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with its mandate to promote health and reduce the 
risk of harm, the Food and Drug Administration 
routinely makes decisions about whether and how 
products may be marketed in the United States. 
(45) The Federal Trade Commission was cre-
ated to protect consumers from unfair or deceptive 
acts or practices, and to regulate unfair methods of 
competition. Its focus is on those marketplace prac-
tices 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 Ad-
ministration possesses the scientific expertise needed 
to implement effectively all provisions of the Family 
Smoking Prevention and Tobacco Control Act. 
(46) If manufacturers state or imply in 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 like-
ly to be confused and misled. Depending upon the 
particular language used and its context, such a 
statement could result in consumers being misled 
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into believing that the product is endorsed by the 
Food and Drug Administration for use or in con-
sumers being misled about the harmfulness of the 
product because of such regulation, inspection, ap-
proval, or compliance. 
(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, con-
sumers 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 con-
sumers 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 cig-
arette 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 cig-
arette companies dramatically increased their adver-
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tising and promotional spending in ways that en-
courage youth to start smoking subsequent to the 
signing of the Master Settlement Agreement in 
1998. USA v Philip Morris, USA, Inc., et al. (Civil 
Action No. 99–2496 (GK), August 17, 2006). 
(50) In August 2006 a United States district 
court judge found that the major United States cig-
arette companies have designed their cigarettes to 
precisely 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 regulatory 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-
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ticular concern to public health officials, especially 
the use of tobacco by young people and dependence 
on tobacco; 
(3) to authorize the Food and Drug Adminis-
tration 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 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 
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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 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 au-
thorize the Secretary to take certain actions with regard 
to tobacco and tobacco products shall not be construed to 
affect any authority of the Secretary of Agriculture under 
existing law regarding the growing, cultivation, or curing 
of raw tobacco. 
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(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 to-
bacco products shall not be construed to affect any author-
ity 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. 
TITLE I—AUTHORITY OF THE 
FOOD AND DRUG ADMINIS-
TRATION 
SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND 
COSMETIC ACT. 
(a) DEFINITION OF TOBACCO PRODUCTS.—Section 
201 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321) is amended by adding at the end the fol-
lowing: 
‘‘(rr)(1) The term ‘tobacco product’ means any prod-
uct made or derived from tobacco that is intended for 
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human consumption, including any component, part, or 
accessory of a tobacco product (except for raw materials 
other than tobacco used in manufacturing a component, 
part, or accessory of a tobacco product). 
‘‘(2) The term ‘tobacco product’ does not mean an 
article that is a drug under subsection (g)(1), a device 
under subsection (h), or a combination product described 
in section 503(g). 
‘‘(3) The products described in paragraph (2) shall 
be subject to chapter V of this Act. 
‘‘(4) A tobacco product may not be marketed in com-
bination with any other article or product regulated under 
this Act (including a drug, biologic, food, cosmetic, med-
ical device, or a dietary supplement).’’. 
(b) FDA AUTHORITY OVER TOBACCO PRODUCTS.— 
The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.) is amended— 
(1) by redesignating chapter IX as chapter X; 
(2) by redesignating sections 901 through 910 
as sections 1001 through 1010; and 
(3) by inserting after chapter VIII the fol-
lowing: 
‘‘CHAPTER IX—TOBACCO PRODUCTS 
‘‘SEC. 900. DEFINITIONS. 
‘‘In this chapter: 
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‘‘(1) ADDITIVE.—The term ‘additive’ means 
any substance the intended use of which results or 
may reasonably be expected to result, directly or in-
directly, in its becoming a component or otherwise 
affecting the characteristic of any tobacco product 
(including any substances intended for use as a fla-
voring or coloring or in producing, manufacturing, 
packing, processing, preparing, treating, packaging, 
transporting, or holding), except that such term does 
not include tobacco or a pesticide chemical residue 
in or on raw tobacco or a pesticide chemical. 
‘‘(2) BRAND.—The term ‘brand’ means a vari-
ety of tobacco product distinguished by the tobacco 
used, tar content, nicotine content, flavoring used, 
size, filtration, packaging, logo, registered trade-
mark, brand name, identifiable pattern of colors, or 
any combination of such attributes. 
‘‘(3) CIGARETTE.—The term ‘cigarette’— 
‘‘(A) means a product that— 
‘‘(i) is a tobacco product; and 
‘‘(ii) meets the definition of the term 
‘cigarette’ in section 3(1) of the Federal 
Cigarette Labeling and Advertising Act; 
and 
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‘‘(B) includes tobacco, in any form, that is 
functional in the product, which, because of its 
appearance, the type of tobacco used in the 
filler, or its packaging and labeling, is likely to 
be offered to, or purchased by, consumers as a 
cigarette or as roll-your-own tobacco. 
‘‘(4) CIGARETTE
TOBACCO.—The term ‘ciga-
rette tobacco’ means any product that consists of 
loose tobacco that is intended for use by consumers 
in a cigarette. Unless otherwise stated, the require-
ments applicable to cigarettes under this chapter 
shall also apply to cigarette tobacco. 
‘‘(5) COMMERCE.—The term ‘commerce’ has 
the meaning given that term by section 3(2) of the 
Federal Cigarette Labeling and Advertising Act. 
‘‘(6) COUNTERFEIT TOBACCO PRODUCT.—The 
term ‘counterfeit tobacco product’ means a tobacco 
product (or the container or labeling of such a prod-
uct) that, without authorization, bears the trade-
mark, trade name, or other identifying mark, im-
print, or device, or any likeness thereof, of a tobacco 
product listed in a registration under section 
905(i)(1). 
‘‘(7) DISTRIBUTOR.—The term ‘distributor’ as 
regards a tobacco product means any person who 
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