Family Smoking Prevention and Tobacco Control Act
PL 111-31 (H.R.1256), enacted 06/22/2009

123 STAT. 1776 
PUBLIC LAW 111–31—JUNE 22, 2009 
Public Law 111–31 
111th Congress 
An Act 
To protect the public health by providing the Food and Drug Administration with 
certain authority to regulate tobacco products, to amend title 5, United States 
Code, to make certain modifications in the Thrift Savings Plan, the Civil Service 
Retirement System, and the Federal Employees’ Retirement System, and for 
other purposes. 
Be it enacted by the Senate and House of Representatives of 
the United States of America in Congress assembled, 
DIVISION 
A—FAMILY 
SMOKING 
PRE-
VENTION AND TOBACCO CONTROL 
ACT 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This division may be cited as the ‘‘Family 
Smoking Prevention and Tobacco Control Act’’. 
(b) TABLE OF CONTENTS.—The table of contents of this division 
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. Modification of deadlines for Secretarial action. 
TITLE I—AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION 
Sec. 101. Amendment of Federal Food, Drug, and Cosmetic Act. 
Sec. 102. Final rule. 
Sec. 103. Conforming and other amendments to general provisions. 
Sec. 104. Study on raising the minimum age to purchase tobacco products. 
Sec. 105. Enforcement action plan for advertising and promotion restrictions. 
Sec. 106. Studies of progress and effectiveness. 
TITLE II—TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE 
CONSTITUENT DISCLOSURE 
Sec. 201. Cigarette label and advertising warnings. 
Sec. 202. Authority to revise cigarette warning label statements. 
Sec. 203. State regulation of cigarette advertising and promotion. 
Sec. 204. Smokeless tobacco labels and advertising warnings. 
Sec. 205. Authority to revise smokeless tobacco product warning label statements. 
Sec. 206. Tar, nicotine, and other smoke constituent disclosure to the public. 
TITLE III—PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS 
Sec. 301. Labeling, recordkeeping, records inspection. 
Sec. 302. Study and report. 
SEC. 2. FINDINGS. 
The Congress finds the following: 
21 USC 387 note. 
21 USC 301 note. 
Family Smoking 
Prevention and 
Tobacco Control 
Act. 
June 22, 2009 
[H.R. 1256] 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00320
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1777 
PUBLIC LAW 111–31—JUNE 22, 2009 
(1) The use of tobacco products by the Nation’s children 
is a pediatric disease of considerable proportions that results 
in new generations of tobacco-dependent children and adults. 
(2) A consensus exists within the scientific and medical 
communities that tobacco products are inherently dangerous 
and cause cancer, heart disease, and other serious adverse 
health effects. 
(3) Nicotine is an addictive drug. 
(4) Virtually all new users of tobacco products are under 
the minimum legal age to purchase such products. 
(5) Tobacco advertising and marketing contribute signifi-
cantly to the use of nicotine-containing tobacco products by 
adolescents. 
(6) Because past efforts to restrict advertising and mar-
keting of tobacco products have failed adequately to curb 
tobacco use by adolescents, comprehensive restrictions on the 
sale, promotion, and distribution of such products are needed. 
(7) Federal and State governments have lacked the legal 
and regulatory authority and resources they need to address 
comprehensively the public health and societal problems caused 
by the use of tobacco products. 
(8) Federal and State public health officials, the public 
health community, and the public at large recognize that the 
tobacco industry should be subject to ongoing oversight. 
(9) Under article I, section 8 of the Constitution, the Con-
gress is vested with the responsibility for regulating interstate 
commerce and commerce with Indian tribes. 
(10) The sale, distribution, marketing, advertising, and use 
of tobacco products are activities in and substantially affecting 
interstate commerce because they are sold, marketed, adver-
tised, and distributed in interstate commerce on a nationwide 
basis, and have a substantial effect on the Nation’s economy. 
(11) The sale, distribution, marketing, advertising, and use 
of such products substantially affect interstate commerce 
through the health care and other costs attributable to the 
use of tobacco products. 
(12) It is in the public interest for Congress to enact legisla-
tion that provides the Food and Drug Administration with 
the authority to regulate tobacco products and the advertising 
and promotion of such products. The benefits to the American 
people from enacting such legislation would be significant in 
human and economic terms. 
(13) Tobacco use is the foremost preventable cause of pre-
mature death in America. It causes over 400,000 deaths in 
the United States each year, and approximately 8,600,000 
Americans have chronic illnesses related to smoking. 
(14) Reducing the use of tobacco by minors by 50 percent 
would prevent well over 10,000,000 of today’s children from 
becoming regular, daily smokers, saving over 3,000,000 of them 
from premature death due to tobacco-induced disease. Such 
a reduction in youth smoking would also result in approxi-
mately $75,000,000,000 in savings attributable to reduced 
health care costs. 
(15) Advertising, marketing, and promotion of tobacco prod-
ucts have been especially directed to attract young persons 
to use tobacco products, and these efforts have resulted in 
increased use of such products by youth. Past efforts to oversee 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00321
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1778 
PUBLIC LAW 111–31—JUNE 22, 2009 
these activities have not been successful in adequately pre-
venting such increased use. 
(16) In 2005, the cigarette manufacturers spent more than 
$13,000,000,000 to attract new users, retain current users, 
increase current consumption, and generate favorable long-term 
attitudes toward smoking and tobacco use. 
(17) Tobacco product advertising often misleadingly por-
trays the use of tobacco as socially acceptable and healthful 
to minors. 
(18) Tobacco product advertising is regularly seen by per-
sons under the age of 18, and persons under the age of 18 
are regularly exposed to tobacco product promotional efforts. 
(19) Through advertisements during and sponsorship of 
sporting events, tobacco has become strongly associated with 
sports and has become portrayed as an integral part of sports 
and the healthy lifestyle associated with rigorous sporting 
activity. 
(20) Children are exposed to substantial and unavoidable 
tobacco advertising that leads to favorable beliefs about tobacco 
use, plays a role in leading young people to overestimate the 
prevalence of tobacco use, and increases the number of young 
people who begin to use tobacco. 
(21) The use of tobacco products in motion pictures and 
other mass media glamorizes its use for young people and 
encourages them to use tobacco products. 
(22) Tobacco advertising expands the size of the tobacco 
market by increasing consumption of tobacco products including 
tobacco use by young people. 
(23) Children are more influenced by tobacco marketing 
than adults: more than 80 percent of youth smoke three heavily 
marketed brands, while only 54 percent of adults, 26 and older, 
smoke these same brands. 
(24) Tobacco company documents indicate that young 
people are an important and often crucial segment of the 
tobacco market. Children, who tend to be more price sensitive 
than adults, are influenced by advertising and promotion prac-
tices that result in drastically reduced cigarette prices. 
(25) Comprehensive advertising restrictions will have a 
positive effect on the smoking rates of young people. 
(26) Restrictions on advertising are necessary to prevent 
unrestricted tobacco advertising from undermining legislation 
prohibiting access to young people and providing for education 
about tobacco use. 
(27) International experience shows that advertising regu-
lations that are stringent and comprehensive have a greater 
impact on overall tobacco use and young people’s use than 
weaker or less comprehensive ones. 
(28) Text only requirements, although not as stringent 
as a ban, will help reduce underage use of tobacco products 
while preserving the informational function of advertising. 
(29) It is in the public interest for Congress to adopt legisla-
tion to address the public health crisis created by actions of 
the tobacco industry. 
(30) The final regulations promulgated by the Secretary 
of Health and Human Services in the August 28, 1996, issue 
of the Federal Register (61 Fed. Reg. 44615–44618) for inclusion 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00322
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1779 
PUBLIC LAW 111–31—JUNE 22, 2009 
as part 897 of title 21, Code of Federal Regulations, are con-
sistent with the first amendment to the United States Constitu-
tion and with the standards set forth in the amendments made 
by this subtitle for the regulation of tobacco products by the 
Food and Drug Administration, and the restriction on the sale 
and distribution of, including access to and the advertising 
and promotion of, tobacco products contained in such regula-
tions are substantially related to accomplishing the public 
health goals of this division. 
(31) The regulations described in paragraph (30) will 
directly and materially advance the Federal Government’s 
substantial interest in reducing the number of children and 
adolescents who use cigarettes and smokeless tobacco and in 
preventing the life-threatening health consequences associated 
with tobacco use. An overwhelming majority of Americans who 
use tobacco products begin using such products while they 
are minors and become addicted to the nicotine in those prod-
ucts before reaching the age of 18. Tobacco advertising and 
promotion play a crucial role in the decision of these minors 
to begin using tobacco products. Less restrictive and less com-
prehensive approaches have not and will not be effective in 
reducing the problems addressed by such regulations. The 
reasonable restrictions on the advertising and promotion of 
tobacco products contained in such regulations will lead to 
a significant decrease in the number of minors using and 
becoming addicted to those products. 
(32) The regulations described in paragraph (30) impose 
no more extensive restrictions on communication by tobacco 
manufacturers and sellers than are necessary to reduce the 
number of children and adolescents who use cigarettes and 
smokeless tobacco and to prevent the life-threatening health 
consequences associated with tobacco use. Such regulations are 
narrowly tailored to restrict those advertising and promotional 
practices which are most likely to be seen or heard by youth 
and most likely to entice them into tobacco use, while affording 
tobacco manufacturers and sellers ample opportunity to convey 
information about their products to adult consumers. 
(33) Tobacco dependence is a chronic disease, one that 
typically requires repeated interventions to achieve long-term 
or permanent abstinence. 
(34) Because the only known safe alternative to smoking 
is cessation, interventions should target all smokers to help 
them quit completely. 
(35) Tobacco products have been used to facilitate and 
finance criminal activities both domestically and internation-
ally. Illicit trade of tobacco products has been linked to orga-
nized crime and terrorist groups. 
(36) It is essential that the Food and Drug Administration 
review products sold or distributed for use to reduce risks 
or exposures associated with tobacco products and that it be 
empowered to review any advertising and labeling for such 
products. It is also essential that manufacturers, prior to mar-
keting such products, be required to demonstrate that such 
products will meet a series of rigorous criteria, and will benefit 
the health of the population as a whole, taking into account 
both users of tobacco products and persons who do not currently 
use tobacco products. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00323
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1780 
PUBLIC LAW 111–31—JUNE 22, 2009 
(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 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00324
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1781 
PUBLIC LAW 111–31—JUNE 22, 2009 
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; 
21 USC 387 note. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00325
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1782 
PUBLIC LAW 111–31—JUNE 22, 2009 
(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. 
21 USC 387 note. 
21 USC 387 note. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00326
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1783 
PUBLIC LAW 111–31—JUNE 22, 2009 
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. 
Applicability. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00327
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1784 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(4) A tobacco product shall not be marketed in combination 
with any other article or product regulated under this Act (including 
a drug, biologic, food, cosmetic, medical device, or a dietary supple-
ment).’’. 
(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 following: 
‘‘CHAPTER IX—TOBACCO PRODUCTS 
‘‘SEC. 900. DEFINITIONS. 
‘‘In this chapter: 
‘‘(1) ADDITIVE.—The term ‘additive’ means any substance 
the intended use of which results or may reasonably be expected 
to result, directly or indirectly, in its becoming a component 
or otherwise affecting the characteristic of any tobacco product 
(including any substances intended for use as a flavoring 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 variety of tobacco 
product distinguished by the tobacco used, tar content, nicotine 
content, flavoring used, size, filtration, packaging, logo, reg-
istered trademark, 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 
‘‘(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 ‘cigarette tobacco’ 
means any product that consists of loose tobacco that is 
intended for use by consumers in a cigarette. Unless otherwise 
stated, the requirements 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 ‘counter-
feit tobacco product’ means a tobacco product (or the container 
or labeling of such a product) that, without authorization, bears 
the trademark, trade name, or other identifying mark, imprint, 
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 furthers the distribution 
of a tobacco product, whether domestic or imported, at any 
21 USC 387. 
21 USC 391 
et seq. 
21 USC 391, 
301 note, 
392 and note, 
393–399a. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00328
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1785 
PUBLIC LAW 111–31—JUNE 22, 2009 
point from the original place of manufacture to the person 
who sells or distributes the product to individuals for personal 
consumption. Common carriers are not considered distributors 
for purposes of this chapter. 
‘‘(8) ILLICIT TRADE.—The term ‘illicit trade’ means any prac-
tice or conduct prohibited by law which relates to production, 
shipment, receipt, possession, distribution, sale, or purchase 
of tobacco products including any practice or conduct intended 
to facilitate such activity. 
‘‘(9) INDIAN COUNTRY.—The term ‘Indian country’ has the 
meaning given such term in section 1151 of title 18, United 
States Code. 
‘‘(10) INDIAN
TRIBE.—The term ‘Indian tribe’ has the 
meaning given such term in section 4(e) of the Indian Self- 
Determination and Education Assistance Act. 
‘‘(11) LITTLE CIGAR.—The term ‘little cigar’ means a product 
that— 
‘‘(A) is a tobacco product; and 
‘‘(B) meets the definition of the term ‘little cigar’ in 
section 3(7) of the Federal Cigarette Labeling and Adver-
tising Act. 
‘‘(12) NICOTINE.—The term ‘nicotine’ means the chemical 
substance 
named 
3-(1-Methyl-2-pyrrolidinyl) 
pyridine 
or 
C[10]H[14]N[2], including any salt or complex of nicotine. 
‘‘(13) PACKAGE.—The term ‘package’ means a pack, box, 
carton, or container of any kind or, if no other container, 
any wrapping (including cellophane), in which a tobacco product 
is offered for sale, sold, or otherwise distributed to consumers. 
‘‘(14) RETAILER.—The term ‘retailer’ means any person, 
government, or entity who sells tobacco products to individuals 
for personal consumption, or who operates a facility where 
self-service displays of tobacco products are permitted. 
‘‘(15) ROLL-YOUR-OWN TOBACCO.—The term ‘roll-your-own 
tobacco’ means any tobacco product which, because of its 
appearance, type, packaging, or labeling, is suitable for use 
and likely to be offered to, or purchased by, consumers as 
tobacco for making cigarettes. 
‘‘(16) SMALL TOBACCO PRODUCT MANUFACTURER.—The term 
‘small tobacco product manufacturer’ means a tobacco product 
manufacturer that employs fewer than 350 employees. For pur-
poses of determining the number of employees of a manufac-
turer under the preceding sentence, the employees of a manu-
facturer are deemed to include the employees of each entity 
that controls, is controlled by, or is under common control 
with such manufacturer. 
‘‘(17) SMOKE CONSTITUENT.—The term ‘smoke constituent’ 
means any chemical or chemical compound in mainstream or 
sidestream tobacco smoke that either transfers from any compo-
nent of the cigarette to the smoke or that is formed by the 
combustion or heating of tobacco, additives, or other component 
of the tobacco product. 
‘‘(18) SMOKELESS TOBACCO.—The term ‘smokeless tobacco’ 
means any tobacco product that consists of cut, ground, pow-
dered, or leaf tobacco and that is intended to be placed in 
the oral or nasal cavity. 
‘‘(19) STATE; TERRITORY.—The terms ‘State’ and ‘Territory’ 
shall have the meanings given to such terms in section 201. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00329
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1786 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(20) 
TOBACCO
PRODUCT
MANUFACTURER.—The 
term 
‘tobacco product manufacturer’ means any person, including 
any repacker or relabeler, who— 
‘‘(A) manufactures, fabricates, assembles, processes, or 
labels a tobacco product; or 
‘‘(B) imports a finished tobacco product for sale or 
distribution in the United States. 
‘‘(21) TOBACCO WAREHOUSE.— 
‘‘(A) Subject to subparagraphs (B) and (C), the term 
‘tobacco warehouse’ includes any person— 
‘‘(i) who— 
‘‘(I) removes foreign material from tobacco leaf 
through nothing other than a mechanical process; 
‘‘(II) humidifies tobacco leaf with nothing other 
than potable water in the form of steam or mist; 
or 
‘‘(III) de-stems, dries, and packs tobacco leaf 
for storage and shipment; 
‘‘(ii) who performs no other actions with respect 
to tobacco leaf; and 
‘‘(iii) who provides to any manufacturer to whom 
the person sells tobacco all information related to the 
person’s actions described in clause (i) that is necessary 
for compliance with this Act. 
‘‘(B) The term ‘tobacco warehouse’ excludes any person 
who— 
‘‘(i) reconstitutes tobacco leaf; 
‘‘(ii) is a manufacturer, distributor, or retailer of 
a tobacco product; or 
‘‘(iii) applies any chemical, additive, or substance 
to the tobacco leaf other than potable water in the 
form of steam or mist. 
‘‘(C) The definition of the term ‘tobacco warehouse’ 
in subparagraph (A) shall not apply to the extent to which 
the Secretary determines, through rulemaking, that regula-
tion under this chapter of the actions described in such 
subparagraph is appropriate for the protection of the public 
health. 
‘‘(22) UNITED STATES.—The term ‘United States’ means the 
50 States of the United States of America and the District 
of Columbia, the Commonwealth of Puerto Rico, Guam, the 
Virgin Islands, American Samoa, Wake Island, Midway Islands, 
Kingman Reef, Johnston Atoll, the Northern Mariana Islands, 
and any other trust territory or possession of the United States. 
‘‘SEC. 901. FDA 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 911, shall be regulated by the Secretary under this 
chapter and shall not be subject to the provisions of chapter V. 
‘‘(b) APPLICABILITY.—This chapter shall apply to all cigarettes, 
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and 
to any other tobacco products that the Secretary by regulation 
deems to be subject to this chapter. 
‘‘(c) SCOPE.— 
‘‘(1) IN GENERAL.—Nothing in this chapter, or any policy 
issued or regulation promulgated thereunder, or in sections 
Regulations. 
21 USC 387a. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00330
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1787 
PUBLIC LAW 111–31—JUNE 22, 2009 
101(a), 102, or 103 of title I, title II, or title III of the Family 
Smoking Prevention and Tobacco Control Act, shall be con-
strued to affect, expand, or limit the Secretary’s authority over 
(including the authority to determine whether products may 
be regulated), or the regulation of, products under this Act 
that are not tobacco products under chapter V or any other 
chapter. 
‘‘(2) LIMITATION OF AUTHORITY.— 
‘‘(A) IN GENERAL.—The provisions of this chapter 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 ware-
houses, and tobacco grower cooperatives, nor shall any 
employee of the Food and Drug Administration have any 
authority to enter onto a farm owned by a producer of 
tobacco leaf without the written consent of such producer. 
‘‘(B) EXCEPTION.—Notwithstanding subparagraph (A), 
if a producer of tobacco leaf is also a tobacco product 
manufacturer or controlled by a tobacco product manufac-
turer, the producer shall be subject to this chapter 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. 
‘‘(C) RULE OF CONSTRUCTION.—Nothing in this chapter 
shall be construed to grant the Secretary authority to 
promulgate regulations on any matter that involves the 
production of tobacco leaf or a producer thereof, other than 
activities by a manufacturer affecting production. 
‘‘(d) RULEMAKING PROCEDURES.—Each rulemaking under this 
chapter shall be in accordance with chapter 5 of title 5, United 
States Code. This subsection shall not be construed to affect the 
rulemaking provisions of section 102(a) of the Family Smoking 
Prevention and Tobacco Control Act. 
‘‘(e) CENTER FOR TOBACCO PRODUCTS.—Not later than 90 days 
after the date of enactment of the Family Smoking Prevention 
and Tobacco Control Act, the Secretary shall establish within the 
Food and Drug Administration the Center for Tobacco Products, 
which shall report to the Commissioner of Food and Drugs in 
the same manner as the other agency centers within the Food 
and Drug Administration. The Center shall be responsible for the 
implementation of this chapter and related matters assigned by 
the Commissioner. 
‘‘(f) OFFICE TO ASSIST SMALL TOBACCO PRODUCT MANUFACTUR-
ERS.—The Secretary shall establish within the Food and Drug 
Administration an identifiable office to provide technical and other 
nonfinancial assistance to small tobacco product manufacturers to 
assist them in complying with the requirements of this Act. 
‘‘(g) CONSULTATION PRIOR TO RULEMAKING.—Prior to promul-
gating rules under this chapter, the Secretary shall endeavor to 
consult with other Federal agencies as appropriate. 
‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS. 
‘‘A tobacco product shall be deemed to be adulterated if— 
‘‘(1) it consists in whole or in part of any filthy, putrid, 
or decomposed substance, or is otherwise contaminated by any 
21 USC 387b. 
Establishment. 
Deadline. 
Establishment. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00331
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1788 
PUBLIC LAW 111–31—JUNE 22, 2009 
added poisonous or added deleterious substance that may 
render the product injurious to health; 
‘‘(2) it has been prepared, packed, or held under insanitary 
conditions whereby it may have been contaminated with filth, 
or whereby it may have been rendered injurious to health; 
‘‘(3) its package is composed, in whole or in part, of any 
poisonous or deleterious substance which may render the con-
tents injurious to health; 
‘‘(4) the manufacturer or importer of the tobacco product 
fails to pay a user fee assessed to such manufacturer or 
importer pursuant to section 919 by the date specified in section 
919 or by the 30th day after final agency action on a resolution 
of any dispute as to the amount of such fee; 
‘‘(5) it is, or purports to be or is represented as, a tobacco 
product which is subject to a tobacco product standard estab-
lished under section 907 unless such tobacco product is in 
all respects in conformity with such standard; 
‘‘(6)(A) it is required by section 910(a) to have premarket 
review and does not have an order in effect under section 
910(c)(1)(A)(i); or 
‘‘(B) it is in violation of an order under section 910(c)(1)(A); 
‘‘(7) the methods used in, or the facilities or controls used 
for, its manufacture, packing, or storage are not in conformity 
with applicable requirements under section 906(e)(1) or an 
applicable condition prescribed by an order under section 
906(e)(2); or 
‘‘(8) it is in violation of section 911. 
‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—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) the name and place of business of the tobacco 
product manufacturer, packer, or distributor; 
‘‘(B) an accurate statement of the quantity of the con-
tents in terms of weight, measure, or numerical count; 
‘‘(C) an accurate statement of the percentage of the 
tobacco used in the product that is domestically grown 
tobacco and the percentage that is foreign grown tobacco; 
and 
‘‘(D) the statement required under section 920(a), 
except that under subparagraph (B) reasonable variations shall 
be permitted, and exemptions as to small packages shall be 
established, by regulations prescribed by the Secretary; 
‘‘(3) if any word, statement, or other information required 
by or under authority of this chapter to appear on the label 
or labeling is not prominently placed thereon with such 
conspicuousness (as compared with other words, statements, 
or designs in the labeling) and in such terms as to render 
it likely to be read and understood by the ordinary individual 
under customary conditions of purchase and use; 
‘‘(4) if it has an established name, unless its label bears, 
to the exclusion of any other nonproprietary name, its estab-
lished name prominently printed in type as required by the 
Secretary by regulation; 
Regulations. 
Labeling. 
21 USC 387c. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00332
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1789 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(5) if the Secretary has issued regulations requiring that 
its labeling bear adequate directions for use, or adequate 
warnings against use by children, that are necessary for the 
protection of users unless its labeling conforms in all respects 
to such regulations; 
‘‘(6) if it was manufactured, prepared, propagated, com-
pounded, or processed in an establishment not duly registered 
under section 905(b), 905(c), 905(d), or 905(h), if it was not 
included in a list required by section 905(i), if a notice or 
other information respecting it was not provided as required 
by such section or section 905(j), or if it does not bear such 
symbols from the uniform system for identification of tobacco 
products prescribed under section 905(e) as the Secretary by 
regulation requires; 
‘‘(7) if, in the case of any tobacco product distributed or 
offered for sale in any State— 
‘‘(A) its advertising is false or misleading in any par-
ticular; or 
‘‘(B) it is sold or distributed in violation of regulations 
prescribed under section 906(d); 
‘‘(8) unless, in the case of any tobacco product distributed 
or offered for sale in any State, the manufacturer, packer, 
or distributor thereof includes in all advertisements and other 
descriptive printed matter issued or caused to be issued by 
the manufacturer, packer, or distributor with respect to that 
tobacco product— 
‘‘(A) a true statement of the tobacco product’s estab-
lished name as described in paragraph (4), printed promi-
nently; and 
‘‘(B) a brief statement of— 
‘‘(i) the uses of the tobacco product and relevant 
warnings, precautions, side effects, and contraindica-
tions; and 
‘‘(ii) in the case of specific tobacco products made 
subject to a finding by the Secretary after notice and 
opportunity for comment that such action is appro-
priate to protect the public health, a full description 
of the components of such tobacco product or the for-
mula showing quantitatively each ingredient of such 
tobacco product to the extent required in regulations 
which shall be issued by the Secretary after an oppor-
tunity for a hearing; 
‘‘(9) if it is a tobacco product subject to a tobacco product 
standard established under section 907, unless it bears such 
labeling as may be prescribed in such tobacco product standard; 
or 
‘‘(10) if there was a failure or refusal— 
‘‘(A) to comply with any requirement prescribed under 
section 904 or 908; or 
‘‘(B) to furnish any material or information required 
under section 909. 
‘‘(b) PRIOR APPROVAL OF LABEL STATEMENTS.—The Secretary 
may, by regulation, require prior approval of statements made 
on the label of a tobacco product to ensure that such statements 
do not violate the misbranding provisions of subsection (a) and 
that such statements comply with other provisions of the Family 
Regulations. 
Hearings. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00333
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1790 
PUBLIC LAW 111–31—JUNE 22, 2009 
Smoking Prevention and Tobacco Control Act (including the amend-
ments made by such Act). No regulation issued under this sub-
section may require prior approval by the Secretary of the content 
of any advertisement, except for modified risk tobacco products 
as provided in section 911. No advertisement of a tobacco product 
published after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act shall, with respect to the lan-
guage of label statements as prescribed under section 4 of the 
Federal Cigarette Labeling and Advertising Act and section 3 of 
the Comprehensive Smokeless Tobacco Health Education Act of 
1986 or the regulations issued under such sections, be subject 
to the provisions of sections 12 through 15 of the Federal Trade 
Commission Act. 
‘‘SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE SEC-
RETARY. 
‘‘(a) REQUIREMENT.—Each tobacco product manufacturer or 
importer, or agents thereof, shall submit to the Secretary the fol-
lowing information: 
‘‘(1) Not later than 6 months after the date of enactment 
of the Family Smoking Prevention and Tobacco Control Act, 
a listing of all ingredients, including tobacco, substances, com-
pounds, 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 subbrand. 
‘‘(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 
Secretary in accordance with section 4(e) of the Federal Ciga-
rette Labeling and Advertising Act. 
‘‘(3) Beginning 3 years after the date of enactment of the 
Family Smoking Prevention and Tobacco Control Act, a listing 
of all constituents, including smoke constituents as applicable, 
identified by the Secretary as harmful or potentially 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. Effective beginning 3 years after 
such date of enactment, the manufacturer, importer, or agent 
shall comply with regulations promulgated under section 915 
in 
reporting 
information 
under 
this 
paragraph, 
where 
applicable. 
‘‘(4) Beginning 6 months after the date of enactment of 
the Family Smoking Prevention and Tobacco Control Act, all 
documents developed after such date of enactment that relate 
to health, toxicological, behavioral, or physiologic effects of cur-
rent or future tobacco products, their constituents (including 
smoke constituents), ingredients, components, and additives. 
‘‘(b) DATA SUBMISSION.—At the request of the Secretary, 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 manufac-
turer (or agents thereof) on the health, toxicological, behavioral, 
or physiologic effects of tobacco products and their constituents 
Effective date. 
Effective date. 
Deadline. 
21 USC 387d. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00334
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1791 
PUBLIC LAW 111–31—JUNE 22, 2009 
(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 manufac-
turer (or agents thereof) that relate to the issue of whether 
a reduction in risk to health from tobacco products can occur 
upon the employment of technology available or known to the 
manufacturer. 
‘‘(3) Any or all documents (including underlying scientific 
or financial information) relating to marketing research 
involving the use of tobacco products or marketing practices 
and the effectiveness of such practices used by tobacco manufac-
turers and distributors. 
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) TIME FOR SUBMISSION.— 
‘‘(1) IN GENERAL.—At least 90 days prior to the delivery 
for introduction into interstate commerce of a tobacco product 
not on the market on the date of enactment of the Family 
Smoking Prevention and Tobacco Control Act, the manufacturer 
of such product shall provide the information required under 
subsection (a). 
‘‘(2) DISCLOSURE OF ADDITIVE.—If at any time a tobacco 
product manufacturer adds to its tobacco products a new 
tobacco additive or increases the quantity of an existing tobacco 
additive, the manufacturer shall, except as provided in para-
graph (3), at least 90 days prior to such action so advise 
the Secretary in writing. 
‘‘(3) DISCLOSURE
OF
OTHER
ACTIONS.—If at any time a 
tobacco product manufacturer eliminates or decreases an 
existing additive, or adds or increases an additive that has 
by regulation been designated by the Secretary as an additive 
that is not a human or animal carcinogen, or otherwise harmful 
to health under intended conditions of use, the manufacturer 
shall within 60 days of such action so advise the Secretary 
in writing. 
‘‘(d) DATA LIST.— 
‘‘(1) IN GENERAL.—Not later than 3 years after the date 
of enactment of the Family Smoking Prevention and Tobacco 
Control Act, and annually thereafter, the Secretary shall pub-
lish in a format that is understandable and not misleading 
to a lay person, and place on public display (in a manner 
determined by the Secretary) the list established under sub-
section (e). 
‘‘(2) CONSUMER
RESEARCH.—The Secretary 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 Family 
Smoking Prevention and Tobacco Control Act, the Secretary 
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. 
‘‘(e) DATA COLLECTION.—Not later than 24 months after the 
date of enactment of the Family Smoking Prevention and Tobacco 
Control Act, the Secretary shall establish, and periodically revise 
Deadline. 
Deadline. 
Reports. 
Recommenda- 
tions. 
Deadlines. 
Publication. 
Public 
information. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00335
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1792 
PUBLIC LAW 111–31—JUNE 22, 2009 
as appropriate, a list of harmful and potentially harmful constitu-
ents, including smoke constituents, to health in each tobacco product 
by brand and by quantity in each brand and subbrand. The Sec-
retary shall publish a public notice requesting the submission by 
interested persons of scientific and other information concerning 
the harmful and potentially harmful constituents in tobacco prod-
ucts and tobacco smoke. 
‘‘SEC. 905. ANNUAL REGISTRATION. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) MANUFACTURE, PREPARATION, COMPOUNDING, OR PROC-
ESSING.—The term ‘manufacture, preparation, compounding, or 
processing’ shall include repackaging or otherwise changing 
the container, wrapper, or labeling of any tobacco product pack-
age in furtherance of the distribution of the tobacco product 
from the original place of manufacture to the person who makes 
final delivery or sale to the ultimate consumer or user. 
‘‘(2) NAME.—The term ‘name’ shall include in the case 
of a partnership the name of each partner and, in the case 
of a corporation, the name of each corporate officer and director, 
and the State of incorporation. 
‘‘(b) REGISTRATION BY OWNERS AND OPERATORS.—On or before 
December 31 of each year, every person who owns or operates 
any establishment in any State engaged in the manufacture, 
preparation, compounding, or processing of a tobacco product or 
tobacco products shall register with the Secretary the name, places 
of business, and all such establishments of that person. If enactment 
of the Family Smoking Prevention and Tobacco Control Act occurs 
in the second half of the calendar year, the Secretary shall designate 
a date no later than 6 months into the subsequent calendar year 
by which registration pursuant to this subsection shall occur. 
‘‘(c) REGISTRATION BY NEW OWNERS AND OPERATORS.—Every 
person upon first engaging in the manufacture, preparation, 
compounding, or processing of a tobacco product or tobacco products 
in any establishment owned or operated in any State by that 
person shall immediately register with the Secretary that person’s 
name, place of business, and such establishment. 
‘‘(d) REGISTRATION OF ADDED ESTABLISHMENTS.—Every person 
required to register under subsection (b) or (c) shall immediately 
register with the Secretary any additional establishment which 
that person owns or operates in any State and in which that 
person begins the manufacture, preparation, compounding, or proc-
essing of a tobacco product or tobacco products. 
‘‘(e) UNIFORM PRODUCT IDENTIFICATION SYSTEM.—The Sec-
retary may by regulation prescribe a uniform system for the identi-
fication of tobacco products and may require that persons who 
are required to list such tobacco products under subsection (i) 
shall list such tobacco products in accordance with such system. 
‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMATION.—The Sec-
retary shall make available for inspection, to any person so 
requesting, any registration filed under this section. 
‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTABLISHMENTS.— 
Every establishment registered with the Secretary under this sec-
tion shall be subject to inspection under section 704 or subsection 
(h), and every such establishment engaged in the manufacture, 
compounding, or processing of a tobacco product or tobacco products 
shall be so inspected by 1 or more officers or employees duly 
Deadline. 
21 USC 387e. 
Publication. 
Notice. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00336
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1793 
PUBLIC LAW 111–31—JUNE 22, 2009 
designated by the Secretary at least once in the 2-year period 
beginning with the date of registration of such establishment under 
this section and at least once in every successive 2-year period 
thereafter. 
‘‘(h) 
REGISTRATION
BY
FOREIGN
ESTABLISHMENTS.—Any 
establishment within any foreign country engaged in the manufac-
ture, preparation, compounding, or processing of a tobacco product 
or tobacco products, shall register under this section under regula-
tions promulgated by the Secretary. Such regulations shall require 
such establishment to provide the information required by sub-
section (i) and shall include provisions for registration of any such 
establishment upon condition that adequate and effective means 
are available, by arrangement with the government of such foreign 
country or otherwise, to enable the Secretary to determine from 
time to time whether tobacco products manufactured, prepared, 
compounded, or processed in such establishment, if imported or 
offered for import into the United States, shall be refused admission 
on any of the grounds set forth in section 801(a). 
‘‘(i) REGISTRATION INFORMATION.— 
‘‘(1) PRODUCT LIST.—Every person who registers with the 
Secretary under subsection (b), (c), (d), or (h) shall, at the 
time of registration under any such subsection, file with the 
Secretary a list of all tobacco products which are being manufac-
tured, prepared, compounded, or processed by that person for 
commercial distribution and which have not been included in 
any list of tobacco products filed by that person with the Sec-
retary under this paragraph or paragraph (2) before such time 
of registration. Such list shall be prepared in such form and 
manner as the Secretary may prescribe and shall be accom-
panied by— 
‘‘(A) in the case of a tobacco product contained in 
the applicable list with respect to which a tobacco product 
standard has been established under section 907 or which 
is subject to section 910, a reference to the authority for 
the marketing of such tobacco product and a copy of all 
labeling for such tobacco product; 
‘‘(B) in the case of any other tobacco product contained 
in an applicable list, a copy of all consumer information 
and other labeling for such tobacco product, a representa-
tive sampling of advertisements for such tobacco product, 
and, upon request made by the Secretary for good cause, 
a copy of all advertisements for a particular tobacco 
product; and 
‘‘(C) if the registrant filing a list has determined that 
a tobacco product contained in such list is not subject 
to a tobacco product standard established under section 
907, a brief statement of the basis upon which the reg-
istrant made such determination if the Secretary requests 
such a statement with respect to that particular tobacco 
product. 
‘‘(2) CONSULTATION
WITH
RESPECT
TO
FORMS.—The Sec-
retary shall consult with the Secretary of the Treasury in 
developing the forms to be used for registration under this 
section to minimize the burden on those persons required to 
register with both the Secretary and the Tax and Trade Bureau 
of the Department of the Treasury. 
Regulations. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00337
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1794 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(3) BIANNUAL REPORT OF ANY CHANGE IN PRODUCT LIST.— 
Each person who registers with the Secretary under this section 
shall report to the Secretary once during the month of June 
of each year and once during the month of December of each 
year the following: 
‘‘(A) A list of each tobacco product introduced by the 
registrant for commercial distribution which has not been 
included in any list previously filed by that person with 
the Secretary under this subparagraph or paragraph (1). 
A list under this subparagraph shall list a tobacco product 
by its established 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 that person has discontinued the 
manufacture, preparation, compounding, or processing for 
commercial distribution of a tobacco product included in 
a list filed under subparagraph (A) or paragraph (1), notice 
of such discontinuance, the date of such discontinuance, 
and the identity of its established name. 
‘‘(C) If since the date the registrant reported under 
subparagraph (B) a notice of discontinuance that person 
has resumed the manufacture, preparation, compounding, 
or processing for commercial distribution of the tobacco 
product with respect to which such notice of discontinuance 
was reported, notice of such resumption, the date of such 
resumption, the identity of such tobacco product by estab-
lished name, and other information required by paragraph 
(1), unless the registrant has previously reported such 
resumption to the Secretary under this subparagraph. 
‘‘(D) Any material change in any information previously 
submitted under this paragraph or paragraph (1). 
‘‘(j) REPORT PRECEDING INTRODUCTION OF CERTAIN SUBSTAN-
TIALLY EQUIVALENT PRODUCTS INTO INTERSTATE COMMERCE.— 
‘‘(1) IN GENERAL.—Each person who is required to register 
under this section and who proposes to begin the introduction 
or delivery for introduction into interstate commerce for 
commercial distribution of a tobacco product intended for 
human use that was not commercially marketed (other than 
for test marketing) in the United States as of February 15, 
2007, shall, at least 90 days prior to making such introduction 
or delivery, report to the Secretary (in such form and manner 
as the Secretary shall prescribe)— 
‘‘(A) the basis for such person’s determination that— 
‘‘(i) the tobacco product is substantially equivalent, 
within the meaning of section 910, to a tobacco product 
commercially marketed (other than for test marketing) 
in the United States as of February 15, 2007, or to 
a tobacco product that the Secretary has previously 
determined, pursuant to subsection (a)(3) of section 
910, is substantially equivalent and that is in compli-
ance with the requirements of this Act; or 
‘‘(ii) the tobacco product is modified within the 
meaning of paragraph (3), the modifications are to 
a product that is commercially marketed and in compli-
ance with the requirements of this Act, and all of 
the modifications are covered by exemptions granted 
by the Secretary pursuant to paragraph (3); and 
Notice. 
Notice. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00338
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1795 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(B) action taken by such person to comply with the 
requirements under section 907 that are applicable to the 
tobacco product. 
‘‘(2) APPLICATION TO CERTAIN POST-FEBRUARY 15, 2007, PROD-
UCTS.—A report under this subsection for a tobacco product 
that was first introduced or delivered for introduction into 
interstate commerce for commercial distribution in the United 
States after February 15, 2007, and prior to the date that 
is 21 months after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act shall be submitted to the 
Secretary not later than 21 months after such date of enact-
ment. 
‘‘(3) EXEMPTIONS.— 
‘‘(A) IN
GENERAL.—The Secretary may exempt from 
the requirements of this subsection relating to the dem-
onstration that a tobacco product is substantially equiva-
lent within the meaning of section 910, tobacco products 
that are modified by adding or deleting a tobacco additive, 
or increasing or decreasing the quantity of an existing 
tobacco additive, if the Secretary determines that— 
‘‘(i) such modification would be a minor modifica-
tion of a tobacco product that can be sold under this 
Act; 
‘‘(ii) a report under this subsection is not necessary 
to ensure that permitting the tobacco product to be 
marketed would be appropriate for protection of the 
public health; and 
‘‘(iii) an exemption is otherwise appropriate. 
‘‘(B) REGULATIONS.—Not later than 15 months after 
the date of enactment of the Family Smoking Prevention 
and Tobacco Control Act, the Secretary shall issue regula-
tions to implement this paragraph. 
‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO 
PRODUCTS. 
‘‘(a) IN GENERAL.—Any requirement established by or under 
section 902, 903, 905, or 909 applicable to a tobacco product shall 
apply to such tobacco product until the applicability of the require-
ment to the tobacco product has been changed by action taken 
under section 907, section 910, section 911, or subsection (d) of 
this section, and any requirement established by or under section 
902, 903, 905, or 909 which is inconsistent with a requirement 
imposed on such tobacco product under section 907, section 910, 
section 911, 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 
907, 908, 909, 910, or 911 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 
Notice. 
Federal Register, 
publication. 
Applicability. 
21 USC 387f. 
Deadline. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00339
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1796 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(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 Secretary by a notice published in the Federal Register 
stating good cause therefore. 
‘‘(c) LIMITED CONFIDENTIALITY OF INFORMATION.—Any informa-
tion reported to or otherwise obtained by the Secretary or the 
Secretary’s representative under section 903, 904, 907, 908, 909, 
910, 911, or 704, 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 chapter, 
or when relevant in any proceeding under this chapter. 
‘‘(d) RESTRICTIONS.— 
‘‘(1) IN GENERAL.—The Secretary may by regulation require 
restrictions on the sale and distribution of a tobacco product, 
including restrictions on the access to, and the advertising 
and promotion of, the tobacco product, if the Secretary deter-
mines that such regulation would be appropriate for the protec-
tion of the public health. The Secretary may by regulation 
impose restrictions on the advertising and promotion of a 
tobacco product consistent with and to full extent permitted 
by the first amendment to the Constitution. The finding as 
to whether such regulation would be appropriate for the protec-
tion of the public health shall be determined with respect 
to the risks and benefits to the population as a whole, including 
users and nonusers of the tobacco product, and taking into 
account— 
‘‘(A) the increased or decreased likelihood that existing 
users of tobacco products will stop using such products; 
and 
‘‘(B) the increased or decreased likelihood that those 
who do not use tobacco products will start using such 
products. 
No such regulation may require that the sale or distribution 
of a tobacco product be limited to the written or oral authoriza-
tion of a practitioner licensed by law to prescribe medical 
products. 
‘‘(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 Secretary 
may in such regulation prescribe. 
‘‘(3) LIMITATIONS.— 
‘‘(A) IN GENERAL.—No restrictions under paragraph (1) 
may— 
‘‘(i) prohibit the sale of any tobacco product in 
face-to-face transactions by a specific category of retail 
outlets; or 
‘‘(ii) establish a minimum age of sale of tobacco 
products to any person older than 18 years of age. 
‘‘(B) MATCHBOOKS.—For purposes of any regulations 
issued by the Secretary, matchbooks of conventional size 
containing not more than 20 paper matches, and which 
are customarily given away for free with the purchase 
Time period. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00340
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1797 
PUBLIC LAW 111–31—JUNE 22, 2009 
of tobacco products, shall be considered as adult-written 
publications which shall be permitted to contain adver-
tising. Notwithstanding the preceding sentence, if the Sec-
retary finds that such treatment of matchbooks is not 
appropriate for the protection of the public health, the 
Secretary may determine by regulation that matchbooks 
shall not be considered adult-written publications. 
‘‘(4) REMOTE SALES.— 
‘‘(A) IN GENERAL.—The Secretary shall— 
‘‘(i) within 18 months after the date of enactment 
of the Family Smoking Prevention and Tobacco Control 
Act, promulgate regulations regarding the sale and 
distribution of tobacco products that occur through 
means other than a direct, face-to-face exchange 
between a retailer and a consumer in order to prevent 
the sale and distribution of tobacco products to individ-
uals who have not attained the minimum age estab-
lished by applicable law for the purchase of such prod-
ucts, including requirements for age verification; and 
‘‘(ii) within 2 years after such date of enactment, 
issue regulations to address the promotion and mar-
keting of tobacco products that are sold or distributed 
through means other than a direct, face-to-face 
exchange between a retailer and a consumer in order 
to protect individuals who have not attained the min-
imum age established by applicable law for the pur-
chase of such products. 
‘‘(B) RELATION TO OTHER AUTHORITY.—Nothing in this 
paragraph limits the authority of the Secretary to take 
additional actions under the other paragraphs of this sub-
section. 
‘‘(e) GOOD MANUFACTURING PRACTICE REQUIREMENTS.— 
‘‘(1) METHODS, FACILITIES, AND CONTROLS TO CONFORM.— 
‘‘(A) IN GENERAL.—In applying manufacturing restric-
tions to tobacco, the Secretary 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 pro-
tected and that the tobacco product is in compliance with 
this chapter. Such regulations may provide for the testing 
of raw tobacco for pesticide chemical residues regardless 
of whether a tolerance for such chemical residues has been 
established. 
‘‘(B) REQUIREMENTS.—The Secretary shall— 
‘‘(i) before promulgating any regulation under 
subparagraph (A), afford the Tobacco Products Sci-
entific Advisory Committee an opportunity to submit 
recommendations with respect to the regulation pro-
posed to be promulgated; 
Recommenda- 
tions. 
Regulations. 
Deadlines. 
Regulations. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00341
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1798 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(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); 
‘‘(iv) in establishing the effective date of a regula-
tion 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; and 
‘‘(v) not require any small tobacco product manu-
facturer to comply with a regulation under subpara-
graph (A) for at least 4 years following the effective 
date established by the Secretary for such regulation. 
‘‘(2) EXEMPTIONS; VARIANCES.— 
‘‘(A) PETITION.—Any person subject to any requirement 
prescribed under paragraph (1) may petition the Secretary 
for a permanent or temporary exemption or variance from 
such requirement. Such a petition shall be submitted to 
the Secretary in such form and manner as the Secretary 
shall prescribe and shall— 
‘‘(i) in the case of a petition for an exemption 
from a requirement, set forth the basis for the peti-
tioner’s determination that compliance with the 
requirement is not required to assure that the tobacco 
product will be in compliance with this chapter; 
‘‘(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 Sec-
retary shall prescribe. 
‘‘(B) REFERRAL TO THE TOBACCO PRODUCTS SCIENTIFIC 
ADVISORY
COMMITTEE.—The Secretary may refer to the 
Tobacco Products Scientific Advisory Committee any peti-
tion submitted under subparagraph (A). The Tobacco Prod-
ucts Scientific Advisory Committee shall report its rec-
ommendations to the Secretary 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 
Secretary under subparagraph (A); or 
‘‘(ii) the day after the petition was referred to 
the Tobacco Products Scientific Advisory Committee, 
whichever occurs later, the Secretary shall by order either 
deny the petition or approve it. 
‘‘(C) APPROVAL.—The Secretary may approve— 
‘‘(i) a petition for an exemption for a tobacco 
product from a requirement if the Secretary determines 
Reports. 
Deadline. 
Compliance date. 
Hearings. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00342
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1799 
PUBLIC LAW 111–31—JUNE 22, 2009 
that compliance with such requirement is not required 
to assure that the tobacco product will be in compliance 
with this chapter; and 
‘‘(ii) a petition for a variance for a tobacco product 
from a requirement if the Secretary determines that 
the methods to be used in, and the facilities and con-
trols 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 chapter. 
‘‘(D) CONDITIONS.—An order of the Secretary approving 
a petition for a variance shall prescribe such conditions 
respecting the methods used in, and the facilities and con-
trols 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 chapter. 
‘‘(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 the Family 
Smoking Prevention and Tobacco Control Act. 
‘‘(f) RESEARCH AND DEVELOPMENT.—The Secretary may enter 
into contracts for research, testing, and demonstrations respecting 
tobacco products and may obtain tobacco products for research, 
testing, and demonstration purposes. 
‘‘SEC. 907. TOBACCO PRODUCT STANDARDS. 
‘‘(a) IN GENERAL.— 
‘‘(1) SPECIAL RULES.— 
‘‘(A) SPECIAL
RULE
FOR
CIGARETTES.—Beginning 3 
months after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act, a cigarette or any 
of its component parts (including the tobacco, filter, or 
paper) shall not contain, as a constituent (including a 
smoke constituent) or additive, an artificial or natural 
flavor (other than tobacco or menthol) or an herb or spice, 
including strawberry, grape, orange, clove, cinnamon, pine-
apple, vanilla, coconut, licorice, cocoa, chocolate, cherry, 
or coffee, that is a characterizing flavor of the tobacco 
product or tobacco smoke. Nothing in this subparagraph 
shall be construed to limit the Secretary’s authority to 
take action under this section or other sections of this 
Act applicable to menthol or any artificial or natural flavor, 
herb, or spice not specified in this subparagraph. 
‘‘(B) ADDITIONAL
SPECIAL
RULE.—Beginning 2 years 
after the date of enactment of the Family Smoking Preven-
tion and Tobacco Control Act, a tobacco product manufac-
turer shall not use tobacco, including foreign grown tobacco, 
that contains a pesticide chemical residue that is at a 
level greater than is specified by any tolerance applicable 
under Federal law to domestically grown tobacco. 
Effective dates. 
21 USC 387g. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00343
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1800 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(2) REVISION OF TOBACCO PRODUCT STANDARDS.—The Sec-
retary may revise the tobacco product standards in paragraph 
(1) in accordance with subsection (c). 
‘‘(3) TOBACCO PRODUCT STANDARDS.— 
‘‘(A) IN GENERAL.—The Secretary may adopt tobacco 
product standards in addition to those in paragraph (1) 
if the Secretary finds that a tobacco product standard is 
appropriate for the protection of the public health. 
‘‘(B) DETERMINATIONS.— 
‘‘(i) 
CONSIDERATIONS.—In 
making 
a 
finding 
described in subparagraph (A), the Secretary shall con-
sider scientific evidence concerning— 
‘‘(I) the risks and benefits to the population 
as a whole, including users and nonusers of tobacco 
products, of the proposed standard; 
‘‘(II) the increased or decreased likelihood that 
existing users of tobacco products will stop using 
such products; and 
‘‘(III) the increased or decreased likelihood 
that those who do not use tobacco products will 
start using such products. 
‘‘(ii) ADDITIONAL
CONSIDERATIONS.—In the event 
that the Secretary makes a determination, set forth 
in a proposed tobacco product 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 tobacco product because the 
Secretary has found that the additive, constituent, or 
other component is or may be 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 Sec-
retary’s consideration scientific evidence that dem-
onstrates that the proposed standard will not reduce 
or eliminate the risk of illness or injury. 
‘‘(4) CONTENT OF TOBACCO PRODUCT STANDARDS.—A tobacco 
product standard established under this section for a tobacco 
product— 
‘‘(A) shall include provisions that are appropriate for 
the protection of the public health, including provisions, 
where appropriate— 
‘‘(i) for nicotine yields of the product; 
‘‘(ii) for the reduction or elimination of other 
constituents, including smoke constituents, or harmful 
components of the product; or 
‘‘(iii) relating to any other requirement under 
subparagraph (B); 
‘‘(B) shall, where appropriate for the protection of the 
public health, include— 
‘‘(i) provisions respecting the construction, compo-
nents, ingredients, additives, constituents, including 
smoke constituents, and properties of the tobacco 
product; 
‘‘(ii) provisions for the testing (on a sample basis 
or, if necessary, on an individual basis) of the tobacco 
product; 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00344
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1801 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(iii) provisions for the measurement of the tobacco 
product characteristics of the tobacco product; 
‘‘(iv) provisions requiring that the results of each 
or of certain of the tests of the tobacco product required 
to be made under clause (ii) show that the tobacco 
product is in conformity with the portions of the 
standard for which the test or tests were required; 
and 
‘‘(v) a provision requiring that the sale and dis-
tribution of the tobacco product be restricted but only 
to the extent that the sale and distribution of a tobacco 
product may be restricted under a regulation under 
section 906(d); 
‘‘(C) shall, where appropriate, require the use and pre-
scribe the form and content of labeling for the proper 
use of the tobacco product; and 
‘‘(D) shall require tobacco products containing foreign- 
grown tobacco to meet the same standards applicable to 
tobacco products containing domestically grown tobacco. 
‘‘(5) PERIODIC REEVALUATION OF TOBACCO PRODUCT STAND-
ARDS.—The Secretary shall provide for periodic evaluation of 
tobacco product standards established under this section to 
determine whether such standards should be changed to reflect 
new medical, scientific, or other technological data. The Sec-
retary may provide for testing under paragraph (4)(B) by any 
person. 
‘‘(6) INVOLVEMENT
OF
OTHER
AGENCIES; INFORMED
PER-
SONS.—In carrying out duties under this section, the Secretary 
shall endeavor to— 
‘‘(A) use personnel, facilities, and other technical sup-
port 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 Sec-
retary’s judgment can make a significant contribution. 
‘‘(b) CONSIDERATIONS BY SECRETARY.— 
‘‘(1) TECHNICAL ACHIEVABILITY.—The Secretary shall con-
sider information submitted in connection with a proposed 
standard regarding the technical achievability of compliance 
with such standard. 
‘‘(2) OTHER CONSIDERATIONS.—The Secretary shall consider 
all other information submitted in connection with a proposed 
standard, including information concerning the countervailing 
effects of the tobacco product standard on the health of adoles-
cent tobacco users, adult tobacco users, or nontobacco users, 
such as the creation of a significant demand for contraband 
or other tobacco products that do not meet the requirements 
of this chapter and the significance of such demand. 
‘‘(c) PROPOSED STANDARDS.— 
‘‘(1) IN GENERAL.—The Secretary shall publish in the Fed-
eral Register a notice of proposed rulemaking for the establish-
ment, amendment, or revocation of any tobacco product 
standard. 
Federal Register, 
publication. 
Notice. 
Consultation. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00345
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1802 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(2) REQUIREMENTS OF NOTICE.—A notice of proposed rule-
making for the establishment or amendment of a tobacco 
product standard for a tobacco product shall— 
‘‘(A) set forth a finding with supporting justification 
that the tobacco product standard is appropriate for the 
protection of the public health; 
‘‘(B) invite interested persons to submit a draft or 
proposed tobacco product standard for consideration by the 
Secretary; 
‘‘(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 tobacco product 
standard. 
‘‘(3) FINDING.—A notice of proposed rulemaking for the 
revocation of a tobacco product standard shall set forth a finding 
with supporting justification that the tobacco product standard 
is no longer appropriate for the protection of the public health. 
‘‘(4) COMMENT.—The Secretary shall provide for a comment 
period of not less than 60 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 tobacco product standard and after 
consideration of comments submitted under subsections (b) and 
(c) and any report from the Tobacco Products Scientific Advisory 
Committee, the Secretary shall— 
‘‘(A) if the Secretary determines that the standard 
would be appropriate for the protection of the public health, 
promulgate a regulation establishing a tobacco product 
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 tobacco 
product 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 Secretary determines that an earlier effective date is nec-
essary 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 effec-
tive date or dates, the Secretary 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. If the Secretary 
determines, based on the Secretary’s evaluation of submitted 
comments, that a product standard can be met only by manufac-
turers requiring substantial changes to the methods of farming 
the domestically grown tobacco used by the manufacturer, the 
Publication. 
Notice. 
Regulations. 
Federal Register, 
publication. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00346
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1803 
PUBLIC LAW 111–31—JUNE 22, 2009 
effective date of that product standard shall be not less than 
2 years after the date of publication of the final regulation 
establishing the standard. 
‘‘(3) LIMITATION
ON
POWER
GRANTED
TO
THE
FOOD
AND 
DRUG ADMINISTRATION.—Because of the importance of a decision 
of the Secretary to issue a regulation— 
‘‘(A) banning all cigarettes, all smokeless tobacco prod-
ucts, all little cigars, all cigars other than little cigars, 
all pipe tobacco, or all roll-your-own tobacco products; or 
‘‘(B) requiring the reduction of nicotine yields of a 
tobacco product to zero, 
the Secretary is prohibited from taking such actions under 
this Act. 
‘‘(4) AMENDMENT; REVOCATION.— 
‘‘(A) AUTHORITY.—The Secretary, upon the Secretary’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 tobacco product standard. 
‘‘(B) EFFECTIVE DATE.—The Secretary may declare a 
proposed amendment of a tobacco product 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 Secretary determines that making 
it so effective is in the public interest. 
‘‘(5) REFERRAL TO ADVISORY COMMITTEE.— 
‘‘(A) IN GENERAL.—The Secretary may refer a proposed 
regulation for the establishment, amendment, or revocation 
of a tobacco product standard to the Tobacco Products 
Scientific Advisory Committee for a report and rec-
ommendation with respect to any matter involved in the 
proposed regulation which requires the exercise of scientific 
judgment. 
‘‘(B) INITIATION
OF
REFERRAL.—The Secretary may 
make a referral under this paragraph— 
‘‘(i) on the Secretary’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 regu-
lation. 
‘‘(C) PROVISION OF DATA.—If a proposed regulation is 
referred under this paragraph to the Tobacco Products 
Scientific Advisory Committee, the Secretary 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 60 
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 Secretary and other 
data and information before it, submit to the Secretary 
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. 
Statement. 
Deadline. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00347
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1804 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(E) PUBLIC AVAILABILITY.—The Secretary shall make 
a copy of each report and recommendation under subpara-
graph (D) publicly available. 
‘‘(e) MENTHOL CIGARETTES.— 
‘‘(1) REFERRAL; CONSIDERATIONS.—Immediately upon the 
establishment of the Tobacco Products Scientific Advisory Com-
mittee under section 917(a), the Secretary shall refer to the 
Committee for report and recommendation, under section 
917(c)(4), the issue of the impact of the use of menthol in 
cigarettes on the public health, including such use among chil-
dren, African-Americans, Hispanics, and other racial and ethnic 
minorities. In its review, the Tobacco Products Scientific 
Advisory Committee shall address the considerations listed in 
subsections (a)(3)(B)(i) and (b). 
‘‘(2) REPORT AND RECOMMENDATION.—Not later than 1 year 
after its establishment, the Tobacco Product Scientific Advisory 
Committee shall submit to the Secretary the report and rec-
ommendations required pursuant to paragraph (1). 
‘‘(3) RULE OF CONSTRUCTION.—Nothing in this subsection 
shall be construed to limit the Secretary’s authority to take 
action under this section or other sections of this Act applicable 
to menthol. 
‘‘(f) DISSOLVABLE TOBACCO PRODUCTS.— 
‘‘(1) REFERRAL; CONSIDERATIONS.—The Secretary shall refer 
to the Tobacco Products Scientific Advisory Committee for 
report and recommendation, under section 917(c)(4), the issue 
of the nature and impact of the use of dissolvable tobacco 
products on the public health, including such use among chil-
dren. In its review, the Tobacco Products Scientific Advisory 
Committee shall address the considerations listed in subsection 
(a)(3)(B)(i). 
‘‘(2) REPORT
AND
RECOMMENDATION.—Not later than 2 
years after its establishment, the Tobacco Product Scientific 
Advisory Committee shall submit to the Secretary the report 
and recommendations required pursuant to paragraph (1). 
‘‘(3) RULE OF CONSTRUCTION.—Nothing in this subsection 
shall be construed to limit the Secretary’s authority to take 
action under this section or other sections of this Act at any 
time applicable to any dissolvable tobacco product. 
‘‘SEC. 908. NOTIFICATION AND OTHER REMEDIES. 
‘‘(a) NOTIFICATION.—If the Secretary determines that— 
‘‘(1) a tobacco product which is introduced or delivered 
for introduction into interstate commerce for commercial dis-
tribution presents an unreasonable risk of substantial harm 
to the public health; and 
‘‘(2) notification under this subsection is necessary to elimi-
nate the unreasonable risk of such harm and no more prac-
ticable means is available under the provisions of this chapter 
(other than this section) to eliminate such risk, 
the Secretary 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 Secretary may order notification 
by any appropriate means, including public service announcements. 
21 USC 387h. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00348
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1805 
PUBLIC LAW 111–31—JUNE 22, 2009 
Before issuing an order under this subsection, the Secretary 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 Secretary finds that there is a 
reasonable probability that a tobacco product contains a manu-
facturing or other defect not ordinarily contained in tobacco 
products on the market that would cause serious, adverse 
health consequences or death, the Secretary shall issue an 
order requiring the appropriate person (including the manufac-
turers, 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 Secretary determines that inadequate grounds exist to sup-
port the actions required by the order, the Secretary 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 Secretary 
determines that the order should be amended to include 
a recall of the tobacco product with respect to which the 
order was issued, the Secretary shall, except as provided 
in subparagraph (B), amend the order to require a recall. 
The Secretary shall specify a timetable in which the tobacco 
product recall will occur and shall require periodic reports 
to the Secretary 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 Secretary 
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 Secretary 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 sub-
section (a). 
‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PRODUCTS. 
‘‘(a) IN GENERAL.—Every person who is a tobacco product manu-
facturer or importer of a tobacco product shall establish and main-
tain such records, make such reports, and provide such information, 
as the Secretary may by regulation reasonably require to assure 
Regulations. 
21 USC 387i. 
Notification. 
Timetable. 
Reports. 
Deadline. 
Order. 
Consultation. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00349
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1806 
PUBLIC LAW 111–31—JUNE 22, 2009 
that such tobacco product is not adulterated or misbranded and 
to otherwise protect public health. Regulations prescribed under 
the preceding sentence— 
‘‘(1) may require a tobacco product manufacturer or 
importer to report to the Secretary whenever the manufacturer 
or importer receives or otherwise becomes aware of information 
that reasonably suggests that one of its marketed tobacco prod-
ucts may have caused or contributed to a serious unexpected 
adverse experience associated with the use of the product or 
any significant increase in the frequency of a serious, expected 
adverse product experience; 
‘‘(2) shall require reporting of other significant adverse 
tobacco product experiences as determined by the Secretary 
to be necessary to be reported; 
‘‘(3) shall not impose requirements unduly burdensome to 
a tobacco product manufacturer or importer, taking into account 
the cost of complying with such requirements and the need 
for the protection of the public health and the implementation 
of this chapter; 
‘‘(4) when prescribing the procedure for making requests 
for reports or information, shall require that each request made 
under such regulations for submission of a report or information 
to the Secretary state the reason or purpose for such request 
and identify to the fullest extent practicable such report or 
information; 
‘‘(5) when requiring submission of a report or information 
to the Secretary, shall state the reason or purpose for the 
submission of such report or information and identify to the 
fullest extent practicable such report or information; and 
‘‘(6) may not require that the identity of any patient or 
user be disclosed in records, reports, or information required 
under this subsection unless required for the medical welfare 
of an individual, to determine risks to public health of a tobacco 
product, or to verify a record, report, or information submitted 
under this chapter. 
In prescribing regulations under this subsection, the Secretary shall 
have due regard for the professional ethics of the medical profession 
and the interests of patients. The prohibitions of paragraph (6) 
continue to apply to records, reports, and information concerning 
any individual who has been a patient, irrespective of whether 
or when he ceases to be a patient. 
‘‘(b) REPORTS OF REMOVALS AND CORRECTIONS.— 
‘‘(1) IN GENERAL.—Except as provided in paragraph (2), 
the Secretary shall by regulation require a tobacco product 
manufacturer or importer of a tobacco product to report 
promptly to the Secretary any corrective action taken or 
removal from the market of a tobacco product undertaken by 
such manufacturer or importer if the removal or correction 
was undertaken— 
‘‘(A) to reduce a risk to health posed by the tobacco 
product; or 
‘‘(B) to remedy a violation of this chapter caused by 
the tobacco product which may present a risk to health. 
A tobacco product manufacturer or importer of a tobacco 
product who undertakes a corrective action or removal from 
the market of a tobacco product which is not required to be 
Applicability. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00350
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1807 
PUBLIC LAW 111–31—JUNE 22, 2009 
reported under this subsection shall keep a record of such 
correction or removal. 
‘‘(2) EXCEPTION.—No report of the corrective action or 
removal of a tobacco product may be required under paragraph 
(1) if a report of the corrective action or removal is required 
and has been submitted under subsection (a). 
‘‘SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TOBACCO PROD-
UCTS. 
‘‘(a) IN GENERAL.— 
‘‘(1) NEW TOBACCO PRODUCT DEFINED.—For purposes of this 
section the term ‘new tobacco product’ means— 
‘‘(A) any tobacco product (including those products in 
test markets) that was not commercially marketed in the 
United States as of February 15, 2007; or 
‘‘(B) any modification (including a change in design, 
any component, any part, or any constituent, including 
a smoke constituent, or in the content, delivery or form 
of nicotine, or any other additive or ingredient) of a tobacco 
product where the modified product was commercially mar-
keted in the United States after February 15, 2007. 
‘‘(2) PREMARKET REVIEW REQUIRED.— 
‘‘(A) NEW
PRODUCTS.—An order under subsection 
(c)(1)(A)(i) for a new tobacco product is required unless— 
‘‘(i) the manufacturer has submitted a report under 
section 905(j); and the Secretary has issued an order 
that the tobacco product— 
‘‘(I) is substantially equivalent to a tobacco 
product commercially marketed (other than for test 
marketing) in the United States as of February 
15, 2007; and 
‘‘(II) is in compliance with the requirements 
of this Act; or 
‘‘(ii) the tobacco product is exempt from the 
requirements of section 905(j) pursuant to a regulation 
issued under section 905(j)(3). 
‘‘(B) APPLICATION TO CERTAIN POST-FEBRUARY 15, 2007, 
PRODUCTS.—Subparagraph (A) shall not apply to a tobacco 
product— 
‘‘(i) that was first introduced or delivered for 
introduction into interstate commerce for commercial 
distribution in the United States after February 15, 
2007, and prior to the date that is 21 months after 
the date of enactment of the Family Smoking Preven-
tion and Tobacco Control Act; and 
‘‘(ii) for which a report was submitted under section 
905(j) within such 21-month period, 
except that subparagraph (A) shall apply to the tobacco 
product if the Secretary issues an order that the tobacco 
product is not substantially equivalent. 
‘‘(3) SUBSTANTIALLY EQUIVALENT DEFINED.— 
‘‘(A) IN GENERAL.—In this section and section 905(j), 
the term ‘substantially equivalent’ or ‘substantial equiva-
lence’ means, with respect to the tobacco product being 
compared to the predicate tobacco product, that the Sec-
retary by order has found that the tobacco product— 
21 USC 387j. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00351
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1808 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(i) has the same characteristics as the predicate 
tobacco product; or 
‘‘(ii) has different characteristics and the informa-
tion submitted contains information, including clinical 
data if deemed necessary by the Secretary, that dem-
onstrates that it is not appropriate to regulate the 
product under this section because the product does 
not raise different questions of public health. 
‘‘(B) CHARACTERISTICS.—In subparagraph (A), the term 
‘characteristics’ means the materials, ingredients, design, 
composition, heating source, or other features of a tobacco 
product. 
‘‘(C) LIMITATION.—A tobacco product may not be found 
to be substantially equivalent to a predicate tobacco product 
that has been removed from the market at the initiative 
of the Secretary or that has been determined by a judicial 
order to be misbranded or adulterated. 
‘‘(4) HEALTH INFORMATION.— 
‘‘(A) SUMMARY.—As part of a submission under section 
905(j) respecting a tobacco product, the person required 
to file a premarket notification under such section shall 
provide an adequate summary of any health information 
related to the tobacco product or state that such informa-
tion will be made available upon request by any person. 
‘‘(B) REQUIRED
INFORMATION.—Any summary under 
subparagraph (A) respecting a tobacco product shall contain 
detailed information regarding data concerning adverse 
health effects and shall be made available to the public 
by the Secretary within 30 days of the issuance of a deter-
mination that such tobacco product is substantially equiva-
lent to another tobacco product. 
‘‘(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 tobacco product and whether such 
tobacco product presents less risk than other tobacco prod-
ucts; 
‘‘(B) a full statement of the components, ingredients, 
additives, and properties, and of the principle or principles 
of operation, of such tobacco product; 
‘‘(C) a full description of the methods used in, and 
the facilities and controls used for, the manufacture, proc-
essing, and, when relevant, packing and installation of, 
such tobacco product; 
‘‘(D) an identifying reference to any tobacco product 
standard under section 907 which would be applicable to 
any aspect of such tobacco product, and either adequate 
information to show that such aspect of such tobacco 
product fully meets such tobacco product standard or ade-
quate information to justify any deviation from such 
standard; 
‘‘(E) such samples of such tobacco product and of 
components thereof as the Secretary may reasonably 
require; 
Public 
information. 
Deadline. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00352
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1809 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(F) specimens of the labeling proposed to be used 
for such tobacco product; and 
‘‘(G) such other information relevant to the subject 
matter of the application as the Secretary may require. 
‘‘(2) REFERRAL TO TOBACCO PRODUCTS SCIENTIFIC ADVISORY 
COMMITTEE.—Upon receipt of an application meeting the 
requirements set forth in paragraph (1), the Secretary— 
‘‘(A) may, on the Secretary’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 Secretary may establish) of a report and 
recommendation respecting the application, together with all 
underlying data and the reasons or basis for the recommenda-
tion. 
‘‘(c) ACTION ON APPLICATION.— 
‘‘(1) DEADLINE.— 
‘‘(A) IN GENERAL.—As promptly as possible, but in no 
event later than 180 days after the receipt of an application 
under subsection (b), the Secretary, after considering the 
report and recommendation submitted under subsection 
(b)(2), shall— 
‘‘(i) issue an order that the new product may be 
introduced or delivered for introduction into interstate 
commerce if the Secretary finds that none of the 
grounds specified in paragraph (2) of this subsection 
applies; or 
‘‘(ii) issue an order that the new product may 
not be introduced or delivered for introduction into 
interstate commerce if the Secretary finds (and sets 
forth the basis for such finding as part of or accom-
panying such denial) that 1 or more grounds for denial 
specified in paragraph (2) of this subsection apply. 
‘‘(B) RESTRICTIONS
ON
SALE
AND
DISTRIBUTION.—An 
order under subparagraph (A)(i) may require that the sale 
and distribution of the tobacco product be restricted but 
only to the extent that the sale and distribution of a tobacco 
product may be restricted under a regulation under section 
906(d). 
‘‘(2) DENIAL
OF
APPLICATION.—The Secretary shall deny 
an application submitted under subsection (b) if, upon the 
basis of the information submitted to the Secretary as part 
of the application and any other information before the Sec-
retary with respect to such tobacco product, the Secretary finds 
that— 
‘‘(A) there is a lack of a showing that permitting such 
tobacco product 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 
tobacco product do not conform to the requirements of 
section 906(e); 
‘‘(C) based on a fair evaluation of all material facts, 
the proposed labeling is false or misleading in any par-
ticular; or 
‘‘(D) such tobacco product is not shown to conform 
in all respects to a tobacco product standard in effect under 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00353
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1810 
PUBLIC LAW 111–31—JUNE 22, 2009 
section 907, 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 Secretary 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 Secretary). 
‘‘(4) BASIS FOR FINDING.—For purposes of this section, the 
finding as to whether the marketing of a tobacco product 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 population as a whole, 
including users and nonusers of the tobacco product, and taking 
into account— 
‘‘(A) the increased or decreased likelihood that existing 
users of tobacco products will stop using such products; 
and 
‘‘(B) the increased or decreased likelihood that those 
who do not use tobacco products will start using such 
products. 
‘‘(5) BASIS FOR ACTION.— 
‘‘(A) INVESTIGATIONS.—For purposes of paragraph 
(2)(A), whether permitting a tobacco product to be marketed 
would be appropriate for the protection of the public health 
shall, when appropriate, be determined on the basis of 
well-controlled investigations, which may include 1 or more 
clinical investigations by experts qualified by training and 
experience to evaluate the tobacco product. 
‘‘(B) OTHER
EVIDENCE.—If the Secretary determines 
that there exists valid scientific evidence (other than evi-
dence derived from investigations described in subpara-
graph (A)) which is sufficient to evaluate the tobacco 
product, the Secretary may authorize that the determina-
tion for purposes of paragraph (2)(A) be made on the basis 
of such evidence. 
‘‘(d) WITHDRAWAL AND TEMPORARY SUSPENSION.— 
‘‘(1) IN
GENERAL.—The Secretary 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 tobacco 
product for which an order was issued under subsection 
(c)(1)(A)(i), issue an order withdrawing the order if the Sec-
retary finds— 
‘‘(A) that the continued marketing of such tobacco 
product 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 909; 
Notice. 
Hearings. 
Statement. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00354
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1811 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(ii) has refused to permit access to, or copying 
or verification of, such records as required by section 
704; or 
‘‘(iii) has not complied with the requirements of 
section 905; 
‘‘(D) on the basis of new information before the Sec-
retary with respect to such tobacco product, evaluated 
together with the evidence before the Secretary when the 
application was reviewed, that the methods used in, or 
the facilities and controls used for, the manufacture, proc-
essing, packing, or installation of such tobacco product 
do not conform with the requirements of section 906(e) 
and were not brought into conformity with such require-
ments within a reasonable time after receipt of written 
notice from the Secretary of nonconformity; 
‘‘(E) on the basis of new information before the Sec-
retary, evaluated together with the evidence before the 
Secretary when the application was reviewed, that the 
labeling of such tobacco product, 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 Secretary of such fact; or 
‘‘(F) on the basis of new information before the Sec-
retary, evaluated together with the evidence before the 
Secretary when such order was issued, that such tobacco 
product is not shown to conform in all respects to a tobacco 
product standard which is in effect under section 907, 
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)(i) 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 912. 
‘‘(3) TEMPORARY SUSPENSION.—If, after providing an oppor-
tunity for an informal hearing, the Secretary determines there 
is reasonable probability that the continuation of distribution 
of a tobacco product under an order would cause serious, 
adverse health consequences or death, that is greater than 
ordinarily caused by tobacco products on the market, the Sec-
retary shall by order temporarily suspend the authority of 
the manufacturer to market the product. If the Secretary issues 
such an order, the Secretary shall proceed expeditiously under 
paragraph (1) to withdraw such application. 
‘‘(e) SERVICE
OF ORDER.—An order issued by the Secretary 
under this section shall be served— 
‘‘(1) in person by any officer or employee of the department 
designated by the Secretary; 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 Secretary. 
‘‘(f) RECORDS.— 
‘‘(1) ADDITIONAL INFORMATION.—In the case of any tobacco 
product for which an order issued pursuant to subsection 
Reports. 
Order. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00355
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1812 
PUBLIC LAW 111–31—JUNE 22, 2009 
(c)(1)(A)(i) for an application filed under subsection (b) is in 
effect, the applicant shall establish and maintain such records, 
and make such reports to the Secretary, as the Secretary 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 Secretary 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 cus-
tody thereof, shall, upon request of an officer or employee 
designated by the Secretary, permit such officer or employee 
at all reasonable times to have access to and copy and verify 
such records. 
‘‘(g) INVESTIGATIONAL
TOBACCO
PRODUCT
EXEMPTION
FOR 
INVESTIGATIONAL USE.—The Secretary may exempt tobacco prod-
ucts intended for investigational use from the provisions of this 
chapter under such conditions as the Secretary may by regulation 
prescribe. 
‘‘SEC. 911. 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 commer-
cially marketed tobacco products’ means a tobacco 
product— 
‘‘(i) the label, labeling, or advertising of which rep-
resents 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’, or ‘low’ or similar 
descriptors; 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 Family Smoking Preven-
tion and Tobacco Control Act, respecting the product 
21 USC 387k. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00356
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1813 
PUBLIC LAW 111–31—JUNE 22, 2009 
that would be reasonably expected to result in con-
sumers 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 prod-
ucts, 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 consid-
ered 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’ 
solely because its label, labeling, or advertising uses the 
following phrases to describe such product and its use: 
‘smokeless tobacco’, ‘smokeless tobacco product’, ‘not con-
sumed by smoking’, ‘does not produce smoke’, ‘smokefree’, 
‘smoke-free’, ‘without smoke’, ‘no smoke’, or ‘not smoke’. 
‘‘(3) 
EFFECTIVE
DATE.—The 
provisions 
of 
paragraph 
(2)(A)(ii) shall take effect 12 months after the date of enactment 
of the Family Smoking Prevention and Tobacco Control Act 
for those products whose label, labeling, or advertising contains 
the terms described in such paragraph on such date of enact-
ment. The 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 conform-
ance with paragraph (2)(A)(ii). 
‘‘(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 Food and Drug Administration and is subject to the require-
ments of chapter V. 
‘‘(d) FILING.—Any person may file with the Secretary an applica-
tion 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 informa-
tion) 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 Secretary may require. 
‘‘(e) PUBLIC
AVAILABILITY.—The Secretary shall make the 
application described in subsection (d) publicly available (except 
Comment period. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00357
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1814 
PUBLIC LAW 111–31—JUNE 22, 2009 
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 applica-
tion and on the label, labeling, and advertising accompanying such 
application. 
‘‘(f) ADVISORY COMMITTEE.— 
‘‘(1) IN GENERAL.—The Secretary shall refer to the Tobacco 
Products Scientific Advisory Committee any application sub-
mitted 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 Com-
mittee shall report its recommendations on the application 
to the Secretary. 
‘‘(g) MARKETING.— 
‘‘(1) MODIFIED RISK PRODUCTS.—Except as provided in para-
graph (2), the Secretary 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 Sec-
retary 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) benefit the health of the population as a whole 
taking into account both users of tobacco products and 
persons who do not currently use tobacco products. 
‘‘(2) SPECIAL RULE FOR CERTAIN PRODUCTS.— 
‘‘(A) IN GENERAL.—The Secretary 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 adver-
tising 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 rep-
resentation 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 with-
out conducting long-term epidemiological studies dem-
onstrates that a measurable and substantial reduction 
in morbidity or mortality among individual tobacco 
users is reasonably likely in subsequent studies. 
Order. 
Deadline. 
Reports. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00358
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1815 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(B) ADDITIONAL
FINDINGS
REQUIRED.—To issue an 
order under subparagraph (A) the Secretary must also 
find that the applicant has demonstrated that— 
‘‘(i) the magnitude of the overall reductions in expo-
sure 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 meas-
urable 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 less 
harmful; or 
‘‘(II) presents or has been demonstrated to 
present less of a risk of disease than 1 or more 
other commercially marketed tobacco products; 
and 
‘‘(iv) issuance of an order with respect to the 
application is expected to benefit the health of the 
population as a whole taking into account both users 
of tobacco products and persons who do not currently 
use tobacco products. 
‘‘(C) CONDITIONS OF MARKETING.— 
‘‘(i) IN GENERAL.—Applications subject to an order 
under this paragraph shall be limited to a term of 
not more than 5 years, but may be renewed upon 
a finding by the Secretary that the requirements of 
this paragraph continue to be satisfied based on the 
filing of a new application. 
‘‘(ii) AGREEMENTS BY APPLICANT.—An order under 
this paragraph shall be conditioned on the applicant’s 
agreement to conduct postmarket surveillance and 
studies and to submit to the Secretary the results 
of such surveillance and studies to determine the 
impact of the order on consumer perception, behavior, 
and health and to enable the Secretary to review the 
accuracy of the determinations upon which the order 
was based in accordance with a protocol approved by 
the Secretary. 
‘‘(iii) ANNUAL
SUBMISSION.—The results of such 
postmarket surveillance and studies described in clause 
(ii) shall be submitted annually. 
‘‘(3) BASIS.—The determinations under paragraphs (1) and 
(2) shall be based on— 
‘‘(A) the scientific evidence submitted by the applicant; 
and 
Study. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00359
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1816 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(B) scientific evidence and other information that is 
made available to the Secretary. 
‘‘(4) BENEFIT TO HEALTH OF INDIVIDUALS AND OF POPU-
LATION
AS
A
WHOLE.—In making the determinations under 
paragraphs (1) and (2), the Secretary shall take into account— 
‘‘(A) the relative health risks to individuals of the 
tobacco product that is the subject of the application; 
‘‘(B) the increased or decreased likelihood that existing 
users of tobacco products who would otherwise stop using 
such products will switch to the tobacco product that is 
the subject of the application; 
‘‘(C) the increased or decreased likelihood that persons 
who do not use tobacco products will start using the tobacco 
product that is the subject of the application; 
‘‘(D) the risks and benefits to persons from the use 
of the tobacco product that is the subject of the application 
as compared to the use of products for smoking cessation 
approved under chapter V to treat nicotine dependence; 
and 
‘‘(E) comments, data, and information submitted by 
interested persons. 
‘‘(h) ADDITIONAL CONDITIONS FOR MARKETING.— 
‘‘(1) MODIFIED RISK PRODUCTS.—The Secretary 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 informa-
tion 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 Secretary may require for the 
marketing of a product under this subsection that a claim 
comparing a tobacco product to 1 or more other commer-
cially 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 Secretary 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. 
‘‘(3) LABEL DISCLOSURE.— 
‘‘(A) IN
GENERAL.—The Secretary may require the 
disclosure on the label of other substances in the tobacco 
product, or substances that may be produced by the 
consumption of that tobacco product, that may affect a 
disease or health-related condition or may increase the 
risk of other diseases or health-related conditions associ-
ated with the use of tobacco products. 
‘‘(B) CONDITIONS OF USE.—If the conditions of use of 
the tobacco product may affect the risk of the product 
to human health, the Secretary may require the labeling 
of conditions of use. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00360
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1817 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(4) TIME.—An order issued under subsection (g)(1) shall 
be effective for a specified period of time. 
‘‘(5) ADVERTISING.—The Secretary may require, with 
respect to a product for which an applicant obtained an order 
under subsection (g)(1), that the product comply with require-
ments relating to advertising and promotion of the tobacco 
product. 
‘‘(i) POSTMARKET SURVEILLANCE AND STUDIES.— 
‘‘(1) IN GENERAL.—The Secretary shall require, with respect 
to a product for which an applicant obtained an order under 
subsection (g)(1), that the applicant conduct postmarket surveil-
lance and studies for such a tobacco product to determine 
the impact of the order issuance on consumer perception, 
behavior, and health, to enable the Secretary to review the 
accuracy of the determinations upon which the order was based, 
and to provide information that the Secretary 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 Secretary 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 Secretary, a protocol for the required surveil-
lance. The Secretary, within 60 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 des-
ignated by the Secretary as necessary to protect the public 
health. 
‘‘(j) WITHDRAWAL OF AUTHORIZATION.—The Secretary, after an 
opportunity for an informal hearing, shall withdraw an order under 
subsection (g) if the Secretary determines that— 
‘‘(1) the applicant, based on new information, can no longer 
make the demonstrations required under subsection (g), or 
the Secretary 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 907; 
‘‘(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 applica-
tion; 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). 
Hearings. 
Deadlines. 
Notice. 
Deadline. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00361
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1818 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(k) CHAPTER IV OR V.—A product for which the Secretary 
has issued an order pursuant to subsection (g) shall not be subject 
to chapter IV or V. 
‘‘(l) IMPLEMENTING REGULATIONS OR GUIDANCE.— 
‘‘(1) SCIENTIFIC EVIDENCE.—Not later than 2 years after 
the date of enactment of the Family Smoking Prevention and 
Tobacco Control Act, the Secretary 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 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 appro-
priate; 
‘‘(C) establish minimum standards for postmarket 
studies, that shall include regular and long-term assess-
ments of health outcomes and mortality, intermediate clin-
ical 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; 
‘‘(E) require that data from the required studies and 
surveillance be made available to the Secretary prior to 
the decision on renewal of a modified risk tobacco product; 
and 
‘‘(F) establish a reasonable timetable for the Secretary 
to review an application under this section. 
‘‘(2) CONSULTATION.—The regulations or guidance issued 
under paragraph (1) shall be developed in consultation with 
the Institute of Medicine, and with the input of other appro-
priate scientific and medical experts, on the design and conduct 
of such studies and surveillance. 
‘‘(3) REVISION.—The regulations or guidance under para-
graph (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 Family Smoking Prevention and 
Tobacco Control Act, the Secretary 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 
910 and which the applicant seeks to commercially market 
under this section. 
‘‘(m) DISTRIBUTORS.—Except as provided in this section, no 
distributor may take any action, after the date of enactment of 
the Family Smoking Prevention and Tobacco Control Act, with 
respect to a tobacco product that would reasonably be expected 
to result in consumers believing that the tobacco product or its 
smoke may present a lower risk of disease or is less harmful 
Deadline. 
Deadline. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00362
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1819 
PUBLIC LAW 111–31—JUNE 22, 2009 
than one or more commercially marketed tobacco products, or pre-
sents a reduced exposure to, or does not contain or is free of, 
a substance or substances. 
‘‘SEC. 912. JUDICIAL REVIEW. 
‘‘(a) RIGHT TO REVIEW.— 
‘‘(1) IN GENERAL.—Not later than 30 days after— 
‘‘(A) the promulgation of a regulation under section 
907 establishing, amending, or revoking a tobacco product 
standard; or 
‘‘(B) a denial of an application under section 910(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 Secretary. 
‘‘(B) RECORD OF PROCEEDINGS.—On receipt of a petition 
under subparagraph (A), the Secretary 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 Secretary 
with respect to such regulation or order; 
‘‘(iii) proceedings of any panel or advisory com-
mittee with respect to such regulation or order; 
‘‘(iv) any hearing held with respect to such regula-
tion or order; and 
‘‘(v) any other information identified by the Sec-
retary, 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. 
Statement. 
Deadline. 
21 USC 387l. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00363
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1820 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(d) OTHER REMEDIES.—The remedies provided for in this sec-
tion 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 906, 907, 908, 909, 910, or 916 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. 913. EQUAL TREATMENT OF RETAIL OUTLETS. 
‘‘The Secretary shall issue regulations to require that retail 
establishments for which the predominant business is the sale 
of tobacco products comply with any advertising restrictions 
applicable to retail establishments accessible to individuals under 
the age of 18. 
‘‘SEC. 914. JURISDICTION OF AND COORDINATION WITH THE FEDERAL 
TRADE COMMISSION. 
‘‘(a) JURISDICTION.— 
‘‘(1) IN GENERAL.—Except where expressly provided in this 
chapter, nothing in this chapter 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. 
‘‘(2) ENFORCEMENT.—Any advertising that violates this 
chapter or a provision of the regulations referred to in section 
102 of the Family Smoking Prevention and Tobacco Control 
Act, is an unfair or deceptive act or practice under section 
5(a) of the Federal Trade Commission Act and shall be consid-
ered a violation of a rule promulgated under section 18 of 
that Act. 
‘‘(b) COORDINATION.—With respect to the requirements of sec-
tion 4 of the Federal Cigarette Labeling and Advertising Act and 
section 3 of the Comprehensive Smokeless Tobacco Health Edu-
cation Act of 1986— 
‘‘(1) the Chairman of the Federal Trade Commission shall 
coordinate with the Secretary concerning the enforcement of 
such Act as such enforcement relates to unfair or deceptive 
acts or practices in the advertising of cigarettes or smokeless 
tobacco; and 
‘‘(2) the Secretary shall consult with the Chairman of such 
Commission in revising the label statements and requirements 
under such sections. 
‘‘SEC. 915. REGULATION REQUIREMENT. 
‘‘(a) TESTING, REPORTING, AND DISCLOSURE.—Not later than 
36 months after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act, the Secretary 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 testing and reporting of tobacco product 
constituents, ingredients, and additives, including smoke 
constituents, by brand and subbrand that the Secretary deter-
mines should be tested to protect the public health, provided 
that, for purposes of the testing requirements of this paragraph, 
21 USC 387o. 
Consultation. 
21 USC 387n. 
Regulations. 
21 USC 387m. 
Statement. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00364
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1821 
PUBLIC LAW 111–31—JUNE 22, 2009 
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; and 
‘‘(2) may require that tobacco product manufacturers, pack-
agers, or importers make disclosures relating to the results 
of the testing of tar and nicotine through labels or advertising 
or other appropriate means, and make disclosures regarding 
the results of the testing of other constituents, including smoke 
constituents, ingredients, or additives, that the Secretary deter-
mines should be disclosed to the public to protect the public 
health and will not mislead consumers about the risk of tobacco- 
related disease. 
‘‘(c) AUTHORITY.—The Secretary shall have the authority under 
this chapter to conduct or to require the testing, reporting, or 
disclosure of tobacco product constituents, including smoke constitu-
ents. 
‘‘(d) SMALL TOBACCO PRODUCT MANUFACTURERS.— 
‘‘(1) FIRST
COMPLIANCE
DATE.—The initial regulations 
promulgated under subsection (a) shall not impose require-
ments on small tobacco product manufacturers before the later 
of— 
‘‘(A) the end of the 2-year period following the final 
promulgation of such regulations; and 
‘‘(B) the initial date set by the Secretary for compliance 
with such regulations by manufacturers that are not small 
tobacco product manufacturers. 
‘‘(2) TESTING AND REPORTING INITIAL COMPLIANCE PERIOD.— 
‘‘(A) 4-YEAR PERIOD.—The initial regulations promul-
gated under subsection (a) shall give each small tobacco 
product manufacturer a 4-year period over which to conduct 
testing and reporting for all of its tobacco products. Subject 
to paragraph (1), the end of the first year of such 4- 
year period shall coincide with the initial date of compliance 
under this section set by the Secretary with respect to 
manufacturers that are not small tobacco product manufac-
turers or the end of the 2-year period following the final 
promulgation of such regulations, as described in para-
graph (1)(A). A small tobacco product manufacturer shall 
be required— 
‘‘(i) to conduct such testing and reporting for 25 
percent of its tobacco products during each year of 
such 4-year period; and 
‘‘(ii) to conduct such testing and reporting for its 
largest-selling tobacco products (as determined by the 
Secretary) before its other tobacco products, or in such 
other order of priority as determined by the Secretary. 
‘‘(B) CASE-BY-CASE DELAY.—Notwithstanding subpara-
graph (A), the Secretary may, on a case-by-case basis, 
delay the date by which an individual small tobacco product 
manufacturer must conduct testing and reporting for its 
tobacco products under this section based upon a showing 
of undue hardship to such manufacturer. Notwithstanding 
the preceding sentence, the Secretary shall not extend the 
deadline for a small tobacco product manufacturer to con-
duct testing and reporting for all of its tobacco products 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00365
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1822 
PUBLIC LAW 111–31—JUNE 22, 2009 
beyond a total of 5 years after the initial date of compliance 
under this section set by the Secretary with respect to 
manufacturers that are not small tobacco product manufac-
turers. 
‘‘(3) 
SUBSEQUENT
AND
ADDITIONAL
TESTING
AND 
REPORTING.—The regulations promulgated under subsection (a) 
shall provide that, with respect to any subsequent or additional 
testing and reporting of tobacco products required under this 
section, such testing and reporting by a small tobacco product 
manufacturer shall be conducted in accordance with the time-
frames described in paragraph (2)(A), except that, in the case 
of a new product, or if there has been a modification described 
in section 910(a)(1)(B) of any product of a small tobacco product 
manufacturer since the last testing and reporting required 
under this section, the Secretary shall require that any subse-
quent or additional testing and reporting be conducted in 
accordance with the same timeframe applicable to manufactur-
ers that are not small tobacco product manufacturers. 
‘‘(4) JOINT LABORATORY TESTING SERVICES.—The Secretary 
shall allow any 2 or more small 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 sub-
section (a) shall provide that a small tobacco product manufac-
turer shall not be considered to be in violation of this section 
before the deadline applicable under paragraphs (3) and (4), 
if— 
‘‘(A) the tobacco products of such manufacturer are 
in compliance with all other requirements of this chapter; 
and 
‘‘(B) the conditions described in paragraph (2) are met. 
‘‘(2) CONDITIONS.—Notwithstanding the requirements of 
this section, the Secretary may delay the date by which a 
small 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 small tobacco product manufacturer provides evidence 
to the Secretary demonstrating that— 
‘‘(A) the manufacturer has submitted the required prod-
ucts for testing to a laboratory and has done so sufficiently 
in advance of the deadline to create a reasonable expecta-
tion 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 Secretary, taking into account the 
laboratory testing capacity that is available to tobacco product 
manufacturers, shall review and verify the evidence submitted 
by a small tobacco product manufacturer in accordance with 
paragraph (2). If the Secretary finds that the conditions 
described in such paragraph are met, the Secretary shall notify 
Notification. 
Deadline. 
Evidence. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00366
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1823 
PUBLIC LAW 111–31—JUNE 22, 2009 
the small 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 Secretary has not 
made a finding before the reporting deadline, the manufacturer 
shall not be considered to be in violation of such requirements 
until the Secretary finds that the conditions described in para-
graph (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 Secretary may pro-
vide further extensions of time, in increments of no more than 
1 year, for required testing and reporting to occur if the Sec-
retary determines, based on evidence properly and timely sub-
mitted by a small 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 or the Family Smoking Prevention and Tobacco Control Act 
other than this section. 
‘‘SEC. 916. PRESERVATION OF STATE AND LOCAL AUTHORITY. 
‘‘(a) IN GENERAL.— 
‘‘(1) PRESERVATION.—Except as provided in paragraph 
(2)(A), nothing in this chapter, or rules promulgated under 
this chapter, shall be construed to limit the authority of a 
Federal agency (including the Armed Forces), a State or polit-
ical 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, or more stringent than, requirements 
established under this chapter, including a law, rule, regulation, 
or other measure relating to or prohibiting the sale, distribu-
tion, possession, exposure to, access to, advertising and pro-
motion of, or use of tobacco products by individuals of any 
age, information reporting to the State, or measures relating 
to fire safety standards for tobacco products. No provision of 
this chapter shall limit or otherwise affect any State, tribal, 
or local taxation of tobacco products. 
‘‘(2) PREEMPTION OF CERTAIN STATE AND LOCAL REQUIRE-
MENTS.— 
‘‘(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 provi-
sions of this chapter relating to tobacco product standards, 
premarket review, adulteration, misbranding, labeling, reg-
istration, 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, exposure to, access to, 
the advertising and promotion of, or use of, tobacco products 
21 USC 387p. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00367
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1824 
PUBLIC LAW 111–31—JUNE 22, 2009 
by individuals of any age, or relating to fire safety stand-
ards for tobacco products. 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 chapter 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. 917. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE. 
‘‘(a) ESTABLISHMENT.—Not later than 6 months after the date 
of enactment of the Family Smoking Prevention and Tobacco Con-
trol Act, the Secretary shall establish a 12-member advisory com-
mittee, 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 Secretary shall appoint as mem-
bers of the Tobacco Products Scientific Advisory Committee 
individuals who are technically qualified by training and 
experience in medicine, medical ethics, science, or tech-
nology involving the manufacture, evaluation, or use of 
tobacco products, who are of appropriately diversified 
professional backgrounds. The committee shall be composed 
of— 
‘‘(i) 7 individuals who are physicians, dentists, sci-
entists, or health care professionals practicing in the 
area of oncology, pulmonology, cardiology, toxicology, 
pharmacology, addiction, or any other relevant spe-
cialty; 
‘‘(ii) 1 individual who is an officer or employee 
of a State or local government or of the Federal Govern-
ment; 
‘‘(iii) 1 individual as a representative of the general 
public; 
‘‘(iv) 1 individual as a representative of the 
interests of the tobacco manufacturing industry; 
‘‘(v) 1 individual as a 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 rel-
evant to the topics being considered by the Advisory 
Committee; and 
‘‘(vi) 1 individual as a representative of the 
interests of the tobacco growers. 
‘‘(B) NONVOTING MEMBERS.—The members of the com-
mittee appointed under clauses (iv), (v), and (vi) of subpara-
graph (A) shall serve as consultants to those described 
in clauses (i) through (iii) of subparagraph (A) and shall 
be nonvoting representatives. 
‘‘(C) CONFLICTS OF INTEREST.—No members of the com-
mittee, 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 
Deadline. 
21 USC 387q. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00368
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1825 
PUBLIC LAW 111–31—JUNE 22, 2009 
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. 
‘‘(2) LIMITATION.—The Secretary may not appoint to the 
Advisory Committee any individual who is in the regular full- 
time employ of the Food and Drug Administration or any agency 
responsible for the enforcement of this Act. The Secretary may 
appoint Federal officials as ex officio members. 
‘‘(3) CHAIRPERSON.—The Secretary 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 Com-
mittee shall provide advice, information, and recommendations to 
the Secretary— 
‘‘(1) as provided in this chapter; 
‘‘(2) on the effects of the alteration of the nicotine yields 
from tobacco products; 
‘‘(3) on whether there is a threshold level below which 
nicotine yields do not produce dependence on the tobacco 
product involved; and 
‘‘(4) on its review of other safety, dependence, or health 
issues relating to tobacco products as requested by the Sec-
retary. 
‘‘(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 com-
mittee or otherwise engaged in its business, shall be entitled 
to receive compensation at rates to be fixed by the Secretary, 
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 subsist-
ence, as authorized by section 5703 of title 5, United States 
Code, for persons in the Government service employed intermit-
tently. 
‘‘(2) ADMINISTRATIVE SUPPORT.—The Secretary 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 Com-
mittee. 
‘‘(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 sec-
tion 552(b) of title 5, United States Code. 
‘‘SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE. 
‘‘(a) IN GENERAL.—The Secretary shall— 
‘‘(1) at the request of the applicant, consider designating 
products for smoking cessation, including nicotine replacement 
products as fast track research and approval products within 
the meaning of section 506; 
21 USC 387r. 
Records. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00369
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1826 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(2) consider approving the extended use of nicotine replace-
ment products (such as nicotine patches, nicotine gum, and 
nicotine lozenges) for the treatment of tobacco dependence; 
and 
‘‘(3) review and consider the evidence for additional indica-
tions for nicotine replacement products, such as for craving 
relief or relapse prevention. 
‘‘(b) REPORT ON INNOVATIVE PRODUCTS.— 
‘‘(1) IN GENERAL.—Not later than 3 years after the date 
of enactment of the Family Smoking Prevention and Tobacco 
Control Act, the Secretary, 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 regulate, 
promote, and encourage the development of innovative 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. 
‘‘(2) RECOMMENDATIONS.—The report under paragraph (1) 
shall include the recommendations of the Secretary on how 
the Food and Drug Administration should coordinate and facili-
tate the exchange of information on such innovative products 
and treatments among relevant offices and centers within the 
Administration and within the National Institutes of Health, 
the Centers for Disease Control and Prevention, and other 
relevant agencies. 
‘‘SEC. 919. USER FEES. 
‘‘(a) ESTABLISHMENT OF QUARTERLY FEE.—Beginning on the 
date of enactment of the Family Smoking Prevention and Tobacco 
Control Act, the Secretary shall in accordance with this section 
assess user fees on, and collect such fees from, each manufacturer 
and importer of tobacco products subject to this chapter. The fees 
shall be assessed and collected with respect to each quarter of 
each fiscal year, and the total amount assessed and collected for 
a fiscal year shall be the amount specified in subsection (b)(1) 
for such year, subject to subsection (c). 
‘‘(b) ASSESSMENT OF USER FEE.— 
‘‘(1) AMOUNT OF ASSESSMENT.—The total amount of user 
fees authorized to be assessed and collected under subsection 
(a) for a fiscal year is the following, as applicable to the fiscal 
year involved: 
‘‘(A) For fiscal year 2009, $85,000,000 (subject to sub-
section (e)). 
‘‘(B) For fiscal year 2010, $235,000,000. 
‘‘(C) For fiscal year 2011, $450,000,000. 
‘‘(D) For fiscal year 2012, $477,000,000. 
‘‘(E) For fiscal year 2013, $505,000,000. 
‘‘(F) For fiscal year 2014, $534,000,000. 
‘‘(G) For fiscal year 2015, $566,000,000. 
‘‘(H) For fiscal year 2016, $599,000,000. 
Effective date. 
21 USC 387s. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00370
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1827 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(I) For fiscal year 2017, $635,000,000. 
‘‘(J) For fiscal year 2018, $672,000,000. 
‘‘(K) For fiscal year 2019 and each subsequent fiscal 
year, $712,000,000. 
‘‘(2) ALLOCATIONS OF ASSESSMENT BY CLASS OF TOBACCO 
PRODUCTS.— 
‘‘(A) IN GENERAL.—The total user fees assessed and 
collected under subsection (a) each fiscal year with respect 
to each class of tobacco products shall be an amount that 
is equal to the applicable percentage of each class for 
the fiscal year multiplied by the amount specified in para-
graph (1) for the fiscal year. 
‘‘(B) APPLICABLE PERCENTAGE.— 
‘‘(i) IN GENERAL.—For purposes of subparagraph 
(A), the applicable percentage for a fiscal year for each 
of the following classes of tobacco products shall be 
determined in accordance with clause (ii): 
‘‘(I) Cigarettes. 
‘‘(II) Cigars, including small cigars and cigars 
other than small cigars. 
‘‘(III) Snuff. 
‘‘(IV) Chewing tobacco. 
‘‘(V) Pipe tobacco. 
‘‘(VI) Roll-your-own tobacco. 
‘‘(ii) ALLOCATIONS.—The applicable percentage of 
each class of tobacco product described in clause (i) 
for a fiscal year shall be the percentage determined 
under section 625(c) of Public Law 108–357 for each 
such class of product for such fiscal year. 
‘‘(iii) REQUIREMENT
OF
REGULATIONS.—Notwith-
standing clause (ii), no user fees shall be assessed 
on a class of tobacco products unless such class of 
tobacco products is listed in section 901(b) or is deemed 
by the Secretary in a regulation under section 901(b) 
to be subject to this chapter. 
‘‘(iv) REALLOCATIONS.—In the case of a class of 
tobacco products that is not listed in section 901(b) 
or deemed by the Secretary in a regulation under sec-
tion 901(b) to be subject to this chapter, the amount 
of user fees that would otherwise be assessed to such 
class of tobacco products shall be reallocated to the 
classes of tobacco products that are subject to this 
chapter in the same manner and based on the same 
relative percentages otherwise determined under 
clause (ii). 
‘‘(3) DETERMINATION OF USER FEE BY COMPANY.— 
‘‘(A) IN GENERAL.—The total user fee to be paid by 
each manufacturer or importer of a particular class of 
tobacco products shall be determined for each quarter by 
multiplying— 
‘‘(i) such manufacturer’s or importer’s percentage 
share as determined under paragraph (4); by 
‘‘(ii) the portion of the user fee amount for the 
current quarter to be assessed on all manufacturers 
and importers of such class of tobacco products as 
determined under paragraph (2). 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00371
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1828 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(B) NO FEE IN EXCESS OF PERCENTAGE SHARE.—No 
manufacturer or importer of tobacco products shall be 
required to pay a user fee in excess of the percentage 
share of such manufacturer or importer. 
‘‘(4) ALLOCATION OF ASSESSMENT WITHIN EACH CLASS OF 
TOBACCO PRODUCT.—The percentage share of each manufac-
turer or importer of a particular class of tobacco products 
of the total user fee to be paid by all manufacturers or importers 
of that class of tobacco products shall be the percentage deter-
mined for purposes of allocations under subsections (e) through 
(h) of section 625 of Public Law 108–357. 
‘‘(5) ALLOCATION FOR CIGARS.—Notwithstanding paragraph 
(4), if a user fee assessment is imposed on cigars, the percentage 
share of each manufacturer or importer of cigars shall be based 
on the excise taxes paid by such manufacturer or importer 
during the prior fiscal year. 
‘‘(6) TIMING OF ASSESSMENT.—The Secretary shall notify 
each manufacturer and importer of tobacco products subject 
to this section of the amount of the quarterly assessment 
imposed on such manufacturer or importer under this sub-
section for each quarter of each fiscal year. Such notifications 
shall occur not later than 30 days prior to the end of the 
quarter for which such assessment is made, and payments 
of all assessments shall be made by the last day of the quarter 
involved. 
‘‘(7) MEMORANDUM OF UNDERSTANDING.— 
‘‘(A) IN
GENERAL.—The Secretary shall request the 
appropriate Federal agency to enter into a memorandum 
of understanding that provides for the regular and timely 
transfer from the head of such agency to the Secretary 
of the information described in paragraphs (2)(B)(ii) and 
(4) and all necessary information regarding all tobacco 
product manufacturers and importers required to pay user 
fees. The Secretary shall maintain all disclosure restric-
tions established by the head of such agency regarding 
the information provided under the memorandum of under-
standing. 
‘‘(B) ASSURANCES.—Beginning not later than fiscal year 
2015, and for each subsequent fiscal year, the Secretary 
shall ensure that the Food and Drug Administration is 
able to determine the applicable percentages described in 
paragraph (2) and the percentage shares described in para-
graph (4). The Secretary may carry out this subparagraph 
by entering into a contract with the head of the Federal 
agency referred to in subparagraph (A) to continue to pro-
vide the necessary information. 
‘‘(c) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN
GENERAL.—Fees authorized under subsection (a) 
shall be collected and available for obligation only to the extent 
and in the amount provided in advance in appropriations Acts, 
subject to paragraph (2)(D). Such fees are authorized to remain 
available until expended. Such sums as may be necessary may 
be transferred from the Food and Drug Administration salaries 
and expenses appropriation account without fiscal year limita-
tion to such appropriation account for salaries and expenses 
with such fiscal year limitation. 
‘‘(2) AVAILABILITY.— 
Effective dates. 
Disclosure. 
Deadlines. 
Notification. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00372
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1829 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(A) IN GENERAL.—Fees appropriated under paragraph 
(3) are available only for the purpose of paying the costs 
of the activities of the Food and Drug Administration 
related to the regulation of tobacco products under this 
chapter and the Family Smoking Prevention and Tobacco 
Control Act (referred to in this subsection as ‘tobacco regu-
lation activities’), except that such fees may be used for 
the reimbursement specified in subparagraph (C). 
‘‘(B) PROHIBITION AGAINST USE OF OTHER FUNDS.— 
‘‘(i) IN
GENERAL.—Except as provided in clause 
(ii), fees collected under subsection (a) are the only 
funds authorized to be made available for tobacco regu-
lation activities. 
‘‘(ii) STARTUP
COSTS.—Clause (i) does not apply 
until October 1, 2009. Until such date, any amounts 
available to the Food and Drug Administration 
(excluding user fees) shall be available and allocated 
as needed to pay the costs of tobacco regulation activi-
ties. 
‘‘(C) REIMBURSEMENT OF START-UP AMOUNTS.— 
‘‘(i) IN GENERAL.—Any amounts allocated for the 
start-up period pursuant to subparagraph (B)(ii) shall 
be reimbursed through any appropriated fees collected 
under subsection (a), in such manner as the Secretary 
determines appropriate to ensure that such allocation 
results in no net change in the total amount of funds 
otherwise available, for the period from October 1, 
2008, through September 30, 2010, for Food and Drug 
Administration programs and activities (other than 
tobacco regulation activities) for such period. 
‘‘(ii) TREATMENT
OF
REIMBURSED
AMOUNTS.— 
Amounts reimbursed under clause (i) shall be available 
for the programs and activities for which funds allo-
cated for the start-up period were available, prior to 
such allocation, until September 30, 2010, notwith-
standing any otherwise applicable limits on amounts 
for such programs or activities for a fiscal year. 
‘‘(D) FEE COLLECTED DURING START-UP PERIOD.—Not-
withstanding the first sentence of paragraph (1), fees under 
subsection (a) may be collected through September 30, 2009 
under subparagraph (B)(ii) and shall be available for obliga-
tion and remain available until expended. Such offsetting 
collections shall be credited to the salaries and expenses 
account of the Food and Drug Administration. 
‘‘(E) OBLIGATION OF START-UP COSTS IN ANTICIPATION 
OF
AVAILABLE
FEE
COLLECTIONS.—Notwithstanding any 
other provision of law, following the enactment of an appro-
priation for fees under this section for fiscal year 2010, 
or any portion thereof, obligations for costs of tobacco regu-
lation activities during the start-up period may be incurred 
in anticipation of the receipt of offsetting fee collections 
through procedures specified in section 1534 of title 31, 
United States Code. 
‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For fiscal year 
2009 and each subsequent fiscal year, there is authorized to 
be appropriated for fees under this section an amount equal 
to the amount specified in subsection (b)(1) for the fiscal year. 
Deadline. 
Deadline. 
Effective date. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00373
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1830 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(d) COLLECTION
OF UNPAID FEES.—In any case where the 
Secretary does not receive payment of a fee assessed under sub-
section (a) within 30 days after it is due, such fee shall be treated 
as a claim of the United States Government subject to subchapter 
II of chapter 37 of title 31, United States Code. 
‘‘(e) APPLICABILITY TO FISCAL YEAR 2009.—If the date of enact-
ment of the Family Smoking Prevention and Tobacco Control Act 
occurs during fiscal year 2009, the following applies, subject to 
subsection (c): 
‘‘(1) The Secretary shall determine the fees that would 
apply for a single quarter of such fiscal year according to 
the application of subsection (b) to the amount specified in 
paragraph (1)(A) of such subsection (referred to in this sub-
section as the ‘quarterly fee amounts’). 
‘‘(2) For the quarter in which such date of enactment occurs, 
the amount of fees assessed shall be a pro rata amount, deter-
mined according to the number of days remaining in the quarter 
(including such date of enactment) and according to the daily 
equivalent of the quarterly fee amounts. Fees assessed under 
the preceding sentence shall not be collected until the next 
quarter. 
‘‘(3) For the quarter following the quarter to which para-
graph (2) applies, the full quarterly fee amounts shall be 
assessed and collected, in addition to collection of the pro rata 
fees assessed under paragraph (2).’’. 
(c) CONFORMING AMENDMENT.—Section 9(1) of the Comprehen-
sive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 
4408(i)) is amended to read as follows: 
‘‘(1) The term ‘smokeless tobacco’ has the meaning given 
such term by section 900(18) of the Federal Food, Drug, and 
Cosmetic Act.’’. 
SEC. 102. FINAL RULE. 
(a) CIGARETTES AND SMOKELESS TOBACCO.— 
(1) IN GENERAL.—On the first day of publication of the 
Federal Register that is 180 days or more after the date of 
enactment of this Act, the Secretary of Health and Human 
Services shall publish in the Federal Register a final rule 
regarding cigarettes and smokeless tobacco, which— 
(A) is deemed to be issued under chapter 9 of the 
Federal Food, Drug, and Cosmetic Act, as added by section 
101 of this division; and 
(B) shall be deemed to be in compliance with all 
applicable provisions of chapter 5 of title 5, United States 
Code, and all other provisions of law relating to rulemaking 
procedures. 
(2) CONTENTS OF RULE.—Except as provided in this sub-
section, the final rule published under paragraph (1), shall 
be identical in its provisions to part 897 of the regulations 
promulgated by the Secretary of Health and Human Services 
in the August 28, 1996, issue of the Federal Register (61 
Fed. Reg. 44615–44618). Such rule shall— 
(A) provide for the designation of jurisdictional 
authority that is in accordance with this subsection in 
accordance with this division and the amendments made 
by this division; 
(B) strike Subpart C—Labels and section 897.32(c); 
Deadline. 
Federal Register, 
publication. 
21 USC 387a–1. 
Fees. 
Deadline. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00374
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1831 
PUBLIC LAW 111–31—JUNE 22, 2009 
(C) strike paragraphs (a), (b), and (i) of section 897.3 
and insert definitions of the terms ‘‘cigarette’’, ‘‘cigarette 
tobacco’’, and ‘‘smokeless tobacco’’ as defined in section 
900 of the Federal Food, Drug, and Cosmetic Act; 
(D) insert ‘‘or roll-your-own paper’’ in section 897.34(a) 
after ‘‘other than cigarettes or smokeless tobacco’’; 
(E) include such modifications to section 897.30(b), if 
any, that the Secretary determines are appropriate in light 
of governing First Amendment case law, including the deci-
sion of the Supreme Court of the United States in Lorillard 
Tobacco Co. v. Reilly (533 U.S. 525 (2001)); 
(F) become effective on the date that is 1 year after 
the date of enactment of this Act; and 
(G) amend paragraph (d) of section 897.16 to read 
as follows: 
‘‘(d)(1) Except as provided in subparagraph (2), no manufac-
turer, distributor, or retailer may distribute or cause to be distrib-
uted any free samples of cigarettes, smokeless tobacco, or other 
tobacco products (as such term is defined in section 201 of the 
Federal Food, Drug, and Cosmetic Act). 
‘‘(2)(A) Subparagraph (1) does not prohibit a manufacturer, 
distributor, or retailer from distributing or causing to be distributed 
free samples of smokeless tobacco in a qualified adult-only facility. 
‘‘(B) This subparagraph does not affect the authority of a State 
or local government to prohibit or otherwise restrict the distribution 
of free samples of smokeless tobacco. 
‘‘(C) For purposes of this paragraph, the term ‘qualified adult- 
only facility’ means a facility or restricted area that— 
‘‘(i) requires each person present to provide to a law enforce-
ment officer (whether on or off duty) or to a security guard 
licensed by a governmental entity government-issued identifica-
tion showing a photograph and at least the minimum age 
established by applicable law for the purchase of smokeless 
tobacco; 
‘‘(ii) does not sell, serve, or distribute alcohol; 
‘‘(iii) is not located adjacent to or immediately across from 
(in any direction) a space that is used primarily for youth- 
oriented marketing, promotional, or other activities; 
‘‘(iv) is a temporary structure constructed, designated, and 
operated as a distinct enclosed area for the purpose of distrib-
uting free samples of smokeless tobacco in accordance with 
this subparagraph; 
‘‘(v) is enclosed by a barrier that— 
‘‘(I) is constructed of, or covered with, an opaque mate-
rial (except for entrances and exits); 
‘‘(II) extends from no more than 12 inches above the 
ground or floor (which area at the bottom of the barrier 
must be covered with material that restricts visibility but 
may allow airflow) to at least 8 feet above the ground 
or floor (or to the ceiling); and 
‘‘(III) prevents persons outside the qualified adult-only 
facility from seeing into the qualified adult-only facility, 
unless they make unreasonable efforts to do so; and 
‘‘(vi) does not display on its exterior— 
‘‘(I) any tobacco product advertising; 
Effective date. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00375
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1832 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(II) a brand name other than in conjunction with 
words for an area or enclosure to identify an adult-only 
facility; or 
‘‘(III) any combination of words that would imply to 
a reasonable observer that the manufacturer, distributor, 
or retailer has a sponsorship that would violate section 
897.34(c). 
‘‘(D) Distribution of samples of smokeless tobacco under this 
subparagraph permitted to be taken out of the qualified adult- 
only facility shall be limited to 1 package per adult consumer 
containing no more than 0.53 ounces (15 grams) of smokeless 
tobacco. If such package of smokeless tobacco contains individual 
portions of smokeless tobacco, the individual portions of smokeless 
tobacco shall not exceed 8 individual portions and the collective 
weight of such individual portions shall not exceed 0.53 ounces 
(15 grams). Any manufacturer, distributor, or retailer who distrib-
utes or causes to be distributed free samples also shall take reason-
able steps to ensure that the above amounts are limited to one 
such package per adult consumer per day. 
‘‘(3) Notwithstanding subparagraph (2), no manufacturer, dis-
tributor, or retailer may distribute or cause to be distributed any 
free samples of smokeless tobacco— 
‘‘(A) to a sports team or entertainment group; or 
‘‘(B) at any football, basketball, baseball, soccer, or hockey 
event or any other sporting or entertainment event determined 
by the Secretary to be covered by this subparagraph. 
‘‘(4) The Secretary shall implement a program to ensure compli-
ance with this paragraph and submit a report to the Congress 
on such compliance not later than 18 months after the date of 
enactment of the Family Smoking Prevention and Tobacco Control 
Act. 
‘‘(5) Nothing in this paragraph shall be construed to authorize 
any person to distribute or cause to be distributed any sample 
of a tobacco product to any individual who has not attained the 
minimum age established by applicable law for the purchase of 
such product.’’. 
(3) AMENDMENTS TO RULE.—Prior to making amendments 
to the rule published under paragraph (1), the Secretary shall 
promulgate a proposed rule in accordance with chapter 5 of 
title 5, United States Code. 
(4) RULE OF CONSTRUCTION.—Except as provided in para-
graph (3), nothing in this section shall be construed to limit 
the authority of the Secretary to amend, in accordance with 
chapter 5 of title 5, United States Code, the regulation promul-
gated pursuant to this section, including the provisions of such 
regulation relating to distribution of free samples. 
(5) ENFORCEMENT OF RETAIL SALE PROVISIONS.—The Sec-
retary of Health and Human Services shall ensure that the 
provisions of this division, the amendments made by this divi-
sion, and the implementing regulations (including such provi-
sions, amendments, and regulations relating to the retail sale 
of tobacco products) are enforced with respect to the United 
States and Indian tribes. 
(6) QUALIFIED
ADULT-ONLY
FACILITY.—A qualified adult- 
only facility (as such term is defined in section 897.16(d) of 
the final rule published under paragraph (1)) that is also a 
retailer and that commits a violation as a retailer shall not 
Penalties. 
Reports. 
Deadline. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00376
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1833 
PUBLIC LAW 111–31—JUNE 22, 2009 
be subject to the limitations in section 103(q) and shall be 
subject to penalties applicable to a qualified adult-only facility. 
(7) CONGRESSIONAL
REVIEW
PROVISIONS.—Section 801 of 
title 5, United States Code, shall not apply to the final rule 
published under paragraph (1). 
(b) LIMITATION ON ADVISORY OPINIONS.—As of the date of enact-
ment of this Act, the following documents issued by the Food 
and Drug Administration shall not constitute advisory opinions 
under section 10.85(d)(1) of title 21, Code of Federal Regulations, 
except as they apply to tobacco products, and shall not be cited 
by the Secretary of Health and Human Services or the Food and 
Drug Administration as binding precedent: 
(1) The preamble to the proposed rule in the document 
titled ‘‘Regulations Restricting the Sale and Distribution of 
Cigarettes and Smokeless Tobacco Products to Protect Children 
and Adolescents’’ (60 Fed. Reg. 41314–41372 (August 11, 1995)). 
(2) The document titled ‘‘Nicotine in Cigarettes and Smoke-
less Tobacco Products is a Drug and These Products Are Nico-
tine Delivery Devices Under the Federal Food, Drug, and Cos-
metic Act’’ (60 Fed. Reg. 41453–41787 (August 11, 1995)). 
(3) The preamble to the final rule in the document titled 
‘‘Regulations Restricting the Sale and Distribution of Cigarettes 
and Smokeless Tobacco to Protect Children and Adolescents’’ 
(61 Fed. Reg. 44396–44615 (August 28, 1996)). 
(4) The document titled ‘‘Nicotine in Cigarettes and Smoke-
less Tobacco is a Drug and These Products are Nicotine Delivery 
Devices Under the Federal Food, Drug, and Cosmetic Act; Juris-
dictional Determination’’ (61 Fed. Reg. 44619–45318 (August 
28, 1996)). 
SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GENERAL 
PROVISIONS. 
(a) AMENDMENT
OF FEDERAL FOOD, DRUG, AND COSMETIC 
ACT.—Except as otherwise expressly provided, whenever in this 
section an amendment is expressed in terms of an amendment 
to, or repeal of, a section or other provision, the reference is to 
a section or other provision of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.). 
(b) SECTION 301.—Section 301 (21 U.S.C. 331) is amended— 
(1) in subsection (a), by inserting ‘‘tobacco product,’’ after 
‘‘device,’’; 
(2) in subsection (b), by inserting ‘‘tobacco product,’’ after 
‘‘device,’’; 
(3) in subsection (c), by inserting ‘‘tobacco product,’’ after 
‘‘device,’’; 
(4) in subsection (e)— 
(A) by striking the period after ‘‘572(i)’’; and 
(B) by striking ‘‘or 761 or the refusal to permit access 
to’’ and inserting ‘‘761, 909, or 920 or the refusal to permit 
access to’’; 
(5) in subsection (g), by inserting ‘‘tobacco product,’’ after 
‘‘device,’’; 
(6) in subsection (h), by inserting ‘‘tobacco product,’’ after 
‘‘device,’’; 
(7) in subsection (j)— 
(A) by striking the period after ‘‘573’’; and 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00377
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1834 
PUBLIC LAW 111–31—JUNE 22, 2009 
(B) by striking ‘‘708, or 721’’ and inserting ‘‘708, 721, 
904, 905, 906, 907, 908, 909, or 920(b)’’; 
(8) in subsection (k), by inserting ‘‘tobacco product,’’ after 
‘‘device,’’; 
(9) by striking subsection (p) and inserting the following: 
‘‘(p) The failure to register in accordance with section 510 
or 905, the failure to provide any information required by section 
510(j), 510(k), 905(i), or 905(j), or the failure to provide a notice 
required by section 510(j)(2) or 905(i)(3).’’; 
(10) by striking subsection (q)(1) and inserting the fol-
lowing: 
‘‘(q)(1) The failure or refusal— 
‘‘(A) to comply with any requirement prescribed under sec-
tion 518, 520(g), 903(b), 907, 908, or 915; 
‘‘(B) to furnish any notification or other material or informa-
tion required by or under section 519, 520(g), 904, 909, or 
920; or 
‘‘(C) to comply with a requirement under section 522 or 
913.’’; 
(11) in subsection (q)(2), by striking ‘‘device,’’ and inserting 
‘‘device or tobacco product,’’; 
(12) in subsection (r), by inserting ‘‘or tobacco product’’ 
after the term ‘‘device’’ each time that such term appears; 
and 
(13) by adding at the end the following: 
‘‘(oo) The sale of tobacco products in violation of a no-tobacco- 
sale order issued under section 303(f). 
‘‘(pp) The introduction or delivery for introduction into inter-
state commerce of a tobacco product in violation of section 911. 
‘‘(qq)(1) Forging, counterfeiting, simulating, or falsely rep-
resenting, or without proper authority using any mark, stamp 
(including tax stamp), tag, label, or other identification device upon 
any tobacco product or container or labeling thereof so as to render 
such tobacco product a counterfeit tobacco product. 
‘‘(2) Making, selling, disposing of, or keeping in possession, 
control, or custody, or concealing any punch, die, plate, stone, or 
other item that is designed to print, imprint, or reproduce the 
trademark, trade name, or other identifying mark, imprint, or device 
of another or any likeness of any of the foregoing upon any tobacco 
product or container or labeling thereof so as to render such tobacco 
product a counterfeit tobacco product. 
‘‘(3) The doing of any act that causes a tobacco product to 
be a counterfeit tobacco product, or the sale or dispensing, or 
the holding for sale or dispensing, of a counterfeit tobacco product. 
‘‘(rr) The charitable distribution of tobacco products. 
‘‘(ss) The failure of a manufacturer or distributor to notify 
the Attorney General and the Secretary of the Treasury of their 
knowledge of tobacco products used in illicit trade. 
‘‘(tt) Making any express or implied statement or representation 
directed to consumers with respect to a tobacco product, in a label 
or labeling or through the media or advertising, that either conveys, 
or misleads or would mislead consumers into believing, that— 
‘‘(1) the product is approved by the Food and Drug Adminis-
tration; 
‘‘(2) the Food and Drug Administration deems the product 
to be safe for use by consumers; 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00378
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1835 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(3) the product is endorsed by the Food and Drug Adminis-
tration for use by consumers; or 
‘‘(4) the product is safe or less harmful by virtue of— 
‘‘(A) its regulation or inspection by the Food and Drug 
Administration; or 
‘‘(B) its compliance with regulatory requirements set 
by the Food and Drug Administration; 
including any such statement or representation rendering the 
product misbranded under section 903.’’. 
(c) SECTION 303.—Section 303(f) (21 U.S.C. 333(f)) is amended— 
(1) in paragraph (5)— 
(A) by striking ‘‘paragraph (1), (2), (3), or (4)’’ each 
place such appears and inserting ‘‘paragraph (1), (2), (3), 
(4), or (9)’’; 
(B) in subparagraph (A)— 
(i) by striking ‘‘assessed’’ the first time it appears 
and inserting ‘‘assessed, or a no-tobacco-sale order may 
be imposed,’’; and 
(ii) by striking ‘‘penalty’’ the second time it appears 
and inserting ‘‘penalty, or upon whom a no-tobacco- 
sale order is to be imposed,’’; 
(C) in subparagraph (B)— 
(i) by inserting after ‘‘penalty,’’ the following: ‘‘or 
the period to be covered by a no-tobacco-sale order,’’; 
and 
(ii) by adding at the end the following: ‘‘A no- 
tobacco-sale order permanently prohibiting an indi-
vidual retail outlet from selling tobacco products shall 
include provisions that allow the outlet, after a speci-
fied period of time, to request that the Secretary com-
promise, modify, or terminate the order.’’; and 
(D) by adding at the end the following: 
‘‘(D) The Secretary may compromise, modify, or terminate, with 
or without conditions, any no-tobacco-sale order.’’; 
(2) in paragraph (6)— 
(A) by inserting ‘‘or the imposition of a no-tobacco- 
sale order’’ after the term ‘‘penalty’’ each place such term 
appears; and 
(B) by striking ‘‘issued.’’ and inserting ‘‘issued, or on 
which the no-tobacco-sale order was imposed, as the case 
may be.’’; and 
(3) by adding at the end the following: 
‘‘(8) If the Secretary finds that a person has committed repeated 
violations of restrictions promulgated under section 906(d) at a 
particular retail outlet then the Secretary may impose a no-tobacco- 
sale order on that person prohibiting the sale of tobacco products 
in that outlet. A no-tobacco-sale order may be imposed with a 
civil penalty under paragraph (1). Prior to the entry of a no- 
sale order under this paragraph, a person shall be entitled to 
a hearing pursuant to the procedures established through regula-
tions of the Food and Drug Administration for assessing civil money 
penalties, including at a retailer’s request a hearing by telephone, 
or at the nearest regional or field office of the Food and Drug 
Administration, or at a Federal, State, or county facility within 
100 miles from the location of the retail outlet, if such a facility 
is available. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00379
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1836 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(9) CIVIL MONETARY PENALTIES FOR VIOLATION OF TOBACCO 
PRODUCT REQUIREMENTS.— 
‘‘(A) IN GENERAL.—Subject to subparagraph (B), any person 
who violates a requirement of this Act which relates to tobacco 
products shall be liable to the United States for a civil penalty 
in an amount not to exceed $15,000 for each such violation, 
and not to exceed $1,000,000 for all such violations adjudicated 
in a single proceeding. 
‘‘(B) ENHANCED PENALTIES.— 
‘‘(i) Any person who intentionally violates a require-
ment of section 902(5), 902(6), 904, 908(c), or 911(a), shall 
be subject to a civil monetary penalty of— 
‘‘(I) not to exceed $250,000 per violation, and not 
to exceed $1,000,000 for all such violations adjudicated 
in a single proceeding; or 
‘‘(II) in the case of a violation that continues after 
the Secretary provides written notice to such person, 
$250,000 for the first 30-day period (or any portion 
thereof) that the person continues to be in violation, 
and such amount shall double for every 30-day period 
thereafter that the violation continues, not to exceed 
$1,000,000 for any 30-day period, and not to exceed 
$10,000,000 for all such violations adjudicated in a 
single proceeding. 
‘‘(ii) Any person who violates a requirement of section 
911(g)(2)(C)(ii) or 911(i)(1), shall be subject to a civil mone-
tary penalty of— 
‘‘(I) not to exceed $250,000 per violation, and not 
to exceed $1,000,000 for all such violations adjudicated 
in a single proceeding; or 
‘‘(II) in the case of a violation that continues after 
the Secretary provides written notice to such person, 
$250,000 for the first 30-day period (or any portion 
thereof) that the person continues to be in violation, 
and such amount shall double for every 30-day period 
thereafter that the violation continues, not to exceed 
$1,000,000 for any 30-day period, and not to exceed 
$10,000,000 for all such violations adjudicated in a 
single proceeding. 
‘‘(iii) In determining the amount of a civil penalty 
under clause (i)(II) or (ii)(II), the Secretary shall take into 
consideration whether the person is making efforts toward 
correcting the violation of the requirements of the section 
for which such person is subject to such civil penalty.’’. 
(d) SECTION 304.—Section 304 (21 U.S.C. 334) is amended— 
(1) in subsection (a)(2)— 
(A) by striking ‘‘and’’ before ‘‘(D)’’; and 
(B) by striking ‘‘device.’’ and inserting the following: 
‘‘device, and (E) Any adulterated or misbranded tobacco 
product.’’; 
(2) in subsection (d)(1), by inserting ‘‘tobacco product,’’ after 
‘‘device,’’; 
(3) in subsection (g)(1), by inserting ‘‘or tobacco product’’ 
after the term ‘‘device’’ each place such term appears; and 
(4) in subsection (g)(2)(A), by inserting ‘‘or tobacco product’’ 
after ‘‘device’’. 
Notice. 
Notice. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00380
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1837 
PUBLIC LAW 111–31—JUNE 22, 2009 
(e) SECTION 505.—Section 505(n)(2) (21 U.S.C. 355(n)(2)) is 
amended by striking ‘‘section 904’’ and inserting ‘‘section 1004’’. 
(f) SECTION 523.—Section 523(b)(2)(D) (21 U.S.C. 360m(b)(2)(D)) 
is amended by striking ‘‘section 903(g)’’ and inserting ‘‘section 
1003(g)’’. 
(g) SECTION
702.—Section 702(a)(1) (U.S.C. 372(a)(1)) is 
amended— 
(1) by striking ‘‘(a)(1)’’ and inserting ‘‘(a)(1)(A)’’; and 
(2) by adding at the end the following: 
‘‘(B)(i) For a tobacco product, to the extent feasible, the Sec-
retary shall contract with the States in accordance with this para-
graph to carry out inspections of retailers within that State in 
connection with the enforcement of this Act. 
‘‘(ii) The Secretary shall not enter into any contract under 
clause (i) with the government of any of the several States to 
exercise enforcement authority under this Act on Indian country 
without the express written consent of the Indian tribe involved.’’. 
(h) SECTION 703.—Section 703 (21 U.S.C. 373) is amended— 
(1) by inserting ‘‘tobacco product,’’ after the term ‘‘device,’’ 
each place such term appears; and 
(2) by inserting ‘‘tobacco products,’’ after the term ‘‘devices,’’ 
each place such term appears. 
(i) SECTION 704.—Section 704 (21 U.S.C. 374) is amended— 
(1) in subsection (a)(1)— 
(A) by striking ‘‘devices, or cosmetics’’ each place it 
appears and inserting ‘‘devices, tobacco products, or cos-
metics’’; 
(B) by striking ‘‘or restricted devices’’ each place it 
appears and inserting ‘‘restricted devices, or tobacco prod-
ucts’’; and 
(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’’; 
(2) in subsection (b), by inserting ‘‘tobacco product,’’ after 
‘‘device,’’; and 
(3) in subsection (g)(13), by striking ‘‘section 903(g)’’ and 
inserting ‘‘section 1003(g)’’. 
(j) SECTION 705.—Section 705(b) (21 U.S.C. 375(b)) is amended 
by inserting ‘‘tobacco products,’’ after ‘‘devices,’’. 
(k) SECTION 709.—Section 709 (21 U.S.C. 379a) is amended 
by inserting ‘‘tobacco product,’’ after ‘‘device,’’. 
(l) SECTION 801.—Section 801 (21 U.S.C. 381) is amended— 
(1) in subsection (a)— 
(A) by inserting ‘‘tobacco products,’’ after the term 
‘‘devices,’’; 
(B) by inserting ‘‘or section 905(h)’’ after ‘‘section 510’’; 
and 
(C) by striking the term ‘‘drugs or devices’’ each time 
such term appears and inserting ‘‘drugs, devices, or tobacco 
products’’; 
(2) in subsection (e)(1)— 
(A) by inserting ‘‘tobacco product’’ after ‘‘drug, device,’’; 
and 
Contracts. 
Inter- 
governmental 
relations. 
21 USC 372. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00381
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1838 
PUBLIC LAW 111–31—JUNE 22, 2009 
(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—’’; and 
(3) by adding at the end the following: 
‘‘(p)(1) Not later than 36 months after the date of enactment 
of the Family Smoking Prevention and Tobacco Control Act, and 
annually thereafter, the Secretary shall submit to the Committee 
on Health, Education, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of Representa-
tives, a report regarding— 
‘‘(A) the nature, extent, and destination of United States 
tobacco product exports that do not conform to tobacco product 
standards established pursuant to this Act; 
‘‘(B) the public health implications of such exports, 
including any evidence of a negative public health impact; 
and 
‘‘(C) recommendations or assessments of policy alternatives 
available to Congress and the executive branch to reduce any 
negative public health impact caused by such exports. 
‘‘(2) The Secretary is authorized to establish appropriate 
information disclosure requirements to carry out this subsection.’’. 
(m) SECTION 1003.—Section 1003(d)(2)(C) (as redesignated by 
section 101(b)) is amended— 
(1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and 
(2) inserting ‘‘, and tobacco products’’ after ‘‘devices’’. 
(n) SECTION 1009.—Section 1009(b) (as redesignated by section 
101(b)) is amended by striking ‘‘section 908’’ and inserting ‘‘section 
1008’’. 
(o) SECTION 409 OF THE FEDERAL MEAT INSPECTION ACT.— 
Section 409(a) of the Federal Meat Inspection Act (21 U.S.C. 679(a)) 
is amended by striking ‘‘section 902(b)’’ and inserting ‘‘section 
1002(b)’’. 
(p) RULE
OF
CONSTRUCTION.—Nothing in this section is 
intended or shall be construed to expand, contract, or otherwise 
modify or amend the existing limitations on State government 
authority over tribal restricted fee or trust lands. 
(q) GUIDANCE AND EFFECTIVE DATES.— 
(1) IN
GENERAL.—The Secretary of Health and Human 
Services shall issue guidance— 
(A) defining the term ‘‘repeated violation’’, as used 
in section 303(f)(8) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 333(f)(8)) as amended by subsection (c), 
as including at least 5 violations of particular requirements 
over a 36-month period at a particular retail outlet that 
constitute a repeated violation and providing for civil pen-
alties in accordance with paragraph (2); 
(B) providing for timely and effective notice by certified 
or registered mail or personal delivery to the retailer of 
each alleged violation at a particular retail outlet prior 
to conducting a followup compliance check, such notice 
to be sent to the location specified on the retailer’s registra-
tion or to the retailer’s registered agent if the retailer 
has provider such agent information to the Food and Drug 
Administration prior to the violation; 
(C) providing for a hearing pursuant to the procedures 
established through regulations of the Food and Drug 
Administration 
for 
assessing 
civil 
money 
penalties, 
21 USC 333 note. 
21 USC 331 note. 
21 USC 399. 
21 USC 393. 
Requirements. 
Deadline. 
Reports. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00382
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1839 
PUBLIC LAW 111–31—JUNE 22, 2009 
including at a retailer’s request a hearing by telephone 
or at the nearest regional or field office of the Food and 
Drug Administration, and providing for an expedited proce-
dure for the administrative appeal of an alleged violation; 
(D) providing that a person may not be charged with 
a violation at a particular retail outlet unless the Secretary 
has provided notice to the retailer of all previous violations 
at that outlet; 
(E) establishing that civil money penalties for multiple 
violations shall increase from one violation to the next 
violation pursuant to paragraph (2) within the time periods 
provided for in such paragraph; 
(F) providing that good faith reliance on the presen-
tation of a false government-issued photographic identifica-
tion that contains a date of birth does not constitute a 
violation of any minimum age requirement for the sale 
of tobacco products if the retailer has taken effective steps 
to prevent such violations, including— 
(i) adopting and enforcing a written policy against 
sales to minors; 
(ii) informing its employees of all applicable laws; 
(iii) 
establishing 
disciplinary 
sanctions 
for 
employee noncompliance; and 
(iv) requiring its employees to verify age by way 
of photographic identification or electronic scanning 
device; and 
(G) providing for the Secretary, in determining whether 
to impose a no-tobacco-sale order and in determining 
whether to compromise, modify, or terminate such an order, 
to consider whether the retailer has taken effective steps 
to prevent violations of the minimum age requirements 
for the sale of tobacco products, including the steps listed 
in subparagraph (F). 
(2) PENALTIES FOR VIOLATIONS.— 
(A) IN GENERAL.—The amount of the civil penalty to 
be applied for violations of restrictions promulgated under 
section 906(d), as described in paragraph (1), shall be as 
follows: 
(i) With respect to a retailer with an approved 
training program, the amount of the civil penalty shall 
not exceed— 
(I) in the case of the first violation, $0.00 
together with the issuance of a warning letter 
to the retailer; 
(II) in the case of a second violation within 
a 12-month period, $250; 
(III) in the case of a third violation within 
a 24-month period, $500; 
(IV) in the case of a fourth violation within 
a 24-month period, $2,000; 
(V) in the case of a fifth violation within a 
36-month period, $5,000; and 
(VI) in the case of a sixth or subsequent viola-
tion within a 48-month period, $10,000 as deter-
mined by the Secretary on a case-by-case basis. 
21 USC 333 note. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00383
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1840 
PUBLIC LAW 111–31—JUNE 22, 2009 
(ii) With respect to a retailer that does not have 
an approved training program, the amount of the civil 
penalty shall not exceed— 
(I) in the case of the first violation, $250; 
(II) in the case of a second violation within 
a 12-month period, $500; 
(III) in the case of a third violation within 
a 24-month period, $1,000; 
(IV) in the case of a fourth violation within 
a 24-month period, $2,000; 
(V) in the case of a fifth violation within a 
36-month period, $5,000; and 
(VI) in the case of a sixth or subsequent viola-
tion within a 48-month period, $10,000 as deter-
mined by the Secretary on a case-by-case basis. 
(B) TRAINING PROGRAM.—For purposes of subparagraph 
(A), the term ‘‘approved training program’’ means a training 
program that complies with standards developed by the 
Food and Drug Administration for such programs. 
(C) CONSIDERATION
OF
STATE
PENALTIES.—The Sec-
retary shall coordinate with the States in enforcing the 
provisions of this Act and, for purposes of mitigating a 
civil penalty to be applied for a violation by a retailer 
of any restriction promulgated under section 906(d), shall 
consider the amount of any penalties paid by the retailer 
to a State for the same violation. 
(3) GENERAL EFFECTIVE DATE.—The amendments made by 
paragraphs (2), (3), and (4) of subsection (c) shall take effect 
upon the issuance of guidance described in paragraph (1) of 
this subsection. 
(4) SPECIAL EFFECTIVE DATE.—The amendment made by 
subsection (c)(1) shall take effect on the date of enactment 
of this Act. 
(5) PACKAGE
LABEL
REQUIREMENTS.—The package label 
requirements of paragraphs (3) and (4) of section 903(a) of 
the Federal Food, Drug, and Cosmetic Act (as amended by 
this division) shall take effect on the date that is 12 months 
after the date of enactment of this Act. The package label 
requirements of paragraph (2) of such section 903(a) for ciga-
rettes shall take effect on the date that is 15 months after 
the issuance of the regulations required by section 4(d) of 
the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 
1333), as amended by section 201 of this division. The package 
label requirements of paragraph (2) of such section 903(a) for 
tobacco products other than cigarettes shall take effect on the 
date that is 12 months after the date of enactment of this 
Act. The 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 conform-
ance with section 903(a) (2), (3), and (4) and section 920(a) 
of the Federal Food, Drug, and Cosmetic Act. 
(6) ADVERTISING REQUIREMENTS.—The advertising require-
ments of section 903(a)(8) of the Federal Food, Drug, and Cos-
metic Act (as amended by this division) shall take effect on 
21 USC 387c 
note. 
21 USC 333 note. 
21 USC 333 note. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00384
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1841 
PUBLIC LAW 111–31—JUNE 22, 2009 
the date that is 12 months after the date of enactment of 
this Act. 
SEC. 104. STUDY ON RAISING THE MINIMUM AGE TO PURCHASE 
TOBACCO PRODUCTS. 
The Secretary of Health and Human Services shall— 
(1) convene an expert panel to conduct a study on the 
public health implications of raising the minimum age to pur-
chase tobacco products; and 
(2) not later than 5 years after the date of enactment 
of this Act, submit a report to the Congress on the results 
of such study. 
SEC. 105. ENFORCEMENT ACTION PLAN FOR ADVERTISING AND PRO-
MOTION RESTRICTIONS. 
(a) ACTION PLAN.— 
(1) DEVELOPMENT.—Not later than 6 months after the date 
of enactment of this Act, the Secretary of Health and Human 
Services (in this section referred to as the ‘‘Secretary’’) shall 
develop and publish an action plan to enforce restrictions 
adopted pursuant to section 906 of the Federal Food, Drug, 
and Cosmetic Act, as added by section 101(b) of this division, 
or pursuant to section 102(a) of this division, on promotion 
and advertising of menthol and other cigarettes to youth. 
(2) CONSULTATION.—The action plan required by paragraph 
(1) shall be developed in consultation with public health 
organizations and other stakeholders with demonstrated exper-
tise and experience in serving minority communities. 
(3) PRIORITY.—The action plan required by paragraph (1) 
shall include provisions designed to ensure enforcement of the 
restrictions described in paragraph (1) in minority communities. 
(b) STATE AND LOCAL ACTIVITIES.— 
(1) INFORMATION ON AUTHORITY.—Not later than 3 months 
after the date of enactment of this Act, the Secretary shall 
inform State, local, and tribal governments of the authority 
provided to such entities under section 5(c) of the Federal 
Cigarette Labeling and Advertising Act, as added by section 
203 of this division, or preserved by such entities under section 
916 of the Federal Food, Drug, and Cosmetic Act, as added 
by section 101(b) of this division. 
(2) COMMUNITY
ASSISTANCE.—At the request of commu-
nities seeking assistance to prevent underage tobacco use, the 
Secretary shall provide such assistance, including assistance 
with strategies to address the prevention of underage tobacco 
use in communities with a disproportionate use of menthol 
cigarettes by minors. 
SEC. 106. STUDIES OF PROGRESS AND EFFECTIVENESS. 
(a) FDA REPORT.—Not later than 3 years after the date of 
enactment of this Act, and not less than every 2 years thereafter, 
the Secretary of Health and Human Services shall submit to the 
Committee on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives, a report concerning— 
(1) the progress of the Food and Drug Administration in 
implementing this division, including major accomplishments, 
objective measurements of progress, and the identification of 
any areas that have not been fully implemented; 
21 USC 387u. 
Deadline. 
Deadline. 
Publication. 
21 USC 387f–1. 
Deadline. 
Reports. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00385
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1842 
PUBLIC LAW 111–31—JUNE 22, 2009 
(2) impediments identified by the Food and Drug Adminis-
tration to progress in implementing this division and to meeting 
statutory timeframes; 
(3) data on the number of new product applications received 
under section 910 of the Federal Food, Drug, and Cosmetic 
Act and modified risk product applications received under sec-
tion 911 of such Act, and the number of applications acted 
on under each category; and 
(4) data on the number of full time equivalents engaged 
in implementing this division. 
(b) GAO REPORT.—Not later than 5 years after the date of 
enactment of this Act, the Comptroller General of the United States 
shall conduct a study of, and submit to the Committees described 
in subsection (a) a report concerning— 
(1) the adequacy of the authority and resources provided 
to the Secretary of Health and Human Services for this division 
to carry out its goals and purposes; and 
(2) any recommendations for strengthening that authority 
to more effectively protect the public health with respect to 
the manufacture, marketing, and distribution of tobacco prod-
ucts. 
(c) PUBLIC AVAILABILITY.—The Secretary of Health and Human 
Services and the Comptroller General of the United States, respec-
tively, shall make the reports required under subsection (a) and 
(b) available to the public, including by posting such reports on 
the respective Internet websites of the Food and Drug Administra-
tion and the Government Accountability Office. 
TITLE II—TOBACCO PRODUCT WARN-
INGS; 
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 dis-
ease. 
‘‘WARNING: Smoking during pregnancy can harm your 
baby. 
‘‘WARNING: Smoking can kill you. 
‘‘WARNING: Tobacco smoke causes fatal lung disease 
in nonsmokers. 
Web posting. 
Study. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00386
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1843 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘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 upper portion 
of the front and rear panels of the package, directly on the 
package underneath the cellophane or other clear wrapping. 
Each label statement shall comprise the top 50 percent of 
the front and rear panels of the package. The word ‘WARNING’ 
shall appear in capital letters and all text shall be in con-
spicuous 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 provi-
sions of this subsection do not apply to a tobacco product 
manufacturer or distributor of cigarettes which does not manu-
facture, 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 tobacco product manufacturer, importer, or dis-
tributor; 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 ciga-
rettes 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 con-
stituent (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 top of each advertisement within the trim area. The 
Secretary may revise the required type sizes in such area 
in such manner as the Secretary determines appropriate. 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’ 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00387
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1844 
PUBLIC LAW 111–31—JUNE 22, 2009 
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 advertise-
ment; 39-point type for a half-page broadsheet newspaper 
advertisement; 39-point type for a whole-page tabloid news-
paper advertisement; 27-point type for a half-page tabloid news-
paper 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 tobacco products, 
each label statement required by subsection (a) may be printed 
on the inside cover of the matchbook. 
‘‘(4) ADJUSTMENT
BY
SECRETARY.—The Secretary may, 
through a rulemaking under section 553 of title 5, United 
States Code, adjust the format and type sizes for the label 
statements required by this section; the text, format, and type 
sizes of any required tar, nicotine yield, or other constituent 
(including smoke constituent) disclosures; or the text, format, 
and type sizes for any other disclosures required under the 
Federal Food, Drug, and Cosmetic Act. The text of any such 
label statements or disclosures shall be required to appear 
only within the 20 percent area of cigarette advertisements 
provided by paragraph (2). The Secretary shall promulgate 
regulations which provide for adjustments in the format and 
type sizes of any text required to appear in such area to 
ensure that the total text required to appear by law will fit 
within such area. 
‘‘(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 tobacco product manu-
facturer, importer, distributor, or retailer and approved by the 
Secretary. 
‘‘(2) ROTATION.—The label statements specified in sub-
section (a)(1) shall be rotated quarterly in alternating sequence 
in advertisements for each brand of cigarettes in accordance 
with a plan submitted by the tobacco product manufacturer, 
importer, distributor, or retailer to, and approved by, the Sec-
retary. 
‘‘(3) REVIEW.—The Secretary shall review each plan sub-
mitted under paragraph (2) and approve it if the plan— 
Deadline. 
Time period. 
Regulations. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00388
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1845 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(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 tobacco product manufac-
turer, importer, distributor, or retailer at the same time. 
‘‘(4) APPLICABILITY TO RETAILERS.—This subsection and sub-
section (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). 
‘‘(d) GRAPHIC LABEL STATEMENTS.—Not later than 24 months 
after the date of enactment of the Family Smoking Prevention 
and Tobacco Control Act, the Secretary shall issue regulations that 
require color graphics depicting the negative health consequences 
of smoking to accompany the label statements specified in sub-
section (a)(1). The Secretary may adjust the type size, text and 
format of the label statements specified in subsections (a)(2) and 
(b)(2) as the Secretary determines appropriate so that both the 
graphics and the accompanying label statements are clear, con-
spicuous, legible and appear within the specified area.’’. 
(b) EFFECTIVE DATE.—The amendment made by subsection (a) 
shall take effect 15 months after the issuance of the regulations 
required by subsection (a). 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. AUTHORITY TO REVISE CIGARETTE WARNING LABEL STATE-
MENTS. 
(a) PREEMPTION.—Section 5(a) of the Federal Cigarette Labeling 
and Advertising Act (15 U.S.C. 1334(a)) is amended by striking 
‘‘No’’ and inserting ‘‘Except to the extent the Secretary requires 
additional or different statements on any cigarette package by 
a regulation, by an order, by a standard, by an authorization 
to market a product, or by a condition of marketing a product, 
pursuant to the Family Smoking Prevention and Tobacco Control 
Act (and the amendments made by that Act), or as required under 
section 903(a)(2) or section 920(a) of the Federal Food, Drug, and 
Cosmetic Act, no’’. 
(b) CHANGE IN REQUIRED STATEMENTS.—Section 4 of the Fed-
eral Cigarette Labeling and Advertising Act (15 U.S.C. 1333), as 
amended by section 201, is further amended by adding at the 
end the following: 
‘‘(d) CHANGE
IN
REQUIRED
STATEMENTS.—The Secretary 
through a rulemaking conducted under section 553 of title 5, United 
States Code, may adjust the format, type size, color graphics, and 
text of any of the label requirements, or establish the format, 
type size, and text of any other disclosures required under the 
Federal Food, Drug, and Cosmetic Act, if the Secretary finds that 
15 USC 1333 
note. 
Deadline. 
Regulations. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00389
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1846 
PUBLIC LAW 111–31—JUNE 22, 2009 
such a change would promote greater public understanding of the 
risks associated with the use of tobacco products.’’. 
SEC. 203. STATE REGULATION OF CIGARETTE ADVERTISING AND PRO-
MOTION. 
Section 5 of the Federal Cigarette Labeling and Advertising 
Act (15 U.S.C. 1334) is amended by adding at the end the following: 
‘‘(c) EXCEPTION.—Notwithstanding subsection (b), a State or 
locality may enact statutes and promulgate regulations, based on 
smoking and health, that take effect after the effective date of 
the Family Smoking Prevention and Tobacco Control Act, imposing 
specific bans or restrictions on the time, place, and manner, but 
not content, of the advertising or promotion of any cigarettes.’’. 
SEC. 
204. 
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 is not a safe alternative 
to cigarettes. 
‘‘WARNING: Smokeless tobacco is addictive. 
‘‘(2) Each label statement required by paragraph (1) shall 
be— 
‘‘(A) located on the 2 principal display panels of the 
package, and each label statement shall comprise at least 
30 percent of each such display panel; and 
‘‘(B) in 17-point conspicuous and legible type and in 
black text on a white background, or white text on a 
black background, in a manner that contrasts by typog-
raphy, layout, or color, with all other printed material 
on the package, in an alternating fashion under the plan 
submitted under subsection (b)(3), except that if the text 
of a label statement would occupy more than 70 percent 
of the area specified by subparagraph (A), such text may 
appear in a smaller type size, so long as at least 60 percent 
of such warning area is occupied by the label statement. 
‘‘(3) The label statements required by paragraph (1) shall 
be introduced by each tobacco product manufacturer, packager, 
importer, distributor, or retailer of smokeless tobacco products 
concurrently into the distribution chain of such products. 
‘‘(4) The provisions of this subsection do not apply to a 
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. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00390
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1847 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(5) 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 tobacco product manufacturer, importer, or dis-
tributor; 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 tobacco product manufac-
turer, 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 stand-
ards set forth in this paragraph. 
‘‘(B) For press and poster advertisements, each such state-
ment and (where applicable) any required statement relating 
to tar, 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 leg-
ible 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 centi-
meter 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 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00391
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1848 
PUBLIC LAW 111–31—JUNE 22, 2009 
a plan submitted by the 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 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 tobacco product manufac-
turer, 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. 
‘‘(4) The Secretary may, through a rulemaking under sec-
tion 553 of title 5, United States Code, adjust the format 
and type sizes for the label statements required by this section; 
the text, format, and type sizes of any required tar, nicotine 
yield, or other constituent disclosures; or the text, format, and 
type sizes for any other disclosures required under the Federal 
Food, Drug, and Cosmetic Act. The text of any such label 
statements or disclosures shall be required to appear only 
within the 20 percent area of advertisements provided by para-
graph (2). The Secretary shall promulgate regulations which 
provide for adjustments in the format and type sizes of any 
text required to appear in such area to ensure that the total 
text required to appear by law will fit within such area. 
‘‘(c) TELEVISION AND RADIO ADVERTISING.—It is unlawful to 
advertise smokeless tobacco on any medium of electronic commu-
nications subject to the jurisdiction of the Federal Communications 
Commission.’’. 
(b) EFFECTIVE DATE.—The amendment made by subsection (a) 
shall take effect 12 months after the date of enactment of this 
Act. Such effective date shall be with respect to the date of manufac-
ture, 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). 
SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT 
WARNING LABEL STATEMENTS. 
(a) IN GENERAL.—Section 3 of the Comprehensive Smokeless 
Tobacco Health Education Act of 1986 (15 U.S.C. 4402), as amended 
by section 204, is further amended by adding at the end the fol-
lowing: 
‘‘(d) AUTHORITY TO REVISE WARNING LABEL STATEMENTS.— 
The Secretary may, by a rulemaking conducted under section 553 
15 USC 4402 
note. 
Regulations. 
Applicability. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00392
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1849 
PUBLIC LAW 111–31—JUNE 22, 2009 
of title 5, United States Code, adjust the format, type size, and 
text of any of the label requirements, require color graphics to 
accompany the text, increase the required label area from 30 percent 
up to 50 percent of the front and rear panels of the package, 
or establish the format, type size, and text of any other disclosures 
required under the Federal Food, Drug, and Cosmetic Act, if the 
Secretary finds that such a change would promote greater public 
understanding of the risks associated with the use of smokeless 
tobacco products.’’. 
(b) PREEMPTION.—Section 7(a) of the Comprehensive Smokeless 
Tobacco Health Education Act of 1986 (15 U.S.C. 4406(a)) is 
amended by striking ‘‘No’’ and inserting ‘‘Except as provided in 
the Family Smoking Prevention and Tobacco Control Act (and the 
amendments made by that Act), no’’. 
SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT DISCLO-
SURE TO THE PUBLIC. 
Section 4 of the Federal Cigarette Labeling and Advertising 
Act (15 U.S.C. 1333), as amended by sections 201 and 202, is 
further amended by adding at the end the following: 
‘‘(e) TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT DISCLO-
SURE.— 
‘‘(1) IN GENERAL.—The Secretary shall, by a rulemaking 
conducted under section 553 of title 5, United States Code, 
determine (in the Secretary’s sole discretion) whether cigarette 
and other tobacco product manufacturers shall be required 
to include in the area of each cigarette advertisement specified 
by subsection (b) of this section, or on the package label, or 
both, the tar and nicotine yields of the advertised or packaged 
brand. Any such disclosure shall be in accordance with the 
methodology established under such regulations, shall conform 
to the type size requirements of subsection (b) of this section, 
and shall appear within the area specified in subsection (b) 
of this section. 
‘‘(2) 
RESOLUTION
OF
DIFFERENCES.—Any 
differences 
between the requirements established by the Secretary under 
paragraph (1) and tar and nicotine yield reporting requirements 
established by the Federal Trade Commission shall be resolved 
by a memorandum of understanding between the Secretary 
and the Federal Trade Commission. 
‘‘(3) CIGARETTE AND OTHER TOBACCO PRODUCT CONSTITU-
ENTS.—In addition to the disclosures required by paragraph 
(1), the Secretary may, under a rulemaking conducted under 
section 553 of title 5, United States Code, prescribe disclosure 
requirements regarding the level of any cigarette or other 
tobacco product constituent including any smoke constituent. 
Any such disclosure may be required if the Secretary deter-
mines that disclosure would be of benefit to the public health, 
or otherwise would increase consumer awareness of the health 
consequences of the use of tobacco products, except that no 
such prescribed disclosure shall be required on the face of 
any cigarette package or advertisement. Nothing in this section 
shall prohibit the Secretary from requiring such prescribed 
disclosure through a cigarette or other tobacco product package 
or advertisement insert, or by any other means under the 
Federal Food, Drug, and Cosmetic Act. 
Memorandum. 
Regulations. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00393
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1850 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(4) RETAILERS.—This subsection applies to a retailer only 
if that retailer is responsible for or directs the label statements 
required under this section.’’. 
TITLE III—PREVENTION OF ILLICIT 
TRADE IN TOBACCO PRODUCTS 
SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPECTION. 
Chapter IX of the Federal Food, Drug, and Cosmetic Act, as 
added by section 101, is further amended by adding at the end 
the following: 
‘‘SEC. 920. LABELING, RECORDKEEPING, RECORDS INSPECTION. 
‘‘(a) ORIGIN LABELING.— 
‘‘(1) REQUIREMENT.—Beginning 1 year after the date of 
enactment of the Family Smoking Prevention and Tobacco Con-
trol Act, the label, packaging, and shipping containers of tobacco 
products other than cigarettes for introduction or delivery for 
introduction into interstate commerce in the United States 
shall bear the statement ‘sale only allowed in the United 
States’. Beginning 15 months after the issuance of the regula-
tions required by section 4(d) of the Federal Cigarette Labeling 
and Advertising Act (15 U.S.C. 1333), as amended by section 
201 of Family Smoking Prevention and Tobacco Control Act, 
the label, packaging, and shipping containers of cigarettes for 
introduction or delivery for introduction into interstate com-
merce in the United States shall bear the statement ‘Sale 
only allowed in the United States’. 
‘‘(2) EFFECTIVE DATE.—The effective date specified in para-
graph (1) shall be with respect to the date of manufacture, 
provided that, in any case, beginning 30 days after such effec-
tive 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 such 
paragraph. 
‘‘(b) REGULATIONS CONCERNING RECORDKEEPING FOR TRACKING 
AND TRACING.— 
‘‘(1) IN GENERAL.—The Secretary shall promulgate regula-
tions regarding the establishment and maintenance of records 
by any person who manufactures, processes, transports, distrib-
utes, receives, packages, holds, exports, or imports tobacco prod-
ucts. 
‘‘(2) 
INSPECTION.—In 
promulgating 
the 
regulations 
described in paragraph (1), the Secretary shall consider which 
records are needed for inspection to monitor the movement 
of tobacco products from the point of manufacture through 
distribution to retail outlets to assist in investigating potential 
illicit trade, smuggling, or counterfeiting of tobacco products. 
‘‘(3) CODES.—The Secretary may require codes on the labels 
of tobacco products or other designs or devices for the purpose 
of tracking or tracing the tobacco product through the distribu-
tion system. 
‘‘(4) SIZE
OF
BUSINESS.—The Secretary shall take into 
account the size of a business in promulgating regulations 
under this section. 
Effective dates. 
21 USC 387t. 
Applicability. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00394
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1851 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(5) RECORDKEEPING BY RETAILERS.—The Secretary shall 
not require any retailer to maintain records relating to indi-
vidual purchasers of tobacco products for personal consumption. 
‘‘(c) RECORDS INSPECTION.—If the Secretary has a reasonable 
belief that a tobacco product is part of an illicit trade or smuggling 
or is a counterfeit product, each person who manufactures, proc-
esses, transports, distributes, receives, holds, packages, exports, 
or imports tobacco products shall, at the request of an officer 
or employee duly designated by the Secretary, permit such officer 
or employee, at reasonable times and within reasonable limits and 
in a reasonable manner, upon the presentation of appropriate 
credentials and a written notice to such person, to have access 
to and copy all records (including financial records) relating to 
such article that are needed to assist the Secretary in investigating 
potential illicit trade, smuggling, or counterfeiting of tobacco prod-
ucts. The Secretary shall not authorize an officer or employee 
of the government of any of the several States to exercise authority 
under the preceding sentence on Indian country without the express 
written consent of the Indian tribe involved. 
‘‘(d) KNOWLEDGE OF ILLEGAL TRANSACTION.— 
‘‘(1) NOTIFICATION.—If the manufacturer or distributor of 
a tobacco product has knowledge which reasonably supports 
the conclusion that a tobacco product manufactured or distrib-
uted by such manufacturer or distributor that has left the 
control of such person may be or has been— 
‘‘(A) imported, exported, distributed, or offered for sale 
in interstate commerce by a person without paying duties 
or taxes required by law; or 
‘‘(B) imported, exported, distributed, or diverted for 
possible illicit marketing, 
the manufacturer or distributor shall promptly notify the 
Attorney General and the Secretary of the Treasury of such 
knowledge. 
‘‘(2) KNOWLEDGE DEFINED.—For purposes of this subsection, 
the term ‘knowledge’ as applied to a manufacturer or distributor 
means— 
‘‘(A) the actual knowledge that the manufacturer or 
distributor had; or 
‘‘(B) the knowledge which a reasonable person would 
have had under like circumstances or which would have 
been obtained upon the exercise of due care. 
‘‘(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.’’. 
SEC. 302. STUDY AND REPORT. 
(a) STUDY.—The Comptroller General of the United States shall 
conduct a study of cross-border trade in tobacco products to— 
(1) collect data on cross-border trade in tobacco products, 
including illicit trade and trade of counterfeit tobacco products 
and make recommendations on the monitoring of such trade; 
(2) collect data on cross-border advertising (any advertising 
intended to be broadcast, transmitted, or distributed from the 
United States to another country) of tobacco products and make 
recommendations on how to prevent or eliminate, and what 
technologies could help facilitate the elimination of, cross-border 
advertising; and 
Notice. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00395
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1852 
PUBLIC LAW 111–31—JUNE 22, 2009 
(3) collect data on the health effects (particularly with 
respect to individuals under 18 years of age) resulting from 
cross-border trade in tobacco products, including the health 
effects resulting from— 
(A) the illicit trade of tobacco products and the trade 
of counterfeit tobacco products; and 
(B) the differing tax rates applicable to tobacco prod-
ucts. 
(b) REPORT.—Not later than 18 months after the date of enact-
ment of this Act, the Comptroller General of the United States 
shall submit to the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on Energy and Com-
merce of the House of Representatives a report on the study 
described in subsection (a). 
(c) DEFINITION.—In this section: 
(1) The term ‘‘cross-border trade’’ means trade across a 
border of the United States, a State or Territory, or Indian 
country. 
(2) The term ‘‘Indian country’’ has the meaning given to 
such term in section 1151 of title 18, United States Code. 
(3) The terms ‘‘State’’ and ‘‘Territory’’ have the meanings 
given to those terms in section 201 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321). 
DIVISION B—FEDERAL RETIREMENT 
REFORM ACT 
SEC. 100. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This division may be cited as the ‘‘Federal 
Retirement Reform Act of 2009’’. 
(b) TABLE OF CONTENTS.—The table of contents for this division 
is as follows: 
DIVISION B—FEDERAL RETIREMENT REFORM ACT 
Sec. 100. Short title; table of contents. 
TITLE I—PROVISIONS RELATING TO FEDERAL EMPLOYEES RETIREMENT 
Sec. 101. Short title. 
Sec. 102. Automatic enrollments and immediate employing agency contributions. 
Sec. 103. Qualified Roth contribution program. 
Sec. 104. Authority to establish mutual fund window. 
Sec. 105. Reporting requirements. 
Sec. 106. Acknowledgment of risk. 
Sec. 107. Subpoena authority. 
Sec. 108. Amounts in Thrift Savings Funds subject to legal proceedings. 
Sec. 109. Accounts for surviving spouses. 
Sec. 110. Treatment of members of the uniformed services under the Thrift Savings 
Plan. 
TITLE II—SPECIAL SURVIVOR INDEMNITY ALLOWANCE FOR SURVIVING 
SPOUSES OF ARMED FORCES MEMBERS 
Sec. 201. Increase in monthly amount of special survivor indemnity allowance for 
widows and widowers of deceased members of the Armed Forces affected 
by required Survivor Benefit Plan annuity offset for dependency and in-
demnity compensation. 
5 USC 101 note. 
Federal 
Retirement 
Reform Act 
of 2009. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00396
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1853 
PUBLIC LAW 111–31—JUNE 22, 2009 
TITLE I—PROVISIONS RELATING TO 
FEDERAL EMPLOYEES RETIREMENT 
SEC. 101. SHORT TITLE. 
This title may be cited as the ‘‘Thrift Savings Plan Enhance-
ment Act of 2009’’. 
SEC. 102. AUTOMATIC ENROLLMENTS AND IMMEDIATE EMPLOYING 
AGENCY CONTRIBUTIONS. 
(a) IN GENERAL.—Section 8432(b) of title 5, United States Code, 
is amended by striking paragraphs (2) through (4) and inserting 
the following: 
‘‘(2)(A) The Executive Director shall by regulation provide for 
an eligible individual to be automatically enrolled to make contribu-
tions under subsection (a) at the default percentage of basic pay. 
‘‘(B) For purposes of this paragraph, the default percentage 
shall be equal to 3 percent or such other percentage, not less 
than 2 percent nor more than 5 percent, as the Board may prescribe. 
‘‘(C) The regulations shall include provisions under which any 
individual who would otherwise be automatically enrolled in accord-
ance with subparagraph (A) may— 
‘‘(i) modify the percentage or amount to be contributed 
pursuant to automatic enrollment, effective not later than the 
first full pay period following receipt of the election by the 
appropriate processing entity; or 
‘‘(ii) decline automatic enrollment altogether. 
‘‘(D)(i) Except as provided in clause (ii), for purposes of this 
paragraph, the term ‘eligible individual’ means any individual who, 
after any regulations under subparagraph (A) first take effect, 
is appointed, transferred, or reappointed to a position in which 
that individual becomes eligible to contribute to the Thrift Savings 
Fund. 
‘‘(ii) Members of the uniformed services shall not be eligible 
individuals for purposes of this paragraph. 
‘‘(E) Sections 8351(a)(1), 8440a(a)(1), 8440b(a)(1), 8440c(a)(1), 
8440d(a)(1), and 8440e(a)(1) shall be applied in a manner consistent 
with the purposes of this paragraph.’’. 
(b) TECHNICAL AMENDMENT.—Section 8432(b)(1) of title 5, 
United States Code, is amended by striking the parenthetical matter 
in subparagraph (B). 
SEC. 103. QUALIFIED ROTH CONTRIBUTION PROGRAM. 
(a) IN GENERAL.—Subchapter III of chapter 84 of title 5, United 
States Code, is amended by inserting after section 8432c the fol-
lowing: 
‘‘§ 8432d. Qualified Roth contribution program 
‘‘(a) DEFINITIONS.—For purposes of this section— 
‘‘(1) the term ‘qualified Roth contribution program’ means 
a program described in paragraph (1) of section 402A(b) of 
the Internal Revenue Code of 1986 which meets the require-
ments of paragraph (2) of such section; and 
‘‘(2) the terms ‘designated Roth contribution’ and ‘elective 
deferral’ have the meanings given such terms in section 402A 
of the Internal Revenue Code of 1986. 
Applicability. 
Regulations. 
5 USC 101 note. 
Thrift 
Savings Plan 
Enhancement 
Act of 2009. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00397
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1854 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(b) AUTHORITY TO ESTABLISH.—The Executive Director shall 
by regulation provide for the inclusion in the Thrift Savings Plan 
of a qualified Roth contribution program, under such terms and 
conditions as the Board may prescribe. 
‘‘(c) REQUIRED PROVISIONS.—The regulations under subsection 
(b) shall include— 
‘‘(1) provisions under which an election to make designated 
Roth contributions may be made— 
‘‘(A) by any individual who is eligible to make contribu-
tions under section 8351, 8432(a), 8440a, 8440b, 8440c, 
8440d, or 8440e; and 
‘‘(B) by any individual, not described in subparagraph 
(A), who is otherwise eligible to make elective deferrals 
under the Thrift Savings Plan; 
‘‘(2) any provisions which may, as a result of enactment 
of this section, be necessary in order to clarify the meaning 
of any reference to an ‘account’ made in section 8432(f), 8433, 
8434(d), 8435, 8437, or any other provision of law; and 
‘‘(3) any other provisions which may be necessary to carry 
out this section.’’. 
(b) CLERICAL AMENDMENT.—The analysis for chapter 84 of title 
5, United States Code, is amended by inserting after the item 
relating to section 8432c the following: 
‘‘8432d. Qualified Roth contribution program.’’. 
SEC. 104. AUTHORITY TO ESTABLISH MUTUAL FUND WINDOW. 
(a) IN GENERAL.—Section 8438(b)(1) of title 5, United States 
Code, is amended— 
(1) in subparagraph (D), by striking ‘‘and’’ at the end; 
(2) in subparagraph (E), by striking the period and 
inserting ‘‘; and’’; and 
(3) by adding after subparagraph (E) the following: 
‘‘(F) a service that enables participants to invest in 
mutual funds, if the Board authorizes the mutual fund 
window under paragraph (5).’’. 
(b) REQUIREMENTS.—Section 8438(b) of title 5, United States 
Code, is amended by adding at the end the following: 
‘‘(5)(A) The Board may authorize the addition of a mutual 
fund window under the Thrift Savings Plan if the Board determines 
that such addition would be in the best interests of participants. 
‘‘(B) The Board shall ensure that any expenses charged for 
use of the mutual fund window are borne solely by the participants 
who use such window. 
‘‘(C) The Board may establish such other terms and conditions 
for the mutual fund window as the Board considers appropriate 
to protect the interests of participants, including requirements 
relating to risk disclosure. 
‘‘(D) The Board shall consult with the Employee Thrift Advisory 
Council (established under section 8473) before authorizing the 
addition of a mutual fund window or establishing a service that 
enables participants to invest in mutual funds.’’. 
(c) 
TECHNICAL
AND
CONFORMING
AMENDMENT.—Section 
8438(d)(1) of title 5, United States Code, is amended by inserting 
‘‘and options’’ after ‘‘investment funds’’. 
Consultation. 
Regulations. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00398
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1855 
PUBLIC LAW 111–31—JUNE 22, 2009 
SEC. 105. REPORTING REQUIREMENTS. 
(a) ANNUAL REPORT.—The Board shall, not later than June 
30 of each year, submit to Congress an annual report on the 
operations of the Thrift Savings Plan. Such report shall include, 
for the prior calendar year, information on the number of partici-
pants as of the last day of such prior calendar year, the median 
balance in participants’ accounts as of such last day, demographic 
information on participants, the percentage allocation of amounts 
among investment funds or options, the status of the development 
and implementation of the mutual fund window, the diversity demo-
graphics of any company, investment adviser, or other entity 
retained to invest and manage the assets of the Thrift Savings 
Fund, and such other information as the Board considers appro-
priate. A copy of each annual report under this subsection shall 
be made available to the public through an Internet website. 
(b) REPORTING OF FEES AND OTHER INFORMATION.— 
(1) IN GENERAL.—The Board shall include in the periodic 
statements provided to participants under section 8439(c) of 
title 5, United States Code, the amount of the investment 
management fees, administrative expenses, and any other fees 
or expenses paid with respect to each investment fund and 
option under the Thrift Savings Plan. Any such statement 
shall also provide a statement notifying participants as to how 
they may access the annual report described in subsection 
(a), as well as any other information concerning the Thrift 
Savings Plan that might be useful. 
(2) USE
OF
ESTIMATES.—For purposes of providing the 
information required under this subsection, the Board may 
provide a reasonable and representative estimate of any fees 
or expenses described in paragraph (1) and shall indicate any 
such estimate as being such an estimate. Any such estimate 
shall be based on the previous year’s experience. 
(c) DEFINITIONS.—For purposes of this section— 
(1) the term ‘‘Board’’ has the meaning given such term 
by 8401(5) of title 5, United States Code; 
(2) the term ‘‘participant’’ has the meaning given such 
term by section 8471(3) of title 5, United States Code; and 
(3) the term ‘‘account’’ means an account established under 
section 8439 of title 5, United States Code. 
SEC. 106. ACKNOWLEDGMENT OF RISK. 
(a) IN GENERAL.—Section 8439(d) of title 5, United States Code, 
is amended— 
(1) by striking the matter after ‘‘who elects to invest in’’ 
and before ‘‘shall sign an acknowledgment’’ and inserting ‘‘any 
investment fund or option under this chapter, other than the 
Government Securities Investment Fund,’’; and 
(2) by striking ‘‘either such Fund’’ and inserting ‘‘any such 
fund or option’’. 
(b) COORDINATION WITH PROVISIONS RELATING TO FIDUCIARY 
RESPONSIBILITIES, 
LIABILITIES, 
AND
PENALTIES.—Section 
8477(e)(1)(C) of title 5, United States Code, is amended— 
(1) by redesignating subparagraph (C) as subparagraph 
(C)(i); and 
(2) by adding at the end the following: 
‘‘(ii) A fiduciary shall not be liable under subparagraph (A), 
and no civil action may be brought against a fiduciary— 
Notification. 
Public 
information. 
Web posting. 
5 USC 8439 note. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00399
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1856 
PUBLIC LAW 111–31—JUNE 22, 2009 
‘‘(I) for providing for the automatic enrollment of a partici-
pant in accordance with section 8432(b)(2)(A); 
‘‘(II) for enrolling a participant in a default investment 
fund in accordance with section 8438(c)(2); or 
‘‘(III) for allowing a participant to invest through the 
mutual fund window or for establishing restrictions applicable 
to participants’ ability to invest through the mutual fund 
window.’’. 
SEC. 107. SUBPOENA AUTHORITY. 
(a) IN GENERAL.—Chapter 84 of title 5, United States Code, 
is amended by inserting after section 8479 the following: 
‘‘§ 8480. Subpoena authority 
‘‘(a) In order to carry out the responsibilities specified in this 
subchapter and subchapter III of this chapter, the Executive 
Director may issue subpoenas commanding each person to whom 
the subpoena is directed to produce designated books, documents, 
records, electronically stored information, or tangible materials in 
the possession or control of that individual. 
‘‘(b) Notwithstanding any Federal, State, or local law, any per-
son, including officers, agents, and employees, receiving a subpoena 
under this section, who complies in good faith with the subpoena 
and thus produces the materials sought, shall not be liable in 
any court of any State or the United States to any individual, 
domestic or foreign corporation or upon a partnership or other 
unincorporated association for such production. 
‘‘(c) When a person fails to obey a subpoena issued under 
this section, the district court of the United States for the district 
in which the investigation is conducted or in which the person 
failing to obey is found, shall on proper application issue an order 
directing that person to comply with the subpoena. The court may 
punish as contempt any disobedience of its order. 
‘‘(d) The Executive Director shall prescribe regulations to carry 
out subsection (a).’’. 
(b) TECHNICAL AND CONFORMING AMENDMENT.—The table of 
sections for chapter 84 of title 5, United States Code, is amended 
by inserting after the item relating to section 8479 the following: 
‘‘8480. Subpoena authority.’’. 
SEC. 108. AMOUNTS IN THRIFT SAVINGS FUNDS SUBJECT TO LEGAL 
PROCEEDINGS. 
Section 8437(e)(3) of title 5, United States Code, is amended 
in the first sentence by striking ‘‘or relating to the enforcement 
of a judgment for the physically, sexually, or emotionally abusing 
a child as provided under section 8467(a)’’ and inserting ‘‘the 
enforcement of an order for restitution under section 3663A of 
title 18, forfeiture under section 8432(g)(5) of this title, or an obliga-
tion of the Executive Director to make a payment to another person 
under section 8467 of this title’’. 
SEC. 109. ACCOUNTS FOR SURVIVING SPOUSES. 
Section 8433(e) of title 5, United States Code, is amended— 
(1) by inserting ‘‘(1)’’ after ‘‘(e)’’; and 
(2) by adding at the end the following: 
‘‘(2) Notwithstanding section 8424(d), if an employee, Member, 
former employee, or former Member dies and has designated as 
Regulations. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00400
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1857 
PUBLIC LAW 111–31—JUNE 22, 2009 
sole or partial beneficiary his or her spouse at the time of death, 
or, if an employee, Member, former employee, or former Member, 
dies with no designated beneficiary and is survived by a spouse, 
the spouse may maintain the portion of the employee’s or Member’s 
account to which the spouse is entitled in accordance with the 
following terms: 
‘‘(A) Subject to the limitations of subparagraph (B), the 
spouse shall have the same withdrawal options under sub-
section (b) as the employee or Member were the employee 
or Member living. 
‘‘(B) The spouse may not make withdrawals under sub-
section (g) or (h). 
‘‘(C) The spouse may not make contributions or transfers 
to the account. 
‘‘(D) The account shall be disbursed upon the death of 
the surviving spouse. A beneficiary or surviving spouse of a 
deceased spouse who has inherited an account is ineligible 
to maintain the inherited spousal account. 
‘‘(3) The Executive Director shall prescribe regulations to carry 
out this subsection.’’. 
SEC. 110. TREATMENT OF MEMBERS OF THE UNIFORMED SERVICES 
UNDER THE THRIFT SAVINGS PLAN. 
(a) SENSE OF CONGRESS.—It is the sense of Congress that— 
(1) members of the uniformed services should have a retire-
ment system that is at least as generous as the one which 
is available to Federal civilian employees; and 
(2) Federal civilian employees receive matching contribu-
tions from their employing agencies for their contributions to 
the Thrift Savings Fund, but the costs of requiring such a 
matching contribution from the Department of Defense could 
be significant. 
(b) REPORTING REQUIREMENT.—Not later than 180 days after 
the date of the enactment of this Act, the Secretary of Defense 
shall report to Congress on— 
(1) the cost to the Department of Defense of providing 
a matching payment with respect to contributions made to 
the Thrift Savings Fund by members of the Armed Forces; 
(2) the effect that requiring such a matching payment 
would have on recruitment and retention; and 
(3) any other information that the Secretary of Defense 
considers appropriate. 
TITLE II—SPECIAL SURVIVOR INDEM-
NITY ALLOWANCE FOR SURVIVING 
SPOUSES OF ARMED FORCES MEM-
BERS 
SEC. 201. INCREASE IN MONTHLY AMOUNT OF SPECIAL SURVIVOR 
INDEMNITY ALLOWANCE FOR WIDOWS AND WIDOWERS OF 
DECEASED MEMBERS OF THE ARMED FORCES AFFECTED 
BY REQUIRED SURVIVOR BENEFIT PLAN ANNUITY OFFSET 
FOR DEPENDENCY AND INDEMNITY COMPENSATION. 
(a) PAYMENT AMOUNT PER FISCAL YEAR.—Paragraph (2) of 
section 1450(m) of title 10, United States Code, is amended— 
Regulations. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00401
Fmt 6580
Sfmt 6581
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB
123 STAT. 1858 
PUBLIC LAW 111–31—JUNE 22, 2009 
LEGISLATIVE HISTORY—H.R. 1256: 
HOUSE REPORTS: No. 111–58, Pt. 1 (Comm. on Energy and Commerce) and 
Pt. 2 (Comm. on Oversight and Government Reform). 
CONGRESSIONAL RECORD, Vol. 155 (2009): 
Apr. 1, 2, considered and passed House. 
June 3, 4, 8–11, considered and passed Senate, amended. 
June 12, House concurred in Senate amendment. 
DAILY COMPILATION OF PRESIDENTIAL DOCUMENTS (2009): 
June 22, Presidential remarks. 
(1) in subparagraph (E), by striking ‘‘and’’ after the semi-
colon; and 
(2) by striking subparagraph (F) and inserting the following 
new subparagraphs: 
‘‘(F) for months during fiscal year 2014, $150; 
‘‘(G) for months during fiscal year 2015, $200; 
‘‘(H) for months during fiscal year 2016, $275; and 
‘‘(I) for months during fiscal year 2017, $310.’’. 
(b) DURATION.—Paragraph (6) of such section is amended— 
(1) by striking ‘‘February 28, 2016’’ and inserting ‘‘Sep-
tember 30, 2017’’; and 
(2) by striking ‘‘March 1, 2016’’ both places it appears 
and inserting ‘‘October 1, 2017’’. 
Approved June 22, 2009. 
VerDate Nov 24 2008 
08:02 Sep 19, 2011
Jkt 079194
PO 00000
Frm 00402
Fmt 6580
Sfmt 6580
G:\GSDD\STATUTES\2009\79194PT2.001
MCNODE
jbender on DSKFWWRZC1 with $$_JOB