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 
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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 indi-
vidual 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 pre-
ventable deaths in the United States. Cigarette 
smoking significantly increases the risk of developing 
lung cancer, heart disease, chronic bronchitis, em-
physema 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 fre-
quency, 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 
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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 to-
bacco which poses the most significant risk of seri-
ous diseases. 
(6) Quitting cigarette smoking significantly re-
duces the risk for serious diseases. 
(7) Adult tobacco consumers have a right to be 
fully and accurately informed about the risks of seri-
ous diseases, the significant differences in the com-
parative risks of different tobacco and nicotine-based 
products, and the benefits of quitting. This informa-
tion 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 infor-
mation about the various health risks and compara-
tive 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 mor-
tality associated with tobacco use. Regulations 
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should enhance the information available to adult 
consumers to permit them to make informed choices, 
and encourage the development of tobacco and nico-
tine products with lower risks than cigarettes cur-
rently sold in the United States. 
(10) The form of regulation should be based on 
the risks and comparative risks of tobacco and nico-
tine 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 to-
bacco products. 
(12) Reducing the diseases and deaths associ-
ated 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 ele-
ment of any comprehensive public policy surrounding 
the health consequences of tobacco use. 
(13) Significant reductions in the harm associ-
ated with the use of cigarettes can be achieved by 
providing accurate information regarding the com-
parative risks of tobacco products to adult tobacco 
consumers, thereby encouraging smokers to migrate 
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to the use of smoke-free tobacco and nicotine prod-
ucts, and by developing new smoke-free tobacco and 
nicotine products and other actions. 
(14) Governments, public health officials, man-
ufacturers, tobacco producers and consumers should 
support the development, production, and commer-
cial introduction of tobacco leaf, and tobacco and 
nicotine-based products that are scientifically shown 
to reduce the risks associated with the use of exist-
ing tobacco products, particularly cigarettes. 
(15) Adult tobacco consumers should have ac-
cess 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 smoke-
less 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 ben-
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efit because of the large number of cigarette smok-
ers 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 al-
ready gone on record endorsing Harm Reduction as 
an approach to further reducing tobacco related ill-
ness 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; 
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(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 au-
thority 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 reg-
ulate the levels of tar, nicotine, and other harmful 
components of tobacco products; 
(6) to ensure that consumers are better in-
formed 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 under-
age 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-re-
lated diseases; 
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(10) to provide authority to the Department of 
Health and Human Services to regulate tobacco 
products; 
(11) to establish national policies that effec-
tively reduce disease and death associated with ciga-
rette smoking and other tobacco use; 
(12) to establish national policies that encour-
age prevention, cessation, and harm reduction meas-
ures 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 accu-
rately and consistently inform adult tobacco con-
sumers of significant differences in risk between re-
spective tobacco products; 
(15) to establish national policies that encour-
age and assist the development and awareness of 
noncombustible tobacco and nicotine products; 
(16) to coordinate national and State preven-
tion, cessation, and harm reduction programs; 
(17) to impose measures to ensure tobacco 
products are not sold or accessible to underage pur-
chasers; and 
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(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 ac-
tion; 
(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 compo-
nent parts manufactured in the United States for 
export. 
(b) AGRICULTURAL ACTIVITIES.—The provisions of 
this Act (or an amendment made by this Act) which au-
thorize the Administrator to take certain actions with re-
gard to tobacco and tobacco products shall not be con-
strued to affect any authority of the Secretary of Agri-
culture under existing law regarding the growing, cultiva-
tion, 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 au-
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thority 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 effec-
tive date of this Act shall be the date of its enactment. 
TITLE I—AUTHORITY OF THE TO-
BACCO 
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 prod-
ucts may lawfully be sold. 
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(3) The term ‘‘adult-only facility’’ means a fa-
cility or restricted area, whether open-air or en-
closed, where the operator ensures, or has a reason-
able basis to believe, that no youth is present. A fa-
cility or restricted area need not be permanently re-
stricted 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 con-
trol with, another person. The terms ‘‘owns,’’ ‘‘is 
owned’’, and ‘‘ownership’’ refer to ownership of an 
equity interest, or the equivalent thereof, of 50 per-
cent 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 prod-
uct manufacturer manufactures for commercial dis-
tribution domestically. 
(6) The term ‘‘brand name’’ means a brand 
name of a tobacco product distributed or sold do-
mestically, alone, or in conjunction with any other 
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word, trademark, logo, symbol, motto, selling mes-
sage, recognizable pattern of colors, or any other in-
dicium 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 manufac-
turer 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, prod-
uct 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 
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(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 para-
graph (1). 
(11) The term ‘‘competent and reliable sci-
entific evidence’’ means evidence based on tests, 
analyses, research, or studies, conducted and evalu-
ated 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 con-
sidered 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, mar-
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keting, 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 prod-
uct 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 trans-
fer, 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. 
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(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, enti-
tled ‘‘Routine analytical cigarette-smoking ma-
chine—Definition of standard conditions’’; ISO 
4387, entitled ‘‘Cigarettes—Determination of total 
and nicotine-free dry particulate matter using a rou-
tine analytical smoking machine’’; ISO 10315, enti-
tled ‘‘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 meth-
od’’. A cigarette that does not burn down in accord-
ance 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 
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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 ju-
risdiction. 
(21) The term ‘‘label’’ means a display of writ-
ten, printed, or graphic matter upon or applied se-
curely to the immediate container of a tobacco prod-
uct. 
(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 to-
bacco 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. 
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(24) The term ‘‘loose tobacco’’ means any form 
of tobacco, alone or in combination with any other 
ingredient or material, that, because of its appear-
ance, 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 in-
clude— 
(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 dis-
tributor, 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 
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(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 con-
tainer 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, or-
ganization 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 photo-
graph 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 manu-
facturer 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 
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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 toxi-
cants, as compared to an appropriate reference to-
bacco product or category of tobacco products. A 
statement or representation that a tobacco product 
or the tobacco in a tobacco product contains ‘‘no ad-
ditives’’ 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 re-
quired 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 smok-
ing article provides to users of that product a re-
duced 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 arti-
cle 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 
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article contains ‘‘no additives,’’ or is ‘‘natural,’’ or 
that uses a substantially similar term is not a re-
duced-risk claim if the advertising or labeling that 
contains such statement or representation also con-
tains 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 to-
bacco products to individuals for personal con-
sumption is permitted. 
(34) The term ‘‘small business’’ means a to-
bacco 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, re-
constituted, processed or shaped tobacco, leaf to-
bacco, or stem tobacco, whether or not combined 
with any other ingredient, whether or not in extract 
or extracted form, and whether or not incorporated 
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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 to-
bacco-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 organi-
zation, 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’’. 
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(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 mate-
rials, including any by-product, extract, extracted 
pulp material, or any other material (other than pu-
rified 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 Rev-
enue Code of 1986; 
(B) any other product that contains to-
bacco as a principal ingredient and that, be-
cause of its appearance, type, or the tobacco 
used in the product, or its packaging and label-
ing, is likely to be offered to, or purchased by, 
consumers as a tobacco product as described in 
subparagraph (A); and 
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(C) any form of tobacco or any construct 
incorporating tobacco, intended for human con-
sumption, whether by— 
(i) placement in the oral or nasal cav-
ity; 
(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 in-
cludes tobacco products classified as cigarettes, loose 
tobacco for roll-your-own tobacco products, little ci-
gars, cigars, pipe tobacco, moist snuff, dry snuff, 
chewing tobacco, and other forms of tobacco prod-
ucts (which are treated in this Act collectively as a 
single category). 
(42) The term ‘‘tobacco product communica-
tion’’ means any means, medium, or manner for pro-
viding information relating to any tobacco product, 
including face-to-face interaction, mailings by postal 
service or courier to an individual who is an ad-
dressee, and electronic mail to an individual who is 
an addressee. 
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(43) The term ‘‘tobacco product manufacturer’’ 
means an entity that directly— 
(A) manufactures anywhere a tobacco 
product that is intended to be distributed com-
mercially in the United States, including a to-
bacco product intended to be distributed com-
mercially in the United States through an im-
porter; 
(B) is the first purchaser for resale in the 
United States of tobacco products manufac-
tured 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 sev-
eral States, as defined in this Act. 
(47) The term ‘‘youth’’ means any individual 
who in not an adult. 
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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 regu-
lated by the Administrator under this Act. 
(b) APPLICABILITY.—This Act shall apply to all ciga-
rettes, 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 Cen-
ter. 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 mat-
ter of this Act, and have the authority to promulgate regu-
lations for the efficient enforcement of this Act. In pro-
mulgating any regulations under such authority, in whole 
or in part or any regulation that is likely to have an an-
nual 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— 
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(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 rel-
evantly similar regulations at the Federal or State 
level; 
(3) determine the reasonableness of the rela-
tionship 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 meas-
urable and substantial reductions in morbidity and 
mortality among individual tobacco users; 
(5) determine the impact to United States to-
bacco 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 to-
bacco products. 
(d) LIMITATION OF AUTHORITY.— 
(1) IN GENERAL.—The provisions of this Act 
shall not apply to tobacco leaf that is not in the pos-
session of a manufacturer of tobacco products, or to 
the producers of tobacco leaf, including tobacco 
growers, tobacco warehouses, and tobacco grower co-
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operatives, 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 con-
sent 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 manufac-
turer. The exception in this subparagraph shall not 
apply to a producer of tobacco leaf who grows to-
bacco under a contract with a tobacco product man-
ufacturer 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 pro-
ducer 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 
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shall endeavor to consult with other Federal agencies as 
appropriate. 
SEC. 102. EXCLUSION OF OTHER REGULATORY PROGRAMS. 
(a) EXCLUSION OF TOBACCO PRODUCTS AND NICO-
TINE-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 com-
mercially distributed domestically and any nicotine-con-
taining 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, treat-
ment, 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 ac-
tion; or 
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(2) affect any action pending in any Federal, 
State, or Tribal court, or any agreement, consent de-
cree, or contract of any kind. 
(c) EXCLUSIONS FROM AUTHORITY
OF ADMINIS-
TRATOR.—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 para-
graph (3); or 
(3) the activities, materials, facilities, or prac-
tices of persons that are not tobacco product manu-
facturers and that are— 
(A) producers of raw tobacco, including to-
bacco 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 
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(F) persons that store raw tobacco for 
aging. 
If a producer of raw tobacco is also a tobacco prod-
uct 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 manufac-
turer. 
SEC. 103. EXISTING FEDERAL STATUTES MAINTAINED. 
Except as amended or repealed by this Act, all Fed-
eral statutes in effect as of the effective date of this Act 
that regulate tobacco, tobacco products, or tobacco prod-
uct manufacturers shall remain in full force and effect. 
Such statutes include, without limitation— 
(1) the Federal Cigarette Labeling and Adver-
tising 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 
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(4) those statutes authorizing regulation of to-
bacco, tobacco products, or tobacco product manu-
facturers by the Federal Trade Commission, the De-
partment of Agriculture, the Environmental Protec-
tion 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 AC-
TION. 
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 dis-
trict in any proceeding under this section. No State, 
or political subdivision thereof, may proceed or inter-
vene in any Federal or State court under this Act 
or under any regulation promulgated under it, or al-
lege any violation thereof except a violation by the 
Administrator. Nothing in this Act shall be con-
strued to create a right of action by any private per-
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son for any violation of any provision of this Act or 
of any regulation promulgated under it. 
(2) With respect to any subject matter ad-
dressed by this Act or by any regulation promul-
gated under it, no requirement or prohibition shall 
be imposed under State or local law upon any to-
bacco product manufacturer or distributor. 
(3) Paragraph (2) shall not apply to any re-
quirement 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 regula-
tion 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 unaccept-
able 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 adulter-
ated— 
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(1) if it bears or contains any poisonous or del-
eterious substance other than— 
(A) tobacco; 
(B) a substance naturally present in to-
bacco; 
(C) a pesticide or fungicide chemical res-
idue in or on tobacco if such pesticide or fun-
gicide chemical is registered by the Environ-
mental Protection Agency for use on tobacco in 
the United States; or 
(D) in the case of imported tobacco, a res-
idue 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 reg-
istration 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 sub-
stance, such tobacco product shall not be 
considered adulterated under this sub-
section if the quantity of such substance in 
such tobacco product does not ordinarily 
render it injurious to health; 
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longs and by any proprietary name, and shall 
be accompanied by the other information re-
quired 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 im-
port into the United States of a brand style in-
cluded in a list filed by such registrant under 
subparagraph (A) or paragraph (1), notice of 
such discontinuance, the date of such dis-
continuance, 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 re-
ported pursuant to subparagraph (B) a notice 
of discontinuance of a tobacco product, the reg-
istrant has resumed the manufacture, prepara-
tion, or processing for commercial distribution 
domestically or for import into the United 
States of that brand style, notice of such re-
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tain tobacco products for research, testing, and dem-
onstration 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 re-
spect to any cigarette brand style commercially 
distributed domestically, on the portion of the 
package of such cigarette brand style that cus-
tomarily is visible to consumers before pur-
chase, 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.’’ 
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(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 confec-
tion made from sugar or sugar substitute, 
including any confection identified generi-
cally 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 vari-
ety, 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 exten-
sions or variations of such words. 
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(d) PROMULGATION.— 
(1) IN GENERAL.—After the expiration of the 
period for comment on a notice of proposed rule-
making published under subsection (c) respecting a 
standard and after consideration of comments sub-
mitted under subsections (b) and (c) and any report 
from the Tobacco Products Scientific Advisory Com-
mittee, 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 re-
ferred to in subsection (c); or 
(B) publish a notice terminating the pro-
ceeding for the development of the standard to-
gether with the reasons for such termination. 
(2) EFFECTIVE
DATE.—A regulation estab-
lishing a smoking article standard shall set forth the 
date or dates upon which the standard shall take ef-
fect, 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 
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