In the nature of a substitute.

SA 1247. Mr. DODD proposed an amendment to the bill H.R. 1256, to
protect the public health by providing the Food and Drug Administration
with certain authority to regulate tobacco products, to amend title 5,
United States Code, to make certain modifications in the Thrift Savings
Plan, the Civil Service Retirement System, and the Federal Employees'
Retirement System, and for other purposes; as follows:

Strike all after the enacting clause and insert the
following:

DIVISION A--FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title.--This division may be cited as the
``Family Smoking Prevention and Tobacco Control Act''.
(b) Table of Contents.--The table of contents of this
division 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. Modification of deadlines for Secretarial action.

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.
Sec. 106. Studies of progress and effectiveness.

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.
(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.

[[Page S6102]]

(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 division.
(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 division are--
(1) to provide authority to the Food and Drug
Administration to regulate tobacco products under the Federal
Food, Drug, and 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 division;
(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;

[[Page S6103]]

(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 division (or an
amendment made by this division) 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
division (or an amendment made by this division) 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 division
(or an amendment made by this division) 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 division, of the amendments made
by this division, or of the regulations promulgated under
this division (or under such amendments), or the application
of any such provision to any person or circumstance is held
to be invalid, the remainder of this division, such
amendments and such regulations, and the application of such
provisions to any other person or circumstance shall not be
affected and shall continue to be enforced to the fullest
extent possible.

SEC. 6. MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION.

(a) Delayed Commencement of Dates for Secretarial Action.--
(1) In general.--Except as provided in subsection (c), with
respect to any time periods specified in this division (or in
an amendment made by this division) that begin on the date of
enactment of this Act, within which the Secretary of Health
and Human Services is required to carry out and complete
specified activities, the calculation of such time periods
shall commence on the date described in subsection (b).
(2) Limitation.--Subsection (a) shall only apply with
respect to obligations of the Secretary of Health and Human
Services that must be completed within a specified time
period and shall not apply to the obligations of any other
person or to any other provision of this division (including
the amendments made by this division) that do not create such
obligations of the Secretary and are not contingent on
actions by the Secretary.
(b) Date Described.--The date described in this subsection
is the first day of the first fiscal quarter following the
initial 2 consecutive fiscal quarters of fiscal year 2010 for
which the Secretary of Health and Human Services has
collected fees under section 919 of the Federal Food, Drug,
and Cosmetic Act (as added by section 101).
(c) Exception.--Subsection (a) shall not apply to any time
period (or date) contained--
(1) in section 102, except that the reference to ``180
days'' in subsection (a)(1) of such section shall be deemed
to be ``270 days''; and
(2) in sections 201 through 204 (or the amendments made by
any such sections).
(d) Adjustment.--The Secretary of Health and Human Services
may extend or reduce the duration of one or more time periods
to which subsection (a) applies if the Secretary determines
appropriate, except that no such period shall be extended for
more than 90 days.

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

[[Page S6104]]

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.--
``(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;

[[Page S6105]]

``(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 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 to ensure that such
statements do not violate the misbranding provisions of
subsection (a) and that such statements comply with other
provisions of the Family Smoking Prevention and Tobacco
Control Act (including the amendments made by such Act). 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.

[[Page S6106]]

``(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 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

[[Page S6107]]

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 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.

[[Page S6108]]

``(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 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

[[Page S6109]]

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.
``(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.
``(f) Dissolvable Tobacco Products.--
``(1) Referral; considerations.--The Secretary shall refer
to the Tobacco Products Scientific Advisory Committee for
report and recommendation, under section 917(c)(4), the issue
of the nature and impact of the use of dissolvable tobacco
products on the public health, including such use among
children. In its review, the Tobacco Products Scientific
Advisory Committee shall address the considerations listed in
subsection (a)(3)(B)(i).
``(2) Report and recommendation.--Not later than 2 years
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 at
any time applicable to any dissolvable tobacco product.

``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

[[Page S6110]]

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,

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

[[Page S6111]]

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 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

[[Page S6112]]

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 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

[[Page S6113]]

``(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 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

[[Page S6114]]

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 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-

[[Page S6115]]

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--
``(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

[[Page S6116]]

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, subject to paragraph (2)(D). 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 (referred
to in this subsection as `tobacco regulation activities'),
except that such fees may be used for the reimbursement
specified in subparagraph (C).
``(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 tobacco regulation activities.
``(ii) Startup costs.--Clause (i) does not apply until
October 1, 2009. Until such date, any amounts available to
the Food and Drug Administration (excluding user fees) shall
be available and allocated as needed to pay the costs of
tobacco regulation activities.
``(C) Reimbursement of start-up amounts.--
``(i) In general.--Any amounts allocated for the start-up
period pursuant to subparagraph (B)(ii) shall be reimbursed
through any appropriated fees collected under subsection (a),
in such manner as the Secretary determines appropriate to
ensure that such allocation results in no net change in the
total amount of funds otherwise available, for the period
from October 1, 2008, through September 30, 2010, for Food
and Drug Administration programs and activities (other than
tobacco regulation activities) for such period.
``(ii) Treatment of reimbursed amounts.--Amounts reimbursed
under clause (i) shall be available for the programs and
activities for which funds allocated for the start-up period
were available, prior to such allocation, until September 30,
2010, notwithstanding any otherwise applicable limits on
amounts for such programs or activities for a fiscal year.
``(D) Fee collected during start-up period.--
Notwithstanding the first sentence of paragraph (1), fees
under subsection (a) may be collected through September 30,
2009 under subparagraph (B)(ii) and shall be available for
obligation and remain available until expended. Such
offsetting collections shall be credited to the salaries and
expenses account of the Food and Drug Administration.
``(E) Obligation of start-up costs in anticipation of
available fee collections.--Notwithstanding any other
provision of law, following the enactment of an appropriation
for fees under this section for fiscal year 2010, or any
portion thereof, obligations for costs of tobacco regulation
activities during the start-up period may be incurred in
anticipation of the receipt of offsetting fee collections
through procedures specified in section 1534 of title 31,
United States Code.
``(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 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).''.
(c) Conforming Amendment.--Section 9(1) of the
Comprehensive Smokeless Tobacco Health Education Act of 1986
(15 U.S.C. 4408(i)) is amended to read as follows:
``(1) The term `smokeless tobacco' has the meaning given
such term by section 900(18) of the Federal Food, Drug, and
Cosmetic Act.''.

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
division; 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 division and the amendments made by this division;
(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) include such modifications to section 897.30(b), if
any, that the Secretary determines are appropriate in light
of governing First Amendment case law, including the decision
of the Supreme Court of the United States in Lorillard
Tobacco Co. v. Reilly (533 U.S. 525 (2001));
(F) become effective on the date that is 1 year after the
date of enactment of this Act; and
(G) 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;
``(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

[[Page S6117]]

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 division, the amendments made by this division, 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
(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 915;
``(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) Making any express or implied statement or
representation directed to consumers with respect to a
tobacco product, in a label or labeling or through the media
or advertising, that either conveys, or misleads or would
mislead consumers into believing, that--
``(1) the product is approved by the Food and Drug
Administration;
``(2) the Food and Drug Administration deems the product to
be safe for use by consumers;
``(3) the product is endorsed by the Food and Drug
Administration for use by consumers; or
``(4) the product is safe or less harmful by virtue of--
``(A) its regulation or inspection by the Food and Drug
Administration; or
``(B) its compliance with regulatory requirements set by
the Food and Drug Administration;

including any such statement or representation rendering the
product misbranded under section 903.''.
(c) Section 303.--Section 303(f) (21 U.S.C. 333(f)) is
amended--
(1) in paragraph (5)--
(A) by striking ``paragraph (1), (2), (3), or (4)'' each
place such appears and inserting ``paragraph (1), (2), (3),
(4), or (9)'';
(B) 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,'';
(C) 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
(D) by adding at the end the following:
``(D) The Secretary may compromise, modify, or terminate,
with or without conditions, any no-tobacco-sale order.'';
(2) 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
(3) by adding at the end the following:

[[Page S6118]]

``(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.
``(9) Civil Monetary Penalties for Violation of Tobacco
Product Requirements.--
``(A) In general.--Subject to subparagraph (B), any person
who violates a requirement of this Act which relates to
tobacco products shall be liable to the United States for a
civil penalty in an amount not to exceed $15,000 for each
such violation, and not to exceed $1,000,000 for all such
violations adjudicated in a single proceeding.
``(B) Enhanced penalties.--
``(i) Any person who intentionally violates a requirement
of section 902(5), 902(6), 904, 908(c), or 911(a), shall be
subject to a civil monetary penalty of--
``(I) not to exceed $250,000 per violation, and not to
exceed $1,000,000 for all such violations adjudicated in a
single proceeding; or
``(II) in the case of a violation that continues after the
Secretary provides written notice to such person, $250,000
for the first 30-day period (or any portion thereof) that the
person continues to be in violation, and such amount shall
double for every 30-day period thereafter that the violation
continues, not to exceed $1,000,000 for any 30-day period,
and not to exceed $10,000,000 for all such violations
adjudicated in a single proceeding.
``(ii) Any person who violates a requirement of section
911(g)(2)(C)(ii) or 911(i)(1), shall be subject to a civil
monetary penalty of--
``(I) not to exceed $250,000 per violation, and not to
exceed $1,000,000 for all such violations adjudicated in a
single proceeding; or
``(II) in the case of a violation that continues after the
Secretary provides written notice to such person, $250,000
for the first 30-day period (or any portion thereof) that the
person continues to be in violation, and such amount shall
double for every 30-day period thereafter that the violation
continues, not to exceed $1,000,000 for any 30-day period,
and not to exceed $10,000,000 for all such violations
adjudicated in a single proceeding.
``(iii) In determining the amount of a civil penalty under
clause (i)(II) or (ii)(II), the Secretary shall take into
consideration whether the person is making efforts toward
correcting the violation of the requirements of the section
for which such person is subject to such civil penalty.''.
(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''; and
(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--''; and
(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.''.
(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

[[Page S6119]]

(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 (3) and (4) of section 903(a) of
the Federal Food, Drug, and Cosmetic Act (as amended by this
division) shall take effect on the date that is 12 months
after the date of enactment of this Act. The package label
requirements of paragraph (2) of such section 903(a) for
cigarettes shall take effect on the date that is 15 months
after the issuance of the regulations required by section
4(d) of the Federal Cigarette Labeling and Advertising Act
(15 U.S.C. 1333), as amended by section 201 of this division.
The package label requirements of paragraph (2) of such
section 903(a) for tobacco products other than cigarettes
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 division) 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 division, or pursuant to section 102(a) of this
division, 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 division, or preserved by such entities under
section 916 of the Federal Food, Drug, and Cosmetic Act, as
added by section 101(b) of this division.
(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.

SEC. 106. STUDIES OF PROGRESS AND EFFECTIVENESS.

(a) FDA Report.--Not later than 3 years after the date of
enactment of this Act, and not less than every 2 years
thereafter, the Secretary of Health and Human Services 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
concerning--
(1) the progress of the Food and Drug Administration in
implementing this division, including major accomplishments,
objective measurements of progress, and the identification of
any areas that have not been fully implemented;
(2) impediments identified by the Food and Drug
Administration to progress in implementing this division and
to meeting statutory timeframes;
(3) data on the number of new product applications received
under section 910 of the Federal Food, Drug, and Cosmetic Act
and modified risk product applications received under section
911 of such Act, and the number of applications acted on
under each category; and
(4) data on the number of full time equivalents engaged in
implementing this division.
(b) GAO Report.--Not later than 5 years after the date of
enactment of this Act, the Comptroller General of the United
States shall conduct a study of, and submit to the Committees
described in subsection (a) a report concerning--
(1) the adequacy of the authority and resources provided to
the Secretary of Health and Human Services for this division
to carry out its goals and purposes; and
(2) any recommendations for strengthening that authority to
more effectively protect the public health with respect to
the manufacture, marketing, and distribution of tobacco
products.
(c) Public Availability.--The Secretary of Health and Human
Services and the Comptroller General of the United States,
respectively, shall make the reports required under
subsection (a) and (b) available to the public, including by
posting such reports on the respective Internet websites of
the Food and Drug Administration and the Government
Accountability Office.

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.
``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 the top 50
percent of the front and rear panels of the package. The word

[[Page S6120]]

`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).
``(d) Graphic Label Statements.--Not later than 24 months
after the date of enactment of the Family Smoking Prevention
and Tobacco Control Act, the Secretary shall issue
regulations that require color graphics depicting the
negative health consequences of smoking to accompany the
label statements specified in subsection (a)(1). The
Secretary may adjust the type size, text and format of the
label statements specified in subsections (a)(2) and (b)(2)
as the Secretary determines appropriate so that both the
graphics and the accompanying label statements are clear,
conspicuous, legible and appear within the specified area.''.
(b) Effective Date.--The amendment made by subsection (a)
shall take effect 15 months after the issuance of the
regulations required by subsection (a). 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 through
a rulemaking conducted under section 553 of title 5, United
States Code, may adjust the format, type size, color
graphics, and text of any of the label requirements, 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--

[[Page S6121]]

``(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
``(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.

[[Page S6122]]

``(4) Retailers.--This subsection applies to a retailer
only if that retailer is responsible 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 other than cigarettes for introduction or
delivery for introduction into interstate commerce in the
United States shall bear the statement `sale only allowed in
the United States'. Beginning 15 months after the issuance of
the regulations required by section 4(d) of the Federal
Cigarette Labeling and Advertising Act (15 U.S.C. 1333), as
amended by section 201 of Family Smoking Prevention and
Tobacco Control Act, the label, packaging, and shipping
containers of cigarettes 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).

DIVISION B--FEDERAL RETIREMENT REFORM ACT

SEC. 100. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title.--This division may be cited as the
``Federal Retirement Reform Act of 2009''.
(b) Table of Contents.--The table of contents for this
division is as follows:

DIVISION B--FEDERAL RETIREMENT REFORM ACT

Sec. 100. Short title; table of contents.

TITLE I--PROVISIONS RELATING TO FEDERAL EMPLOYEES RETIREMENT

Sec. 101. Short title.
Sec. 102. Automatic enrollments and immediate employing agency
contributions.
Sec. 103. Qualified Roth contribution program.
Sec. 104. Authority to establish mutual fund window.
Sec. 105. Reporting requirements.
Sec. 106. Acknowledgment of risk.
Sec. 107. Subpoena authority.
Sec. 108. Amounts in Thrift Savings Funds subject to legal proceedings.
Sec. 109. Accounts for surviving spouses.
Sec. 110. Treatment of members of the uniformed services under the
Thrift Savings Plan.

TITLE II--SPECIAL SURVIVOR INDEMNITY ALLOWANCE FOR SURVIVING SPOUSES OF
ARMED FORCES MEMBERS

Sec. 201. Increase in monthly amount of special survivor indemnity
allowance for widows and widowers of deceased members of
the Armed Forces affected by required Survivor Benefit
Plan annuity offset for dependency and indemnity
compensation.

TITLE I--PROVISIONS RELATING TO FEDERAL EMPLOYEES RETIREMENT

SEC. 101. SHORT TITLE.

This title may be cited as the ``Thrift Savings Plan
Enhancement Act of 2009''.

SEC. 102. AUTOMATIC ENROLLMENTS AND IMMEDIATE EMPLOYING
AGENCY CONTRIBUTIONS.

(a) In General.--Section 8432(b) of title 5, United States
Code, is amended by striking paragraphs (2) through (4) and
inserting the following:
``(2)(A) The Executive Director shall by regulation provide
for an eligible individual to be automatically enrolled to
make contributions under subsection (a) at the default
percentage of basic pay.
``(B) For purposes of this paragraph, the default
percentage shall be equal to 3 percent or such other
percentage, not less than 2 percent nor more than 5 percent,
as the Board may prescribe.
``(C) The regulations shall include provisions under which
any individual who would otherwise be automatically enrolled
in accordance with subparagraph (A) may--
``(i) modify the percentage or amount to be contributed
pursuant to automatic enrollment, effective not later than
the first full pay period following receipt of the election
by the appropriate processing entity; or
``(ii) decline automatic enrollment altogether.
``(D)(i) Except as provided in clause (ii), for purposes of
this paragraph, the term `eligible individual' means any
individual who, after any regulations under subparagraph (A)
first take effect, is appointed, transferred, or reappointed
to a position in which that individual becomes eligible to
contribute to the Thrift Savings Fund.

[[Page S6123]]

``(ii) Members of the uniformed services shall not be
eligible individuals for purposes of this paragraph.
``(E) Sections 8351(a)(1), 8440a(a)(1), 8440b(a)(1),
8440c(a)(1), 8440d(a)(1), and 8440e(a)(1) shall be applied in
a manner consistent with the purposes of this paragraph.''.
(b) Technical Amendment.--Section 8432(b)(1) of title 5,
United States Code, is amended by striking the parenthetical
matter in subparagraph (B).

SEC. 103. QUALIFIED ROTH CONTRIBUTION PROGRAM.

(a) In General.--Subchapter III of chapter 84 of title 5,
United States Code, is amended by inserting after section
8432c the following:

``Sec. 8432d. Qualified Roth contribution program

``(a) Definitions.--For purposes of this section--
``(1) the term `qualified Roth contribution program' means
a program described in paragraph (1) of section 402A(b) of
the Internal Revenue Code of 1986 which meets the
requirements of paragraph (2) of such section; and
``(2) the terms `designated Roth contribution' and
`elective deferral' have the meanings given such terms in
section 402A of the Internal Revenue Code of 1986.
``(b) Authority To Establish.--The Executive Director shall
by regulation provide for the inclusion in the Thrift Savings
Plan of a qualified Roth contribution program, under such
terms and conditions as the Board may prescribe.
``(c) Required Provisions.--The regulations under
subsection (b) shall include--
``(1) provisions under which an election to make designated
Roth contributions may be made--
``(A) by any individual who is eligible to make
contributions under section 8351, 8432(a), 8440a, 8440b,
8440c, 8440d, or 8440e; and
``(B) by any individual, not described in subparagraph (A),
who is otherwise eligible to make elective deferrals under
the Thrift Savings Plan;
``(2) any provisions which may, as a result of enactment of
this section, be necessary in order to clarify the meaning of
any reference to an `account' made in section 8432(f), 8433,
8434(d), 8435, 8437, or any other provision of law; and
``(3) any other provisions which may be necessary to carry
out this section.''.
(b) Clerical Amendment.--The analysis for chapter 84 of
title 5, United States Code, is amended by inserting after
the item relating to section 8432c the following:

``8432d. Qualified Roth contribution program.''.

SEC. 104. AUTHORITY TO ESTABLISH MUTUAL FUND WINDOW.

(a) In General.--Section 8438(b)(1) of title 5, United
States Code, is amended--
(1) in subparagraph (D), by striking ``and'' at the end;
(2) in subparagraph (E), by striking the period and
inserting ``; and''; and
(3) by adding after subparagraph (E) the following:
``(F) a service that enables participants to invest in
mutual funds, if the Board authorizes the mutual fund window
under paragraph (5).''.
(b) Requirements.--Section 8438(b) of title 5, United
States Code, is amended by adding at the end the following:
``(5)(A) The Board may authorize the addition of a mutual
fund window under the Thrift Savings Plan if the Board
determines that such addition would be in the best interests
of participants.
``(B) The Board shall ensure that any expenses charged for
use of the mutual fund window are borne solely by the
participants who use such window.
``(C) The Board may establish such other terms and
conditions for the mutual fund window as the Board considers
appropriate to protect the interests of participants,
including requirements relating to risk disclosure.
``(D) The Board shall consult with the Employee Thrift
Advisory Council (established under section 8473) before
authorizing the addition of a mutual fund window or
establishing a service that enables participants to invest in
mutual funds.''.
(c) Technical and Conforming Amendment.--Section 8438(d)(1)
of title 5, United States Code, is amended by inserting ``and
options'' after ``investment funds''.

SEC. 105. REPORTING REQUIREMENTS.

(a) Annual Report.--The Board shall, not later than June 30
of each year, submit to Congress an annual report on the
operations of the Thrift Savings Plan. Such report shall
include, for the prior calendar year, information on the
number of participants as of the last day of such prior
calendar year, the median balance in participants' accounts
as of such last day, demographic information on participants,
the percentage allocation of amounts among investment funds
or options, the status of the development and implementation
of the mutual fund window, the diversity demographics of any
company, investment adviser, or other entity retained to
invest and manage the assets of the Thrift Savings Fund, and
such other information as the Board considers appropriate. A
copy of each annual report under this subsection shall be
made available to the public through an Internet website.
(b) Reporting of Fees and Other Information.--
(1) In general.--The Board shall include in the periodic
statements provided to participants under section 8439(c) of
title 5, United States Code, the amount of the investment
management fees, administrative expenses, and any other fees
or expenses paid with respect to each investment fund and
option under the Thrift Savings Plan. Any such statement
shall also provide a statement notifying participants as to
how they may access the annual report described in subsection
(a), as well as any other information concerning the Thrift
Savings Plan that might be useful.
(2) Use of estimates.--For purposes of providing the
information required under this subsection, the Board may
provide a reasonable and representative estimate of any fees
or expenses described in paragraph (1) and shall indicate any
such estimate as being such an estimate. Any such estimate
shall be based on the previous year's experience.
(c) Definitions.--For purposes of this section--
(1) the term ``Board'' has the meaning given such term by
8401(5) of title 5, United States Code;
(2) the term ``participant'' has the meaning given such
term by section 8471(3) of title 5, United States Code; and
(3) the term ``account'' means an account established under
section 8439 of title 5, United States Code.

SEC. 106. ACKNOWLEDGMENT OF RISK.

(a) In General.--Section 8439(d) of title 5, United States
Code, is amended--
(1) by striking the matter after ``who elects to invest
in'' and before ``shall sign an acknowledgment'' and
inserting ``any investment fund or option under this chapter,
other than the Government Securities Investment Fund,''; and
(2) by striking ``either such Fund'' and inserting ``any
such fund or option''.
(b) Coordination With Provisions Relating to Fiduciary
Responsibilities, Liabilities, and Penalties.--Section
8477(e)(1)(C) of title 5, United States Code, is amended--
(1) by redesignating subparagraph (C) as subparagraph
(C)(i); and
(2) by adding at the end the following:
``(ii) A fiduciary shall not be liable under subparagraph
(A), and no civil action may be brought against a fiduciary--
``(I) for providing for the automatic enrollment of a
participant in accordance with section 8432(b)(2)(A);
``(II) for enrolling a participant in a default investment
fund in accordance with section 8438(c)(2); or
``(III) for allowing a participant to invest through the
mutual fund window or for establishing restrictions
applicable to participants' ability to invest through the
mutual fund window.''.

SEC. 107. SUBPOENA AUTHORITY.

(a) In General.--Chapter 84 of title 5, United States Code,
is amended by inserting after section 8479 the following:

``Sec. 8480. Subpoena authority

``(a) In order to carry out the responsibilities specified
in this subchapter and subchapter III of this chapter, the
Executive Director may issue subpoenas commanding each person
to whom the subpoena is directed to produce designated books,
documents, records, electronically stored information, or
tangible materials in the possession or control of that
individual.
``(b) Notwithstanding any Federal, State, or local law, any
person, including officers, agents, and employees, receiving
a subpoena under this section, who complies in good faith
with the subpoena and thus produces the materials sought,
shall not be liable in any court of any State or the United
States to any individual, domestic or foreign corporation or
upon a partnership or other unincorporated association for
such production.
``(c) When a person fails to obey a subpoena issued under
this section, the district court of the United States for the
district in which the investigation is conducted or in which
the person failing to obey is found, shall on proper
application issue an order directing that person to comply
with the subpoena. The court may punish as contempt any
disobedience of its order.
``(d) The Executive Director shall prescribe regulations to
carry out subsection (a).''.
(b) Technical and Conforming Amendment.--The table of
sections for chapter 84 of title 5, United States Code, is
amended by inserting after the item relating to section 8479
the following:

``8480. Subpoena authority.''.

SEC. 108. AMOUNTS IN THRIFT SAVINGS FUNDS SUBJECT TO LEGAL
PROCEEDINGS.

Section 8437(e)(3) of title 5, United States Code, is
amended in the first sentence by striking ``or relating to
the enforcement of a judgment for the physically, sexually,
or emotionally abusing a child as provided under section
8467(a)'' and inserting ``the enforcement of an order for
restitution under section 3663A of title 18, forfeiture under
section 8432(g)(5) of this title, or an obligation of the
Executive Director to make a payment to another person under
section 8467 of this title''.

SEC. 109. ACCOUNTS FOR SURVIVING SPOUSES.

Section 8433(e) of title 5, United States Code, is
amended--
(1) by inserting ``(1)'' after ``(e)''; and
(2) by adding at the end the following:
``(2) Notwithstanding section 8424(d), if an employee,
Member, former employee, or former Member dies and has
designated as sole or partial beneficiary his or her spouse
at the time of death, or, if an employee, Member, former
employee, or former Member, dies with no designated
beneficiary and

[[Page S6124]]

is survived by a spouse, the spouse may maintain the portion
of the employee's or Member's account to which the spouse is
entitled in accordance with the following terms:
``(A) Subject to the limitations of subparagraph (B), the
spouse shall have the same withdrawal options under
subsection (b) as the employee or Member were the employee or
Member living.
``(B) The spouse may not make withdrawals under subsection
(g) or (h).
``(C) The spouse may not make contributions or transfers to
the account.
``(D) The account shall be disbursed upon the death of the
surviving spouse. A beneficiary or surviving spouse of a
deceased spouse who has inherited an account is ineligible to
maintain the inherited spousal account.
``(3) The Executive Director shall prescribe regulations to
carry out this subsection.''.

SEC. 110. TREATMENT OF MEMBERS OF THE UNIFORMED SERVICES
UNDER THE THRIFT SAVINGS PLAN.

(a) Sense of Congress.--It is the sense of Congress that--
(1) members of the uniformed services should have a
retirement system that is at least as generous as the one
which is available to Federal civilian employees; and
(2) Federal civilian employees receive matching
contributions from their employing agencies for their
contributions to the Thrift Savings Fund, but the costs of
requiring such a matching contribution from the Department of
Defense could be significant.
(b) Reporting Requirement.--Not later than 180 days after
the date of the enactment of this Act, the Secretary of
Defense shall report to Congress on--
(1) the cost to the Department of Defense of providing a
matching payment with respect to contributions made to the
Thrift Savings Fund by members of the Armed Forces;
(2) the effect that requiring such a matching payment would
have on recruitment and retention; and
(3) any other information that the Secretary of Defense
considers appropriate.

TITLE II--SPECIAL SURVIVOR INDEMNITY ALLOWANCE FOR SURVIVING SPOUSES OF
ARMED FORCES MEMBERS

SEC. 201. INCREASE IN MONTHLY AMOUNT OF SPECIAL SURVIVOR
INDEMNITY ALLOWANCE FOR WIDOWS AND WIDOWERS OF
DECEASED MEMBERS OF THE ARMED FORCES AFFECTED
BY REQUIRED SURVIVOR BENEFIT PLAN ANNUITY
OFFSET FOR DEPENDENCY AND INDEMNITY
COMPENSATION.

(a) Payment Amount Per Fiscal Year.--Paragraph (2) of
section 1450(m) of title 10, United States Code, is amended--
(1) in subparagraph (E), by striking ``and'' after the
semicolon; and
(2) by striking subparagraph (F) and inserting the
following new subparagraphs:
``(F) for months during fiscal year 2014, $150;
``(G) for months during fiscal year 2015, $200;
``(H) for months during fiscal year 2016, $275; and
``(I) for months during fiscal year 2017, $310.''.
(b) Duration.--Paragraph (6) of such section is amended--
(1) by striking ``February 28, 2016'' and inserting
``September 30, 2017''; and
(2) by striking ``March 1, 2016'' both places it appears
and inserting ``October 1, 2017''.
______