In the nature of a substitute.

SA 1246. Mr. BURR (for himself and Mrs. Hagan) submitted an amendment
intended to be proposed to amendment SA 1247 proposed by Mr. Dodd 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:

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title.--This Act may be cited as the ``Preventing
Disease and Death from Tobacco Use Act''.
(b) Table of Contents.--The table of contents of this Act
is as follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.
Sec. 5. Severability.
Sec. 6. Effective date.

TITLE I--AUTHORITY OF THE TOBACCO HARM REDUCTION CENTER

Sec. 100. Definitions.
Sec. 101. Center authority over tobacco products.
Sec. 102. Exclusion of other regulatory programs.

[[Page S6079]]

Sec. 103. Existing Federal statutes maintained.
Sec. 104. Proceedings in the name of the United States; subpoenas;
preemption of State and local law; no private right of
action.
Sec. 105. Adulterated tobacco products.
Sec. 106. Misbranded tobacco products.
Sec. 107. Submission of health information to the Administrator.
Sec. 108. Registration and listing.
Sec. 109. General provisions respecting control of tobacco products.
Sec. 110. Smoking article standards.
Sec. 111. Notification and other remedies.
Sec. 112. Records and reports on tobacco products.
Sec. 113. Application for review of certain smoking articles.
Sec. 114. Reduced risk tobacco products.
Sec. 115. Judicial review.
Sec. 116. Jurisdiction of and coordination with the Federal Trade
Commission.
Sec. 117. Regulation requirement.
Sec. 118. Preservation of State and local authority.
Sec. 119. Tobacco Products Scientific Advisory Committee.
Sec. 120. Drug products used to treat tobacco dependence.

TITLE II--TOBACCO PRODUCTS WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT
DISCLOSURE

Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Smokeless tobacco labels and advertising warnings.

TITLE III--PUBLIC DISCLOSURES BY TOBACCO PRODUCTS MANUFACTURERS

Sec. 301. Disclosures on packages of tobacco products.
Sec. 302. Disclosures on packages of smokeless tobacco.
Sec. 303. Public disclosure of ingredients.

TITLE IV--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS

Sec. 401. Study and report on illicit trade.
Sec. 402. Amendment to section 1926 of the Public Health Service Act.
Sec. 403. Establishment of rankings.

TITLE V--ENFORCEMENT PROVISIONS

Sec. 501. Prohibited acts.
Sec. 502. Injunction proceedings.
Sec. 503. Penalties.
Sec. 504. Seizure.
Sec. 505. Report of minor violations.
Sec. 506. Inspection.
Sec. 507. Effect of compliance.
Sec. 508. Imports.
Sec. 509. Tobacco products for export.

TITLE VI--MISCELLANEOUS PROVISIONS

Sec. 601. Use of payments under the master settlement agreement and
individual State settlement agreements.
Sec. 602. Inspection by the alcohol and tobacco tax trade bureau of
records of certain cigarette and smokeless tobacco
sellers.
Sec. 603. Severability.

TITLE VII--TOBACCO GROWER PROTECTION

Sec. 701. Tobacco grower protection.

TITLE VIII--RESTRICTIONS ON YOUTH ACCESS TO TOBACCO PRODUCTS AND
EXPOSURE OF YOUTHS TO TOBACCO PRODUCT MARKETING AND ADVERTISING

Sec. 801. Prohibitions on youth targeting.

TITLE IX--MISCELLANEOUS PROVISIONS

Sec. 901. User fees.

SEC. 2. FINDINGS.

The Congress finds the following:
(1) Cigarette smoking is a leading cause of preventable
deaths in the United States. Cigarette smoking significantly
increases the risk of developing lung cancer, heart disease,
chronic bronchitis, emphysema and other serious diseases with
adverse health conditions.
(2) The risk for serious diseases is significantly affected
by the type of tobacco product and the frequency, duration
and manner of use.
(3) No tobacco product has been shown to be safe and
without risks. The health risks associated with cigarettes
are significantly greater than those associated with the use
of smoke-free tobacco and nicotine products.
(4) Nicotine in tobacco products is addictive but is not
considered a significant threat to health.
(5) It is the smoke inhaled from burning tobacco which
poses the most significant risk of serious diseases.
(6) Quitting cigarette smoking significantly reduces the
risk for serious diseases.
(7) Adult tobacco consumers have a right to be fully and
accurately informed about the risks of serious diseases, the
significant differences in the comparative risks of different
tobacco and nicotine-based products, and the benefits of
quitting. This information should be based on sound science.
(8) Governments, public health officials, tobacco
manufacturers and others share a responsibility to provide
adult tobacco consumers with accurate information about the
various health risks and comparative risks associated with
the use of different tobacco and nicotine products.
(9) Tobacco products should be regulated in a manner that
is designed to achieve significant and measurable reductions
in the morbidity and mortality associated with tobacco use.
Regulations should enhance the information available to adult
consumers to permit them to make informed choices, and
encourage the development of tobacco and nicotine products
with lower risks than cigarettes currently sold in the United
States.
(10) The form of regulation should be based on the risks
and comparative risks of tobacco and nicotine products and
their respective product categories.
(11) The regulation of marketing of tobacco products should
be consistent with constitutional protections and enhance an
adult consumer's ability to make an informed choice by
providing accurate information on the risks and comparative
risks of tobacco products.
(12) Reducing the diseases and deaths associated with the
use of cigarettes serves public health goals and is in the
best interest of consumers and society. Harm reduction should
be the critical element of any comprehensive public policy
surrounding the health consequences of tobacco use.
(13) Significant reductions in the harm associated with the
use of cigarettes can be achieved by providing accurate
information regarding the comparative risks of tobacco
products to adult tobacco consumers, thereby encouraging
smokers to migrate to the use of smoke-free tobacco and
nicotine products, and by developing new smoke-free tobacco
and nicotine products and other actions.
(14) Governments, public health officials, manufacturers,
tobacco producers and consumers should support the
development, production, and commercial introduction of
tobacco leaf, and tobacco and nicotine-based products that
are scientifically shown to reduce the risks associated with
the use of existing tobacco products, particularly
cigarettes.
(15) Adult tobacco consumers should have access to a range
of commercially viable tobacco and nicotine-based products.
(16) There is substantial scientific evidence that selected
smokeless tobacco products can satisfy the nicotine addiction
of inveterate smokers while eliminating most, if not all,
risk of pulmonary and cardiovascular complications of smoking
and while reducing the risk of cancer by more than 95
percent.
(17) Transitioning smokers to selected smokeless tobacco
products will eliminate environmental tobacco smoke and fire-
related hazards.
(18) Current ``abstain, quit, or die'' tobacco control
policies in the United States may have reached their maximum
possible public health benefit because of the large number of
cigarette smokers either unwilling or unable to discontinue
their addiction to nicotine.
(19) There is evidence that harm reduction works and can be
accomplished in a way that will not increase initiation or
impede smoking cessation.
(20) Health-related agencies and organizations, both within
the United States and abroad have already gone on record
endorsing Harm Reduction as an approach to further reducing
tobacco related illness and death.
(21) Current Federal policy requires tobacco product
labeling that leaves the incorrect impression that all
tobacco product present equal risk.

SEC. 3. PURPOSE.

The purposes of this Act are--
(1) to provide authority to the Tobacco Harm Reduction
Center by recognizing it as the primary Federal regulatory
authority with respect to tobacco products as provided for in
this Act;
(2) to ensure that the Center has the authority to address
issues of particular concern to public health officials,
especially the use of tobacco by young people and dependence
on tobacco;
(3) to authorize the Center to set national standards
controlling the manufacture of tobacco products and the
identity, public disclosure, and amount of ingredients used
in such products;
(4) to provide new and flexible enforcement authority to
ensure that there is effective oversight of the tobacco
industry's efforts to develop, introduce, and promote less
harmful tobacco products;
(5) to vest the Center with the authority to regulate the
levels of tar, nicotine, and other harmful components of
tobacco products;
(6) to ensure that consumers are better informed regarding
the relative risks for death and disease between categories
of tobacco products;
(7) to continue to allow the sale of tobacco products to
adults in conjunction with measures to ensure that they are
not sold or accessible to underage purchasers;
(8) to impose appropriate regulatory controls on the
tobacco industry;
(9) to promote prevention, cessation, and harm reduction
policies and regulations to reduce disease risk and the
social costs associated with tobacco-related diseases;
(10) to provide authority to the Department of Health and
Human Services to regulate tobacco products;
(11) to establish national policies that effectively reduce
disease and death associated with cigarette smoking and other
tobacco use;
(12) to establish national policies that encourage
prevention, cessation, and harm reduction measures regarding
the use of tobacco products;
(13) to encourage current cigarette smokers who will not
quit to use noncombustible tobacco or nicotine products that
have significantly less risk than cigarettes;

[[Page S6080]]

(14) to establish national policies that accurately and
consistently inform adult tobacco consumers of significant
differences in risk between respective tobacco products;
(15) to establish national policies that encourage and
assist the development and awareness of noncombustible
tobacco and nicotine products;
(16) to coordinate national and State prevention,
cessation, and harm reduction programs;
(17) to impose measures to ensure tobacco products are not
sold or accessible to underage purchasers; and
(18) to strengthen Federal and State legislation to prevent
illicit trade in tobacco products.

SEC. 4. SCOPE AND EFFECT.

(a) Intended Effect.--Nothing in this Act (or an amendment
made by this Act) shall be construed to--
(1) establish a precedent with regard to any other
industry, situation, circumstance, or legal action;
(2) affect any action pending in Federal, State, or Tribal
court, or any agreement, consent decree, or contract of any
kind; or
(3) be applicable to tobacco products or component parts
manufactured in the United States for export.
(b) Agricultural Activities.--The provisions of this Act
(or an amendment made by this Act) which authorize the
Administrator to take certain actions with regard to tobacco
and tobacco products shall not be construed to affect any
authority of the Secretary of Agriculture under existing law
regarding the growing, cultivation, or curing of raw tobacco.
(c) Revenue Activities.--The provisions of this Act (or an
amendment made by this Act) which authorize the Administrator
to take certain actions with regard to tobacco products shall
not be construed to affect any authority of the Secretary of
the Treasury under chapter 52 of the Internal Revenue Code of
1986.

SEC. 5. SEVERABILITY.

If any provision of this Act, the amendments made by this
Act, or the application of any provision of this Act to any
person or circumstance is held to be invalid, the remainder
of this Act, the amendments made by this Act, and the
application of the provisions of this Act to any other person
or circumstance shall not be affected and shall continue to
be enforced to the fullest extent possible.

SEC. 6. EFFECTIVE DATE.

Except as otherwise specifically provided, the effective
date of this Act shall be the date of its enactment.

TITLE I--AUTHORITY OF THE TOBACCO HARM REDUCTION CENTER

SEC. 100. DEFINITIONS.

In this Act:
(1) The term ``Administrator'' means the chief executive of
the Tobacco Regulatory Agency (the Agency responsible for
administering and enforcing this Act and regulations
promulgated pursuant to this Act).
(2) The term ``adult'' means any individual who has
attained the minimum age under applicable State law to be an
individual to whom tobacco products may lawfully be sold.
(3) The term ``adult-only facility'' means a facility or
restricted area, whether open-air or enclosed, where the
operator ensures, or has a reasonable basis to believe, that
no youth is present. A facility or restricted area need not
be permanently restricted to adults in order to constitute an
adult-only facility, if the operator ensures, or has a
reasonable basis to believe, that no youth is present during
any period of operation as an adult-only facility.
(4) The term ``advertising'' means a communication to the
general public by a tobacco product manufacturer,
distributor, retailer, or its agents, which identifies a
tobacco product by brand name and is intended by such
manufacturer, distributor, retailer, or its agents to promote
purchases of such tobacco product. Such term shall not
include--
(A) any advertising or other communication in any tobacco
trade publication or tobacco trade promotional material;
(B) the content of any scientific publication or
presentation, or any patent application or other
communication to the United States Patent and Trademark
Office or any similar office in any other country;
(C) any corporate or financial report or financial
communication;
(D) any communication to a lending institution or to
securities holders;
(E) any communication not intended for public display or
public exposure, except that a direct mailing or direct
electronic communication of what otherwise is advertising
shall be deemed to be advertising;
(F) any communication in, on, or within a factory, office,
plant, warehouse, or other facility related to or associated
with the development, manufacture, or storage of tobacco
products;
(G) any communication to any governmental agency, body,
official, or employee;
(H) any communication to any journalist, editor, Internet
blogger, or other author;
(I) any communication in connection with litigation,
including arbitration and like proceedings; or
(J) any editorial advertisement that addresses a public
issue.
(5) The term ``affiliate'' means a person that directly or
indirectly owns or controls, is owned or controlled by, or is
under common ownership or control with, another person. The
terms ``owns,'' ``is owned'', and ``ownership'' refer to
ownership of an equity interest, or the equivalent thereof,
of 50 percent or more.
(6) The term ``Agency'' means the Tobacco Regulatory
Agency.
(7) The term ``age-verified adult'' means any individual
who is an adult and--
(A) who has stated or acknowledged, after being asked, that
he or she is an adult and a tobacco product user, and has
presented proof of age identifying the individual and
verifying that the individual is an adult; or
(B) whose status as an adult has been verified by a
commercially available database of such information.
(8) The term ``annual report'' means a tobacco product
manufacturer's annual report to the Agency, which provides
ingredient information and nicotine yield ratings for each
brand style that tobacco product manufacturer manufactures
for commercial distribution domestically.
(9) The term ``brand name'' means a brand name of a tobacco
product distributed or sold domestically, alone, or in
conjunction with any other word, trademark, logo, symbol,
motto, selling message, recognizable pattern of colors, or
any other indicium of product identification identical or
similar to, or identifiable with, those used for any domestic
brand of tobacco product. The term shall not include the
corporate name of any tobacco product manufacturer that does
not, after the effective date of this Act, sell a brand style
of tobacco product in the United States that includes such
corporate name.
(10) The term ``brand name sponsorship'' means an athletic,
musical, artistic, or other social or cultural event, series,
or tour, with respect to which payment is made, or other
consideration is provided, in exchange for use of a brand
name or names--
(A) as part of the name of the event; or
(B) to identify, advertise, or promote such event or an
entrant, participant, or team in such event in any other way.
(11) The term ``brand style'' means a tobacco product
having a brand name, and distinguished by the selection of
the tobacco, ingredients, structural materials, format,
configuration, size, package, product descriptor, amount of
tobacco, or yield of ``tar'' or nicotine.
(12) The term ``carton'' means a container into which
packages of tobacco products are directly placed for
distribution or sale, but does not include cases intended for
shipping. Such term includes a carton containing 10 packages
of cigarettes.
(13) The term ``cartoon'' means any drawing or other
depiction of an object, person, animal, creature or any
similar caricature that satisfies any of the following
criteria:
(A) The use of comically exaggerated features.
(B) The attribution of human characteristics to animals,
plants or other objects, or the similar use of
anthropomorphic technique.
(C) The attribution of unnatural or extrahuman abilities,
such as imperviousness to pain or injury, X-ray vision,
tunneling at very high speeds, or transformation.

The term does not include any drawing or other depiction
that, on the effective date of this Act, was in use in the
United States in any tobacco product manufacturer's corporate
logo or in any tobacco product manufacturer's tobacco product
packaging.
(14) The term ``cigar'' has the meaning assigned that term
by the Alcohol and Tobacco Tax and Trade Bureau in section
40.11 of title 27, Code of Federal Regulations.
(15) The term ``cigarette'' means--
(A) any roll of tobacco wrapped in paper or in any
substance not containing tobacco; or
(B) any roll of tobacco wrapped in any substance containing
tobacco which, because of the appearance of the roll of
tobacco, the type of tobacco used in the filler, or its
package or labeling, is likely to be offered to, or purchased
by, consumers as a cigarette described in subparagraph (A).
(16) The term ``competent and reliable scientific
evidence'' means evidence based on tests, analyses, research,
or studies, conducted and evaluated in an objective manner by
individuals qualified to do so, using procedures generally
accepted in the relevant scientific disciplines to yield
accurate and reliable results.
(17) The term ``distributor'' means any person who furthers
the distribution of tobacco products, whether domestic or
imported, at any point from the original place of manufacture
to the person who sells or distributes the tobacco product to
individuals for personal consumption. Common carriers,
retailers, and those engaged solely in advertising are not
considered distributors for purposes of this Act.
(18) The terms ``domestic'' and ``domestically'' mean
within the United States, including activities within the
United States involving advertising, marketing, distribution,
or sale of tobacco products that are intended for consumption
within the United States.
(19) The term ``human image'' means any photograph,
drawing, silhouette, statue, model, video, likeness, or
depiction of the appearance of a human being, or the
appearance of any portion of the body of a human being.
(20) The term ``illicit tobacco product'' means any tobacco
product intended for use by consumers in the United States--
(A) as to which not all applicable duties or taxes have
been paid in full;

[[Page S6081]]

(B) that has been stolen, smuggled, or is otherwise
contraband;
(C) that is counterfeit; or
(D) that has or had a label, labeling, or packaging
stating, or that stated, that the product is or was for
export only, or that it is or was at any time restricted by
section 5704 of title 26, United States Code.
(21) The term ``illicit trade'' means any transfer,
distribution, or sale in interstate commerce of any illicit
tobacco product.
(22) The term ``immediate container'' does not include
package liners.
(23) The term ``Indian tribe'' has the meaning assigned
that term in section 4(e) of the Indian Self Determination
and Education Assistance Act (25 U.S.C. 450b(e)).
(24) The term ``ingredient'' means tobacco and any
substance added to tobacco to have an effect in the final
tobacco product or when the final tobacco product is used by
a consumer.
(25) The term ``International Organization for
Standardization (ISO) testing regimen'' means the methods for
measuring cigarette smoke yields, as set forth in the most
recent version of ISO 3308, entitled ``Routine analytical
cigarette-smoking machine--Definition of standard
conditions''; ISO 4387, entitled ``Cigarettes--Determination
of total and nicotine-free dry particulate matter using a
routine analytical smoking machine''; ISO 10315, entitled
``Cigarettes--Determination of nicotine in smoke
condensates--Gas-chromatographic method''; ISO 10362-1,
entitled ``Cigarettes--Determination of water in smoke
condensates--Part 1: Gas-chromatographic method''; and ISO
8454, entitled ``Cigarettes--Determination of carbon monoxide
in the vapour phase of cigarette smoke--NDIR method''. A
cigarette that does not burn down in accordance with the
testing regimen standards may be measured under the same puff
regimen using the number of puffs that such a cigarette
delivers before it extinguishes, plus an additional three
puffs, or with such other modifications as the Administrator
may approve.
(26) The term ``interstate commerce'' means all trade,
traffic, or other commerce--
(A) within the District of Columbia, or any territory or
possession of the United States;
(B) between any point in a State and any point outside
thereof;
(C) between points within the same State through any place
outside such State; or
(D) over which the United States has jurisdiction.
(27) The term ``label'' means a display of written,
printed, or graphic matter upon or applied securely to the
immediate container of a tobacco product.
(28) The term ``labeling'' means all labels and other
written, printed, or graphic matter (1) upon or applied
securely to any tobacco product or any of its containers or
wrappers, or (2) accompanying a tobacco product.
(29) The term ``little cigar'' has the meaning assigned
that term by the Alcohol and Tobacco Tax and Trade Bureau in
section 40.11 of title 27, Code of Federal Regulations.
(30) The term ``loose tobacco'' means any form of tobacco,
alone or in combination with any other ingredient or
material, that, because of its appearance, form, type,
packaging, or labeling, is suitable for use and likely to be
offered to, or purchased by, consumers as tobacco for making
or assembling cigarettes, incorporation into pipes, or
otherwise used by consumers to make any smoking article.
(31) The term ``manufacture'' means to design, manufacture,
fabricate, assemble, process, package, or repackage, label,
or relabel, import, or hold or store in a commercial
quantity, but does not include--
(A) the growing, curing, de-stemming, or aging of tobacco;
or
(B) the holding, storing or transporting of a tobacco
product by a common carrier for hire, a public warehouse, a
testing laboratory, a distributor, or a retailer.
(32) The term ``nicotine-containing product'' means a
product intended for human consumption, other than a tobacco
product, that contains added nicotine, produced and intended
to be absorbed from the skin, mouth, or nose, or inhaled as a
vapor or aerosol.
(33) The term ``outdoor advertising''--
(A) except as provided in subparagraph (B), means--
(i) billboards;
(ii) signs and placards in arenas, stadiums, shopping
malls, and video game arcades (whether any of such are open
air or enclosed), but not including any such sign or placard
located in an adult-only facility; and
(iii) any other advertisements placed outdoors; and
(B) does not include--
(i) an advertisement on the outside of a tobacco product
manufacturing facility; or
(ii) an advertisement that--

(I) is inside a retail establishment that sells tobacco
products (other than solely through a vending machine or
vending machines);
(II) is placed on the inside surface of a window facing
outward; and
(III) is no larger than 14 square feet.

(34) The term ``package'' means a pack, box, carton, pouch,
or container of any kind in which a tobacco product or
tobacco products are offered for sale, sold, or otherwise
distributed to consumers. The term ``package'' does not
include an outer container used solely for shipping one or
more packages of a tobacco product or tobacco products.
(35) The term ``person'' means any individual, partnership,
corporation, committee, association, organization or group of
persons, or other legal or business entity.
(36) The term ``proof of age'' means a driver's license or
other form of identification that is issued by a governmental
authority and includes a photograph and a date of birth of
the individual.
(37) The term ``raw tobacco'' means tobacco in a form that
is received by a tobacco product manufacturer as an
agricultural commodity, whether in a form that is--
(A) natural, stem or leaf;
(B) cured or aged; or (3)
(C) as parts or pieces, but not in a reconstituted form,
extracted pulp form, or extract form.
(38) The term ``reduced-exposure claim'' means a statement
in advertising or labeling that a tobacco product provides a
reduced exposure to one or more toxicants, as compared to an
appropriate reference tobacco product within the same
category of tobacco products. Such a statement must include
the wording ``reduction in risk has not been demonstrated for
this reduction in exposure''. A statement or representation
that a tobacco product or the tobacco in a tobacco product
contains ``no additives'' or is ``natural'' or that uses a
substantially similar term is not a reduced-exposure claim if
the advertising or labeling that contains such statement or
representation also contains the disclosure required by
section 108(h) of this Act.
(39) The term ``reduced-risk claim'' means a statement in
advertising or labeling that a tobacco product provides a
reduced risk of illness and death compared to cigarettes. A
statement or representation that a tobacco product or the
tobacco in a tobacco product contains ``no additives,'' or is
``natural,'' or that uses a substantially similar term is not
a reduced-risk claim if the advertising or labeling that
contains such statement or representation also contains the
disclosure required by section 108(h).
(40) The term ``retailer'' means any person that--
(A) sells tobacco products to individuals for personal
consumption; or
(B) operates a facility where the sale of tobacco products
to individuals for personal consumption is permitted.
(41) The term ``sample'' means a tobacco product
distributed to members of the public at no cost for the
purpose of promoting the product, but excludes tobacco
products distributed--
(A) in conjunction with the sale of other tobacco products;
(B) for market research, medical or scientific study or
testing, or teaching;
(C) to persons employed in the trade;
(D) to adult consumers in response to consumer complaints;
or
(E) to employees of the manufacturer of the tobacco
product.
(42) The term ``small business'' means a tobacco product
manufacturer that--
(A) has 150 or fewer employees; and
(B) during the 3-year period prior to the current calendar
year, had an average annual gross revenue from tobacco
products that did not exceed $40,000,000.
(43) The term ``smokeless tobacco product'' means any form
of finely cut, ground, powdered, reconstituted, processed or
shaped tobacco, leaf tobacco, or stem tobacco, whether or not
combined with any other ingredient, whether or not in extract
or extracted form, and whether or not incorporated within any
carrier or construct, that is intended to be placed in the
oral or nasal cavity, including dry snuff, moist snuff, and
chewing tobacco.
(44) The term ``smoking article'' means any tobacco-
containing article that is intended, when used by a consumer,
to be burned or otherwise to employ heat to produce a vapor,
aerosol or smoke that--
(A) incorporates components of tobacco or derived from
tobacco; and
(B) is intended to be inhaled by the user.
(45) The term ``State'' means any State of the United
States and, except as otherwise specifically provided,
includes any Indian tribe or tribal organization, the
District of Columbia, the Commonwealth of Puerto Rico, Guam,
the Virgin Islands, American Samoa, Wake Island, Midway
Island, Kingman Reef, Johnston Atoll, the Northern Marianas,
and any other trust territory or possession of the United
States.
(46) The term ``tar'' means nicotine-free dry particulate
matter as defined in ISO 4387, entitled ``Cigarettes--
Determination of total and nicotine-free dry particulate
matter using a routine analytical smoking machine''.
(47) The term ``tobacco'' means a tobacco plant or any part
of a harvested tobacco plant intended for use in the
production of a tobacco product, including leaf, lamina,
stem, or stalk, whether in green, cured, or aged form,
whether in raw, treated, or processed form, and whether or
not combined with other materials, including any by-product,
extract, extracted pulp material, or any other material
(other than purified nicotine) derived from a tobacco plant
or any component thereof, and including strip, filler, stem,
powder, and granulated, blended, or reconstituted forms of
tobacco.
(48) The term ``tobacco product'' means--
(A) the singular of ``tobacco products'' as defined in
section 5702(c) of the Internal Revenue Code of 1986;
(B) any other product that contains tobacco as a principal
ingredient and that, because of its appearance, type, or the
tobacco

[[Page S6082]]

used in the product, or its packaging and labeling, is likely
to be offered to, or purchased by, consumers as a tobacco
product as described in subparagraph (A); and
(C) any form of tobacco or any construct incorporating
tobacco, intended for human consumption, whether by--
(i) placement in the oral or nasal cavity;
(ii) inhalation of vapor, aerosol, or smoke; or
(iii) any other means.
(49) The term ``tobacco product category'' means a type of
tobacco product characterized by its composition, components,
and intended use, and includes tobacco products classified as
cigarettes, loose tobacco for roll-your-own tobacco products,
little cigars, cigars, pipe tobacco, moist snuff, dry snuff,
chewing tobacco, and other forms of tobacco products (which
are treated in this Act collectively as a single category).
(50) The term ``tobacco product communication'' means any
means, medium, or manner for providing information relating
to any tobacco product, including face-to-face interaction,
mailings by postal service or courier to an individual who is
an addressee, and electronic mail to an individual who is an
addressee.
(51) The term ``tobacco product manufacturer'' means an
entity that directly--
(A) manufactures anywhere a tobacco product that is
intended to be distributed commercially in the United States,
including a tobacco product intended to be distributed
commercially in the United States through an importer;
(B) is the first purchaser for resale in the United States
of tobacco products manufactured outside the United States
for distribution commercially in the United States; or
(C) is a successor or assign of any of the foregoing.
(52) The term ``toxicant'' means a chemical or physical
agent that produces an adverse biological effect.
(53) The term ``transit advertisements'' means advertising
on or within private or public vehicles and all
advertisements placed at, on, or within any bus stop, taxi
stand, transportation waiting area, train station, airport,
or any similar location.
(54) The term ``tribal organization'' has the meaning
assigned that term in section 4(1) of the Indian Self
Determination and Education Assistance Act (25 U.S.C.
450b(1)).
(55) The term ``United States'' means the several States,
as defined in this Act.
(56) The term ``vending machine'' means any mechanical,
electric, or electronic self-service device that, upon
insertion of money, tokens, or any other form of payment,
automatically dispenses tobacco products.
(57) The term ``video game arcade'' means an entertainment
establishment primarily consisting of video games (other than
video games intended primarily for use by adults) or pinball
machines.
(58) The term ``youth'' means any individual who in not an
adult.

SEC. 101. CENTER AUTHORITY OVER TOBACCO PRODUCTS.

(a) In General.--Tobacco products, including reduced risk
tobacco products for which an order has been issued in
accordance with section 117, shall be regulated by the
Administrator under this Act.
(b) Applicability.--This Act shall apply to all cigarettes,
cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco and to any other tobacco products that the
Administrator by regulation deems to be subject to this Act.
(c) Center.--The Secretary of Health and Human Services
shall establish within the Department of Health and Human
Services the Tobacco Harm Reduction Center. The head of the
Center shall be an Administrator, who shall assume the
statutory authority conferred by this Act, perform the
functions that relate to the subject matter of this Act, to
conduct postmarket surveillance, research, and public
education activities and have the authority to promulgate
regulations for the efficient enforcement of this Act. In
promulgating any regulations under such authority, in whole
or in part or any regulation that is likely to have an annual
effect on the economy of $50,000,000 or more or have a
material adverse effect on adult users of tobacco products,
tobacco product manufacturers, distributors, or retailers,
the Administrator shall--
(1) determine the technological and economic ability of
parties that would be required to comply with the regulation
to comply with it;
(2) consider experience gained under any relevantly similar
regulations at the Federal or State level;
(3) determine the reasonableness of the relationship
between the costs of complying with such regulation and the
public health benefits to be achieved by such regulation;
(4) determine the reasonable likelihood of measurable and
substantial reductions in morbidity and mortality among
individual tobacco users;
(5) determine the impact to United States tobacco producers
and farm operations;
(6) determine the impact on the availability and use of
tobacco products by minors; and
(7) determine the impact on illicit trade of tobacco
products.
(d) Limitation of Authority.--
(1) In general.--The provisions of this Act shall not apply
to tobacco leaf that is not in the possession of a
manufacturer of tobacco products, or to the producers of
tobacco leaf, including tobacco growers, tobacco warehouses,
and tobacco grower cooperatives, nor shall any employee of
the Center have any authority to enter onto a farm owned by a
producer of tobacco leaf without the written consent of such
producer.
(2) Exception.--Notwithstanding paragraph (1), if a
producer of tobacco leaf is also a tobacco product
manufacturer or controlled by a tobacco product manufacturer,
the producer shall be subject to this Act in the producer's
capacity as a manufacturer. The exception in this
subparagraph shall not apply to a producer of tobacco leaf
who grows tobacco under a contract with a tobacco product
manufacturer and who is not otherwise engaged in the
manufacturing process.
(3) Rule of construction.--Nothing in this Act shall be
construed to grant the Administrator authority to promulgate
regulations on any matter that involves the production of
tobacco leaf or a producer thereof.
(e) Rulemaking Procedures.--Each rulemaking under this Act
shall be in accordance with chapter 5 of title 5, United
States Code.
(f) Consultation Prior to Rulemaking.--Prior to
promulgating rules under this Act, the Administrator shall
endeavor to consult with other Federal agencies as
appropriate.

SEC. 102. EXCLUSION OF OTHER REGULATORY PROGRAMS.

(a) Exclusion of Tobacco Products and Nicotine-Containing
Products From the Federal Food, Drug, and Cosmetic Act.--No
tobacco product and no nicotine-containing product shall be
regulated as a food, drug, or device in accordance with
section 201 (f), (g) or (h) or Chapter IV or V of the Federal
Food, Drug, and Cosmetic Act, except that any tobacco product
commercially distributed domestically and any nicotine-
containing product commercially distributed domestically
shall be subject to Chapter V of the Federal Food, Drug, and
Cosmetic Act if the manufacturer or a distributor of such
product markets it with an explicit claim that the product is
intended for use in the cure, mitigation, treatment, or
prevention of disease in man or other animals, within the
meaning of section 201(g)(1)(C) or section 201(h)(2) of that
Act.
(b) Limitation on Effect of This Act.--Nothing in this Act
shall be construed to--
(1) establish a precedent with regard to any other
industry, situation, circumstance, or legal action; or
(2) affect any action pending in any Federal, State, or
Tribal court, or any agreement, consent decree, or contract
of any kind.
(c) Exclusions From Authority of Administrator.--The
authority granted to the Administrator under this Act shall
not apply to--
(1) raw tobacco that is not in the possession or control of
a tobacco product manufacturer;
(2) raw tobacco that is grown for a tobacco product
manufacturer by a grower, and that is in the possession of
that grower or of a person that is not a tobacco product
manufacturer and is within the scope of subparagraphs (A)
through(F) of paragraph (3); or
(3) the activities, materials, facilities, or practices of
persons that are not tobacco product manufacturers and that
are--
(A) producers of raw tobacco, including tobacco growers;
(B) tobacco warehouses, and other persons that receive raw
tobacco from growers;
(C) tobacco grower cooperatives;
(D) persons that cure raw tobacco;
(E) persons that process raw tobacco; and
(F) persons that store raw tobacco for aging.

If a producer of raw tobacco is also a tobacco product
manufacturer, an affiliate of a tobacco product manufacturer,
or a person producing raw tobacco for a tobacco product
manufacturer, then that producer shall be subject to this Act
only to the extent of that producer's capacity as a tobacco
product manufacturer.

SEC. 103. EXISTING FEDERAL STATUTES MAINTAINED.

Except as amended or repealed by this Act, all Federal
statutes in effect as of the effective date of this Act that
regulate tobacco, tobacco products, or tobacco product
manufacturers shall remain in full force and effect. Such
statutes include, without limitation--
(1) the Federal Cigarette Labeling and Advertising Act,
sections 1331-1340 of title 15, United States Code, except
that section 1335 of title 15, United States Code, is
repealed;
(2) the Comprehensive Smokeless Tobacco Health Education
Act of 1986, sections 4401-4408 of title 15, United States
Code, except that section 4402(f) of title 15, United States
Code, is repealed;
(3) section 300x-26 of title 42, United States Code; and
(4) those statutes authorizing regulation of tobacco,
tobacco products, or tobacco product manufacturers by the
Federal Trade Commission, the Department of Agriculture, the
Environmental Protection Agency, the Internal Revenue
Service, and the Alcohol and Tobacco Tax and Trade Bureau of
the Department of the Treasury.

SEC. 104. PROCEEDINGS IN THE NAME OF THE UNITED STATES;
SUBPOENAS; PREEMPTION OF STATE AND LOCAL LAW;
NO PRIVATE RIGHT OF ACTION.

In furtherance of this Act:
(1) All proceedings for the enforcement, or to restrain
violations, of this Act shall be by and in the name of the
United States. Subpoenas for witnesses who are required to
attend a court of the United States, in any district, may run
into any other district in any

[[Page S6083]]

proceeding under this section. No State, or political
subdivision thereof, may proceed or intervene in any Federal
or State court under this Act or under any regulation
promulgated under it, or allege any violation thereof except
a violation by the Administrator. Nothing in this Act shall
be construed to create a right of action by any private
person for any violation of any provision of this Act or of
any regulation promulgated under it.
(2) With respect to any subject matter addressed by this
Act or by any regulation promulgated under it, no requirement
or prohibition shall be imposed under State or local law upon
any tobacco product manufacturer or distributor.
(3) Paragraph (2) shall not apply to any requirement or
prohibition imposed under State or local law before the date
of introduction of the bill that was enacted as this Act.

SEC. 105. ADULTERATED TOBACCO PRODUCTS.

A tobacco product shall be deemed to be adulterated--
(1) if it bears or contains any poisonous or deleterious
substance other than--
(A) tobacco;
(B) a substance naturally present in tobacco;
(C) a pesticide or fungicide chemical residue in or on
tobacco if such pesticide or fungicide chemical is registered
by the Environmental Protection Agency for use on tobacco in
the United States; or
(D) in the case of imported tobacco, a residue of a
pesticide or fungicide chemical that--
(i) is approved for use in the country of origin of the
tobacco; and
(ii) has not been banned, and the registration of which has
not been canceled, by the Environmental Protection Agency for
use on tobacco in the United States) that may render it
injurious to health; but, in case the substance is not an
added substance, such tobacco product shall not be considered
adulterated under this subsection if the quantity of such
substance in such tobacco product does not ordinarily render
it injurious to health;
(2) if there is significant scientific agreement that, as a
result of the tobacco it contains, the tobacco product
presents a risk to human health that is materially higher
than the risk presented by--
(A) such product on the effective date of this Act; or
(B) if such product was not distributed commercially
domestically on that date, by comparable tobacco products of
the same style and within the same category that were
commercially distributed domestically on that date;
(3) if it has been prepared, packed, or held under
unsanitary conditions whereby it may have become contaminated
with filth;
(4) if its package is composed, in whole or in part, of any
poisonous or deleterious substance that may render the
contents injurious to health; or
(5) if its ``tar'' yield is in violation of section 111.

SEC. 106. MISBRANDED TOBACCO PRODUCTS.

A tobacco product shall be deemed to be misbranded--
(1) if its labeling is false or misleading in any
particular;
(2) if in package form unless it bears a label containing--
(A) an identification of the type of product it is, by the
common or usual name of such type of product;
(B) an accurate statement of the quantity of the contents
in the package in terms of weight, measure, or numerical
count, except that reasonable variations shall be permitted,
and exemptions as to small packages shall be established by
regulations promulgated by the Administrator;
(C) the name and place of business of the tobacco product
manufacturer, packer, or distributor; and
(D) the information required by section 201(c) and (e) or
section 202(c) and (e), as applicable;
(3) if any word, statement, or other information required
by or under authority of this Act to appear on the label,
labeling, or advertising is not prominently placed thereon
with such conspicuousness (as compared with other words,
statements, or designs on the label, labeling, or
advertising, as applicable) and in such terms as to render it
reasonably likely to be read and understood by the ordinary
individual under customary conditions of purchase and use;
(4) if any word, statement, or other information is
required by or under this Act to appear on the label, unless
such word, statement, or other information also appears on
the outside container or wrapper, if any, of the retail
package of such tobacco product, or is easily legible through
the outside container or wrapper;
(5) if it was manufactured, prepared, or processed in an
establishment not duly registered under section 109, if it
was not included in a list required by section 109, or if a
notice or other information respecting it was not provided as
required by section 109;
(6) if its packaging, labeling, or advertising is in
violation of this Act or of an applicable regulation
promulgated in accordance with this Act;
(7) if it contains tobacco or another ingredient as to
which a required disclosure under this Act was not made;
(8) if it is labeled or advertised, or the tobacco
contained in it is advertised, as--
(A) containing ``no additives,'' or any substantially
similar term, unless the labeling or advertising, as
applicable, also contains, clearly and prominently, the
following disclosure: ``No additives in our tobacco does NOT
mean safer.''; or
(B) being ``natural,'' or any substantially similar term,
unless the labeling or advertising, as applicable, also
contains, clearly and prominently, the following disclosure:
``Natural does NOT mean safer.'';
(9) if in its labeling or advertising a term descriptive of
the tobacco in the tobacco product is used otherwise than in
accordance with a sanction or approval granted by a Federal
agency;
(10) if with respect to such tobacco product a disclosure
required by section 603 was not made;
(11) if with respect to such tobacco product a
certification required by section 803 was not submitted or is
materially false or misleading; or
(12) if its manufacturer or distributor made with respect
to it a claim prohibited by section 115.

SEC. 107. SUBMISSION OF HEALTH INFORMATION TO THE
ADMINISTRATOR.

(a) Requirement.--Each tobacco product manufacturer or
importer, or agents thereof, shall submit to the
Administrator the following information:
(1) Not later than 18 months after the date of enactment of
the Act, a listing of all ingredients, including tobacco,
substances, compounds, and additives that are, as of such
date, added by the manufacturer to the tobacco, paper,
filter, or other part of each tobacco product by brand and by
quantity in each brand and brand style.
(2) A description of the content, delivery, and form of
nicotine in each tobacco product measured in milligrams of
nicotine in accordance with regulations promulgated by the
Administrator in accordance with section 4(e) of the Federal
Cigarette Labeling and Advertising Act.
(3) Beginning 4 years after the date of enactment of this
Act, a listing of all constituents, including smoke
constituents as applicable, identified by the Administrator
as harmful to health in each tobacco product, and as
applicable in the smoke of each tobacco product, by brand and
by quantity in each brand and subbrand.
(b) Data Submission.--At the request of the Administrator,
each tobacco product manufacturer or importer of tobacco
products, or agents thereof, shall submit the following:
(1) Any or all documents (including underlying scientific
information) relating to research activities, and research
findings, conducted, supported, or possessed by the
manufacturer (or agents thereof) on the health,
toxicological, or physiologic effects of tobacco products and
their constituents (including smoke constituents),
ingredients, components, and additives.
(2) Any or all documents (including underlying scientific
information) relating to research activities, and research
findings, conducted, supported, or possessed by the
manufacturer (or agents thereof) that relate to the issue of
whether a significant reduction in risk to health from
tobacco products can occur upon the employment of technology
available to the manufacturer.

An importer of a tobacco product not manufactured in the
United States shall supply the information required of a
tobacco product manufacturer under this subsection.
(c) Data List.--
(1) In general.--Not later than 4 years after the date of
enactment of the Act, and annually thereafter, the
Administrator shall publish in a format that is
understandable and not misleading to a lay person, and place
on public display (in a manner determined by the
Administrator) the list established under subsection (d).
(2) Consumer research.--The Administrator shall conduct
periodic consumer research to ensure that the list published
under paragraph (1) is not misleading to lay persons. Not
later than 5 years after the date of enactment of the Act,
the Administrator shall submit to the appropriate committees
of Congress a report on the results of such research,
together with recommendations on whether such publication
should be continued or modified.
(d) Data Collection.--Not later than 36 months after the
date of enactment of this Act, the Administrator shall
establish, and periodically revise as appropriate, a list of
harmful constituents, including smoke constituents, to health
in each tobacco product by brand and by quantity in each
brand and subbrand.

SEC. 108. REGISTRATION AND LISTING.

(a) Definitions.--As used in this section:
(1) The term ``manufacture, preparation, or processing''
shall include repackaging or otherwise changing the
container, wrapper, or label of any tobacco product package
other than the carton in furtherance of the distribution of
the tobacco product from the original place of manufacture to
the person that makes final delivery or sale to the ultimate
consumer or user, but shall not include the addition of a tax
marking or other marking required by law to an already
packaged tobacco product.
(2) The term ``name'' shall include in the case of a
partnership the name of the general partner and, in the case
of a privately held corporation, the name of the chief
executive officer of the corporation and the State of
incorporation.
(b) Annual Registration.--Commencing one year after
enactment, on or before December 31 of each year, every
person that

[[Page S6084]]

owns or operates any establishment in any State engaged in
the manufacture, preparation, or processing of a tobacco
product or products for commercial distribution domestically
shall register with the Administrator its name, places of
business, and all such establishments.
(c) New Producers.--Every person upon first engaging, for
commercial distribution domestically, in the manufacture,
preparation, or processing of a tobacco product or products
in any establishment that it owns or operates in any State
shall immediately register with the Administrator its name,
places of business, and such establishment.
(d) Registration of Foreign Establishments.--
(1) Commencing one year after enactment of this Act, on or
before December 31 of each year, the person that, within any
foreign country, owns or operates any establishment engaged
in the manufacture, preparation, or processing of a tobacco
product that is imported or offered for import into the
United States shall, through electronic means or other means
permitted by the Administrator, register with the
Administrator the name and place of business of each such
establishment, the name of the United States agent for the
establishment, and the name of each importer of such tobacco
product in the United States that is known to such person.
(2) Such person also shall provide the information required
by subsection (j), including sales made by mail, or through
the Internet, or other electronic means.
(3) The Administrator is authorized to enter into
cooperative arrangements with officials of foreign countries
to ensure that adequate and effective means are available for
purposes of determining, from time to time, whether tobacco
products manufactured, prepared, or processed by an
establishment described in paragraph (1), if imported or
offered for import into the United States, shall be refused
admission on any of the grounds set forth in section 708.
(e) Additional Establishments.--Every person duly
registered in accordance with the foregoing subsections of
this section shall immediately register with the
Administrator any additional establishment that it owns or
operates and in which it begins the manufacture, preparation,
or processing of a tobacco product or products for commercial
distribution domestically or for import into the United
States.
(f) Exclusions From Application of This Section.--The
foregoing subsections of this section shall not apply to--
(1) persons that manufacture, prepare, or process tobacco
products solely for use in research, teaching, chemical or
biological analysis, or export; or
(2) such other classes of persons as the Administrator may
by regulation exempt from the application of this section
upon a finding that registration by such classes of persons
in accordance with this section is not necessary for the
protection of the public health.
(g) Inspection of Premises.--Every establishment registered
with the Administrator pursuant to this section shall be
subject to inspection pursuant to section 706; and every such
establishment engaged in the manufacture, preparation, or
processing of a tobacco product or products shall be so
inspected by one or more officers or employees duly
designated by the Administrator at least once in the two-year
period beginning with the date of registration of such
establishment pursuant to this section and at least once in
every successive two-year period thereafter, except that
inspection of establishments outside the United States may be
conducted by other personnel pursuant to a cooperative
arrangement under subsection (d)(3).
(h) Filing of Lists of Tobacco Products Manufactured,
Prepared, or Processed by Registrants; Statements;
Accompanying Disclosures.--
(1) Every person that registers with the Administrator
under subsection (b), (c), (d), or (e) shall, at the time of
registration under any such subsection, file with the
Administrator a list of all brand styles (with each brand
style in each list listed by the common or usual name of the
tobacco product category to which it belongs and by any
proprietary name) that are being manufactured, prepared, or
processed by such person for commercial distribution
domestically or for import into the United States, and that
such person has not included in any list of tobacco products
filed by such person with the Administrator under this
paragraph or paragraph (2) before such time of registration.
Such list shall be prepared in such form and manner as the
Administrator may prescribe, and shall be accompanied by the
label for each such brand style and a representative sampling
of any other labeling and advertising for each;
(2) Each person that registers with the Administrator under
this section shall report to the Administrator each August
for the preceding six-month period from January through June,
and each February for the preceding six-month period form
July through December, following information:
(A) A list of each brand style introduced by the registrant
for commercial distribution domestically or for import into
the United States that has not been included in any list
previously filed by such registrant with the Administrator
under this subparagraph or paragraph (1). A list under this
subparagraph shall list a brand style by the common or usual
name of the tobacco product category to which it belongs and
by any proprietary name, and shall be accompanied by the
other information required by paragraph (1).
(B) If since the date the registrant last made a report
under this paragraph (or if such registrant has not
previously made a report under this paragraph, since the
effective date of this Act) such registrant has discontinued
the manufacture, preparation, or processing for commercial
distribution domestically or for import into the United
States of a brand style included in a list filed by such
registrant under subparagraph (A) or paragraph (1), notice of
such discontinuance, the date of such discontinuance, and the
identity (by the common or usual name of the tobacco product
category to which it belongs and by any proprietary name) of
such tobacco product.
(C) If, since the date the registrant reported pursuant to
subparagraph (B) a notice of discontinuance of a tobacco
product, the registrant has resumed the manufacture,
preparation, or processing for commercial distribution
domestically or for import into the United States of that
brand style, notice of such resumption, the date of such
resumption, the identity of such brand style (by the common
or usual name of the tobacco product category to which it
belongs and by any proprietary name), and the other
information required by paragraph (1), unless the registrant
has previously reported such resumption to the Administrator
pursuant to this subparagraph.
(D) Any material change in any information previously
submitted pursuant to this paragraph (2) or paragraph (1).
(i) Electronic Registration.--Registrations under
subsections (b), (c), (d), and (e) (including the submission
of updated information) shall be submitted to the
Administrator by electronic means, unless the Administrator
grants a request for waiver of such requirement because use
of electronic means is not reasonable for the person
requesting such waiver.

SEC. 109. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO
PRODUCTS.

(a) In General.--Any requirement established by or under
section 106, 107, or 113 applicable to a tobacco product
shall apply to such tobacco product until the applicability
of the requirement to the tobacco product has been changed by
action taken under section 111, section 114, section 115, or
subsection (d) of this section, and any requirement
established by or under section 106, 107, or 113 which is
inconsistent with a requirement imposed on such tobacco
product under section 111, section 114, section 115, or
subsection (d) of this section shall not apply to such
tobacco product.
(b) Information on Public Access and Comment.--Each notice
of proposed rulemaking or other notification under section
111, 112, 113, 114, or 115 or under this section, any other
notice which is published in the Federal Register with
respect to any other action taken under any such section and
which states the reasons for such action, and each
publication of findings required to be made in connection
with rulemaking under any such section shall set forth--
(1) the manner in which interested persons may examine data
and other information on which the notice or findings is
based; and
(2) the period within which interested persons may present
their comments on the notice or findings (including the need
therefore) orally or in writing, which period shall be at
least 60 days but may not exceed 90 days unless the time is
extended by the Administrator by a notice published in the
Federal Register stating good cause therefore.
(c) Limited Confidentiality of Information.--Any
information reported to or otherwise obtained by the
Administrator or the Administrator's representative under
section 107, 108, 111, 112, 113, 114, 115, or 504, or under
subsection (e) or (f) of this section, which is exempt from
disclosure under subsection (a) of section 552 of title 5,
United States Code, by reason of subsection (b)(4) of that
section shall be considered confidential and shall not be
disclosed, except that the information may be disclosed to
other officers or employees concerned with carrying out this
Act, or when relevant in any proceeding under this Act.
(d) Restrictions.--
(1) In general.--The Administrator may issue regulations,
consistent with this Act, regarding tobacco products if the
Administrator determines that such regulation would be
appropriate for the protection of the public health. The
finding as to whether such regulation would be appropriate
for the protection of the public health shall be determined
with respect to the risks and benefits to the users of the
tobacco product, and taking into account that the standard is
reasonably likely to result in measurable and substantial
reductions in morbidly and mortality among individual tobacco
users.
(2) Label statements.--The label of a tobacco product shall
bear such appropriate statements of the restrictions required
by a regulation under subsection (a) as the Administrator may
in such regulation prescribe.
(e) Good Manufacturing Practice Requirements.--
(1) Methods, facilities, and controls to conform.--
(A) In general.--In applying manufacturing restrictions to
tobacco, the Administrator shall, in accordance with
subparagraph (B), prescribe regulations (which may differ
based on the type of tobacco product involved) requiring that
the methods used in, and the facilities and controls used
for, the

[[Page S6085]]

manufacture, preproduction design validation (including a
process to assess the performance of a tobacco product),
packing, and storage of a tobacco product conform to current
good manufacturing practice, or hazard analysis and critical
control point methodology, as prescribed in such regulations
to assure that the public health is protected and that the
tobacco product is in compliance with this Act. Such
regulations may provide for the testing of raw tobacco for
pesticide chemical residues after a tolerance for such
chemical residues has been established.
(B) Requirements.--The Administrator shall--
(i) before promulgating any regulation under subparagraph
(A), afford the Tobacco Products Scientific Advisory
Committee an opportunity to submit recommendations with
respect to the regulation proposed to be promulgated;
(ii) before promulgating any regulation under subparagraph
(A), afford opportunity for an oral hearing;
(iii) provide the Tobacco Products Scientific Advisory
Committee a reasonable time to make its recommendation with
respect to proposed regulations under subparagraph (A); and
(iv) in establishing the effective date of a regulation
promulgated under this subsection, take into account the
differences in the manner in which the different types of
tobacco products have historically been produced, the
financial resources of the different tobacco product
manufacturers, and the state of their existing manufacturing
facilities, and shall provide for a reasonable period of time
for such manufacturers to conform to good manufacturing
practices but no earlier than four years from date of
enactment.
(C) Additional special rule.--A tobacco product
manufactured in or imported into the United States shall not
contain foreign-grown flue-cured or burley tobacco that--
(i) was knowingly grown or processed using a pesticide
chemical that is not approved under applicable Federal law
for use in domestic tobacco farming and processing; or
(ii) in the case of a pesticide chemical that is so
approved, was grown or processed using the pesticide chemical
in a manner inconsistent with the approved labeling for use
of the pesticide chemical in domestic tobacco farming and
processing.
(D) Exclusion.--Subparagraph (C)(ii) shall not apply to
tobacco products manufactured with foreign-grown flue-cured
or burley tobacco so long as that foreign grown tobacco was
either--
(i) in the inventory of a manufacturer prior to the
effective date, or
(ii) planted by the farmer prior to the effective date of
this Act and utilized by the manufacturer no later than 3
years after the effective date.
(E) Setting of maximum residue limits.--The Administrator
shall adopt the following pesticide residue standards:
Pesticide residue standards
The maximum concentration of residues of the following
pesticides allowed in flue-cured or burley tobacco, expressed
as parts by weight of the residue per one million parts by
weight of the tobacco (PPM) are:
CHLORDANE.....3.0
DIBROMOCHLOROPROPANE (DBCP).....1.0
DICAMBA (Temporary).... 5.0
ENDRIN....0.1
ETHYLENE DIBROMIDE (EDB)....0.1
FORMOTHION.....0.5
HEXACHLOROBENZENE (HCB)....0.1
METHOXYCHLOR.....0.1
TOXAPHENE.....0.3
2,4-D (Temporary).....5.0
2,4,5-T.....0.1
Sum of ALDRIN and DIELDRIN.....0.1
Sum of CYPERMETHRIN and PERMETHRIN (Temporary).....3.0
Sum of DDT, TDE (DDD), and DDE .....0.4
Sum of HEPTACHLOR and HEPTACHLOR EPOXIDE.....0.1
(F) Maximum residue limits.--The Administrator shall adopt
regulations within one year of the effective date of this Act
to establish maximum residue limits for pesticides identified
under subparagraph (E) but not included in the table of such
subparagraph to account for the fact that weather and
agronomic conditions will cause pesticides identified in
subparagraph (E) to be detected in foreign-grown tobacco even
where the farmer has not knowingly added such pesticide.
(2) Exemptions; variances.--
(A) Petition.--Any person subject to any requirement
prescribed under paragraph (1) may petition the Administrator
for a permanent or temporary exemption or variance from such
requirement. Such a petition shall be submitted to the
Administrator in such form and manner as the Administrator
shall prescribe and shall--
(i) in the case of a petition for an exemption from a
requirement, set forth the basis for the petitioner's
determination that compliance with the requirement is not
required to assure that the tobacco product will be in
compliance with this Act;
(ii) in the case of a petition for a variance from a
requirement, set forth the methods proposed to be used in,
and the facilities and controls proposed to be used for, the
manufacture, packing, and storage of the tobacco product in
lieu of the methods, facilities, and controls prescribed by
the requirement; and
(iii) contain such other information as the Administrator
shall prescribe.
(B) Referral to the tobacco products scientific advisory
committee.--The Administrator may refer to the Tobacco
Products Scientific Advisory Committee any petition submitted
under subparagraph (A). The Tobacco Products Scientific
Advisory Committee shall report its recommendations to the
Administrator with respect to a petition referred to it
within 60 days after the date of the petition's referral.
Within 60 days after--
(i) the date the petition was submitted to the
Administrator under subparagraph (A); or
(ii) the day after the petition was referred to the Tobacco
Products Scientific Advisory Committee,
whichever occurs later, the Administrator shall by order
either deny the petition or approve it.
(C) Approval.--The Administrator may approve--
(i) a petition for an exemption for a tobacco product from
a requirement if the Administrator determines that compliance
with such requirement is not required to assure that the
tobacco product will be in compliance with this Act; and
(ii) a petition for a variance for a tobacco product from a
requirement if the Administrator determines that the methods
to be used in, and the facilities and controls to be used
for, the manufacture, packing, and storage of the tobacco
product in lieu of the methods, facilities, and controls
prescribed by the requirement are sufficient to assure that
the tobacco product will be in compliance with this Act.
(D) Conditions.--An order of the Administrator approving a
petition for a variance shall prescribe such conditions
respecting the methods used in, and the facilities and
controls used for, the manufacture, packing, and storage of
the tobacco product to be granted the variance under the
petition as may be necessary to assure that the tobacco
product will be in compliance with this Act.
(E) Hearing.--After the issuance of an order under
subparagraph (B) respecting a petition, the petitioner shall
have an opportunity for an informal hearing on such order.
(3) Compliance.--Compliance with requirements under this
subsection shall not be required before the end of the 3-year
period following the date of enactment of this Act.
(f) Research and Development.--The Administrator may enter
into contracts for research, testing, and demonstrations
respecting tobacco products and may obtain tobacco products
for research, testing, and demonstration purposes.

SEC. 110. SMOKING ARTICLE STANDARDS.

(a) In General.--
(1) Restrictions on descriptors used in marketing of
cigarettes.--
(A) In general.--Except as provided in subparagraph (B), no
person shall use, with respect to any cigarette brand style
commercially distributed domestically, on the portion of the
package of such cigarette brand style that customarily is
visible to consumers before purchase, or in advertising of
such cigarette brand style any of the following as a
descriptor of any cigarette brand style--
(i) the name of any candy or fruit;
(ii) the word ``candy,'' ``citrus,'' ``cream,'' ``fruit,''
``sugar,'' ``sweet,'' ``tangy,'' or ``tart,''; or
(iii) any extension or variation of any of the words
``candy,'' ``citrus,'' ``cream,'' ``fruit,'' ``sugar,''
``sweet,'' ``tangy,'' or ``tart,'' including but not limited
to ``creamy,'' or ``fruity.''
(B) Limitation.--Subparagraph (A) shall not apply to the
use of the following words or to any extension or variation
of any of them: ``clove'' and ``menthol''.
(C) Scented materials.--No person shall use, in the
advertising or labeling of any cigarette commercially
distributed domestically, any scented materials, except in an
adult-only facility.
(D) Definitions.--In this section:
(i) The term ``candy'' means a confection made from sugar
or sugar substitute, including any confection identified
generically or by brand, and shall include the words
``cacao,'' ``chocolate,'' ``cinnamon,'' ``cocoa,'' ``honey,''
``licorice,'' ``maple,'' ``mocha,'' and ``vanilla.''
(ii) The term ``fruit'' means any fruit identified by
generic name, type, or variety, including but not limited to
``apple,'' ``banana,'' ``cherry,'' and ``orange.'' The term
``fruit'' does not include words that identify seeds, nuts or
peppers, or types or varieties thereof or words that are
extensions or variations of such words.
(2) Smoking article standards.--
(A) In general.--The Administrator may adopt smoking
article standards in addition to those in paragraph (1) if
the Administrator finds that a smoking article standard is
appropriate for the protection of the public health.
(B) Determinations.--
(i) Considerations.--In making a finding described in
subparagraph (A), the Administrator shall consider scientific
evidence concerning--

(I) the risks and benefits to the users of smoking articles
of the proposed standard; and
(II) that the standard is reasonably likely to result in
measurable and substantial reductions in morbidity and
mortality among individual tobacco users.

(ii) Additional considerations.--In the event that the
Administrator makes a determination, set forth in a proposed
smoking article standard in a proposed rule, that it is

[[Page S6086]]

appropriate for the protection of public health to require
the reduction or elimination of an additive, constituent
(including a smoke constituent), or other component of a
smoking article because the Administrator has found that the
additive, constituent, or other component is harmful, any
party objecting to the proposed standard on the ground that
the proposed standard will not reduce or eliminate the risk
of illness or injury may provide for the Administrator's
consideration scientific evidence that demonstrates that the
proposed standard will not reduce or eliminate the risk of
illness or injury.
(3) Content of smoking article standards.--A smoking
article standard established under this section for a smoking
article--
(A) may include provisions that are appropriate for the
protection of the public health, including provisions, where
appropriate--
(i) for ``tar'' and nicotine yields of the product;
(ii) for the reduction of other constituents, including
smoke constituents, or harmful components of the product; or
(iii) relating to any other requirement under subparagraph
(B); and
(B) may, where appropriate for the protection of the public
health, include--
(i) provisions respecting the construction, components,
ingredients, additives, constituents, including smoke
constituents, and properties of the smoking article;
(ii) provisions for the testing (on a sample basis or, if
necessary, on an individual basis) of the smoking article;
(iii) provisions for the measurement of the smoking article
characteristics of the smoking article; and
(iv) provisions requiring that the results of each or of
certain of the tests of the smoking article required to be
made under clause (ii) show that the smoking article is in
conformity with the portions of the standard for which the
test or tests were required.
(4) Periodic reevaluation of smoking article standards.--
The Administrator may provide for periodic evaluation of
smoking article standards established under this section to
determine whether such standards should be changed to reflect
new medical, scientific, or other technological data.
(5) Cigarette ``tar'' limits.--
(A) No increase in ``tar'' yields.--No cigarette
manufacturer shall distribute for sale domestically a brand
style of cigarettes that generates a ``tar'' yield greater
than the ``tar'' yield of that brand style of cigarettes on
the date of introduction of this Act, as determined by the
ISO smoking regimen and its associated tolerances. The
``tar'' tolerances for cigarettes with ISO ``tar'' yields in
the range of 1 to 20 milligrams per cigarette, based on
variations arising from sampling procedure, test method, and
sampled product, itself, are the greater of plus or minus--
(i) 15 percent; or
(ii) 1 milligram per cigarette.
(B) Limit on new cigarettes.--After the effective date of
this Act, no cigarette manufacturer shall manufacture for
commercial distribution domestically a brand style of
cigarettes that both--
(i) was not in commercial distribution domestically on the
effective date of this Act, and
(ii) generates a ``tar'' yield of greater than 20
milligrams per cigarette as determined by the ISO smoking
regimen and its associated tolerances.
(C) Limit on all cigarettes.--After December 31, 2010, no
cigarette manufacturer shall manufacture for commercial
distribution domestically a brand style of cigarettes that
generates a ``tar'' yield greater than 20 milligrams per
cigarette as determined by the ISO smoking regimen and its
associated tolerances.
(D) Review by administrator.--After the effective date of
this Act, the Administrator shall evaluate the available
scientific evidence addressing the potential relationship
between historical ``tar'' yield values and risk of harm to
smokers. If upon a review of that evidence, and after
consultation with technical experts of the Tobacco Harm
Reduction Center and the Centers for Disease Control and
Prevention and notice and an opportunity for public comment,
the Administrator determines, that a reduction in ``tar''
yield may reasonably be expected to provide a meaningful
reduction of the risk or risks of harm to smokers, the
Administrator shall issue an order that--
(i) provides that no cigarette manufacturer shall
manufacture for commercial distribution domestically a
cigarette that generates a ``tar'' yield that exceeds 14
milligrams as determined by the ISO smoking regimen and its
associated tolerances; and
(ii) provides a reasonable time for manufacturers to come
into compliance with such prohibition.
(6) Involvement of other agencies; informed persons.--In
carrying out duties under this section, the Administrator
shall endeavor to--
(A) use personnel, facilities, and other technical support
available in other Federal agencies;
(B) consult with other Federal agencies concerned with
standard setting and other nationally or internationally
recognized standard-setting entities; and
(C) invite appropriate participation, through joint or
other conferences, workshops, or other means, by informed
persons representative of scientific, professional, industry,
agricultural, or consumer organizations who in the
Administrator's judgment can make a significant contribution.
(b) Considerations by Administrator.--
(1) Technical achievability.--The Administrator shall
consider information submitted in connection with a proposed
standard regarding the technical achievability of compliance
with such standard.
(2) Other considerations.--The Administrator shall consider
all other information submitted in connection with a proposed
standard, such as the creation of a significant demand for
contraband or other tobacco products that do not meet the
requirements of this Act and the significance of such demand.
(c) Proposed Standards.--
(1) In general.--The Administrator shall publish in the
Federal Register a notice of proposed rulemaking for the
establishment, amendment, or revocation of any smoking
article standard.
(2) Requirements of notice.--A notice of proposed
rulemaking for the establishment or amendment of a smoking
article standard shall--
(A) set forth a finding with supporting justification that
the smoking article standard is appropriate for the
protection of the public health;
(B) invite interested persons to submit a draft or proposed
smoking article standard for consideration by the
Administrator;
(C) invite interested persons to submit comments on
structuring the standard so that it does not advantage
foreign-grown tobacco over domestically grown tobacco; and
(D) invite the Secretary of Agriculture to provide any
information or analysis which the Secretary of Agriculture
believes is relevant to the proposed smoking article
standard.
(3) Finding.--A notice of proposed rulemaking for the
revocation of a smoking article standard shall set forth a
finding with supporting justification that the smoking
article standard is no longer appropriate for the protection
of the public health.
(4) Comment.--The Administrator shall provide for a comment
period of not less than 90 days.
(d) Promulgation.--
(1) In general.--After the expiration of the period for
comment on a notice of proposed rulemaking published under
subsection (c) respecting a standard and after consideration
of comments submitted under subsections (b) and (c) and any
report from the Tobacco Products Scientific Advisory
Committee, if the Administrator determines that the standard
would be appropriate for the protection of the public health,
the Administrator shall--
(A) promulgate a regulation establishing a smoking article
standard and publish in the Federal Register findings on the
matters referred to in subsection (c); or
(B) publish a notice terminating the proceeding for the
development of the standard together with the reasons for
such termination.
(2) Effective date.--A regulation establishing a smoking
article standard shall set forth the date or dates upon which
the standard shall take effect, but no such regulation may
take effect before 1 year after the date of its publication
unless the Administrator determines that an earlier effective
date is necessary for the protection of the public health.
Such date or dates shall be established so as to minimize,
consistent with the public health, economic loss to, and
disruption or dislocation of, domestic and international
trade. In establishing such effective date or dates, the
Administrator shall consider information submitted in
connection with a proposed product standard by interested
parties, including manufacturers and tobacco growers,
regarding the technical achievability of compliance with the
standard, and including information concerning the existence
of patents that make it impossible to comply in the timeframe
envisioned in the proposed standard.
(3) Limitation on power granted.--Because of the importance
of a decision of the Administrator to issue a regulation--
(A) banning cigarettes, smokeless smoking articles, little
cigars, cigars other than little cigars, pipe tobacco, or
roll-your-own smoking articles;
(B) requiring the reduction of ``tar'' or nicotine yields
of a smoking article to zero;
(C) prohibiting the sale of any smoking article in face-to-
face transactions by a specific category of retail outlets;
(D) establishing a minimum age of sale of smoking articles
to any person older than 18 years of age; or
(E) requiring that the sale or distribution of a smoking
article be limited to the written or oral authorization of a
practitioner licensed by law to prescribe medical products,
the Administrator is prohibited from taking such actions
under this Act.
(4) Matchbooks.--For purposes of any regulations issued by
the Administrator under this Act, matchbooks of conventional
size containing not more than 20 paper matches, and which are
customarily given away for free with the purchase of smoking
articles, shall be considered as adult-written publications
which shall be permitted to contain advertising.
(5) Amendment; revocation.--
(A) Authority.--The Administrator, upon the Administrator's
own initiative or upon petition of an interested person, may
by a regulation, promulgated in accordance with the
requirements of subsection (c) and paragraph (2), amend or
revoke a smoking article standard.

[[Page S6087]]

(B) Effective date.--The Administrator may declare a
proposed amendment of a smoking article standard to be
effective on and after its publication in the Federal
Register and until the effective date of any final action
taken on such amendment if the Administrator determines that
making it so effective is in the public interest.
(6) Referral to advisory committee.--
(A) In general.--The Administrator shall refer a proposed
regulation for the establishment, amendment, or revocation of
a smoking article standard to the Tobacco Products Scientific
Advisory Committee for a report and recommendation with
respect to any matter involved in the proposed regulation
which requires the exercise of scientific judgment.
(B) Initiation of referral.--The Administrator shall make a
referral under this paragraph--
(i) on the Administrator's own initiative; or
(ii) upon the request of an interested person that--

(I) demonstrates good cause for the referral; and
(II) is made before the expiration of the period for
submission of comments on the proposed regulation.

(C) Provision of data.--If a proposed regulation is
referred under this paragraph to the Tobacco Products
Scientific Advisory Committee, the Administrator shall
provide the Advisory Committee with the data and information
on which such proposed regulation is based.
(D) Report and recommendation.--The Tobacco Products
Scientific Advisory Committee shall, within 90 days after the
referral of a proposed regulation under this paragraph and
after independent study of the data and information furnished
to it by the Administrator and other data and information
before it, submit to the Administrator a report and
recommendation respecting such regulation, together with all
underlying data and information and a statement of the reason
or basis for the recommendation.
(E) Public availability.--The Administrator shall make a
copy of each report and recommendation under subparagraph (D)
publicly available.

SEC. 111. NOTIFICATION AND OTHER REMEDIES.

(a) Notification.--If the Administrator determines that--
(1) a tobacco product which is introduced or delivered for
introduction into interstate commerce for commercial
distribution presents an unreasonable risk of substantial
harm materially above the risk for death and disease of
tobacco products currently in interstate commerce, to the
public health; and
(2) notification under this subsection is necessary to
eliminate the unreasonable risk of such harm and no more
practicable means is available under the provisions of this
Act (other than this section) to eliminate such risk,

the Administrator may issue such order as may be necessary to
assure that adequate notification is provided in an
appropriate form, by the persons and means best suited under
the circumstances involved, to all persons who should
properly receive such notification in order to eliminate such
risk. The Administrator may order notification by any
appropriate means, including public service announcements.
Before issuing an order under this subsection, the
Administrator shall consult with the persons who are to give
notice under the order.
(b) No Exemption From Other Liability.--Compliance with an
order issued under this section shall not relieve any person
from liability under Federal or State law. In awarding
damages for economic loss in an action brought for the
enforcement of any such liability, the value to the plaintiff
in such action of any remedy provided under such order shall
be taken into account.
(c) Recall Authority.--
(1) In general.--If the Administrator finds that there is a
reasonable probability that a tobacco product contains a
manufacturing or other defect not ordinarily contained in
tobacco products on the market that would cause serious,
acute adverse health consequences or death, the Administrator
shall issue an order requiring the appropriate person
(including the manufacturers, importers, distributors, or
retailers of the tobacco product) to immediately cease
distribution of such tobacco product. The order shall provide
the person subject to the order with an opportunity for an
informal hearing, to be held not later than 10 days after the
date of the issuance of the order, on the actions required by
the order and on whether the order should be amended to
require a recall of such tobacco product. If, after providing
an opportunity for such a hearing, the Administrator
determines that inadequate grounds exist to support the
actions required by the order, the Administrator shall vacate
the order.
(2) Amendment of order to require recall.--
(A) In general.--If, after providing an opportunity for an
informal hearing under paragraph (1), the Administrator
determines that the order should be amended to include a
recall of the tobacco product with respect to which the order
was issued, the Administrator shall, except as provided in
subparagraph (B), amend the order to require a recall. The
Administrator shall specify a timetable in which the tobacco
product recall will occur and shall require periodic reports
to the Administrator describing the progress of the recall.
(B) Notice.--An amended order under subparagraph (A)--
(i) shall not include recall of a tobacco product from
individuals; and
(ii) shall provide for notice to persons subject to the
risks associated with the use of such tobacco product.

In providing the notice required by clause (ii), the
Administrator may use the assistance of retailers and other
persons who distributed such tobacco product. If a
significant number of such persons cannot be identified, the
Administrator shall notify such persons under section 705(b).
(3) Remedy not exclusive.--The remedy provided by this
subsection shall be in addition to remedies provided by
subsection (a).

SEC. 112. RECORDS AND REPORTS ON TOBACCO PRODUCTS.

Every person who is a tobacco product manufacturer or
importer of a tobacco product shall establish and maintain
such records, make such reports, and provide such
information, as the Administrator may by regulation
reasonably require to assure that such tobacco product is not
adulterated or misbranded.

SEC. 113. APPLICATION FOR REVIEW OF CERTAIN SMOKING ARTICLES.

(a) In General.--
(1) New smoking article defined.--For purposes of this
section the term ``new smoking article'' means--
(A) any smoking article that was not commercially marketed
in the United States as of the date of enactment of this Act;
and
(B) any smoking article that incorporates a significant
modification (including changes in design, component, part,
or constituent, including a smoke constituent, or in the
content, delivery or form of nicotine, or other additive or
ingredient) of a smoking article where the reduced product
was commercially marketed in the United States after the date
of enactment of this Act.
(2) Premarket review required.--
(A) New products.--An order under subsection (c)(1)(A) for
a new smoking article is required unless the product--
(i) is substantially equivalent to a smoking article
commercially marketed in the United States as of date of
enactment of this Act; and
(ii) is in compliance with the requirements of this Act.
(B) Consumer testing.--This section shall not apply to
smoking articles that are provided to adult tobacco consumers
for purposes of consumer testing. For purposes of this
section, the term ``consumer testing'' means an assessment of
smoking articles that is conducted by or under the control
and direction of a manufacturer for the purpose of evaluating
consumer acceptance of such smoking articles, utilizing only
the quantity of cigarettes that is reasonably necessary for
such assessment
(3) Substantially equivalent defined.--
(A) In general.--In this section, the term ``substantially
equivalent'' or ``substantial equivalence'' means, with
respect to the smoking article being compared to the
predicate smoking article, that the Administrator by order
has found that the smoking article--
(i) has the same general characteristics as the predicate
smoking article; or
(ii) has different characteristics and the information
submitted contains information, including clinical data if
deemed necessary by the Administrator, that demonstrates that
it is not appropriate to regulate the product under this
section because the product does not raise different
questions of public health for the consumer of the product.
(B) Characteristics.--In subparagraph (A), the term
``characteristics'' means the materials, ingredients, design,
composition, heating source, or other features of a smoking
article.
(C) Limitation.--A smoking article may not be found to be
substantially equivalent to a predicate smoking article that
has been removed from the market at the initiative of the
Administrator or that has been determined by a judicial order
to be misbranded or adulterated.
(4) Health information.--As part of a submission respecting
a smoking article, the person required to file a premarket
notification shall provide an adequate summary of any health
information related to the smoking article or state that such
information will be made available upon request by any
person.
(b) Application.--
(1) Contents.--An application under this section shall
contain--
(A) full reports of all information, published or known to,
or which should reasonably be known to, the applicant,
concerning investigations which have been made to show the
health risks of such smoking article and whether such smoking
article presents less risk than other smoking articles;
(B) a full statement of the components, ingredients,
additives, and properties, and of the principle or principles
of operation, of such smoking article;
(C) a full description of the methods used in, and the
facilities and controls used for, the manufacture,
processing, and, when relevant, packing and installation of,
such smoking article;
(D) an identifying reference to any smoking article
standard under section 111 which would be applicable to any
aspect of such smoking article, and either adequate
information to show that such aspect of such smoking article
fully meets such smoking

[[Page S6088]]

article standard or adequate information to justify any
deviation from such standard;
(E) such samples of such smoking article and of components
thereof as the Administrator may reasonably require;
(F) specimens of the labeling proposed to be used for such
smoking article; and
(G) such other information relevant to the subject matter
of the application as the Administrator may require.
(2) Referral to tobacco products scientific advisory
committee.--Upon receipt of an application meeting the
requirements set forth in paragraph (1), the Administrator--
(A) may, on the Administrator's own initiative; or
(B) may, upon the request of an applicant,
refer such application to the Tobacco Products Scientific
Advisory Committee for reference and for submission (within
such period as the Administrator may establish) of a report
and recommendation respecting the application, together with
all underlying data and the reasons or basis for the
recommendation.
(c) Action on Application.--
(1) Deadline.--As promptly as possible, but in no event
later than 90 days after the receipt of an application under
subsection (b), the Administrator, after considering the
report and recommendation submitted under subsection (b)(2),
shall--
(A) issue an order that the new product may be introduced
or delivered for introduction into interstate commerce if the
Administrator finds that none of the grounds specified in
paragraph (2) of this subsection applies; or
(B) issue an order that the new product may not be
introduced or delivered for introduction into interstate
commerce if the Administrator finds (and sets forth the basis
for such finding as part of or accompanying such denial) that
1 or more grounds for denial specified in paragraph (2) of
this subsection apply.
(2) Denial of application.--The Administrator shall deny an
application submitted under subsection (b) if, upon the basis
of the information submitted to the Administrator as part of
the application and any other information before the
Administrator with respect to such smoking article, the
Administrator finds that--
(A) there is a lack of a showing that permitting such
smoking article to be marketed would be appropriate for the
protection of the public health;
(B) the methods used in, or the facilities or controls used
for, the manufacture, processing, or packing of such smoking
article do not conform to the requirements of section 110(e);
(C) based on a fair evaluation of all material facts, the
proposed labeling is false or misleading in any particular;
or
(D) such smoking article is not shown to conform to a
smoking article standard in effect under section 111, and
there is a lack of adequate information to justify the
deviation from such standard.
(3) Denial information.--Any denial of an application
shall, insofar as the Administrator determines to be
practicable, be accompanied by a statement informing the
applicant of the measures required to remove such application
from deniable form (which measures may include further
research by the applicant in accordance with 1 or more
protocols prescribed by the Administrator).
(4) Basis for finding.--For purposes of this section, the
finding as to whether the commercial introduction of a
smoking article for which an application has been submitted
is appropriate for the protection of the public health shall
be determined with respect to the risks and benefits to the
users of the smoking article, and taking into account whether
such commercial introduction is reasonably likely to increase
the morbidly and mortality among individual tobacco users.
(d) Withdrawal and Temporary Suspension.--
(1) In general.--The Administrator shall, upon obtaining,
where appropriate, advice on scientific matters from the
Tobacco Products Scientific Advisory Committee, and after due
notice and opportunity for informal hearing for a smoking
article for which an order was issued under subsection
(c)(1)(A), issue an order withdrawing the order if the
Administrator finds--
(A) that the continued marketing of such smoking article no
longer is appropriate for the protection of the public
health;
(B) that the application contained or was accompanied by an
untrue statement of a material fact;
(C) that the applicant--
(i) has failed to establish a system for maintaining
records, or has repeatedly or deliberately failed to maintain
records or to make reports, required by an applicable
regulation under section 113; or
(ii) has refused to permit access to, or copying or
verification of, such records as required by section 110; or
(D) on the basis of new information before the
Administrator with respect to such smoking article, evaluated
together with the evidence before the Administrator when the
application was reviewed, that the methods used in, or the
facilities and controls used for, the manufacture,
processing, packing, or installation of such smoking article
do not conform with the requirements of section 110(e) and
were not brought into conformity with such requirements
within a reasonable time after receipt of written notice from
the Administrator of nonconformity;
(E) on the basis of new information before the
Administrator, evaluated together with the evidence before
the Administrator when the application was reviewed, that the
labeling of such smoking article, based on a fair evaluation
of all material facts, is false or misleading in any
particular and was not corrected within a reasonable time
after receipt of written notice from the Administrator of
such fact; or
(F) on the basis of new information before the
Administrator, evaluated together with the evidence before
the Administrator when such order was issued, that such
smoking article is not shown to conform in all respects to a
smoking article standard which is in effect under section
111, compliance with which was a condition to the issuance of
an order relating to the application, and that there is a
lack of adequate information to justify the deviation from
such standard.
(2) Appeal.--The holder of an application subject to an
order issued under paragraph (1) withdrawing an order issued
pursuant to subsection (c)(1)(A) may, by petition filed on or
before the 30th day after the date upon which such holder
receives notice of such withdrawal, obtain review thereof in
accordance with section 116.
(3) Temporary suspension.--If, after providing an
opportunity for an informal hearing, the Administrator
determines there is reasonable probability that the
continuation of distribution of a smoking article under an
order would cause serious, adverse health consequences or
death, that is greater than ordinarily caused by smoking
articles on the market, the Administrator shall by order
temporarily suspend the authority of the manufacturer to
market the product. If the Administrator issues such an
order, the Administrator shall proceed expeditiously under
paragraph (1) to withdraw such application.
(e) Service of Order.--An order issued by the Administrator
under this section shall be served--
(1) in person by any officer or employee of the department
designated by the Administrator; or
(2) by mailing the order by registered mail or certified
mail addressed to the applicant at the applicant's last known
address in the records of the Administrator.
(f) Records.--
(1) Additional information.--In the case of any smoking
article for which an order issued pursuant to subsection
(c)(1)(A) for an application filed under subsection (b) is in
effect, the applicant shall establish and maintain such
records, and make such reports to the Administrator, as the
Administrator may by regulation, or by order with respect to
such application, prescribe on the basis of a finding that
such records and reports are necessary in order to enable the
Administrator to determine, or facilitate a determination of,
whether there is or may be grounds for withdrawing or
temporarily suspending such order.
(2) Access to records.--Each person required under this
section to maintain records, and each person in charge of
custody thereof, shall, upon request of an officer or
employee designated by the Administrator, permit such officer
or employee at all reasonable times to have access to and
copy and verify such records.
(g) Investigational Smoking Article Exemption for
Investigational Use.--The Administrator may exempt smoking
articles intended for investigational use from the provisions
of this Act under such conditions as the Administrator may by
regulation prescribe.

SEC. 114. REDUCED RISK TOBACCO PRODUCTS.

(a) In General.--No person may introduce or deliver for
introduction into interstate commerce any reduced risk
tobacco product unless an order issued pursuant to subsection
(g) is effective with respect to such product.
(b) Definitions.--In this section:
(1) Reduced risk tobacco product.--The term ``reduced 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'', ``low'', ``medium'', ``ultra
light'', ``low tar'' or ``ultra low tar''; or
(iii) the tobacco product manufacturer of which has taken
any action directed to consumers through the media or
otherwise, other than by means of the tobacco product's
label, labeling, or advertising, after the date of enactment
of the Act, respecting the product that would be reasonably
expected to result in consumers believing that the tobacco
product or its smoke may present a lower

[[Page S6089]]

risk of disease or is less harmful than one or more
commercially marketed tobacco products, or presents a reduced
exposure to, or does not contain or is free of, a substance
or substances.
(B) Limitation.--No tobacco product shall be considered to
be ``sold or distributed for use to reduce harm or the risk
of tobacco-related disease associated with commercially
marketed tobacco products'', except as described in
subparagraph (A).
(C) Smokeless tobacco product.--No smokeless tobacco
product shall be considered to be ``sold or distributed for
use to reduce harm or the risk of tobacco-related disease
associated with commercially marketed tobacco products''.
(3) Effective date.--The provisions of paragraph (2)(A)(ii)
shall take effect 12 months after the date of enactment of
the Act.
(c) Tobacco Dependence Products.--A product that is
intended to be used for the treatment of tobacco dependence,
including smoking cessation, is not a reduced risk tobacco
product under this section if it has been approved as a drug
or device by the Center and is subject to the requirements of
chapter V.
(d) Filing.--Any person may file with the Administrator an
application for a reduced risk tobacco product. Such
application shall include--
(1) a description of the proposed product and any proposed
advertising and labeling;
(2) the conditions for using the product;
(3) the formulation of the product;
(4) sample product labels and labeling;
(5) all documents (including underlying scientific
information) relating to research findings conducted,
supported, or possessed by the tobacco product manufacturer
relating to the effect of the product on tobacco-related
diseases and health-related conditions, including information
both favorable and unfavorable to the ability of the product
to reduce risk or exposure and relating to human health;
(6) data and information on how consumers actually use the
tobacco product; and
(7) such other information as the Administrator may
require.
(e) Public Availability.--The Administrator shall make the
application described in subsection (d) publicly available
(except matters in the application which are trade secrets or
otherwise confidential, commercial information) and shall
request comments by interested persons on the information
contained in the application and on the label, labeling, and
advertising accompanying such application.
(f) Advisory Committee.--
(1) In general.--The Administrator shall refer to the
Tobacco Products Scientific Advisory Committee any
application submitted under this section.
(2) Recommendations.--Not later than 60 days after the date
an application is referred to the Tobacco Products Scientific
Advisory Committee under paragraph (1), the Advisory
Committee shall report its recommendations on the application
to the Administrator.
(g) Marketing.--
(1) Reduced risk products.--Except as provided in paragraph
(2), the Administrator shall, with respect to an application
submitted under this section, issue an order that a reduced
risk product may be commercially marketed only if the
Administrator determines that the applicant has demonstrated
that such product, as it is actually used by consumers,
will--
(A) significantly reduce harm and the risk of tobacco-
related disease to individual tobacco users; and
(B) is reasonably likely to result in measurable and
substantial reductions in morbidity and mortality among
individual tobacco users.
(2) Special rule for certain products.--The Administrator
may issue an order that a tobacco product may be introduced
or delivered for introduction into interstate commerce,
pursuant to an application under this section, with respect
to a tobacco product that may not be commercially marketed
under paragraph (1) if the Secretary makes the findings
required under this paragraph and determines that the
applicant has demonstrated that--
(A) such order would be appropriate to promote the public
health; and
(B) 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.
(3) Basis.--The determinations under paragraphs (1) and (2)
shall be based on--
(A) the scientific evidence submitted by the applicant; and
(B) scientific evidence and other information that is made
available to the Administrator.
(h) Additional Conditions for Marketing.--
(1) Reduced risk products.--The Administrator shall require
for the marketing of a product under this section that any
advertising or labeling concerning reduced risk products
enable the public to comprehend the information concerning
reduced 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 cigarettes and other tobacco
products.
(2) Comparative claims.--The Administrator may require for
the marketing of a product under this subsection that a claim
comparing a tobacco product to other commercially marketed
tobacco products shall compare the tobacco product to the
known risk of cigarettes.
(i) Postmarket Surveillance and Studies.--Under the
guidance of the Scientific Advisory Committee, the Tobacco
Harm Reduction Center shall engage in postmarket surveillance
studies and other research as needed to ascertain the health
impact of each of the major classes of tobacco and other
nicotine containing products in the United States, ascertain
the possible presence of unusual levels of harm from specific
tobacco products, and determine the steps that should be
taken to further reduce illness, death and other social harms
from tobacco products.
(j) Withdrawal of Authorization.--The Administrator, after
an opportunity for an informal hearing, shall withdraw an
order under subsection (g) if the Administrator determines
that--
(1) the applicant, based on new information, can no longer
make the demonstrations required under subsection (g), or the
Administrator can no longer make the determinations required
under subsection (g);
(2) the application failed to include material information
or included any untrue statement of material fact;
(3) any explicit or implicit representation that the
product reduces risk or exposure is no longer valid,
including if--
(A) a tobacco product standard is established pursuant to
section 111;
(B) an action is taken that affects the risks presented by
other commercially marketed tobacco products that were
compared to the product that is the subject of the
application; or
(C) any postmarket surveillance or studies reveal that the
order is no longer consistent with the protection of the
public health;
(4) the applicant failed to conduct or submit the
postmarket surveillance and studies required under subsection
(g)(2)(C)(ii) or subsection (i); or
(5) the applicant failed to meet a condition imposed under
subsection (h).
(k) Chapter IV or V.--A product for which the Administrator
has issued an order pursuant to subsection (g) shall not be
subject to chapter IV or V of the Federal Food, Drug, and
Cosmetic Act.
(l) Implementing Regulations or Guidance.--
(1) Scientific evidence.--Not later than 2 years after the
date of enactment of the Act, the Administrator shall issue
regulations or guidance (or any combination thereof) on the
scientific evidence required for assessment and ongoing
review of reduced risk tobacco products. Such regulations or
guidance shall--
(A) to the extent that adequate scientific evidence exists,
establish minimum standards for scientific studies needed
prior to issuing an order under subsection (g) to show a
reasonable likelihood that a substantial reduction in
morbidity or mortality among individual tobacco users occurs
for products described in subsection (g)(1) or is reasonably
likely for products described in subsection (g)(2);
(B) include validated biomarkers, intermediate clinical
endpoints, and other feasible outcome measures, as
appropriate;
(C) establish minimum standards for postmarket studies,
that shall include regular and long-term assessments of
health outcomes and mortality, intermediate clinical
endpoints, consumer perception of harm reduction, and the
impact on quitting behavior and new use of tobacco products,
as appropriate;
(D) establish minimum standards for required postmarket
surveillance, including ongoing assessments of consumer
perception; and
(E) establish a reasonable timetable for the Administrator
to review an application under this section.
(2) Consultation.--The regulations or guidance issued under
paragraph (1) may be developed in consultation with the
Institute of Medicine, and with the input of other
appropriate scientific and medical experts, on the design and
conduct of such studies and surveillance.
(3) Revision.--The regulations or guidance under paragraph
(1) shall be revised on a regular basis as new scientific
information becomes available.
(4) New tobacco products.--Not later than 2 years after the
date of enactment of the Act, the Administrator shall issue a
regulation or guidance that permits the filing of a single
application for any tobacco product that is a new tobacco
product under section 114 and which the applicant seeks to
commercially market under this section.

SEC. 115. JUDICIAL REVIEW.

(a) Right To Review.--
(1) In general.--Not later than 60 days after--
(A) the promulgation of a regulation under section 111
establishing, amending, or revoking a tobacco product
standard; or
(B) a denial of an application under section 114(c),

any person adversely affected by such regulation or denial
may file a petition for judicial review of such regulation or
denial with the United States Court of Appeals for the
District of Columbia or for the circuit in which such person
resides or has their principal place of business.

[[Page S6090]]

(2) Requirements.--
(A) Copy of petition.--A copy of the petition filed under
paragraph (1) shall be transmitted by the clerk of the court
involved to the Administrator.
(B) Record of proceedings.--On receipt of a petition under
subparagraph (A), the Administrator shall file in the court
in which such petition was filed--
(i) the record of the proceedings on which the regulation
or order was based; and
(ii) a statement of the reasons for the issuance of such a
regulation or order.
(C) Definition of record.--In this section, the term
``record'' means--
(i) all notices and other matter published in the Federal
Register with respect to the regulation or order reviewed;
(ii) all information submitted to the Administrator with
respect to such regulation or order;
(iii) proceedings of any panel or advisory committee with
respect to such regulation or order;
(iv) any hearing held with respect to such regulation or
order; and
(v) any other information identified by the Administrator,
in the administrative proceeding held with respect to such
regulation or order, as being relevant to such regulation or
order.
(b) Standard of Review.--Upon the filing of the petition
under subsection (a) for judicial review of a regulation or
order, the court shall have jurisdiction to review the
regulation or order in accordance with chapter 7 of title 5,
United States Code, and to grant appropriate relief,
including interim relief, as provided for in such chapter. A
regulation or denial described in subsection (a) shall be
reviewed in accordance with section 706(2)(A) of title 5,
United States Code.
(c) Finality of Judgment.--The judgment of the court
affirming or setting aside, in whole or in part, any
regulation or order shall be final, subject to review by the
Supreme Court of the United States upon certiorari or
certification, as provided in section 1254 of title 28,
United States Code.
(d) Other Remedies.--The remedies provided for in this
section shall be in addition to, and not in lieu of, any
other remedies provided by law.
(e) Regulations and Orders Must Recite Basis in Record.--To
facilitate judicial review, a regulation or order issued
under section 110, 111, 112, 113, 114, or 119 shall contain a
statement of the reasons for the issuance of such regulation
or order in the record of the proceedings held in connection
with its issuance.

SEC. 116. JURISDICTION OF AND COORDINATION WITH THE FEDERAL
TRADE COMMISSION.

Except where expressly provided in this Act, nothing in
this Act shall be construed as limiting or diminishing the
authority of the Federal Trade Commission to enforce the laws
under its jurisdiction with respect to the advertising, sale,
or distribution of tobacco products.

SEC. 117. REGULATION REQUIREMENT.

(a) Testing, Reporting, and Disclosure.--Not later than 36
months after the date of enactment of the Act, the
Administrator shall promulgate regulations under this Act
that meet the requirements of subsection (b).
(b) Contents of Rules.--The regulations promulgated under
subsection (a)--
(1) shall require annual testing and reporting of tobacco
product constituents, ingredients, and additives, including
smoke constituents, by brand style that the Administrator
determines should be tested to protect the public health,
provided that, for purposes of the testing requirements of
this paragraph, tobacco products manufactured and sold by a
single tobacco product manufacturer that are identical in all
respects except the labels, packaging design, logo, trade
dress, trademark, brand name, or any combination thereof,
shall be considered as a single brand style; and
(2) may require that tobacco product manufacturers,
packagers, or importers make disclosures relating to the
results of the testing of tar and nicotine through labels or
advertising.
(c) Authority.--The Administrator shall have the authority
under this Act to conduct or to require the testing,
reporting, or disclosure of tobacco product constituents,
including smoke constituents.
(d) Joint Laboratory Testing Services.--The Administrator
shall allow any 2 or more tobacco product manufacturers to
join together to purchase laboratory testing services
required by this section on a group basis in order to ensure
that such manufacturers receive access to, and fair pricing
of, such testing services.
(e) Extensions for Limited Laboratory Capacity.--
(1) In general.--The regulations promulgated under
subsection (a) shall provide that a tobacco product
manufacturer shall not be considered to be in violation of
this section before the applicable deadline, if--
(A) the tobacco products of such manufacturer are in
compliance with all other requirements of this Act; and
(B) the conditions described in paragraph (2) are met.
(2) Conditions.--Notwithstanding the requirements of this
section, the Administrator may delay the date by which a
tobacco product manufacturer must be in compliance with the
testing and reporting required by this section until such
time as the testing is reported if, not later than 90 days
before the deadline for reporting in accordance with this
section, a tobacco product manufacturer provides evidence to
the Administrator demonstrating that--
(A) the manufacturer has submitted the required products
for testing to a laboratory and has done so sufficiently in
advance of the deadline to create a reasonable expectation of
completion by the deadline;
(B) the products currently are awaiting testing by the
laboratory; and
(C) neither that laboratory nor any other laboratory is
able to complete testing by the deadline at customary,
nonexpedited testing fees.
(3) Extension.--The Administrator, taking into account the
laboratory testing capacity that is available to tobacco
product manufacturers, shall review and verify the evidence
submitted by a tobacco product manufacturer in accordance
with paragraph (2). If the Administrator finds that the
conditions described in such paragraph are met, the
Administrator shall notify the tobacco product manufacturer
that the manufacturer shall not be considered to be in
violation of the testing and reporting requirements of this
section until the testing is reported or until 1 year after
the reporting deadline has passed, whichever occurs sooner.
If, however, the Administrator has not made a finding before
the reporting deadline, the manufacturer shall not be
considered to be in violation of such requirements until the
Administrator finds that the conditions described in
paragraph (2) have not been met, or until 1 year after the
reporting deadline, whichever occurs sooner.
(4) Additional extension.--In addition to the time that may
be provided under paragraph (3), the Administrator may
provide further extensions of time, in increments of no more
than 1 year, for required testing and reporting to occur if
the Administrator determines, based on evidence properly and
timely submitted by a tobacco product manufacturer in
accordance with paragraph (2), that a lack of available
laboratory capacity prevents the manufacturer from completing
the required testing during the period described in paragraph
(3).
(f) Rule of Construction.--Nothing in subsection (d) or (e)
shall be construed to authorize the extension of any
deadline, or to otherwise affect any timeframe, under any
provision of this Act other than this section.

SEC. 118. PRESERVATION OF STATE AND LOCAL AUTHORITY.

(a) In General.--
(1) Preservation.--Except as provided in paragraph (2)(A),
nothing in this Act, or rules promulgated under this Act,
shall be construed to limit the authority of a Federal agency
(including the Armed Forces), a State or political
subdivision of a State, or the government of an Indian tribe
to enact, adopt, promulgate, and enforce any law, rule,
regulation, or other measure with respect to tobacco products
that is in addition to requirements established under this
Act, including a law, rule, regulation, or other measure
relating to or prohibiting the sale, distribution,
possession, or use of tobacco products by individuals of any
age, information reporting to the State. No provision of this
Act shall limit or otherwise affect any State, Tribal, or
local taxation of tobacco products.
(2) Preemption of certain state and local requirements.--
(A) In general.--No State or political subdivision of a
State may establish or continue in effect with respect to a
tobacco product any requirement which is different from, or
in addition to, any requirement under the provisions of this
Act relating to tobacco product standards, premarket review,
adulteration, misbranding, labeling, registration, good
manufacturing standards, or reduced risk tobacco products.
(B) Exception.--Subparagraph (A) does not apply to
requirements relating to the sale, distribution, possession,
information reporting to the State, use of, tobacco product
by individuals of any age. Information disclosed to a State
under subparagraph (A) that is exempt from disclosure under
section 552(b)(4) of title 5, United States Code, shall be
treated as a trade secret and confidential information by the
State.
(b) Rule of Construction Regarding Product Liability.--No
provision of this Act relating to a tobacco product shall be
construed to modify or otherwise affect any action or the
liability of any person under the product liability law of
any State.

SEC. 119. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.

(a) Establishment.--Not later than 6 months after the date
of enactment of this Act, the Administrator shall establish a
19-member advisory committee, to be known as the Tobacco
Products Scientific Advisory Committee (in this section
referred to as the ``Advisory Committee'').
(b) Membership.--
(1) In general.--
(A) Members.--The Administrator shall appoint as members of
the Tobacco Harm Reduction Advisory Committee individuals who
are technically qualified by training and experience in
medicine, public health, medical ethics or other science or
technology involving the means by which cigarettes and other
tobacco products cause illness, death and other societal
harms, and the steps that can be taken by government and the
private sector to most rapidly and substantially reduce said
illness, death and other societal harms. The committee shall
be composed of--

[[Page S6091]]

(i) 10 individuals who are physicians, dentists, other
scientists or other public health or healthcare
professionals;
(ii) 4 individuals representing the general public;
(iii) 2 representatives of the interests of the tobacco
manufacturing industry;
(iv) 1 representative of the interests of the small
business tobacco manufacturing industry, which position may
be filled on a rotating, sequential basis by representatives
of different small business tobacco manufacturers based on
areas of expertise relevant to the topics being considered by
the Advisory Committee;
(v) 1 individual as a representative of the interests of
the tobacco growers; and
(vi) 1 individual who is an expert in illicit trade of
tobacco products.
(B) Conflicts of interest.--No members of the committee,
other than members appointed pursuant to clauses (iv), (v),
and (vi) of subparagraph (A) shall, during the member's
tenure on the committee or for the 18-month period prior to
becoming such a member, receive any salary, grants, or other
payments or support from any business that manufactures,
distributes, markets, or sells cigarettes or other tobacco
products or government agency with any form of jurisdiction
over tobacco products.
(2) Limitation.--The Administrator may not appoint to the
Advisory Committee any individual who is in the regular full-
time employ of the Tobacco Harm Reduction Center or any
agency responsible for the enforcement of this Act. The
Administrator may appoint Federal officials as ex officio
members.
(3) Chairperson.--The Administrator shall designate 1 of
the members appointed under clauses (i), (ii), and (iii) of
paragraph (1)(A) to serve as chairperson.
(c) Duties.--The Tobacco Products Scientific Advisory
Committee shall provide advice, information, and
recommendations to the Administrator--
(1) as provided in this Act;
(2) on the implementation of prevention, cessation, and
harm reduction policies;
(3) on implementation of policies and programs to fully
inform consumers of the respective risks of tobacco products;
and
(4) on its review of other safety, dependence, or health
issues relating to tobacco products as requested by the
Administrator.
(d) Compensation; Support; FACA.--
(1) Compensation and travel.--Members of the Advisory
Committee who are not officers or employees of the United
States, while attending conferences or meetings of the
committee or otherwise engaged in its business, shall be
entitled to receive compensation at rates to be fixed by the
Administrator, which may not exceed the daily equivalent of
the rate in effect under the Senior Executive Schedule under
section 5382 of title 5, United States Code, for each day
(including travel time) they are so engaged; and while so
serving away from their homes or regular places of business
each member may be allowed travel expenses, including per
diem in lieu of subsistence, as authorized by section 5703 of
title 5, United States Code, for persons in the Government
service employed intermittently.
(2) Administrative support.--The Administrator shall
furnish the Advisory Committee clerical and other assistance.
(3) Nonapplication of faca.--Section 14 of the Federal
Advisory Committee Act does not apply to the Advisory
Committee.
(e) Proceedings of Advisory Panels and Committees.--The
Advisory Committee shall make and maintain a transcript of
any proceeding of the panel or committee. Each such panel and
committee shall delete from any transcript made under this
subsection information which is exempt from disclosure under
section 552(b) of title 5, United States Code.

SEC. 120. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE.

(a) Report on Innovative Products.--
(1) In general.--Not later than 3 years after the date of
enactment of this Act, the Administrator, after consultation
with recognized scientific, medical, and public health
experts (including both Federal agencies and nongovernmental
entities, the Institute of Medicine of the National Academy
of Sciences, and the Society for Research on Nicotine and
Tobacco), shall submit to the Congress a report that examines
how best to promote, and encourage the development and use by
current tobacco users of innovative tobacco and nicotine
products and treatments (including nicotine-based and non-
nicotine-based products and treatments) to better achieve, in
a manner that best protects and promotes the public health--
(A) total abstinence from tobacco use;
(B) reductions in consumption of tobacco; and
(C) reductions in the harm associated with continued
tobacco use by moving current users to noncombustible tobacco
products.
(2) Recommendations.--The report under paragraph (1) shall
include the recommendations of the Administrator on how the
Tobacco Harm and Reduction Center should coordinate and
facilitate the exchange of information on such innovative
products and treatments among relevant offices and centers
within the Center and within the National Institutes of
Health, the Centers for Disease Control and Prevention, and
other relevant Federal and State agencies.

TITLE II--TOBACCO PRODUCTS WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT
DISCLOSURE

SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS.

(a) Amendment.--Section 4 of the Federal Cigarette Labeling
and Advertising Act (15 U.S.C. 1333) is amended to read as
follows:

``SEC. 4. LABELING.

``(a) Label Requirements.--
``(1) In general.--It shall be unlawful for any person to
manufacture, package, sell, offer to sell, distribute, or
import for sale or distribution within the United States any
cigarettes the package of which fails to bear, in accordance
with the requirements of this section, one of the following
labels:
``WARNING: Cigarettes are addictive.
``WARNING: Tobacco smoke can harm your children.
``WARNING: Cigarettes cause fatal lung disease.
``WARNING: Cigarettes cause cancer.
``WARNING: Cigarettes cause strokes and heart disease.
``WARNING: Smoking during pregnancy can harm your baby.
``WARNING: Smoking can kill you.
``WARNING: Tobacco smoke causes fatal lung disease in
nonsmokers.
``WARNING: Quitting smoking now greatly reduces serious
risks to your health.
``(2) Placement; typography; etc.--Each label statement
required by paragraph (1) shall be located in the lower
portion of the front panel of the package, directly on the
package underneath the cellophane or other clear wrapping.
Each label statement shall comprise at least the bottom 25
percent of the front panel of the package. The word `WARNING'
shall appear in capital letters and all text shall be in
conspicuous and legible 17-point type, unless the text of the
label statement would occupy more than 70 percent of such
area, in which case the text may be in a smaller conspicuous
and legible type size, provided that at least 60 percent of
such area is occupied by required text. The text shall be
black on a white background, or white on a black background,
in a manner that contrasts, by typography, layout, or color,
with all other printed material on the package, in an
alternating fashion under the plan submitted under subsection
(c). The Secretary shall by regulation adjust the format and
type size of the warnings required under this Act to include
color graphics depicting the negative health consequences of
smoking on the bottom portion of the front and rear panels.
``(3) Does not apply to foreign distribution.--The
provisions of this subsection do not apply to a tobacco
product manufacturer or distributor of cigarettes which does
not manufacture, package, or import cigarettes for sale or
distribution within the United States.
``(4) Applicability to retailers.--A retailer of cigarettes
shall not be in violation of this subsection for packaging
that--
``(A) contains a warning label;
``(B) is supplied to the retailer by a license- or permit-
holding smoking article manufacturer, importer, or
distributor; and
``(C) is not altered by the retailer in a way that is
material to the requirements of this subsection.
``(b) Advertising Requirements.--
``(1) In general.--It shall be unlawful for any tobacco
product manufacturer, importer, distributor, or retailer of
cigarettes to advertise or cause to be advertised within the
United States any cigarette unless its advertising bears, in
accordance with the requirements of this section, one of the
labels specified in subsection (a).
``(2) Typography, etc.--Each label statement required by
subsection (a) in cigarette advertising shall comply with the
standards set forth in this paragraph. For press and poster
advertisements, each such statement and (where applicable)
any required statement relating to tar, nicotine, or other
constituent (including a smoke constituent) yield shall
comprise at least 20 percent of the area of the advertisement
and shall appear in a conspicuous and prominent format and
location at the bottom of each advertisement within the trim
area. The word `WARNING' shall appear in capital letters, and
each label statement shall appear in conspicuous and legible
type. The text of the label statement shall be black if the
background is white and white if the background is black,
under the plan submitted under subsection (c). The label
statements shall be enclosed by a rectangular border that is
the same color as the letters of the statements and that is
the width of the first downstroke of the capital `W' of the
word `WARNING' in the label statements. The text of such
label statements shall be in a typeface pro rata to the
following requirements: 45-point type for a whole-page
broadsheet newspaper advertisement; 39-point type for a half-
page broadsheet newspaper advertisement; 39-point type for a
whole-page tabloid newspaper advertisement; 27-point type for
a half-page tabloid newspaper advertisement; 31.5-point type
for a double page spread magazine or whole-page magazine
advertisement; 22.5-point type for a 28 centimeter by 3
column advertisement; and 15-point type for a 20 centimeter
by 2 column advertisement. The label statements shall be in
English, except that--
``(A) in the case of an advertisement that appears in a
newspaper, magazine, periodical, or other publication that is
not in English, the statements shall appear in the
predominant language of the publication; and
``(B) in the case of any other advertisement that is not in
English, the statements shall

[[Page S6092]]

appear in the same language as that principally used in the
advertisement.
``(3) Matchbooks.--Notwithstanding paragraph (2), for
matchbooks (defined as containing not more than 20 matches)
customarily given away with the purchase of smokeless tobacco
products, each label statement required by subsection (a) may
be printed on the inside cover of the matchbook.
``(c) Marketing Requirements.--
``(1) Random display.--The label statements specified in
subsection (a)(1) shall be randomly displayed in each 12-
month period, in as equal a number of times as is possible on
each brand of the product and be randomly distributed in all
areas of the United States in which the product is marketed
in accordance with a plan submitted by the smokeless tobacco
product manufacturer, importer, distributor, or retailer and
approved by the Secretary.
``(2) Rotation.--The label statements specified in
subsection (a)(1) shall be rotated quarterly in alternating
sequence in advertisements for each brand of cigarettes in
accordance with a plan submitted by the smokeless tobacco
product manufacturer, importer, distributor, or retailer to,
and approved by, the Secretary.
``(3) Review.--The Secretary shall review each plan
submitted under paragraph (2) and approve it if the plan--
``(A) will provide for the equal distribution and display
on packaging and the rotation required in advertising under
this subsection; and
``(B) assures that all of the labels required under this
section will be displayed by the smokeless tobacco product
manufacturer, importer, distributor, or retailer at the same
time.
``(4) Applicability to retailers.--This subsection and
subsection (b) apply to a retailer only if that retailer is
responsible for or directs the label statements required
under this section except that this paragraph shall not
relieve a retailer of liability if the retailer displays, in
a location open to the public, an advertisement that does not
contain a warning label or has been altered by the retailer
in a way that is material to the requirements of this
subsection and subsection (b).''.
(b) Effective Date.--The amendment made by subsection (a)
shall take effect 24 months after the date of enactment of
this Act. Such effective date shall be with respect to the
date of manufacture, provided that, in any case, beginning 30
days after such effective date, a manufacturer shall not
introduce into the domestic commerce of the United States any
product, irrespective of the date of manufacture, that is not
in conformance with section 4 of the Federal Cigarette
Labeling and Advertising Act (15 U.S.C. 1333), as amended by
subsection (a).

SEC. 202. SMOKELESS TOBACCO LABELS AND ADVERTISING WARNINGS.

(a) Amendment.--Section 3 of the Comprehensive Smokeless
Tobacco Health Education Act of 1986 (15 U.S.C. 4402) is
amended to read as follows:

``SEC. 3. SMOKELESS TOBACCO WARNING.

``(a) General Rule.--
``(1) It shall be unlawful for any person to manufacture,
package, sell, offer to sell, distribute, or import for sale
or distribution within the United States any smokeless
tobacco product unless the product package bears, in
accordance with the requirements of this Act, the following
labels:
``WARNING: Smokeless tobacco is addictive.
``(2) Rotating warnings for all smokeless products shall
consist of `lower risk than cigarettes' and `addictive' and
the Secretary shall have the discretion to add warnings
relating to mouth cancer, gum disease, and tooth loss to
those smokeless products that have a demonstrated risk of
such hazards.
``(3) The two main rotating warnings should be extended to
the `nicotine containing products.'
``(4) The label statements required by paragraph (1) shall
be introduced by each smokeless tobacco product manufacturer,
packager, importer, distributor, or retailer of smokeless
tobacco products concurrently into the distribution chain of
such products.
``(5) The provisions of this subsection do not apply to a
smokeless tobacco product manufacturer or distributor of any
smokeless tobacco product that does not manufacture, package,
or import smokeless tobacco products for sale or distribution
within the United States.
``(6) A retailer of smokeless tobacco products shall not be
in violation of this subsection for packaging that--
``(A) contains a warning label;
``(B) is supplied to the retailer by a license- or permit-
holding smokeless tobacco product manufacturer, importer, or
distributor; and
``(C) is not altered by the retailer in a way that is
material to the requirements of this subsection.
``(b) Required Labels.--
``(1) It shall be unlawful for any smokeless tobacco
product manufacturer, packager, importer, distributor, or
retailer of smokeless tobacco products to advertise or cause
to be advertised within the United States any smokeless
tobacco product unless its advertising bears, in accordance
with the requirements of this section, one of the labels
specified in subsection (a).
``(2)(A) Each label statement required by subsection (a) in
smokeless tobacco advertising shall comply with the standards
set forth in this paragraph.
``(B) For press and poster advertisements, each such
statement and (where applicable) any required statement
relating to nicotine, or other constituent yield shall
comprise at least 20 percent of the area of the
advertisement.
``(C) The word `WARNING' shall appear in capital letters,
and each label statement shall appear in conspicuous and
legible type.
``(D) The text of the label statement shall be black on a
white background, or white on a black background, in an
alternating fashion under the plan submitted under paragraph
(3).
``(E) The label statements shall be enclosed by a
rectangular border that is the same color as the letters of
the statements and that is the width of the first downstroke
of the capital `W' of the word `WARNING' in the label
statements.
``(F) The text of such label statements shall be in a
typeface pro rata to the following requirements: 45-point
type for a whole-page broadsheet newspaper advertisement; 39-
point type for a half-page broadsheet newspaper
advertisement; 39-point type for a whole-page tabloid
newspaper advertisement; 27-point type for a half-page
tabloid newspaper advertisement; 31.5-point type for a double
page spread magazine or whole-page magazine advertisement;
22.5-point type for a 28 centimeter by 3 column
advertisement; and 15-point type for a 20 centimeter by 2
column advertisement.
``(G) The label statements shall be in English, except
that--
``(i) in the case of an advertisement that appears in a
newspaper, magazine, periodical, or other publication that is
not in English, the statements shall appear in the
predominant language of the publication; and
``(ii) in the case of any other advertisement that is not
in English, the statements shall appear in the same language
as that principally used in the advertisement.
``(3)(A) The label statements specified in subsection
(a)(1) shall be randomly displayed in each 12-month period,
in as equal a number of times as is possible on each brand of
the product and be randomly distributed in all areas of the
United States in which the product is marketed in accordance
with a plan submitted by the smokeless tobacco product
manufacturer, importer, distributor, or retailer and approved
by the Secretary.
``(B) The label statements specified in subsection (a)(1)
shall be rotated quarterly in alternating sequence in
advertisements for each brand of smokeless tobacco product in
accordance with a plan submitted by the smokeless tobacco
product manufacturer, importer, distributor, or retailer to,
and approved by, the Secretary.
``(C) The Secretary shall review each plan submitted under
subparagraphs (A) and (B) and approve it if the plan--
``(i) will provide for the equal distribution and display
on packaging and the rotation required in advertising under
this subsection; and
``(ii) assures that all of the labels required under this
section will be displayed by the smokeless tobacco product
manufacturer, importer, distributor, or retailer at the same
time.
``(D) This paragraph applies to a retailer only if that
retailer is responsible for or directs the label statements
under this section, unless the retailer displays, in a
location open to the public, an advertisement that does not
contain a warning label or has been altered by the retailer
in a way that is material to the requirements of this
subsection.
``(c) Television and Radio Advertising.--It is unlawful to
advertise smokeless tobacco on any medium of electronic
communications subject to the jurisdiction of the Federal
Communications Commission.''.
(b) Effective Date.--The amendment made by subsection (a)
shall take effect 24 months after the date of enactment of
this Act. Such effective date shall be with respect to the
date of manufacture, provided that, in any case, beginning 30
days after such effective date, a manufacturer shall not
introduce into the domestic commerce of the United States any
product, irrespective of the date of manufacture, that is not
in conformance with section 3 of the Comprehensive Smokeless
Tobacco Health Education Act of 1986 (15 U.S.C. 4402), as
amended by subsection (a).

TITLE III--PUBIC DISCLOSURES BY TOBACCO PRODUCTS MANUFACTURERS

SEC. 301. DISCLOSURES ON PACKAGES OF TOBACCO PRODUCTS.

(a) Back Face for Required Disclosures.--For purposes of
this section--
(1) the principal face of a package of a tobacco product is
the face that has the largest surface area or, for faces with
identical surface areas, any of the faces that have the
largest surface area; a package shall not be characterized as
having more than 2 principal faces;
(2) the front face shall be the principal face of the
package;
(3) if the front and back faces are of different sizes in
terms of area, then the larger face shall be the front face;
(4) the back face shall be the principal face of a package
that is opposite the front face of the package;
(5) the bottom 50 percent of the back face of the package
shall be allocated for required package disclosures in
accordance with this section; and
(6) if a package of a tobacco product is cylindrical, a
contiguous area constituting 30 percent of the total surface
area of the cylinder shall be deemed the back face.

[[Page S6093]]

(b) Required Information on Back Face.--Not later than 24
months after the effective date of this Act, the bottom 50
percent of the back face of a package of a tobacco product
shall be available solely for disclosures required by or
under this Act, the Federal Cigarette Labeling and
Advertising Act, sections 1331-1340 of title 15, United
States Code, and any other Federal statute. Such disclosures
shall include--
(1) the printed name and address of the manufacturer,
packer, or distributor, and any other identification
associated with the manufacturer, packer, or distributor or
with the tobacco product that the Administrator may require;
(2) a list of ingredients as required by subsection (e);
and
(3) the appropriate tax registration number.
(c) Package Disclosure of Ingredients.--Not later than 24
months after the effective date of this Act, the package of a
tobacco product shall bear a list of the common or usual
names of the ingredients present in the tobacco product in an
amount greater than 0.1 percent of the total dry weight of
the tobacco (including all ingredients), that shall comply
with the following:
(1) Such listing of ingredients shall appear under, or be
conspicuously accompanied by, the heading ``Tobacco and
principal tobacco ingredients''.
(2) Tobacco may be listed as ``tobacco,'' and shall be the
first listed ingredient.
(3) After tobacco, the ingredients shall be listed in
descending order of predominance, by weight.
(4) Spices and natural and artificial flavors may be
listed, respectively, as ``spices'' and ``natural and
artificial flavors'' without naming each.
(5) Preservatives may be listed as ``preservatives''
without naming each.
(6) The disclosure of any ingredient in accordance with
this section may, at the option of the tobacco product
manufacturer, designate the functionality or purpose of that
ingredient.
(7) The package say state ``Not for sale to minors''.
(8) In the case of a package of cigarettes, the package
shall state that smokeless tobacco has significantly lower
risks for disease and death than cigarettes.

SEC. 302. DISCLOSURES ON PACKAGES OF SMOKELESS TOBACCO.

(a) Back Face for Required Disclosures.--For purposes of
this section--
(1) the principal face of a package of smokeless tobacco is
the face that has the largest surface area or, for faces with
identical surface areas, any of the faces that have the
largest surface area; a package shall not be characterized as
having more than two principal faces;
(2) the front or top face shall be the principal face of
the package;
(3) if the front or top and back or bottom faces are of
different sizes in terms of area, then the larger face shall
be the front or top face;
(4) the back or bottom face of the package shall be the
principal face of a package that is opposite the front or top
face of the package;
(5) beginning 24 months after the effective date of this
Act, 50 percent of the back or bottom face of the package
shall be allocated for required package disclosures in
accordance with this section; and
(6) if the package is cylindrical, a contiguous area
constituting 30 percent of the total surface area of the
cylinder shall be deemed the back face.
(b) Required Information on Back or Bottom Face.--50
percent of the back or bottom face of a package of smokeless
tobacco shall be available solely for disclosures required by
or under this Act, the Comprehensive Smokeless Tobacco Health
Education Act of 1986, sections 4401-4408 of title 15, United
States Code, and any other Federal statute. Such disclosures
shall include a list of ingredients as required by subsection
(e).
(c) Package Disclosure of Ingredients.--Commencing 24
months after the effective date of this Act, a package of
smokeless tobacco shall bear a list of the common or usual
names of the ingredients present in the smokeless tobacco in
an amount greater than 0.1 percent of the total dry weight of
the tobacco (including all ingredients).
(1) Such listing of ingredients shall appears under, or be
conspicuously accompanied by, the heading ``Tobacco and
principal tobacco ingredients''.
(2) Tobacco may be listed as ``tobacco,'' and shall be the
first listed ingredient.
(3) After tobacco, the ingredients shall be listed in
descending order of predominance, by weight.
(4) Spices and natural and artificial flavors may be
listed, respectively, as ``spices'' and ``natural and
artificial flavors'' without naming each.
(5) Preservatives may be listed as ``preservatives''
without naming each.
(6) The disclosure of any ingredient in accordance with
this section may, at the option of the tobacco product
manufacturer, designate the functionality or purpose of that
ingredient.
(7) Not for sale to minors.

SEC. 303. PUBLIC DISCLOSURE OF INGREDIENTS.

(a) Regulations.--Not later than 24 months after the
effective date of this Act, the Administrator shall, by
regulation, establish standards under which each tobacco
product manufacturer shall disclose publicly, and update at
least annually--
(1) a list of the ingredients it uses in each brand style
it manufactures for commercial distribution domestically, as
provided in subsection (b); and
(2) a composite list of all the ingredients it uses in any
of the brand styles it manufactures for commercial
distribution domestically, as provided in subsection (c).
(b) Ingredients To Be Disclosed as to Each Brand Style.--
(1) In general.--With respect to the public disclosure
required by subsection (a)(1), as to each brand style, the
tobacco product manufacture shall disclose the common or
usual name of each ingredient present in the brand style in
an amount greater than 0.1 percent of the total dry weight of
the tobacco (including all ingredients).
(2) Requirements.--Disclosure under paragraph (1) shall
comply with the following:
(A) Tobacco may be listed as ``tobacco,'' and shall be the
first listed ingredient.
(B) After tobacco, the ingredients shall be listed in
descending order of predominance, by weight.
(C) Spices and natural and artificial flavors may be
listed, respectively, as ``spices'' and ``natural and
artificial flavors'' without naming each.
(D) Preservatives may be listed as ``preservatives''
without naming each.
(E) The disclosure of any ingredient in accordance with
this section may, at the option of the tobacco product
manufacturer, designate the functionality or purpose of that
ingredient.
(c) Aggregate Disclosure of Ingredients.--
(1) In general.--The public disclosure required of a
tobacco product manufacturer by subsection (a)(2) shall
consist of a single list of all ingredients used in any brand
style a tobacco product manufacturer manufactures for
commercial distribution domestically, without regard to the
quantity used, and including, separately, each spice, each
natural or artificial flavoring, and each preservative.
(2) Listing.--The ingredients shall be listed by their
respective common or usual names in descending order of
predominance by the total weight used annually by the tobacco
product manufacturer in manufacturing tobacco products for
commercial distribution domestically.
(d) No Required Disclosure of Quantities.--The
Administrator shall not require any public disclosure of
quantitative information about any ingredient in a tobacco
product.
(e) Disclosure on Website.--The public disclosures required
by subsection (a) of this section may be by posting on an
Internet-accessible website, or other location electronically
accessible to the public, which is identified on all packages
of a tobacco product manufacturer's tobacco products.
(f) Timing of Initial Required Disclosures.--No disclosure
pursuant to this section shall be required to commence until
the regulations under subsection (a) have been in effect for
not less than 1 year.

TITLE IV--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS

SEC. 401. STUDY AND REPORT ON ILLICIT TRADE.

(a) The Administrator shall, after consultation with other
relevant agencies including Customs and Tobacco Tax Bureau,
conduct a study of trade in tobacco products that involves
passage of tobacco products either between the States or from
or to any other country across any border of the United
States to--
(1) collect data on such trade in tobacco products,
including illicit trade involving tobacco products, and make
recommendations on the monitoring and enforcement of such
trade;
(2) collect data on any advertising intended to be
broadcast, transmitted, or distributed from or to the United
States from or to another country and make recommendations on
how to prevent or eliminate, and what technologies could help
facilitate the elimination of, such advertising; and
(3) collect data on such trade in tobacco products by
person that is not--
(A) a participating manufacturer (as that term is defined
in section II(jj) of the Master Settlement Agreement of
November 23, 1998, between certain of the States and certain
tobacco product manufacturers); or
(B) an affiliate or subsidiary of a participating
manufacturer.
(b) Not later than 18 months after the effective date of
this Act, the Administrator shall submit to the Secretary,
and committees of relevant jurisdiction in Congress, a report
the recommendations of the study conducted under subsection
(a).

SEC. 402. AMENDMENT TO SECTION 1926 OF THE PUBLIC HEALTH
SERVICE ACT.

Section 1926 of the Public Health Service Act (42 U.S.C.
Sec.  300x-26) is amended by adding at the end thereof the
following:
``(e)(1) Subject to paragraphs (2) and (3), for the first
fiscal year after enactment and each subsequent fiscal year,
the Secretary shall reduce, as provided in subsection (h),
the amount of any grant under section 300x-21 of this title
for any State that does not have in effect a statute with
substantially the following provisions:

`` `SEC. 1. DISTRIBUTION TO MINORS.

`` `(a) No person shall distribute a tobacco product to an
individual under 18 years of age or a different minimum age
established under State law. A person who violates this
subsection is liable for a civil money penalty of not less
than $25 nor more than $125 for each violation of this
subsection;
`` `(b) The employer of an employee who has violated
subsection (a) twice while in the

[[Page S6094]]

employ of such employer is liable for a civil money penalty
of $125 for each subsequent violation by such employee.
`` `(c) It shall be a defense to a charge brought under
subsection (a) that--
`` `(1) the defendant--
`` `(A) relied upon proof of age that appeared on its face
to be valid in accordance with the Preventing Disease and
Death from Tobacco Use Act;
`` `(B) had complied with the requirements of section 5
and, if applicable, section 7; or
`` `(C) relied upon a commercially available electronic age
verification service to confirm that the person was an age-
verified adult; or
`` `(2) the individual to whom the tobacco product was
distributed was at the time of the distribution used in
violation of subsection 7(b).

`` `SEC. 2. OUT-OF-PACKAGE DISTRIBUTION.

`` `It shall be unlawful for any person to distribute
cigarettes or a smokeless tobacco product other than in an
unopened package that complies in full with section 108 of
the Preventing Disease and Death from Tobacco Use Act. A
person who distributes a cigarette or a smokeless tobacco
product in violation of this section is liable for a civil
money penalty of not less than $25 nor more than $125 for
each such violation.

`` `SEC. 3. SIGNAGE.

`` `It shall be unlawful for any person who sells tobacco
products over-the-counter to fail to post conspicuously on
the premises where such person sells tobacco products over-
the-counter a sign communicating that--
`` `(1) the sale of tobacco products to individuals under
18 years of age or a different minimum age established under
State law is prohibited by law;
`` `(2) the purchase of tobacco products by individuals
under 18 years of age or a different minimum age established
under State law is prohibited by law; and
`` `(3) proof of age may be demanded before tobacco
products are sold.

A person who fails to post a sign that complies fully with
this section is liable for a civil money penalty of not less
than $25 nor more than $125.

`` `SEC. 4. NOTIFICATION OF EMPLOYEES.

`` `(a) Within 180 days of the effective date of the
Preventing Disease and Death from Tobacco Use Act, every
person engaged in the business of selling tobacco products at
retail shall implement a program to notify each employee
employed by that person who sells tobacco products at retail
that--
`` `(1) the sale or other distribution of tobacco products
to any individual under 18 years of age or a different
minimum age established under State law, and the purchase,
receipt, or possession of tobacco products in a place open to
the public by any individual under 18 years of age or a
different minimum age established under State law, is
prohibited; and
`` `(2) out-of-package distribution of cigarettes and
smokeless tobacco products is prohibited.

Any employer failing to provide the required notice to any
employee shall be liable for a civil money penalty of not
less than $25 nor more than $125 for each such violation.
`` `(b) It shall be a defense to a charge that an employer
violated subsection (a) of this section that the employee
acknowledged receipt, either in writing or by electronic
means, prior to the alleged violation, of a statement in
substantially the following form:
``I understand that State law prohibits the distribution of
tobacco products to individuals under 18 years of age or a
different minimum age established under State law and out-of-
package distribution of cigarettes and smokeless tobacco
products, and permits a defense based on evidence that a
prospective purchaser's proof of age was reasonably relied
upon and appeared on its face to be valid. I understand that
if I sell, give, or voluntarily provide a tobacco product to
an individual under 18 years of age or a different minimum
age established under State law, I may be found responsible
for a civil money penalty of not less than $25 nor more than
$125 for each violation. I promise to comply with this law.''
' ''
`` `(c) If an employer is charged with a violation of
subsection (a) and the employer uses as a defense to such
charge the defense provided by subsection (b), the employer
shall be deemed to be liable for such violation if such
employer pays the penalty imposed on the employee involved in
such violation or in any way reimburses the employee for such
penalty.

`` `SEC. 5. SELF-SERVICE DISPLAYS.

`` `(a) It shall be unlawful for any person who sells
tobacco products over-the-counter at retail to maintain
packages of such products in any location accessible to
customers that is not under the control of a cashier or other
employee during regular business hours. This subsection does
not apply to any adult-only facility.
`` `(b) Any person who violates subsection (a) is liable
for a civil money penalty of not less than $25 nor more than
$125 for each such violation, except that no person shall be
responsible for more than one violation per day at any one
retail store.

`` `SEC. 6. DISTRIBUTION BY MAIL OR COURIER.

`` `(a) It shall be unlawful to distribute or sell tobacco
products directly to consumers by mail or courier, unless the
person receiving purchase requests for tobacco products takes
reasonable action to prevent delivery to individuals who are
not adults by--
`` `(1) requiring that addressees of the tobacco products
be age-verified adults;
`` `(2) making good faith efforts to verify that such
addressees have attained the minimum age for purchase of
tobacco products established by the respective States wherein
the addresses of the addressees are located; and
`` `(3) addressing the tobacco products delivered by mail
or courier to a physical addresses and not to post office
boxes.
`` `(b) Any person who violates subsection (a) is liable
for a civil money penalty of not less than $25 nor more than
$125 for each such violation.

`` `SEC. 7. RANDOM UNANNOUNCED INSPECTIONS; REPORTING; AND
COMPLIANCE.

`` `(a) The State Police, or a local law enforcement
authority duly designated by the State Police, or a public
health authority shall enforce this Act in a manner that can
reasonably be expected to reduce the extent to which tobacco
products are distributed to individuals under 18 years of age
or a different minimum age established under State law and
shall conduct random, unannounced inspections in accordance
with the procedures set forth in this Act and in regulations
issued under section 1926 of the Federal Public Health
Service Act (42 U.S.C. Sec.  300x-26).
`` `(b) The State may engage an individual under 18 years
of age or a different minimum age established under State law
to test compliance with this Act, except that such an
individual may be used to test compliance with this Act only
if the testing is conducted under the following conditions:
`` `(1) Prior to use of any individual under 18 years of
age or a different minimum age established under State law in
a random, unannounced inspection, written consent shall be
obtained from a parent, custodian, or guardian of such
individual;
`` `(2) An individual under 18 years of age or a different
minimum age established under State law shall act solely
under the supervision and direction of the State Police or a
local law enforcement authority, or public health authority
duly designated by the State Police during a random,
unannounced inspection;
`` `(3) An individual under 18 years of age or a different
minimum age established under State law used in random,
unannounced inspections shall not be used in any such
inspection at a store in which such individual is a regular
customer; and
`` `(4) If an individual under 18 years of age or a
different minimum age established under State law
participating in random, unannounced inspections is
questioned during such an inspection about such individual's
age, such individual shall state his or her actual age and
shall present a true and correct proof of age if requested at
any time during the inspection to present it.
`` `(c) Any person who uses any individual under 18 years
of age or a different minimum age established under State
law, other than as permitted by subsection (b), to test
compliance with this Act, is liable for a civil money penalty
of not less than $25 nor more than $125 for each such
violation.
`` `(d) Civil money penalties collected for violations of
this Act and fees collected under section 9 shall be used
only to defray the costs of administration and enforcement of
this Act.

`` `SEC. 8. LICENSURE.

`` `(a) Each person engaged in the over-the-counter
distribution at retail of tobacco products shall hold a
license issued under this section. A separate license shall
be required for each place of business where tobacco products
are distributed at retail. A license issued under this
section is not assignable and is valid only for the person in
whose name it is issued and for the place of business
designated in the license.
`` `(b) The annual license fee is $25 for each place of
business where tobacco products are distributed at retail.
`` `(c) Every application for a license, including renewal
of a license, under this section shall be made upon a form
provided by the appropriate State agency or department, and
shall set forth the name under which the applicant transacts
or intends to transact business, the location of the place of
business for which the license is to be issued, the street
address to which all notices relevant to the license are to
be sent (in this Act referred to as ``notice address''), and
any other identifying information that the appropriate State
agency or department may require.
`` `(d) The appropriate State agency or department shall
issue or renew a license or deny an application for a license
or the renewal of a license within 30 days of receiving a
properly completed application and the license fee. The
appropriate State agency or department shall provide notice
to an applicant of action on an application denying the
issuance of a license or refusing to renew a license.
`` `(e) Every license issued by the appropriate State
agency or department pursuant to this section shall be valid
for 1 year from the date of issuance and shall be renewed
upon application except as otherwise provided in this Act.
`` `(f) Upon notification of a change of address for a
place of business for which a license has been issued, a
license shall be reissued for the new address without the
filing of a new application.
`` `(g) The appropriate State agency or department shall
notify every person in the State who is engaged in the
distribution at retail of tobacco products of the license
requirements of this section and of the date by

[[Page S6095]]

which such person should have obtained a license.
`` `(h)(1) Except as provided in paragraph (2), any person
who engages in the distribution at retail of tobacco products
without a license required by this section is liable for a
civil money penalty in an amount equal to (i) two times the
applicable license fee, and (ii) $50 for each day that such
distribution continues without a license.
`` `(2) Any person who engages in the distribution at
retail of tobacco products after a license issued under this
section has been suspended or revoked is liable for a civil
money penalty of $100 per day for each day on which such
distribution continues after the date such person received
notice of such suspension or revocation.
`` `(i) No person shall engage in the distribution at
retail of tobacco products on or after 180 days after the
date of enactment this Act unless such person is authorized
to do so by a license issued pursuant to this section or is
an employee or agent of a person that has been issued such a
license.

`` `SEC. 9. SUSPENSION, REVOCATION, DENIAL, AND NONRENEWAL OF
LICENSES.

`` `(a) Upon a finding that a licensee has been determined
by a court of competent jurisdiction to have violated this
Act during the license term, the State shall notify the
licensee in writing, served personally or by registered mail
at the notice address, that any subsequent violation of this
Act at the same place of business may result in an
administrative action to suspend the license for a period
determined by the specify the appropriate State agency or
department.
`` `(b) Upon finding that a further violation by this Act
has occurred involving the same place of business for which
the license was issued and the licensee has been served
notice once under subsection (a), the appropriate State
agency or department may initiate an administrative action to
suspend the license for a period to be determined by the
appropriate State agency or department but not to exceed six
months. If an administrative action to suspend a license is
initiated, the appropriate State agency or department shall
immediately notify the licensee in writing at the notice
address of the initiation of the action and the reasons
therefor and permit the licensee an opportunity, at least 30
days after written notice is served personally or by
registered mail upon the licensee, to show why suspension of
the license would be unwarranted or unjust.
`` `(c) The appropriate State agency or department may
initiate an administrative action to revoke a license that
previously has been suspended under subsection (b) if, after
the suspension and during the one-year period for which the
license was issued, the licensee committed a further
violation of this Act, at the same place of business for
which the license was issued. If an administrative action to
revoke a license is initiated, the appropriate State agency
or department shall immediately notify the licensee in
writing at the notice address of the initiation of the action
and the reasons therefor and permit the licensee an
opportunity, at least 30 days after written notice is served
personally or by registered mail upon the licensee, to show
why revocation of the license would be unwarranted or unjust.
`` `(d) A person whose license has been suspended or
revoked with respect to a place of business pursuant to this
section shall pay a fee of $50 for the renewal or reissuance
of the license at that same place of business, in addition to
any applicable annual license fees.
`` `(e) Revocation of a license under subsection (c) with
respect to a place of business shall not be grounds to deny
an application by any person for a new license with respect
to such place of business for more than 12 months subsequent
to the date of such revocation. Revocation or suspension of a
license with respect to a particular place of business shall
not be grounds to deny an application for a new license, to
refuse to renew a license, or to revoke or suspend an
existing license at any other place of business.
`` `(f) A licensee may seek judicial review of an action of
the appropriate State agency or department suspending,
revoking, denying, or refusing to renew a license under this
section by filing a complaint in a court of competent
jurisdiction. Any such complaint shall be filed within 30
days after the date on which notice of the action is received
by the licensee. The court shall review the evidence de novo.
`` `(g) The State shall not report any action suspending,
revoking, denying, or refusing to renew a license under this
section to the Federal Secretary of Health and Human
Services, unless the opportunity for judicial review of the
action pursuant to subsection (f), if any, has been exhausted
or the time for seeking such judicial review has expired.

`` `SEC. 10. NO PRIVATE RIGHT OF ACTION.

`` `Nothing in this Act shall be construed to create a
right of action by any private person for any violation of
any provision of this Act.

`` `SEC. 11. JURISDICTION AND VENUE.

`` `Any action alleging a violation of this Act may be
brought only in a court of general jurisdiction in the city
or county where the violation is alleged to have occurred.

`` `SEC. 12. REPORT.

`` `The appropriate State agency or department shall
prepare for submission annually to the Federal Secretary of
Health and Human Services the report required by section 1926
of the Federal Public Health Service Act (42 U.S.C. 300x-
26).' ''.
``(2) In the case of a State whose legislature does not
convene a regular session in fiscal year 2007, and in the
case of a State whose legislature does not convene a regular
session in fiscal year 2008, the requirement described in
subsection (e)(1) as a condition of a receipt of a grant
under section 300x-21 of this title shall apply only for
fiscal year 2009 and subsequent fiscal years.
``(3) Subsection (e)(1) shall not affect any State or local
law that (A) was in effect on the date of introduction of the
Federal Tobacco Act of 2007, and (B) covers the same subject
matter as the law described in subsection (e)(1). Any State
law that meets the conditions of this paragraph shall also be
deemed to meet the requirement described in subsection (e)(1)
as a condition of a receipt of a grant under section 300x-21
of this title, if such State law is at least as stringent as
the law described in subsection (e)(1).
``(f)(1) For the first applicable fiscal year and for each
subsequent fiscal year, a funding agreement for a grant under
section 300x-21 of this title is a funding agreement under
which the State involved will enforce the law described in
subsection (e)(1) of this section in a manner that can
reasonably be expected to reduce the extent to which tobacco
products are available to individuals under the age of 18 or
a different minimum age established under State law for the
purchase of tobacco products.
``(2) For the first applicable fiscal year and for each
subsequent fiscal year, a funding agreement for a grant under
section 300x-21 of this title is a funding agreement under
which the State involved will--
``(A) conduct random, unannounced inspections to ensure
compliance with the law described in subsection (e)(1); and
``(B) annually submit to the Secretary a report
describing--
``(i) the activities carried out by the State to enforce
such law during the fiscal year preceding the fiscal year for
which the State is seeking the grant;
``(ii) the extent of success the State has achieved in
reducing the availability of tobacco products to individuals
under 18 years of age or a different minimum age established
under State law, including the results of the inspections
conducted under subparagraph (A); and
``(iii) the strategies to be utilized by the State for
enforcing such law during the fiscal year for which the grant
is sought.
``(g) The law specified in subsection (e)(1) may be
administered and enforced by a State using--
``(1) any amounts made available to the State through a
grant under section 300x-21 of this title;
``(2) any amounts made available to the State under section
300w of this title;
``(3) any fees collected for licenses issued pursuant to
the law described in subsection (e)(1);
``(4) any fines or penalties assessed for violations of the
law specified in subsection (e)(1); or
``(5) any other funding source that the legislature of the
State may prescribe by statute.
``(h) Before making a grant under section 300x-21 of this
title to a State for the first applicable fiscal year or any
subsequent fiscal year, the Secretary shall make a
determination of whether the State has maintained compliance
with subsections (e) and (f) of this section. If, after
notice to the State and an opportunity for a hearing, the
Secretary determines that the State is not in compliance with
such subsections, the Secretary shall reduce the amount of
the allotment under section 300x-21 of this title for the
State for the fiscal year involved by an amount equal to--
``(1) In the case of the first applicable fiscal year, 10
percent of the amount determined under section 300x-33 for
the State for the fiscal year;
``(2) In the case of the first fiscal year following such
applicable fiscal year, 20 percent of the amount determined
under section 300x-33 for the State for the fiscal year;
``(3) In the case of the second such fiscal year, 30
percent of the amount determined under section 300x-33 for
the State for the fiscal year; and
``(4) In the case of the third such fiscal year or any
subsequent fiscal year, 40 percent of the amount determined
under section 300x-33 for the State for the fiscal year.

The Secretary shall not have authority or discretion to grant
to any State a waiver of the terms and requirements of this
subsection or subsection (e) or (f).
``(i) For the purposes of subsections (e) through (h) of
this section the term `first applicable fiscal year' means--
``(1) fiscal year 2009, in the case of any State described
in subsection (e)(2) of this section; and
``(2) fiscal year 2008, in the case of any other State.
``(j) For purposes of subsections (e) through (h) of this
section, references to section 300x-21 shall include any
successor grant programs.`'
``(k) As required by paragraph (1), and subject to
paragraph (4), an Indian tribe shall satisfy the requirements
of subsection (e)(1) of this section by enacting a law or
ordinance with substantially the same provisions as the law
described in subsection (e)(1).
``(1) An Indian tribe shall comply with subsection (e)(1)
of this section within 180 days after the Administrator
finds, in accordance with this paragraph, that--
``(A) the Indian tribe has a governing body carrying out
substantial governmental powers and duties;

[[Page S6096]]

``(B) the functions to be exercised by the Indian tribe
under this Act pertain to activities on trust land within the
jurisdiction of the tribe; and
``(C) the Indian tribe is reasonably expected to be capable
of carrying out the functions required under this section.

Within 2 years of the date of enactment of the Federal
Tobacco Act of 2007, as to each Indian tribe in the United
States, the Administrator shall make the findings
contemplated by this paragraph or determine that such
findings cannot be made, in accordance with the procedures
specified in paragraph (4).
``(2) As to Indian tribes subject to subsection (e)(1) of
this section, the Administrator shall promulgate regulations
that--
``(A) provide whether and to what extent, if any, the law
described in subsection (e)(1) may be modified as adopted by
Indian tribes; and
``(B) ensure, to the extent possible, that each Indian
tribe's retailer licensing program under subsection (e)(1) is
no less stringent than the program of the State or States in
which the Indian tribe is located.
``(3) If with respect to any Indian tribe the Administrator
determines that compliance with the requirements of
subsection (e)(1) is inappropriate or administratively
infeasible, the Administrator shall specify other means for
the Indian tribe to achieve the purposes of the law described
in subsection (e)(1) with respect to persons who engage in
the distribution at retail of tobacco products on tribal
lands.
``(4) The findings and regulations promulgated under
paragraphs (1) and (2) shall be promulgated in conformance
with section 553 of title 5, United States Code, and shall
comply with the following provisions:
``(A) In making findings as provided in paragraph (1), and
in drafting and promulgating regulations as provided in
paragraph (2) (including drafting and promulgating any
revised regulations), the Administrator shall confer with,
and allow for active participation by, representatives and
members of Indian tribes, and tribal organizations.
``(B) In carrying out rulemaking processes under this
subsection, the Administrator shall follow the guidance of
subchapter III of chapter 5 of title 5, United States Code,
commonly known as the `Negotiated Rulemaking Act of 1990.'
``(C) The tribal participants in the negotiation process
referred to in subparagraph (B) shall be nominated by and
shall represent the groups described in this subsection and
shall include tribal representatives from all geographic
regions.
``(D) The negotiations conducted under this paragraph (4)
shall be conducted in a timely manner.
``(E) If the Administrator determines that an extension of
the deadlines under subsection (k)(1) of this section is
appropriate, the Secretary may submit proposed legislation to
Congress for the extension of such deadlines.
``(5) This subsection shall not affect any law or ordinance
that (A) was in effect on tribal lands on the date of
introduction of the Preventing Disease and Death from Tobacco
Use Act, and (B) covers the same subject matter as the law
described in subsection (e)(1). Any law or ordinance that
meets the conditions of this paragraph shall also be deemed
to meet the requirement described in subsection (k)(1), if
such law or ordinance is at least as stringent as the law
described in subsection (e)(1).
``(6) For purposes of this subsection--
``(A) `Administrator' means the Administrator of the
Tobacco Harm Reduction Center.
``(B) `Indian tribe' has the meaning assigned that term in
section 4(e) of the Indian Self Determination and Education
Assistance Act, section 450b(e) of title 25, United States
Code.
``(C) `Tribal lands' means all lands within the exterior
boundaries of any Indian reservation, all lands the title to
which is held by the United States in trust for an Indian
tribe, or lands the title to which is held by an Indian tribe
subject to a restriction by the United States against
alienation, and all dependent Indian communities.
``(D) `tribal organization' has the meaning assigned that
term in section 4(l) of the Indian Self Determination and
Education Assistance Act, section 450b(l) of title 25, United
States Code.''.

SEC. 403. ESTABLISHMENT OF RANKINGS.

(a) Standards and Procedures for Rankings.--Within 24
months after the effective date of this Act, the
Administrator shall, by regulation, after consultation with
an Advisory Committee established for such purpose, establish
the standards and procedures for promulgating rankings,
comprehensible to consumers of tobacco products, of the
following categories of tobacco products and also nicotine-
containing products on the basis of the relative risks of
serious or chronic tobacco-related diseases and adverse
health conditions those categories of tobacco products and
also nicotine-containing products respectively present--
(1) smoking articles, including--
(A) cigarettes;
(B) cigars;
(C) little cigars;
(D) loose tobacco for roll-your own tobacco products;
(E) loose tobacco for pipes, hookas, and other pipe-like
devices; and
(F) other smoking articles;
(2) smokeless products, including--
(A) chewing tobacco;
(B) dry snuff;
(C) snus (a type of moist snuff);
(D) other forms of moist snuff; and
(E) dissolvable tobacco products (such as sticks, orbs, or
lozenges); and
(3) nicotine containing non-tobacco or tobacco extract
products, including--
(A) nicotine gum;
(B) nicotine patches;
(C) electronic cigarettes; and
(D) other forms of such products.
The Administrator shall not have authority or discretion to
establish a relative-risk ranking of any category or
subcategory of tobacco products or any category or
subcategory of nicotine-containing products other than the
ten categories specified in this subsection.
(b) Considerations in Promulgating Regulations.--In
promulgating regulations under this section, the
Administrator--
(1) shall take into account relevant epidemiologic studies
and other relevant competent and reliable scientific
evidence; and
(2) in assessing the risks of serious or chronic tobacco-
related diseases and adverse health conditions presented by a
particular category, shall consider the range of tobacco
products or nicotine-containing products within the category,
and shall give appropriate weight to the market shares of the
respective products in the category.
(c) Promulgation of Rankings of Categories.--Once the
initial regulations required by subsection (a) are in effect,
the Administrator shall promptly, by order, after notice and
an opportunity for comment, promulgate to the general public
rankings of the categories of tobacco products and nicotine-
containing products in accordance with those regulations. The
Administrator shall promulgate the initial rankings of those
categories of tobacco products and nicotine-containing
products to the general public not later than January 1,
2010. Thereafter, on an annual basis, the Administrator
shall, by order, promulgate to the general public updated
rankings that are (1) in accordance with those regulations,
and (2) reflect the scientific evidence available at the time
of promulgation. The Administrator shall open and maintain an
ongoing public docket for receipt of data and other
information submitted by any person with respect to such
annual promulgation of rankings.

TITLE V--ENFORCEMENT PROVISIONS

SEC. 501. PROHIBITED ACTS.

The following acts and the causing thereof are hereby
prohibited--
(1) the introduction or delivery for introduction into
interstate commerce of any tobacco product that is
adulterated or misbranded;
(2) the adulteration or misbranding of any tobacco product
in interstate commerce;
(3) the receipt in interstate commerce of any tobacco
product that is known to be adulterated or misbranded, and
the delivery or proffered delivery thereof for pay or
otherwise;
(4) the failure to establish or maintain any record, or
make any report or other submission, or to provide any notice
required by or under this Act; or the refusal to permit
access to, verification of, or copying of any record as
required by this Act;
(5) the refusal to permit entry or inspection as authorized
by this Act;
(6) the making to the Administrator of a statement, report,
certification or other submission required by this Act, with
knowledge that such statement, report, certification, or
other submission is false in a material aspect;
(7) the manufacturing, shipping, receiving, storing,
selling, distributing, possession, or use of any tobacco
product with knowledge that it is an illicit tobacco product;
(8) the forging, simulating without proper permission,
falsely representing, or without proper authority using any
brand name;
(9) the using by any person to his or her own advantage, or
revealing, other than to the Administrator or officers or
employees of the Agency, or to the courts when relevant in
any judicial proceeding under this Act, any information
acquired under authority of this Act concerning any item
which as a trade secret is entitled to protection; except
that the foregoing does not authorize the withholding of
information from either House of Congress or from, to the
extent of matter within its jurisdiction, any committee or
subcommittee of such committee or any joint committee of
Congress or any subcommittee of such joint committee;
(10) the alteration, mutilation, destruction, obliteration,
or removal of the whole or any part of the labeling of, or
the doing of any other act with respect to, a tobacco
product, if such act is done while such tobacco product is
held for sale (whether or not the first sale) after shipment
in interstate commerce, and results in such tobacco product
being adulterated or misbranded;
(11) the importation of any tobacco product that is
adulterated, misbranded, or otherwise not in compliance with
this Act; and
(12) the commission of any act prohibited by section 201 of
this Act.

SEC. 502. INJUNCTION PROCEEDINGS.

(a) The district courts of the United States shall have
jurisdiction, for cause shown, to restrain violations of this
Act, except for violations of section 701(k).
(b) In case of an alleged violation of an injunction or
restraining order issued under this section, which also
constitutes a violation of this Act, trial shall be by the
court, or upon demand of the defendant, by a jury.

[[Page S6097]]

SEC. 503. PENALTIES.

(a) Criminal Penalties.--Any person who willfully violates
a provision of section 501 of this Act shall be imprisoned
for not more than one year or fined not more than $25,000, or
both.
(b) Civil Penalties for Violation of Section 803.--
(1) Any person who knowingly distributes or sells, other
than through retail sale or retail offer for sale, any
cigarette brand style in violation of section 803(a)--
(A) for a first offense shall be liable for a civil penalty
not to exceed $10,000 for each distribution or sale, or
(B) for a second offense shall be liable for a civil
penalty not to exceed $25,000 for each distribution or sale,
except that the penalty imposed against any person with
respect to violations during any 30-day period shall not
exceed $100,000.
(2) Any retailer who knowingly distributes, sells or offers
for sale any cigarette brand style in violation of section
803(a) shall--
(A) for a first offense for each sale or offer for sale of
cigarettes, if the total number of packages of cigarettes
sold or offered for sale--
(i) does not exceed 50 packages of cigarettes, be liable
for a civil penalty not to exceed $500 for each sale or offer
for sale, and
(ii) exceeds 50 packages of cigarettes, be liable for a
civil penalty not to exceed $1,000 for each sale or offer for
sale;
(B) for each subsequent offense for each sale or offer for
sale of cigarettes, if the total number of cigarettes sold or
offered for sale--
(i) does not exceed 50 packages of cigarettes, be liable
for a civil penalty not to exceed $2,000 for each sale or
offer for sale, and
(ii) exceeds 50 packages of cigarettes, be liable for a
civil penalty not to exceed $5,000 for each sale or offer for
sale;
except that the penalty imposed against any person during any
30-day period shall not exceed $25,000.

SEC. 504. SEIZURE.

(a) Articles Subject to Seizure.--
(1) Any tobacco product that is adulterated or misbranded
when introduced into or while in interstate commerce or while
held for sale (whether or not the first sale) after shipment
in interstate commerce, or which may not, under the
provisions of this Act, be introduced into interstate
commerce, shall be liable to be proceeded against while in
interstate commerce, or at any time thereafter, on libel of
information and condemned in any district court of the United
States within the jurisdiction of which the tobacco product
is found. No libel for condemnation shall be instituted under
this Act for any alleged misbranding if there is pending in
any court a libel for condemnation proceeding under this Act
based upon the same alleged misbranding, and not more than
one such proceeding shall be instituted if no such proceeding
is so pending, except that such limitations shall not apply--
(A) when such misbranding has been the basis of a prior
judgment in favor of the United States, in a criminal,
injunction, or libel for condemnation proceeding under this
Act, or
(B) when the Administrator has probable cause to believe
from facts found, without hearing, by the Administrator or
any officer or employee of the Agency that the misbranded
tobacco product is dangerous to health beyond the inherent
danger to health posed by tobacco, or that the labeling of
the misbranded tobacco product is fraudulent, or would be in
a material respect misleading to the injury or damage of the
purchaser or consumer. In any case where the number of libel
for condemnation proceedings is limited as above provided,
the proceeding pending or instituted shall, on application of
the claimant, seasonably made, be removed for trial to any
district agreed upon by stipulation between the parties, or,
in case of failure to so stipulate within a reasonable time,
the claimant may apply to the court of the district in which
the seizure has been made, and such court (after giving the
United States attorney for such district reasonable notice
and opportunity to be heard) shall by order, unless good
cause to the contrary is shown, specify a district of
reasonable proximity to the claimant's principal place of
business, to which the case shall be removed for trial.
(2) The following shall be liable to be proceeded against
at any time on libel of information and condemned in any
district court of the United States within the jurisdiction
of which they are found--
(A) any tobacco product that is an illicit tobacco product;
(B) any container of an illicit tobacco product;
(C) any equipment or thing used in making an illicit
tobacco product; and
(D) any adulterated or misbranded tobacco product.
(3)(A) Except as provided in subparagraph (B), no libel for
condemnation may be instituted under paragraph (1) or (2)
against any tobacco product which--
(i) is misbranded under this Act because of its
advertising, and
(ii) is being held for sale to the ultimate consumer in an
establishment other than an establishment owned or operated
by a manufacturer, packer, or distributor of the tobacco
product.
(B) A libel for condemnation may be instituted under
paragraph (1) or (2) against a tobacco product described in
subparagraph (A) if the tobacco product's advertising which
resulted in the tobacco product being misbranded was
disseminated in the establishment in which the tobacco
product is being held for sale to the ultimate consumer--
(i) such advertising was disseminated by, or under the
direction of, the owner or operator of such establishment, or
(ii) all or part of the cost of such advertising was paid
by such owner or operator.
(b) Procedures.--The tobacco product, equipment, or other
thing proceeded against shall be liable to seizure by process
pursuant to the libel, and the procedure in cases under this
section shall conform, as nearly as may be, to the procedure
in admiralty; except that on demand of either party any issue
of fact joined in any such case shall be tried by jury. When
libel for condemnation proceedings under this section,
involving the same claimant and the same issues of
adulteration or misbranding, are pending in two or more
jurisdictions, such pending proceedings, upon application of
the claimant seasonably made to the court of one such
jurisdiction, shall be consolidated for trial by order of
such court, and tried in (1) any district selected by the
claimant where one of such proceedings is pending; or (2) a
district agreed upon by stipulation between the parties. If
no order for consolidation is so made within a reasonable
time, the claimant may apply to the court of one such
jurisdiction and such court (after giving the United States
attorney for such district reasonable notice and opportunity
to be heard) shall by order, unless good cause to the
contrary is shown, specify a district of reasonable proximity
to the claimant's principal place of business, in which all
such pending proceedings shall be consolidated for trial and
tried. Such order of consolidation shall not apply so as to
require the removal of any case the date for trial of which
has been fixed. The court granting such order shall give
prompt notification thereof to the other courts having
jurisdiction of the cases covered thereby.
(c) Samples and Analyses.--The court at any time after
seizure up to a reasonable time before trial shall by order
allow any party to a condemnation proceeding, the party's
attorney or agent, to obtain a representative sample of the
article seized and a true copy of the analysis, if any, on
which the proceeding is based and the identifying marks or
numbers, if any, of the packages from which the samples
analyzed were obtained.
(d) Disposition of Condemned Tobacco Products.--(1) Any
tobacco product condemned under this section shall, after
entry of the decree, be disposed of by destruction or sale as
the court may, in accordance with the provisions of this
section, direct; and the proceeds thereof, if sold, less the
legal costs and charges, shall be paid into the Treasury of
the United States; but such tobacco product shall not be sold
under such decree contrary to the provisions of this Act or
the laws of the jurisdiction in which sold. After entry of
the decree and upon the payment of the costs of such
proceedings and the execution of a good and sufficient bond
conditioned that such article shall not be sold or disposed
of contrary to the provisions of this Act or the laws of any
State in which sold, the court may by order direct that such
tobacco product be delivered to the owner thereof to be
destroyed or brought into compliance with the provisions of
this Act, under the supervision of an officer or employee
duly designated by the Administrator; and the expenses of
such supervision shall be paid by the person obtaining
release of the tobacco product under bond. If the tobacco
product was imported into the United States and the person
seeking its release establishes (A) that the adulteration,
misbranding, or violation did not occur after the tobacco
product was imported, and (B) that the person seeking the
release of the tobacco product had no cause for believing
that it was adulterated, misbranded, or in violation before
it was released from customs custody, the court may permit
the tobacco product to be delivered to the owner for
exportation under section 709 in lieu of destruction upon a
showing by the owner that there is a reasonable certainty
that the tobacco product will not be re-imported into the
United States.
(2) The provisions of paragraph (1) of this subsection
shall, to the extent deemed appropriate by the court, apply
to any equipment or other thing which is not otherwise within
the scope of such paragraph and which is referred to in
paragraph (2) of subsection (a).
(3) Whenever in any proceeding under this section,
involving paragraph (2) of subsection (a), the condemnation
of any equipment or thing (other than a tobacco product) is
decreed, the court shall allow the claim of any claimant, to
the extent of such claimant's interest, for remission or
mitigation of such forfeiture if such claimant proves to the
satisfaction of the court (A) that such claimant has not
caused the equipment or thing to be within one of the
categories referred to in such paragraph (2) and has no
interest in any tobacco product referred to therein, (B) that
such claimant has an interest in such equipment or other
thing as owner or lienor or otherwise, acquired by such
claimant in good faith, and (C) that such claimant at no time
had any knowledge or reason to believe that such equipment or
other thing was being or would be used in, or to facilitate,
the violation of laws of the United States relating to any
illicit tobacco product.
(e) Costs and Fees.--When a decree of condemnation is
entered against the tobacco product or other article, court
costs and fees, and storage and other proper expenses shall

[[Page S6098]]

be awarded against the person, if any, intervening as
claimant of the tobacco product or other article.
(f) Removal for Trial.--In the case of removal for trial of
any case as provided by subsection (a) or (b)--
(1) The clerk of the court from which removal is made shall
promptly transmit to the court in which the case is to be
tried all records in the case necessary in order that such
court may exercise jurisdiction.
(2) The court to which such case was removed shall have the
powers and be subject to the duties, for purposes of such
case, which the court from which removal was made would have
had, or to which such court would have been subject, if such
case had not been removed.
(g) Administrative Detention of Tobacco Products.--
(1) Detention authority.--
(A) In general.--An officer or qualified employee of the
Agency may order the detention, in accordance with this
subsection, of any tobacco product that is found during an
inspection, examination, or investigation under this Act
conducted by such officer or qualified employee, if the
officer or qualified employee has credible evidence or
information indicating that such article presents a threat of
serious adverse health consequences beyond those normally
inherent in the use of tobacco products.
(B) Administrator's approval.--A tobacco product or
component thereof may be ordered detained under subparagraph
(A) if, but only if, the Administrator or an official
designated by the Administrator approves the order. An
official may not be so designated unless the official is an
officer with supervisory responsibility for the inspection,
examination, or investigation that led to the order.
(2) Period of detention.--A tobacco product may be detained
under paragraph (1) for a reasonable period, not to exceed 20
days, unless a greater period, not to exceed 30 days, is
necessary, to institute an action under subsection (a) or
section 702.
(3) Security of detained tobacco product.--An order under
paragraph (1) may require that the tobacco product to be
detained be labeled or marked as detained, and shall require
that the tobacco product be maintained in or removed to a
secure facility, as appropriate. A tobacco product subject to
such an order shall not be transferred by any person from the
place at which the tobacco product is ordered detained, or
from the place to which the tobacco product is so removed, as
the case may be, until released by the Administrator or until
the expiration of the detention period applicable under such
order, whichever occurs first. This subsection may not be
construed as authorizing the delivery of the tobacco product
pursuant to the execution of a bond while the tobacco product
is subject to the order, and section 709 does not authorize
the delivery of the tobacco product pursuant to the execution
of a bond while the article is subject to the order.
(4) Appeal of detention order.--
(A) In general.--With respect to a tobacco product ordered
detained under paragraph (1), any person who would be
entitled to be a claimant of such tobacco product if the
tobacco product were seized under subsection (a) may appeal
the order to the Administrator. Within five days after such
an appeal is filed, the Administrator, after providing
opportunity for an informal hearing, shall confirm or
terminate the order involved, and such confirmation by the
Administrator shall be considered a final agency action for
purposes of section 702 of title 5, United States Code. If
during such five-day period the Administrator fails to
provide such an opportunity, or to confirm or terminate such
order, the order is deemed to be terminated.
(B) Effect of instituting court action.--The process under
subparagraph (A) for the appeal of an order under paragraph
(1) terminates if the Administrator institutes an action
under subsection (a) or section 702 regarding the tobacco
product involved.

SEC. 505. REPORT OF MINOR VIOLATIONS.

Nothing in this Act shall be construed as requiring the
Administrator to report for prosecution, or for institution
of libel or injunction proceedings, minor violations of this
Act whenever the Administrator believes that the public
interest will be adequately served by a suitable written
notice or warning.

SEC. 506. INSPECTION.

(a) Authority To Inspect.--The Administrator shall have the
power to inspect the premises of a tobacco product
manufacturer for purposes of determining compliance with this
Act, or the regulations promulgated under it. Officers of the
Agency designated by the Administrator, upon presenting
appropriate credentials and a written notice to the person in
charge of the premises, are authorized to enter, at
reasonable times, without a search warrant, any factory,
warehouse, or other establishment in which tobacco products
are manufactured, processed, packaged, or held for domestic
distribution. Any such inspection shall be conducted within
reasonable limits and in a reasonable manner, and shall be
limited to examining only those things, including but not
limited to records, relevant to determining whether
violations of this Act, or regulations under it, have
occurred. No inspection authorized by this section shall
extend to financial data, sales data other than shipment
data, pricing data, personnel data (other than data as to
qualifications of technical and professional personnel
performing functions subject to this Act), or research data.
A separate notice shall be given for each such inspection,
but a notice shall not be required for each entry made during
the period covered by the inspection. Each such inspection
shall be commenced and completed with reasonable promptness.
(b) Report of Observations.--Before leaving the premises,
the officer of the Agency who has supervised or conducted the
inspection shall give to the person in charge of the premises
a report in writing setting forth any conditions or practices
that appear to manifest a violation of this Act, or the
regulations under it.
(c) Samples.--If the officer has obtained any sample in the
course of inspection, prior to leaving the premises that
officer shall give to the person in charge of the premises a
receipt describing the samples obtained. As to each sample
obtained, the officer shall furnish promptly to the person in
charge of the premises a copy of the sample and of any
analysis made upon the sample.

SEC. 507. EFFECT OF COMPLIANCE.

Compliance with the provisions of this Act and the
regulations promulgated under it shall constitute a complete
defense to any civil action, including but not limited to any
products liability action, that seeks to recover damages,
whether compensatory or punitive, based upon an alleged
defect in the labeling or advertising of any tobacco product
distributed for sale domestically.

SEC. 508. IMPORTS.

(a) Imports; List of Registered Foreign Establishments;
Samples From Unregistered Foreign Establishments; Examination
and Refusal of Admission.--The Secretary of Homeland Security
shall deliver to the Administrator, upon request by the
Administrator, samples of tobacco products that are being
imported or offered for import into the United States, giving
notice thereof to the owner or consignee, who may appear
before the Administrator and have the right to introduce
testimony. The Administrator shall furnish to the Secretary
of Homeland Security a list of establishments registered
pursuant to subsection (d) of section 109 of this Act, and
shall request that, if any tobacco products manufactured,
prepared, or processed in an establishment not so registered
are imported or offered for import into the United States,
samples of such tobacco products be delivered to the
Administrator, with notice of such delivery to the owner or
consignee, who may appear before the Administrator and have
the right to introduce testimony. If it appears from the
examination of such samples or otherwise that (1) such
tobacco product is forbidden or restricted in sale in the
country in which it was produced or from which it was
exported, or (2) such tobacco product is adulterated,
misbranded, or otherwise in violation of this Act, then such
tobacco product shall be refused admission, except as
provided in subsection (b) of this section. The Secretary of
Homeland Security shall cause the destruction of any such
tobacco product refused admission unless such tobacco product
is exported, under regulations prescribed by the Secretary of
Homeland Security, within ninety days of the date of notice
of such refusal or within such additional time as may be
permitted pursuant to such regulations.
(b) Disposition of Refused Tobacco Products.--Pending
decision as to the admission of a tobacco product being
imported or offered for import, the Secretary of Homeland
Security may authorize delivery of such tobacco product to
the owner or consignee upon the execution by such consignee
of a good and sufficient bond providing for the payment of
such liquidated damages in the event of default as may be
required pursuant to regulations of the Secretary of Homeland
Security. If it appears to the Administrator that a tobacco
product included within the provisions of clause (3) of
subsection (a) of this section can, by relabeling or other
action, be brought into compliance with this Act or rendered
other than a tobacco product, final determination as to
admission of such tobacco product may be deferred and, upon
filing of timely written application by the owner or
consignee and the execution by such consignee of a bond as
provided in the preceding provisions of this subsection, the
Administrator may, in accordance with regulations, authorize
the applicant to perform such relabeling or other action
specified in such authorization (including destruction or
export of rejected tobacco products or portions thereof, as
may be specified in the Administrator's authorization). All
such relabeling or other action pursuant to such
authorization shall in accordance with regulations be under
the supervision of an officer or employee of the Agency
designated by the Administrator, or an officer or employee of
the Department of Homeland Security designated by the
Secretary of Homeland Security.
(c) Charges Concerning Refused Tobacco Products.--All
expenses (including travel, per diem or subsistence, and
salaries of officers or employees of the United States) in
connection with the destruction provided for in subsection
(a) of this section and the supervision of the relabeling or
other action authorized under the provisions of subsection
(b) of this section, the amount of such expenses to be
determined in accordance with regulations, and all expenses
in connection with the storage, cartage, or labor with
respect to any tobacco product refused admission under
subsection (a) of this section, shall be paid by the owner or
consignee and, in default of such payment, shall

[[Page S6099]]

constitute a lien against any future importations made by
such owner or consignee.

SEC. 509. TOBACCO PRODUCTS FOR EXPORT.

(a) Exemption for Tobacco Products Exported.--Except as
provided in subsection (b), a tobacco product intended for
export shall be exempt from this Act if--
(1) it is not in conflict with the laws of the country to
which it is intended fore export, as shown by either (A) a
document issued by the government of that country or (B) a
document provided by a person knowledgeable with respect to
the relevant laws of that country and qualified by training
and experience to opine on whether the tobacco product is or
is not in conflict with such laws;
(2) it is labeled on the outside of the shipping package
that it is intended for export; and
(3) the particular units of tobacco product intended for
export have not been sold or offered for sale in domestic
commerce.
(b) Products for U.S. Armed Forces Overseas.--A tobacco
product intended for export shall not be exempt from this Act
if it is intended for sale or distribution to members or
units of the Armed Forces of the United States located
outside of the United States.
(c) This Act shall not apply to a person that manufactures
and/or distributes tobacco products solely for export under
subsection (a), except to the extent such tobacco products
are subject to subsection (b).

TITLE VI--MISCELLANEOUS PROVISIONS

SEC. 601. USE OF PAYMENTS UNDER THE MASTER SETTLEMENT
AGREEMENT AND INDIVIDUAL STATE SETTLEMENT
AGREEMENTS.

(a) Reduction of Grant Amounts.--(1) For fiscal year 2010
and each subsequent fiscal year, the Secretary shall reduce,
as provided in subsection (b), the amount of any grant under
section 1921 of the Public Health Service Act (42 U.S.C.
Sec.  300x-21) for any State that spends on tobacco control
programs from the funds received by such State pursuant to
the Master Settlement Agreement, the Florida Settlement
Agreement, the Minnesota Settlement Agreement, the
Mississippi Memorandum of Understanding, or the Texas
Settlement Agreement, as applicable, less than 20 percent of
the amounts received by that State from settlement payments.
(2) In the case of a State whose legislature does not
convene a regular session in fiscal year 2009 or 2010, and in
the case of a State whose legislature does not convene a
regular session in fiscal year 2010, the requirement
described in subsection (a)(1) as a condition of receipt of a
grant under section 1921 of the Public Health Service Act
shall apply only for fiscal year 2009 and subsequent fiscal
years.
(b) Determination of State Spending.--Before making a grant
under section 1921 of the Public Health Service Act, section
300x-21 of title 42, United States Code, to a State for the
first applicable fiscal year or any subsequent fiscal year,
the Secretary shall make a determination of whether, during
the immediately preceding fiscal year, the State has spent on
tobacco control programs, from the funds received by such
State pursuant to the Master Settlement Agreement, the
Florida Settlement Agreement, the Minnesota Settlement
Agreement, the Mississippi Memorandum of Understanding, or
the Texas Settlement Agreement, as applicable, at least the
amount referenced in (a)(1). If, after notice to the State
and an opportunity for a hearing, the Secretary determines
that the State has spent less than such amount, the Secretary
shall reduce the amount of the allotment under section 300x-
21 of title 42, United States Code, for the State for the
fiscal year involved by an amount equal to--
(1) in the case of the first applicable fiscal year, 10
percent of the amount determined under section 300x-33 of
title 42, United States Code, for the State for the fiscal
year;
(2) in the case of the first fiscal year following such
applicable fiscal year, 20 percent of the amount determined
under section 300x-33 of title 42, United States Code, for
the State for the fiscal year;
(3) in the case of the second such fiscal year, 30 percent
of the amount determined under section 300x-33 of title 42,
United States Code, for the State for the fiscal year; and
(4) in the case of the third such fiscal year or any
subsequent fiscal year, 40 percent of the amount determined
under section 300x-33 of title 42, United States Code, for
the State for the fiscal year.
The Secretary shall not have authority or discretion to grant
to any State a waiver of the terms and requirements of this
subsection or subsection (a).
(c) Definitions.--For the purposes of this section--
(1) The term ``first applicable fiscal year'' means--
(A) fiscal year 2011, in the case of any State described in
subsection (a)(2) of this section; and
(B) fiscal year 2010, in the case of any other State.
(2) The term ``Florida Settlement Agreement'' means the
Settlement Agreement, together with the exhibits thereto,
entered into on August 25, 1997, between the State of Florida
and signatory tobacco product manufacturers, as specified
therein.
(3) The term ``Master Settlement Agreement'' means the
Master Settlement Agreement, together with the exhibits
thereto, entered into on November 23, 1998, between the
signatory States and signatory tobacco product manufacturers,
as specified therein.
(4) The term ``Minnesota Settlement Agreement'' means the
Settlement Agreement, together with the exhibits thereto,
entered into on May 8, 1998, between the State of Minnesota
and signatory tobacco product manufacturers, as specified
therein.
(5) The term ``Mississippi Memorandum of Understanding''
means the Memorandum of Understanding, together with the
exhibits thereto and Settlement Agreement contemplated
therein, entered into on July 2, 1997, between the State of
Mississippi and signatory tobacco product manufacturers, as
specified therein.
(6) The term ``Secretary'' means the Secretary of Health
and Human Services.
(7) The term ``Texas Settlement Agreement'' means the
Settlement Agreement, together with the exhibits thereto,
entered into on January 16, 1998, between the State of Texas
and signatory tobacco product manufacturers, as specified
therein.

SEC. 602. INSPECTION BY THE ALCOHOL AND TOBACCO TAX TRADE
BUREAU OF RECORDS OF CERTAIN CIGARETTE AND
SMOKELESS TOBACCO SELLERS.

(a) In General.--Any officer of the Bureau of the Alcohol
and Tobacco Tax Trade Bureau may, during normal business
hours, enter the premises of any person described in
subsection (b) for the purposes of inspecting--
(1) any records or information required to be maintained by
such person under the provisions of law referred to in
subsection (d); or
(2) any cigarettes or smokeless tobacco kept or stored by
such person at such premises.
(b) Covered Persons.--Subsection (a) applies to any person
who engages in a delivery sale, and who ships, sells,
distributes, or receives any quantity in excess of 10,000
cigarettes, or any quantity in excess of 500 single-unit
consumer-sized cans or packages of smokeless tobacco, within
a single month.
(c) Relief.--
(1) In general.--The district courts of the United States
shall have the authority in a civil action under this
subsection to compel inspections authorized by subsection
(a).
(2) Violations.--Whoever violates subsection (a) or an
order issued pursuant to paragraph (1) shall be subject to a
civil penalty in an amount not to exceed $10,000 for each
violation.
(d) Covered Provisions of Law.--The provisions of law
referred to in this subsection are--
(1) the Act of October 19, 1949 (15 U.S.C. 375; commonly
referred to as the ``Jenkins Act'');
(2) chapter 114 of title 18, United States Code; and
(3) this Act.
(e) Delivery Sale Defined.--In this section, the term
``delivery sale'' has the meaning given that term in 2343(e)
of title 18, United States Code, as amended by this Act.

SEC. 603. SEVERABILITY.

If any provision of this Act, the amendments made by this
Act, or the application of any provision of this Act to any
person or circumstance is held to be invalid, the remainder
of this Act, the amendments made by this Act, and the
application of the provisions of this Act to any other person
or circumstance shall not be affected, and shall continue to
be enforced to the fullest extent possible.

TITLE VII--TOBACCO GROWER PROTECTION

SEC. 701. TOBACCO GROWER PROTECTION.

No provision in this Act shall allow the Administrator or
any other person to require changes to traditional farming
practices, including standard cultivation practices, curing
processes, seed composition, tobacco type, fertilization,
soil, record keeping, or any other requirement affecting
farming practices.

TITLE VIII--RESTRICTIONS ON YOUTH ACCESS TO TOBACCO PRODUCTS AND
EXPOSURE OF YOUTHS TO TOBACCO PRODUCT MARKETING AND ADVERTISING

SEC. 801. PROHIBITIONS ON YOUTH TARGETING.

Effective beginning on the date that is 18 months after the
effective date of this Act, no person shall engage in any of
the following activities or practices in the advertising,
promotion, or marketing of any tobacco product:
(1) The use, or causing the use, of any cartoon in the
advertising, promoting, packaging, or labeling of any tobacco
product.
(2) The use, or causing the use, of any human image in the
advertising, promoting, packaging, or labeling of any tobacco
product, except for the following:
(A) The use, or continued use, in advertising, promoting,
marketing, packaging, or labeling of any human image
appearing on a tobacco product package before December 31,
2009.
(B) The use, or continued use, of a human image in the
advertising, promoting, or marketing of a tobacco product, if
conducted solely in an adult-only facility or facilities.
(C) The use, or continued use, of a human image in a
tobacco product communication means directed solely to
persons that the tobacco product manufacturer has a good-
faith belief are age-verified adults.
(3) The advertising of tobacco products in any magazine or
newspaper intended for distribution to the general public.
(4) The engaging in any brand name sponsorship in the
United States, other than a brand name sponsorship occurring
solely in an adult-only facility or facilities.

[[Page S6100]]

(5) The engaging in any brand name sponsorship of any event
in the United States in which any paid participants or
contestants are youths.
(6) The sponsoring of any athletic event between opposing
teams in any football, basketball, baseball, soccer, or
hockey league.
(7)(A) The securing of a right, by agreement, to name any
stadium or arena located within the United States with a
brand name; or
(B) otherwise causing a stadium or arena located within the
United States to be named with a brand name.
(8) The securing of a right by agreement pursuant to which
payment is made or other consideration is provided to use a
brand name in association with any football, basketball,
baseball, soccer, or hockey league, or any team involved in
any such league.
(9) The use of, or causing the use of, by agreement
requiring the payment of money or other consideration, a
brand name with any nationally recognized or nationally
established trade name or brand designation of any non-
tobacco item or service, or any nationally recognized or
nationally established sports team, entertainment group or
individual celebrity for purposes of advertising, except for
an agreement between or among persons that enter into such
agreement for the sole purpose of avoiding infringement
claims.
(10) The license, express authorization, or otherwise
causing of any person to use or advertise within the United
States any brand name in a manner that--
(A) does not pertain to a tobacco product; or
(B) causes that person to use the brand name to advertise,
promote, package or label, distribute, or sell any product or
service that is not a tobacco product.
(11) The marketing, distribution, offering, selling,
licensing, or authorizing of, or the causing to be marketed,
distributed, offered, sold, licensed, or authorized, any
apparel or other merchandise (other than a tobacco product)
bearing a brand name, except--
(A) apparel or other merchandise that is used by
individuals representing a tobacco product manufacturer
within an adult-only facility and that is not distributed, by
sale or otherwise, to any member of the general public;
(B) apparel or merchandise provided to an adult employee of
a tobacco product manufacturer for use by such employee;
(C) items or materials used to hold or display tobacco
products at retail;
(D) items or materials the sole function of which is to
advertise tobacco products;
(E) written or electronic publications;
(F) coupons or other items used by adults solely in
connection with the purchase of tobacco products;
(G) that the composition, structure, form, or appearance of
any tobacco product, package, label, or labeling shall not be
affected by the prohibitions of this paragraph; and
(H) that no person shall be required to retrieve, collect
or otherwise recover any item or material that was marketed,
distributed, offered, sold, licensed, or caused to be
marketed, distributed, offered, sold, or licensed by such
person.
(12) The distribution, or causing the distribution, of any
free sample domestically, except in an adult-only facility or
facilities to individuals who are age-verified adults.
(13) The making of, or causing to be made, any payment or
the payment of, or causing to be paid, any other
consideration to any other person to use, display, make
reference to, or use as a prop in any performance medium (for
the purposes of this paragraph, the terms ``performance
medium'' and ``performance media'' mean any motion picture,
television show, theatrical production or other live
performance, live or recorded performance of music,
commercial film or video, or video game), any tobacco
product, tobacco product package, advertisement for a tobacco
product, or any other item bearing a brand name; except for
the following:
(A) Performance media for which the audience or viewers are
within one or more adult-only facilities, if such performance
media are not audible or visible to persons outside such
adult-only facility or facilities.
(B) Performance media not intended to be heard or viewed by
the general public.
(C) Instructional performance media that concern tobacco
products and their use, and that are intended to be heard or
viewed only by, or provided only to, age-verified adults.
(D) Performance media used in tobacco product
communications to age-verified adults.
(14) Engaging in outdoor advertising or transit
advertisements of tobacco products within the United States,
except for the following:
(A) Advertising that is within an adult-only facility.
(B) The use of outdoor advertising for purposes of
identification of an adult-only facility, to the extent that
such outdoor advertising is placed at the site, premises, or
location of the adult-only facility.
(C) The use of outdoor advertising in identifying a brand
name sponsorship at an adult-only facility, if such outdoor
advertising--
(i) is placed at the site, premises, or location of the
adult-only facility where such brand name sponsorship will
occur no more than 30 days before the start of the initial
sponsored event; and
(ii) is removed within 10 days after the end of the last
sponsored event.
(15) The distribution or sale domestically of any package
or other container of cigarettes containing fewer than 20
cigarettes.
(16) The advertising of tobacco products on any broadcast,
cable, or satellite transmission to a television or radio
receiver, or other medium of electronic communication subject
to the jurisdiction of the Federal Communications Commission,
except electronic communications--
(A) contained on log-in or home pages containing no tobacco
product advertising other than brand name identification;
(B) in an adult-only facility or facilities; or
(C) through the Internet or other individual user-
accessible electronic communication means, including websites
accessible using the Internet, if the advertiser takes
reasonable action to restrict access to individuals who are
adults by--
(i) requiring individuals accessing such electronic
communications to be age-verified adults, and
(ii) making good faith efforts to verify that such
individuals are adults.
(17) The distribution or sale of tobacco products directly
to consumers by mail or courier, unless the person receiving
purchase requests for tobacco products takes reasonable
action to prevent delivery to individuals who are not adults
by--
(A) requiring that the addressees of the tobacco products
be age-verified adults;
(B) making good faith efforts to verify that such
addressees are adults; and
(C) addressing the tobacco products delivered by mail,
courier or common carrier to a physical address and not a
post office box.
(18) The providing of any gift of a non-tobacco product,
except matches, in connection with the purchase of a tobacco
product.
(19) The engaging in the sponsorship or promotion, or
causing the sponsorship or promotion, of any consumer
sweepstakes, contest, drawing, or similar activity resulting
in the award of a prize in connection with advertising.
(20) The offering, promoting, conducting, or authorizing,
or causing to be offered, promoted, conducted, or authorized,
any consumer sweepstakes, drawing, contest, or other activity
resulting in the award of a prize, based on redemption of a
proof-of-purchase, coupon, or other item awarded as a result
of the purchase or use of a tobacco product.
(21) The making of, or causing to be made, any payment or
the payment of, or causing to be paid, any other
consideration, to any other person with regard to the display
or placement of any cigarettes, or any advertising for
cigarettes, in any retail establishment that is not an adult-
only facility.

TITLE IX--USER FEES

SEC. 901. USER FEES.

(a) Assessment of User Fees.--The Administrator shall
assess an annual user fee for each fiscal year beginning in
fiscal year 2010, in an amount calculated in accordance with
this section, upon each tobacco product manufacturer
(including each importer) that is subject to this Act.
(b) Use of Fee.--The Administrator shall utilize an amount
equal to the amount of user fees collected under this section
in each fiscal year to pay for the costs of the activities of
the Tobacco Regulatory Agency related to the regulation of
tobacco products under this Act.
(c) Amount of Fee.--
(1) In general.--Except as provided in paragraph (2), the
total amount of user fees assessed for each fiscal year
pursuant to this section shall be sufficient, and shall not
exceed the amount necessary, to pay for the costs of the
activities described in subsection (b) for that fiscal year.
(2) Total.--The total assessment under this section--
(A) for fiscal years 2010, 2011, and 2012 shall be
$100,000,000; and
(B) for each subsequent fiscal year, shall not exceed the
limit on the assessment imposed during the previous fiscal
year, as adjusted by the Administrator (after notice,
published in the Federal Register) to be determined on the
basis of both inflationary increases and guidance from the
Scientific Advisory Committee--
(3) Notification.--The Administrator shall notify each
tobacco product manufacturer subject to this section of the
amount of the annual assessment imposed on such tobacco
product manufacturer under subsection (d). Such notifications
shall occur not later than the July 31 prior to the beginning
of the fiscal year for which such assessment is made, and
payments of all assessments shall be made not later than 60
days after each such notification. Such notification shall
contain a complete list of the assessments imposed on tobacco
product manufacturers for that fiscal year.
(d) Liability of Tobacco Product Manufacturers for User
Fees.--
(1) In general.--The user fee to be paid by each tobacco
product manufacturer shall be determined in each fiscal year
by multiplying--
(A) such tobacco product manufacturer's market share of
tobacco products, as determined under regulations issued
pursuant to subsection (e); by
(B) the total user fee assessment for such fiscal year, as
determined under subsection (c).
(2) Limitation.--Except as provided in paragraph (3), no
tobacco product manufacturer shall be required to pay a
percentage of a total annual user fee for all tobacco product
manufacturers that exceeds the market share of such
manufacturer.

[[Page S6101]]

(3) Failure to pay.--If--
(A) a tobacco product manufacturer fails to pay its user
fee share in full by the due date;
(B) the Administrator, after diligent inquiry, concludes
that such manufacturer is unlikely to pay its user fee share
in full by the time such payment will be needed by the
Administrator; and
(C) the Administrator and the Department of Justice make
diligent efforts to obtain payment in full from such tobacco
product manufacturer;
the Administrator may re-allocate the unpaid amount owed by
that tobacco product manufacturer to the other tobacco
product manufacturers on the basis of their respective market
shares. If the Administrator takes such action, the
Administrator shall set a reasonable time, not less than 60
days from the date of the notice of the amount due, for
payment of that amount. If and to the extent that the
Administrator ultimately receives from that tobacco product
manufacturer or any successor to such tobacco product
manufacturer any payment in respect of the previously unpaid
obligation, the Administrator shall credit such payment to
the tobacco product manufacturers that paid portions of the
re-allocated amount, in proportion to their respective
payments of such amount.
(e) Regulations.--Not later than 12 months after the date
of enactment of this Act, the Administrator shall, by
regulation, establish a system for determining the market
shares of tobacco products for each tobacco product
manufacturer subject to this section. In promulgating
regulations under this subsection, the Administrator shall--
(1) take into account the differences between categories
and subcategories of tobacco products in terms of sales,
manner of unit packaging, and any other factors relevant to
the calculation of market share for a tobacco product
manufacturer;
(2) take into account that different tobacco product
manufacturers rely to varying degrees on the sales of
different categories and subcategories of tobacco products;
and
(3) provide that the market share of tobacco products for
each tobacco product manufacturer shall be recalculated on an
annual basis.
______