bacco products, whether express or implied, even if ac-
companied by disclaimers would be detrimental to the 
public health. 
(43) The only way to effectively protect the pub-
lic health from the dangers of unsubstantiated modi-
fied risk tobacco products is to empower the Food and 
Drug Administration to require that products that to-
bacco manufacturers sold or distributed for risk re-
duction be reviewed in advance of marketing, and to 
require that the evidence relied on to support claims 
be fully verified. 
(44) The Food and Drug Administration is a 
regulatory agency with the scientific expertise to iden-
tify harmful substances in products to which con-
sumers are exposed, to design standards to limit expo-
sure to those substances, to evaluate scientific studies 
supporting claims about the safety of products, and to 
evaluate the impact of labels, labeling, and adver-
tising on consumer behavior in order to reduce the 
risk of harm and promote understanding of the im-
pact of the product on health. In connection with its 
mandate to promote health and reduce the risk of 
harm, the Food and Drug Administration routinely 
makes decisions about whether and how products may 
be marketed in the United States. 
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(45) The Federal Trade Commission was created 
to protect consumers from unfair or deceptive acts or 
practices, and to regulate unfair methods of competi-
tion. Its focus is on those marketplace practices that 
deceive or mislead consumers, and those that give 
some competitors an unfair advantage. Its mission is 
to regulate activities in the marketplace. Neither the 
Federal Trade Commission nor any other Federal 
agency except the Food and Drug Administration 
possesses the scientific expertise needed to implement 
effectively all provisions of the Family Smoking Pre-
vention and Tobacco Control Act. 
(46) If manufacturers state or imply in commu-
nications directed to consumers through the media or 
through a label, labeling, or advertising, that a to-
bacco product is approved or inspected by the Food 
and Drug Administration or complies with Food and 
Drug Administration standards, consumers are likely 
to be confused and misled. Depending upon the par-
ticular language used and its context, such a state-
ment could result in consumers being misled into be-
lieving that the product is endorsed by the Food and 
Drug Administration for use or in consumers being 
misled about the harmfulness of the product because 
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of such regulation, inspection, approval, or compli-
ance. 
(47) If manufacturers are permitted to state or 
imply in communications directed to consumers that 
a tobacco product is approved or inspected by the 
Food and Drug Administration or complies with 
Food and Drug Administration standards, consumers 
are likely to be confused and misled. Such a statement 
could result in consumers being misled into believing 
that the product is endorsed by the Food and Drug 
Administration for use or in consumers being misled 
about the harmfulness of the product because of such 
regulation, inspection, or compliance. 
(48) In August 2006 a United States district 
court judge found that the major United States ciga-
rette companies continue to target and market to 
youth. USA v Philip Morris, USA, Inc., et al. (Civil 
Action No. 99–2496 (GK), August 17, 2006). 
(49) In August 2006 a United States district 
court judge found that the major United States ciga-
rette companies dramatically increased their adver-
tising and promotional spending in ways that en-
courage youth to start smoking subsequent to the sign-
ing of the Master Settlement Agreement in 1998. USA 
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v Philip Morris, USA, Inc., et al. (Civil Action No. 
99–2496 (GK), August 17, 2006). 
(50) In August 2006 a United States district 
court judge found that the major United States ciga-
rette companies have designed their cigarettes to pre-
cisely control nicotine delivery levels and provide 
doses of nicotine sufficient to create and sustain ad-
diction while also concealing much of their nicotine- 
related research. USA v Philip Morris, USA, Inc., et 
al. (Civil Action No. 99–2496 (GK), August 17, 
2006). 
SEC. 3. PURPOSE. 
The purposes of this Act are— 
(1) to provide authority to the Food and Drug 
Administration to regulate tobacco products under the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.), by recognizing it as the primary Federal reg-
ulatory authority with respect to the manufacture, 
marketing, and distribution of tobacco products as 
provided for in this Act; 
(2) to ensure that the Food and Drug Adminis-
tration has the authority to address issues of par-
ticular 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 Food and Drug Administra-
tion to set national standards controlling the manu-
facture 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 Food and Drug Administration 
with the authority to regulate the levels of tar, nico-
tine, and other harmful components of tobacco prod-
ucts; 
(6) in order to ensure that consumers are better 
informed, to require tobacco product manufacturers to 
disclose research which has not previously been made 
available, as well as research generated in the future, 
relating to the health and dependency effects or safety 
of tobacco products; 
(7) to continue to permit the sale of tobacco 
products to adults in conjunction with measures to 
ensure that they are not sold or accessible to underage 
purchasers; 
(8) to impose appropriate regulatory controls on 
the tobacco industry; 
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(9) to promote cessation to reduce disease risk 
and the social costs associated with tobacco-related 
diseases; and 
(10) to strengthen legislation against illicit trade 
in tobacco products. 
SEC. 4. SCOPE AND EFFECT. 
(a) INTENDED EFFECT.—Nothing in this Act (or an 
amendment made by this Act) shall be construed to— 
(1) establish a precedent with regard to any 
other industry, situation, circumstance, or legal ac-
tion; or 
(2) affect any action pending in Federal, State, 
or tribal court, or any agreement, consent decree, or 
contract of any kind. 
(b) AGRICULTURAL ACTIVITIES.—The provisions of 
this Act (or an amendment made by this Act) which author-
ize the Secretary to take certain actions with regard to to-
bacco and tobacco products shall not be construed to affect 
any authority of the Secretary of Agriculture under existing 
law regarding the growing, cultivation, or curing of raw 
tobacco. 
(c) REVENUE ACTIVITIES.—The provisions of this Act 
(or an amendment made by this Act) which authorize the 
Secretary to take certain actions with regard to tobacco 
products shall not be construed to affect any authority of 
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the Secretary of the Treasury under chapter 52 of the Inter-
nal Revenue Code of 1986. 
SEC. 5. SEVERABILITY. 
If any provision of this Act, the amendments made by 
this Act, or the application of any provision of this Act 
to any person or circumstance is held to be invalid, the 
remainder of this Act, the amendments made by this Act, 
and the application of the provisions of this Act to any 
other person or circumstance shall not be affected and shall 
continue to be enforced to the fullest extent possible. 
TITLE 
I—AUTHORITY 
OF 
THE 
FOOD AND DRUG ADMINIS-
TRATION 
SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COS-
METIC ACT. 
(a) DEFINITION
OF TOBACCO PRODUCTS.—Section 
201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321) is amended by adding at the end the following: 
‘‘(rr)(1) The term ‘tobacco product’ means any product 
made or derived from tobacco that is intended for human 
consumption, including any component, part, or accessory 
of a tobacco product (except for raw materials other than 
tobacco used in manufacturing a component, part, or acces-
sory of a tobacco product). 
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