H. R. 1256—5 
(37) Unless tobacco products that purport to reduce the 
risks to the public of tobacco use actually reduce such risks, 
those products can cause substantial harm to the public health 
to the extent that the individuals, who would otherwise not 
consume tobacco products or would consume such products 
less, use tobacco products purporting to reduce risk. Those 
who use products sold or distributed as modified risk products 
that do not in fact reduce risk, rather than quitting or reducing 
their use of tobacco products, have a substantially increased 
likelihood of suffering disability and premature death. The 
costs to society of the widespread use of products sold or distrib-
uted as modified risk products that do not in fact reduce risk 
or that increase risk include thousands of unnecessary deaths 
and injuries and huge costs to our health care system. 
(38) As the National Cancer Institute has found, many 
smokers mistakenly believe that ‘‘low tar’’ and ‘‘light’’ cigarettes 
cause fewer health problems than other cigarettes. As the 
National Cancer Institute has also found, mistaken beliefs 
about the health consequences of smoking ‘‘low tar’’ and ‘‘light’’ 
cigarettes can reduce the motivation to quit smoking entirely 
and thereby lead to disease and death. 
(39) Recent studies have demonstrated that there has been 
no reduction in risk on a population-wide basis from ‘‘low 
tar’’ and ‘‘light’’ cigarettes, and such products may actually 
increase the risk of tobacco use. 
(40) The dangers of products sold or distributed as modified 
risk tobacco products that do not in fact reduce risk are so 
high that there is a compelling governmental interest in 
ensuring that statements about modified risk tobacco products 
are complete, accurate, and relate to the overall disease risk 
of the product. 
(41) As the Federal Trade Commission has found, con-
sumers have misinterpreted advertisements in which one 
product is claimed to be less harmful than a comparable 
product, even in the presence of disclosures and advisories 
intended to provide clarification. 
(42) Permitting manufacturers to make unsubstantiated 
statements concerning modified risk tobacco products, whether 
express or implied, even if accompanied by disclaimers would 
be detrimental to the public health. 
(43) The only way to effectively protect the public health 
from the dangers of unsubstantiated modified risk tobacco prod-
ucts is to empower the Food and Drug Administration to require 
that products that tobacco manufacturers sold or distributed 
for risk reduction 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 identify harmful sub-
stances in products to which consumers are exposed, to design 
standards to limit exposure to those substances, to evaluate 
scientific studies supporting claims about the safety of products, 
and to evaluate the impact of labels, labeling, and advertising 
on consumer behavior in order to reduce the risk of harm 
and promote understanding of the impact of the product on 
health. In connection with its mandate to promote health and 
reduce the risk of harm, the Food and Drug Administration
H. R. 1256—6 
routinely makes decisions about whether and how products 
may be marketed in the United States. 
(45) The Federal Trade Commission was created to protect 
consumers from unfair or deceptive acts or practices, and to 
regulate unfair methods of competition. Its focus is on those 
marketplace practices that deceive or mislead consumers, and 
those that give some competitors an unfair advantage. Its mis-
sion 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 Prevention and Tobacco Control Act. 
(46) If manufacturers state or imply in communications 
directed to consumers through the media or through a label, 
labeling, or advertising, 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. Depending upon the particular 
language used and its context, 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, approval, or compliance. 
(47) In August 2006 a United States district court judge 
found that the major United States cigarette companies con-
tinue to target and market to youth. USA v. Philip Morris, 
USA, Inc., et al. (Civil Action No. 99–2496 (GK), August 17, 
2006). 
(48) In August 2006 a United States district court judge 
found that the major United States cigarette companies 
dramatically increased their advertising and promotional 
spending in ways that encourage youth to start smoking subse-
quent 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). 
(49) In August 2006 a United States district court judge 
found that the major United States cigarette companies have 
designed their cigarettes to precisely control nicotine delivery 
levels and provide doses of nicotine sufficient to create and 
sustain addiction 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 division are— 
(1) to provide authority to the Food and Drug Administra-
tion 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 prod-
ucts as provided for in this division; 
(2) to ensure that the Food and Drug Administration 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;
H. R. 1256—7 
(3) to authorize the Food and Drug Administration to set 
national standards controlling the manufacture of tobacco prod-
ucts and the identity, public disclosure, and amount of ingredi-
ents 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 Food and Drug Administration with the 
authority to regulate the levels of tar, nicotine, and other 
harmful components of tobacco products; 
(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; 
(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 division (or an amend-
ment made by this division) 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 Federal, State, or tribal 
court, or any agreement, consent decree, or contract of any 
kind. 
(b) AGRICULTURAL ACTIVITIES.—The provisions of this division 
(or an amendment made by this division) which authorize the 
Secretary to take certain actions with regard to tobacco and tobacco 
products shall not be construed to affect any authority of the Sec-
retary of Agriculture under existing law regarding the growing, 
cultivation, or curing of raw tobacco. 
(c) REVENUE ACTIVITIES.—The provisions of this division (or 
an amendment made by this division) which authorize the Secretary 
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 division, of the amendments made 
by this division, or of the regulations promulgated under this divi-
sion (or under such amendments), or the application of any such 
provision to any person or circumstance is held to be invalid, 
the remainder of this division, such amendments and such regula-
tions, and the application of such provisions to any other person 
or circumstance shall not be affected and shall continue to be 
enforced to the fullest extent possible.
H. R. 1256—8 
SEC. 6. MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION. 
(a) DELAYED COMMENCEMENT
OF DATES
FOR SECRETARIAL 
ACTION.— 
(1) IN GENERAL.—Except as provided in subsection (c), with 
respect to any time periods specified in this division (or in 
an amendment made by this division) that begin on the date 
of enactment of this Act, within which the Secretary of Health 
and Human Services is required to carry out and complete 
specified activities, the calculation of such time periods shall 
commence on the date described in subsection (b). 
(2) LIMITATION.—Subsection (a) shall only apply with 
respect to obligations of the Secretary of Health and Human 
Services that must be completed within a specified time period 
and shall not apply to the obligations of any other person 
or to any other provision of this division (including the amend-
ments made by this division) that do not create such obligations 
of the Secretary and are not contingent on actions by the 
Secretary. 
(b) DATE DESCRIBED.—The date described in this subsection 
is the first day of the first fiscal quarter following the initial 
2 consecutive fiscal quarters of fiscal year 2010 for which the 
Secretary of Health and Human Services has collected fees under 
section 919 of the Federal Food, Drug, and Cosmetic Act (as added 
by section 101). 
(c) EXCEPTION.—Subsection (a) shall not apply to any time 
period (or date) contained— 
(1) in section 102, except that the reference to ‘‘180 days’’ 
in subsection (a)(1) of such section shall be deemed to be 
‘‘270 days’’; and 
(2) in sections 201 through 204 (or the amendments made 
by any such sections). 
(d) ADJUSTMENT.—The Secretary of Health and Human Services 
may extend or reduce the duration of one or more time periods 
to which subsection (a) applies if the Secretary determines appro-
priate, except that no such period shall be extended for more than 
90 days. 
TITLE I—AUTHORITY OF THE FOOD 
AND DRUG ADMINISTRATION 
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 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 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.