[House Report 111-72]
[From the U.S. Government Publishing Office]
111th Congress Report
HOUSE OF REPRESENTATIVES
1st Session 111-72
======================================================================
PROVIDING FOR CONSIDERATION OF THE BILL (H.R. 1256) TO PROTECT THE
PUBLIC HEALTH BY PROVIDING THE FOOD AND DRUG ADMINISTRATION WITH
CERTAIN AUTHORITY TO REGULATE TOBACCO PRODUCTS
_______
March 31, 2009.--Referred to the House Calendar and ordered to be
printed
_______
Mr. Polis, from the Committee on Rules,
submitted the following
R E P O R T
[To accompany H. Res. 307]
The Committee on Rules, having had under consideration
House Resolution 307, by a nonrecord vote, report the same to
the House with the recommendation that the resolution be
adopted.
SUMMARY OF PROVISIONS OF THE RESOLUTION
The resolution provides for consideration of H.R. 1256, the
``Family Smoking Prevention and Tobacco Control Act,'' under a
structured rule. The resolution provides one hour of general
debate equally divided and controlled by the chair and ranking
minority member of the Committee on Energy and Commerce.
The resolution waives all points of order against
consideration of the bill except those arising under clause 9
or 10 of rule XXI. It provides that the amendment printed in
part A of this report shall be considered as adopted and the
bill, as amended, shall be considered as read. The resolution
waives all points of order against provisions in the bill, as
amended. This waiver does not affect the point of order
available under clause 9 of rule XXI (regarding earmark
disclosure).
The resolution makes in order the amendment printed in part
B of this report if offered by Rep. Steve Buyer of Indiana or
his designee. The amendment printed in part B of this report
shall be considered as read and shall be debatable for 30
minutes equally divided and controlled by the proponent and an
opponent. The resolution waives all points of order against the
amendment printed in part B of this report except those arising
under clause 9 or 10 of rule XXI. The resolution provides one
motion to recommit with or without instructions.
The resolution provides that, in the engrossment of H.R.
1256, the Clerk shall add at the end of H.R. 1256 as new matter
the text of H.R. 1804, as passed by the House. H.R. 1804 shall
be laid on the table.
EXPLANATION OF WAIVERS
Although the rule waives all points of order against
consideration of the bill (except those arising under clause 9
or 10 of rule XXI), the Committee is not aware of any points of
order against consideration of the bill. The waiver of all
points of order against consideration of the bill is
prophylactic.
Although the resolution waives all points of order against
the bill, the Committee is not aware of any points of order.
The waiver of all points of order against the bill is
prophylactic.
COMMITTEE VOTES
The results of each record vote on an amendment or motion
to report, together with the names of those voting for and
against, are printed below:
Rules Committee record vote No. 56
Date: March 31, 2009.
Measure: H.R. 1256.
Motion by: Mr. Dreier.
Summary of motion: To make in order and provide appropriate
waivers for an amendment by Rep. Rogers, Mike (MI) #4, which
would ensure that no FDA general funds would be used to fund
the regulation of tobacco.
Results: Defeated 2-7.
Vote by Members: McGovern--Nay; Hastings--Nay; Arcuri--Nay;
Perlmutter--Nay; Pingree--Nay; Polis--Nay; Dreier--Yea; Foxx--
Yea; Slaughter--Nay.
Rules Committee record vote No. 57
Date: March 31, 2009.
Measure: H.R. 1256.
Motion by: Dr. Foxx.
Summary of motion: To make in order and provide appropriate
waivers for an amendment by Rep. Burgess, Michael (TX) #1,
which would give the FDA the power to reduce nicotine levels to
zero.
Results: Defeated 2-7.
Vote by Members: McGovern--Nay; Hastings--Nay; Arcuri--Nay;
Perlmutter--Nay; Pingree--Nay; Polis--Nay; Dreier--Yea; Foxx--
Yea; Slaughter--Nay.
SUMMARY OF AMENDMENT IN PART A TO BE CONSIDERED AS ADOPTED
The amendment adds language making clear that the report
required by section 907(e) will examine the impact of the use
of menthol in cigarettes among children. It makes technical
corrections to fully integrate new tobacco provisions contained
in the bill into the Federal Food, Drug, and Cosmetic Act. It
adds language clarifying application of the bill's provisions
to exported tobacco products. It adds language making clear
that the Secretary should consult as appropriate with the
Departments of Treasury and Justice in carrying out section 301
of the bill. Finally, it strikes Title IV of the bill (relating
to TSP and other federal programs).
SUMMARY OF AMENDMENT IN PART B TO BE MADE IN ORDER
The amendment in the nature of a substitute would create a
Tobacco Harm Reduction Center under the Department of HHS to
regulate all tobacco products and establishes a regulatory
scheme to provide for tobacco prevention, education, and
cessation programs.
PART A: TEXT OF AMENDMENT TO BE CONSIDERED AS ADOPTED
Page 75, line 1, insert ``children,'' before ``African
Americans''.
Page 157, lines 8 to 24, move the margin of paragraph (8) 2
ems to the left.
Page 159, lines 19 through 24, strike paragraphs (1) and (2)
and insert the following:
(1) in subsection (a)(1)--
(A) by striking ``devices, or cosmetics''
each place it appears and inserting ``devices,
tobacco products, or cosmetics'';
(B) by striking ``or restricted devices''
each place it appears and inserting
``restricted devices, or tobacco products'';
(C) by striking ``and devices and subject
to'' and all that follows through ``other drugs
or devices'' and inserting ``devices, and
tobacco products and subject to reporting and
inspection under regulations lawfully issued
pursuant to section 505(i) or (k), section 519,
section 520(g), or chapter IX and data relating
to other drugs, devices, or tobacco products'';
Page 160, lines 1 and 3, redesignate paragraphs (3) and (4)
as paragraphs (2) and (3), respectively.
Page 160, lines 20 and 21, strike paragraph (2) and insert
the following:
(2) in subsection (e)(1)--
(A) by inserting ``tobacco product'' after
``drug, device,''; and
(B) by inserting ``, and a tobacco product
intended for export shall not be deemed to be
in violation of section 906(e), 907, 911, or
920(a),'' before ``if it--'';
Page 194, line 6, strike the close quotation mark and the
period at the end and insert the following:
``(e) Consultation.--In carrying out this section, the
Secretary shall consult with the Attorney General of the United
States and the Secretary of the Treasury, as appropriate.''.
Strike title IV of the bill (and make such conforming changes
to the table of contents in section 1(b) of the bill as may be
appropriate).
PART B: TEXT OF AMENDMENT TO BE MADE IN ORDER
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Youth
Prevention and Tobacco Harm Reduction Act''.
(b) Table of Contents.--The table of contents of this Act is
as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.
Sec. 5. Severability.
Sec. 6. Effective date.
TITLE I--AUTHORITY OF THE TOBACCO HARM REDUCTION CENTER
Sec. 100. Definitions.
Sec. 101. Center authority over tobacco products.
Sec. 102. Exclusion of other regulatory programs.
Sec. 103. Existing Federal statutes maintained.
Sec. 104. Proceedings in the name of the United States; subpoenas;
preemption of State and local law; no private right of action.
Sec. 105. Illicit trade.
Sec. 106. Adulterated tobacco products.
Sec. 107. Misbranded tobacco products.
Sec. 108. Submission of health information to the Administrator.
Sec. 109. Registration and listing.
Sec. 110. General provisions respecting control of tobacco products.
Sec. 111. Smoking article standards.
Sec. 112. Notification and other remedies.
Sec. 113. Records and reports on tobacco products.
Sec. 114. Application for review of certain smoking articles.
Sec. 115. Modified risk tobacco products.
Sec. 116. Judicial review.
Sec. 117. Jurisdiction of and coordination with the Federal Trade
Commission.
Sec. 118. Regulation requirement.
Sec. 119. Preservation of State and local authority.
Sec. 120. Tobacco Products Scientific Advisory Committee.
Sec. 121. Drug products used to treat tobacco dependence.
Sec. 122. Advertising and marketing of tobacco products.
TITLE II--TOBACCO PRODUCTS WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT
DISCLOSURE
Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Smokeless tobacco labels and advertising warnings.
TITLE III--PUBIC DISCLOSURES BY TOBACCO PRODUCTS MANUFACTURERS
Sec. 301. Disclosures on packages of tobacco products.
Sec. 302. Disclosures on packages of smokeless tobacco.
Sec. 303. Public disclosure of ingredients.
TITLE IV--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS
Sec. 401. Study and report on illicit trade.
Sec. 402. Amendment to section 1926 of the Public Health Service Act.
Sec. 403. Establishment of rankings.
TITLE V--ENFORCEMENT PROVISIONS
Sec. 501. Prohibited acts.
Sec. 502. Injunction proceedings.
Sec. 503. Penalties.
Sec. 504. Seizure.
Sec. 505. Report of minor violations.
Sec. 506. Inspection.
Sec. 507. Effect of compliance.
Sec. 508. Imports.
Sec. 509. Tobacco products for export.
TITLE VI--MISCELLANEOUS PROVISIONS
Sec. 601. Use of payments under the master settlement agreement and
individual State settlement agreements.
Sec. 602. Preemption of State Laws Implementing Fire Safety Standard for
Cigarettes.
Sec. 603. Inspection by the alcohol and tobacco tax trade bureau of
records of certain cigarette and smokeless tobacco sellers.
Sec. 604. Severability.
TITLE VII--TOBACCO GROWER PROTECTION
Sec. 701. Tobacco grower protection.
SEC. 2. FINDINGS.
The Congress finds the following:
(1) Cigarette smoking is a leading cause of
preventable deaths in the United States. Cigarette
smoking significantly increases the risk of developing
lung cancer, heart disease, chronic bronchitis,
emphysema and other serious diseases with adverse
health conditions.
(2) The risk for serious diseases is significantly
affected by the type of tobacco product and the
frequency, duration and manner of use.
(3) No tobacco product has been shown to be safe and
without risks. The health risks associated with
cigarettes are significantly greater than those
associated with the use of smoke-free tobacco and
nicotine products.
(4) Nicotine in tobacco products is addictive but is
not considered a significant threat to health.
(5) It is the smoke inhaled from burning tobacco
which poses the most significant risk of serious
diseases.
(6) Quitting cigarette smoking significantly reduces
the risk for serious diseases.
(7) Adult tobacco consumers have a right to be fully
and accurately informed about the risks of serious
diseases, the significant differences in the
comparative risks of different tobacco and nicotine-
based products, and the benefits of quitting. This
information should be based on sound science.
(8) Governments, public health officials, tobacco
manufacturers and others share a responsibility to
provide adult tobacco consumers with accurate
information about the various health risks and
comparative risks associated with the use of different
tobacco and nicotine products.
(9) Tobacco products should be regulated in a manner
that is designed to achieve significant and measurable
reductions in the morbidity and mortality associated
with tobacco use. Regulations should enhance the
information available to adult consumers to permit them
to make informed choices, and encourage the development
of tobacco and nicotine products with lower risks than
cigarettes currently sold in the United States.
(10) The form of regulation should be based on the
risks and comparative risks of tobacco and nicotine
products and their respective product categories.
(11) The regulation of marketing of tobacco products
should be consistent with constitutional protections
and enhance an adult consumer's ability to make an
informed choice by providing accurate information on
the risks and comparative risks of tobacco products.
(12) Reducing the diseases and deaths associated with
the use of cigarettes serves public health goals and is
in the best interest of consumers and society. Harm
reduction should be the critical element of any
comprehensive public policy surrounding the health
consequences of tobacco use.
(13) Significant reductions in the harm associated
with the use of cigarettes can be achieved by providing
accurate information regarding the comparative risks of
tobacco products to adult tobacco consumers, thereby
encouraging smokers to migrate to the use of smoke-free
tobacco and nicotine products, and by developing new
smoke-free tobacco and nicotine products and other
actions.
(14) Governments, public health officials,
manufacturers, tobacco producers and consumers should
support the development, production, and commercial
introduction of tobacco leaf, and tobacco and nicotine-
based products that are scientifically shown to reduce
the risks associated with the use of existing tobacco
products, particularly cigarettes.
(15) Adult tobacco consumers should have access to a
range of commercially viable tobacco and nicotine-based
products.
(16) There is substantial scientific evidence that
selected smokeless tobacco products can satisfy the
nicotine addiction of inveterate smokers while
eliminating most, if not all, risk of pulmonary and
cardiovascular complications of smoking and while
reducing the risk of cancer by more than 95 percent.
(17) Transitioning smokers to selected smokeless
tobacco products will eliminate environmental tobacco
smoke and fire-related hazards.
(18) Current ``abstain, quit, or die'' tobacco
control policies in the United States may have reached
their maximum possible public health benefit because of
the large number of cigarette smokers either unwilling
or unable to discontinue their addiction to nicotine.
(19) There is evidence that harm reduction works and
can be accomplished in a way that will not increase
initiation or impede smoking cessation.
(20) Health-related agencies and organizations, both
within the United States and abroad have already gone
on record endorsing Harm Reduction as an approach to
further reducing tobacco related illness and death.
(21) Current Federal policy requires tobacco product
labeling that leaves the incorrect impression that all
tobacco product present equal risk.
SEC. 3. PURPOSE.
The purposes of this Act are--
(1) to provide authority to the Tobacco Harm
Reduction Center by recognizing it as the primary
Federal regulatory authority with respect to tobacco
products as provided for in this Act;
(2) to ensure that the Center has the authority to
address issues of particular concern to public health
officials, especially the use of tobacco by young
people and dependence on tobacco;
(3) to authorize the Center to set national standards
controlling the manufacture of tobacco products and the
identity, public disclosure, and amount of ingredients
used in such products;
(4) to provide new and flexible enforcement authority
to ensure that there is effective oversight of the
tobacco industry's efforts to develop, introduce, and
promote less harmful tobacco products;
(5) to vest the Center with the authority to regulate
the levels of tar, nicotine, and other harmful
components of tobacco products;
(6) to ensure that consumers are better informed
regarding the relative risks for death and disease
between categories of tobacco products;
(7) to continue to allow the sale of tobacco products
to adults in conjunction with measures to ensure that
they are not sold or accessible to underage purchasers;
(8) to impose appropriate regulatory controls on the
tobacco industry;
(9) to promote prevention, cessation, and harm
reduction policies and regulations to reduce disease
risk and the social costs associated with tobacco-
related diseases;
(10) to provide authority to the Department of Health
and Human Services to regulate tobacco products;
(11) to establish national policies that effectively
reduce disease and death associated with cigarette
smoking and other tobacco use;
(12) to establish national policies that encourage
prevention, cessation, and harm reduction measures
regarding the use of tobacco products;
(13) to encourage current cigarette smokers who will
not quit to use noncombustible tobacco or nicotine
products that have significantly less risk than
cigarettes;
(14) to establish national policies that accurately
and consistently inform adult tobacco consumers of
significant differences in risk between respective
tobacco products;
(15) to establish national policies that encourage
and assist the development and awareness of
noncombustible tobacco and nicotine products;
(16) to coordinate national and State prevention,
cessation, and harm reduction programs;
(17) to impose measures to ensure tobacco products
are not sold or accessible to underage purchasers; and
(18) to strengthen Federal and State legislation to
prevent illicit trade in tobacco products.
SEC. 4. SCOPE AND EFFECT.
(a) Intended Effect.--Nothing in this Act (or an amendment
made by this Act) shall be construed to--
(1) establish a precedent with regard to any other
industry, situation, circumstance, or legal action;
(2) affect any action pending in Federal, State, or
Tribal court, or any agreement, consent decree, or
contract of any kind; or
(3) be applicable to tobacco products or component
parts manufactured in the United States for export.
(b) Agricultural Activities.--The provisions of this Act (or
an amendment made by this Act) which authorize the
Administrator to take certain actions with regard to tobacco
and tobacco products shall not be construed to affect any
authority of the Secretary of Agriculture under existing law
regarding the growing, cultivation, or curing of raw tobacco.
(c) Revenue Activities.--The provisions of this Act (or an
amendment made by this Act) which authorize the Administrator
to take certain actions with regard to tobacco products shall
not be construed to affect any authority of the Secretary of
the Treasury under chapter 52 of the Internal Revenue Code of
1986.
SEC. 5. SEVERABILITY.
If any provision of this Act, the amendments made by this
Act, or the application of any provision of this Act to any
person or circumstance is held to be invalid, the remainder of
this Act, the amendments made by this Act, and the application
of the provisions of this Act to any other person or
circumstance shall not be affected and shall continue to be
enforced to the fullest extent possible.
SEC. 6. EFFECTIVE DATE.
Except as otherwise specifically provided, the effective date
of this Act shall be the date of its enactment.
TITLE I--AUTHORITY OF THE TOBACCO HARM REDUCTION CENTER
SEC. 100. DEFINITIONS.
In this Act:
(1) The term ``Administrator'' means the chief
executive of the Tobacco Harm Reduction Center.
(2) The term ``adult'' means any individual who has
attained the minimum age under applicable State law to
be an individual to whom tobacco products may lawfully
be sold.
(3) The term ``adult-only facility'' means a facility
or restricted area, whether open-air or enclosed, where
the operator ensures, or has a reasonable basis to
believe, that no youth is present. A facility or
restricted area need not be permanently restricted to
adults in order to constitute an adult-only facility,
if the operator ensures, or has a reasonable basis to
believe, that no youth is present during any period of
operation as an adult-only facility.
(4) The term ``affiliate'' means a person that
directly or indirectly owns or controls, is owned or
controlled by, or is under common ownership or control
with, another person. The terms ``owns,'' ``is owned'',
and ``ownership'' refer to ownership of an equity
interest, or the equivalent thereof, of 50 percent or
more.
(5) The term ``annual report'' means a tobacco
product manufacturer's annual report to the Center,
which provides ingredient information and nicotine
yield ratings for each brand style that tobacco product
manufacturer manufactures for commercial distribution
domestically.
(6) The term ``brand name'' means a brand name of a
tobacco product distributed or sold domestically,
alone, or in conjunction with any other word,
trademark, logo, symbol, motto, selling message,
recognizable pattern of colors, or any other indicium
of product identification identical or similar to, or
identifiable with, those used for any domestic brand of
tobacco product. The term shall not include the
corporate name of any tobacco product manufacturer that
does not, after the effective date of this Act, sell a
brand style of tobacco product in the United States
that includes such corporate name.
(7) The term ``brand style'' means a tobacco product
having a brand name, and distinguished by the selection
of the tobacco, ingredients, structural materials,
format, configuration, size, package, product
descriptor, amount of tobacco, or yield of ``tar'' or
nicotine.
(8) The term ``Center'' means the Tobacco Harm
Reduction Center.
(9) The term ``cigar'' has the meaning assigned that
term by the Alcohol and Tobacco Tax and Trade Bureau in
section 40.11 of title 27, Code of Federal Regulations.
(10) The term ``cigarette'' means--
(A) any roll of tobacco wrapped in paper or
in any substance not containing tobacco; or
(B) any roll of tobacco wrapped in any
substance containing tobacco which, because of
the appearance of the roll of tobacco, the type
of tobacco used in the filler, or its package
or labeling, is likely to be offered to, or
purchased by, consumers as a cigarette
described in paragraph (1).
(11) The term ``competent and reliable scientific
evidence'' means evidence based on tests, analyses,
research, or studies, conducted and evaluated in an
objective manner by individuals qualified to do so,
using procedures generally accepted in the relevant
scientific disciplines to yield accurate and reliable
results.
(12) The term ``distributor'' means any person who
furthers the distribution of tobacco products, whether
domestic or imported, at any point from the original
place of manufacture to the person who sells or
distributes the tobacco product to individuals for
personal consumption. Common carriers, retailers, and
those engaged solely in advertising are not considered
distributors for purposes of this Act.
(13) The terms ``domestic'' and ``domestically'' mean
within the United States, including activities within
the United States involving advertising, marketing,
distribution, or sale of tobacco products that are
intended for consumption within the United States.
(14) The term ``illicit tobacco product'' means any
tobacco product intended for use by consumers in the
United States--
(A) as to which not all applicable duties or
taxes have been paid in full;
(B) that has been stolen, smuggled, or is
otherwise contraband;
(C) that is counterfeit; or
(D) that has or had a label, labeling, or
packaging stating, or that stated, that the
product is or was for export only, or that it
is or was at any time restricted by section
5704 of title 26, United States Code.
(15) The term ``illicit trade'' means any transfer,
distribution, or sale in interstate commerce of any
illicit tobacco product.
(16) The term ``immediate container'' does not
include package liners.
(17) The term ``Indian tribe'' has the meaning
assigned that term in section 4(e) of the Indian Self
Determination and Education Assistance Act.
(18) The term ``ingredient'' means tobacco and any
substance added to tobacco to have an effect in the
final tobacco product or when the final tobacco product
is used by a consumer.
(19) The term ``International Organization for
Standardization (ISO) testing regimen'' means the
methods for measuring cigarette smoke yields, as set
forth in the most recent version of ISO 3308, entitled
``Routine analytical cigarette-smoking machine--
Definition of standard conditions''; ISO 4387, entitled
``Cigarettes--Determination of total and nicotine-free
dry particulate matter using a routine analytical
smoking machine''; ISO 10315, entitled ``Cigarettes--
Determination of nicotine in smoke condensates--Gas-
chromatographic method''; ISO 10362-1, entitled
``Cigarettes--Determination of water in smoke
condensates--Part 1: Gas-chromatographic method''; and
ISO 8454, entitled ``Cigarettes--Determination of
carbon monoxide in the vapour phase of cigarette
smoke--NDIR method''. A cigarette that does not burn
down in accordance with the testing regimen standards
may be measured under the same puff regimen using the
number of puffs that such a cigarette delivers before
it extinguishes, plus an additional three puffs, or
with such other modifications as the Administrator may
approve.
(20) The term ``interstate commerce'' means all
trade, traffic, or other commerce--
(A) within the District of Columbia, or any
territory or possession of the United States;
(B) between any point in a State and any
point outside thereof;
(C) between points within the same State
through any place outside such State; or
(D) over which the United States has
jurisdiction.
(21) The term ``label'' means a display of written,
printed, or graphic matter upon or applied securely to
the immediate container of a tobacco product.
(22) The term ``labeling'' means all labels and other
written, printed, or graphic matter (1) upon or applied
securely to any tobacco product or any of its
containers or wrappers, or (2) accompanying a tobacco
product.
(23) The term ``little cigar'' has the meaning
assigned that term by the Alcohol and Tobacco Tax and
Trade Bureau in section 40.11 of title 27, Code of
Federal Regulations.
(24) The term ``loose tobacco'' means any form of
tobacco, alone or in combination with any other
ingredient or material, that, because of its
appearance, form, type, packaging, or labeling, is
suitable for use and likely to be offered to, or
purchased by, consumers as tobacco for making or
assembling cigarettes, incorporation into pipes, or
otherwise used by consumers to make any tobacco
product.
(25) The term ``manufacture'' means to design,
manufacture, fabricate, assemble, process, package, or
repackage, label, or relabel, import, or hold or store
in a commercial quantity, but does not include--
(A) the growing, curing, de-stemming, or
aging of tobacco; or
(B) the holding, storing or transporting of a
tobacco product by a common carrier for hire, a
public warehouse, a testing laboratory, a
distributor, or a retailer.
(26) The term ``nicotine-containing product'' means a
product, other than a tobacco product, that contains
added nicotine, whether or not in the form of a salt or
solvate, that has been--
(A) synthetically produced, or
(B) obtained from tobacco or other source of
nicotine.
(27) The term ``package'' means a pack, box, carton,
pouch, or container of any kind in which a tobacco
product or tobacco products are offered for sale, sold,
or otherwise distributed to consumers. The term
``package'' does not include an outer container used
solely for shipping one or more packages of a tobacco
product or tobacco products.
(28) The term ``person'' means any individual,
partnership, corporation, committee, association,
organization or group of persons, or other legal or
business entity.
(29) The term ``proof of age'' means a driver's
license or other form of identification that is issued
by a governmental authority and includes a photograph
and a date of birth of the individual.
(30) The term ``raw tobacco'' means tobacco in a form
that is received by a tobacco product manufacturer as
an agricultural commodity, whether in a form that is
natural, stem, or leaf, cured or aged, or as parts or
pieces, but not in a reconstituted form, extracted pulp
form, or extract form.
(31) The term ``reduced-exposure claim'' means a
statement in advertising or labeling intended for one
or more consumers of tobacco products, that a tobacco
product provides a reduced exposure of users of that
tobacco product to one or more toxicants, as compared
to an appropriate reference tobacco product or category
of tobacco products. A statement or representation that
a tobacco product or the tobacco in a tobacco product
contains ``no additives'' or is ``natural'' or that
uses a substantially similar term is not a reduced-
exposure claim if the advertising or labeling that
contains such statement or representation also contains
the disclosure required by section 108(h) of this Act.
(32) The term ``reduced-risk claim'' means a
statement in advertising or labeling intended for one
or more consumers of smoking articles, that a smoking
article provides to users of that product a reduced
risk of morbidity or mortality resulting from one or
more chronic diseases or serious adverse health
conditions associated with tobacco use, as compared to
an appropriate reference smoking article or category of
smoking articles, even if it is not stated,
represented, or implied that all health risks
associated with using that smoking article have been
reduced or eliminated. A statement or representation
that a smoking article or the tobacco in a smoking
article contains ``no additives,'' or is ``natural,''
or that uses a substantially similar term is not a
reduced-risk claim if the advertising or labeling that
contains such statement or representation also contains
the disclosure required by section 108(h).
(33) The term ``retailer'' means any person that--
(A) sells tobacco products to individuals for
personal consumption; or
(B) operates a facility where the sale of
tobacco products to individuals for personal
consumption is permitted.
(34) The term ``small business'' means a tobacco
product manufacturer that--
(A) has 150 or fewer employees; and
(B) during the 3-year period prior to the
current calendar year, had an average annual
gross revenue from tobacco products that did
not exceed $40,000,000.
(35) The term ``smokeless tobacco product'' means any
form of finely cut, ground, powdered, reconstituted,
processed or shaped tobacco, leaf tobacco, or stem
tobacco, whether or not combined with any other
ingredient, whether or not in extract or extracted
form, and whether or not incorporated within any
carrier or construct, that is intended to be placed in
the oral or nasal cavity, including dry snuff, moist
snuff, and chewing tobacco.
(36) The term ``smoking article'' means any tobacco-
containing article that is intended, when used by a
consumer, to be burned or otherwise to employ heat to
produce a vapor, aerosol or smoke that--
(A) incorporates components of tobacco or
derived from tobacco; and
(B) is intended to be inhaled by the user.
(37) The term ``State'' means any State of the United
States and, except as otherwise specifically provided,
includes any Indian tribe or tribal organization, the
District of Columbia, the Commonwealth of Puerto Rico,
Guam, the Virgin Islands, American Samoa, Wake Island,
Midway Island, Kingman Reef, Johnston Atoll, the
Northern Marianas, and any other trust territory or
possession of the United States.
(38) The term ``tar'' means nicotine-free dry
particulate matter as defined in ISO 4387, entitled
``Cigarettes--Determination of total and nicotine-free
dry particulate matter using a routine analytical
smoking machine''.
(39) The term ``tobacco'' means a tobacco plant or
any part of a harvested tobacco plant intended for use
in the production of a tobacco product, including leaf,
lamina, stem, or stalk, whether in green, cured, or
aged form, whether in raw, treated, or processed form,
and whether or not combined with other materials,
including any by-product, extract, extracted pulp
material, or any other material (other than purified
nicotine) derived from a tobacco plant or any component
thereof, and including strip, filler, stem, powder, and
granulated, blended, or reconstituted forms of tobacco.
(40) The term ``tobacco product'' means--
(A) the singular of ``tobacco products'' as
defined in section 5702(c) of the Internal
Revenue Code of 1986;
(B) any other product that contains tobacco
as a principal ingredient and that, because of
its appearance, type, or the tobacco used in
the product, or its packaging and labeling, is
likely to be offered to, or purchased by,
consumers as a tobacco product as described in
subparagraph (A); and
(C) any form of tobacco or any construct
incorporating tobacco, intended for human
consumption, whether by--
(i) placement in the oral or nasal
cavity;
(ii) inhalation of vapor, aerosol, or
smoke; or
(iii) any other means.
(41) The term ``tobacco product category'' means a
type of tobacco product characterized by its
composition, components, and intended use, and includes
tobacco products classified as cigarettes, loose
tobacco for roll-your-own tobacco products, little
cigars, cigars, pipe tobacco, moist snuff, dry snuff,
chewing tobacco, and other forms of tobacco products
(which are treated in this Act collectively as a single
category).
(42) The term ``tobacco product communication'' means
any means, medium, or manner for providing information
relating to any tobacco product, including face-to-face
interaction, mailings by postal service or courier to
an individual who is an addressee, and electronic mail
to an individual who is an addressee.
(43) The term ``tobacco product manufacturer'' means
an entity that directly--
(A) manufactures anywhere a tobacco product
that is intended to be distributed commercially
in the United States, including a tobacco
product intended to be distributed commercially
in the United States through an importer;
(B) is the first purchaser for resale in the
United States of tobacco products manufactured
outside the United States for distribution
commercially in the United States; or
(C) is a successor or assign of any of the
foregoing.
(44) The term ``toxicant'' means a chemical or
physical agent that produces an adverse biological
effect.
(45) The term ``tribal organization'' has the meaning
assigned that term in section 4(1) of the Indian Self
Determination and Education Assistance Act.
(46) The term ``United States'' means the several
States, as defined in this Act.
(47) The term ``youth'' means any individual who in
not an adult.
SEC. 101. CENTER AUTHORITY OVER TOBACCO PRODUCTS.
(a) In General.--Tobacco products, including modified risk
tobacco products for which an order has been issued in
accordance with section 117, shall be regulated by the
Administrator under this Act.
(b) Applicability.--This Act shall apply to all cigarettes,
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco
and to any other tobacco products that the Administrator by
regulation deems to be subject to this Act.
(c) Center.--The Secretary of Health and Human Services shall
establish within the Department of Health and Human Services
the Tobacco Harm Reduction Center. The head of the Center shall
be an Administrator, who shall assume the statutory authority
conferred by this Act, perform the functions that relate to the
subject matter of this Act, and have the authority to
promulgate regulations for the efficient enforcement of this
Act. In promulgating any regulations under such authority, in
whole or in part or any regulation that is likely to have an
annual effect on the economy of $50,000,000 or more or have a
material adverse effect on adult users of tobacco products,
tobacco product manufacturers, distributors, or retailers, the
Administrator shall--
(1) determine the technological and economic ability
of parties that would be required to comply with the
regulation to comply with it;
(2) consider experience gained under any relevantly
similar regulations at the Federal or State level;
(3) determine the reasonableness of the relationship
between the costs of complying with such regulation and
the public health benefits to be achieved by such
regulation;
(4) determine the reasonable likelihood of measurable
and substantial reductions in morbidity and mortality
among individual tobacco users;
(5) determine the impact to United States tobacco
producers and farm operations;
(6) determine the impact on the availability and use
of tobacco products by minors; and
(7) determine the impact on illicit trade of tobacco
products.
(d) Limitation of Authority.--
(1) In general.--The provisions of this Act shall not
apply to tobacco leaf that is not in the possession of
a manufacturer of tobacco products, or to the producers
of tobacco leaf, including tobacco growers, tobacco
warehouses, and tobacco grower cooperatives, nor shall
any employee of the Center have any authority to enter
onto a farm owned by a producer of tobacco leaf without
the written consent of such producer.
(2) Exception.--Notwithstanding paragraph (1), if a
producer of tobacco leaf is also a tobacco product
manufacturer or controlled by a tobacco product
manufacturer, the producer shall be subject to this Act
in the producer's capacity as a manufacturer. The
exception in this subparagraph shall not apply to a
producer of tobacco leaf who grows tobacco under a
contract with a tobacco product manufacturer and who is
not otherwise engaged in the manufacturing process.
(3) Rule of construction.--Nothing in this Act shall
be construed to grant the Administrator authority to
promulgate regulations on any matter that involves the
production of tobacco leaf or a producer thereof.
(e) Rulemaking Procedures.--Each rulemaking under this Act
shall be in accordance with chapter 5 of title 5, United States
Code.
(f) Consultation Prior to Rulemaking.--Prior to promulgating
rules under this Act, the Administrator shall endeavor to
consult with other Federal agencies as appropriate.
SEC. 102. EXCLUSION OF OTHER REGULATORY PROGRAMS.
(a) Exclusion of Tobacco Products and Nicotine-Containing
Products From the Federal Food, Drug, and Cosmetic Act.--No
tobacco product and no nicotine-containing product shall be
regulated as a food, drug, or device in accordance with section
201 (f), (g) or (h) or Chapter IV or V of the Federal Food,
Drug, and Cosmetic Act, except that any tobacco product
commercially distributed domestically and any nicotine-
containing product commercially distributed domestically shall
be subject to Chapter V of the Federal Food, Drug, and Cosmetic
Act if the manufacturer or a distributor of such product
markets it with an explicit claim that the product is intended
for use in the cure, mitigation, treatment, or prevention of
disease in man or other animals, within the meaning of section
201(g)(1)(C) or section 201(h)(2) of that Act.
(b) Limitation on Effect of This Act.--Nothing in this Act
shall be construed to--
(1) establish a precedent with regard to any other
industry, situation, circumstance, or legal action; or
(2) affect any action pending in any Federal, State,
or Tribal court, or any agreement, consent decree, or
contract of any kind.
(c) Exclusions From Authority of Administrator.--The
authority granted to the Administrator under this Act shall not
apply to--
(1) raw tobacco that is not in the possession or
control of a tobacco product manufacturer;
(2) raw tobacco that is grown for a tobacco product
manufacturer by a grower, and that is in the possession
of that grower or of a person that is not a tobacco
product manufacturer and is within the scope of
subparagraphs (A) through(F) of paragraph (3); or
(3) the activities, materials, facilities, or
practices of persons that are not tobacco product
manufacturers and that are--
(A) producers of raw tobacco, including
tobacco growers;
(B) tobacco warehouses, and other persons
that receive raw tobacco from growers;
(C) tobacco grower cooperatives;
(D) persons that cure raw tobacco;
(E) persons that process raw tobacco; and
(F) persons that store raw tobacco for aging.
If a producer of raw tobacco is also a tobacco product
manufacturer, an affiliate of a tobacco product
manufacturer, or a person producing raw tobacco for a
tobacco product manufacturer, then that producer shall
be subject to this Act only to the extent of that
producer's capacity as a tobacco product manufacturer.
SEC. 103. EXISTING FEDERAL STATUTES MAINTAINED.
Except as amended or repealed by this Act, all Federal
statutes in effect as of the effective date of this Act that
regulate tobacco, tobacco products, or tobacco product
manufacturers shall remain in full force and effect. Such
statutes include, without limitation--
(1) the Federal Cigarette Labeling and Advertising
Act, sections 1331-1340 of title 15, United States
Code, except that section 1335 of title 15, United
States Code, is repealed;
(2) the Comprehensive Smokeless Tobacco Health
Education Act of 1986, sections 4401-4408 of title 15,
United States Code, except that section 4402(f) of
title 15, United States Code, is repealed;
(3) section 300x-26 of title 42, United States Code;
and
(4) those statutes authorizing regulation of tobacco,
tobacco products, or tobacco product manufacturers by
the Federal Trade Commission, the Department of
Agriculture, the Environmental Protection Agency, the
Internal Revenue Service, and the Alcohol and Tobacco
Tax and Trade Bureau of the Department of the Treasury.
SEC. 104. PROCEEDINGS IN THE NAME OF THE UNITED STATES; SUBPOENAS;
PREEMPTION OF STATE AND LOCAL LAW; NO PRIVATE RIGHT
OF ACTION.
In furtherance of this Act:
(1) All proceedings for the enforcement, or to
restrain violations, of this Act shall be by and in the
name of the United States. Subpoenas for witnesses who
are required to attend a court of the United States, in
any district, may run into any other district in any
proceeding under this section. No State, or political
subdivision thereof, may proceed or intervene in any
Federal or State court under this Act or under any
regulation promulgated under it, or allege any
violation thereof except a violation by the
Administrator. Nothing in this Act shall be construed
to create a right of action by any private person for
any violation of any provision of this Act or of any
regulation promulgated under it.
(2) With respect to any subject matter addressed by
this Act or by any regulation promulgated under it, no
requirement or prohibition shall be imposed under State
or local law upon any tobacco product manufacturer or
distributor.
(3) Paragraph (2) shall not apply to any requirement
or prohibition imposed under State or local law before
the date of introduction of the bill that was enacted
as this Act.
SEC. 105. ILLICIT TRADE.
The Administrator shall not promulgate any regulation or take
any other action that has the effect of--
(1) increasing illicit trade involving tobacco or any
tobacco product, or
(2) making affected tobacco products unacceptable to
a substantial number of then current users of such
products, thereby creating a substantial risk that such
users will resort to illicit tobacco products, or
tobacco products that are otherwise noncompliant or
unlawful.
SEC. 106. ADULTERATED TOBACCO PRODUCTS.
A tobacco product shall be deemed to be adulterated--
(1) if it bears or contains any poisonous or
deleterious substance other than--
(A) tobacco;
(B) a substance naturally present in tobacco;
(C) a pesticide or fungicide chemical residue
in or on tobacco if such pesticide or fungicide
chemical is registered by the Environmental
Protection Agency for use on tobacco in the
United States; or
(D) in the case of imported tobacco, a
residue of a pesticide or fungicide chemical
that--
(i) is approved for use in the
country of origin of the tobacco; and
(ii) has not been banned, and the
registration of which has not been
canceled, by the Environmental
Protection Agency for use on tobacco in
the United States) that may render it
injurious to health; but, in case the
substance is not an added substance,
such tobacco product shall not be
considered adulterated under this
subsection if the quantity of such
substance in such tobacco product does
not ordinarily render it injurious to
health;
(2) if there is significant scientific agreement
that, as a result of the tobacco it contains, the
tobacco product presents a risk to human health that is
materially higher than the risk presented by--
(A) such product on the effective date of
this Act; or
(B) if such product was not distributed
commercially domestically on that date, by
comparable tobacco products of the same style
and within the same category that were
commercially distributed domestically on that
date;
(3) if it has been prepared, packed, or held under
unsanitary conditions whereby it may have become
contaminated with filth;
(4) if its package is composed, in whole or in part,
of any poisonous or deleterious substance that may
render the contents injurious to health; or
(5) if its ``tar'' yield is in violation of section
111.
SEC. 107. MISBRANDED TOBACCO PRODUCTS.
A tobacco product shall be deemed to be misbranded--
(1) if its labeling is false or misleading in any
particular;
(2) if in package form unless it bears a label
containing--
(A) an identification of the type of product
it is, by the common or usual name of such type
of product;
(B) an accurate statement of the quantity of
the contents in the package in terms of weight,
measure, or numerical count, except that
reasonable variations shall be permitted, and
exemptions as to small packages shall be
established by regulations promulgated by the
Administrator;
(C) the name and place of business of the
tobacco product manufacturer, packer, or
distributor; and
(D) the information required by section
201(c) and (e) or section 202(c) and (e), as
applicable;
(3) if any word, statement, or other information
required by or under authority of this Act to appear on
the label, labeling, or advertising is not prominently
placed thereon with such conspicuousness (as compared
with other words, statements, or designs on the label,
labeling, or advertising, as applicable) and in such
terms as to render it reasonably likely to be read and
understood by the ordinary individual under customary
conditions of purchase and use;
(4) if any word, statement, or other information is
required by or under this Act to appear on the label,
unless such word, statement, or other information also
appears on the outside container or wrapper, if any, of
the retail package of such tobacco product, or is
easily legible through the outside container or
wrapper;
(5) if it was manufactured, prepared, or processed in
an establishment not duly registered under section 109,
if it was not included in a list required by section
109, or if a notice or other information respecting it
was not provided as required by section 109;
(6) if its packaging, labeling, or advertising is in
violation of this Act or of an applicable regulation
promulgated in accordance with this Act;
(7) if it contains tobacco or another ingredient as
to which a required disclosure under this Act was not
made;
(8) if it is labeled or advertised, or the tobacco
contained in it is advertised, as--
(A) containing ``no additives,'' or any
substantially similar term, unless the labeling
or advertising, as applicable, also contains,
clearly and prominently, the following
disclosure: ``No additives in our tobacco does
NOT mean safer.''; or
(B) being ``natural,'' or any substantially
similar term, unless the labeling or
advertising, as applicable, also contains,
clearly and prominently, the following
disclosure: ``Natural does NOT mean safer.'';
(9) if in its labeling or advertising a term
descriptive of the tobacco in the tobacco product is
used otherwise than in accordance with a sanction or
approval granted by a Federal agency;
(10) if with respect to such tobacco product a
disclosure required by section 603 was not made;
(11) if with respect to such tobacco product a
certification required by section 803 was not submitted
or is materially false or misleading; or
(12) if its manufacturer or distributor made with
respect to it a claim prohibited by section 115.
SEC. 108. SUBMISSION OF HEALTH INFORMATION TO THE ADMINISTRATOR.
(a) Requirement.--Each tobacco product manufacturer or
importer, or agents thereof, shall submit to the Administrator
the following information:
(1) Not later than 18 months after the date of
enactment of the Act, a listing of all ingredients,
including tobacco, substances, compounds, and additives
that are, as of such date, added by the manufacturer to
the tobacco, paper, filter, or other part of each
tobacco product by brand and by quantity in each brand
and brand style.
(2) A description of the content, delivery, and form
of nicotine in each tobacco product measured in
milligrams of nicotine in accordance with regulations
promulgated by the Administrator in accordance with
section 4(e) of the Federal Cigarette Labeling and
Advertising Act.
(3) Beginning 4 years after the date of enactment of
this Act, a listing of all constituents, including
smoke constituents as applicable, identified by the
Administrator as harmful to health in each tobacco
product, and as applicable in the smoke of each tobacco
product, by brand and by quantity in each brand and
subbrand.
(b) Data Submission.--At the request of the Administrator,
each tobacco product manufacturer or importer of tobacco
products, or agents thereof, shall submit the following:
(1) Any or all documents (including underlying
scientific information) relating to research
activities, and research findings, conducted,
supported, or possessed by the manufacturer (or agents
thereof) on the health, toxicological, or physiologic
effects of tobacco products and their constituents
(including smoke constituents), ingredients,
components, and additives.
(2) Any or all documents (including underlying
scientific information) relating to research
activities, and research findings, conducted,
supported, or possessed by the manufacturer (or agents
thereof) that relate to the issue of whether a
significant reduction in risk to health from tobacco
products can occur upon the employment of technology
available to the manufacturer.
An importer of a tobacco product not manufactured in the United
States shall supply the information required of a tobacco
product manufacturer under this subsection.
(c) Data List.--
(1) In general.--Not later than 4 years after the
date of enactment of the Act, and annually thereafter,
the Administrator shall publish in a format that is
understandable and not misleading to a lay person, and
place on public display (in a manner determined by the
Administrator) the list established under subsection
(d).
(2) Consumer research.--The Administrator shall
conduct periodic consumer research to ensure that the
list published under paragraph (1) is not misleading to
lay persons. Not later than 5 years after the date of
enactment of the Act, the Administrator shall submit to
the appropriate committees of Congress a report on the
results of such research, together with recommendations
on whether such publication should be continued or
modified.
(d) Data Collection.--Not later than 36 months after the date
of enactment of this Act, the Administrator shall establish,
and periodically revise as appropriate, a list of harmful
constituents, including smoke constituents, to health in each
tobacco product by brand and by quantity in each brand and
subbrand.
SEC. 109. REGISTRATION AND LISTING.
(a) Definitions.--As used in this section:
(1) The term ``manufacture, preparation, or
processing'' shall include repackaging or otherwise
changing the container, wrapper, or label of any
tobacco product package other than the carton in
furtherance of the distribution of the tobacco product
from the original place of manufacture to the person
that makes final delivery or sale to the ultimate
consumer or user, but shall not include the addition of
a tax marking or other marking required by law to an
already packaged tobacco product.
(2) The term ``name'' shall include in the case of a
partnership the name of the general partner and, in the
case of a privately held corporation, the name of the
chief executive officer of the corporation and the
State of incorporation.
(b) Annual Registration.--Commencing one year after
enactment, on or before December 31 of each year, every person
that owns or operates any establishment in any State engaged in
the manufacture, preparation, or processing of a tobacco
product or products for commercial distribution domestically
shall register with the Administrator its name, places of
business, and all such establishments.
(c) New Producers.--Every person upon first engaging, for
commercial distribution domestically, in the manufacture,
preparation, or processing of a tobacco product or products in
any establishment that it owns or operates in any State shall
immediately register with the Administrator its name, places of
business, and such establishment.
(d) Registration of Foreign Establishments.--
(1) Commencing one year after enactment of this Act,
on or before December 31 of each year, the person that,
within any foreign country, owns or operates any
establishment engaged in the manufacture, preparation,
or processing of a tobacco product that is imported or
offered for import into the United States shall,
through electronic means or other means permitted by
the Administrator, register with the Administrator the
name and place of business of each such establishment,
the name of the United States agent for the
establishment, and the name of each importer of such
tobacco product in the United States that is known to
such person.
(2) Such person also shall provide the information
required by subsection (j), including sales made by
mail, or through the Internet, or other electronic
means.
(3) The Administrator is authorized to enter into
cooperative arrangements with officials of foreign
countries to ensure that adequate and effective means
are available for purposes of determining, from time to
time, whether tobacco products manufactured, prepared,
or processed by an establishment described in paragraph
(1), if imported or offered for import into the United
States, shall be refused admission on any of the
grounds set forth in section 708.
(e) Additional Establishments.--Every person duly registered
in accordance with the foregoing subsections of this section
shall immediately register with the Administrator any
additional establishment that it owns or operates and in which
it begins the manufacture, preparation, or processing of a
tobacco product or products for commercial distribution
domestically or for import into the United States.
(f) Exclusions From Application of This Section.--The
foregoing subsections of this section shall not apply to--
(1) persons that manufacture, prepare, or process
tobacco products solely for use in research, teaching,
chemical or biological analysis, or export; or
(2) such other classes of persons as the
Administrator may by regulation exempt from the
application of this section upon a finding that
registration by such classes of persons in accordance
with this section is not necessary for the protection
of the public health.
(g) Inspection of Premises.--Every establishment registered
with the Administrator pursuant to this section shall be
subject to inspection pursuant to section 706; and every such
establishment engaged in the manufacture, preparation, or
processing of a tobacco product or products shall be so
inspected by one or more officers or employees duly designated
by the Administrator at least once in the two-year period
beginning with the date of registration of such establishment
pursuant to this section and at least once in every successive
two-year period thereafter, except that inspection of
establishments outside the United States may be conducted by
other personnel pursuant to a cooperative arrangement under
subsection (d)(3).
(h) Filing of Lists of Tobacco Products Manufactured,
Prepared, or Processed by Registrants; Statements; Accompanying
Disclosures.--
(1) Every person that registers with the
Administrator under subsection (b), (c), (d), or (e)
shall, at the time of registration under any such
subsection, file with the Administrator a list of all
brand styles (with each brand style in each list listed
by the common or usual name of the tobacco product
category to which it belongs and by any proprietary
name) that are being manufactured, prepared, or
processed by such person for commercial distribution
domestically or for import into the United States, and
that such person has not included in any list of
tobacco products filed by such person with the
Administrator under this paragraph or paragraph (2)
before such time of registration. Such list shall be
prepared in such form and manner as the Administrator
may prescribe, and shall be accompanied by the label
for each such brand style and a representative sampling
of any other labeling and advertising for each;
(2) Each person that registers with the Administrator
under this section shall report to the Administrator
each August for the preceding six-month period from
January through June, and each February for the
preceding six-month period form July through December,
following information:
(A) A list of each brand style introduced by
the registrant for commercial distribution
domestically or for import into the United
States that has not been included in any list
previously filed by such registrant with the
Administrator under this subparagraph or
paragraph (1). A list under this subparagraph
shall list a brand style by the common or usual
name of the tobacco product category to which
it belongs and by any proprietary name, and
shall be accompanied by the other information
required by paragraph (1).
(B) If since the date the registrant last
made a report under this paragraph (or if such
registrant has not previously made a report
under this paragraph, since the effective date
of this Act) such registrant has discontinued
the manufacture, preparation, or processing for
commercial distribution domestically or for
import into the United States of a brand style
included in a list filed by such registrant
under subparagraph (A) or paragraph (1), notice
of such discontinuance, the date of such
discontinuance, and the identity (by the common
or usual name of the tobacco product category
to which it belongs and by any proprietary
name) of such tobacco product.
(C) If, since the date the registrant
reported pursuant to subparagraph (B) a notice
of discontinuance of a tobacco product, the
registrant has resumed the manufacture,
preparation, or processing for commercial
distribution domestically or for import into
the United States of that brand style, notice
of such resumption, the date of such
resumption, the identity of such brand style
(by the common or usual name of the tobacco
product category to which it belongs and by any
proprietary name), and the other information
required by paragraph (1), unless the
registrant has previously reported such
resumption to the Administrator pursuant to
this subparagraph.
(D) Any material change in any information
previously submitted pursuant to this paragraph
(2) or paragraph (1).
(i) Electronic Registration.--Registrations under subsections
(b), (c), (d), and (e) (including the submission of updated
information) shall be submitted to the Administrator by
electronic means, unless the Administrator grants a request for
waiver of such requirement because use of electronic means is
not reasonable for the person requesting such waiver.
SEC. 110. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO PRODUCTS.
(a) In General.--Any requirement established by or under
section 106, 107, or 113 applicable to a tobacco product shall
apply to such tobacco product until the applicability of the
requirement to the tobacco product has been changed by action
taken under section 111, section 114, section 115, or
subsection (d) of this section, and any requirement established
by or under section 106, 107, or 113 which is inconsistent with
a requirement imposed on such tobacco product under section
111, section 114, section 115, or subsection (d) of this
section shall not apply to such tobacco product.
(b) Information on Public Access and Comment.--Each notice of
proposed rulemaking or other notification under section 111,
112, 113, 114, or 115 or under this section, any other notice
which is published in the Federal Register with respect to any
other action taken under any such section and which states the
reasons for such action, and each publication of findings
required to be made in connection with rulemaking under any
such section shall set forth--
(1) the manner in which interested persons may
examine data and other information on which the notice
or findings is based; and
(2) the period within which interested persons may
present their comments on the notice or findings
(including the need therefore) orally or in writing,
which period shall be at least 60 days but may not
exceed 90 days unless the time is extended by the
Administrator by a notice published in the Federal
Register stating good cause therefore.
(c) Limited Confidentiality of Information.--Any information
reported to or otherwise obtained by the Administrator or the
Administrator's representative under section 107, 108, 111,
112, 113, 114, 115, or 504, or under subsection (e) or (f) of
this section, which is exempt from disclosure under subsection
(a) of section 552 of title 5, United States Code, by reason of
subsection (b)(4) of that section shall be considered
confidential and shall not be disclosed, except that the
information may be disclosed to other officers or employees
concerned with carrying out this Act, or when relevant in any
proceeding under this Act.
(d) Restrictions.--
(1) In general.--The Administrator may issue
regulations, consistent with this Act, regarding
tobacco products if the Administrator determines that
such regulation would be appropriate for the protection
of the public health. The finding as to whether such
regulation would be appropriate for the protection of
the public health shall be determined with respect to
the risks and benefits to the users of the tobacco
product, and taking into account that the standard is
reasonably likely to result in measurable and
substantial reductions in morbidly and mortality among
individual tobacco users.
(2) Label statements.--The label of a tobacco product
shall bear such appropriate statements of the
restrictions required by a regulation under subsection
(a) as the Administrator may in such regulation
prescribe.
(e) Good Manufacturing Practice Requirements.--
(1) Methods, facilities, and controls to conform.--
(A) In general.--In applying manufacturing
restrictions to tobacco, the Administrator
shall, in accordance with subparagraph (B),
prescribe regulations (which may differ based
on the type of tobacco product involved)
requiring that the methods used in, and the
facilities and controls used for, the
manufacture, preproduction design validation
(including a process to assess the performance
of a tobacco product), packing, and storage of
a tobacco product conform to current good
manufacturing practice, or hazard analysis and
critical control point methodology, as
prescribed in such regulations to assure that
the public health is protected and that the
tobacco product is in compliance with this Act.
Such regulations may provide for the testing of
raw tobacco for pesticide chemical residues
after a tolerance for such chemical residues
has been established.
(B) Requirements.--The Administrator shall--
(i) before promulgating any
regulation under subparagraph (A),
afford the Tobacco Products Scientific
Advisory Committee an opportunity to
submit recommendations with respect to
the regulation proposed to be
promulgated;
(ii) before promulgating any
regulation under subparagraph (A),
afford opportunity for an oral hearing;
(iii) provide the Tobacco Products
Scientific Advisory Committee a
reasonable time to make its
recommendation with respect to proposed
regulations under subparagraph (A); and
(iv) in establishing the effective
date of a regulation promulgated under
this subsection, take into account the
differences in the manner in which the
different types of tobacco products
have historically been produced, the
financial resources of the different
tobacco product manufacturers, and the
state of their existing manufacturing
facilities, and shall provide for a
reasonable period of time for such
manufacturers to conform to good
manufacturing practices but no earlier
than four years from date of enactment.
(C) Additional special rule.--A tobacco
product manufactured in or imported into the
United States shall not contain foreign-grown
flue-cured or burley tobacco that--
(i) was knowingly grown or processed
using a pesticide chemical that is not
approved under applicable Federal law
for use in domestic tobacco farming and
processing; or
(ii) in the case of a pesticide
chemical that is so approved, was grown
or processed using the pesticide
chemical in a manner inconsistent with
the approved labeling for use of the
pesticide chemical in domestic tobacco
farming and processing.
(D) Exclusion.--Subparagraph (C)(ii) shall
not apply to tobacco products manufactured with
foreign-grown flue-cured or burley tobacco so
long as that foreign grown tobacco was either--
(i) in the inventory of a
manufacturer prior to the effective
date, or
(ii) planted by the farmer prior to
the effective date of this Act and
utilized by the manufacturer no later
than 3 years after the effective date.
(E) Setting of maximum residue limits.--The
Administrator shall adopt the following
pesticide residue standards:
Pesticide residue standards
The maximum concentration of residues of the following
pesticides allowed in flue-cured or burley tobacco, expressed
as parts by weight of the residue per one million parts by
weight of the tobacco (PPM) are:
CHLORDANE.....3.0
DIBROMOCHLOROPROPANE (DBCP).....1.0
DICAMBA (Temporary).... 5.0
ENDRIN....0.1
ETHYLENE DIBROMIDE (EDB)....0.1
FORMOTHION.....0.5
HEXACHLOROBENZENE (HCB)....0.1
METHOXYCHLOR.....0.1
TOXAPHENE.....0.3
2,4-D (Temporary).....5.0
2,4,5-T.....0.1
Sum of ALDRIN and DIELDRIN.....0.1
Sum of CYPERMETHRIN and PERMETHRIN (Temporary).....3.0
Sum of DDT, TDE (DDD), and DDE .....0.4
Sum of HEPTACHLOR and HEPTACHLOR EPOXIDE.....0.1
(F) Maximum residue limits.--The
Administrator shall adopt regulations within
one year of the effective date of this Act to
establish maximum residue limits for pesticides
identified under subparagraph (E) but not
included in the table of such subparagraph to
account for the fact that weather and agronomic
conditions will cause pesticides identified in
subparagraph (E) to be detected in foreign-
grown tobacco even where the farmer has not
knowingly added such pesticide.
(2) Exemptions; variances.--
(A) Petition.--Any person subject to any
requirement prescribed under paragraph (1) may
petition the Administrator for a permanent or
temporary exemption or variance from such
requirement. Such a petition shall be submitted
to the Administrator in such form and manner as
the Administrator shall prescribe and shall--
(i) in the case of a petition for an
exemption from a requirement, set forth
the basis for the petitioner's
determination that compliance with the
requirement is not required to assure
that the tobacco product will be in
compliance with this Act;
(ii) in the case of a petition for a
variance from a requirement, set forth
the methods proposed to be used in, and
the facilities and controls proposed to
be used for, the manufacture, packing,
and storage of the tobacco product in
lieu of the methods, facilities, and
controls prescribed by the requirement;
and
(iii) contain such other information
as the Administrator shall prescribe.
(B) Referral to the tobacco products
scientific advisory committee.--The
Administrator may refer to the Tobacco Products
Scientific Advisory Committee any petition
submitted under subparagraph (A). The Tobacco
Products Scientific Advisory Committee shall
report its recommendations to the Administrator
with respect to a petition referred to it
within 60 days after the date of the petition's
referral. Within 60 days after--
(i) the date the petition was
submitted to the Administrator under
subparagraph (A); or
(ii) the day after the petition was
referred to the Tobacco Products
Scientific Advisory Committee,
whichever occurs later, the Administrator shall
by order either deny the petition or approve
it.
(C) Approval.--The Administrator may
approve--
(i) a petition for an exemption for a
tobacco product from a requirement if
the Administrator determines that
compliance with such requirement is not
required to assure that the tobacco
product will be in compliance with this
Act; and
(ii) a petition for a variance for a
tobacco product from a requirement if
the Administrator determines that the
methods to be used in, and the
facilities and controls to be used for,
the manufacture, packing, and storage
of the tobacco product in lieu of the
methods, facilities, and controls
prescribed by the requirement are
sufficient to assure that the tobacco
product will be in compliance with this
Act.
(D) Conditions.--An order of the
Administrator approving a petition for a
variance shall prescribe such conditions
respecting the methods used in, and the
facilities and controls used for, the
manufacture, packing, and storage of the
tobacco product to be granted the variance
under the petition as may be necessary to
assure that the tobacco product will be in
compliance with this Act.
(E) Hearing.--After the issuance of an order
under subparagraph (B) respecting a petition,
the petitioner shall have an opportunity for an
informal hearing on such order.
(3) Compliance.--Compliance with requirements under
this subsection shall not be required before the end of
the 3-year period following the date of enactment of
this Act.
(f) Research and Development.--The Administrator may enter
into contracts for research, testing, and demonstrations
respecting tobacco products and may obtain tobacco products for
research, testing, and demonstration purposes.
SEC. 111. SMOKING ARTICLE STANDARDS.
(a) In General.--
(1) Restrictions on descriptors used in marketing of
cigarettes.--
(A) In general.--Except as provided in
subparagraph (B), no person shall use, with
respect to any cigarette brand style
commercially distributed domestically, on the
portion of the package of such cigarette brand
style that customarily is visible to consumers
before purchase, or in advertising of such
cigarette brand style any of the following as a
descriptor of any cigarette brand style--
(i) the name of any candy or fruit;
(ii) the word ``candy,'' ``citrus,''
``cream,'' ``fruit,'' ``sugar,''
``sweet,'' ``tangy,'' or ``tart,''; or
(iii) any extension or variation of
any of the words ``candy,'' ``citrus,''
``cream,'' ``fruit,'' ``sugar,''
``sweet,'' ``tangy,'' or ``tart,''
including but not limited to
``creamy,'' or ``fruity.''
(B) Limitation.--Subparagraph (A) shall not
apply to the use of the following words or to
any extension or variation of any of them:
``coffee,'' ``mint,'' and ``menthol''.
(C) Scented materials.--No person shall use,
in the advertising or labeling of any cigarette
commercially distributed domestically, any
scented materials, except in an adult-only
facility.
(D) Definitions.--In this section:
(i) The term ``candy'' means a
confection made from sugar or sugar
substitute, including any confection
identified generically or by brand, and
shall include the words ``cacao,''
``chocolate,'' ``cinnamon,'' ``cocoa,''
``honey,'' ``licorice,'' ``maple,''
``mocha,'' and ``vanilla.''
(ii) The term ``fruit'' means any
fruit identified by generic name, type,
or variety, including but not limited
to ``apple,'' ``banana,'' ``cherry,''
and ``orange.'' The term ``fruit'' does
not include words that identify seeds,
nuts or peppers, or types or varieties
thereof or words that are extensions or
variations of such words.
(2) Smoking article standards.--
(A) In general.--The Administrator may adopt
smoking article standards in addition to those
in paragraph (1) if the Administrator finds
that a smoking article standard is appropriate
for the protection of the public health.
(B) Determinations.--
(i) Considerations.--In making a
finding described in subparagraph (A),
the Administrator shall consider
scientific evidence concerning--
(I) the risks and benefits to
the users of smoking articles
of the proposed standard; and
(II) that the standard is
reasonably likely to result in
measurable and substantial
reductions in morbidity and
mortality among individual
tobacco users.
(ii) Additional considerations.--In
the event that the Administrator makes
a determination, set forth in a
proposed smoking article standard in a
proposed rule, that it is appropriate
for the protection of public health to
require the reduction or elimination of
an additive, constituent (including a
smoke constituent), or other component
of a smoking article because the
Administrator has found that the
additive, constituent, or other
component is harmful, any party
objecting to the proposed standard on
the ground that the proposed standard
will not reduce or eliminate the risk
of illness or injury may provide for
the Administrator's consideration
scientific evidence that demonstrates
that the proposed standard will not
reduce or eliminate the risk of illness
or injury.
(3) Content of smoking article standards.--A smoking
article standard established under this section for a
smoking article--
(A) may include provisions that are
appropriate for the protection of the public
health, including provisions, where
appropriate--
(i) for ``tar'' and nicotine yields
of the product;
(ii) for the reduction of other
constituents, including smoke
constituents, or harmful components of
the product; or
(iii) relating to any other
requirement under subparagraph (B); and
(B) may, where appropriate for the protection
of the public health, include--
(i) provisions respecting the
construction, components, ingredients,
additives, constituents, including
smoke constituents, and properties of
the smoking article;
(ii) provisions for the testing (on a
sample basis or, if necessary, on an
individual basis) of the smoking
article;
(iii) provisions for the measurement
of the smoking article characteristics
of the smoking article; and
(iv) provisions requiring that the
results of each or of certain of the
tests of the smoking article required
to be made under clause (ii) show that
the smoking article is in conformity
with the portions of the standard for
which the test or tests were required.
(4) Periodic reevaluation of smoking article
standards.--The Administrator may provide for periodic
evaluation of smoking article standards established
under this section to determine whether such standards
should be changed to reflect new medical, scientific,
or other technological data.
(5) Cigarette ``tar'' limits.--
(A) No increase in ``tar'' yields.--No
cigarette manufacturer shall distribute for
sale domestically a brand style of cigarettes
that generates a ``tar'' yield greater than the
``tar'' yield of that brand style of cigarettes
on the date of introduction of this Act, as
determined by the ISO smoking regimen and its
associated tolerances. The ``tar'' tolerances
for cigarettes with ISO ``tar'' yields in the
range of 1 to 20 milligrams per cigarette,
based on variations arising from sampling
procedure, test method, and sampled product,
itself, are the greater of plus or minus--
(i) 15 percent; or
(ii) 1 milligram per cigarette.
(B) Limit on new cigarettes.--After the
effective date of this Act, no cigarette
manufacturer shall manufacture for commercial
distribution domestically a brand style of
cigarettes that both--
(i) was not in commercial
distribution domestically on the
effective date of this Act, and
(ii) generates a ``tar'' yield of
greater than 20 milligrams per
cigarette as determined by the ISO
smoking regimen and its associated
tolerances.
(C) Limit on all cigarettes.--After December
31, 2010, no cigarette manufacturer shall
manufacture for commercial distribution
domestically a brand style of cigarettes that
generates a ``tar'' yield greater than 20
milligrams per cigarette as determined by the
ISO smoking regimen and its associated
tolerances.
(D) Review by administrator.--After the
effective date of this Act, the Administrator
shall evaluate the available scientific
evidence addressing the potential relationship
between historical ``tar'' yield values and
risk of harm to smokers. If upon a review of
that evidence, and after consultation with
technical experts of the Tobacco Harm Reduction
Center and the Centers for Disease Control and
Prevention and notice and an opportunity for
public comment, the Administrator determines,
that a reduction in ``tar'' yield may
reasonably be expected to provide a meaningful
reduction of the risk or risks of harm to
smokers, the Administrator shall issue an order
that--
(i) provides that no cigarette
manufacturer shall manufacture for
commercial distribution domestically a
cigarette that generates a ``tar''
yield that exceeds 14 milligrams as
determined by the ISO smoking regimen
and its associated tolerances; and
(ii) provides a reasonable time for
manufacturers to come into compliance
with such prohibition.
(6) Involvement of other agencies; informed
persons.--In carrying out duties under this section,
the Administrator shall endeavor to--
(A) use personnel, facilities, and other
technical support available in other Federal
agencies;
(B) consult with other Federal agencies
concerned with standard setting and other
nationally or internationally recognized
standard-setting entities; and
(C) invite appropriate participation, through
joint or other conferences, workshops, or other
means, by informed persons representative of
scientific, professional, industry,
agricultural, or consumer organizations who in
the Administrator's judgment can make a
significant contribution.
(b) Considerations by Administrator.--
(1) Technical achievability.--The Administrator shall
consider information submitted in connection with a
proposed standard regarding the technical achievability
of compliance with such standard.
(2) Other considerations.--The Administrator shall
consider all other information submitted in connection
with a proposed standard, such as the creation of a
significant demand for contraband or other tobacco
products that do not meet the requirements of this Act
and the significance of such demand.
(c) Proposed Standards.--
(1) In general.--The Administrator shall publish in
the Federal Register a notice of proposed rulemaking
for the establishment, amendment, or revocation of any
smoking article standard.
(2) Requirements of notice.--A notice of proposed
rulemaking for the establishment or amendment of a
smoking article standard shall--
(A) set forth a finding with supporting
justification that the smoking article standard
is appropriate for the protection of the public
health;
(B) invite interested persons to submit a
draft or proposed smoking article standard for
consideration by the Administrator;
(C) invite interested persons to submit
comments on structuring the standard so that it
does not advantage foreign-grown tobacco over
domestically grown tobacco; and
(D) invite the Secretary of Agriculture to
provide any information or analysis which the
Secretary of Agriculture believes is relevant
to the proposed smoking article standard.
(3) Finding.--A notice of proposed rulemaking for the
revocation of a smoking article standard shall set
forth a finding with supporting justification that the
smoking article standard is no longer appropriate for
the protection of the public health.
(4) Comment.--The Administrator shall provide for a
comment period of not less than 90 days.
(d) Promulgation.--
(1) In general.--After the expiration of the period
for comment on a notice of proposed rulemaking
published under subsection (c) respecting a standard
and after consideration of comments submitted under
subsections (b) and (c) and any report from the Tobacco
Products Scientific Advisory Committee, if the
Administrator determines that the standard would be
appropriate for the protection of the public health,
the Administrator shall--
(A) promulgate a regulation establishing a
smoking article standard and publish in the
Federal Register findings on the matters
referred to in subsection (c); or
(B) publish a notice terminating the
proceeding for the development of the standard
together with the reasons for such termination.
(2) Effective date.--A regulation establishing a
smoking article standard shall set forth the date or
dates upon which the standard shall take effect, but no
such regulation may take effect before 1 year after the
date of its publication unless the Administrator
determines that an earlier effective date is necessary
for the protection of the public health. Such date or
dates shall be established so as to minimize,
consistent with the public health, economic loss to,
and disruption or dislocation of, domestic and
international trade. In establishing such effective
date or dates, the Administrator shall consider
information submitted in connection with a proposed
product standard by interested parties, including
manufacturers and tobacco growers, regarding the
technical achievability of compliance with the
standard, and including information concerning the
existence of patents that make it impossible to comply
in the timeframe envisioned in the proposed standard.
(3) Limitation on power granted.--Because of the
importance of a decision of the Administrator to issue
a regulation--
(A) banning cigarettes, smokeless smoking
articles, little cigars, cigars other than
little cigars, pipe tobacco, or roll-your-own
smoking articles;
(B) requiring the reduction of ``tar'' or
nicotine yields of a smoking article to zero;
(C) prohibiting the sale of any smoking
article in face-to-face transactions by a
specific category of retail outlets;
(D) establishing a minimum age of sale of
smoking articles to any person older than 18
years of age; or
(E) requiring that the sale or distribution
of a smoking article be limited to the written
or oral authorization of a practitioner
licensed by law to prescribe medical products,
the Administrator is prohibited from taking such
actions under this Act.
(4) Matchbooks.--For purposes of any regulations
issued by the Administrator under this Act, matchbooks
of conventional size containing not more than 20 paper
matches, and which are customarily given away for free
with the purchase of smoking articles, shall be
considered as adult-written publications which shall be
permitted to contain advertising.
(5) Amendment; revocation.--
(A) Authority.--The Administrator, upon the
Administrator's own initiative or upon petition
of an interested person, may by a regulation,
promulgated in accordance with the requirements
of subsection (c) and paragraph (2), amend or
revoke a smoking article standard.
(B) Effective date.--The Administrator may
declare a proposed amendment of a smoking
article standard to be effective on and after
its publication in the Federal Register and
until the effective date of any final action
taken on such amendment if the Administrator
determines that making it so effective is in
the public interest.
(6) Referral to advisory committee.--
(A) In general.--The Administrator shall
refer a proposed regulation for the
establishment, amendment, or revocation of a
smoking article standard to the Tobacco
Products Scientific Advisory Committee for a
report and recommendation with respect to any
matter involved in the proposed regulation
which requires the exercise of scientific
judgment.
(B) Initiation of referral.--The
Administrator shall make a referral under this
paragraph--
(i) on the Administrator's own
initiative; or
(ii) upon the request of an
interested person that--
(I) demonstrates good cause
for the referral; and
(II) is made before the
expiration of the period for
submission of comments on the
proposed regulation.
(C) Provision of data.--If a proposed
regulation is referred under this paragraph to
the Tobacco Products Scientific Advisory
Committee, the Administrator shall provide the
Advisory Committee with the data and
information on which such proposed regulation
is based.
(D) Report and recommendation.--The Tobacco
Products Scientific Advisory Committee shall,
within 90 days after the referral of a proposed
regulation under this paragraph and after
independent study of the data and information
furnished to it by the Administrator and other
data and information before it, submit to the
Administrator a report and recommendation
respecting such regulation, together with all
underlying data and information and a statement
of the reason or basis for the recommendation.
(E) Public availability.--The Administrator
shall make a copy of each report and
recommendation under subparagraph (D) publicly
available.
SEC. 112. NOTIFICATION AND OTHER REMEDIES.
(a) Notification.--If the Administrator determines that--
(1) a tobacco product which is introduced or
delivered for introduction into interstate commerce for
commercial distribution presents an unreasonable risk
of substantial harm materially above the risk for death
and disease of tobacco products currently in interstate
commerce, to the public health; and
(2) notification under this subsection is necessary
to eliminate the unreasonable risk of such harm and no
more practicable means is available under the
provisions of this Act (other than this section) to
eliminate such risk,
the Administrator may issue such order as may be necessary to
assure that adequate notification is provided in an appropriate
form, by the persons and means best suited under the
circumstances involved, to all persons who should properly
receive such notification in order to eliminate such risk. The
Administrator may order notification by any appropriate means,
including public service announcements. Before issuing an order
under this subsection, the Administrator shall consult with the
persons who are to give notice under the order.
(b) No Exemption From Other Liability.--Compliance with an
order issued under this section shall not relieve any person
from liability under Federal or State law. In awarding damages
for economic loss in an action brought for the enforcement of
any such liability, the value to the plaintiff in such action
of any remedy provided under such order shall be taken into
account.
(c) Recall Authority.--
(1) In general.--If the Administrator finds that
there is a reasonable probability that a tobacco
product contains a manufacturing or other defect not
ordinarily contained in tobacco products on the market
that would cause serious, acute adverse health
consequences or death, the Administrator shall issue an
order requiring the appropriate person (including the
manufacturers, importers, distributors, or retailers of
the tobacco product) to immediately cease distribution
of such tobacco product. The order shall provide the
person subject to the order with an opportunity for an
informal hearing, to be held not later than 10 days
after the date of the issuance of the order, on the
actions required by the order and on whether the order
should be amended to require a recall of such tobacco
product. If, after providing an opportunity for such a
hearing, the Administrator determines that inadequate
grounds exist to support the actions required by the
order, the Administrator shall vacate the order.
(2) Amendment of order to require recall.--
(A) In general.--If, after providing an
opportunity for an informal hearing under
paragraph (1), the Administrator determines
that the order should be amended to include a
recall of the tobacco product with respect to
which the order was issued, the Administrator
shall, except as provided in subparagraph (B),
amend the order to require a recall. The
Administrator shall specify a timetable in
which the tobacco product recall will occur and
shall require periodic reports to the
Administrator describing the progress of the
recall.
(B) Notice.--An amended order under
subparagraph (A)--
(i) shall not include recall of a
tobacco product from individuals; and
(ii) shall provide for notice to
persons subject to the risks associated
with the use of such tobacco product.
In providing the notice required by clause
(ii), the Administrator may use the assistance
of retailers and other persons who distributed
such tobacco product. If a significant number
of such persons cannot be identified, the
Administrator shall notify such persons under
section 705(b).
(3) Remedy not exclusive.--The remedy provided by
this subsection shall be in addition to remedies
provided by subsection (a).
SEC. 113. RECORDS AND REPORTS ON TOBACCO PRODUCTS.
Every person who is a tobacco product manufacturer or
importer of a tobacco product shall establish and maintain such
records, make such reports, and provide such information, as
the Administrator may by regulation reasonably require to
assure that such tobacco product is not adulterated or
misbranded.
SEC. 114. APPLICATION FOR REVIEW OF CERTAIN SMOKING ARTICLES.
(a) In General.--
(1) New smoking article defined.--For purposes of
this section the term ``new smoking article'' means--
(A) any smoking article that was not
commercially marketed in the United States as
of the date of enactment of this Act; and
(B) any smoking article that incorporates a
significant modification (including changes in
design, component, part, or constituent,
including a smoke constituent, or in the
content, delivery or form of nicotine, or other
additive or ingredient) of a smoking article
where the modified product was commercially
marketed in the United States after the date of
enactment of this Act.
(2) Premarket review required.--
(A) New products.--An order under subsection
(c)(1)(A) for a new smoking article is required
unless the product--
(i) is substantially equivalent to a
smoking article commercially marketed
in the United States as of date of
enactment of this Act; and
(ii) is in compliance with the
requirements of this Act.
(B) Consumer testing.--This section shall not
apply to smoking articles that are provided to
adult tobacco consumers for purposes of
consumer testing. For purposes of this section,
the term ``consumer testing'' means an
assessment of smoking articles that is
conducted by or under the control and direction
of a manufacturer for the purpose of evaluating
consumer acceptance of such smoking articles,
utilizing only the quantity of cigarettes that
is reasonably necessary for such assessment
(3) Substantially equivalent defined.--
(A) In general.--In this section, the term
``substantially equivalent'' or ``substantial
equivalence'' means, with respect to the
smoking article being compared to the predicate
smoking article, that the Administrator by
order has found that the smoking article--
(i) has the same general
characteristics as the predicate
smoking article; or
(ii) has different characteristics
and the information submitted contains
information, including clinical data if
deemed necessary by the Administrator,
that demonstrates that it is not
appropriate to regulate the product
under this section because the product
does not raise different questions of
public health for the consumer of the
product.
(B) Characteristics.--In subparagraph (A),
the term ``characteristics'' means the
materials, ingredients, design, composition,
heating source, or other features of a smoking
article.
(C) Limitation.--A smoking article may not be
found to be substantially equivalent to a
predicate smoking article that has been removed
from the market at the initiative of the
Administrator or that has been determined by a
judicial order to be misbranded or adulterated.
(4) Health information.--As part of a submission
respecting a smoking article, the person required to
file a premarket notification shall provide an adequate
summary of any health information related to the
smoking article or state that such information will be
made available upon request by any person.
(b) Application.--
(1) Contents.--An application under this section
shall contain--
(A) full reports of all information,
published or known to, or which should
reasonably be known to, the applicant,
concerning investigations which have been made
to show the health risks of such smoking
article and whether such smoking article
presents less risk than other smoking articles;
(B) a full statement of the components,
ingredients, additives, and properties, and of
the principle or principles of operation, of
such smoking article;
(C) a full description of the methods used
in, and the facilities and controls used for,
the manufacture, processing, and, when
relevant, packing and installation of, such
smoking article;
(D) an identifying reference to any smoking
article standard under section 111 which would
be applicable to any aspect of such smoking
article, and either adequate information to
show that such aspect of such smoking article
fully meets such smoking article standard or
adequate information to justify any deviation
from such standard;
(E) such samples of such smoking article and
of components thereof as the Administrator may
reasonably require;
(F) specimens of the labeling proposed to be
used for such smoking article; and
(G) such other information relevant to the
subject matter of the application as the
Administrator may require.
(2) Referral to tobacco products scientific advisory
committee.--Upon receipt of an application meeting the
requirements set forth in paragraph (1), the
Administrator--
(A) may, on the Administrator's own
initiative; or
(B) may, upon the request of an applicant,
refer such application to the Tobacco Products
Scientific Advisory Committee for reference and for
submission (within such period as the Administrator may
establish) of a report and recommendation respecting
the application, together with all underlying data and
the reasons or basis for the recommendation.
(c) Action on Application.--
(1) Deadline.--As promptly as possible, but in no
event later than 90 days after the receipt of an
application under subsection (b), the Administrator,
after considering the report and recommendation
submitted under subsection (b)(2), shall--
(A) issue an order that the new product may
be introduced or delivered for introduction
into interstate commerce if the Administrator
finds that none of the grounds specified in
paragraph (2) of this subsection applies; or
(B) issue an order that the new product may
not be introduced or delivered for introduction
into interstate commerce if the Administrator
finds (and sets forth the basis for such
finding as part of or accompanying such denial)
that 1 or more grounds for denial specified in
paragraph (2) of this subsection apply.
(2) Denial of application.--The Administrator shall
deny an application submitted under subsection (b) if,
upon the basis of the information submitted to the
Administrator as part of the application and any other
information before the Administrator with respect to
such smoking article, the Administrator finds that--
(A) there is a lack of a showing that
permitting such smoking article to be marketed
would be appropriate for the protection of the
public health;
(B) the methods used in, or the facilities or
controls used for, the manufacture, processing,
or packing of such smoking article do not
conform to the requirements of section 110(e);
(C) based on a fair evaluation of all
material facts, the proposed labeling is false
or misleading in any particular; or
(D) such smoking article is not shown to
conform to a smoking article standard in effect
under section 111, and there is a lack of
adequate information to justify the deviation
from such standard.
(3) Denial information.--Any denial of an application
shall, insofar as the Administrator determines to be
practicable, be accompanied by a statement informing
the applicant of the measures required to remove such
application from deniable form (which measures may
include further research by the applicant in accordance
with 1 or more protocols prescribed by the
Administrator).
(4) Basis for finding.--For purposes of this section,
the finding as to whether the commercial introduction
of a smoking article for which an application has been
submitted is appropriate for the protection of the
public health shall be determined with respect to the
risks and benefits to the users of the smoking article,
and taking into account whether such commercial
introduction is reasonably likely to increase the
morbidly and mortality among individual tobacco users.
(d) Withdrawal and Temporary Suspension.--
(1) In general.--The Administrator shall, upon
obtaining, where appropriate, advice on scientific
matters from the Tobacco Products Scientific Advisory
Committee, and after due notice and opportunity for
informal hearing for a smoking article for which an
order was issued under subsection (c)(1)(A), issue an
order withdrawing the order if the Administrator
finds--
(A) that the continued marketing of such
smoking article no longer is appropriate for
the protection of the public health;
(B) that the application contained or was
accompanied by an untrue statement of a
material fact;
(C) that the applicant--
(i) has failed to establish a system
for maintaining records, or has
repeatedly or deliberately failed to
maintain records or to make reports,
required by an applicable regulation
under section 113; or
(ii) has refused to permit access to,
or copying or verification of, such
records as required by section 110; or
(D) on the basis of new information before
the Administrator with respect to such smoking
article, evaluated together with the evidence
before the Administrator when the application
was reviewed, that the methods used in, or the
facilities and controls used for, the
manufacture, processing, packing, or
installation of such smoking article do not
conform with the requirements of section 110(e)
and were not brought into conformity with such
requirements within a reasonable time after
receipt of written notice from the
Administrator of nonconformity;
(E) on the basis of new information before
the Administrator, evaluated together with the
evidence before the Administrator when the
application was reviewed, that the labeling of
such smoking article, based on a fair
evaluation of all material facts, is false or
misleading in any particular and was not
corrected within a reasonable time after
receipt of written notice from the
Administrator of such fact; or
(F) on the basis of new information before
the Administrator, evaluated together with the
evidence before the Administrator when such
order was issued, that such smoking article is
not shown to conform in all respects to a
smoking article standard which is in effect
under section 111, compliance with which was a
condition to the issuance of an order relating
to the application, and that there is a lack of
adequate information to justify the deviation
from such standard.
(2) Appeal.--The holder of an application subject to
an order issued under paragraph (1) withdrawing an
order issued pursuant to subsection (c)(1)(A) may, by
petition filed on or before the 30th day after the date
upon which such holder receives notice of such
withdrawal, obtain review thereof in accordance with
section 116.
(3) Temporary suspension.--If, after providing an
opportunity for an informal hearing, the Administrator
determines there is reasonable probability that the
continuation of distribution of a smoking article under
an order would cause serious, adverse health
consequences or death, that is greater than ordinarily
caused by smoking articles on the market, the
Administrator shall by order temporarily suspend the
authority of the manufacturer to market the product. If
the Administrator issues such an order, the
Administrator shall proceed expeditiously under
paragraph (1) to withdraw such application.
(e) Service of Order.--An order issued by the Administrator
under this section shall be served--
(1) in person by any officer or employee of the
department designated by the Administrator; or
(2) by mailing the order by registered mail or
certified mail addressed to the applicant at the
applicant's last known address in the records of the
Administrator.
(f) Records.--
(1) Additional information.--In the case of any
smoking article for which an order issued pursuant to
subsection (c)(1)(A) for an application filed under
subsection (b) is in effect, the applicant shall
establish and maintain such records, and make such
reports to the Administrator, as the Administrator may
by regulation, or by order with respect to such
application, prescribe on the basis of a finding that
such records and reports are necessary in order to
enable the Administrator to determine, or facilitate a
determination of, whether there is or may be grounds
for withdrawing or temporarily suspending such order.
(2) Access to records.--Each person required under
this section to maintain records, and each person in
charge of custody thereof, shall, upon request of an
officer or employee designated by the Administrator,
permit such officer or employee at all reasonable times
to have access to and copy and verify such records.
(g) Investigational Smoking Article Exemption for
Investigational Use.--The Administrator may exempt smoking
articles intended for investigational use from the provisions
of this Act under such conditions as the Administrator may by
regulation prescribe.
SEC. 115. MODIFIED RISK TOBACCO PRODUCTS.
(a) In General.--No person may introduce or deliver for
introduction into interstate commerce any modified risk tobacco
product unless an order issued pursuant to subsection (g) is
effective with respect to such product.
(b) Definitions.--In this section:
(1) Modified risk tobacco product.--The term
``modified risk tobacco product'' means any tobacco
product that is sold or distributed for use to reduce
harm or the risk of tobacco-related disease associated
with commercially marketed tobacco products.
(2) Sold or distributed.--
(A) In general.--With respect to a tobacco
product, the term ``sold or distributed for use
to reduce harm or the risk of tobacco-related
disease associated with commercially marketed
tobacco products'' means a tobacco product--
(i) the label, labeling, or
advertising of which represents
explicitly or implicitly that--
(I) the tobacco product
presents a lower risk of
tobacco-related disease or is
less harmful than one or more
other commercially marketed
tobacco products;
(II) the tobacco product or
its smoke contains a reduced
level of a substance or
presents a reduced exposure to
a substance; or
(III) the tobacco product or
its smoke does not contain or
is free of a substance;
(ii) the label, labeling, or
advertising of which uses the
descriptors ``light'', ``mild'',
``low'', ``medium'', ``ultra light'',
``low tar'' or ``ultra low tar''; or
(iii) the tobacco product
manufacturer of which has taken any
action directed to consumers through
the media or otherwise, other than by
means of the tobacco product's label,
labeling, or advertising, after the
date of enactment of the Act,
respecting the product that would be
reasonably expected to result in
consumers believing that the tobacco
product or its smoke may present a
lower risk of disease or is less
harmful than one or more commercially
marketed tobacco products, or presents
a reduced exposure to, or does not
contain or is free of, a substance or
substances.
(B) Limitation.--No tobacco product shall be
considered to be ``sold or distributed for use
to reduce harm or the risk of tobacco-related
disease associated with commercially marketed
tobacco products'', except as described in
subparagraph (A).
(C) Smokeless tobacco product.--No smokeless
tobacco product shall be considered to be
``sold or distributed for use to reduce harm or
the risk of tobacco-related disease associated
with commercially marketed tobacco products''.
(3) Effective date.--The provisions of paragraph
(2)(A)(ii) shall take effect 12 months after the date
of enactment of the Act.
(c) Tobacco Dependence Products.--A product that is intended
to be used for the treatment of tobacco dependence, including
smoking cessation, is not a modified risk tobacco product under
this section if it has been approved as a drug or device by the
Center and is subject to the requirements of chapter V.
(d) Filing.--Any person may file with the Administrator an
application for a modified risk tobacco product. Such
application shall include--
(1) a description of the proposed product and any
proposed advertising and labeling;
(2) the conditions for using the product;
(3) the formulation of the product;
(4) sample product labels and labeling;
(5) all documents (including underlying scientific
information) relating to research findings conducted,
supported, or possessed by the tobacco product
manufacturer relating to the effect of the product on
tobacco-related diseases and health-related conditions,
including information both favorable and unfavorable to
the ability of the product to reduce risk or exposure
and relating to human health;
(6) data and information on how consumers actually
use the tobacco product; and
(7) such other information as the Administrator may
require.
(e) Public Availability.--The Administrator shall make the
application described in subsection (d) publicly available
(except matters in the application which are trade secrets or
otherwise confidential, commercial information) and shall
request comments by interested persons on the information
contained in the application and on the label, labeling, and
advertising accompanying such application.
(f) Advisory Committee.--
(1) In general.--The Administrator shall refer to the
Tobacco Products Scientific Advisory Committee any
application submitted under this section.
(2) Recommendations.--Not later than 60 days after
the date an application is referred to the Tobacco
Products Scientific Advisory Committee under paragraph
(1), the Advisory Committee shall report its
recommendations on the application to the
Administrator.
(g) Marketing.--
(1) Modified risk products.--Except as provided in
paragraph (2), the Administrator shall, with respect to
an application submitted under this section, issue an
order that a modified risk product may be commercially
marketed only if the Administrator determines that the
applicant has demonstrated that such product, as it is
actually used by consumers, will--
(A) significantly reduce harm and the risk of
tobacco-related disease to individual tobacco
users; and
(B) is reasonably likely to result in
measurable and substantial reductions in
morbidity and mortality among individual
tobacco users.
(2) Special rule for certain products.--
(A) In general.--The Administrator may issue
an order that a tobacco product may be
introduced or delivered for introduction into
interstate commerce, pursuant to an application
under this section, with respect to a tobacco
product that may not be commercially marketed
under paragraph (1) if the Secretary makes the
findings required under this paragraph and
determines that the applicant has demonstrated
that--
(i) such order would be appropriate
to promote the public health;
(ii) any aspect of the label,
labeling, and advertising for such
product that would cause the tobacco
product to be a modified risk tobacco
product under subsection (b) is limited
to an explicit or implicit
representation that such tobacco
product or its smoke does not contain
or is free of a substance or contains a
reduced level of a substance, or
presents a reduced exposure to a
substance in tobacco smoke;
(iii) scientific evidence is not
available and, using the best available
scientific methods, cannot be made
available without conducting long-term
epidemiological studies for an
application to meet the standards set
forth in paragraph (1); and
(iv) the scientific evidence that is
available without conducting long-term
epidemiological studies demonstrates
that a measurable and substantial
reduction in morbidity or mortality
among individual tobacco users is
reasonably likely in subsequent
studies.
(B) Additional findings required.--To issue
an order under subparagraph (A) the
Administrator must also find that the applicant
has demonstrated that--
(i) the magnitude of the overall
reductions in exposure to the substance
or substances which are the subject of
the application is substantial, such
substance or substances are harmful,
and the product as actually used
exposes consumers to the specified
reduced level of the substance or
substances;
(ii) the product as actually used by
consumers will not expose them to
higher levels of other harmful
substances compared to the similar
types of tobacco products then on the
market unless such increases are
minimal and the reasonably likely
overall impact of use of the product
remains a substantial and measurable
reduction in overall morbidity and
mortality among individual tobacco
users;
(iii) testing of actual consumer
perception shows that, as the applicant
proposes to label and market the
product, consumers will not be misled
into believing that the product--
(I) is or has been
demonstrated to be
significantly less harmful; or
(II) presents or has been
demonstrated to present
significant less of a risk of
disease than other commercially
marketed tobacco products; and
(iv) issuance of an order with
respect to the application is expected
to benefit the health of users of
tobacco products.
(3) Basis.--The determinations under paragraphs (1)
and (2) shall be based on--
(A) the scientific evidence submitted by the
applicant; and
(B) scientific evidence and other information
that is made available to the Administrator.
(h) Additional Conditions for Marketing.--
(1) Modified risk products.--The Administrator shall
require for the marketing of a product under this
section that any advertising or labeling concerning
modified risk products enable the public to comprehend
the information concerning modified risk and to
understand the relative significance of such
information in the context of total health and in
relation to all of the diseases and health-related
conditions associated with the use of tobacco products.
(2) Comparative claims.--
(A) In general.--The Administrator may
require for the marketing of a product under
this subsection that a claim comparing a
tobacco product to other commercially marketed
tobacco products shall compare the tobacco
product to a commercially marketed tobacco
product that is representative of that type of
tobacco product on the market (for example the
average value of the top 3 brands of an
established regular tobacco product).
(B) Quantitative comparisons.--The
Administrator may also require, for purposes of
subparagraph (A), that the percent (or
fraction) of change and identity of the
reference tobacco product and a quantitative
comparison of the amount of the substance
claimed to be reduced shall be stated in
immediate proximity to the most prominent
claim.
(i) Postmarket Surveillance and Studies.--
(1) In general.--The Administrator shall require,
with respect to a product for which an applicant
obtained an order under subsection (g)(1), that the
applicant conduct postmarket surveillance and studies
for such a tobacco product to determine the impact of
the order issuance on consumer perception, behavior,
and health, to enable the Administrator to review the
accuracy of the determinations upon which the order was
based, and to provide information that the
Administrator determines is otherwise necessary
regarding the use or health risks involving the tobacco
product. The results of postmarket surveillance and
studies shall be submitted to the Administrator on an
annual basis.
(2) Surveillance protocol.--Each applicant required
to conduct a surveillance of a tobacco product under
paragraph (1) shall, within 30 days after receiving
notice that the applicant is required to conduct such
surveillance, submit, for the approval of the
Administrator, a protocol for the required
surveillance. The Administrator, within 30 days of the
receipt of such protocol, shall determine if the
principal investigator proposed to be used in the
surveillance has sufficient qualifications and
experience to conduct such surveillance and if such
protocol will result in collection of the data or other
information designated by the Administrator as
necessary to protect the public health.
(j) Withdrawal of Authorization.--The Administrator, after an
opportunity for an informal hearing, shall withdraw an order
under subsection (g) if the Administrator determines that--
(1) the applicant, based on new information, can no
longer make the demonstrations required under
subsection (g), or the Administrator can no longer make
the determinations required under subsection (g);
(2) the application failed to include material
information or included any untrue statement of
material fact;
(3) any explicit or implicit representation that the
product reduces risk or exposure is no longer valid,
including if--
(A) a tobacco product standard is established
pursuant to section 111;
(B) an action is taken that affects the risks
presented by other commercially marketed
tobacco products that were compared to the
product that is the subject of the application;
or
(C) any postmarket surveillance or studies
reveal that the order is no longer consistent
with the protection of the public health;
(4) the applicant failed to conduct or submit the
postmarket surveillance and studies required under
subsection (g)(2)(C)(ii) or subsection (i); or
(5) the applicant failed to meet a condition imposed
under subsection (h).
(k) Chapter IV or V.--A product for which the Administrator
has issued an order pursuant to subsection (g) shall not be
subject to chapter IV or V of the Federal Food, Drug, and
Cosmetic Act.
(l) Implementing Regulations or Guidance.--
(1) Scientific evidence.--Not later than 2 years
after the date of enactment of the Act, the
Administrator shall issue regulations or guidance (or
any combination thereof) on the scientific evidence
required for assessment and ongoing review of modified
risk tobacco products. Such regulations or guidance
shall--
(A) to the extent that adequate scientific
evidence exists, establish minimum standards
for scientific studies needed prior to issuing
an order under subsection (g) to show a
reasonable likelihood that a substantial
reduction in morbidity or mortality among
individual tobacco users occurs for products
described in subsection (g)(1) or is reasonably
likely for products described in subsection
(g)(2);
(B) include validated biomarkers,
intermediate clinical endpoints, and other
feasible outcome measures, as appropriate;
(C) establish minimum standards for
postmarket studies, that shall include regular
and long-term assessments of health outcomes
and mortality, intermediate clinical endpoints,
consumer perception of harm reduction, and the
impact on quitting behavior and new use of
tobacco products, as appropriate;
(D) establish minimum standards for required
postmarket surveillance, including ongoing
assessments of consumer perception; and
(E) establish a reasonable timetable for the
Administrator to review an application under
this section.
(2) Consultation.--The regulations or guidance issued
under paragraph (1) may be developed in consultation
with the Institute of Medicine, and with the input of
other appropriate scientific and medical experts, on
the design and conduct of such studies and
surveillance.
(3) Revision.--The regulations or guidance under
paragraph (1) shall be revised on a regular basis as
new scientific information becomes available.
(4) New tobacco products.--Not later than 2 years
after the date of enactment of the Act, the
Administrator shall issue a regulation or guidance that
permits the filing of a single application for any
tobacco product that is a new tobacco product under
section 114 and which the applicant seeks to
commercially market under this section.
SEC. 116. JUDICIAL REVIEW.
(a) Right To Review.--
(1) In general.--Not later than 60 days after--
(A) the promulgation of a regulation under
section 111 establishing, amending, or revoking
a tobacco product standard; or
(B) a denial of an application under section
114(c),
any person adversely affected by such regulation or
denial may file a petition for judicial review of such
regulation or denial with the United States Court of
Appeals for the District of Columbia or for the circuit
in which such person resides or has their principal
place of business.
(2) Requirements.--
(A) Copy of petition.--A copy of the petition
filed under paragraph (1) shall be transmitted
by the clerk of the court involved to the
Administrator.
(B) Record of proceedings.--On receipt of a
petition under subparagraph (A), the
Administrator shall file in the court in which
such petition was filed--
(i) the record of the proceedings on
which the regulation or order was
based; and
(ii) a statement of the reasons for
the issuance of such a regulation or
order.
(C) Definition of record.--In this section,
the term ``record'' means--
(i) all notices and other matter
published in the Federal Register with
respect to the regulation or order
reviewed;
(ii) all information submitted to the
Administrator with respect to such
regulation or order;
(iii) proceedings of any panel or
advisory committee with respect to such
regulation or order;
(iv) any hearing held with respect to
such regulation or order; and
(v) any other information identified
by the Administrator, in the
administrative proceeding held with
respect to such regulation or order, as
being relevant to such regulation or
order.
(b) Standard of Review.--Upon the filing of the petition
under subsection (a) for judicial review of a regulation or
order, the court shall have jurisdiction to review the
regulation or order in accordance with chapter 7 of title 5,
United States Code, and to grant appropriate relief, including
interim relief, as provided for in such chapter. A regulation
or denial described in subsection (a) shall be reviewed in
accordance with section 706(2)(A) of title 5, United States
Code.
(c) Finality of Judgment.--The judgment of the court
affirming or setting aside, in whole or in part, any regulation
or order shall be final, subject to review by the Supreme Court
of the United States upon certiorari or certification, as
provided in section 1254 of title 28, United States Code.
(d) Other Remedies.--The remedies provided for in this
section shall be in addition to, and not in lieu of, any other
remedies provided by law.
(e) Regulations and Orders Must Recite Basis in Record.--To
facilitate judicial review, a regulation or order issued under
section 110, 111, 112, 113, 114, or 119 shall contain a
statement of the reasons for the issuance of such regulation or
order in the record of the proceedings held in connection with
its issuance.
SEC. 117. JURISDICTION OF AND COORDINATION WITH THE FEDERAL TRADE
COMMISSION.
Except where expressly provided in this Act, nothing in this
Act shall be construed as limiting or diminishing the authority
of the Federal Trade Commission to enforce the laws under its
jurisdiction with respect to the advertising, sale, or
distribution of tobacco products.
SEC. 118. REGULATION REQUIREMENT.
(a) Testing, Reporting, and Disclosure.--Not later than 36
months after the date of enactment of the Act, the
Administrator shall promulgate regulations under this Act that
meet the requirements of subsection (b).
(b) Contents of Rules.--The regulations promulgated under
subsection (a)--
(1) shall require annual testing and reporting of
tobacco product constituents, ingredients, and
additives, including smoke constituents, by brand style
that the Administrator determines should be tested to
protect the public health, provided that, for purposes
of the testing requirements of this paragraph, tobacco
products manufactured and sold by a single tobacco
product manufacturer that are identical in all respects
except the labels, packaging design, logo, trade dress,
trademark, brand name, or any combination thereof,
shall be considered as a single brand style; and
(2) may require that tobacco product manufacturers,
packagers, or importers make disclosures relating to
the results of the testing of tar and nicotine through
labels or advertising.
(c) Authority.--The Administrator shall have the authority
under this Act to conduct or to require the testing, reporting,
or disclosure of tobacco product constituents, including smoke
constituents.
(d) Joint Laboratory Testing Services.--The Administrator
shall allow any 2 or more tobacco product manufacturers to join
together to purchase laboratory testing services required by
this section on a group basis in order to ensure that such
manufacturers receive access to, and fair pricing of, such
testing services.
(e) Extensions for Limited Laboratory Capacity.--
(1) In general.--The regulations promulgated under
subsection (a) shall provide that a tobacco product
manufacturer shall not be considered to be in violation
of this section before the applicable deadline, if--
(A) the tobacco products of such manufacturer
are in compliance with all other requirements
of this Act; and
(B) the conditions described in paragraph (2)
are met.
(2) Conditions.--Notwithstanding the requirements of
this section, the Administrator may delay the date by
which a tobacco product manufacturer must be in
compliance with the testing and reporting required by
this section until such time as the testing is reported
if, not later than 90 days before the deadline for
reporting in accordance with this section, a tobacco
product manufacturer provides evidence to the
Administrator demonstrating that--
(A) the manufacturer has submitted the
required products for testing to a laboratory
and has done so sufficiently in advance of the
deadline to create a reasonable expectation of
completion by the deadline;
(B) the products currently are awaiting
testing by the laboratory; and
(C) neither that laboratory nor any other
laboratory is able to complete testing by the
deadline at customary, nonexpedited testing
fees.
(3) Extension.--The Administrator, taking into
account the laboratory testing capacity that is
available to tobacco product manufacturers, shall
review and verify the evidence submitted by a tobacco
product manufacturer in accordance with paragraph (2).
If the Administrator finds that the conditions
described in such paragraph are met, the Administrator
shall notify the tobacco product manufacturer that the
manufacturer shall not be considered to be in violation
of the testing and reporting requirements of this
section until the testing is reported or until 1 year
after the reporting deadline has passed, whichever
occurs sooner. If, however, the Administrator has not
made a finding before the reporting deadline, the
manufacturer shall not be considered to be in violation
of such requirements until the Administrator finds that
the conditions described in paragraph (2) have not been
met, or until 1 year after the reporting deadline,
whichever occurs sooner.
(4) Additional extension.--In addition to the time
that may be provided under paragraph (3), the
Administrator may provide further extensions of time,
in increments of no more than 1 year, for required
testing and reporting to occur if the Administrator
determines, based on evidence properly and timely
submitted by a tobacco product manufacturer in
accordance with paragraph (2), that a lack of available
laboratory capacity prevents the manufacturer from
completing the required testing during the period
described in paragraph (3).
(f) Rule of Construction.--Nothing in subsection (d) or (e)
shall be construed to authorize the extension of any deadline,
or to otherwise affect any timeframe, under any provision of
this Act other than this section.
SEC. 119. PRESERVATION OF STATE AND LOCAL AUTHORITY.
(a) In General.--
(1) Preservation.--Except as provided in paragraph
(2)(A), nothing in this Act, or rules promulgated under
this Act, shall be construed to limit the authority of
a Federal agency (including the Armed Forces), a State
or political subdivision of a State, or the government
of an Indian tribe to enact, adopt, promulgate, and
enforce any law, rule, regulation, or other measure
with respect to tobacco products that is in addition to
requirements established under this Act, including a
law, rule, regulation, or other measure relating to or
prohibiting the sale, distribution, possession, or use
of tobacco products by individuals of any age,
information reporting to the State. No provision of
this Act shall limit or otherwise affect any State,
Tribal, or local taxation of tobacco products.
(2) Preemption of certain state and local
requirements.--
(A) In general.--No State or political
subdivision of a State may establish or
continue in effect with respect to a tobacco
product any requirement which is different
from, or in addition to, any requirement under
the provisions of this Act relating to tobacco
product standards, premarket review,
adulteration, misbranding, labeling,
registration, good manufacturing standards, or
modified risk tobacco products.
(B) Exception.--Subparagraph (A) does not
apply to requirements relating to the sale,
distribution, possession, information reporting
to the State, use of, tobacco product by
individuals of any age. Information disclosed
to a State under subparagraph (A) that is
exempt from disclosure under section 552(b)(4)
of title 5, United States Code, shall be
treated as a trade secret and confidential
information by the State.
(b) Rule of Construction Regarding Product Liability.--No
provision of this Act relating to a tobacco product shall be
construed to modify or otherwise affect any action or the
liability of any person under the product liability law of any
State.
SEC. 120. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.
(a) Establishment.--Not later than 6 months after the date of
enactment of this Act, the Administrator shall establish a 16-
member advisory committee, to be known as the Tobacco Products
Scientific Advisory Committee (in this section referred to as
the ``Advisory Committee'').
(b) Membership.--
(1) In general.--
(A) Members.--The Administrator shall appoint
as members of the Tobacco Harm Reduction
Advisory Committee individuals who are
technically qualified by training and
experience in medicine, medical ethics,
science, or technology involving the
manufacture, evaluation, or use of tobacco
products, who are of appropriately diversified
professional backgrounds. The committee shall
be composed of--
(i) 6 individuals who are physicians,
dentists, scientists, or health care
professionals practicing in the area of
oncology, pulmonology, cardiology,
toxicology, pharmacology, addiction, or
any other relevant specialty;
(ii) 2 individuals who are an officer
or employee of a State or local
government or of the Federal
Government;
(iii) 2 representatives of the
general public;
(iv) 2 representatives of the
interests of the tobacco manufacturing
industry;
(v) 1 representative of the interests
of the small business tobacco
manufacturing industry, which position
may be filled on a rotating, sequential
basis by representatives of different
small business tobacco manufacturers
based on areas of expertise relevant to
the topics being considered by the
Advisory Committee;
(vi) 1 individual as a representative
of the interests of the tobacco
growers; and
(vii) 1 individual who is an expert
in illicit trade of tobacco products.
(B) Conflicts of interest.--No members of the
committee, other than members appointed
pursuant to clauses (iv), (v), and (vi) of
subparagraph (A) shall, during the member's
tenure on the committee or for the 18-month
period prior to becoming such a member, receive
any salary, grants, or other payments or
support from any business that manufactures,
distributes, markets, or sells cigarettes or
other tobacco products or government agency
with any form of jurisdiction over tobacco
products.
(2) Limitation.--The Administrator may not appoint to
the Advisory Committee any individual who is in the
regular full-time employ of the Tobacco Harm Reduction
Center or any agency responsible for the enforcement of
this Act. The Administrator may appoint Federal
officials as ex officio members.
(3) Chairperson.--The Administrator shall designate 1
of the members appointed under clauses (i), (ii), and
(iii) of paragraph (1)(A) to serve as chairperson.
(c) Duties.--The Tobacco Products Scientific Advisory
Committee shall provide advice, information, and
recommendations to the Administrator--
(1) as provided in this Act;
(2) on the implementation of prevention, cessation,
and harm reduction policies;
(3) on implementation of policies and programs to
fully inform consumers of the respective risks of
tobacco products; and
(4) on its review of other safety, dependence, or
health issues relating to tobacco products as requested
by the Administrator.
(d) Compensation; Support; FACA.--
(1) Compensation and travel.--Members of the Advisory
Committee who are not officers or employees of the
United States, while attending conferences or meetings
of the committee or otherwise engaged in its business,
shall be entitled to receive compensation at rates to
be fixed by the Administrator, which may not exceed the
daily equivalent of the rate in effect under the Senior
Executive Schedule under section 5382 of title 5,
United States Code, for each day (including travel
time) they are so engaged; and while so serving away
from their homes or regular places of business each
member may be allowed travel expenses, including per
diem in lieu of subsistence, as authorized by section
5703 of title 5, United States Code, for persons in the
Government service employed intermittently.
(2) Administrative support.--The Administrator shall
furnish the Advisory Committee clerical and other
assistance.
(3) Nonapplication of faca.--Section 14 of the
Federal Advisory Committee Act does not apply to the
Advisory Committee.
(e) Proceedings of Advisory Panels and Committees.--The
Advisory Committee shall make and maintain a transcript of any
proceeding of the panel or committee. Each such panel and
committee shall delete from any transcript made under this
subsection information which is exempt from disclosure under
section 552(b) of title 5, United States Code.
SEC. 121. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE.
(a) Report on Innovative Products.--
(1) In general.--Not later than 3 years after the
date of enactment of this Act, the Administrator, after
consultation with recognized scientific, medical, and
public health experts (including both Federal agencies
and nongovernmental entities, the Institute of Medicine
of the National Academy of Sciences, and the Society
for Research on Nicotine and Tobacco), shall submit to
the Congress a report that examines how best to
promote, and encourage the development and use by
current tobacco users of innovative tobacco and
nicotine products and treatments (including nicotine-
based and non-nicotine-based products and treatments)
to better achieve, in a manner that best protects and
promotes the public health--
(A) total abstinence from tobacco use;
(B) reductions in consumption of tobacco; and
(C) reductions in the harm associated with
continued tobacco use by moving current users
to noncombustible tobacco products.
(2) Recommendations.--The report under paragraph (1)
shall include the recommendations of the Administrator
on how the Tobacco Harm and Reduction Center should
coordinate and facilitate the exchange of information
on such innovative products and treatments among
relevant offices and centers within the Center and
within the National Institutes of Health, the Centers
for Disease Control and Prevention, and other relevant
Federal and State agencies.
SEC. 122. ADVERTISING AND MARKETING OF TOBACCO PRODUCTS.
(a) Within 18 months of enactment of the Act, the
Administrator shall report to Congress on the benefits to
public health of imposing restrictions or prohibitions on the
advertising and marketing, consistent with or in addition to
such restrictions or prohibitions contained in the Master
Settlement Agreement, on tobacco products.
(b) The Administrator shall specify in the report
constitutional free speech implications for each recommended
restriction or prohibition.
(c) The Administrator shall also specify the class of tobacco
products to which the prohibition or restriction would be
applicable and the impact of such actions on harm reduction
policies, practices, and accurate information available to
tobacco users.
(d) The Administrator shall establish and consult with an
advisory committee consisting of experts in constitutional law,
harm reduction policies, marketing practices, and consumer
behavior in preparing this report.
TITLE II--TOBACCO PRODUCTS WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT
DISCLOSURE
SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS.
(a) Amendment.--Section 4 of the Federal Cigarette Labeling
and Advertising Act (15 U.S.C. 1333) is amended to read as
follows:
``SEC. 4. LABELING.
``(a) Label Requirements.--
``(1) In general.--It shall be unlawful for any
person to manufacture, package, sell, offer to sell,
distribute, or import for sale or distribution within
the United States any cigarettes the package of which
fails to bear, in accordance with the requirements of
this section, one of the following labels:
``WARNING: Cigarettes are addictive.
``WARNING: Tobacco smoke can harm your
children.
``WARNING: Cigarettes cause fatal lung
disease.
``WARNING: Cigarettes cause cancer.
``WARNING: Cigarettes cause strokes and heart
disease.
``WARNING: Smoking during pregnancy can harm
your baby.
``WARNING: Smoking can kill you.
``WARNING: Tobacco smoke causes fatal lung
disease in nonsmokers.
``WARNING: Quitting smoking now greatly
reduces serious risks to your health.
``(2) Placement; typography; etc.--Each label
statement required by paragraph (1) shall be located in
the lower portion of the front panel of the package,
directly on the package underneath the cellophane or
other clear wrapping. Each label statement shall
comprise at least the bottom 25 percent of the front
panel of the package. The word `WARNING' shall appear
in capital letters and all text shall be in conspicuous
and legible 17-point type, unless the text of the label
statement would occupy more than 70 percent of such
area, in which case the text may be in a smaller
conspicuous and legible type size, provided that at
least 60 percent of such area is occupied by required
text. The text shall be black on a white background, or
white on a black background, in a manner that
contrasts, by typography, layout, or color, with all
other printed material on the package, in an
alternating fashion under the plan submitted under
subsection (c).
``(3) Does not apply to foreign distribution.--The
provisions of this subsection do not apply to a tobacco
product manufacturer or distributor of cigarettes which
does not manufacture, package, or import cigarettes for
sale or distribution within the United States.
``(4) Applicability to retailers.--A retailer of
cigarettes shall not be in violation of this subsection
for packaging that--
``(A) contains a warning label;
``(B) is supplied to the retailer by a
license- or permit-holding smoking article
manufacturer, importer, or distributor; and
``(C) is not altered by the retailer in a way
that is material to the requirements of this
subsection.
``(b) Advertising Requirements.--
``(1) In general.--It shall be unlawful for any
tobacco product manufacturer, importer, distributor, or
retailer of cigarettes to advertise or cause to be
advertised within the United States any cigarette
unless its advertising bears, in accordance with the
requirements of this section, one of the labels
specified in subsection (a).
``(2) Typography, etc.--Each label statement required
by subsection (a) in cigarette advertising shall comply
with the standards set forth in this paragraph. For
press and poster advertisements, each such statement
and (where applicable) any required statement relating
to tar, nicotine, or other constituent (including a
smoke constituent) yield shall comprise at least 20
percent of the area of the advertisement and shall
appear in a conspicuous and prominent format and
location at the bottom of each advertisement within the
trim area. The word `WARNING' shall appear in capital
letters, and each label statement shall appear in
conspicuous and legible type. The text of the label
statement shall be black if the background is white and
white if the background is black, under the plan
submitted under subsection (c). The label statements
shall be enclosed by a rectangular border that is the
same color as the letters of the statements and that is
the width of the first downstroke of the capital `W' of
the word `WARNING' in the label statements. The text of
such label statements shall be in a typeface pro rata
to the following requirements: 45-point type for a
whole-page broadsheet newspaper advertisement; 39-point
type for a half-page broadsheet newspaper
advertisement; 39-point type for a whole-page tabloid
newspaper advertisement; 27-point type for a half-page
tabloid newspaper advertisement; 31.5-point type for a
double page spread magazine or whole-page magazine
advertisement; 22.5-point type for a 28 centimeter by 3
column advertisement; and 15-point type for a 20
centimeter by 2 column advertisement. The label
statements shall be in English, except that--
``(A) in the case of an advertisement that
appears in a newspaper, magazine, periodical,
or other publication that is not in English,
the statements shall appear in the predominant
language of the publication; and
``(B) in the case of any other advertisement
that is not in English, the statements shall
appear in the same language as that principally
used in the advertisement.
``(3) Matchbooks.--Notwithstanding paragraph (2), for
matchbooks (defined as containing not more than 20
matches) customarily given away with the purchase of
smokeless tobacco products, each label statement
required by subsection (a) may be printed on the inside
cover of the matchbook.
``(c) Marketing Requirements.--
``(1) Random display.--The label statements specified
in subsection (a)(1) shall be randomly displayed in
each 12-month period, in as equal a number of times as
is possible on each brand of the product and be
randomly distributed in all areas of the United States
in which the product is marketed in accordance with a
plan submitted by the smokeless tobacco product
manufacturer, importer, distributor, or retailer and
approved by the Secretary.
``(2) Rotation.--The label statements specified in
subsection (a)(1) shall be rotated quarterly in
alternating sequence in advertisements for each brand
of cigarettes in accordance with a plan submitted by
the smokeless tobacco product manufacturer, importer,
distributor, or retailer to, and approved by, the
Secretary.
``(3) Review.--The Secretary shall review each plan
submitted under paragraph (2) and approve it if the
plan--
``(A) will provide for the equal distribution
and display on packaging and the rotation
required in advertising under this subsection;
and
``(B) assures that all of the labels required
under this section will be displayed by the
smokeless tobacco product manufacturer,
importer, distributor, or retailer at the same
time.
``(4) Applicability to retailers.--This subsection
and subsection (b) apply to a retailer only if that
retailer is responsible for or directs the label
statements required under this section except that this
paragraph shall not relieve a retailer of liability if
the retailer displays, in a location open to the
public, an advertisement that does not contain a
warning label or has been altered by the retailer in a
way that is material to the requirements of this
subsection and subsection (b).''.
(b) Effective Date.--The amendment made by subsection (a)
shall take effect 24 months after the date of enactment of this
Act. Such effective date shall be with respect to the date of
manufacture, provided that, in any case, beginning 30 days
after such effective date, a manufacturer shall not introduce
into the domestic commerce of the United States any product,
irrespective of the date of manufacture, that is not in
conformance with section 4 of the Federal Cigarette Labeling
and Advertising Act (15 U.S.C. 1333), as amended by subsection
(a).
SEC. 202. SMOKELESS TOBACCO LABELS AND ADVERTISING WARNINGS.
(a) Amendment.--Section 3 of the Comprehensive Smokeless
Tobacco Health Education Act of 1986 (15 U.S.C. 4402) is
amended to read as follows:
``SEC. 3. SMOKELESS TOBACCO WARNING.
``(a) General Rule.--
``(1) It shall be unlawful for any person to
manufacture, package, sell, offer to sell, distribute,
or import for sale or distribution within the United
States any smokeless tobacco product unless the product
package bears, in accordance with the requirements of
this Act, one of the following labels:
``WARNING: This product can cause mouth
cancer.
``WARNING: This product can cause gum disease
and tooth loss.
``WARNING: This product has significantly
lower risks for diseases associated with
cigarettes.
``WARNING: Smokeless tobacco is addictive.
``(2) The label statements required by paragraph (1)
shall be introduced by each smokeless tobacco product
manufacturer, packager, importer, distributor, or
retailer of smokeless tobacco products concurrently
into the distribution chain of such products.
``(3) The provisions of this subsection do not apply
to a smokeless tobacco product manufacturer or
distributor of any smokeless tobacco product that does
not manufacture, package, or import smokeless tobacco
products for sale or distribution within the United
States.
``(4) A retailer of smokeless tobacco products shall
not be in violation of this subsection for packaging
that--
``(A) contains a warning label;
``(B) is supplied to the retailer by a
license- or permit-holding smokeless tobacco
product manufacturer, importer, or distributor;
and
``(C) is not altered by the retailer in a way
that is material to the requirements of this
subsection.
``(b) Required Labels.--
``(1) It shall be unlawful for any smokeless tobacco
product manufacturer, packager, importer, distributor,
or retailer of smokeless tobacco products to advertise
or cause to be advertised within the United States any
smokeless tobacco product unless its advertising bears,
in accordance with the requirements of this section,
one of the labels specified in subsection (a).
``(2)(A) Each label statement required by subsection
(a) in smokeless tobacco advertising shall comply with
the standards set forth in this paragraph.
``(B) For press and poster advertisements, each such
statement and (where applicable) any required statement
relating to nicotine, or other constituent yield shall
comprise at least 20 percent of the area of the
advertisement.
``(C) The word `WARNING' shall appear in capital
letters, and each label statement shall appear in
conspicuous and legible type.
``(D) The text of the label statement shall be black
on a white background, or white on a black background,
in an alternating fashion under the plan submitted
under paragraph (3).
``(E) The label statements shall be enclosed by a
rectangular border that is the same color as the
letters of the statements and that is the width of the
first downstroke of the capital `W' of the word
`WARNING' in the label statements.
``(F) The text of such label statements shall be in a
typeface pro rata to the following requirements: 45-
point type for a whole-page broadsheet newspaper
advertisement; 39-point type for a half-page broadsheet
newspaper advertisement; 39-point type for a whole-page
tabloid newspaper advertisement; 27-point type for a
half-page tabloid newspaper advertisement; 31.5-point
type for a double page spread magazine or whole-page
magazine advertisement; 22.5-point type for a 28
centimeter by 3 column advertisement; and 15-point type
for a 20 centimeter by 2 column advertisement.
``(G) The label statements shall be in English,
except that--
``(i) in the case of an advertisement that
appears in a newspaper, magazine, periodical,
or other publication that is not in English,
the statements shall appear in the predominant
language of the publication; and
``(ii) in the case of any other advertisement
that is not in English, the statements shall
appear in the same language as that principally
used in the advertisement.
``(3)(A) The label statements specified in subsection
(a)(1) shall be randomly displayed in each 12-month
period, in as equal a number of times as is possible on
each brand of the product and be randomly distributed
in all areas of the United States in which the product
is marketed in accordance with a plan submitted by the
smokeless tobacco product manufacturer, importer,
distributor, or retailer and approved by the Secretary.
``(B) The label statements specified in subsection
(a)(1) shall be rotated quarterly in alternating
sequence in advertisements for each brand of smokeless
tobacco product in accordance with a plan submitted by
the smokeless tobacco product manufacturer, importer,
distributor, or retailer to, and approved by, the
Secretary.
``(C) The Secretary shall review each plan submitted
under subparagraphs (A) and (B) and approve it if the
plan--
``(i) will provide for the equal distribution
and display on packaging and the rotation
required in advertising under this subsection;
and
``(ii) assures that all of the labels
required under this section will be displayed
by the smokeless tobacco product manufacturer,
importer, distributor, or retailer at the same
time.
``(D) This paragraph applies to a retailer only if
that retailer is responsible for or directs the label
statements under this section, unless the retailer
displays, in a location open to the public, an
advertisement that does not contain a warning label or
has been altered by the retailer in a way that is
material to the requirements of this subsection.
``(c) Television and Radio Advertising.--It is unlawful to
advertise smokeless tobacco on any medium of electronic
communications subject to the jurisdiction of the Federal
Communications Commission.''.
(b) Effective Date.--The amendment made by subsection (a)
shall take effect 24 months after the date of enactment of this
Act. Such effective date shall be with respect to the date of
manufacture, provided that, in any case, beginning 30 days
after such effective date, a manufacturer shall not introduce
into the domestic commerce of the United States any product,
irrespective of the date of manufacture, that is not in
conformance with section 3 of the Comprehensive Smokeless
Tobacco Health Education Act of 1986 (15 U.S.C. 4402), as
amended by subsection (a).
TITLE III--PUBIC DISCLOSURES BY TOBACCO PRODUCTS MANUFACTURERS
SEC. 301. DISCLOSURES ON PACKAGES OF TOBACCO PRODUCTS.
(a) Back Face for Required Disclosures.--For purposes of this
section--
(1) the principal face of a package of a tobacco
product is the face that has the largest surface area
or, for faces with identical surface areas, any of the
faces that have the largest surface area; a package
shall not be characterized as having more than 2
principal faces;
(2) the front face shall be the principal face of the
package;
(3) if the front and back faces are of different
sizes in terms of area, then the larger face shall be
the front face;
(4) the back face shall be the principal face of a
package that is opposite the front face of the package;
(5) the bottom 50 percent of the back face of the
package shall be allocated for required package
disclosures in accordance with this section; and
(6) if a package of a tobacco product is cylindrical,
a contiguous area constituting 30 percent of the total
surface area of the cylinder shall be deemed the back
face.
(b) Required Information on Back Face.--Not later than 24
months after the effective date of this Act, the bottom 50
percent of the back face of a package of a tobacco product
shall be available solely for disclosures required by or under
this Act, the Federal Cigarette Labeling and Advertising Act,
sections 1331-1340 of title 15, United States Code, and any
other Federal statute. Such disclosures shall include--
(1) the printed name and address of the manufacturer,
packer, or distributor, and any other identification
associated with the manufacturer, packer, or
distributor or with the tobacco product that the
Administrator may require;
(2) a list of ingredients as required by subsection
(e); and
(3) the appropriate tax registration number.
(c) Package Disclosure of Ingredients.--Not later than 24
months after the effective date of this Act, the package of a
tobacco product shall bear a list of the common or usual names
of the ingredients present in the tobacco product in an amount
greater than 0.1 percent of the total dry weight of the tobacco
(including all ingredients), that shall comply with the
following:
(1) Such listing of ingredients shall appear under,
or be conspicuously accompanied by, the heading
``Tobacco and principal tobacco ingredients''.
(2) Tobacco may be listed as ``tobacco,'' and shall
be the first listed ingredient.
(3) After tobacco, the ingredients shall be listed in
descending order of predominance, by weight.
(4) Spices and natural and artificial flavors may be
listed, respectively, as ``spices'' and ``natural and
artificial flavors'' without naming each.
(5) Preservatives may be listed as ``preservatives''
without naming each.
(6) The disclosure of any ingredient in accordance
with this section may, at the option of the tobacco
product manufacturer, designate the functionality or
purpose of that ingredient.
(7) The package say state ``Not for sale to minors''.
(8) In the case of a package of cigarettes, the
package shall state that smokeless tobacco has
significantly lower risks for disease and death than
cigarettes.
SEC. 302. DISCLOSURES ON PACKAGES OF SMOKELESS TOBACCO.
(a) Back Face for Required Disclosures.--For purposes of this
section--
(1) the principal face of a package of smokeless
tobacco is the face that has the largest surface area
or, for faces with identical surface areas, any of the
faces that have the largest surface area; a package
shall not be characterized as having more than two
principal faces;
(2) the front or top face shall be the principal face
of the package;
(3) if the front or top and back or bottom faces are
of different sizes in terms of area, then the larger
face shall be the front or top face;
(4) the back or bottom face of the package shall be
the principal face of a package that is opposite the
front or top face of the package;
(5) beginning 24 months after the effective date of
this Act, 50 percent of the back or bottom face of the
package shall be allocated for required package
disclosures in accordance with this section; and
(6) if the package is cylindrical, a contiguous area
constituting 30 percent of the total surface area of
the cylinder shall be deemed the back face.
(b) Required Information on Back or Bottom Face.--50 percent
of the back or bottom face of a package of smokeless tobacco
shall be available solely for disclosures required by or under
this Act, the Comprehensive Smokeless Tobacco Health Education
Act of 1986, sections 4401-4408 of title 15, United States
Code, and any other Federal statute. Such disclosures shall
include a list of ingredients as required by subsection (e).
(c) Package Disclosure of Ingredients.--Commencing 24 months
after the effective date of this Act, a package of smokeless
tobacco shall bear a list of the common or usual names of the
ingredients present in the smokeless tobacco in an amount
greater than 0.1 percent of the total dry weight of the tobacco
(including all ingredients).
(1) Such listing of ingredients shall appears under,
or be conspicuously accompanied by, the heading
``Tobacco and principal tobacco ingredients''.
(2) Tobacco may be listed as ``tobacco,'' and shall
be the first listed ingredient.
(3) After tobacco, the ingredients shall be listed in
descending order of predominance, by weight.
(4) Spices and natural and artificial flavors may be
listed, respectively, as ``spices'' and ``natural and
artificial flavors'' without naming each.
(5) Preservatives may be listed as ``preservatives''
without naming each.
(6) The disclosure of any ingredient in accordance
with this section may, at the option of the tobacco
product manufacturer, designate the functionality or
purpose of that ingredient.
(7) Not for sale to minors.
SEC. 303. PUBLIC DISCLOSURE OF INGREDIENTS.
(a) Regulations.--Not later than 24 months after the
effective date of this Act, the Administrator shall, by
regulation, establish standards under which each tobacco
product manufacturer shall disclose publicly, and update at
least annually--
(1) a list of the ingredients it uses in each brand
style it manufactures for commercial distribution
domestically, as provided in subsection (b); and
(2) a composite list of all the ingredients it uses
in any of the brand styles it manufactures for
commercial distribution domestically, as provided in
subsection (c).
(b) Ingredients To Be Disclosed as to Each Brand Style.--
(1) In general.--With respect to the public
disclosure required by subsection (a)(1), as to each
brand style, the tobacco product manufacture shall
disclose the common or usual name of each ingredient
present in the brand style in an amount greater than
0.1 percent of the total dry weight of the tobacco
(including all ingredients).
(2) Requirements.--Disclosure under paragraph (1)
shall comply with the following:
(A) Tobacco may be listed as ``tobacco,'' and
shall be the first listed ingredient.
(B) After tobacco, the ingredients shall be
listed in descending order of predominance, by
weight.
(C) Spices and natural and artificial flavors
may be listed, respectively, as ``spices'' and
``natural and artificial flavors'' without
naming each.
(D) Preservatives may be listed as
``preservatives'' without naming each.
(E) The disclosure of any ingredient in
accordance with this section may, at the option
of the tobacco product manufacturer, designate
the functionality or purpose of that
ingredient.
(c) Aggregate Disclosure of Ingredients.--
(1) In general.--The public disclosure required of a
tobacco product manufacturer by subsection (a)(2) shall
consist of a single list of all ingredients used in any
brand style a tobacco product manufacturer manufactures
for commercial distribution domestically, without
regard to the quantity used, and including, separately,
each spice, each natural or artificial flavoring, and
each preservative.
(2) Listing.--The ingredients shall be listed by
their respective common or usual names in descending
order of predominance by the total weight used annually
by the tobacco product manufacturer in manufacturing
tobacco products for commercial distribution
domestically.
(d) No Required Disclosure of Quantities.--The Administrator
shall not require any public disclosure of quantitative
information about any ingredient in a tobacco product.
(e) Disclosure on Website.--The public disclosures required
by subsection (a) of this section may be by posting on an
Internet-accessible website, or other location electronically
accessible to the public, which is identified on all packages
of a tobacco product manufacturer's tobacco products.
(f) Timing of Initial Required Disclosures.--No disclosure
pursuant to this section shall be required to commence until
the regulations under subsection (a) have been in effect for
not less than 1 year.
TITLE IV--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS
SEC. 401. STUDY AND REPORT ON ILLICIT TRADE.
(a) The Administrator shall, after consultation with other
relevant agencies including Customs and Tobacco Tax Bureau,
conduct a study of trade in tobacco products that involves
passage of tobacco products either between the States or from
or to any other country across any border of the United States
to--
(1) collect data on such trade in tobacco products,
including illicit trade involving tobacco products, and
make recommendations on the monitoring and enforcement
of such trade;
(2) collect data on any advertising intended to be
broadcast, transmitted, or distributed from or to the
United States from or to another country and make
recommendations on how to prevent or eliminate, and
what technologies could help facilitate the elimination
of, such advertising; and
(3) collect data on such trade in tobacco products by
person that is not--
(A) a participating manufacturer (as that
term is defined in section II(jj) of the Master
Settlement Agreement of November 23, 1998,
between certain of the States and certain
tobacco product manufacturers); or
(B) an affiliate or subsidiary of a
participating manufacturer.
(b) Not later than 18 months after the effective date of this
Act, the Administrator shall submit to the Secretary, and
committees of relevant jurisdiction in Congress, a report the
recommendations of the study conducted under subsection (a).
SEC. 402. AMENDMENT TO SECTION 1926 OF THE PUBLIC HEALTH SERVICE ACT.
Section 1926 of the Public Health Service Act (42 U.S.C.
Sec. 300x-26) is amended by adding at the end thereof the
following:
``(e)(1) Subject to paragraphs (2) and (3), for the first
fiscal year after enactment and each subsequent fiscal year,
the Secretary shall reduce, as provided in subsection (h), the
amount of any grant under section 300x-21 of this title for any
State that does not have in effect a statute with substantially
the following provisions:
```SEC. 1. DISTRIBUTION TO MINORS.
```(a) No person shall distribute a tobacco product to an
individual under 18 years of age or a different minimum age
established under State law. A person who violates this
subsection is liable for a civil money penalty of not less than
$25 nor more than $125 for each violation of this subsection;
```(b) The employer of an employee who has violated
subsection (a) twice while in the employ of such employer is
liable for a civil money penalty of $125 for each subsequent
violation by such employee.
```(c) It shall be a defense to a charge brought under
subsection (a) that--
```(1) the defendant--
```(A) relied upon proof of age that appeared
on its face to be valid in accordance with the
Federal Tobacco Act of 2007;
```(B) had complied with the requirements of
section 5 and, if applicable, section 7; or
```(C) relied upon a commercially available
electronic age verification service to confirm
that the person was an age-verified adult; or
```(2) the individual to whom the tobacco product was
distributed was at the time of the distribution used in
violation of subsection 8(b).
```SEC. 2. PURCHASE, RECEIPT, OR POSSESSION BY MINORS PROHIBITED.
```(a) An individual under 18 years of age or a different
minimum age established under State law shall not purchase or
attempt to purchase, receive or attempt to receive, possess or
attempt to possess, a tobacco product. An individual who
violates this subsection is liable for a civil money penalty of
not less than $25 nor more than $125 for each such violation,
and shall be required to perform not less than four hours nor
more than ten hours of community service. Upon the second or
each subsequent violation of this subsection, such individual
shall be required to perform not less than eight hours nor more
than twenty hours of community service.
```(b) A law enforcement agency, upon determining that an
individual under 18 years of age or a different minimum age
established under State law allegedly purchased, received,
possessed, or attempted to purchase, receive, or possess, a
tobacco product in violation of subsection (a) shall notify the
individual's parent or parents, custodian, or guardian as to
the nature of the alleged violation if the name and address of
a parent or parents, guardian, or custodian is reasonably
ascertainable by the law enforcement agency. The notice
required by this subsection shall be made not later than 48
hours after the individual who allegedly violated subsection
(a) is cited by such agency for the violation. The notice may
be made by any means reasonably calculated to give prompt
actual notice, including notice in person, by telephone, or by
first-class mail.
```(c) Subsection (a) does not prohibit an individual under
18 years of age or a different minimum age established under
State law from possessing a tobacco product during regular
working hours and in the course of such individual's employment
if the tobacco product is not possessed for such individual's
consumption.
```SEC. 3. OUT-OF-PACKAGE DISTRIBUTION.
```It shall be unlawful for any person to distribute
cigarettes or a smokeless tobacco product other than in an
unopened package that complies in full with section 108 of the
Federal Tobacco Act of 2007. A person who distributes a
cigarette or a smokeless tobacco product in violation of this
section is liable for a civil money penalty of not less than
$25 nor more than $125 for each such violation.
```SEC. 4. SIGNAGE.
```It shall be unlawful for any person who sells tobacco
products over-the-counter to fail to post conspicuously on the
premises where such person sells tobacco products over-the-
counter a sign communicating that--
```(1) the sale of tobacco products to individuals
under 18 years of age or a different minimum age
established under State law is prohibited by law;
```(2) the purchase of tobacco products by
individuals under 18 years of age or a different
minimum age established under State law is prohibited
by law; and
```(3) proof of age may be demanded before tobacco
products are sold.
A person who fails to post a sign that complies fully with this
section is liable for a civil money penalty of not less than
$25 nor more than $125.
```SEC. 5. NOTIFICATION OF EMPLOYEES.
```(a) Within 180 days of the effective date of the Youth
Prevention and Tobacco Harm Reduction Act, every person engaged
in the business of selling tobacco products at retail shall
implement a program to notify each employee employed by that
person who sells tobacco products at retail that--
```(1) the sale or other distribution of tobacco
products to any individual under 18 years of age or a
different minimum age established under State law, and
the purchase, receipt, or possession of tobacco
products in a place open to the public by any
individual under 18 years of age or a different minimum
age established under State law, is prohibited; and
```(2) out-of-package distribution of cigarettes and
smokeless tobacco products is prohibited.
Any employer failing to provide the required notice to any
employee shall be liable for a civil money penalty of not less
than $25 nor more than $125 for each such violation.
```(b) It shall be a defense to a charge that an employer
violated subsection (a) of this section that the employee
acknowledged receipt, either in writing or by electronic means,
prior to the alleged violation, of a statement in substantially
the following form:
``I understand that State law prohibits the distribution of
tobacco products to individuals under 18 years of age or a
different minimum age established under State law and out-of-
package distribution of cigarettes and smokeless tobacco
products, and permits a defense based on evidence that a
prospective purchaser's proof of age was reasonably relied upon
and appeared on its face to be valid. I understand that if I
sell, give, or voluntarily provide a tobacco product to an
individual under 18 years of age or a different minimum age
established under State law, I may be found responsible for a
civil money penalty of not less than $25 nor more than $125 for
each violation. I promise to comply with this law.''
```(c) If an employer is charged with a violation of
subsection (a) and the employer uses as a defense to such
charge the defense provided by subsection (b), the employer
shall be deemed to be liable for such violation if such
employer pays the penalty imposed on the employee involved in
such violation or in any way reimburses the employee for such
penalty.
```SEC. 6. SELF-SERVICE DISPLAYS.
```(a) It shall be unlawful for any person who sells tobacco
products over-the-counter at retail to maintain packages of
such products in any location accessible to customers that is
not under the control of a cashier or other employee during
regular business hours. This subsection does not apply to any
adult-only facility.
```(b) Any person who violates subsection (a) is liable for a
civil money penalty of not less than $25 nor more than $125 for
each such violation, except that no person shall be responsible
for more than one violation per day at any one retail store.
```SEC. 7. DISTRIBUTION BY MAIL OR COURIER.
```(a) It shall be unlawful to distribute or sell tobacco
products directly to consumers by mail or courier, unless the
person receiving purchase requests for tobacco products takes
reasonable action to prevent delivery to individuals who are
not adults by--
```(1) requiring that addressees of the tobacco
products be age-verified adults;
```(2) making good faith efforts to verify that such
addressees have attained the minimum age for purchase
of tobacco products established by the respective
States wherein the addresses of the addressees are
located; and
```(3) addressing the tobacco products delivered by
mail or courier to a physical addresses and not to post
office boxes.
```(b) Any person who violates subsection (a) is liable for a
civil money penalty of not less than $25 nor more than $125 for
each such violation.
```SEC. 8. RANDOM UNANNOUNCED INSPECTIONS; REPORTING; AND COMPLIANCE.
```(a) The State Police, or a local law enforcement authority
duly designated by the State Police, shall enforce this Act in
a manner that can reasonably be expected to reduce the extent
to which tobacco products are distributed to individuals under
18 years of age or a different minimum age established under
State law and shall conduct random, unannounced inspections in
accordance with the procedures set forth in this Act and in
regulations issued under section 1926 of the Federal Public
Health Service Act (42 U.S.C. Sec. 300x-26).
```(b) The State may engage an individual under 18 years of
age or a different minimum age established under State law to
test compliance with this Act, except that such an individual
may be used to test compliance with this Act only if the
testing is conducted under the following conditions:
```(1) Prior to use of any individual under 18 years
of age or a different minimum age established under
State law in a random, unannounced inspection, written
consent shall be obtained from a parent, custodian, or
guardian of such individual;
```(2) An individual under 18 years of age or a
different minimum age established under State law shall
act solely under the supervision and direction of the
State Police or a local law enforcement authority duly
designated by the State Police during a random,
unannounced inspection;
```(3) An individual under 18 years of age or a
different minimum age established under State law used
in random, unannounced inspections shall not be used in
any such inspection at a store in which such individual
is a regular customer; and
```(4) If an individual under 18 years of age or a
different minimum age established under State law
participating in random, unannounced inspections is
questioned during such an inspection about such
individual's age, such individual shall state his or
her actual age and shall present a true and correct
proof of age if requested at any time during the
inspection to present it.
```(c) Any person who uses any individual under 18 years of
age or a different minimum age established under State law,
other than as permitted by subsection (b), to test compliance
with this Act, is liable for a civil money penalty of not less
than $25 nor more than $125 for each such violation.
```(d) Civil money penalties collected for violations of this
Act and fees collected under section 9 shall be used only to
defray the costs of administration and enforcement of this Act.
```SEC. 9. LICENSURE.
```(a) Each person engaged in the over-the-counter
distribution at retail of tobacco products shall hold a license
issued under this section. A separate license shall be required
for each place of business where tobacco products are
distributed at retail. A license issued under this section is
not assignable and is valid only for the person in whose name
it is issued and for the place of business designated in the
license.
```(b) The annual license fee is $25 for each place of
business where tobacco products are distributed at retail.
```(c) Every application for a license, including renewal of
a license, under this section shall be made upon a form
provided by the appropriate State agency or department, and
shall set forth the name under which the applicant transacts or
intends to transact business, the location of the place of
business for which the license is to be issued, the street
address to which all notices relevant to the license are to be
sent (in this Act referred to as ``notice address''), and any
other identifying information that the appropriate State agency
or department may require.
```(d) The appropriate State agency or department shall issue
or renew a license or deny an application for a license or the
renewal of a license within 30 days of receiving a properly
completed application and the license fee. The appropriate
State agency or department shall provide notice to an applicant
of action on an application denying the issuance of a license
or refusing to renew a license.
```(e) Every license issued by the appropriate State agency
or department pursuant to this section shall be valid for 1
year from the date of issuance and shall be renewed upon
application except as otherwise provided in this Act.
```(f) Upon notification of a change of address for a place
of business for which a license has been issued, a license
shall be reissued for the new address without the filing of a
new application.
```(g) The appropriate State agency or department shall
notify every person in the State who is engaged in the
distribution at retail of tobacco products of the license
requirements of this section and of the date by which such
person should have obtained a license.
```(h)(1) Except as provided in paragraph (2), any person who
engages in the distribution at retail of tobacco products
without a license required by this section is liable for a
civil money penalty in an amount equal to (i) two times the
applicable license fee, and (ii) $50 for each day that such
distribution continues without a license.
```(2) Any person who engages in the distribution at
retail of tobacco products after a license issued under
this section has been suspended or revoked is liable
for a civil money penalty of $100 per day for each day
on which such distribution continues after the date
such person received notice of such suspension or
revocation.
```(i) No person shall engage in the distribution at retail
of tobacco products on or after 180 days after the date of
enactment this Act unless such person is authorized to do so by
a license issued pursuant to this section or is an employee or
agent of a person that has been issued such a license.
```SEC. 10. SUSPENSION, REVOCATION, DENIAL, AND NONRENEWAL OF LICENSES.
```(a) Upon a finding that a licensee has been determined by
a court of competent jurisdiction to have violated this Act
during the license term, the State shall notify the licensee in
writing, served personally or by registered mail at the notice
address, that any subsequent violation of this Act at the same
place of business may result in an administrative action to
suspend the license for a period determined by the specify the
appropriate State agency or department.
```(b) Upon finding that a further violation by this Act has
occurred involving the same place of business for which the
license was issued and the licensee has been served notice once
under subsection (a), the appropriate State agency or
department may initiate an administrative action to suspend the
license for a period to be determined by the appropriate State
agency or department but not to exceed six months. If an
administrative action to suspend a license is initiated, the
appropriate State agency or department shall immediately notify
the licensee in writing at the notice address of the initiation
of the action and the reasons therefor and permit the licensee
an opportunity, at least 30 days after written notice is served
personally or by registered mail upon the licensee, to show why
suspension of the license would be unwarranted or unjust.
```(c) The appropriate State agency or department may
initiate an administrative action to revoke a license that
previously has been suspended under subsection (b) if, after
the suspension and during the one-year period for which the
license was issued, the licensee committed a further violation
of this Act, at the same place of business for which the
license was issued. If an administrative action to revoke a
license is initiated, the appropriate State agency or
department shall immediately notify the licensee in writing at
the notice address of the initiation of the action and the
reasons therefor and permit the licensee an opportunity, at
least 30 days after written notice is served personally or by
registered mail upon the licensee, to show why revocation of
the license would be unwarranted or unjust.
```(d) A person whose license has been suspended or revoked
with respect to a place of business pursuant to this section
shall pay a fee of $50 for the renewal or reissuance of the
license at that same place of business, in addition to any
applicable annual license fees.
```(e) Revocation of a license under subsection (c) with
respect to a place of business shall not be grounds to deny an
application by any person for a new license with respect to
such place of business for more than 12 months subsequent to
the date of such revocation. Revocation or suspension of a
license with respect to a particular place of business shall
not be grounds to deny an application for a new license, to
refuse to renew a license, or to revoke or suspend an existing
license at any other place of business.
```(f) A licensee may seek judicial review of an action of
the appropriate State agency or department suspending,
revoking, denying, or refusing to renew a license under this
section by filing a complaint in a court of competent
jurisdiction. Any such complaint shall be filed within 30 days
after the date on which notice of the action is received by the
licensee. The court shall review the evidence de novo.
```(g) The State shall not report any action suspending,
revoking, denying, or refusing to renew a license under this
section to the Federal Secretary of Health and Human Services,
unless the opportunity for judicial review of the action
pursuant to subsection (f), if any, has been exhausted or the
time for seeking such judicial review has expired.
```SEC. 11. NO PRIVATE RIGHT OF ACTION.
```Nothing in this Act shall be construed to create a right
of action by any private person for any violation of any
provision of this Act.
```SEC. 12. JURISDICTION AND VENUE.
```Any action alleging a violation of this Act may be brought
only in a court of general jurisdiction in the city or county
where the violation is alleged to have occurred.
```SEC. 13. REPORT.
```The appropriate State agency or department shall prepare
for submission annually to the Federal Secretary of Health and
Human Services the report required by section 1926 of the
Federal Public Health Service Act (42 U.S.C. 300x-26).'''.
``(2) In the case of a State whose legislature does
not convene a regular session in fiscal year 2007, and
in the case of a State whose legislature does not
convene a regular session in fiscal year 2008, the
requirement described in subsection (e)(1) as a
condition of a receipt of a grant under section 300x-21
of this title shall apply only for fiscal year 2009 and
subsequent fiscal years.
``(3) Subsection (e)(1) shall not affect any State or
local law that (A) was in effect on the date of
introduction of the Federal Tobacco Act of 2007, and
(B) covers the same subject matter as the law described
in subsection (e)(1). Any State law that meets the
conditions of this paragraph shall also be deemed to
meet the requirement described in subsection (e)(1) as
a condition of a receipt of a grant under section 300x-
21 of this title, if such State law is at least as
stringent as the law described in subsection (e)(1).
``(f)(1) For the first applicable fiscal year and for each
subsequent fiscal year, a funding agreement for a grant under
section 300x-21 of this title is a funding agreement under
which the State involved will enforce the law described in
subsection (e)(1) of this section in a manner that can
reasonably be expected to reduce the extent to which tobacco
products are available to individuals under the age of 18 or a
different minimum age established under State law for the
purchase of tobacco products.
``(2) For the first applicable fiscal year and for each
subsequent fiscal year, a funding agreement for a grant under
section 300x-21 of this title is a funding agreement under
which the State involved will--
``(A) conduct random, unannounced inspections to
ensure compliance with the law described in subsection
(e)(1); and
``(B) annually submit to the Secretary a report
describing--
``(i) the activities carried out by the State
to enforce such law during the fiscal year
preceding the fiscal year for which the State
is seeking the grant;
``(ii) the extent of success the State has
achieved in reducing the availability of
tobacco products to individuals under 18 years
of age or a different minimum age established
under State law, including the results of the
inspections conducted under subparagraph (A);
and
``(iii) the strategies to be utilized by the
State for enforcing such law during the fiscal
year for which the grant is sought.
``(g) The law specified in subsection (e)(1) may be
administered and enforced by a State using--
``(1) any amounts made available to the State through
a grant under section 300x-21 of this title;
``(2) any amounts made available to the State under
section 300w of this title;
``(3) any fees collected for licenses issued pursuant
to the law described in subsection (e)(1);
``(4) any fines or penalties assessed for violations
of the law specified in subsection (e)(1); or
``(5) any other funding source that the legislature
of the State may prescribe by statute.
``(h) Before making a grant under section 300x-21 of this
title to a State for the first applicable fiscal year or any
subsequent fiscal year, the Secretary shall make a
determination of whether the State has maintained compliance
with subsections (e) and (f) of this section. If, after notice
to the State and an opportunity for a hearing, the Secretary
determines that the State is not in compliance with such
subsections, the Secretary shall reduce the amount of the
allotment under section 300x-21 of this title for the State for
the fiscal year involved by an amount equal to--
``(1) In the case of the first applicable fiscal
year, 10 percent of the amount determined under section
300x-33 for the State for the fiscal year;
``(2) In the case of the first fiscal year following
such applicable fiscal year, 20 percent of the amount
determined under section 300x-33 for the State for the
fiscal year;
``(3) In the case of the second such fiscal year, 30
percent of the amount determined under section 300x-33
for the State for the fiscal year; and
``(4) In the case of the third such fiscal year or
any subsequent fiscal year, 40 percent of the amount
determined under section 300x-33 for the State for the
fiscal year.
The Secretary shall not have authority or discretion to grant
to any State a waiver of the terms and requirements of this
subsection or subsection (e) or (f).
``(i) For the purposes of subsections (e) through (h) of this
section the term `first applicable fiscal year' means--
``(1) fiscal year 2009, in the case of any State
described in subsection (e)(2) of this section; and
``(2) fiscal year 2008, in the case of any other
State.
``(j) For purposes of subsections (e) through (h) of this
section, references to section 300x-21 shall include any
successor grant programs.`'
``(k) As required by paragraph (1), and subject to paragraph
(4), an Indian tribe shall satisfy the requirements of
subsection (e)(1) of this section by enacting a law or
ordinance with substantially the same provisions as the law
described in subsection (e)(1).
``(1) An Indian tribe shall comply with subsection
(e)(1) of this section within 180 days after the
Administrator finds, in accordance with this paragraph,
that--
``(A) the Indian tribe has a governing body
carrying out substantial governmental powers
and duties;
``(B) the functions to be exercised by the
Indian tribe under this Act pertain to
activities on trust land within the
jurisdiction of the tribe; and
``(C) the Indian tribe is reasonably expected
to be capable of carrying out the functions
required under this section.
Within 2 years of the date of enactment of the Federal
Tobacco Act of 2007, as to each Indian tribe in the
United States, the Administrator shall make the
findings contemplated by this paragraph or determine
that such findings cannot be made, in accordance with
the procedures specified in paragraph (4).
``(2) As to Indian tribes subject to subsection
(e)(1) of this section, the Administrator shall
promulgate regulations that--
``(A) provide whether and to what extent, if
any, the law described in subsection (e)(1) may
be modified as adopted by Indian tribes; and
``(B) ensure, to the extent possible, that
each Indian tribe's retailer licensing program
under subsection (e)(1) is no less stringent
than the program of the State or States in
which the Indian tribe is located.
``(3) If with respect to any Indian tribe the
Administrator determines that compliance with the
requirements of subsection (e)(1) is inappropriate or
administratively infeasible, the Administrator shall
specify other means for the Indian tribe to achieve the
purposes of the law described in subsection (e)(1) with
respect to persons who engage in the distribution at
retail of tobacco products on tribal lands.
``(4) The findings and regulations promulgated under
paragraphs (1) and (2) shall be promulgated in
conformance with section 553 of title 5, United States
Code, and shall comply with the following provisions:
``(A) In making findings as provided in
paragraph (1), and in drafting and promulgating
regulations as provided in paragraph (2)
(including drafting and promulgating any
revised regulations), the Administrator shall
confer with, and allow for active participation
by, representatives and members of Indian
tribes, and tribal organizations.
``(B) In carrying out rulemaking processes
under this subsection, the Administrator shall
follow the guidance of subchapter III of
chapter 5 of title 5, United States Code,
commonly known as the `Negotiated Rulemaking
Act of 1990.'
``(C) The tribal participants in the
negotiation process referred to in subparagraph
(B) shall be nominated by and shall represent
the groups described in this subsection and
shall include tribal representatives from all
geographic regions.
``(D) The negotiations conducted under this
paragraph (4) shall be conducted in a timely
manner.
``(E) If the Administrator determines that an
extension of the deadlines under subsection
(k)(1) of this section is appropriate, the
Secretary may submit proposed legislation to
Congress for the extension of such deadlines.
``(5) This subsection shall not affect any law or
ordinance that (A) was in effect on tribal lands on the
date of introduction of the Youth Prevention and
Tobacco Harm Reduction Act, and (B) covers the same
subject matter as the law described in subsection
(e)(1). Any law or ordinance that meets the conditions
of this paragraph shall also be deemed to meet the
requirement described in subsection (k)(1), if such law
or ordinance is at least as stringent as the law
described in subsection (e)(1).
``(6) For purposes of this subsection--
``(A) `Administrator' means the Administrator
of the Tobacco Harm Reduction Center.
``(B) `Indian tribe' has the meaning assigned
that term in section 4(e) of the Indian Self
Determination and Education Assistance Act,
section 450b(e) of title 25, United States
Code.
``(C) `Tribal lands' means all lands within
the exterior boundaries of any Indian
reservation, all lands the title to which is
held by the United States in trust for an
Indian tribe, or lands the title to which is
held by an Indian tribe subject to a
restriction by the United States against
alienation, and all dependent Indian
communities.
``(D) `tribal organization' has the meaning
assigned that term in section 4(l) of the
Indian Self Determination and Education
Assistance Act, section 450b(l) of title 25,
United States Code.''.
SEC. 403. ESTABLISHMENT OF RANKINGS.
(a) Standards and Procedures for Rankings.--Within 24 months
after the effective date of this Act, the Administrator shall,
by regulation, after consultation with an Advisory Committee
established for such purpose, establish the standards and
procedures for promulgating rankings, comprehensible to
consumers of tobacco products, of the following categories of
tobacco products and also nicotine-containing products on the
basis of the relative risks of serious or chronic tobacco-
related diseases and adverse health conditions those categories
of tobacco products and also nicotine-containing products
respectively present--
(1) cigarettes;
(2) loose tobacco for roll-your-own tobacco products;
(3) little cigars;
(4) cigars;
(5) pipe tobacco;
(6) moist snuff;
(7) dry snuff;
(8) chewing tobacco;
(9) other forms of tobacco products, including
pelletized tobacco and compressed tobacco, treated
collectively as a single category; and
(10) other nicotine-containing products, treated
collectively as a single category.
The Administrator shall not have authority or discretion to
establish a relative-risk ranking of any category or
subcategory of tobacco products or any category or subcategory
of nicotine-containing products other than the ten categories
specified in this subsection.
(b) Considerations in Promulgating Regulations.--In
promulgating regulations under this section, the
Administrator--
(1) shall take into account relevant epidemiologic
studies and other relevant competent and reliable
scientific evidence; and
(2) in assessing the risks of serious or chronic
tobacco-related diseases and adverse health conditions
presented by a particular category, shall consider the
range of tobacco products or nicotine-containing
products within the category, and shall give
appropriate weight to the market shares of the
respective products in the category.
(c) Promulgation of Rankings of Categories.--Once the initial
regulations required by subsection (a) are in effect, the
Administrator shall promptly, by order, after notice and an
opportunity for comment, promulgate to the general public
rankings of the categories of tobacco products and nicotine-
containing products in accordance with those regulations. The
Administrator shall promulgate the initial rankings of those
categories of tobacco products and nicotine-containing products
to the general public not later than January 1, 2010.
Thereafter, on an annual basis, the Administrator shall, by
order, promulgate to the general public updated rankings that
are (1) in accordance with those regulations, and (2) reflect
the scientific evidence available at the time of promulgation.
The Administrator shall open and maintain an ongoing public
docket for receipt of data and other information submitted by
any person with respect to such annual promulgation of
rankings.
TITLE V--ENFORCEMENT PROVISIONS
SEC. 501. PROHIBITED ACTS.
The following acts and the causing thereof are hereby
prohibited--
(1) the introduction or delivery for introduction
into interstate commerce of any tobacco product that is
adulterated or misbranded;
(2) the adulteration or misbranding of any tobacco
product in interstate commerce;
(3) the receipt in interstate commerce of any tobacco
product that is known to be adulterated or misbranded,
and the delivery or proffered delivery thereof for pay
or otherwise;
(4) the failure to establish or maintain any record,
or make any report or other submission, or to provide
any notice required by or under this Act; or the
refusal to permit access to, verification of, or
copying of any record as required by this Act;
(5) the refusal to permit entry or inspection as
authorized by this Act;
(6) the making to the Administrator of a statement,
report, certification or other submission required by
this Act, with knowledge that such statement, report,
certification, or other submission is false in a
material aspect;
(7) the manufacturing, shipping, receiving, storing,
selling, distributing, possession, or use of any
tobacco product with knowledge that it is an illicit
tobacco product;
(8) the forging, simulating without proper
permission, falsely representing, or without proper
authority using any brand name;
(9) the using by any person to his or her own
advantage, or revealing, other than to the
Administrator or officers or employees of the Agency,
or to the courts when relevant in any judicial
proceeding under this Act, any information acquired
under authority of this Act concerning any item which
as a trade secret is entitled to protection; except
that the foregoing does not authorize the withholding
of information from either House of Congress or from,
to the extent of matter within its jurisdiction, any
committee or subcommittee of such committee or any
joint committee of Congress or any subcommittee of such
joint committee;
(10) the alteration, mutilation, destruction,
obliteration, or removal of the whole or any part of
the labeling of, or the doing of any other act with
respect to, a tobacco product, if such act is done
while such tobacco product is held for sale (whether or
not the first sale) after shipment in interstate
commerce, and results in such tobacco product being
adulterated or misbranded;
(11) the importation of any tobacco product that is
adulterated, misbranded, or otherwise not in compliance
with this Act; and
(12) the commission of any act prohibited by section
201 of this Act.
SEC. 502. INJUNCTION PROCEEDINGS.
(a) The district courts of the United States shall have
jurisdiction, for cause shown, to restrain violations of this
Act, except for violations of section 701(k).
(b) In case of an alleged violation of an injunction or
restraining order issued under this section, which also
constitutes a violation of this Act, trial shall be by the
court, or upon demand of the defendant, by a jury.
SEC. 503. PENALTIES.
(a) Criminal Penalties.--Any person who willfully violates a
provision of section 501 of this Act shall be imprisoned for
not more than one year or fined not more than $25,000, or both.
(b) Civil Penalties for Violation of Section 803.--
(1) Any person who knowingly distributes or sells,
other than through retail sale or retail offer for
sale, any cigarette brand style in violation of section
803(a)--
(A) for a first offense shall be liable for a
civil penalty not to exceed $10,000 for each
distribution or sale, or
(B) for a second offense shall be liable for
a civil penalty not to exceed $25,000 for each
distribution or sale,
except that the penalty imposed against any person with
respect to violations during any 30-day period shall
not exceed $100,000.
(2) Any retailer who knowingly distributes, sells or
offers for sale any cigarette brand style in violation
of section 803(a) shall--
(A) for a first offense for each sale or
offer for sale of cigarettes, if the total
number of packages of cigarettes sold or
offered for sale--
(i) does not exceed 50 packages of
cigarettes, be liable for a civil
penalty not to exceed $500 for each
sale or offer for sale, and
(ii) exceeds 50 packages of
cigarettes, be liable for a civil
penalty not to exceed $1,000 for each
sale or offer for sale;
(B) for each subsequent offense for each sale
or offer for sale of cigarettes, if the total
number of cigarettes sold or offered for sale--
(i) does not exceed 50 packages of
cigarettes, be liable for a civil
penalty not to exceed $2,000 for each
sale or offer for sale, and
(ii) exceeds 50 packages of
cigarettes, be liable for a civil
penalty not to exceed $5,000 for each
sale or offer for sale;
except that the penalty imposed against any
person during any 30-day period shall not
exceed $25,000.
SEC. 504. SEIZURE.
(a) Articles Subject to Seizure.--
(1) Any tobacco product that is adulterated or
misbranded when introduced into or while in interstate
commerce or while held for sale (whether or not the
first sale) after shipment in interstate commerce, or
which may not, under the provisions of this Act, be
introduced into interstate commerce, shall be liable to
be proceeded against while in interstate commerce, or
at any time thereafter, on libel of information and
condemned in any district court of the United States
within the jurisdiction of which the tobacco product is
found. No libel for condemnation shall be instituted
under this Act for any alleged misbranding if there is
pending in any court a libel for condemnation
proceeding under this Act based upon the same alleged
misbranding, and not more than one such proceeding
shall be instituted if no such proceeding is so
pending, except that such limitations shall not apply--
(A) when such misbranding has been the basis
of a prior judgment in favor of the United
States, in a criminal, injunction, or libel for
condemnation proceeding under this Act, or
(B) when the Administrator has probable cause
to believe from facts found, without hearing,
by the Administrator or any officer or employee
of the Agency that the misbranded tobacco
product is dangerous to health beyond the
inherent danger to health posed by tobacco, or
that the labeling of the misbranded tobacco
product is fraudulent, or would be in a
material respect misleading to the injury or
damage of the purchaser or consumer. In any
case where the number of libel for condemnation
proceedings is limited as above provided, the
proceeding pending or instituted shall, on
application of the claimant, seasonably made,
be removed for trial to any district agreed
upon by stipulation between the parties, or, in
case of failure to so stipulate within a
reasonable time, the claimant may apply to the
court of the district in which the seizure has
been made, and such court (after giving the
United States attorney for such district
reasonable notice and opportunity to be heard)
shall by order, unless good cause to the
contrary is shown, specify a district of
reasonable proximity to the claimant's
principal place of business, to which the case
shall be removed for trial.
(2) The following shall be liable to be proceeded
against at any time on libel of information and
condemned in any district court of the United States
within the jurisdiction of which they are found--
(A) any tobacco product that is an illicit
tobacco product;
(B) any container of an illicit tobacco
product;
(C) any equipment or thing used in making an
illicit tobacco product; and
(D) any adulterated or misbranded tobacco
product.
(3)(A) Except as provided in subparagraph (B), no
libel for condemnation may be instituted under
paragraph (1) or (2) against any tobacco product
which--
(i) is misbranded under this Act
because of its advertising, and
(ii) is being held for sale to the
ultimate consumer in an establishment
other than an establishment owned or
operated by a manufacturer, packer, or
distributor of the tobacco product.
(B) A libel for condemnation may be
instituted under paragraph (1) or (2) against a
tobacco product described in subparagraph (A)
if the tobacco product's advertising which
resulted in the tobacco product being
misbranded was disseminated in the
establishment in which the tobacco product is
being held for sale to the ultimate consumer--
(i) such advertising was disseminated
by, or under the direction of, the
owner or operator of such
establishment, or
(ii) all or part of the cost of such
advertising was paid by such owner or
operator.
(b) Procedures.--The tobacco product, equipment, or other
thing proceeded against shall be liable to seizure by process
pursuant to the libel, and the procedure in cases under this
section shall conform, as nearly as may be, to the procedure in
admiralty; except that on demand of either party any issue of
fact joined in any such case shall be tried by jury. When libel
for condemnation proceedings under this section, involving the
same claimant and the same issues of adulteration or
misbranding, are pending in two or more jurisdictions, such
pending proceedings, upon application of the claimant
seasonably made to the court of one such jurisdiction, shall be
consolidated for trial by order of such court, and tried in (1)
any district selected by the claimant where one of such
proceedings is pending; or (2) a district agreed upon by
stipulation between the parties. If no order for consolidation
is so made within a reasonable time, the claimant may apply to
the court of one such jurisdiction and such court (after giving
the United States attorney for such district reasonable notice
and opportunity to be heard) shall by order, unless good cause
to the contrary is shown, specify a district of reasonable
proximity to the claimant's principal place of business, in
which all such pending proceedings shall be consolidated for
trial and tried. Such order of consolidation shall not apply so
as to require the removal of any case the date for trial of
which has been fixed. The court granting such order shall give
prompt notification thereof to the other courts having
jurisdiction of the cases covered thereby.
(c) Samples and Analyses.--The court at any time after
seizure up to a reasonable time before trial shall by order
allow any party to a condemnation proceeding, the party's
attorney or agent, to obtain a representative sample of the
article seized and a true copy of the analysis, if any, on
which the proceeding is based and the identifying marks or
numbers, if any, of the packages from which the samples
analyzed were obtained.
(d) Disposition of Condemned Tobacco Products.--(1) Any
tobacco product condemned under this section shall, after entry
of the decree, be disposed of by destruction or sale as the
court may, in accordance with the provisions of this section,
direct; and the proceeds thereof, if sold, less the legal costs
and charges, shall be paid into the Treasury of the United
States; but such tobacco product shall not be sold under such
decree contrary to the provisions of this Act or the laws of
the jurisdiction in which sold. After entry of the decree and
upon the payment of the costs of such proceedings and the
execution of a good and sufficient bond conditioned that such
article shall not be sold or disposed of contrary to the
provisions of this Act or the laws of any State in which sold,
the court may by order direct that such tobacco product be
delivered to the owner thereof to be destroyed or brought into
compliance with the provisions of this Act, under the
supervision of an officer or employee duly designated by the
Administrator; and the expenses of such supervision shall be
paid by the person obtaining release of the tobacco product
under bond. If the tobacco product was imported into the United
States and the person seeking its release establishes (A) that
the adulteration, misbranding, or violation did not occur after
the tobacco product was imported, and (B) that the person
seeking the release of the tobacco product had no cause for
believing that it was adulterated, misbranded, or in violation
before it was released from customs custody, the court may
permit the tobacco product to be delivered to the owner for
exportation under section 709 in lieu of destruction upon a
showing by the owner that there is a reasonable certainty that
the tobacco product will not be re-imported into the United
States.
(2) The provisions of paragraph (1) of this subsection shall,
to the extent deemed appropriate by the court, apply to any
equipment or other thing which is not otherwise within the
scope of such paragraph and which is referred to in paragraph
(2) of subsection (a).
(3) Whenever in any proceeding under this section, involving
paragraph (2) of subsection (a), the condemnation of any
equipment or thing (other than a tobacco product) is decreed,
the court shall allow the claim of any claimant, to the extent
of such claimant's interest, for remission or mitigation of
such forfeiture if such claimant proves to the satisfaction of
the court (A) that such claimant has not caused the equipment
or thing to be within one of the categories referred to in such
paragraph (2) and has no interest in any tobacco product
referred to therein, (B) that such claimant has an interest in
such equipment or other thing as owner or lienor or otherwise,
acquired by such claimant in good faith, and (C) that such
claimant at no time had any knowledge or reason to believe that
such equipment or other thing was being or would be used in, or
to facilitate, the violation of laws of the United States
relating to any illicit tobacco product.
(e) Costs and Fees.--When a decree of condemnation is entered
against the tobacco product or other article, court costs and
fees, and storage and other proper expenses shall be awarded
against the person, if any, intervening as claimant of the
tobacco product or other article.
(f) Removal for Trial.--In the case of removal for trial of
any case as provided by subsection (a) or (b)--
(1) The clerk of the court from which removal is made
shall promptly transmit to the court in which the case
is to be tried all records in the case necessary in
order that such court may exercise jurisdiction.
(2) The court to which such case was removed shall
have the powers and be subject to the duties, for
purposes of such case, which the court from which
removal was made would have had, or to which such court
would have been subject, if such case had not been
removed.
(g) Administrative Detention of Tobacco Products.--
(1) Detention authority.--
(A) In general.--An officer or qualified
employee of the Agency may order the detention,
in accordance with this subsection, of any
tobacco product that is found during an
inspection, examination, or investigation under
this Act conducted by such officer or qualified
employee, if the officer or qualified employee
has credible evidence or information indicating
that such article presents a threat of serious
adverse health consequences beyond those
normally inherent in the use of tobacco
products.
(B) Administrator's approval.--A tobacco
product or component thereof may be ordered
detained under subparagraph (A) if, but only
if, the Administrator or an official designated
by the Administrator approves the order. An
official may not be so designated unless the
official is an officer with supervisory
responsibility for the inspection, examination,
or investigation that led to the order.
(2) Period of detention.--A tobacco product may be
detained under paragraph (1) for a reasonable period,
not to exceed 20 days, unless a greater period, not to
exceed 30 days, is necessary, to institute an action
under subsection (a) or section 702.
(3) Security of detained tobacco product.--An order
under paragraph (1) may require that the tobacco
product to be detained be labeled or marked as
detained, and shall require that the tobacco product be
maintained in or removed to a secure facility, as
appropriate. A tobacco product subject to such an order
shall not be transferred by any person from the place
at which the tobacco product is ordered detained, or
from the place to which the tobacco product is so
removed, as the case may be, until released by the
Administrator or until the expiration of the detention
period applicable under such order, whichever occurs
first. This subsection may not be construed as
authorizing the delivery of the tobacco product
pursuant to the execution of a bond while the tobacco
product is subject to the order, and section 709 does
not authorize the delivery of the tobacco product
pursuant to the execution of a bond while the article
is subject to the order.
(4) Appeal of detention order.--
(A) In general.--With respect to a tobacco
product ordered detained under paragraph (1),
any person who would be entitled to be a
claimant of such tobacco product if the tobacco
product were seized under subsection (a) may
appeal the order to the Administrator. Within
five days after such an appeal is filed, the
Administrator, after providing opportunity for
an informal hearing, shall confirm or terminate
the order involved, and such confirmation by
the Administrator shall be considered a final
agency action for purposes of section 702 of
title 5, United States Code. If during such
five-day period the Administrator fails to
provide such an opportunity, or to confirm or
terminate such order, the order is deemed to be
terminated.
(B) Effect of instituting court action.--The
process under subparagraph (A) for the appeal
of an order under paragraph (1) terminates if
the Administrator institutes an action under
subsection (a) or section 702 regarding the
tobacco product involved.
SEC. 505. REPORT OF MINOR VIOLATIONS.
Nothing in this Act shall be construed as requiring the
Administrator to report for prosecution, or for institution of
libel or injunction proceedings, minor violations of this Act
whenever the Administrator believes that the public interest
will be adequately served by a suitable written notice or
warning.
SEC. 506. INSPECTION.
(a) Authority To Inspect.--The Administrator shall have the
power to inspect the premises of a tobacco product manufacturer
for purposes of determining compliance with this Act, or the
regulations promulgated under it. Officers of the Agency
designated by the Administrator, upon presenting appropriate
credentials and a written notice to the person in charge of the
premises, are authorized to enter, at reasonable times, without
a search warrant, any factory, warehouse, or other
establishment in which tobacco products are manufactured,
processed, packaged, or held for domestic distribution. Any
such inspection shall be conducted within reasonable limits and
in a reasonable manner, and shall be limited to examining only
those things, including but not limited to records, relevant to
determining whether violations of this Act, or regulations
under it, have occurred. No inspection authorized by this
section shall extend to financial data, sales data other than
shipment data, pricing data, personnel data (other than data as
to qualifications of technical and professional personnel
performing functions subject to this Act), or research data. A
separate notice shall be given for each such inspection, but a
notice shall not be required for each entry made during the
period covered by the inspection. Each such inspection shall be
commenced and completed with reasonable promptness.
(b) Report of Observations.--Before leaving the premises, the
officer of the Agency who has supervised or conducted the
inspection shall give to the person in charge of the premises a
report in writing setting forth any conditions or practices
that appear to manifest a violation of this Act, or the
regulations under it.
(c) Samples.--If the officer has obtained any sample in the
course of inspection, prior to leaving the premises that
officer shall give to the person in charge of the premises a
receipt describing the samples obtained. As to each sample
obtained, the officer shall furnish promptly to the person in
charge of the premises a copy of the sample and of any analysis
made upon the sample.
SEC. 507. EFFECT OF COMPLIANCE.
Compliance with the provisions of this Act and the
regulations promulgated under it shall constitute a complete
defense to any civil action, including but not limited to any
products liability action, that seeks to recover damages,
whether compensatory or punitive, based upon an alleged defect
in the labeling or advertising of any tobacco product
distributed for sale domestically.
SEC. 508. IMPORTS.
(a) Imports; List of Registered Foreign Establishments;
Samples From Unregistered Foreign Establishments; Examination
and Refusal of Admission.--The Secretary of Homeland Security
shall deliver to the Administrator, upon request by the
Administrator, samples of tobacco products that are being
imported or offered for import into the United States, giving
notice thereof to the owner or consignee, who may appear before
the Administrator and have the right to introduce testimony.
The Administrator shall furnish to the Secretary of Homeland
Security a list of establishments registered pursuant to
subsection (d) of section 109 of this Act, and shall request
that, if any tobacco products manufactured, prepared, or
processed in an establishment not so registered are imported or
offered for import into the United States, samples of such
tobacco products be delivered to the Administrator, with notice
of such delivery to the owner or consignee, who may appear
before the Administrator and have the right to introduce
testimony. If it appears from the examination of such samples
or otherwise that (1) such tobacco product is forbidden or
restricted in sale in the country in which it was produced or
from which it was exported, or (2) such tobacco product is
adulterated, misbranded, or otherwise in violation of this Act,
then such tobacco product shall be refused admission, except as
provided in subsection (b) of this section. The Secretary of
Homeland Security shall cause the destruction of any such
tobacco product refused admission unless such tobacco product
is exported, under regulations prescribed by the Secretary of
Homeland Security, within ninety days of the date of notice of
such refusal or within such additional time as may be permitted
pursuant to such regulations.
(b) Disposition of Refused Tobacco Products.--Pending
decision as to the admission of a tobacco product being
imported or offered for import, the Secretary of Homeland
Security may authorize delivery of such tobacco product to the
owner or consignee upon the execution by such consignee of a
good and sufficient bond providing for the payment of such
liquidated damages in the event of default as may be required
pursuant to regulations of the Secretary of Homeland Security.
If it appears to the Administrator that a tobacco product
included within the provisions of clause (3) of subsection (a)
of this section can, by relabeling or other action, be brought
into compliance with this Act or rendered other than a tobacco
product, final determination as to admission of such tobacco
product may be deferred and, upon filing of timely written
application by the owner or consignee and the execution by such
consignee of a bond as provided in the preceding provisions of
this subsection, the Administrator may, in accordance with
regulations, authorize the applicant to perform such relabeling
or other action specified in such authorization (including
destruction or export of rejected tobacco products or portions
thereof, as may be specified in the Administrator's
authorization). All such relabeling or other action pursuant to
such authorization shall in accordance with regulations be
under the supervision of an officer or employee of the Agency
designated by the Administrator, or an officer or employee of
the Department of Homeland Security designated by the Secretary
of Homeland Security.
(c) Charges Concerning Refused Tobacco Products.--All
expenses (including travel, per diem or subsistence, and
salaries of officers or employees of the United States) in
connection with the destruction provided for in subsection (a)
of this section and the supervision of the relabeling or other
action authorized under the provisions of subsection (b) of
this section, the amount of such expenses to be determined in
accordance with regulations, and all expenses in connection
with the storage, cartage, or labor with respect to any tobacco
product refused admission under subsection (a) of this section,
shall be paid by the owner or consignee and, in default of such
payment, shall constitute a lien against any future
importations made by such owner or consignee.
SEC. 509. TOBACCO PRODUCTS FOR EXPORT.
(a) Exemption for Tobacco Products Exported.--Except as
provided in subsection (b), a tobacco product intended for
export shall be exempt from this Act if--
(1) it is not in conflict with the laws of the
country to which it is intended fore export, as shown
by either (A) a document issued by the government of
that country or (B) a document provided by a person
knowledgeable with respect to the relevant laws of that
country and qualified by training and experience to
opine on whether the tobacco product is or is not in
conflict with such laws;
(2) it is labeled on the outside of the shipping
package that it is intended for export; and
(3) the particular units of tobacco product intended
for export have not been sold or offered for sale in
domestic commerce.
(b) Products for U.S. Armed Forces Overseas.--A tobacco
product intended for export shall not be exempt from this Act
if it is intended for sale or distribution to members or units
of the Armed Forces of the United States located outside of the
United States.
(c) This Act shall not apply to a person that manufactures
and/or distributes tobacco products solely for export under
subsection (a), except to the extent such tobacco products are
subject to subsection (b).
TITLE VI--MISCELLANEOUS PROVISIONS
SEC. 601. USE OF PAYMENTS UNDER THE MASTER SETTLEMENT AGREEMENT AND
INDIVIDUAL STATE SETTLEMENT AGREEMENTS.
(a) Reduction of Grant Amounts.--(1) For fiscal year 2010 and
each subsequent fiscal year, the Secretary shall reduce, as
provided in subsection (b), the amount of any grant under
section 1921 of the Public Health Service Act (42 U.S.C. Sec.
300x-21) for any State that spends on tobacco control programs
from the funds received by such State pursuant to the Master
Settlement Agreement, the Florida Settlement Agreement, the
Minnesota Settlement Agreement, the Mississippi Memorandum of
Understanding, or the Texas Settlement Agreement, as
applicable, less than 20 percent of the amounts received by
that State from settlement payments.
(2) In the case of a State whose legislature does not convene
a regular session in fiscal year 2009 or 2010, and in the case
of a State whose legislature does not convene a regular session
in fiscal year 2010, the requirement described in subsection
(a)(1) as a condition of receipt of a grant under section 1921
of the Public Health Service Act shall apply only for fiscal
year 2009 and subsequent fiscal years.
(b) Determination of State Spending.--Before making a grant
under section 1921 of the Public Health Service Act, section
300x-21 of title 42, United States Code, to a State for the
first applicable fiscal year or any subsequent fiscal year, the
Secretary shall make a determination of whether, during the
immediately preceding fiscal year, the State has spent on
tobacco control programs, from the funds received by such State
pursuant to the Master Settlement Agreement, the Florida
Settlement Agreement, the Minnesota Settlement Agreement, the
Mississippi Memorandum of Understanding, or the Texas
Settlement Agreement, as applicable, at least the amount
referenced in (a)(1). If, after notice to the State and an
opportunity for a hearing, the Secretary determines that the
State has spent less than such amount, the Secretary shall
reduce the amount of the allotment under section 300x-21 of
title 42, United States Code, for the State for the fiscal year
involved by an amount equal to--
(1) in the case of the first applicable fiscal year,
10 percent of the amount determined under section 300x-
33 of title 42, United States Code, for the State for
the fiscal year;
(2) in the case of the first fiscal year following
such applicable fiscal year, 20 percent of the amount
determined under section 300x-33 of title 42, United
States Code, for the State for the fiscal year;
(3) in the case of the second such fiscal year, 30
percent of the amount determined under section 300x-33
of title 42, United States Code, for the State for the
fiscal year; and
(4) in the case of the third such fiscal year or any
subsequent fiscal year, 40 percent of the amount
determined under section 300x-33 of title 42, United
States Code, for the State for the fiscal year.
The Secretary shall not have authority or discretion to grant
to any State a waiver of the terms and requirements of this
subsection or subsection (a).
(c) Definitions.--For the purposes of this section--
(1) The term ``first applicable fiscal year'' means--
(A) fiscal year 2011, in the case of any
State described in subsection (a)(2) of this
section; and
(B) fiscal year 2010, in the case of any
other State.
(2) The term ``Florida Settlement Agreement'' means
the Settlement Agreement, together with the exhibits
thereto, entered into on August 25, 1997, between the
State of Florida and signatory tobacco product
manufacturers, as specified therein.
(3) The term ``Master Settlement Agreement'' means
the Master Settlement Agreement, together with the
exhibits thereto, entered into on November 23, 1998,
between the signatory States and signatory tobacco
product manufacturers, as specified therein.
(4) The term ``Minnesota Settlement Agreement'' means
the Settlement Agreement, together with the exhibits
thereto, entered into on May 8, 1998, between the State
of Minnesota and signatory tobacco product
manufacturers, as specified therein.
(5) The term ``Mississippi Memorandum of
Understanding'' means the Memorandum of Understanding,
together with the exhibits thereto and Settlement
Agreement contemplated therein, entered into on July 2,
1997, between the State of Mississippi and signatory
tobacco product manufacturers, as specified therein.
(6) The term ``Secretary'' means the Secretary of
Health and Human Services.
(7) The term ``Texas Settlement Agreement'' means the
Settlement Agreement, together with the exhibits
thereto, entered into on January 16, 1998, between the
State of Texas and signatory tobacco product
manufacturers, as specified therein.
SEC. 602. PREEMPTION OF STATE LAWS IMPLEMENTING FIRE SAFETY STANDARD
FOR CIGARETTES.
(a) In General.--With respect to fire safety standards for
cigarettes, no State or political subdivision shall--
(1) require testing of cigarettes that would be in
addition to, or different from, the testing prescribed
in subsection (b); or
(2) require a performance standard that is in
addition to, or different from, the performance
standard set forth in subsection (b).
(b) Test Method and Performance Standard.--
(1) To the extent a State or political subdivision
enacts or has enacted legislation or a regulation
setting a fire safety standard for cigarettes, the test
method employed shall be--
(A) the American Society of Testing and
Materials (``ASTM'') standard E2187-4, entitled
``Standard Test Method for Measuring the
Ignition Strength of Cigarettes'';
(B) for each cigarette on 10 layers of filter
paper;
(C) so that a replicate test of 40 cigarettes
for each brand style of cigarettes comprises a
complete test trial for that brand style; and
(D) in a laboratory that has been accredited
in accordance with ISO/IEC 17205 of the
International Organization for Standardization
(``ISO'') and that has an implemented quality
control and quality assurance program that
includes a procedure capable of determining the
repeatability of the testing results to a
repeatability value that is no greater than
0.19.
(2) To the extent a State or political subdivision
enacts or has enacted legislation or a regulation
setting a fire safety standard for cigarettes, the
performance standard employed shall be that no more
than 25 percent of the cigarettes of that brand style
tested in a complete test in accordance with paragraph
(1) exhibit full-length burns
(c) Exception to Subsection (b).--In the event that a
manufacturer of a cigarette that a State or political
subdivision or its respective delegated agency determines
cannot be tested in accordance with the test method prescribed
in subsection (b)(1)(A), the manufacturer shall propose a test
method and performance standard for the cigarette to the State
or political subdivision. Upon approval of the proposed test
method and a determination by the State or political division
that the performance standard proposed by the manufacturer is
equivalent to the performance standard prescribed in subsection
(b)(2), the manufacturer may employ such test method and
performance standard to certify such cigarette pursuant to this
subsection notwithstanding subsection (b).
SEC. 603. INSPECTION BY THE ALCOHOL AND TOBACCO TAX TRADE BUREAU OF
RECORDS OF CERTAIN CIGARETTE AND SMOKELESS TOBACCO
SELLERS.
(a) In General.--Any officer of the Bureau of the Alcohol and
Tobacco Tax Trade Bureau may, during normal business hours,
enter the premises of any person described in subsection (b)
for the purposes of inspecting--
(1) any records or information required to be
maintained by such person under the provisions of law
referred to in subsection (d); or
(2) any cigarettes or smokeless tobacco kept or
stored by such person at such premises.
(b) Covered Persons.--Subsection (a) applies to any person
who engages in a delivery sale, and who ships, sells,
distributes, or receives any quantity in excess of 10,000
cigarettes, or any quantity in excess of 500 single-unit
consumer-sized cans or packages of smokeless tobacco, within a
single month.
(c) Relief.--
(1) In general.--The district courts of the United
States shall have the authority in a civil action under
this subsection to compel inspections authorized by
subsection (a).
(2) Violations.--Whoever violates subsection (a) or
an order issued pursuant to paragraph (1) shall be
subject to a civil penalty in an amount not to exceed
$10,000 for each violation.
(d) Covered Provisions of Law.--The provisions of law
referred to in this subsection are--
(1) the Act of October 19, 1949 (15 U.S.C. 375;
commonly referred to as the ``Jenkins Act'');
(2) chapter 114 of title 18, United States Code; and
(3) this Act.
(e) Delivery Sale Defined.--In this section, the term
``delivery sale'' has the meaning given that term in 2343(e) of
title 18, United States Code, as amended by this Act.
SEC. 604. SEVERABILITY.
If any provision of this Act, the amendments made by this
Act, or the application of any provision of this Act to any
person or circumstance is held to be invalid, the remainder of
this Act, the amendments made by this Act, and the application
of the provisions of this Act to any other person or
circumstance shall not be affected, and shall continue to be
enforced to the fullest extent possible.
TITLE VII--TOBACCO GROWER PROTECTION
SEC. 701. TOBACCO GROWER PROTECTION.
No provision in this Act shall allow the Administrator or any
other person to require changes to traditional farming
practices, including standard cultivation practices, curing
processes, seed composition, tobacco type, fertilization, soil,
record keeping, or any other requirement affecting farming
practices.
Amend the title so as to read: ``A bill to protect the public
health by establishing the Tobacco Harm Reduction Center within
the Department of Health and Human Services with certain
authority to regulate tobacco products, and for other
purposes.''.