific matters from the
Tobacco Products Scientific Advisory Committee, and after due
notice and opportunity for informal hearing for a smoking
article for which an order was issued under subsection
(c)(1)(A), issue an order withdrawing the order if the
Administrator finds--
(A) that the continued marketing of such smoking article no
longer is appropriate for the protection of the public
health;
(B) that the application contained or was accompanied by an
untrue statement of a material fact;
(C) that the applicant--
(i) has failed to establish a system for maintaining
records, or has repeatedly or deliberately failed to maintain
records or to make reports, required by an applicable
regulation under section 113; or
(ii) has refused to permit access to, or copying or
verification of, such records as required by section 110; or
(D) on the basis of new information before the
Administrator with respect to such smoking article, evaluated
together with the evidence before the Administrator when the
application was reviewed, that the methods used in, or the
facilities and controls used for, the manufacture,
processing, packing, or installation of such smoking article
do not conform with the requirements of section 110(e) and
were not brought into conformity with such requirements
within a reasonable time after receipt of written notice from
the Administrator of nonconformity;
(E) on the basis of new information before the
Administrator, evaluated together with the evidence before
the Administrator when the application was reviewed, that the
labeling of such smoking article, based on a fair evaluation
of all material facts, is false or misleading in any
particular and was not corrected within a reasonable time
after receipt of written notice from the Administrator of
such fact; or
(F) on the basis of new information before the
Administrator, evaluated together with the evidence before
the Administrator when such order was issued, that such
smoking article is not shown to conform in all respects to a
smoking article standard which is in effect under section
111, compliance with which was a condition to the issuance of
an order relating to the application, and that there is a
lack of adequate information to justify the deviation from
such standard.
(2) Appeal.--The holder of an application subject to an
order issued under paragraph (1) withdrawing an order issued
pursuant to subsection (c)(1)(A) may, by petition filed on or
before the 30th day after the date upon which such holder
receives notice of such withdrawal, obtain review thereof in
accordance with section 116.
(3) Temporary suspension.--If, after providing an
opportunity for an informal hearing, the Administrator
determines there is reasonable probability that the
continuation of distribution of a smoking article under an
order would cause serious, adverse health consequences or
death, that is greater than ordinarily caused by smoking
articles on the market, the Administrator shall by order
temporarily suspend the authority of the manufacturer to
market the product. If the Administrator issues such an
order, the Administrator shall proceed expeditiously under
paragraph (1) to withdraw such application.
(e) Service of Order.--An order issued by the Administrator
under this section shall be served--
(1) in person by any officer or employee of the department
designated by the Administrator; or
(2) by mailing the order by registered mail or certified
mail addressed to the applicant at the applicant's last known
address in the records of the Administrator.
(f) Records.--
(1) Additional information.--In the case of any smoking
article for which an order issued pursuant to subsection
(c)(1)(A) for an application filed under subsection (b) is in
effect, the applicant shall establish and maintain such
records, and make such reports to the Administrator, as the
Administrator may by regulation, or by order with respect to
such application, prescribe on the basis of a finding that
such records and reports are necessary in order to enable the
Administrator to determine, or facilitate a determination of,
whether there is or may be grounds for withdrawing or
temporarily suspending such order.
(2) Access to records.--Each person required under this
section to maintain records, and each person in charge of
custody thereof, shall, upon request of an officer or
employee designated by the Administrator, permit such officer
or employee at all reasonable times to have access to and
copy and verify such records.
(g) Investigational Smoking Article Exemption for
Investigational Use.--The Administrator may exempt smoking
articles intended for investigational use from the provisions
of this Act under such conditions as the Administrator may by
regulation prescribe.
SEC. 115. MODIFIED RISK TOBACCO PRODUCTS.
(a) In General.--No person may introduce or deliver for
introduction into interstate commerce any modified risk
tobacco product unless an order issued pursuant to subsection
(g) is effective with respect to such product.
(b) Definitions.--In this section:
(1) Modified risk tobacco product.--The term ``modified
risk tobacco product'' means any tobacco product that is sold
or distributed for use to reduce harm or the risk of tobacco-
related disease associated with commercially marketed tobacco
products.
(2) Sold or distributed.--
(A) In general.--With respect to a tobacco product, the
term ``sold or distributed for use to reduce harm or the risk
of tobacco-related disease associated with commercially
marketed tobacco products'' means a tobacco product--
(i) the label, labeling, or advertising of which represents
explicitly or implicitly that--
(I) the tobacco product presents a lower risk of tobacco-
related disease or is less harmful than one or more other
commercially marketed tobacco products;
[[Page H4354]]
(II) the tobacco product or its smoke contains a reduced
level of a substance or presents a reduced exposure to a
substance; or
(III) the tobacco product or its smoke does not contain or
is free of a substance;
(ii) the label, labeling, or advertising of which uses the
descriptors ``light'', ``mild'', ``low'', ``medium'', ``ultra
light'', ``low tar'' or ``ultra low tar''; or
(iii) the tobacco product manufacturer of which has taken
any action directed to consumers through the media or
otherwise, other than by means of the tobacco product's
label, labeling, or advertising, after the date of enactment
of the Act, respecting the product that would be reasonably
expected to result in consumers believing that the tobacco
product or its smoke may present a lower risk of disease or
is less harmful than one or more commercially marketed
tobacco products, or presents a reduced exposure to, or does
not contain or is free of, a substance or substances.
(B) Limitation.--No tobacco product shall be considered to
be ``sold or distributed for use to reduce harm or the risk
of tobacco-related disease associated with commercially
marketed tobacco products'', except as described in
subparagraph (A).
(C) Smokeless tobacco product.--No smokeless tobacco
product shall be considered to be ``sold or distributed for
use to reduce harm or the risk of tobacco-related disease
associated with commercially marketed tobacco products''.
(3) Effective date.--The provisions of paragraph (2)(A)(ii)
shall take effect 12 months after the date of enactment of
the Act.
(c) Tobacco Dependence Products.--A product that is
intended to be used for the treatment of tobacco dependence,
including smoking cessation, is not a modified risk tobacco
product under this section if it has been approved as a drug
or device by the Center and is subject to the requirements of
chapter V.
(d) Filing.--Any person may file with the Administrator an
application for a modified risk tobacco product. Such
application shall include--
(1) a description of the proposed product and any proposed
advertising and labeling;
(2) the conditions for using the product;
(3) the formulation of the product;
(4) sample product labels and labeling;
(5) all documents (including underlying scientific
information) relating to research findings conducted,
supported, or possessed by the tobacco product manufacturer
relating to the effect of the product on tobacco-related
diseases and health-related conditions, including information
both favorable and unfavorable to the ability of the product
to reduce risk or exposure and relating to human health;
(6) data and information on how consumers actually use the
tobacco product; and
(7) such other information as the Administrator may
require.
(e) Public Availability.--The Administrator shall make the
application described in subsection (d) publicly available
(except matters in the application which are trade secrets or
otherwise confidential, commercial information) and shall
request comments by interested persons on the information
contained in the application and on the label, labeling, and
advertising accompanying such application.
(f) Advisory Committee.--
(1) In general.--The Administrator shall refer to the
Tobacco Products Scientific Advisory Committee any
application submitted under this section.
(2) Recommendations.--Not later than 60 days after the date
an application is referred to the Tobacco Products Scientific
Advisory Committee under paragraph (1), the Advisory
Committee shall report its recommendations on the application
to the Administrator.
(g) Marketing.--
(1) Modified risk products.--Except as provided in
paragraph (2), the Administrator shall, with respect to an
application submitted under this section, issue an order that
a modified risk product may be commercially marketed only if
the Administrator determines that the applicant has
demonstrated that such product, as it is actually used by
consumers, will--
(A) significantly reduce harm and the risk of tobacco-
related disease to individual tobacco users; and
(B) is reasonably likely to result in measurable and
substantial reductions in morbidity and mortality among
individual tobacco users.
(2) Special rule for certain products.--
(A) In general.--The Administrator may issue an order that
a tobacco product may be introduced or delivered for
introduction into interstate commerce, pursuant to an
application under this section, with respect to a tobacco
product that may not be commercially marketed under paragraph
(1) if the Secretary makes the findings required under this
paragraph and determines that the applicant has demonstrated
that--
(i) such order would be appropriate to promote the public
health;
(ii) any aspect of the label, labeling, and advertising for
such product that would cause the tobacco product to be a
modified risk tobacco product under subsection (b) is limited
to an explicit or implicit representation that such tobacco
product or its smoke does not contain or is free of a
substance or contains a reduced level of a substance, or
presents a reduced exposure to a substance in tobacco smoke;
(iii) scientific evidence is not available and, using the
best available scientific methods, cannot be made available
without conducting long-term epidemiological studies for an
application to meet the standards set forth in paragraph (1);
and
(iv) the scientific evidence that is available without
conducting long-term epidemiological studies demonstrates
that a measurable and substantial reduction in morbidity or
mortality among individual tobacco users is reasonably likely
in subsequent studies.
(B) Additional findings required.--To issue an order under
subparagraph (A) the Administrator must also find that the
applicant has demonstrated that--
(i) the magnitude of the overall reductions in exposure to
the substance or substances which are the subject of the
application is substantial, such substance or substances are
harmful, and the product as actually used exposes consumers
to the specified reduced level of the substance or
substances;
(ii) the product as actually used by consumers will not
expose them to higher levels of other harmful substances
compared to the similar types of tobacco products then on the
market unless such increases are minimal and the reasonably
likely overall impact of use of the product remains a
substantial and measurable reduction in overall morbidity and
mortality among individual tobacco users;
(iii) testing of actual consumer perception shows that, as
the applicant proposes to label and market the product,
consumers will not be misled into believing that the
product--
(I) is or has been demonstrated to be significantly less
harmful; or
(II) presents or has been demonstrated to present
significant less of a risk of disease than other commercially
marketed tobacco products; and
(iv) issuance of an order with respect to the application
is expected to benefit the health of users of tobacco
products.
(3) Basis.--The determinations under paragraphs (1) and (2)
shall be based on--
(A) the scientific evidence submitted by the applicant; and
(B) scientific evidence and other information that is made
available to the Administrator.
(h) Additional Conditions for Marketing.--
(1) Modified risk products.--The Administrator shall
require for the marketing of a product under this section
that any advertising or labeling concerning modified risk
products enable the public to comprehend the information
concerning modified risk and to understand the relative
significance of such information in the context of total
health and in relation to all of the diseases and health-
related conditions associated with the use of tobacco
products.
(2) Comparative claims.--
(A) In general.--The Administrator may require for the
marketing of a product under this subsection that a claim
comparing a tobacco product to other commercially marketed
tobacco products shall compare the tobacco product to a
commercially marketed tobacco product that is representative
of that type of tobacco product on the market (for example
the average value of the top 3 brands of an established
regular tobacco product).
(B) Quantitative comparisons.--The Administrator may also
require, for purposes of subparagraph (A), that the percent
(or fraction) of change and identity of the reference tobacco
product and a quantitative comparison of the amount of the
substance claimed to be reduced shall be stated in immediate
proximity to the most prominent claim.
(i) Postmarket Surveillance and Studies.--
(1) In general.--The Administrator shall require, with
respect to a product for which an applicant obtained an order
under subsection (g)(1), that the applicant conduct
postmarket surveillance and studies for such a tobacco
product to determine the impact of the order issuance on
consumer perception, behavior, and health, to enable the
Administrator to review the accuracy of the determinations
upon which the order was based, and to provide information
that the Administrator determines is otherwise necessary
regarding the use or health risks involving the tobacco
product. The results of postmarket surveillance and studies
shall be submitted to the Administrator on an annual basis.
(2) Surveillance protocol.--Each applicant required to
conduct a surveillance of a tobacco product under paragraph
(1) shall, within 30 days after receiving notice that the
applicant is required to conduct such surveillance, submit,
for the approval of the Administrator, a protocol for the
required surveillance. The Administrator, within 30 days of
the receipt of such protocol, shall determine if the
principal investigator proposed to be used in the
surveillance has sufficient qualifications and experience to
conduct such surveillance and if such protocol will result in
collection of the data or other information designated by the
Administrator as necessary to protect the public health.
(j) Withdrawal of Authorization.--The Administrator, after
an opportunity for an informal hearing, shall withdraw an
order under subsection (g) if the Administrator determines
that--
(1) the applicant, based on new information, can no longer
make the demonstrations required under subsection (g), or the
Administrator can no longer make the determinations required
under subsection (g);
[[Page H4355]]
(2) the application failed to include material information
or included any untrue statement of material fact;
(3) any explicit or implicit representation that the
product reduces risk or exposure is no longer valid,
including if--
(A) a tobacco product standard is established pursuant to
section 111;
(B) an action is taken that affects the risks presented by
other commercially marketed tobacco products that were
compared to the product that is the subject of the
application; or
(C) any postmarket surveillance or studies reveal that the
order is no longer consistent with the protection of the
public health;
(4) the applicant failed to conduct or submit the
postmarket surveillance and studies required under subsection
(g)(2)(C)(ii) or subsection (i); or
(5) the applicant failed to meet a condition imposed under
subsection (h).
(k) Chapter IV or V.--A product for which the Administrator
has issued an order pursuant to subsection (g) shall not be
subject to chapter IV or V of the Federal Food, Drug, and
Cosmetic Act.
(l) Implementing Regulations or Guidance.--
(1) Scientific evidence.--Not later than 2 years after the
date of enactment of the Act, the Administrator shall issue
regulations or guidance (or any combination thereof) on the
scientific evidence required for assessment and ongoing
review of modified risk tobacco products. Such regulations or
guidance shall--
(A) to the extent that adequate scientific evidence exists,
establish minimum standards for scientific studies needed
prior to issuing an order under subsection (g) to show a
reasonable likelihood that a substantial reduction in
morbidity or mortality among individual tobacco users occurs
for products described in subsection (g)(1) or is reasonably
likely for products described in subsection (g)(2);
(B) include validated biomarkers, intermediate clinical
endpoints, and other feasible outcome measures, as
appropriate;
(C) establish minimum standards for postmarket studies,
that shall include regular and long-term assessments of
health outcomes and mortality, intermediate clinical
endpoints, consumer perception of harm reduction, and the
impact on quitting behavior and new use of tobacco products,
as appropriate;
(D) establish minimum standards for required postmarket
surveillance, including ongoing assessments of consumer
perception; and
(E) establish a reasonable timetable for the Administrator
to review an application under this section.
(2) Consultation.--The regulations or guidance issued under
paragraph (1) may be developed in consultation with the
Institute of Medicine, and with the input of other
appropriate scientific and medical experts, on the design and
conduct of such studies and surveillance.
(3) Revision.--The regulations or guidance under paragraph
(1) shall be revised on a regular basis as new scientific
information becomes available.
(4) New tobacco products.--Not later than 2 years after the
date of enactment of the Act, the Administrator shall issue a
regulation or guidance that permits the filing of a single
application for any tobacco product that is a new tobacco
product under section 114 and which the applicant seeks to
commercially market under this section.
SEC. 116. JUDICIAL REVIEW.
(a) Right To Review.--
(1) In general.--Not later than 60 days after--
(A) the promulgation of a regulation under section 111
establishing, amending, or revoking a tobacco product
standard; or
(B) a denial of an application under section 114(c),
any person adversely affected by such regulation or denial
may file a petition for judicial review of such regulation or
denial with the United States Court of Appeals for the
District of Columbia or for the circuit in which such person
resides or has their principal place of business.
(2) Requirements.--
(A) Copy of petition.--A copy of the petition filed under
paragraph (1) shall be transmitted by the clerk of the court
involved to the Administrator.
(B) Record of proceedings.--On receipt of a petition under
subparagraph (A), the Administrator shall file in the court
in which such petition was filed--
(i) the record of the proceedings on which the regulation
or order was based; and
(ii) a statement of the reasons for the issuance of such a
regulation or order.
(C) Definition of record.--In this section, the term
``record'' means--
(i) all notices and other matter published in the Federal
Register with respect to the regulation or order reviewed;
(ii) all information submitted to the Administrator with
respect to such regulation or order;
(iii) proceedings of any panel or advisory committee with
respect to such regulation or order;
(iv) any hearing held with respect to such regulation or
order; and
(v) any other information identified by the Administrator,
in the administrative proceeding held with respect to such
regulation or order, as being relevant to such regulation or
order.
(b) Standard of Review.--Upon the filing of the petition
under subsection (a) for judicial review of a regulation or
order, the court shall have jurisdiction to review the
regulation or order in accordance with chapter 7 of title 5,
United States Code, and to grant appropriate relief,
including interim relief, as provided for in such chapter. A
regulation or denial described in subsection (a) shall be
reviewed in accordance with section 706(2)(A) of title 5,
United States Code.
(c) Finality of Judgment.--The judgment of the court
affirming or setting aside, in whole or in part, any
regulation or order shall be final, subject to review by the
Supreme Court of the United States upon certiorari or
certification, as provided in section 1254 of title 28,
United States Code.
(d) Other Remedies.--The remedies provided for in this
section shall be in addition to, and not in lieu of, any
other remedies provided by law.
(e) Regulations and Orders Must Recite Basis in Record.--To
facilitate judicial review, a regulation or order issued
under section 110, 111, 112, 113, 114, or 119 shall contain a
statement of the reasons for the issuance of such regulation
or order in the record of the proceedings held in connection
with its issuance.
SEC. 117. JURISDICTION OF AND COORDINATION WITH THE FEDERAL
TRADE COMMISSION.
Except where expressly provided in this Act, nothing in
this Act shall be construed as limiting or diminishing the
authority of the Federal Trade Commission to enforce the laws
under its jurisdiction with respect to the advertising, sale,
or distribution of tobacco products.
SEC. 118. REGULATION REQUIREMENT.
(a) Testing, Reporting, and Disclosure.--Not later than 36
months after the date of enactment of the Act, the
Administrator shall promulgate regulations under this Act
that meet the requirements of subsection (b).
(b) Contents of Rules.--The regulations promulgated under
subsection (a)--
(1) shall require annual testing and reporting of tobacco
product constituents, ingredients, and additives, including
smoke constituents, by brand style that the Administrator
determines should be tested to protect the public health,
provided that, for purposes of the testing requirements of
this paragraph, tobacco products manufactured and sold by a
single tobacco product manufacturer that are identical in all
respects except the labels, packaging design, logo, trade
dress, trademark, brand name, or any combination thereof,
shall be considered as a single brand style; and
(2) may require that tobacco product manufacturers,
packagers, or importers make disclosures relating to the
results of the testing of tar and nicotine through labels or
advertising.
(c) Authority.--The Administrator shall have the authority
under this Act to conduct or to require the testing,
reporting, or disclosure of tobacco product constituents,
including smoke constituents.
(d) Joint Laboratory Testing Services.--The Administrator
shall allow any 2 or more tobacco product manufacturers to
join together to purchase laboratory testing services
required by this section on a group basis in order to ensure
that such manufacturers receive access to, and fair pricing
of, such testing services.
(e) Extensions for Limited Laboratory Capacity.--
(1) In general.--The regulations promulgated under
subsection (a) shall provide that a tobacco product
manufacturer shall not be considered to be in violation of
this section before the applicable deadline, if--
(A) the tobacco products of such manufacturer are in
compliance with all other requirements of this Act; and
(B) the conditions described in paragraph (2) are met.
(2) Conditions.--Notwithstanding the requirements of this
section, the Administrator may delay the date by which a
tobacco product manufacturer must be in compliance with the
testing and reporting required by this section until such
time as the testing is reported if, not later than 90 days
before the deadline for reporting in accordance with this
section, a tobacco product manufacturer provides evidence to
the Administrator demonstrating that--
(A) the manufacturer has submitted the required products
for testing to a laboratory and has done so sufficiently in
advance of the deadline to create a reasonable expectation of
completion by the deadline;
(B) the products currently are awaiting testing by the
laboratory; and
(C) neither that laboratory nor any other laboratory is
able to complete testing by the deadline at customary,
nonexpedited testing fees.
(3) Extension.--The Administrator, taking into account the
laboratory testing capacity that is available to tobacco
product manufacturers, shall review and verify the evidence
submitted by a tobacco product manufacturer in accordance
with paragraph (2). If the Administrator finds that the
conditions described in such paragraph are met, the
Administrator shall notify the tobacco product manufacturer
that the manufacturer shall not be considered to be in
violation of the testing and reporting requirements of this
section until the testing is reported or until 1 year after
the reporting deadline has passed, whichever occurs sooner.
If, however,
[[Page H4356]]
the Administrator has not made a finding before the reporting
deadline, the manufacturer shall not be considered to be in
violation of such requirements until the Administrator finds
that the conditions described in paragraph (2) have not been
met, or until 1 year after the reporting deadline, whichever
occurs sooner.
(4) Additional extension.--In addition to the time that may
be provided under paragraph (3), the Administrator may
provide further extensions of time, in increments of no more
than 1 year, for required testing and reporting to occur if
the Administrator determines, based on evidence properly and
timely submitted by a tobacco product manufacturer in
accordance with paragraph (2), that a lack of available
laboratory capacity prevents the manufacturer from completing
the required testing during the period described in paragraph
(3).
(f) Rule of Construction.--Nothing in subsection (d) or (e)
shall be construed to authorize the extension of any
deadline, or to otherwise affect any timeframe, under any
provision of this Act other than this section.
SEC. 119. PRESERVATION OF STATE AND LOCAL AUTHORITY.
(a) In General.--
(1) Preservation.--Except as provided in paragraph (2)(A),
nothing in this Act, or rules promulgated under this Act,
shall be construed to limit the authority of a Federal agency
(including the Armed Forces), a State or political
subdivision of a State, or the government of an Indian tribe
to enact, adopt, promulgate, and enforce any law, rule,
regulation, or other measure with respect to tobacco products
that is in addition to requirements established under this
Act, including a law, rule, regulation, or other measure
relating to or prohibiting the sale, distribution,
possession, or use of tobacco products by individuals of any
age, information reporting to the State. No provision of this
Act shall limit or otherwise affect any State, Tribal, or
local taxation of tobacco products.
(2) Preemption of certain state and local requirements.--
(A) In general.--No State or political subdivision of a
State may establish or continue in effect with respect to a
tobacco product any requirement which is different from, or
in addition to, any requirement under the provisions of this
Act relating to tobacco product standards, premarket review,
adulteration, misbranding, labeling, registration, good
manufacturing standards, or modified risk tobacco products.
(B) Exception.--Subparagraph (A) does not apply to
requirements relating to the sale, distribution, possession,
information reporting to the State, use of, tobacco product
by individuals of any age. Information disclosed to a State
under subparagraph (A) that is exempt from disclosure under
section 552(b)(4) of title 5, United States Code, shall be
treated as a trade secret and confidential information by the
State.
(b) Rule of Construction Regarding Product Liability.--No
provision of this Act relating to a tobacco product shall be
construed to modify or otherwise affect any action or the
liability of any person under the product liability law of
any State.
SEC. 120. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.
(a) Establishment.--Not later than 6 months after the date
of enactment of this Act, the Administrator shall establish a
16-member advisory committee, to be known as the Tobacco
Products Scientific Advisory Committee (in this section
referred to as the ``Advisory Committee'').
(b) Membership.--
(1) In general.--
(A) Members.--The Administrator shall appoint as members of
the Tobacco Harm Reduction Advisory Committee individuals who
are technically qualified by training and experience in
medicine, medical ethics, science, or technology involving
the manufacture, evaluation, or use of tobacco products, who
are of appropriately diversified professional backgrounds.
The committee shall be composed of--
(i) 6 individuals who are physicians, dentists, scientists,
or health care professionals practicing in the area of
oncology, pulmonology, cardiology, toxicology, pharmacology,
addiction, or any other relevant specialty;
(ii) 2 individuals who are an officer or employee of a
State or local government or of the Federal Government;
(iii) 2 representatives of the general public;
(iv) 2 representatives of the interests of the tobacco
manufacturing industry;
(v) 1 representative of the interests of the small business
tobacco manufacturing industry, which position may be filled
on a rotating, sequential basis by representatives of
different small business tobacco manufacturers based on areas
of expertise relevant to the topics being considered by the
Advisory Committee;
(vi) 1 individual as a representative of the interests of
the tobacco growers; and
(vii) 1 individual who is an expert in illicit trade of
tobacco products.
(B) Conflicts of interest.--No members of the committee,
other than members appointed pursuant to clauses (iv), (v),
and (vi) of subparagraph (A) shall, during the member's
tenure on the committee or for the 18-month period prior to
becoming such a member, receive any salary, grants, or other
payments or support from any business that manufactures,
distributes, markets, or sells cigarettes or other tobacco
products or government agency with any form of jurisdiction
over tobacco products.
(2) Limitation.--The Administrator may not appoint to the
Advisory Committee any individual who is in the regular full-
time employ of the Tobacco Harm Reduction Center or any
agency responsible for the enforcement of this Act. The
Administrator may appoint Federal officials as ex officio
members.
(3) Chairperson.--The Administrator shall designate 1 of
the members appointed under clauses (i), (ii), and (iii) of
paragraph (1)(A) to serve as chairperson.
(c) Duties.--The Tobacco Products Scientific Advisory
Committee shall provide advice, information, and
recommendations to the Administrator--
(1) as provided in this Act;
(2) on the implementation of prevention, cessation, and
harm reduction policies;
(3) on implementation of policies and programs to fully
inform consumers of the respective risks of tobacco products;
and
(4) on its review of other safety, dependence, or health
issues relating to tobacco products as requested by the
Administrator.
(d) Compensation; Support; FACA.--
(1) Compensation and travel.--Members of the Advisory
Committee who are not officers or employees of the United
States, while attending conferences or meetings of the
committee or otherwise engaged in its business, shall be
entitled to receive compensation at rates to be fixed by the
Administrator, which may not exceed the daily equivalent of
the rate in effect under the Senior Executive Schedule under
section 5382 of title 5, United States Code, for each day
(including travel time) they are so engaged; and while so
serving away from their homes or regular places of business
each member may be allowed travel expenses, including per
diem in lieu of subsistence, as authorized by section 5703 of
title 5, United States Code, for persons in the Government
service employed intermittently.
(2) Administrative support.--The Administrator shall
furnish the Advisory Committee clerical and other assistance.
(3) Nonapplication of faca.--Section 14 of the Federal
Advisory Committee Act does not apply to the Advisory
Committee.
(e) Proceedings of Advisory Panels and Committees.--The
Advisory Committee shall make and maintain a transcript of
any proceeding of the panel or committee. Each such panel and
committee shall delete from any transcript made under this
subsection information which is exempt from disclosure under
section 552(b) of title 5, United States Code.
SEC. 121. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE.
(a) Report on Innovative Products.--
(1) In general.--Not later than 3 years after the date of
enactment of this Act, the Administrator, after consultation
with recognized scientific, medical, and public health
experts (including both Federal agencies and nongovernmental
entities, the Institute of Medicine of the National Academy
of Sciences, and the Society for Research on Nicotine and
Tobacco), shall submit to the Congress a report that examines
how best to promote, and encourage the development and use by
current tobacco users of innovative tobacco and nicotine
products and treatments (including nicotine-based and non-
nicotine-based products and treatments) to better achieve, in
a manner that best protects and promotes the public health--
(A) total abstinence from tobacco use;
(B) reductions in consumption of tobacco; and
(C) reductions in the harm associated with continued
tobacco use by moving current users to noncombustible tobacco
products.
(2) Recommendations.--The report under paragraph (1) shall
include the recommendations of the Administrator on how the
Tobacco Harm and Reduction Center should coordinate and
facilitate the exchange of information on such innovative
products and treatments among relevant offices and centers
within the Center and within the National Institutes of
Health, the Centers for Disease Control and Prevention, and
other relevant Federal and State agencies.
SEC. 122. ADVERTISING AND MARKETING OF TOBACCO PRODUCTS.
(a) Within 18 months of enactment of the Act, the
Administrator shall report to Congress on the benefits to
public health of imposing restrictions or prohibitions on the
advertising and marketing, consistent with or in addition to
such restrictions or prohibitions contained in the Master
Settlement Agreement, on tobacco products.
(b) The Administrator shall specify in the report
constitutional free speech implications for each recommended
restriction or prohibition.
(c) The Administrator shall also specify the class of
tobacco products to which the prohibition or restriction
would be applicable and the impact of such actions on harm
reduction policies, practices, and accurate information
available to tobacco users.
(d) The Administrator shall establish and consult with an
advisory committee consisting of experts in constitutional
law, harm reduction policies, marketing practices, and
consumer behavior in preparing this report.
[[Page H4357]]
TITLE II--TOBACCO PRODUCTS WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT
DISCLOSURE
SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS.
(a) Amendment.--Section 4 of the Federal Cigarette Labeling
and Advertising Act (15 U.S.C. 1333) is amended to read as
follows:
``SEC. 4. LABELING.
``(a) Label Requirements.--
``(1) In general.--It shall be unlawful for any person to
manufacture, package, sell, offer to sell, distribute, or
import for sale or distribution within the United States any
cigarettes the package of which fails to bear, in accordance
with the requirements of this section, one of the following
labels:
``WARNING: Cigarettes are addictive.
``WARNING: Tobacco smoke can harm your children.
``WARNING: Cigarettes cause fatal lung disease.
``WARNING: Cigarettes cause cancer.
``WARNING: Cigarettes cause strokes and heart disease.
``WARNING: Smoking during pregnancy can harm your baby.
``WARNING: Smoking can kill you.
``WARNING: Tobacco smoke causes fatal lung disease in
nonsmokers.
``WARNING: Quitting smoking now greatly reduces serious
risks to your health.
``(2) Placement; typography; etc.--Each label statement
required by paragraph (1) shall be located in the lower
portion of the front panel of the package, directly on the
package underneath the cellophane or other clear wrapping.
Each label statement shall comprise at least the bottom 25
percent of the front panel of the package. The word `WARNING'
shall appear in capital letters and all text shall be in
conspicuous and legible 17-point type, unless the text of the
label statement would occupy more than 70 percent of such
area, in which case the text may be in a smaller conspicuous
and legible type size, provided that at least 60 percent of
such area is occupied by required text. The text shall be
black on a white background, or white on a black background,
in a manner that contrasts, by typography, layout, or color,
with all other printed material on the package, in an
alternating fashion under the plan submitted under subsection
(c).
``(3) Does not apply to foreign distribution.--The
provisions of this subsection do not apply to a tobacco
product manufacturer or distributor of cigarettes which does
not manufacture, package, or import cigarettes for sale or
distribution within the United States.
``(4) Applicability to retailers.--A retailer of cigarettes
shall not be in violation of this subsection for packaging
that--
``(A) contains a warning label;
``(B) is supplied to the retailer by a license- or permit-
holding smoking article manufacturer, importer, or
distributor; and
``(C) is not altered by the retailer in a way that is
material to the requirements of this subsection.
``(b) Advertising Requirements.--
``(1) In general.--It shall be unlawful for any tobacco
product manufacturer, importer, distributor, or retailer of
cigarettes to advertise or cause to be advertised within the
United States any cigarette unless its advertising bears, in
accordance with the requirements of this section, one of the
labels specified in subsection (a).
``(2) Typography, etc.--Each label statement required by
subsection (a) in cigarette advertising shall comply with the
standards set forth in this paragraph. For press and poster
advertisements, each such statement and (where applicable)
any required statement relating to tar, nicotine, or other
constituent (including a smoke constituent) yield shall
comprise at least 20 percent of the area of the advertisement
and shall appear in a conspicuous and prominent format and
location at the bottom of each advertisement within the trim
area. The word `WARNING' shall appear in capital letters, and
each label statement shall appear in conspicuous and legible
type. The text of the label statement shall be black if the
background is white and white if the background is black,
under the plan submitted under subsection (c). The label
statements shall be enclosed by a rectangular border that is
the same color as the letters of the statements and that is
the width of the first downstroke of the capital `W' of the
word `WARNING' in the label statements. The text of such
label statements shall be in a typeface pro rata to the
following requirements: 45-point type for a whole-page
broadsheet newspaper advertisement; 39-point type for a half-
page broadsheet newspaper advertisement; 39-point type for a
whole-page tabloid newspaper advertisement; 27-point type for
a half-page tabloid newspaper advertisement; 31.5-point type
for a double page spread magazine or whole-page magazine
advertisement; 22.5-point type for a 28 centimeter by 3
column advertisement; and 15-point type for a 20 centimeter
by 2 column advertisement. The label statements shall be in
English, except that--
``(A) in the case of an advertisement that appears in a
newspaper, magazine, periodical, or other publication that is
not in English, the statements shall appear in the
predominant language of the publication; and
``(B) in the case of any other advertisement that is not in
English, the statements shall appear in the same language as
that principally used in the advertisement.
``(3) Matchbooks.--Notwithstanding paragraph (2), for
matchbooks (defined as containing not more than 20 matches)
customarily given away with the purchase of smokeless tobacco
products, each label statement required by subsection (a) may
be printed on the inside cover of the matchbook.
``(c) Marketing Requirements.--
``(1) Random display.--The label statements specified in
subsection (a)(1) shall be randomly displayed in each 12-
month period, in as equal a number of times as is possible on
each brand of the product and be randomly distributed in all
areas of the United States in which the product is marketed
in accordance with a plan submitted by the smokeless tobacco
product manufacturer, importer, distributor, or retailer and
approved by the Secretary.
``(2) Rotation.--The label statements specified in
subsection (a)(1) shall be rotated quarterly in alternating
sequence in advertisements for each brand of cigarettes in
accordance with a plan submitted by the smokeless tobacco
product manufacturer, importer, distributor, or retailer to,
and approved by, the Secretary.
``(3) Review.--The Secretary shall review each plan
submitted under paragraph (2) and approve it if the plan--
``(A) will provide for the equal distribution and display
on packaging and the rotation required in advertising under
this subsection; and
``(B) assures that all of the labels required under this
section will be displayed by the smokeless tobacco product
manufacturer, importer, distributor, or retailer at the same
time.
``(4) Applicability to retailers.--This subsection and
subsection (b) apply to a retailer only if that retailer is
responsible for or directs the label statements required
under this section except that this paragraph shall not
relieve a retailer of liability if the retailer displays, in
a location open to the public, an advertisement that does not
contain a warning label or has been altered by the retailer
in a way that is material to the requirements of this
subsection and subsection (b).''.
(b) Effective Date.--The amendment made by subsection (a)
shall take effect 24 months after the date of enactment of
this Act. Such effective date shall be with respect to the
date of manufacture, provided that, in any case, beginning 30
days after such effective date, a manufacturer shall not
introduce into the domestic commerce of the United States any
product, irrespective of the date of manufacture, that is not
in conformance with section 4 of the Federal Cigarette
Labeling and Advertising Act (15 U.S.C. 1333), as amended by
subsection (a).
SEC. 202. SMOKELESS TOBACCO LABELS AND ADVERTISING WARNINGS.
(a) Amendment.--Section 3 of the Comprehensive Smokeless
Tobacco Health Education Act of 1986 (15 U.S.C. 4402) is
amended to read as follows:
``SEC. 3. SMOKELESS TOBACCO WARNING.
``(a) General Rule.--
``(1) It shall be unlawful for any person to manufacture,
package, sell, offer to sell, distribute, or import for sale
or distribution within the United States any smokeless
tobacco product unless the product package bears, in
accordance with the requirements of this Act, one of the
following labels:
``WARNING: This product can cause mouth cancer.
``WARNING: This product can cause gum disease and tooth
loss.
``WARNING: This product has significantly lower risks for
diseases associated with cigarettes.
``WARNING: Smokeless tobacco is addictive.
``(2) The label statements required by paragraph (1) shall
be introduced by each smokeless tobacco product manufacturer,
packager, importer, distributor, or retailer of smokeless
tobacco products concurrently into the distribution chain of
such products.
``(3) The provisions of this subsection do not apply to a
smokeless tobacco product manufacturer or distributor of any
smokeless tobacco product that does not manufacture, package,
or import smokeless tobacco products for sale or distribution
within the United States.
``(4) A retailer of smokeless tobacco products shall not be
in violation of this subsection for packaging that--
``(A) contains a warning label;
``(B) is supplied to the retailer by a license- or permit-
holding smokeless tobacco product manufacturer, importer, or
distributor; and
``(C) is not altered by the retailer in a way that is
material to the requirements of this subsection.
``(b) Required Labels.--
``(1) It shall be unlawful for any smokeless tobacco
product manufacturer, packager, importer, distributor, or
retailer of smokeless tobacco products to advertise or cause
to be advertised within the United States any smokeless
tobacco product unless its advertising bears, in accordance
with the requirements of this section, one of the labels
specified in subsection (a).
``(2)(A) Each label statement required by subsection (a) in
smokeless tobacco advertising shall comply with the standards
set forth in this paragraph.
``(B) For press and poster advertisements, each such
statement and (where applicable) any required statement
relating to nicotine, or other constituent yield shall
comprise at least 20 percent of the area of the
advertisement.
[[Page H4358]]
``(C) The word `WARNING' shall appear in capital letters,
and each label statement shall appear in conspicuous and
legible type.
``(D) The text of the label statement shall be black on a
white background, or white on a black background, in an
alternating fashion under the plan submitted under paragraph
(3).
``(E) The label statements shall be enclosed by a
rectangular border that is the same color as the letters of
the statements and that is the width of the first downstroke
of the capital `W' of the word `WARNING' in the label
statements.
``(F) The text of such label statements shall be in a
typeface pro rata to the following requirements: 45-point
type for a whole-page broadsheet newspaper advertisement; 39-
point type for a half-page broadsheet newspaper
advertisement; 39-point type for a whole-page tabloid
newspaper advertisement; 27-point type for a half-page
tabloid newspaper advertisement; 31.5-point type for a double
page spread magazine or whole-page magazine advertisement;
22.5-point type for a 28 centimeter by 3 column
advertisement; and 15-point type for a 20 centimeter by 2
column advertisement.
``(G) The label statements shall be in English, except
that--
``(i) in the case of an advertisement that appears in a
newspaper, magazine, periodical, or other publication that is
not in English, the statements shall appear in the
predominant language of the publication; and
``(ii) in the case of any other advertisement that is not
in English, the statements shall appear in the same language
as that principally used in the advertisement.
``(3)(A) The label statements specified in subsection
(a)(1) shall be randomly displayed in each 12-month period,
in as equal a number of times as is possible on each brand of
the product and be randomly distributed in all areas of the
United States in which the product is marketed in accordance
with a plan submitted by the smokeless tobacco product
manufacturer, importer, distributor, or retailer and approved
by the Secretary.
``(B) The label statements specified in subsection (a)(1)
shall be rotated quarterly in alternating sequence in
advertisements for each brand of smokeless tobacco product in
accordance with a plan submitted by the smokeless tobacco
product manufacturer, importer, distributor, or retailer to,
and approved by, the Secretary.
``(C) The Secretary shall review each plan submitted under
subparagraphs (A) and (B) and approve it if the plan--
``(i) will provide for the equal distribution and display
on packaging and the rotation required in advertising under
this subsection; and
``(ii) assures that all of the labels required under this
section will be displayed by the smokeless tobacco product
manufacturer, importer, distributor, or retailer at the same
time.
``(D) This paragraph applies to a retailer only if that
retailer is responsible for or directs the label statements
under this section, unless the retailer displays, in a
location open to the public, an advertisement that does not
contain a warning label or has been altered by the retailer
in a way that is material to the requirements of this
subsection.
``(c) Television and Radio Advertising.--It is unlawful to
advertise smokeless tobacco on any medium of electronic
communications subject to the jurisdiction of the Federal
Communications Commission.''.
(b) Effective Date.--The amendment made by subsection (a)
shall take effect 24 months after the date of enactment of
this Act. Such effective date shall be with respect to the
date of manufacture, provided that, in any case, beginning 30
days after such effective date, a manufacturer shall not
introduce into the domestic commerce of the United States any
product, irrespective of the date of manufacture, that is not
in conformance with section 3 of the Comprehensive Smokeless
Tobacco Health Education Act of 1986 (15 U.S.C. 4402), as
amended by subsection (a).
TITLE III--PUBIC DISCLOSURES BY TOBACCO PRODUCTS MANUFACTURERS
SEC. 301. DISCLOSURES ON PACKAGES OF TOBACCO PRODUCTS.
(a) Back Face for Required Disclosures.--For purposes of
this section--
(1) the principal face of a package of a tobacco product is
the face that has the largest surface area or, for faces with
identical surface areas, any of the faces that have the
largest surface area; a package shall not be characterized as
having more than 2 principal faces;
(2) the front face shall be the principal face of the
package;
(3) if the front and back faces are of different sizes in
terms of area, then the larger face shall be the front face;
(4) the back face shall be the principal face of a package
that is opposite the front face of the package;
(5) the bottom 50 percent of the back face of the package
shall be allocated for required package disclosures in
accordance with this section; and
(6) if a package of a tobacco product is cylindrical, a
contiguous area constituting 30 percent of the total surface
area of the cylinder shall be deemed the back face.
(b) Required Information on Back Face.--Not later than 24
months after the effective date of this Act, the bottom 50
percent of the back face of a package of a tobacco product
shall be available solely for disclosures required by or
under this Act, the Federal Cigarette Labeling and
Advertising Act, sections 1331-1340 of title 15, United
States Code, and any other Federal statute. Such disclosures
shall include--
(1) the printed name and address of the manufacturer,
packer, or distributor, and any other identification
associated with the manufacturer, packer, or distributor or
with the tobacco product that the Administrator may require;
(2) a list of ingredients as required by subsection (e);
and
(3) the appropriate tax registration number.
(c) Package Disclosure of Ingredients.--Not later than 24
months after the effective date of this Act, the package of a
tobacco product shall bear a list of the common or usual
names of the ingredients present in the tobacco product in an
amount greater than 0.1 percent of the total dry weight of
the tobacco (including all ingredients), that shall comply
with the following:
(1) Such listing of ingredients shall appear under, or be
conspicuously accompanied by, the heading ``Tobacco and
principal tobacco ingredients''.
(2) Tobacco may be listed as ``tobacco,'' and shall be the
first listed ingredient.
(3) After tobacco, the ingredients shall be listed in
descending order of predominance, by weight.
(4) Spices and natural and artificial flavors may be
listed, respectively, as ``spices'' and ``natural and
artificial flavors'' without naming each.
(5) Preservatives may be listed as ``preservatives''
without naming each.
(6) The disclosure of any ingredient in accordance with
this section may, at the option of the tobacco product
manufacturer, designate the functionality or purpose of that
ingredient.
(7) The package say state ``Not for sale to minors''.
(8) In the case of a package of cigarettes, the package
shall state that smokeless tobacco has significantly lower
risks for disease and death than cigarettes.
SEC. 302. DISCLOSURES ON PACKAGES OF SMOKELESS TOBACCO.
(a) Back Face for Required Disclosures.--For purposes of
this section--
(1) the principal face of a package of smokeless tobacco is
the face that has the largest surface area or, for faces with
identical surface areas, any of the faces that have the
largest surface area; a package shall not be characterized as
having more than two principal faces;
(2) the front or top face shall be the principal face of
the package;
(3) if the front or top and back or bottom faces are of
different sizes in terms of area, then the larger face shall
be the front or top face;
(4) the back or bottom face of the package shall be the
principal face of a package that is opposite the front or top
face of the package;
(5) beginning 24 months after the effective date of this
Act, 50 percent of the back or bottom face of the package
shall be allocated for required package disclosures in
accordance with this section; and
(6) if the package is cylindrical, a contiguous area
constituting 30 percent of the total surface area of the
cylinder shall be deemed the back face.
(b) Required Information on Back or Bottom Face.--50
percent of the back or bottom face of a package of smokeless
tobacco shall be available solely for disclosures required by
or under this Act, the Comprehensive Smokeless Tobacco Health
Education Act of 1986, sections 4401-4408 of title 15, United
States Code, and any other Federal statute. Such disclosures
shall include a list of ingredients as required by subsection
(e).
(c) Package Disclosure of Ingredients.--Commencing 24
months after the effective date of this Act, a package of
smokeless tobacco shall bear a list of the common or usual
names of the ingredients present in the smokeless tobacco in
an amount greater than 0.1 percent of the total dry weight of
the tobacco (including all ingredients).
(1) Such listing of ingredients shall appears under, or be
conspicuously accompanied by, the heading ``Tobacco and
principal tobacco ingredients''.
(2) Tobacco may be listed as ``tobacco,'' and shall be the
first listed ingredient.
(3) After tobacco, the ingredients shall be listed in
descending order of predominance, by weight.
(4) Spices and natural and artificial flavors may be
listed, respectively, as ``spices'' and ``natural and
artificial flavors'' without naming each.
(5) Preservatives may be listed as ``preservatives''
without naming each.
(6) The disclosure of any ingredient in accordance with
this section may, at the option of the tobacco product
manufacturer, designate the functionality or purpose of that
ingredient.
(7) Not for sale to minors.
SEC. 303. PUBLIC DISCLOSURE OF INGREDIENTS.
(a) Regulations.--Not later than 24 months after the
effective date of this Act, the Administrator shall, by
regulation, establish standards under which each tobacco
product manufacturer shall disclose publicly, and update at
least annually--
(1) a list of the ingredients it uses in each brand style
it manufactures for commercial distribution domestically, as
provided in subsection (b); and
[[Page H4359]]
(2) a composite list of all the ingredients it uses in any
of the brand styles it manufactures for commercial
distribution domestically, as provided in subsection (c).
(b) Ingredients To Be Disclosed as to Each Brand Style.--
(1) In general.--With respect to the public disclosure
required by subsection (a)(1), as to each brand style, the
tobacco product manufacture shall disclose the common or
usual name of each ingredient present in the brand style in
an amount greater than 0.1 percent of the total dry weight of
the tobacco (including all ingredients).
(2) Requirements.--Disclosure under paragraph (1) shall
comply with the following:
(A) Tobacco may be listed as ``tobacco,'' and shall be the
first listed ingredient.
(B) After tobacco, the ingredients shall be listed in
descending order of predominance, by weight.
(C) Spices and natural and artificial flavors may be
listed, respectively, as ``spices'' and ``natural and
artificial flavors'' without naming each.
(D) Preservatives may be listed as ``preservatives''
without naming each.
(E) The disclosure of any ingredient in accordance with
this section may, at the option of the tobacco product
manufacturer, designate the functionality or purpose of that
ingredient.
(c) Aggregate Disclosure of Ingredients.--
(1) In general.--The public disclosure required of a
tobacco product manufacturer by subsection (a)(2) shall
consist of a single list of all ingredients used in any brand
style a tobacco product manufacturer manufactures for
commercial distribution domestically, without regard to the
quantity used, and including, separately, each spice, each
natural or artificial flavoring, and each preservative.
(2) Listing.--The ingredients shall be listed by their
respective common or usual names in descending order of
predominance by the total weight used annually by the tobacco
product manufacturer in manufacturing tobacco products for
commercial distribution domestically.
(d) No Required Disclosure of Quantities.--The
Administrator shall not require any public disclosure of
quantitative information about any ingredient in a tobacco
product.
(e) Disclosure on Website.--The public disclosures required
by subsection (a) of this section may be by posting on an
Internet-accessible website, or other location electronically
accessible to the public, which is identified on all packages
of a tobacco product manufacturer's tobacco products.
(f) Timing of Initial Required Disclosures.--No disclosure
pursuant to this section shall be required to commence until
the regulations under subsection (a) have been in effect for
not less than 1 year.
TITLE IV--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS
SEC. 401. STUDY AND REPORT ON ILLICIT TRADE.
(a) The Administrator shall, after consultation with other
relevant agencies including Customs and Tobacco Tax Bureau,
conduct a study of trade in tobacco products that involves
passage of tobacco products either between the States or from
or to any other country across any border of the United
States to--
(1) collect data on such trade in tobacco products,
including illicit trade involving tobacco products, and make
recommendations on the monitoring and enforcement of such
trade;
(2) collect data on any advertising intended to be
broadcast, transmitted, or distributed from or to the United
States from or to another country and make recommendations on
how to prevent or eliminate, and what technologies could help
facilitate the elimination of, such advertising; and
(3) collect data on such trade in tobacco products by
person that is not--
(A) a participating manufacturer (as that term is defined
in section II(jj) of the Master Settlement Agreement of
November 23, 1998, between certain of the States and certain
tobacco product manufacturers); or
(B) an affiliate or subsidiary of a participating
manufacturer.
(b) Not later than 18 months after the effective date of
this Act, the Administrator shall submit to the Secretary,
and committees of relevant jurisdiction in Congress, a report
the recommendations of the study conducted under subsection
(a).
SEC. 402. AMENDMENT TO SECTION 1926 OF THE PUBLIC HEALTH
SERVICE ACT.
Section 1926 of the Public Health Service Act (42 U.S.C.
Sec. 300x-26) is amended by adding at the end thereof the
following:
``(e)(1) Subject to paragraphs (2) and (3), for the first
fiscal year after enactment and each subsequent fiscal year,
the Secretary shall reduce, as provided in subsection (h),
the amount of any grant under section 300x-21 of this title
for any State that does not have in effect a statute with
substantially the following provisions:
`` `SEC. 1. DISTRIBUTION TO MINORS.
`` `(a) No person shall distribute a tobacco product to an
individual under 18 years of age or a different minimum age
established under State law. A person who violates this
subsection is liable for a civil money penalty of not less
than $25 nor more than $125 for each violation of this
subsection;
`` `(b) The employer of an employee who has violated
subsection (a) twice while in the employ of such employer is
liable for a civil money penalty of $125 for each subsequent
violation by such employee.
`` `(c) It shall be a defense to a charge brought under
subsection (a) that--
`` `(1) the defendant--
`` `(A) relied upon proof of age that appeared on its face
to be valid in accordance with the Federal Tobacco Act of
2007;
`` `(B) had complied with the requirements of section 5
and, if applicable, section 7; or
`` `(C) relied upon a commercially available electronic age
verification service to confirm that the person was an age-
verified adult; or
`` `(2) the individual to whom the tobacco product was
distributed was at the time of the distribution used in
violation of subsection 8(b).
`` `SEC. 2. PURCHASE, RECEIPT, OR POSSESSION BY MINORS
PROHIBITED.
`` `(a) An individual under 18 years of age or a different
minimum age established under State law shall not purchase or
attempt to purchase, receive or attempt to receive, possess
or attempt to possess, a tobacco product. An individual who
violates this subsection is liable for a civil money penalty
of not less than $25 nor more than $125 for each such
violation, and shall be required to perform not less than
four hours nor more than ten hours of community service. Upon
the second or each subsequent violation of this subsection,
such individual shall be required to perform not less than
eight hours nor more than twenty hours of community service.
`` `(b) A law enforcement agency, upon determining that an
individual under 18 years of age or a different minimum age
established under State law allegedly purchased, received,
possessed, or attempted to purchase, receive, or possess, a
tobacco product in violation of subsection (a) shall notify
the individual's parent or parents, custodian, or guardian as
to the nature of the alleged violation if the name and
address of a parent or parents, guardian, or custodian is
reasonably ascertainable by the law enforcement agency. The
notice required by this subsection shall be made not later
than 48 hours after the individual who allegedly violated
subsection (a) is cited by such agency for the violation. The
notice may be made by any means reasonably calculated to give
prompt actual notice, including notice in person, by
telephone, or by first-class mail.
`` `(c) Subsection (a) does not prohibit an individual
under 18 years of age or a different minimum age established
under State law from possessing a tobacco product during
regular working hours and in the course of such individual's
employment if the tobacco product is not possessed for such
individual's consumption.
`` `SEC. 3. OUT-OF-PACKAGE DISTRIBUTION.
`` `It shall be unlawful for any person to distribute
cigarettes or a smokeless tobacco product other than in an
unopened package that complies in full with section 108 of
the Federal Tobacco Act of 2007. A person who distributes a
cigarette or a smokeless tobacco product in violation of this
section is liable for a civil money penalty of not less than
$25 nor more than $125 for each such violation.
`` `SEC. 4. SIGNAGE.
`` `It shall be unlawful for any person who sells tobacco
products over-the-counter to fail to post conspicuously on
the premises where such person sells tobacco products over-
the-counter a sign communicating that--
`` `(1) the sale of tobacco products to individuals under
18 years of age or a different minimum age established under
State law is prohibited by law;
`` `(2) the purchase of tobacco products by individuals
under 18 years of age or a different minimum age established
under State law is prohibited by law; and
`` `(3) proof of age may be demanded before tobacco
products are sold.
A person who fails to post a sign that complies fully with
this section is liable for a civil money penalty of not less
than $25 nor more than $125.
`` `SEC. 5. NOTIFICATION OF EMPLOYEES.
`` `(a) Within 180 days of the effective date of the Youth
Prevention and Tobacco Harm Reduction Act, every person
engaged in the business of selling tobacco products at retail
shall implement a program to notify each employee employed by
that person who sells tobacco products at retail that--
`` `(1) the sale or other distribution of tobacco products
to any individual under 18 years of age or a different
minimum age established under State law, and the purchase,
receipt, or possession of tobacco products in a place open to
the public by any individual under 18 years of age or a
different minimum age established under State law, is
prohibited; and
`` `(2) out-of-package distribution of cigarettes and
smokeless tobacco products is prohibited.
Any employer failing to provide the required notice to any
employee shall be liable for a civil money penalty of not
less than $25 nor more than $125 for each such violation.
`` `(b) It shall be a defense to a charge that an employer
violated subsection (a) of this section that the employee
acknowledged receipt, either in writing or by electronic
means, prior to the alleged violation, of a statement in
substantially the following form:
``I understand that State law prohibits the distribution of
tobacco products to individuals under 18 years of age or a
different minimum age established under State law and out-of-
package distribution of cigarettes and smokeless tobacco
products, and permits a
[[Page H4360]]
defense based on evidence that a prospective purchaser's
proof of age was reasonably relied upon and appeared on its
face to be valid. I understand that if I sell, give, or
voluntarily provide a tobacco product to an individual under
18 years of age or a different minimum age established under
State law, I may be found responsible for a civil money
penalty of not less than $25 nor more than $125 for each
violation. I promise to comply with this law.' '''
`` `(c) If an employer is charged with a violation of
subsection (a) and the employer uses as a defense to such
charge the defense provided by subsection (b), the employer
shall be deemed to be liable for such violation if such
employer pays the penalty imposed on the employee involved in
such violation or in any way reimburses the employee for such
penalty.
`` `SEC. 6. SELF-SERVICE DISPLAYS.
`` `(a) It shall be unlawful for any person who sells
tobacco products over-the-counter at retail to maintain
packages of such products in any location accessible to
customers that is not under the control of a cashier or other
employee during regular business hours. This subsection does
not apply to any adult-only facility.
`` `(b) Any person who violates subsection (a) is liable
for a civil money penalty of not less than $25 nor more than
$125 for each such violation, except that no person shall be
responsible for more than one violation per day at any one
retail store.
`` `SEC. 7. DISTRIBUTION BY MAIL OR COURIER.
`` `(a) It shall be unlawful to distribute or sell tobacco
products directly to consumers by mail or courier, unless the
person receiving purchase requests for tobacco products takes
reasonable action to prevent delivery to individuals who are
not adults by--
`` `(1) requiring that addressees of the tobacco products
be age-verified adults;
`` `(2) making good faith efforts to verify that such
addressees have attained the minimum age for purchase of
tobacco products established by the respective States wherein
the addresses of the addressees are located; and
`` `(3) addressing the tobacco products delivered by mail
or courier to a physical addresses and not to post office
boxes.
`` `(b) Any person who violates subsection (a) is liable
for a civil money penalty of not less than $25 nor more than
$125 for each such violation.
`` `SEC. 8. RANDOM UNANNOUNCED INSPECTIONS; REPORTING; AND
COMPLIANCE.
`` `(a) The State Police, or a local law enforcement
authority duly designated by the State Police, shall enforce
this Act in a manner that can reasonably be expected to
reduce the extent to which tobacco products are distributed
to individuals under 18 years of age or a different minimum
age established under State law and shall conduct random,
unannounced inspections in accordance with the procedures set
forth in this Act and in regulations issued under section
1926 of the Federal Public Health Service Act (42 U.S.C.
Sec. 300x-26).
`` `(b) The State may engage an individual under 18 years
of age or a different minimum age established under State law
to test compliance with this Act, except that such an
individual may be used to test compliance with this Act only
if the testing is conducted under the following conditions:
`` `(1) Prior to use of any individual under 18 years of
age or a different minimum age established under State law in
a random, unannounced inspection, written consent shall be
obtained from a parent, custodian, or guardian of such
individual;
`` `(2) An individual under 18 years of age or a different
minimum age established under State law shall act solely
under the supervision and direction of the State Police or a
local law enforcement authority duly designated by the State
Police during a random, unannounced inspection;
`` `(3) An individual under 18 years of age or a different
minimum age established under State law used in random,
unannounced inspections shall not be used in any such
inspection at a store in which such individual is a regular
customer; and
`` `(4) If an individual under 18 years of age or a
different minimum age established under State law
participating in random, unannounced inspections is
questioned during such an inspection about such individual's
age, such individual shall state his or her actual age and
shall present a true and correct proof of age if requested at
any time during the inspection to present it.
`` `(c) Any person who uses any individual under 18 years
of age or a different minimum age established under State
law, other than as permitted by subsection (b), to test
compliance with this Act, is liable for a civil money penalty
of not less than $25 nor more than $125 for each such
violation.
`` `(d) Civil money penalties collected for violations of
this Act and fees collected under section 9 shall be used
only to defray the costs of administration and enforcement of
this Act.
`` `SEC. 9. LICENSURE.
`` `(a) Each person engaged in the over-the-counter
distribution at retail of tobacco products shall hold a
license issued under this section. A separate license shall
be required for each place of business where tobacco products
are distributed at retail. A license issued under this
section is not assignable and is valid only for the person in
whose name it is issued and for the place of business
designated in the license.
`` `(b) The annual license fee is $25 for each place of
business where tobacco products are distributed at retail.
`` `(c) Every application for a license, including renewal
of a license, under this section shall be made upon a form
provided by the appropriate State agency or department, and
shall set forth the name under which the applicant transacts
or intends to transact business, the location of the place of
business for which the license is to be issued, the street
address to which all notices relevant to the license are to
be sent (in this Act referred to as ``notice address''), and
any other identifying information that the appropriate State
agency or department may require.
`` `(d) The appropriate State agency or department shall
issue or renew a license or deny an application for a license
or the renewal of a license within 30 days of receiving a
properly completed application and the license fee. The
appropriate State agency or department shall provide notice
to an applicant of action on an application denying the
issuance of a license or refusing to renew a license.
`` `(e) Every license issued by the appropriate State
agency or department pursuant to this section shall be valid
for 1 year from the date of issuance and shall be renewed
upon application except as otherwise provided in this Act.
`` `(f) Upon notification of a change of address for a
place of business for which a license has been issued, a
license shall be reissued for the new address without the
filing of a new application.
`` `(g) The appropriate State agency or department shall
notify every person in the State who is engaged in the
distribution at retail of tobacco products of the license
requirements of this section and of the date by which such
person should have obtained a license.
`` `(h)(1) Except as provided in paragraph (2), any person
who engages in the distribution at retail of tobacco products
without a license required by this section is liable for a
civil money penalty in an amount equal to (i) two times the
applicable license fee, and (ii) $50 for each day that such
distribution continues without a license.
`` `(2) Any person who engages in the distribution at
retail of tobacco products after a license issued under this
section has been suspended or revoked is liable for a civil
money penalty of $100 per day for each day on which such
distribution continues after the date such person received
notice of such suspension or revocation.
`` `(i) No person shall engage in the distribution at
retail of tobacco products on or after 180 days after the
date of enactment this Act unless such person is authorized
to do so by a license issued pursuant to this section or is
an employee or agent of a person that has been issued such a
license.
`` `SEC. 10. SUSPENSION, REVOCATION, DENIAL, AND NONRENEWAL
OF LICENSES.
`` `(a) Upon a finding that a licensee has been determined
by a court of competent jurisdiction to have violated this
Act during the license term, the State shall notify the
licensee in writing, served personally or by registered mail
at the notice address, that any subsequent violation of this
Act at the same place of business may result in an
administrative action to suspend the license for a period
determined by the specify the appropriate State agency or
department.
`` `(b) Upon finding that a further violation by this Act
has occurred involving the same place of business for which
the license was issued and the licensee has been served
notice once under subsection (a), the appropriate State
agency or department may initiate an administrative action to
suspend the license for a period to be determined by the
appropriate State agency or department but not to exceed six
months. If an administrative action to suspend a license is
initiated, the appropriate State agency or department shall
immediately notify the licensee in writing at the notice
address of the initiation of the action and the reasons
therefor and permit the licensee an opportunity, at least 30
days after written notice is served personally or by
registered mail upon the licensee, to show why suspension of
the license would be unwarranted or unjust.
`` `(c) The appropriate State agency or department may
initiate an administrative action to revoke a license that
previously has been suspended under subsection (b) if, after
the suspension and during the one-year period for which the
license was issued, the licensee committed a further
violation of this Act, at the same place of business for
which the license was issued. If an administrative action to
revoke a license is initiated, the appropriate State agency
or department shall immediately notify the licensee in
writing at the notice address of the initiation of the action
and the reasons therefor and permit the licensee an
opportunity, at least 30 days after written notice is served
personally or by registered mail upon the licensee, to show
why revocation of the license would be unwarranted or unjust.
`` `(d) A person whose license has been suspended or
revoked with respect to a place of business pursuant to this
section shall pay a fee of $50 for the renewal or reissuance
of the license at that same place of business, in addition to
any applicable annual license fees.
`` `(e) Revocation of a license under subsection (c) with
respect to a place of business shall not be grounds to deny
an application by any person for a new license with respect
to such place of business for more than 12 months subsequent
to the date of such revocation. Revocation or suspension of a
license with respect to a particular place of
[[Page H4361]]
business shall not be grounds to deny an application for a
new license, to refuse to renew a license, or to revoke or
suspend an existing license at any other place of business.
`` `(f) A licensee may seek judicial review of an action of
the appropriate State agency or department suspending,
revoking, denying, or refusing to renew a license under this
section by filing a complaint in a court of competent
jurisdiction. Any such complaint shall be filed within 30
days after the date on which notice of the action is received
by the licensee. The court shall review the evidence de novo.
`` `(g) The State shall not report any action suspending,
revoking, denying, or refusing to renew a license under this
section to the Federal Secretary of Health and Human
Services, unless the opportunity for judicial review of the
action pursuant to subsection (f), if any, has been exhausted
or the time for seeking such judicial review has expired.
`` `SEC. 11. NO PRIVATE RIGHT OF ACTION.
`` `Nothing in this Act shall be construed to create a
right of action by any private person for any violation of
any provision of this Act.
`` `SEC. 12. JURISDICTION AND VENUE.
`` `Any action alleging a violation of this Act may be
brought only in a court of general jurisdiction in the city
or county where the violation is alleged to have occurred.
`` `SEC. 13. REPORT.
`` `The appropriate State agency or department shall
prepare for submission annually to the Federal Secretary of
Health and Human Services the report required by section 1926
of the Federal Public Health Service Act (42 U.S.C. 300x-
26).' ''.
``(2) In the case of a State whose legislature does not
convene a regular session in fiscal year 2007, and in the
case of a State whose legislature does not convene a regular
session in fiscal year 2008, the requirement described in
subsection (e)(1) as a condition of a receipt of a grant
under section 300x-21 of this title shall apply only for
fiscal year 2009 and subsequent fiscal years.
``(3) Subsection (e)(1) shall not affect any State or local
law that (A) was in effect on the date of introduction of the
Federal Tobacco Act of 2007, and (B) covers the same subject
matter as the law described in subsection (e)(1). Any State
law that meets the conditions of this paragraph shall also be
deemed to meet the requirement described in subsection (e)(1)
as a condition of a receipt of a grant under section 300x-21
of this title, if such State law is at least as stringent as
the law described in subsection (e)(1).
``(f)(1) For the first applicable fiscal year and for each
subsequent fiscal year, a funding agreement for a grant under
section 300x-21 of this title is a funding agreement under
which the State involved will enforce the law described in
subsection (e)(1) of this section in a manner that can
reasonably be expected to reduce the extent to which tobacco
products are available to individuals under the age of 18 or
a different minimum age established under State law for the
purchase of tobacco products.
``(2) For the first applicable fiscal year and for each
subsequent fiscal year, a funding agreement for a grant under
section 300x-21 of this title is a funding agreement under
which the State involved will--
``(A) conduct random, unannounced inspections to ensure
compliance with the law described in subsection (e)(1); and
``(B) annually submit to the Secretary a report
describing--
``(i) the activities carried out by the State to enforce
such law during the fiscal year preceding the fiscal year for
which the State is seeking the grant;
``(ii) the extent of success the State has achieved in
reducing the availability of tobacco products to individuals
under 18 years of age or a different minimum age established
under State law, including the results of the inspections
conducted under subparagraph (A); and
``(iii) the strategies to be utilized by the State for
enforcing such law during the fiscal year for which the grant
is sought.
``(g) The law specified in subsection (e)(1) may be
administered and enforced by a State using--
``(1) any amounts made available to the State through a
grant under section 300x-21 of this title;
``(2) any amounts made available to the State under section
300w of this title;
``(3) any fees collected for licenses issued pursuant to
the law described in subsection (e)(1);
``(4) any fines or penalties assessed for violations of the
law specified in subsection (e)(1); or
``(5) any other funding source that the legislature of the
State may prescribe by statute.
``(h) Before making a grant under section 300x-21 of this
title to a State for the first applicable fiscal year or any
subsequent fiscal year, the Secretary shall make a
determination of whether the State has maintained compliance
with subsections (e) and (f) of this section. If, after
notice to the State and an opportunity for a hearing, the
Secretary determines that the State is not in compliance with
such subsections, the Secretary shall reduce the amount of
the allotment under section 300x-21 of this title for the
State for the fiscal year involved by an amount equal to--
``(1) In the case of the first applicable fiscal year, 10
percent of the amount determined under section 300x-33 for
the State for the fiscal year;
``(2) In the case of the first fiscal year following such
applicable fiscal year, 20 percent of the amount determined
under section 300x-33 for the State for the fiscal year;
``(3) In the case of the second such fiscal year, 30
percent of the amount determined under section 300x-33 for
the State for the fiscal year; and
``(4) In the case of the third such fiscal year or any
subsequent fiscal year, 40 percent of the amount determined
under section 300x-33 for the State for the fiscal year.
The Secretary shall not have authority or discretion to grant
to any State a waiver of the terms and requirements of this
subsection or subsection (e) or (f).
``(i) For the purposes of subsections (e) through (h) of
this section the term `first applicable fiscal year' means--
``(1) fiscal year 2009, in the case of any State described
in subsection (e)(2) of this section; and
``(2) fiscal year 2008, in the case of any other State.
``(j) For purposes of subsections (e) through (h) of this
section, references to section 300x-21 shall include any
successor grant programs.`'
``(k) As required by paragraph (1), and subject to
paragraph (4), an Indian tribe shall satisfy the requirements
of subsection (e)(1) of this section by enacting a law or
ordinance with substantially the same provisions as the law
described in subsection (e)(1).
``(1) An Indian tribe shall comply with subsection (e)(1)
of this section within 180 days after the Administrator
finds, in accordance with this paragraph, that--
``(A) the Indian tribe has a governing body carrying out
substantial governmental powers and duties;
``(B) the functions to be exercised by the Indian tribe
under this Act pertain to activities on trust land within the
jurisdiction of the tribe; and
``(C) the Indian tribe is reasonably expected to be capable
of carrying out the functions required under this section.
Within 2 years of the date of enactment of the Federal
Tobacco Act of 2007, as to each Indian tribe in the United
States, the Administrator shall make the findings
contemplated by this paragraph or determine that such
findings cannot be made, in accordance with the procedures
specified in paragraph (4).
``(2) As to Indian tribes subject to subsection (e)(1) of
this section, the Administrator shall promulgate regulations
that--
``(A) provide whether and to what extent, if any, the law
described in subsection (e)(1) may be modified as adopted by
Indian tribes; and
``(B) ensure, to the extent possible, that each Indian
tribe's retailer licensing program under subsection (e)(1) is
no less stringent than the program of the State or States in
which the Indian tribe is located.
``(3) If with respect to any Indian tribe the Administrator
determines that compliance with the requirements of
subsection (e)(1) is inappropriate or administratively
infeasible, the Administrator shall specify other means for
the Indian tribe to achieve the purposes of the law described
in subsection (e)(1) with respect to persons who engage in
the distribution at retail of tobacco products on tribal
lands.
``(4) The findings and regulations promulgated under
paragraphs (1) and (2) shall be promulgated in conformance
with section 553 of title 5, United States Code, and shall
comply with the following provisions:
``(A) In making findings as provided in paragraph (1), and
in drafting and promulgating regulations as provided in
paragraph (2) (including drafting and promulgating any
revised regulations), the Administrator shall confer with,
and allow for active participation by, representatives and
members of Indian tribes, and tribal organizations.
``(B) In carrying out rulemaking processes under this
subsection, the Administrator shall follow the guidance of
subchapter III of chapter 5 of title 5, United States Code,
commonly known as the `Negotiated Rulemaking Act of 1990.'
``(C) The tribal participants in the negotiation process
referred to in subparagraph (B) shall be nominated by and
shall represent the groups described in this subsection and
shall include tribal representatives from all geographic
regions.
``(D) The negotiations conducted under this paragraph (4)
shall be conducted in a timely manner.
``(E) If the Administrator determines that an extension of
the deadlines under subsection (k)(1) of this section is
appropriate, the Secretary may submit proposed legislation to
Congress for the extension of such deadlines.
``(5) This subsection shall not affect any law or ordinance
that (A) was in effect on tribal lands on the date of
introduction of the Youth Prevention and Tobacco Harm
Reduction Act, and (B) covers the same subject matter as the
law described in subsection (e)(1). Any law or ordinance that
meets the conditions of this paragraph shall also be deemed
to meet the requirement described in subsection (k)(1), if
such law or ordinance is at least as stringent as the law
described in subsection (e)(1).
``(6) For purposes of this subsection--
``(A) `Administrator' means the Administrator of the
Tobacco Harm Reduction Center.
``(B) `Indian tribe' has the meaning assigned that term in
section 4(e) of the Indian
[[Page H4362]]
Self Determination and Education Assistance Act, section
450b(e) of title 25, United States Code.
``(C) `Tribal lands' means all lands within the exterior
boundaries of any Indian reservation, all lands the title to
which is held by the United States in trust for an Indian
tribe, or lands the title to which is held by an Indian tribe
subject to a restriction by the United States against
alienation, and all dependent Indian communities.
``(D) `tribal organization' has the meaning assigned that
term in section 4(l) of the Indian Self Determination and
Education Assistance Act, section 450b(l) of title 25, United
States Code.''.
SEC. 403. ESTABLISHMENT OF RANKINGS.
(a) Standards and Procedures for Rankings.--Within 24
months after the effective date of this Act, the
Administrator shall, by regulation, after consultation with
an Advisory Committee established for such purpose, establish
the standards and procedures for promulgating rankings,
comprehensible to consumers of tobacco products, of the
following categories of tobacco products and also nicotine-
containing products on the basis of the relative risks of
serious or chronic tobacco-related diseases and adverse
health conditions those categories of tobacco products and
also nicotine-containing products respectively present--
(1) cigarettes;
(2) loose tobacco for roll-your-own tobacco products;
(3) little cigars;
(4) cigars;
(5) pipe tobacco;
(6) moist snuff;
(7) dry snuff;
(8) chewing tobacco;
(9) other forms of tobacco products, including pelletized
tobacco and compressed tobacco, treated collectively as a
single category; and
(10) other nicotine-containing products, treated
collectively as a single category.
The Administrator shall not have authority or discretion to
establish a relative-risk ranking of any category or
subcategory of tobacco products or any category or
subcategory of nicotine-containing products other than the
ten categories specified in this subsection.
(b) Considerations in Promulgating Regulations.--In
promulgating regulations under this section, the
Administrator--
(1) shall take into account relevant epidemiologic studies
and other relevant competent and reliable scientific
evidence; and
(2) in assessing the risks of serious or chronic tobacco-
related diseases and adverse health conditions presented by a
particular category, shall consider the range of tobacco
products or nicotine-containing products within the category,
and shall give appropriate weight to the market shares of the
respective products in the category.
(c) Promulgation of Rankings of Categories.--Once the
initial regulations required by subsection (a) are in effect,
the Administrator shall promptly, by order, after notice and
an opportunity for comment, promulgate to the general public
rankings of the categories of tobacco products and nicotine-
containing products in accordance with those regulations. The
Administrator shall promulgate the initial rankings of those
categories of tobacco products and nicotine-containing
products to the general public not later than January 1,
2010. Thereafter, on an annual basis, the Administrator
shall, by order, promulgate to the general public updated
rankings that are (1) in accordance with those regulations,
and (2) reflect the scientific evidence available at the time
of promulgation. The Administrator shall open and maintain an
ongoing public docket for receipt of data and other
information submitted by any person with respect to such
annual promulgation of rankings.
TITLE V--ENFORCEMENT PROVISIONS
SEC. 501. PROHIBITED ACTS.
The following acts and the causing thereof are hereby
prohibited--
(1) the introduction or delivery for introduction into
interstate commerce of any tobacco product that is
adulterated or misbranded;
(2) the adulteration or misbranding of any tobacco product
in interstate commerce;
(3) the receipt in interstate commerce of any tobacco
product that is known to be adulterated or misbranded, and
the delivery or proffered delivery thereof for pay or
otherwise;
(4) the failure to establish or maintain any record, or
make any report or other submission, or to provide any notice
required by or under this Act; or the refusal to permit
access to, verification of, or copying of any record as
required by this Act;
(5) the refusal to permit entry or inspection as authorized
by this Act;
(6) the making to the Administrator of a statement, report,
certification or other submission required by this Act, with
knowledge that such statement, report, certification, or
other submission is false in a material aspect;
(7) the manufacturing, shipping, receiving, storing,
selling, distributing, possession, or use of any tobacco
product with knowledge that it is an illicit tobacco product;
(8) the forging, simulating without proper permission,
falsely representing, or without proper authority using any
brand name;
(9) the using by any person to his or her own advantage, or
revealing, other than to the Administrator or officers or
employees of the Agency, or to the courts when relevant in
any judicial proceeding under this Act, any information
acquired under authority of this Act concerning any item
which as a trade secret is entitled to protection; except
that the foregoing does not authorize the withholding of
information from either House of Congress or from, to the
extent of matter within its jurisdiction, any committee or
subcommittee of such committee or any joint committee of
Congress or any subcommittee of such joint committee;
(10) the alteration, mutilation, destruction, obliteration,
or removal of the whole or any part of the labeling of, or
the doing of any other act with respect to, a tobacco
product, if such act is done while such tobacco product is
held for sale (whether or not the first sale) after shipment
in interstate commerce, and results in such tobacco product
being adulterated or misbranded;
(11) the importation of any tobacco product that is
adulterated, misbranded, or otherwise not in compliance with
this Act; and
(12) the commission of any act prohibited by section 201 of
this Act.
SEC. 502. INJUNCTION PROCEEDINGS.
(a) The district courts of the United States shall have
jurisdiction, for cause shown, to restrain violations of this
Act, except for violations of section 701(k).
(b) In case of an alleged violation of an injunction or
restraining order issued under this section, which also
constitutes a violation of this Act, trial shall be by the
court, or upon demand of the defendant, by a jury.
SEC. 503. PENALTIES.
(a) Criminal Penalties.--Any person who willfully violates
a provision of section 501 of this Act shall be imprisoned
for not more than one year or fined not more than $25,000, or
both.
(b) Civil Penalties for Violation of Section 803.--
(1) Any person who knowingly distributes or sells, other
than through retail sale or retail offer for sale, any
cigarette brand style in violation of section 803(a)--
(A) for a first offense shall be liable for a civil penalty
not to exceed $10,000 for each distribution or sale, or
(B) for a second offense shall be liable for a civil
penalty not to exceed $25,000 for each distribution or sale,
except that the penalty imposed against any person with
respect to violations during any 30-day period shall not
exceed $100,000.
(2) Any retailer who knowingly distributes, sells or offers
for sale any cigarette brand style in violation of section
803(a) shall--
(A) for a first offense for each sale or offer for sale of
cigarettes, if the total number of packages of cigarettes
sold or offered for sale--
(i) does not exceed 50 packages of cigarettes, be liable
for a civil penalty not to exceed $500 for each sale or offer
for sale, and
(ii) exceeds 50 packages of cigarettes, be liable for a
civil penalty not to exceed $1,000 for each sale or offer for
sale;
(B) for each subsequent offense for each sale or offer for
sale of cigarettes, if the total number of cigarettes sold or
offered for sale--
(i) does not exceed 50 packages of cigarettes, be liable
for a civil penalty not to exceed $2,000 for each sale or
offer for sale, and
(ii) exceeds 50 packages of cigarettes, be liable for a
civil penalty not to exceed $5,000 for each sale or offer for
sale;
except that the penalty imposed against any person during any
30-day period shall not exceed $25,000.
SEC. 504. SEIZURE.
(a) Articles Subject to Seizure.--
(1) Any tobacco product that is adulterated or misbranded
when introduced into or while in interstate commerce or while
held for sale (whether or not the first sale) after shipment
in interstate commerce, or which may not, under the
provisions of this Act, be introduced into interstate
commerce, shall be liable to be proceeded against while in
interstate commerce, or at any time thereafter, on libel of
information and condemned in any district court of the United
States within the jurisdiction of which the tobacco product
is found. No libel for condemnation shall be instituted under
this Act for any alleged misbranding if there is pending in
any court a libel for condemnation proceeding under this Act
based upon the same alleged misbranding, and not more than
one such proceeding shall be instituted if no such proceeding
is so pending, except that such limitations shall not apply--
(A) when such misbranding has been the basis of a prior
judgment in favor of the United States, in a criminal,
injunction, or libel for condemnation proceeding under this
Act, or
(B) when the Administrator has probable cause to believe
from facts found, without hearing, by the Administrator or
any officer or employee of the Agency that the misbranded
tobacco product is dangerous to health beyond the inherent
danger to health posed by tobacco, or that the labeling of
the misbranded tobacco product is fraudulent, or would be in
a material respect misleading to the injury or damage of the
purchaser or consumer. In any case where the number of libel
for condemnation proceedings is limited as above provided,
the proceeding pending or instituted shall, on application of
the claimant, seasonably made, be removed for trial to any
district agreed upon by stipulation between the parties, or,
in case of failure to so stipulate within a reasonable time,
the claimant may apply to the court of the district in which
the seizure has been made, and
[[Page H4363]]
such court (after giving the United States attorney for such
district reasonable notice and opportunity to be heard) shall
by order, unless good cause to the contrary is shown, specify
a district of reasonable proximity to the claimant's
principal place of business, to which the case shall be
removed for trial.
(2) The following shall be liable to be proceeded against
at any time on libel of information and condemned in any
district court of the United States within the jurisdiction
of which they are found--
(A) any tobacco product that is an illicit tobacco product;
(B) any container of an illicit tobacco product;
(C) any equipment or thing used in making an illicit
tobacco product; and
(D) any adulterated or misbranded tobacco product.
(3)(A) Except as provided in subparagraph (B), no libel for
condemnation may be instituted under paragraph (1) or (2)
against any tobacco product which--
(i) is misbranded under this Act because of its
advertising, and
(ii) is being held for sale to the ultimate consumer in an
establishment other than an establishment owned or operated
by a manufacturer, packer, or distributor of the tobacco
product.
(B) A libel for condemnation may be instituted under
paragraph (1) or (2) against a tobacco product described in
subparagraph (A) if the tobacco product's advertising which
resulted in the tobacco product being misbranded was
disseminated in the establishment in which the tobacco
product is being held for sale to the ultimate consumer--
(i) such advertising was disseminated by, or under the
direction of, the owner or operator of such establishment, or
(ii) all or part of the cost of such advertising was paid
by such owner or operator.
(b) Procedures.--The tobacco product, equipment, or other
thing proceeded against shall be liable to seizure by process
pursuant to the libel, and the procedure in cases under this
section shall conform, as nearly as may be, to the procedure
in admiralty; except that on demand of either party any issue
of fact joined in any such case shall be tried by jury. When
libel for condemnation proceedings under this section,
involving the same claimant and the same issues of
adulteration or misbranding, are pending in two or more
jurisdictions, such pending proceedings, upon application of
the claimant seasonably made to the court of one such
jurisdiction, shall be consolidated for trial by order of
such court, and tried in (1) any district selected by the
claimant where one of such proceedings is pending; or (2) a
district agreed upon by stipulation between the parties. If
no order for consolidation is so made within a reasonable
time, the claimant may apply to the court of one such
jurisdiction and such court (after giving the United States
attorney for such district reasonable notice and opportunity
to be heard) shall by order, unless good cause to the
contrary is shown, specify a district of reasonable proximity
to the claimant's principal place of business, in which all
such pending proceedings shall be consolidated for trial and
tried. Such order of consolidation shall not apply so as to
require the removal of any case the date for trial of which
has been fixed. The court granting such order shall give
prompt notification thereof to the other courts having
jurisdiction of the cases covered thereby.
(c) Samples and Analyses.--The court at any time after
seizure up to a reasonable time before trial shall by order
allow any party to a condemnation proceeding, the party's
attorney or agent, to obtain a representative sample of the
article seized and a true copy of the analysis, if any, on
which the proceeding is based and the identifying marks or
numbers, if any, of the packages from which the samples
analyzed were obtained.
(d) Disposition of Condemned Tobacco Products.--(1) Any
tobacco product condemned under this section shall, after
entry of the decree, be disposed of by destruction or sale as
the court may, in accordance with the provisions of this
section, direct; and the proceeds thereof, if sold, less the
legal costs and charges, shall be paid into the Treasury of
the United States; but such tobacco product shall not be sold
under such decree contrary to the provisions of this Act or
the laws of the jurisdiction in which sold. After entry of
the decree and upon the payment of the costs of such
proceedings and the execution of a good and sufficient bond
conditioned that such article shall not be sold or disposed
of contrary to the provisions of this Act or the laws of any
State in which sold, the court may by order direct that such
tobacco product be delivered to the owner thereof to be
destroyed or brought into compliance with the provisions of
this Act, under the supervision of an officer or employee
duly designated by the Administrator; and the expenses of
such supervision shall be paid by the person obtaining
release of the tobacco product under bond. If the tobacco
product was imported into the United States and the person
seeking its release establishes (A) that the adulteration,
misbranding, or violation did not occur after the tobacco
product was imported, and (B) that the person seeking the
release of the tobacco product had no cause for believing
that it was adulterated, misbranded, or in violation before
it was released from customs custody, the court may permit
the tobacco product to be delivered to the owner for
exportation under section 709 in lieu of destruction upon a
showing by the owner that there is a reasonable certainty
that the tobacco product will not be re-imported into the
United States.
(2) The provisions of paragraph (1) of this subsection
shall, to the extent deemed appropriate by the court, apply
to any equipment or other thing which is not otherwise within
the scope of such paragraph and which is referred to in
paragraph (2) of subsection (a).
(3) Whenever in any proceeding under this section,
involving paragraph (2) of subsection (a), the condemnation
of any equipment or thing (other than a tobacco product) is
decreed, the court shall allow the claim of any claimant, to
the extent of such claimant's interest, for remission or
mitigation of such forfeiture if such claimant proves to the
satisfaction of the court (A) that such claimant has not
caused the equipment or thing to be within one of the
categories referred to in such paragraph (2) and has no
interest in any tobacco product referred to therein, (B) that
such claimant has an interest in such equipment or other
thing as owner or lienor or otherwise, acquired by such
claimant in good faith, and (C) that such claimant at no time
had any knowledge or reason to believe that such equipment or
other thing was being or would be used in, or to facilitate,
the violation of laws of the United States relating to any
illicit tobacco product.
(e) Costs and Fees.--When a decree of condemnation is
entered against the tobacco product or other article, court
costs and fees, and storage and other proper expenses shall
be awarded against the person, if any, intervening as
claimant of the tobacco product or other article.
(f) Removal for Trial.--In the case of removal for trial of
any case as provided by subsection (a) or (b)--
(1) The clerk of the court from which removal is made shall
promptly transmit to the court in which the case is to be
tried all records in the case necessary in order that such
court may exercise jurisdiction.
(2) The court to which such case was removed shall have the
powers and be subject to the duties, for purposes of such
case, which the court from which removal was made would have
had, or to which such court would have been subject, if such
case had not been removed.
(g) Administrative Detention of Tobacco Products.--
(1) Detention authority.--
(A) In general.--An officer or qualified employee of the
Agency may order the detention, in accordance with this
subsection, of any tobacco product that is found during an
inspection, examination, or investigation under this Act
conducted by such officer or qualified employee, if the
officer or qualified employee has credible evidence or
information indicating that such article presents a threat of
serious adverse health consequences beyond those normally
inherent in the use of tobacco products.
(B) Administrator's approval.--A tobacco product or
component thereof may be ordered detained under subparagraph
(A) if, but only if, the Administrator or an official
designated by the Administrator approves the order. An
official may not be so designated unless the official is an
officer with supervisory responsibility for the inspection,
examination, or investigation that led to the order.
(2) Period of detention.--A tobacco product may be detained
under paragraph (1) for a reasonable period, not to exceed 20
days, unless a greater period, not to exceed 30 days, is
necessary, to institute an action under subsection (a) or
section 702.
(3) Security of detained tobacco product.--An order under
paragraph (1) may require that the tobacco product to be
detained be labeled or marked as detained, and shall require
that the tobacco product be maintained in or removed to a
secure facility, as appropriate. A tobacco product subject to
such an order shall not be transferred by any person from the
place at which the tobacco product is ordered detained, or
from the place to which the tobacco product is so removed, as
the case may be, until released by the Administrator or until
the expiration of the detention period applicable under such
order, whichever occurs first. This subsection may not be
construed as authorizing the delivery of the tobacco product
pursuant to the execution of a bond while the tobacco product
is subject to the order, and section 709 does not authorize
the delivery of the tobacco product pursuant to the execution
of a bond while the article is subject to the order.
(4) Appeal of detention order.--
(A) In general.--With respect to a tobacco product ordered
detained under paragraph (1), any person who would be
entitled to be a claimant of such tobacco product if the
tobacco product were seized under subsection (a) may appeal
the order to the Administrator. Within five days after such
an appeal is filed, the Administrator, after providing
opportunity for an informal hearing, shall confirm or
terminate the order involved, and such confirmation by the
Administrator shall be considered a final agency action for
purposes of section 702 of title 5, United States Code. If
during such five-day period the Administrator fails to
provide such an opportunity, or to confirm or terminate such
order, the order is deemed to be terminated.
(B) Effect of instituting court action.--The process under
subparagraph (A) for the appeal of an order under paragraph
(1) terminates if the Administrator institutes an action
under subsection (a) or section 702 regarding the tobacco
product involved.
[[Page H4364]]
SEC. 505. REPORT OF MINOR VIOLATIONS.
Nothing in this Act shall be construed as requiring the
Administrator to report for prosecution, or for institution
of libel or injunction proceedings, minor violations of this
Act whenever the Administrator believes that the public
interest will be adequately served by a suitable written
notice or warning.
SEC. 506. INSPECTION.
(a) Authority To Inspect.--The Administrator shall have the
power to inspect the premises of a tobacco product
manufacturer for purposes of determining compliance with this
Act, or the regulations promulgated under it. Officers of the
Agency designated by the Administrator, upon presenting
appropriate credentials and a written notice to the person in
charge of the premises, are authorized to enter, at
reasonable times, without a search warrant, any factory,
warehouse, or other establishment in which tobacco products
are manufactured, processed, packaged, or held for domestic
distribution. Any such inspection shall be conducted within
reasonable limits and in a reasonable manner, and shall be
limited to examining only those things, including but not
limited to records, relevant to determining whether
violations of this Act, or regulations under it, have
occurred. No inspection authorized by this section shall
extend to financial data, sales data other than shipment
data, pricing data, personnel data (other than data as to
qualifications of technical and professional personnel
performing functions subject to this Act), or research data.
A separate notice shall be given for each such inspection,
but a notice shall not be required for each entry made during
the period covered by the inspection. Each such inspection
shall be commenced and completed with reasonable promptness.
(b) Report of Observations.--Before leaving the premises,
the officer of the Agency who has supervised or conducted the
inspection shall give to the person in charge of the premises
a report in writing setting forth any conditions or practices
that appear to manifest a violation of this Act, or the
regulations under it.
(c) Samples.--If the officer has obtained any sample in the
course of inspection, prior to leaving the premises that
officer shall give to the person in charge of the premises a
receipt describing the samples obtained. As to each sample
obtained, the officer shall furnish promptly to the person in
charge of the premises a copy of the sample and of any
analysis made upon the sample.
SEC. 507. EFFECT OF COMPLIANCE.
Compliance with the provisions of this Act and the
regulations promulgated under it shall constitute a complete
defense to any civil action, including but not limited to any
products liability action, that seeks to recover damages,
whether compensatory or punitive, based upon an alleged
defect in the labeling or advertising of any tobacco product
distributed for sale domestically.
SEC. 508. IMPORTS.
(a) Imports; List of Registered Foreign Establishments;
Samples From Unregistered Foreign Establishments; Examination
and Refusal of Admission.--The Secretary of Homeland Security
shall deliver to the Administrator, upon request by the
Administrator, samples of tobacco products that are being
imported or offered for import into the United States, giving
notice thereof to the owner or consignee, who may appear
before the Administrator and have the right to introduce
testimony. The Administrator shall furnish to the Secretary
of Homeland Security a list of establishments registered
pursuant to subsection (d) of section 109 of this Act, and
shall request that, if any tobacco products manufactured,
prepared, or processed in an establishment not so registered
are imported or offered for import into the United States,
samples of such tobacco products be delivered to the
Administrator, with notice of such delivery to the owner or
consignee, who may appear before the Administrator and have
the right to introduce testimony. If it appears from the
examination of such samples or otherwise that (1) such
tobacco product is forbidden or restricted in sale in the
country in which it was produced or from which it was
exported, or (2) such tobacco product is adulterated,
misbranded, or otherwise in violation of this Act, then such
tobacco product shall be refused admission, except as
provided in subsection (b) of this section. The Secretary of
Homeland Security shall cause the destruction of any such
tobacco product refused admission unless such tobacco product
is exported, under regulations prescribed by the Secretary of
Homeland Security, within ninety days of the date of notice
of such refusal or within such additional time as may be
permitted pursuant to such regulations.
(b) Disposition of Refused Tobacco Products.--Pending
decision as to the admission of a tobacco product being
imported or offered for import, the Secretary of Homeland
Security may authorize delivery of such tobacco product to
the owner or consignee upon the execution by such consignee
of a good and sufficient bond providing for the payment of
such liquidated damages in the event of default as may be
required pursuant to regulations of the Secretary of Homeland
Security. If it appears to the Administrator that a tobacco
product included within the provisions of clause (3) of
subsection (a) of this section can, by relabeling or other
action, be brought into compliance with this Act or rendered
other than a tobacco product, final determination as to
admission of such tobacco product may be deferred and, upon
filing of timely written application by the owner or
consignee and the execution by such consignee of a bond as
provided in the preceding provisions of this subsection, the
Administrator may, in accordance with regulations, authorize
the applicant to perform such relabeling or other action
specified in such authorization (including destruction or
export of rejected tobacco products or portions thereof, as
may be specified in the Administrator's authorization). All
such relabeling or other action pursuant to such
authorization shall in accordance with regulations be under
the supervision of an officer or employee of the Agency
designated by the Administrator, or an officer or employee of
the Department of Homeland Security designated by the
Secretary of Homeland Security.
(c) Charges Concerning Refused Tobacco Products.--All
expenses (including travel, per diem or subsistence, and
salaries of officers or employees of the United States) in
connection with the destruction provided for in subsection
(a) of this section and the supervision of the relabeling or
other action authorized under the provisions of subsection
(b) of this section, the amount of such expenses to be
determined in accordance with regulations, and all expenses
in connection with the storage, cartage, or labor with
respect to any tobacco product refused admission under
subsection (a) of this section, shall be paid by the owner or
consignee and, in default of such payment, shall constitute a
lien against any future importations made by such owner or
consignee.
SEC. 509. TOBACCO PRODUCTS FOR EXPORT.
(a) Exemption for Tobacco Products Exported.--Except as
provided in subsection (b), a tobacco product intended for
export shall be exempt from this Act if--
(1) it is not in conflict with the laws of the country to
which it is intended fore export, as shown by either (A) a
document issued by the government of that country or (B) a
document provided by a person knowledgeable with respect to
the relevant laws of that country and qualified by training
and experience to opine on whether the tobacco product is or
is not in conflict with such laws;
(2) it is labeled on the outside of the shipping package
that it is intended for export; and
(3) the particular units of tobacco product intended for
export have not been sold or offered for sale in domestic
commerce.
(b) Products for U.S. Armed Forces Overseas.--A tobacco
product intended for export shall not be exempt from this Act
if it is intended for sale or distribution to members or
units of the Armed Forces of the United States located
outside of the United States.
(c) This Act shall not apply to a person that manufactures
and/or distributes tobacco products solely for export under
subsection (a), except to the extent such tobacco products
are subject to subsection (b).
TITLE VI--MISCELLANEOUS PROVISIONS
SEC. 601. USE OF PAYMENTS UNDER THE MASTER SETTLEMENT
AGREEMENT AND INDIVIDUAL STATE SETTLEMENT
AGREEMENTS.
(a) Reduction of Grant Amounts.--(1) For fiscal year 2010
and each subsequent fiscal year, the Secretary shall reduce,
as provided in subsection (b), the amount of any grant under
section 1921 of the Public Health Service Act (42 U.S.C.
Sec. 300x-21) for any State that spends on tobacco control
programs from the funds received by such State pursuant to
the Master Settlement Agreement, the Florida Settlement
Agreement, the Minnesota Settlement Agreement, the
Mississippi Memorandum of Understanding, or the Texas
Settlement Agreement, as applicable, less than 20 percent of
the amounts received by that State from settlement payments.
(2) In the case of a State whose legislature does not
convene a regular session in fiscal year 2009 or 2010, and in
the case of a State whose legislature does not convene a
regular session in fiscal year 2010, the requirement
described in subsection (a)(1) as a condition of receipt of a
grant under section 1921 of the Public Health Service Act
shall apply only for fiscal year 2009 and subsequent fiscal
years.
(b) Determination of State Spending.--Before making a grant
under section 1921 of the Public Health Service Act, section
300x-21 of title 42, United States Code, to a State for the
first applicable fiscal year or any subsequent fiscal year,
the Secretary shall make a determination of whether, during
the immediately preceding fiscal year, the State has spent on
tobacco control programs, from the funds received by such
State pursuant to the Master Settlement Agreement, the
Florida Settlement Agreement, the Minnesota Settlement
Agreement, the Mississippi Memorandum of Understanding, or
the Texas Settlement Agreement, as applicable, at least the
amount referenced in (a)(1). If, after notice to the State
and an opportunity for a hearing, the Secretary determines
that the State has spent less than such amount, the Secretary
shall reduce the amount of the allotment under section 300x-
21 of title 42, United States Code, for the State for the
fiscal year involved by an amount equal to--
(1) in the case of the first applicable fiscal year, 10
percent of the amount determined under section 300x-33 of
title 42, United States Code, for the State for the fiscal
year;
(2) in the case of the first fiscal year following such
applicable fiscal year, 20 percent
[[Page H4365]]
of the amount determined under section 300x-33 of title 42,
United States Code, for the State for the fiscal year;
(3) in the case of the second such fiscal year, 30 percent
of the amount determined under section 300x-33 of title 42,
United States Code, for the State for the fiscal year; and
(4) in the case of the third such fiscal year or any
subsequent fiscal year, 40 percent of the amount determined
under section 300x-33 of title 42, United States Code, for
the State for the fiscal year.
The Secretary shall not have authority or discretion to grant
to any State a waiver of the terms and requirements of this
subsection or subsection (a).
(c) Definitions.--For the purposes of this section--
(1) The term ``first applicable fiscal year'' means--
(A) fiscal year 2011, in the case of any State described in
subsection (a)(2) of this section; and
(B) fiscal year 2010, in the case of any other State.
(2) The term ``Florida Settlement Agreement'' means the
Settlement Agreement, together with the exhibits thereto,
entered into on August 25, 1997, between the State of Florida
and signatory tobacco product manufacturers, as specified
therein.
(3) The term ``Master Settlement Agreement'' means the
Master Settlement Agreement, together with the exhibits
thereto, entered into on November 23, 1998, between the
signatory States and signatory tobacco product manufacturers,
as specified therein.
(4) The term ``Minnesota Settlement Agreement'' means the
Settlement Agreement, together with the exhibits thereto,
entered into on May 8, 1998, between the State of Minnesota
and signatory tobacco product manufacturers, as specified
therein.
(5) The term ``Mississippi Memorandum of Understanding''
means the Memorandum of Understanding, together with the
exhibits thereto and Settlement Agreement contemplated
therein, entered into on July 2, 1997, between the State of
Mississippi and signatory tobacco product manufacturers, as
specified therein.
(6) The term ``Secretary'' means the Secretary of Health
and Human Services.
(7) The term ``Texas Settlement Agreement'' means the
Settlement Agreement, together with the exhibits thereto,
entered into on January 16, 1998, between the State of Texas
and signatory tobacco product manufacturers, as specified
therein.
SEC. 602. PREEMPTION OF STATE LAWS IMPLEMENTING FIRE SAFETY
STANDARD FOR CIGARETTES.
(a) In General.--With respect to fire safety standards for
cigarettes, no State or political subdivision shall--
(1) require testing of cigarettes that would be in addition
to, or different from, the testing prescribed in subsection
(b); or
(2) require a performance standard that is in addition to,
or different from, the performance standard set forth in
subsection (b).
(b) Test Method and Performance Standard.--
(1) To the extent a State or political subdivision enacts
or has enacted legislation or a regulation setting a fire
safety standard for cigarettes, the test method employed
shall be--
(A) the American Society of Testing and Materials
(``ASTM'') standard E2187-4, entitled ``Standard Test Method
for Measuring the Ignition Strength of Cigarettes'';
(B) for each cigarette on 10 layers of filter paper;
(C) so that a replicate test of 40 cigarettes for each
brand style of cigarettes comprises a complete test trial for
that brand style; and
(D) in a laboratory that has been accredited in accordance
with ISO/IEC 17205 of the International Organization for
Standardization (``ISO'') and that has an implemented quality
control and quality assurance program that includes a
procedure capable of determining the repeatability of the
testing results to a repeatability value that is no greater
than 0.19.
(2) To the extent a State or political subdivision enacts
or has enacted legislation or a regulation setting a fire
safety standard for cigarettes, the performance standard
employed shall be that no more than 25 percent of the
cigarettes of that brand style tested in a complete test in
accordance with paragraph (1) exhibit full-length burns.
(c) Exception to Subsection (b).--In the event that a
manufacturer of a cigarette that a State or political
subdivision or its respective delegated agency determines
cannot be tested in accordance with the test method
prescribed in subsection (b)(1)(A), the manufacturer shall
propose a test method and performance standard for the
cigarette to the State or political subdivision. Upon
approval of the proposed test method and a determination by
the State or political division that the performance standard
proposed by the manufacturer is equivalent to the performance
standard prescribed in subsection (b)(2), the manufacturer
may employ such test method and performance standard to
certify such cigarette pursuant to this subsection
notwithstanding subsection (b).
SEC. 603. INSPECTION BY THE ALCOHOL AND TOBACCO TAX TRADE
BUREAU OF RECORDS OF CERTAIN CIGARETTE AND
SMOKELESS TOBACCO SELLERS.
(a) In General.--Any officer of the Bureau of the Alcohol
and Tobacco Tax Trade Bureau may, during normal business
hours, enter the premises of any person described in
subsection (b) for the purposes of inspecting--
(1) any records or information required to be maintained by
such person under the provisions of law referred to in
subsection (d); or
(2) any cigarettes or smokeless tobacco kept or stored by
such person at such premises.
(b) Covered Persons.--Subsection (a) applies to any person
who engages in a delivery sale, and who ships, sells,
distributes, or receives any quantity in excess of 10,000
cigarettes, or any quantity in excess of 500 single-unit
consumer-sized cans or packages of smokeless tobacco, within
a single month.
(c) Relief.--
(1) In general.--The district courts of the United States
shall have the authority in a civil action under this
subsection to compel inspections authorized by subsection
(a).
(2) Violations.--Whoever violates subsection (a) or an
order issued pursuant to paragraph (1) shall be subject to a
civil penalty in an amount not to exceed $10,000 for each
violation.
(d) Covered Provisions of Law.--The provisions of law
referred to in this subsection are--
(1) the Act of October 19, 1949 (15 U.S.C. 375; commonly
referred to as the ``Jenkins Act'');
(2) chapter 114 of title 18, United States Code; and
(3) this Act.
(e) Delivery Sale Defined.--In this section, the term
``delivery sale'' has the meaning given that term in 2343(e)
of title 18, United States Code, as amended by this Act.
SEC. 604. SEVERABILITY.
If any provision of this Act, the amendments made by this
Act, or the application of any provision of this Act to any
person or circumstance is held to be invalid, the remainder
of this Act, the amendments made by this Act, and the
application of the provisions of this Act to any other person
or circumstance shall not be affected, and shall continue to
be enforced to the fullest extent possible.
TITLE VII--TOBACCO GROWER PROTECTION
SEC. 701. TOBACCO GROWER PROTECTION.
No provision in this Act shall allow the Administrator or
any other person to require changes to traditional farming
practices, including standard cultivation practices, curing
processes, seed composition, tobacco type, fertilization,
soil, record keeping, or any other requirement affecting
farming practices.
Amend the title so as to read: ``A bill to protect the
public health by establishing the Tobacco Harm Reduction
Center within the Department of Health and Human Services
with certain authority to regulate tobacco products, and for
other purposes.''.
The SPEAKER pro tempore. Pursuant to House Resolution 307, the
gentleman from Indiana (Mr. Buyer) and a Member opposed each will
control 15 minutes.
The Chair recognizes the gentleman from Indiana.
Mr. BUYER. Thank you.
Mr. Speaker, I have a parliamentary inquiry: Because this is my
substitute, do I speak last on the substitute?
The SPEAKER pro tempore. A manager in opposition will have the right
to close.
Mr. BUYER. Thank you.
With that, I will yield to the cosponsor of this bipartisan
substitute, Mr. McIntyre of North Carolina.
Mr. McINTYRE. Mr. Speaker, I rise this evening in support of the
Youth Prevention and Harm Reduction Act, which is embodied in the
substitute that Mr. Buyer is describing and offering and on which he
and I have worked together, which is a bipartisan bill.
I have worked with Mr. Buyer to craft a practical approach to
government regulation of tobacco that protects health while preserving
a vital economic engine for many communities, not only throughout my
district in southeastern North Carolina and across the great Tar Heel
State, but also across the country.
The underlying bill will grant the Food and Drug Administration wide
authority to dictate to manufacturers and growers dramatic changes in
product design and leaf cultivation, a concern that has been raised
repeatedly by the tobacco growers in my district and tobacco growers
throughout the States that are affected. The last thing we want, of
course, is to have any government bureaucrat coming on the farm or
dictating to farmers about how they grow their crops. This is the part
that we want to be abundantly clear about.
{time} 2015
The tobacco industry contributes over $36 billion to the U.S. economy
each year employing over 19,000 individuals nationwide. In my home
State of North Carolina, over 8,600 people are employed by the industry
with a Statewide economic impact of nearly $24 billion. The
manufacturing provisions and
[[Page H4366]]
the concern about the FDA and its involvement on the farm in the
underlying bill would put many companies and growers out of business.
And in this time of economic uncertainty, the last thing that any of us
can afford is to lose more jobs. Our substitute specifically protects
growers by preventing any government agency from requiring changes to
traditional farming practices, including standard cultivization
practices, curing processes, seed composition, tobacco-type
fertilization, soil, record keeping or any other requirement affecting
farming practices.
In addition, this bill is about public health and prevents minors
from smoking. Our substitute considers cutting-edge scientific
research, as Mr. Buyer has indicated a little while ago, which would
promote a harm-reduction strategy to move smokers to less harmful
tobacco products.
So we're talking about here about protecting public health,
definitely protecting minors, and making sure that our growers and
farmers are not put out of business.
According to applied economics, the use of these reduced tobacco
products increases the average probability of smoking cessation by over
10 percent. The Buyer-McIntyre substitute specifically addresses youth
tobacco by encouraging States to penalize minors for purchasing and
possessing tobacco products. Under current law, retailers are
prohibited from selling tobacco products to minors, but unlike with the
purchase of alcohol, minors are not penalized for underage purchase and
possession of tobacco products.
This also calls upon the States to increase their percentage of the
Master Settlement Agreement dollars to fund tobacco cessation and
public health programs. In the past 10 years, States have spent just
3.2 percent of their total tobacco-generated revenue on tobacco
prevention and cessation programs.
We take this concern about our youth seriously. I had a son. Back
when he was in high school he was part of the Tobacco Free Kids Program
and we understand, appreciate, and respect that; and, in fact, our bill
has even stronger provisions dealing with that.
The Buyer-McIntyre substitute is a commonsense way to help protect
public health and protect our vital tobacco economy and the jobs that
we cannot afford to lose, especially in this time of economic crisis in
our country.
I urge my colleagues to vote ``yes'' on the Buyer-McIntyre
substitute, a bipartisan support, which provides a reasonable and
pragmatic way to deal with tobacco regulation and help protect our
minors from the harms of tobacco.
I reserve my time.
Mr. WAXMAN. Mr. Speaker, at this time, I rise to claim the time in
opposition to the amendment.
The SPEAKER pro tempore. The gentleman from California is recognized.
Mr. WAXMAN. Mr. Speaker, I am pleased at this time to yield 3 minutes
to a very important member of the Energy and Commerce Committee and its
Subcommittee on Health, the gentlelady from California (Mrs. Capps).
Mrs. CAPPS. Mr. Speaker, I thank my colleague and chairman of our
committee and a real pioneer and hero in this area.
I rise to give strong opposition to the Buyer amendment.
The Buyer amendment would undermine the precise goals of this
underlying bill, that is to prevent kids from smoking. There is nothing
in the Buyer amendment that would restrict tobacco marketing to youth,
yet we know that marketing to our kids is a persistent tobacco company
tactic. They do it to draw in new smokers at a very early age to
replace their dwindling client base because of people finally being
able to quit or, unfortunately, dying as a complication of smoking.
As a grandmother, I am horrified that my teenage granddaughters are
the target of disgusting adds like this very one. Dressed to the Nines,
this title was featured repeatedly in many magazines read frequently by
young women and girls. The add highlights the latest fashion trends. It
tells kids how to ``update your closet,'' and it directs them, of all
things, to the Camel cigarettes Web site.
Under the Waxman-Platts bill, however, we specifically eliminate this
kind of marketing to kids that depict smoking as cool or glamorous. And
that's because it is not. Smoking is not cool. It isn't glamorous. It's
an expensive ticket to an early death, and the tobacco companies and
the magazines that run these adds, they know it, and they should be
ashamed of themselves. But these days, corporate shame is in short
supply, and we cannot rely on it to protect our kids.
In addition, this bill gives the FDA the authority to respond to the
inevitable attempts by tobacco companies to circumvent new
restrictions.
So I urge my colleagues to reject this Buyer substitute amendment
because it lacks critical provisions that are so important to prevent
children, our youth, from smoking.
I urge everyone to support the Waxman-Platts bill.
Mr. BUYER. I would say to the gentlelady who just spoke in the well
that Mr. Waxman's bill was drafted years ago, and it was drafted prior
to the Master Settlement Agreement. And it is the Master Settlement
Agreement itself that has great restrictions upon advertisers. So there
is a reason that I don't have it--I say to the gentlelady, there is a
reason I don't have that part in the bill because the Master Settlement
Agreement that is now administered by the attorneys general in 46
States, including the District of Columbia, who work in concert not
only with the FDA but also with the Federal Trade Commission. These
tobacco companies are not even advertising today in these types of
magazines.
But one of the reasons I didn't go further in advertising is that
when we work in concert with the Harm Reduction Center under Health and
Human Services, what we seek to do is to inform the public with regard
to the relative risks among different types of tobacco product, and
that's what we seek to do. We seek to migrate people from the smoking
to other types of products.
If I could, I would like to show exactly what I am about to share.
What I would like to share here with you is a chart, and what is
important about this chart is about the continuum of risk and about all
of the different types of products that are available in the
marketplace today.
So when you think about this and you think about the continuum of
risk, what I did is I sought to say, All right. Let's think about the
products that are presently available out there.
So when you think about that, we have non-filtered cigarettes. That's
the worse. I mean, you get those toxins. You get them right into your
body and substance, and that's really bad. Non-filtered cigarettes.
Then you've got filtered cigarettes. We know that's a little bit
better--all of these tobacco products are harmful. So we go from non-
filtered cigarettes to a filtered cigarette.
Then I have a vented filtered cigarette, but those are really bad,
too, because people try to gain access to that nicotine so they suck a
little harder on that cigarette and they draw it deeper into their
lungs. That's not a good thing.
Then we have tobacco-heated cigarettes like the Accord. Now, we know
that that reduces a lot of the toxic substances, but we're really not
sure where on the continuum of risk does it lie along with the
electronic cigarette because there isn't sufficient science yet to back
that up.
And these are products that--innovation that is coming out in the
marketplace because people every day are making conscious decisions
about what we eat, what we drink on a risk assessment, and that's what
we are trying to do here in the statute.
So after electronic cigarettes, we have smokeless tobacco products.
Now, when I think about this, we can go from a non-filtered cigarette
and go all the way down 90 percent down the health risk chart, 90
percent, to get to a U.S. smokeless product.
Let's talk about the difference between a U.S. smokeless product and
a Swedish Snus. The U.S. smokeless tobacco product is fermented. So
through that fermentation and the natural processing of tobacco and the
nitrosamines, you still have some serious carcinogens and some toxic
substances. But it is still scientifically shown to be a much better
and safer tobacco product than that of smoking.
You see, it is not the nicotine that is killing people. It's the
smoke. It's the
[[Page H4367]]
smoke. It's the smoke. That's killing people.
So to get away from that--I heard somebody coughing. It was the
smoke, I am telling you.
If we can pull them away from the smoke and move them down the
continuum of risk chart--actually if we could get them into a Swedish
snus, get them into a pasteurized product, we take away 98 percent of
the health risk. And then if we can get them to--actually they are now
called dissolvable tobacco products. These are orbs or strips that you
can lay on your tongue or a stick that's a little like an oversized
toothpick that you can stick in your mouth. These are tobacco products
that contain no nitrosamines, and you can eliminate 99 percent of the
health risk, but an individual can still gain their access to nicotine
if they like.
And what we're trying to do, though, is move then down the continuum
of risk, make informed decisions in order for them to be healthier but
still gain access to their nicotine.
Then you have therapeutic nicotine devices, which are your gum, your
patches, your lozenges.
And then we have pharmaceuticals. We want people to quit smoking. But
in order to do this, what we've done--not only Mr. McIntyre but Mr.
Shuler and others here in a bipartisan effort--is to create a harm-
reduction strategy. And we embrace--so not only the goals of Mr. Waxman
on abstinence, but we also embrace the goals of education, prevention
and cessation activities as we try to move people and make informed
choices along this continuum of risk.
Now, what is so, to me, unconscionable is that if, in fact, Mr.
Waxman's bills were to pass, is that these new innovative types of
nicotine delivery devices could not make their access to the market.
Now as I said--I will say it for the umpteenth time--I respect Mr.
Waxman and his desire to try to get people to eliminate smoking. We
just recognized that today only 7 percent success rate with regard to
these type of nicotine replacement therapies, and that's a failure
rate, and we shouldn't do that.
I reserve the balance of my time.
Mr. WAXMAN. Mr. Speaker, may I inquire how much time each side has
remaining?
The SPEAKER pro tempore. The gentleman from California has 13 minutes
remaining. The gentleman from Indiana has 7\1/2\ minutes remaining.
Mr. WAXMAN. Well, I plan to close the debate, and I know that Mr.
Buyer has another speaker on his side, so I want to reserve the balance
of my time.
Mr. BUYER. Mr. Speaker, I would yield to one of the cosponsors of
this substitute, Mr. Shuler of North Carolina, for as much time as he
might consume.
Mr. SHULER. Mr. Chairman, I want to commend you for your hard work,
and although we may disagree on legislation, I want to commend you for
your hard work in the prevention of smoking and trying to get children
off smoking as well.
So, Mr. Speaker, I strongly support the commonsense amendment
proposed by the gentleman from Indiana. And I strongly oppose the
underlying bill.
Putting a dangerous, overworked FDA in charge of tobacco is a threat
to public safety. Last year, the FDA commissioner testified that he had
serious concerns that this bill could undermine the public health role
of the FDA. And the FDA Science Board said the FDA's inability to keep
up with scientific advancements means that Americans' lives will be at
risk.
What are these risks? Well, let me talk about three areas that just
happened last year.
Last summer, 1,400 people were sickened by peppers from Mexico, but
we shut down the entire tomato industry. Just last month, more than 100
people become sick because of salmonella and alfalfa sprouts. And in
January, more than 500 people became sick because of salmonella from
Peanut Corporation of America. Amazingly enough, this plant had never
been inspected even after Canada rejected a shipment of peanuts. That's
right. The FDA is overworked. We have to rely on the Canadians to
inspect our food now.
Instead of putting our food and drug supply at greater risk, let's
deal with the underage smoking head on. This amendment does that by
putting more resources into prevention and harm-reduction programs that
have helped reduce youth smoking by over 50 percent for the last 10
years.
Let's pass this amendment so that we can keep our kids safe from
cigarettes and keep our children safe with the food that they eat.
{time} 2030
I ask my colleagues to support the passage of the Buyer amendment.
Mr. WAXMAN. Mr. Speaker, I am going to reserve my time to close the
debate, so I will allow the gentleman from Indiana (Mr. Buyer) to
continue.
Mr. BUYER. Mr. Speaker, I yield 3 minutes to the gentlewoman from
Tennessee (Mrs. Blackburn).
Mrs. BLACKBURN. Mr. Speaker, I thank the gentleman from Indiana for
the excellent work that he has done on a substitute, for addressing
this issue the way it should be addressed.
We are all concerned about cigarette smoke and the effects of tobacco
on our health, and I don't think that is the debate that is here. But
one of the things that concerns me in this debate is that there are
some pieces that have kind of been left out, that are not being
addressed.
Well, we all are concerned about what has happened with teen smoking,
with the effects of tobacco on an individual's health. One of the
things that has happened is the Synar amendment and the good work that
the Synar language has done in reducing teen smoking has been left out,
and what we are having brought forward is this bill that will actually
give the FDA stamp of approval to some tobacco processes and uses. And
for someone as a wife, a mother, a grandmother, a community volunteer
that has actually worked to address school health curriculums, to
address smoking, to fight and work with smoking cessation programs, I
know that that is a dangerous step to give the FDA stamp of approval to
tobacco usage.
In addition to that, this is legislation that is going to build a
bureaucracy. It is going to pull the government into our farms, into
our manufacturers, into our retailers further and further.
But, Mr. Speaker, I think that actually that's a lot of what is going
on in this entire Congress, growing the bureaucracy. We're hearing it's
going to take 250,000 new Federal employees to implement the stimulus
and this massive budget that is before us; new Federal employees,
250,000 new Federal employees. It is building bureaucracies, taking
power away from individuals, taking power away from the House and
handing it over to a bureaucracy that continues to grow every single
day.
And the steps that are being taken with moving tobacco to the FDA is
another part of that. We know the FDA can't do the job in front of them
now when it comes to dealing with policing drugs, looking at
contaminated food, addressing the issues that we have had with
everything from peanut butter to pistachios. They are not getting the
job done, and now we want to pull them on to our farms and into our
manufacturing facilities addressing tobacco, and we have processes that
already work. But it's not about funding and keeping attention on
processes that work.
What we know is this is all about growing a bureaucracy. I encourage
my colleagues to vote against this bill.
Mr. BUYER. I yield myself such time as I may consume.
According to the Journal of Health Care Law and Policy, dated 2008,
``There is a very strong basis in science for believing that the harm
caused by current cigarettes can be massively reduced by alternative
nicotine delivery systems. Anti-tobacco campaigners who refuse to
discuss harm reduction will merely be ensuring that they are not part
of the ongoing dialogue that will shape this key area of policy.''
I also would like to cite Britton and Edwards in The Lancet, 2007.
``The risk of adverse effects associated with Snus use is lower than
that associated with smoking, overall by an estimated 90 percent.
Whatever the true overall hazard, use of low nitrosamine smokeless
products is clearly substantially less harmful than tobacco smoking.''
Also citing the Scientific Committee on Emerging and Newly Identified
[[Page H4368]]
Health Risks, dated 2007, ``The magnitude of the overall reduction in
hazard,'' meaning switching from cigarettes to smokeless, ``is
difficult to estimate.'' But as outlined in their paper, for
cardiovascular disease, it is at least a 50 percent reduction; for
pancreatic cancer, it is at least 30 percent; for oral and other GI
cancer, it is at least 50 percent reduction and probably more; and for
lung cancer and chronic obstructive pulmonary disease, it's possibly
even 100 percent.
Now, what I'm hopeful is that at some point, I'm going to make this
quest that Mr. Waxman and I can somehow come together, because
according to CBO the reduction in the rates of smoking in the Waxman
bill is two-tenths of 1 percent per year. So we're going to take over
$6 billion to reduce smoking rates under Mr. Waxman's approach by two-
tenths of 1 percent per year. Which means over a 10-year time frame,
the total that we're going to reduce for smoking in the entire country
is 2 percent. We are going to reduce smoking rates in the country under
Mr. Waxman by 2 percent.
We can do much better than that, and that's why we have this
substitute is that we want to move people from smoking down the
continuum of risk to eventually quitting, and I think that's exactly
what the chairman embraces.
Please support the substitute.
The SPEAKER pro tempore. The gentleman's time has expired.
Mr. WAXMAN. Mr. Speaker, I strongly oppose this substitute amendment
offered by Mr. Buyer.
The bill before us, the Waxman-Platts bill, has been carefully
crafted over more than a decade, in close consultation with the public
health community. It's been endorsed by over 1,000 different public
health, scientific, medical, faith, and community organizations. It is
also supported by a prestigious and bipartisan group of former public
health officials, including former Secretaries of Health and Human
Services, Tommy Thompson and Donna Shalala; former Surgeons General,
David Satcher and Richard Carmona; former CDC Director, Julie
Gerberding; and former FDA Commissioner, David Kessler. It reflects a
strong, reasonable, and comprehensive approach to addressing the
tobacco epidemic.
Now, this Buyer substitute is deeply flawed. It represents an
inadequate response for the greatest preventable cause of death and
disease in the United States.
One of the biggest problems in this substitute is that it places
oversight of tobacco under a totally new, untested agency. They create
a new government agency that lacks any experience in protecting the
public health. FDA is our Nation's primary protector of the public
health, and it has both the regulatory and scientific expertise to
handle the complex task of regulating tobacco. The agency devoted 10
years to investigating tobacco in the 1990s. It has over 100 years of
experience in setting science-based standards to protect and promote
the public health.
Mr. Buyer's substitute would ignore all of this expertise, would
ignore the whole record of all of the public health organizations, and
set up a new agency. And the premise of his new agency would be tobacco
harm reduction, and he showed us a chart. That chart in effect said
that what we should do is try to encourage people to reduce the harm
from tobacco by using other tobacco products.
There's no evidence to support his approach. He is basing his
assumption that current smokers will use smokeless tobacco to quit, but
there's no evidence to support this assumption. In fact, the U.S.
Public Health Service's clinical practice guidelines finds no evidence
to suggest that smokeless tobacco is effective in helping smokers quit.
Rather than have smokers quit, it's just as likely that smokeless
tobacco can be used to introduce youth to tobacco use and to discourage
smokers from quitting. I would submit that what his proposal would do
would be to do everything but get smokers to quit, and it does not
focus on getting people not to start smoking in the first place. The
only evidence one can cite for using smokeless tobacco to quit is
inadequate. It's not based on science, and I'm sure it will be a
tremendous boon to the smokeless tobacco industry.
A second major problem with the substitute is that it fails to
provide any dedicated funding for tobacco regulation. Instead, it
relies on a future appropriation that may or may not ever come along,
and then this new agency is supposed to do something to reduce smoking
in this country.
It fails to create effective Federal enforcement to prevent tobacco
sales to minors. The Buyer amendment would not punish individual retail
clerks. Instead, it would fine kids for possession rather than making
sure that they don't have access to cigarettes in the first place. The
Waxman-Platts bill would instead create a strong Federal enforcement
system to ensure that retailers do not sell to minors, while providing
adequate procedural protections for retailers.
Another flaw, it allows tobacco companies to keep targeting the kids.
One of the most critical goals of our bill is to stop tobacco industry
targeting of our children. This bill that's being offered as a
substitute does nothing to address the problem. It leaves companies
free to continue pushing their products on kids and teenagers, and I
would submit that that is not a good substitute for the bill that is
before us.
I'm also extremely concerned that it effectively exempts smokeless
tobacco products such as chewing tobacco from any oversight. It assumes
that those products are safe. Well, there's no evidence for that. It
ignores the range of harm-reduction options that pose far less risk
such as nicotine replacement therapies, which, by the way, are already
being approved as safe by the FDA, and instead, he wants to substitute
smokeless tobacco for smoking cigarettes.
The substitute fails to protect consumers from false and misleading
claims about reduced harm. It would allow tobacco companies to market
products as safer or posing less risk without providing scientific
evidence that those claims are actually true. This means that consumers
would still be vulnerable to false and misleading claims, and we know
those claims: cigarettes are light, cigarettes are low tar. Those are
the claims we've heard over the years, and they're wrong, they're
dangerous, they're misleading, and nothing would be done to stop those
kinds of claims under this substitute. Our bill would allow products to
be marketed as less hazardous only when those claims are based on sound
science and only when the health of the entire population is
considered.
And finally, the substitute gives the tobacco industry a vote in
advising the agency on scientific decisions. This flies in the face of
everything we know about the industry. Big Tobacco has shown repeatedly
that it will distort and discard scientific evidence in service of its
business objectives without regard to the public health. We don't give
drug or device manufacturers a vote in advising the FDA, and we
shouldn't do that here. Giving the tobacco industry voting
representation on a scientific advisory committee has no precedent.
I would submit you can choose between a substitute that's just been
offered only in the last month or so or you can vote for a bill that
has been reviewed by and approved by the Heart Association, the Lung
Association, the Cancer Society, the Campaign for Tobacco-Free Kids,
the American Public Health Association, the American Academy of
Pediatrics, the New England Journal of Medicine, and the AARP, just to
mention a few of the thousand groups that oppose the Buyer amendment
and support the underlying bill.
This tobacco harm-reduction act proposal is no substitute. In fact,
it seems to me that the only harm it reduces is harm to the tobacco
industry.
I urge a ``no'' vote on the Buyer substitute.
I yield back the balance of my time.
The SPEAKER pro tempore. All time for debate has expired.
Pursuant to clause 1(c) of rule XIX, further proceedings on this
measure are postponed.
____________________