113 
‘‘(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 re-
quired for assessment and ongoing review of modi-
fied risk tobacco products. Such regulations or guid-
ance 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 sub-
stantial reduction in morbidity or mortality 
among individual tobacco users occurs for prod-
ucts described in subsection (g)(1) or is reason-
ably likely for products described in subsection 
(g)(2); 
‘‘(B) include validated biomarkers, inter-
mediate clinical endpoints, and other feasible 
outcome measures, as appropriate; 
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‘‘(C) establish minimum standards for 
postmarket studies, that shall include regular 
and long-term assessments of health outcomes 
and mortality, intermediate clinical endpoints, 
consumer perception of harm reduction, and the 
impact on quitting behavior and new use of to-
bacco products, as appropriate; 
‘‘(D) establish minimum standards for re-
quired postmarket surveillance, including ongo-
ing 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 guid-
ance issued under paragraph (1) shall be developed 
in consultation with the Institute of Medicine, and 
with the input of other appropriate scientific and 
medical experts, on the design and conduct of such 
studies and surveillance. 
‘‘(3) REVISION.—The regulations or guidance 
under paragraph (1) shall be revised on a regular 
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basis as new scientific information becomes avail-
able. 
‘‘(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 guid-
ance that permits the filing of a single application 
for any tobacco product that is a new tobacco prod-
uct 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 To-
bacco Control Act, with respect to a tobacco product that 
would reasonably be expected to result in consumers be-
lieving 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 products, or presents a re-
duced exposure to, or does not contain or is free of, a sub-
stance or substances. 
‘‘SEC. 912. JUDICIAL REVIEW. 
‘‘(a) RIGHT TO REVIEW.— 
‘‘(1) IN
GENERAL.—Not later than 30 days 
after— 
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‘‘(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 sec-
tion 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 cir-
cuit in which such person resides or has their prin-
cipal 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 re-
ceipt 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. 
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‘‘(C) DEFINITION
OF
RECORD.—In this 
section, the term ‘record’ means— 
‘‘(i) all notices and other matter pub-
lished 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 ad-
visory committee with respect to such reg-
ulation or order; 
‘‘(iv) any hearing held with respect to 
such regulation or order; and 
‘‘(v) any other information identified 
by the Secretary, in the administrative pro-
ceeding held with respect to such regula-
tion 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 regu-
lation 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 re-
lief, including interim relief, as provided for in such chap-
ter. A regulation or denial described in subsection (a) shall 
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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. 
‘‘(d) OTHER REMEDIES.—The remedies provided for 
in this section 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 regula-
tion 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. 
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‘‘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 au-
thority 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 vio-
lates 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 require-
ments of section 4 of the Federal Cigarette Labeling and 
Advertising Act and section 3 of the Comprehensive 
Smokeless Tobacco Health Education Act of 1986— 
‘‘(1) the Chairman of the Federal Trade Com-
mission shall coordinate with the Secretary con-
cerning the enforcement of such Act as such enforce-
ment relates to unfair or deceptive acts or practices 
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120 
in the advertising of cigarettes or smokeless tobacco; 
and 
‘‘(2) the Secretary shall consult with the Chair-
man of such Commission in revising the label state-
ments 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 pro-
mulgated under subsection (a)— 
‘‘(1) shall require testing and reporting of to-
bacco product constituents, ingredients, and addi-
tives, including smoke constituents, by brand and 
subbrand that the Secretary determines should be 
tested to protect the public health, provided that, for 
purposes of the testing requirements of this para-
graph, tobacco products manufactured and sold by a 
single tobacco product manufacturer that are iden-
tical in all respects except the labels, packaging de-
sign, logo, trade dress, trademark, brand name, or 
any combination thereof, shall be considered as a 
single brand; and 
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‘‘(2) may require that tobacco product manu-
facturers, packagers, or importers make disclosures 
relating to the results of the testing of tar and nico-
tine through labels or advertising or other appro-
priate means, and make disclosures regarding the 
results of the testing of other constituents, including 
smoke constituents, ingredients, or additives, that 
the Secretary determines should be disclosed to the 
public to protect the public health and will not mis-
lead consumers about the risk of tobacco-related dis-
ease. 
‘‘(c) AUTHORITY.—The Secretary shall have the au-
thority under this chapter to conduct or to require the 
testing, reporting, or disclosure of tobacco product con-
stituents, including smoke constituents. 
‘‘(d) SMALL
TOBACCO
PRODUCT
MANUFACTUR-
ERS.— 
‘‘(1) FIRST
COMPLIANCE
DATE.—The initial 
regulations promulgated under subsection (a) shall 
not impose requirements 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 manu-
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facturers that are not small tobacco product 
manufacturers. 
‘‘(2) TESTING AND REPORTING INITIAL COM-
PLIANCE PERIOD.— 
‘‘(A) 4-YEAR PERIOD.—The initial regula-
tions promulgated 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 manufacturers or 
the end of the 2-year period following the final 
promulgation of such regulations, as described 
in paragraph (1)(A). A small tobacco product 
manufacturer shall be required— 
‘‘(i) to conduct such testing and re-
porting for 25 percent of its tobacco prod-
ucts during each year of such 4-year pe-
riod; and 
‘‘(ii) to conduct such testing and re-
porting for its largest-selling tobacco prod-
ucts (as determined by the Secretary) be-
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fore its other tobacco products, or in such 
other order of priority as determined by 
the Secretary. 
‘‘(B) 
CASE-BY-CASE
DELAY.—Notwith-
standing subparagraph (A), the Secretary may, 
on a case-by-case basis, delay the date by which 
an individual small tobacco product manufac-
turer must conduct testing and reporting for its 
tobacco products under this section based upon 
a showing of undue hardship to such manufac-
turer. 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 beyond a total of 5 years after the ini-
tial date of compliance under this section set by 
the Secretary with respect to manufacturers 
that are not small tobacco product manufactur-
ers. 
‘‘(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 report-
ing of tobacco products required under this section, 
such testing and reporting by a small tobacco prod-
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the Secretary may provide further extensions of 
time, in increments of no more than 1 year, for re-
quired testing and reporting to occur if the Sec-
retary determines, based on evidence properly and 
timely submitted by a small tobacco product manu-
facturer 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 sub-
section (d) or (e) shall be construed to authorize the exten-
sion 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 sec-
tion. 
‘‘SEC. 916. PRESERVATION OF STATE AND LOCAL AUTHOR-
ITY. 
‘‘(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 political subdivision 
of a State, or the government of an Indian tribe to 
enact, adopt, promulgate, and enforce any law, rule, 
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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, distribution, pos-
session, 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 to-
bacco 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 REQUIREMENTS.— 
‘‘(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 addi-
tion to, any requirement under the provisions of 
this chapter relating to tobacco product stand-
ards, premarket review, adulteration, mis-
branding, labeling, registration, good manufac-
turing standards, or modified risk tobacco prod-
ucts. 
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‘‘(B) 
EXCEPTION.—Subparagraph 
(A) 
does not apply to requirements relating to the 
sale, distribution, possession, information re-
porting to the State, exposure to, access to, the 
advertising and promotion of, or use of, tobacco 
products by individuals of any age, or relating 
to fire safety standards for tobacco products. 
Information disclosed to a State under subpara-
graph (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 confiden-
tial information by the State. 
‘‘(b) RULE OF CONSTRUCTION REGARDING PRODUCT 
LIABILITY.—No provision of this chapter relating to a to-
bacco 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 Pre-
vention and Tobacco Control Act, the Secretary shall es-
tablish a 12-member advisory committee, to be known as 
the Tobacco Products Scientific Advisory Committee (in 
this section referred to as the ‘Advisory Committee’). 
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‘‘(b) MEMBERSHIP.— 
‘‘(1) IN GENERAL.— 
‘‘(A) MEMBERS.—The Secretary shall ap-
point as members of the Tobacco Products Sci-
entific 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 appro-
priately diversified professional backgrounds. 
The committee shall be composed of— 
‘‘(i) 7 individuals who are physicians, 
dentists, scientists, or health care profes-
sionals practicing in the area of oncology, 
pulmonology, cardiology, toxicology, phar-
macology, addiction, or any other relevant 
specialty; 
‘‘(ii) 1 individual who is an officer or 
employee of a State or local government or 
of the Federal Government; 
‘‘(iii) 1 individual as a representative 
of the general public; 
‘‘(iv) 1 individual as a representative 
of the interests of the tobacco manufac-
turing industry; 
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‘‘(v) 1 individual as a representative 
of the interests of the small business to-
bacco manufacturing industry, which posi-
tion may be filled on a rotating, sequential 
basis by representatives of different small 
business tobacco manufacturers based on 
areas of expertise relevant to the topics 
being considered by the Advisory Com-
mittee; and 
‘‘(vi) 1 individual as a representative 
of the interests of the tobacco growers. 
‘‘(B) NONVOTING
MEMBERS.—The mem-
bers of the committee appointed under clauses 
(iv), (v), and (vi) of subparagraph (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 mem-
bers of the committee, other than members ap-
pointed pursuant to clauses (iv), (v), and (vi) of 
subparagraph (A) shall, during the member’s 
tenure on the committee or for the 18-month 
period prior to becoming such a member, re-
ceive any salary, grants, or other payments or 
support from any business that manufactures, 
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132 
distributes, markets, or sells cigarettes or other 
tobacco products. 
‘‘(2) LIMITATION.—The Secretary may not ap-
point 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 ap-
point Federal officials as ex officio members. 
‘‘(3) CHAIRPERSON.—The Secretary shall des-
ignate 1 of the members appointed under clauses (i), 
(ii), and (iii) of paragraph (1)(A) to serve as chair-
person. 
‘‘(c) DUTIES.—The Tobacco Products Scientific Ad-
visory Committee shall provide advice, information, and 
recommendations to the Secretary— 
‘‘(1) as provided in this chapter; 
‘‘(2) on the effects of the alteration of the nico-
tine 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 re-
quested by the Secretary. 
‘‘(d) COMPENSATION; SUPPORT; FACA.— 
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‘‘(1) COMPENSATION AND TRAVEL.—Members 
of the Advisory Committee who are not officers or 
employees of the United States, while attending con-
ferences or meetings of the committee 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 en-
gaged; 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 
subsistence, as authorized by section 5703 of title 5, 
United States Code, for persons in the Government 
service employed intermittently. 
‘‘(2) ADMINISTRATIVE
SUPPORT.—The Sec-
retary 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 Committee. 
‘‘(e) PROCEEDINGS OF ADVISORY PANELS AND COM-
MITTEES.—The Advisory Committee shall make and 
maintain a transcript of any proceeding of the panel or 
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committee. Each such panel and committee shall delete 
from any transcript made under this subsection informa-
tion which is exempt from disclosure under section 552(b) 
of title 5, United States Code. 
‘‘SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DE-
PENDENCE. 
‘‘(a) IN GENERAL.—The Secretary shall— 
‘‘(1) at the request of the applicant, consider 
designating products for smoking cessation, includ-
ing nicotine replacement products as fast track re-
search and approval products within the meaning of 
section 506; 
‘‘(2) consider approving the extended use of nic-
otine replacement products (such as nicotine patch-
es, nicotine gum, and nicotine lozenges) for the 
treatment of tobacco dependence; and 
‘‘(3) review and consider the evidence for addi-
tional indications 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 
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135 
agencies and nongovernmental entities, the Institute 
of Medicine of the National Academy of Sciences, 
and the Society for Research on Nicotine and To-
bacco), shall submit to the Congress a report that 
examines how best to regulate, promote, and encour-
age the development of innovative products and 
treatments (including nicotine-based and non-nico-
tine-based products and treatments) to better 
achieve, in a manner that best protects and pro-
motes 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 Adminis-
tration should coordinate and facilitate the exchange 
of information on such innovative products and 
treatments among relevant offices and centers within 
the Administration and within the National Insti-
tutes of Health, the Centers for Disease Control and 
Prevention, and other relevant agencies. 
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‘‘SEC. 919. USER FEES. 
‘‘(a) ESTABLISHMENT OF QUARTERLY FEE.—Begin-
ning on the date of enactment of the Family Smoking Pre-
vention and Tobacco Control Act, the Secretary shall in 
accordance with this section assess user fees on, and col-
lect 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 col-
lected 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 subsection (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. 
‘‘(I) For fiscal year 2017, $635,000,000. 
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‘‘(J) For fiscal year 2018, $672,000,000. 
‘‘(K) For fiscal year 2019 and each subse-
quent fiscal year, $712,000,000. 
‘‘(2) ALLOCATIONS OF ASSESSMENT BY CLASS 
OF TOBACCO PRODUCTS.— 
‘‘(A) IN GENERAL.—The total user fees as-
sessed 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 
paragraph (1) for the fiscal year. 
‘‘(B) APPLICABLE PERCENTAGE.— 
‘‘(i) IN
GENERAL.—For purposes of 
subparagraph (A), the applicable percent-
age for a fiscal year for each of the fol-
lowing classes of tobacco products shall be 
determined in accordance with clause (ii): 
‘‘(I) Cigarettes. 
‘‘(II) Cigars, including small ci-
gars and cigars other than small ci-
gars. 
‘‘(III) Snuff. 
‘‘(IV) Chewing tobacco. 
‘‘(V) Pipe tobacco. 
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‘‘(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
REGULA-
TIONS.—Notwithstanding clause (ii), no 
user fees shall be assessed on a class of to-
bacco 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 section 
901(b) to be subject to this chapter, the 
amount of user fees that would otherwise 
be assessed to such class of tobacco prod-
ucts shall be reallocated to the classes of 
tobacco products that are subject to this 
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139 
chapter in the same manner and based on 
the same relative percentages otherwise de-
termined under clause (ii). 
‘‘(3) DETERMINATION OF USER FEE BY COM-
PANY.— 
‘‘(A) IN GENERAL.—The total user fee to 
be paid by each manufacturer or importer of a 
particular class of tobacco products shall be de-
termined 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 as-
sessed on all manufacturers and importers 
of such class of tobacco products as deter-
mined under paragraph (2). 
‘‘(B) NO FEE IN EXCESS OF PERCENTAGE 
SHARE.—No manufacturer or importer of to-
bacco 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 percent-
age share of each manufacturer or importer of a 
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141 
into a memorandum of understanding that pro-
vides 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 import-
ers required to pay user fees. The Secretary 
shall maintain all disclosure restrictions estab-
lished by the head of such agency regarding the 
information provided under the memorandum of 
understanding. 
‘‘(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 deter-
mine the applicable percentages described in 
paragraph (2) and the percentage shares de-
scribed in paragraph (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 
provide the necessary information. 
‘‘(c) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN GENERAL.—Fees authorized under sub-
section (a) shall be collected and available for obliga-
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142 
tion only to the extent and in the amount provided 
in advance in appropriations Acts. Such fees are au-
thorized to remain available until expended. Such 
sums as may be necessary may be transferred from 
the Food and Drug Administration salaries and ex-
penses appropriation account without fiscal year lim-
itation to such appropriation account for salaries 
and expenses with such fiscal year limitation. 
‘‘(2) AVAILABILITY.— 
‘‘(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. No fees collected 
under subsection (a) may be used for any other 
costs. 
‘‘(B) 
PROHIBITION
AGAINST
USE
OF 
OTHER FUNDS.— 
‘‘(i) IN
GENERAL.—Except as pro-
vided in clause (ii), fees collected under 
subsection (a) are the only funds author-
ized to be made available for the purpose 
described in subparagraph (A). 
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143 
‘‘(ii) STARTUP
COSTS.—Clause (i) 
does not apply until the date on which the 
Secretary has collected fees under sub-
section (a) for 2 fiscal year quarters. Until 
such date, other amounts available to the 
Food and Drug Administration (excluding 
fees collected under subsection (a)) are au-
thorized to be made available to pay the 
costs described in subparagraph (A), pro-
vided that such amounts are reimbursed 
through fees collected under subsection (a). 
‘‘(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. 
‘‘(d) COLLECTION OF UNPAID FEES.—In any case 
where the Secretary does not receive payment of a fee as-
sessed under subsection (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 enactment of the Family Smoking Prevention and 
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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 subsection as the 
‘quarterly fee amounts’). 
‘‘(2) For the quarter in which such date of en-
actment occurs, the amount of fees assessed shall be 
a pro rata amount, determined 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 as-
sessed under the preceding sentence shall not be col-
lected until the next quarter. 
‘‘(3) For the quarter following the quarter to 
which paragraph (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).’’. 
SEC. 102. FINAL RULE. 
(a) CIGARETTES AND SMOKELESS TOBACCO.— 
(1) IN GENERAL.—On the first day of publica-
tion of the Federal Register that is 180 days or 
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145 
more after the date of enactment of this Act, the 
Secretary of Health and Human Services shall pub-
lish 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 Act; 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 provi-
sions of law relating to rulemaking procedures. 
(2) CONTENTS OF RULE.—Except as provided 
in this subsection, the final rule published under 
paragraph (1), shall be identical in its provisions to 
part 897 of the regulations promulgated by the Sec-
retary 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 jurisdic-
tional authority that is in accordance with this 
subsection in accordance with this Act and the 
amendments made by this Act; 
(B) strike Subpart C—Labels and section 
897.32(c); 
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(C) strike paragraphs (a), (b), and (i) of 
section 897.3 and insert definitions of the terms 
‘‘cigarette’’, ‘‘cigarette tobacco,’’, and ‘‘smoke-
less tobacco’’ as defined in section 900 of the 
Federal Food, Drug, and Cosmetic Act; 
(D) insert ‘‘or roll-your-own paper’’ in sec-
tion 897.34(a) after ‘‘other than cigarettes or 
smokeless tobacco’’; 
(E) become effective on the date that is 1 
year after the date of enactment of this Act; 
and 
(F) amend paragraph (d) of section 897.16 
to read as follows: 
‘‘(d)(1) Except as provided in subparagraph (2), no 
manufacturer, distributor, or retailer may distribute or 
cause to be distributed 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 manu-
facturer, distributor, or retailer from distributing or caus-
ing 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 
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restrict the distribution of free samples of smokeless to-
bacco. 
‘‘(C) For purposes of this paragraph, the term ‘quali-
fied adult-only facility’ means a facility or restricted area 
that— 
‘‘(i) requires each person present to provide to 
a law enforcement officer (whether on or off duty) 
or to a security guard licensed by a governmental 
entity government-issued identification showing a 
photograph and at least the minimum age estab-
lished by applicable law for the purchase of smoke-
less 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, des-
ignated, and operated as a distinct enclosed area for 
the purpose of distributing free samples of smokeless 
tobacco in accordance with this subparagraph; and 
‘‘(v) is enclosed by a barrier that— 
‘‘(I) is constructed of, or covered with, an 
opaque material (except for entrances and 
exits); 
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148 
‘‘(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 ma-
terial that restricts visibility but may allow air-
flow) to at least 8 feet above the ground or 
floor (or to the ceiling); and 
‘‘(III) prevents persons outside the quali-
fied 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; 
‘‘(II) a brand name other than in conjunc-
tion 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 
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smokeless tobacco contains individual portions of smoke-
less 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 re-
tailer who distributes or causes to be distributed free sam-
ples also shall take reasonable steps to ensure that the 
above amounts are limited to one such package per adult 
consumer per day. 
‘‘(3) Notwithstanding subparagraph (2), no manufac-
turer, distributor, 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, soc-
cer, or hockey event or any other sporting or enter-
tainment event determined by the Secretary to be 
covered by this subparagraph. 
‘‘(4) The Secretary shall implement a program to en-
sure compliance 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 Smok-
ing Prevention and Tobacco Control Act. 
‘‘(5) Nothing in this paragraph shall be construed to 
authorize any person to distribute or cause to be distrib-
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150 
uted any sample of a tobacco product to any individual 
who has not attained the minimum age established by ap-
plicable 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 pro-
vided in paragraph (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 promulgated pur-
suant to this section, including the provisions of 
such regulation relating to distribution of free sam-
ples. 
(5) ENFORCEMENT
OF
RETAIL
SALE
PROVI-
SIONS.—The Secretary of Health and Human Serv-
ices shall ensure that the provisions of this Act, the 
amendments made by this Act, and the imple-
menting regulations (including such provisions, 
amendments, and regulations relating to the retail 
sale of tobacco products) are enforced with respect 
to the United States and Indian tribes. 
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151 
(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 be subject 
to the limitations in section 103(q) and shall be sub-
ject 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 enactment 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 Sec-
retary 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 To-
bacco Products to Protect Children and Adoles-
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152 
cents’’ (60 Fed. Reg. 41314–41372 (August 11, 
1995)). 
(2) The document titled ‘‘Nicotine in Cigarettes 
and Smokeless Tobacco Products is a Drug and 
These Products Are Nicotine Delivery Devices 
Under the Federal Food, Drug, and Cosmetic Act’’ 
(60 Fed. Reg. 41453–41787 (August 11, 1995)). 
(3) The preamble to the final rule in the docu-
ment 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 Smokeless Tobacco is a Drug and These Prod-
ucts are Nicotine Delivery Devices Under the Fed-
eral Food, Drug, and Cosmetic Act; Jurisdictional 
Determination’’ (61 Fed. Reg. 44619–45318 (Au-
gust 28, 1996)). 
SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GEN-
ERAL 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 
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153 
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 
(B) by striking ‘‘708, or 721’’ and insert-
ing ‘‘708, 721, 904, 905, 906, 907, 908, 909, 
or 920(b)’’; 
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(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 re-
quired 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 following: 
‘‘(q)(1) The failure or refusal— 
‘‘(A) to comply with any requirement prescribed 
under section 518, 520(g), 903(b), 907, 908, or 916; 
‘‘(B) to furnish any notification or other mate-
rial or information required by or under section 519, 
520(g), 904, 909, or 920; or 
‘‘(C) to comply with a requirement under sec-
tion 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: 
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‘‘(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 interstate commerce of a tobacco product in violation 
of section 911. 
‘‘(qq)(1) Forging, counterfeiting, simulating, or false-
ly representing, or without proper authority using any 
mark, stamp (including tax stamp), tag, label, or other 
identification device upon any tobacco product or con-
tainer or labeling thereof so as to render such tobacco 
product a counterfeit tobacco product. 
‘‘(2) Making, selling, disposing of, or keeping in pos-
session, control, or custody, or concealing any punch, die, 
plate, stone, or other item that is designed to print, im-
print, or reproduce the trademark, trade name, or other 
identifying mark, imprint, or device of another or any like-
ness 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 prod-
uct to be a counterfeit tobacco product, or the sale or dis-
pensing, or the holding for sale or dispensing, of a coun-
terfeit tobacco product. 
‘‘(rr) The charitable distribution of tobacco products. 
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‘‘(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) With respect to a tobacco product, any state-
ment directed to consumers through the media or through 
the label, labeling, or advertising that would reasonably 
be expected to result in consumers believing that the prod-
uct is regulated, inspected or approved by the Food and 
Drug Administration, or that the product complies with 
the requirements of the Food and Drug Administration, 
including a statement or implication in the label, labeling, 
or advertising of such product, and that could result in 
consumers believing that the product is endorsed for use 
by the Food and Drug Administration or in consumers 
being misled about the harmfulness of the product because 
of such regulation, inspection, or compliance.’’. 
(c) SECTION 303.—Section 303(f) (21 U.S.C. 333(f)) 
is amended— 
(1) in paragraph (1)(A), by inserting ‘‘or to-
bacco products’’ after the term ‘‘devices’’ each place 
such term appears; 
(2) in paragraph (5)— 
(A) in subparagraph (A)— 
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(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,’’; 
(B) 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 fol-
lowing: ‘‘A no-tobacco-sale order perma-
nently prohibiting an individual retail out-
let from selling tobacco products shall in-
clude provisions that allow the outlet, after 
a specified period of time, to request that 
the Secretary compromise, modify, or ter-
minate the order.’’; and 
(C) by adding at the end the following: 
‘‘(D) The Secretary may compromise, modify, or ter-
minate, with or without conditions, any no-tobacco-sale 
order.’’; 
(3) in paragraph (6)— 
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(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 
(4) by adding at the end the following: 
‘‘(8) If the Secretary finds that a person has 
committed repeated violations of restrictions promul-
gated under section 906(d) at a particular retail out-
let 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 para-
graph, a person shall be entitled to a hearing pursu-
ant to the procedures established through regula-
tions of the Food and Drug Administration for as-
sessing civil money penalties, including at a retailer’s 
request a hearing by telephone, or at the nearest re-
gional or field office of the Food and Drug Adminis-
tration, or at a Federal, State, or county facility 
within 100 miles from the location of the retail out-
let, if such a facility is available.’’. 
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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 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 ex-
ports, 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 appro-
priate information disclosure requirements to carry out 
this subsection.’’. 
(m) SECTION 1003.—Section 1003(d)(2)(C) (as re-
designated by section 101(b)) is amended— 
(1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and 
(2) inserting ‘‘, and tobacco products’’ after 
‘‘devices’’. 
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(n) SECTION 1009.—Section 1009(b) (as redesig-
nated by section 101(b)) is amended by striking ‘‘section 
908’’ and inserting ‘‘section 1008’’. 
(o) SECTION 409 OF THE FEDERAL MEAT INSPEC-
TION ACT.—Section 409(a) of the Federal Meat Inspec-
tion Act (21 U.S.C. 679(a)) is amended by striking ‘‘sec-
tion 902(b)’’ and inserting ‘‘section 1002(b)’’. 
(p) RULE OF CONSTRUCTION.—Nothing in this sec-
tion 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 in-
cluding at least 5 violations of particular re-
quirements over a 36-month period at a par-
ticular retail outlet that constitute a repeated 
violation and providing for civil penalties in ac-
cordance with paragraph (2); 
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164 
(B) providing for timely and effective no-
tice 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 
registration or to the retailer’s registered agent 
if the retailer has provider such agent informa-
tion 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 assess-
ing civil money penalties, including at a retail-
er’s request a hearing by telephone or at the 
nearest regional or field office of the Food and 
Drug Administration, and providing for an ex-
pedited procedure 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; 
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(E) establishing that civil money penalties 
for multiple violations shall increase from one 
violation to the next violation pursuant to para-
graph (2) within the time periods provided for 
in such paragraph; 
(F) providing that good faith reliance on 
the presentation of a false government-issued 
photographic identification that contains a date 
of birth does not constitute a violation of any 
minimum age requirement for the sale of to-
bacco 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 ap-
plicable 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 deter-
mining whether to impose a no-tobacco-sale 
order and in determining whether to com-
promise, modify, or terminate such an order, to 
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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 restric-
tions promulgated under section 906(d), as de-
scribed 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 viola-
tion, $0.00 together with the issuance 
of a warning letter to the retailer; 
(II) in the case of a second viola-
tion within a 12-month period, $250; 
(III) in the case of a third viola-
tion within a 24-month period, $500; 
(IV) in the case of a fourth viola-
tion 
within 
a 
24-month 
period, 
$2,000; 
(V) in the case of a fifth violation 
within a 36-month period, $5,000; 
and 
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(VI) in the case of a sixth or sub-
sequent violation within a 48-month 
period, $10,000 as determined by the 
Secretary on a case-by-case basis. 
(ii) With respect to a retailer that 
does not have an approved training pro-
gram, the amount of the civil penalty shall 
not exceed— 
(I) in the case of the first viola-
tion, $250; 
(II) in the case of a second viola-
tion within a 12-month period, $500; 
(III) in the case of a third viola-
tion 
within 
a 
24-month 
period, 
$1,000; 
(IV) in the case of a fourth viola-
tion 
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 sub-
sequent violation within a 48-month 
period, $10,000 as determined by the 
Secretary on a case-by-case basis. 
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(B) TRAINING PROGRAM.—For purposes of 
subparagraph (A), the term ‘‘approved training 
program’’ means a training program that com-
plies with standards developed by the Food and 
Drug Administration for such programs. 
(C) CONSIDERATION
OF
STATE
PEN-
ALTIES.—The Secretary shall coordinate with 
the States in enforcing the provisions of this 
Act and, for purposes of mitigating a civil pen-
alty to be applied for a violation by a retailer 
of any restriction promulgated under section 
906(d), shall consider the amount of any pen-
alties paid by the retailer to a State for the 
same violation. 
(3) GENERAL EFFECTIVE DATE.—The amend-
ments made by paragraphs (2), (3), and (4) of sub-
section (c) shall take effect upon the issuance of 
guidance described in paragraph (1) of this sub-
section. 
(4) SPECIAL
EFFECTIVE
DATE.—The amend-
ment 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 (2), (3), 
and (4) of section 903(a) of the Federal Food, 
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Drug, and Cosmetic Act (as amended by this Act) 
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 intro-
duce into the domestic commerce of the United 
States any product, irrespective of the date of manu-
facture, that is not in conformance with section 
903(a)(2), (3), and (4) and section 920(a) of the 
Federal Food, Drug, and Cosmetic Act. 
(6) ADVERTISING REQUIREMENTS.—The adver-
tising requirements of section 903(a)(8) of the Fed-
eral Food, Drug, and Cosmetic Act (as amended by 
this Act) shall take effect on the date that is 12 
months after the date of enactment of this Act. 
SEC. 104. STUDY ON RAISING THE MINIMUM AGE TO PUR-
CHASE 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 min-
imum age to purchase tobacco products; and 
(2) not later than 5 years after the date of en-
actment of this Act, submit a report to the Congress 
on the results of such study. 
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170 
SEC. 105. ENFORCEMENT ACTION PLAN FOR ADVERTISING 
AND PROMOTION RESTRICTIONS. 
(a) ACTION PLAN.— 
(1) DEVELOPMENT.—Not later than 6 months 
after the date of enactment of this Act, the Sec-
retary of Health and Human Services (in this sec-
tion 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 Act, or pursuant to section 102(a) of 
this Act, 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 stake-
holders with demonstrated expertise 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 trib-
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al governments of the authority provided to such en-
tities under section 5(c) of the Federal Cigarette La-
beling and Advertising Act, as added by section 203 
of this Act, or preserved by such entities under sec-
tion 916 of the Federal Food, Drug, and Cosmetic 
Act, as added by section 101(b) of this Act. 
(2) COMMUNITY ASSISTANCE.—At the request 
of communities seeking assistance to prevent under-
age tobacco use, the Secretary shall provide such as-
sistance, including assistance with strategies to ad-
dress the prevention of underage tobacco use in com-
munities with a disproportionate use of menthol 
cigarettes by minors. 
TITLE 
II—TOBACCO 
PRODUCT 
WARNINGS; 
CONSTITUENT 
AND 
SMOKE 
CONSTITUENT 
DISCLOSURE 
SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS. 
(a) AMENDMENT.—Section 4 of the Federal Ciga-
rette 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, 
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distribute, or import for sale or distribution within 
the United States any cigarettes the package of 
which fails to bear, in accordance with the require-
ments 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 disease. 
‘‘WARNING: Smoking during pregnancy 
can harm your baby. 
‘‘WARNING: Smoking can kill you. 
‘‘WARNING: Tobacco smoke causes fatal 
lung disease in nonsmokers. 
‘‘WARNING: Quitting smoking now great-
ly 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 un-
derneath the cellophane or other clear wrapping. 
Each label statement shall comprise at least the top 
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30 percent of the front and rear panels of the pack-
age. The word ‘WARNING’ shall appear in capital 
letters and all text shall be in conspicuous and leg-
ible 17-point type, unless the text of the label state-
ment would occupy more than 70 percent of such 
area, in which case the text may be in a smaller con-
spicuous 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 con-
trasts, 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 DISTRIBU-
TION.—The provisions of this subsection do not 
apply to a tobacco product manufacturer or dis-
tributor of cigarettes which does not manufacture, 
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 sub-
section for packaging that— 
‘‘(A) contains a warning label; 
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‘‘(B) is supplied to the retailer by a 
license- or permit-holding tobacco product man-
ufacturer, importer, or distributor; and 
‘‘(C) is not altered by the retailer in a way 
that is material to the requirements of this sub-
section. 
‘‘(b) ADVERTISING REQUIREMENTS.— 
‘‘(1) IN GENERAL.—It shall be unlawful for any 
tobacco product manufacturer, importer, distributor, 
or retailer of cigarettes 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 speci-
fied 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 re-
quired statement relating to tar, nicotine, or other 
constituent (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 ad-
vertisement within the trim area. The Secretary may 
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revise the required type sizes in such area in such 
manner as the Secretary determines appropriate. 
The word ‘WARNING’ shall appear in capital let-
ters, and each label statement shall appear in con-
spicuous and legible type. The text of the label state-
ment shall be black if the background is white and 
white if the background is black, under the plan sub-
mitted 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’ in the label state-
ments. 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 ad-
vertisement; 31.5-point type for a double page 
spread magazine or whole-page magazine advertise-
ment; 22.5-point type for a 28 centimeter by 3 col-
umn advertisement; and 15-point type for a 20 cen-
timeter by 2 column advertisement. The label state-
ments shall be in English, except that— 
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‘‘(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 lan-
guage of the publication; and 
‘‘(B) in the case of any other advertise-
ment that is not in English, the statements 
shall appear in the same language as that prin-
cipally used in the advertisement. 
‘‘(3) 
MATCHBOOKS.—Notwithstanding 
para-
graph (2), for matchbooks (defined as containing not 
more than 20 matches) customarily given away with 
the purchase of tobacco products, each label state-
ment required by subsection (a) may be printed on 
the inside cover of the matchbook. 
‘‘(4) ADJUSTMENT BY SECRETARY.—The Sec-
retary 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 re-
quired tar, nicotine yield, or other constituent (in-
cluding smoke constituent) disclosures; or the text, 
format, and type sizes for any other disclosures re-
quired under the Federal Food, Drug, and Cosmetic 
Act. The text of any such label statements or disclo-
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sures shall be required to appear only within the 20 
percent area of cigarette advertisements provided by 
paragraph (2). The Secretary shall promulgate regu-
lations 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 dis-
played in each 12-month period, in as equal a num-
ber 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 manufacturer, importer, distributor, or re-
tailer and approved by the Secretary. 
‘‘(2) ROTATION.—The label statements speci-
fied in subsection (a)(1) shall be rotated quarterly in 
alternating sequence in advertisements for each 
brand of cigarettes in accordance with a plan sub-
mitted by the tobacco product manufacturer, im-
porter, distributor, or retailer to, and approved by, 
the Secretary. 
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‘‘(3) REVIEW.—The Secretary shall review each 
plan submitted under paragraph (2) and approve it 
if the plan— 
‘‘(A) will provide for the equal distribution 
and display on packaging and the rotation re-
quired in advertising under this subsection; and 
‘‘(B) assures that all of the labels required 
under this section will be displayed by the to-
bacco product manufacturer, importer, dis-
tributor, or retailer at the same time. 
‘‘(4) APPLICABILITY TO RETAILERS.—This sub-
section and subsection (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 pub-
lic, an advertisement that does not contain a warn-
ing label or has been altered by the retailer in a way 
that is material to the requirements of this sub-
section and subsection (b).’’. 
(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 manufacture, provided that, in any 
case, beginning 30 days after such effective date, a manu-
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180 
size, and text of any of the label requirements, require 
color graphics to accompany the text, increase the re-
quired label area from 30 percent up to 50 percent of the 
front and rear panels of the package, or establish the for-
mat, 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 tobacco products.’’. 
SEC. 203. STATE REGULATION OF CIGARETTE ADVER-
TISING AND PROMOTION. 
Section 5 of the Federal Cigarette Labeling and Ad-
vertising 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 regu-
lations, 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 re-
strictions on the time, place, and manner, but not content, 
of the advertising or promotion of any cigarettes.’’. 
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181 
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 man-
ufacture, 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 re-
quirements 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 al-
ternative to cigarettes. 
‘‘WARNING: Smokeless tobacco is addict-
ive. 
‘‘(2) Each label statement required by para-
graph (1) shall be— 
‘‘(A) located on the 2 principal display 
panels of the package, and each label statement 
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182 
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 man-
ner 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 (b)(3), except 
that if the text of a label statement would oc-
cupy 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 per-
cent of such warning area is occupied by the 
label statement. 
‘‘(3) The label statements required by para-
graph (1) shall be introduced by each tobacco prod-
uct 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 dis-
tributor of any smokeless tobacco product that does 
not manufacture, package, or import smokeless to-
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bacco products for sale or distribution within the 
United States. 
‘‘(5) A retailer of smokeless tobacco products 
shall not be in violation of this subsection for pack-
aging that— 
‘‘(A) contains a warning label; 
‘‘(B) is supplied to the retailer by a 
license- or permit-holding tobacco product man-
ufacturer, importer, or distributor; and 
‘‘(C) is not altered by the retailer in a way 
that is material to the requirements of this sub-
section. 
‘‘(b) REQUIRED LABELS.— 
‘‘(1) It shall be unlawful for any tobacco prod-
uct manufacturer, 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 sub-
section (a) in smokeless tobacco advertising shall 
comply with the standards set forth in this para-
graph. 
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‘‘(B) For press and poster advertisements, each 
such statement and (where applicable) any required 
statement relating to tar, nicotine, or other con-
stituent 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 legible 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 ad-
vertisement; 31.5-point type for a double page 
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185 
spread magazine or whole-page magazine advertise-
ment; 22.5-point type for a 28 centimeter by 3 col-
umn advertisement; and 15-point type for a 20 cen-
timeter 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 lan-
guage of the publication; and 
‘‘(ii) in the case of any other advertisement 
that is not in English, the statements shall ap-
pear in the same language as that principally 
used in the advertisement. 
‘‘(3)(A) The label statements specified in sub-
section (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 ran-
domly distributed in all areas of the United States 
in which the product is marketed in accordance with 
a plan submitted by the tobacco product manufac-
turer, importer, distributor, or retailer and approved 
by the Secretary. 
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‘‘(4) The Secretary may, through a rulemaking 
under section 553 of title 5, United States Code, ad-
just the format and type sizes for the label state-
ments 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 per-
cent area of 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) TELEVISION AND RADIO ADVERTISING.—It is 
unlawful to advertise smokeless tobacco on any medium 
of electronic communications 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 manufacture, provided that, in any 
case, beginning 30 days after such effective date, a manu-
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facturer 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 Edu-
cation Act of 1986 (15 U.S.C. 4402), as amended by sub-
section (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 following: 
‘‘(d) AUTHORITY
TO
REVISE
WARNING
LABEL 
STATEMENTS.—The Secretary may, by a rulemaking con-
ducted under section 553 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.’’. 
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189 
(b) PREEMPTION.—Section 7(a) of the Comprehen-
sive Smokeless Tobacco Health Education Act of 1986 (15 
U.S.C. 4406(a)) is amended by striking ‘‘No’’ and insert-
ing ‘‘Except as provided in the Family Smoking Preven-
tion and Tobacco Control Act (and the amendments made 
by that Act), no’’. 
SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CON-
STITUENT DISCLOSURE TO THE PUBLIC. 
Section 4 of the Federal Cigarette Labeling and Ad-
vertising 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 CON-
STITUENT DISCLOSURE.— 
‘‘(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 ad-
vertised or packaged brand. Any such disclosure 
shall be in accordance with the methodology estab-
lished under such regulations, shall conform to the 
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190 
type size requirements of subsection (b) of this sec-
tion, and shall appear within the area specified in 
subsection (b) of this section. 
‘‘(2) RESOLUTION OF DIFFERENCES.—Any dif-
ferences between the requirements established by the 
Secretary under paragraph (1) and tar and nicotine 
yield reporting requirements established by the Fed-
eral Trade Commission shall be resolved by a memo-
randum of understanding between the Secretary and 
the Federal Trade Commission. 
‘‘(3) CIGARETTE AND OTHER TOBACCO PROD-
UCT CONSTITUENTS.—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 require-
ments regarding the level of any cigarette or other 
tobacco product constituent including any smoke 
constituent. Any such disclosure may be required if 
the Secretary determines that disclosure would be of 
benefit to the public health, or otherwise would in-
crease consumer awareness of the health con-
sequences 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 
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191 
from requiring such prescribed disclosure through a 
cigarette or other tobacco product package or adver-
tisement insert, or by any other means under the 
Federal Food, Drug, and Cosmetic Act. 
‘‘(4) RETAILERS.—This subsection applies to a 
retailer only if that retailer is responsible for or di-
rects the label statements required under this sec-
tion.’’. 
TITLE III—PREVENTION OF IL-
LICIT 
TRADE 
IN 
TOBACCO 
PRODUCTS 
SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPEC-
TION. 
Chapter IX of the Federal Food, Drug, and Cosmetic 
Act, as added by section 101, is further amended by add-
ing at the end the following: 
‘‘SEC. 920. LABELING, RECORDKEEPING, RECORDS INSPEC-
TION. 
‘‘(a) ORIGIN LABELING.— 
‘‘(1) REQUIREMENT.—Beginning 1 year after 
the date of enactment of the Family Smoking Pre-
vention and Tobacco Control Act, the label, pack-
aging, and shipping containers of tobacco products 
for introduction or delivery for introduction into 
interstate commerce in the United States shall bear 
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192 
the statement ‘sale only allowed in the United 
States’. 
‘‘(2) EFFECTIVE
DATE.—The effective date 
specified in paragraph (1) shall be with respect to 
the date of manufacture, provided that, in any case, 
beginning 30 days after such effective date, a manu-
facturer shall not introduce into the domestic com-
merce of the United States any product, irrespective 
of the date of manufacture, that is not in conform-
ance with such paragraph. 
‘‘(b) REGULATIONS CONCERNING RECORDKEEPING 
FOR TRACKING AND TRACING.— 
‘‘(1) IN GENERAL.—The Secretary shall pro-
mulgate regulations regarding the establishment and 
maintenance of records by any person who manufac-
tures, processes, transports, distributes, receives, 
packages, holds, exports, or imports tobacco prod-
ucts. 
‘‘(2) INSPECTION.—In promulgating the regula-
tions 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 
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193 
trade, smuggling, or counterfeiting of tobacco prod-
ucts. 
‘‘(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 to-
bacco product through the distribution system. 
‘‘(4) SIZE OF BUSINESS.—The Secretary shall 
take into account the size of a business in promul-
gating regulations under this section. 
‘‘(5) RECORDKEEPING
BY
RETAILERS.—The 
Secretary shall not require any retailer to maintain 
records relating to individual 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, processes, transports, distributes, re-
ceives, holds, packages, exports, or imports tobacco prod-
ucts shall, at the request of an officer or employee duly 
designated by the Secretary, permit such officer or em-
ployee, at reasonable times and within reasonable limits 
and in a reasonable manner, upon the presentation of ap-
propriate 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 
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the Secretary in investigating potential illicit trade, smug-
gling, or counterfeiting of tobacco products. The Secretary 
shall not authorize an officer or employee of the govern-
ment 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 to-
bacco product manufactured or distributed by such 
manufacturer or distributor that has left the control 
of such person may be or has been— 
‘‘(A) imported, exported, distributed, or of-
fered for sale in interstate commerce by a per-
son without paying duties or taxes required by 
law; or 
‘‘(B) imported, exported, distributed, or di-
verted for possible illicit marketing, 
the manufacturer or distributor shall promptly no-
tify 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— 
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195 
‘‘(A) the actual knowledge that the manu-
facturer 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 ex-
ercise of due care.’’. 
SEC. 302. STUDY AND REPORT. 
(a) STUDY.—The Comptroller General of the United 
States shall conduct a study of cross-border trade in to-
bacco products to— 
(1) collect data on cross-border trade in tobacco 
products, including illicit trade and trade of counter-
feit 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 coun-
try) of tobacco products and make recommendations 
on how to prevent or eliminate, and what tech-
nologies could help facilitate the elimination of, 
cross-border advertising; and 
(3) collect data on the health effects (particu-
larly with respect to individuals under 18 years of 
age) resulting from cross-border trade in tobacco 
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196 
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 to-
bacco products. 
(b) REPORT.—Not later than 18 months after the 
date of enactment 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 Commerce of the House 
of Representatives a report on the study described in sub-
section (a). 
(c) DEFINITION.—In this section: 
(1) The term ‘‘cross-border trade’’ means trade 
across a border of the United States, a State or Ter-
ritory, or Indian country. 
(2) The term ‘‘Indian country’’ has the mean-
ing 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). 
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197 
TITLE IV—THRIFT SAVINGS 
PLAN ENHANCEMENT 
SEC. 401. SHORT TITLE. 
This title may be cited as the ‘‘Thrift Savings Plan 
Enhancement Act of 2009’’. 
SEC. 402. AUTOMATIC ENROLLMENTS. 
(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 Board shall by regulation provide for an 
eligible individual to be automatically enrolled to make 
contributions under subsection (a) at the default percent-
age of basic pay. 
‘‘(B) For purposes of this paragraph, the default per-
centage shall be equal to 3 percent or such other percent-
age, not less than 2 percent nor more than 5 percent, as 
the Board may by regulation prescribe. 
‘‘(C) The regulations shall include provisions under 
which any individual who would otherwise be automatically 
enrolled in accordance with subparagraph (A) may— 
‘‘(i) modify the percentage or amount to be con-
tributed pursuant to automatic enrollment, effective 
from the start of such enrollment; or 
‘‘(ii) decline automatic enrollment altogether. 
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‘‘(D) For purposes of this paragraph, the term ‘eligi-
ble individual’ means any individual who, after any regula-
tions under subparagraph (A) first take effect, is ap-
pointed, transferred, or reappointed to a position in which 
that individual is eligible to contribute to the Thrift Sav-
ings Fund. 
‘‘(E) Sections 8351(a)(1), 8440a(a)(1), 8440b(a)(1), 
8440c(a)(1), 8440d(a)(1), and 8440e(a)(1) shall be ap-
plied in a manner consistent with the purposes of this 
paragraph. 
‘‘(E)(i) Subject to clause (ii), 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. 
‘‘(ii) The Secretary concerned may, with respect to 
members of the uniformed services under the authority of 
such Secretary, establish such special rules as such Sec-
retary considers necessary for the administration of this 
subparagraph, including rules in accordance with which 
such Secretary may— 
‘‘(I) provide for delayed automatic enrollment; or 
‘‘(II) preclude or suspend the application of 
automatic enrollment.’’. 
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199 
(b) TECHNICAL AMENDMENT.—Section 8432(b)(1) 
of title 5, United States Code, is amended by striking the 
parenthetical matter in subparagraph (B). 
SEC. 403. 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 following: 
‘‘§ 8432d. Qualified Roth contribution program 
‘‘(a) DEFINITIONS.—For purposes of this section— 
‘‘(1) the term ‘qualified Roth contribution pro-
gram’ means a program described in paragraph (1) 
of section 402A(b) of the Internal Revenue Code of 
1986 which meets the requirements 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. 
‘‘(b) AUTHORITY TO ESTABLISH.—The Board shall 
by regulation provide for the inclusion in the Thrift Sav-
ings 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— 
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‘‘(1) provisions under which an election to make 
designated Roth contributions may be made— 
‘‘(A) by any individual who is eligible to 
make 
contributions 
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 Sav-
ings 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 nec-
essary to carry out this section.’’. 
(b) CLERICAL AMENDMENT.—The analysis for chap-
ter 84 of title 5, United States Code, is amended by insert-
ing after the item relating to section 8432c the following: 
‘‘8432d. Qualified Roth contribution program.’’. 
SEC. 404. AUTHORITY TO ESTABLISH SELF-DIRECTED IN-
VESTMENT WINDOW. 
(a) IN GENERAL.—Section 8438(b)(1) of title 5, 
United States Code, is amended— 
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(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 fol-
lowing: 
‘‘(F) a self-directed investment window, if 
the Board authorizes such window under para-
graph (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 
self-directed investment window under the Thrift Savings 
Plan if the Board determines that such addition would be 
in the best interests of participants. 
‘‘(B) The self-directed investment window shall be 
limited to— 
‘‘(i) low-cost, passively-managed index funds 
that offer diversification benefits; and 
‘‘(ii) other investment options, if the Board de-
termines the options to be appropriate retirement in-
vestment vehicles for participants. 
‘‘(C) The Board shall ensure that any administrative 
expenses related to use of the self-directed investment win-
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202 
dow are borne solely by the participants who use such win-
dow. 
‘‘(D) The Board may establish such other terms and 
conditions for the self-directed investment window as the 
Board considers appropriate to protect the interests of 
participants, including requirements relating to risk dis-
closure. 
‘‘(E) The Board shall consult with the Employee 
Thrift Advisory Council (established under section 8473) 
before establishing any self-directed investment window.’’. 
SEC. 405. 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, informa-
tion on the number of participants as of the last day of 
such prior calendar year, the median balance in partici-
pants’ accounts as of such last day, demographic informa-
tion on participants, the percentage allocation of amounts 
among investment funds or options, the status of the de-
velopment and implementation of the self-directed invest-
ment window, the diversity demographics 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 appropriate. A 
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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 INFORMA-
TION.— 
(1) IN GENERAL.—The Board shall include in 
the periodic statements provided to participants 
under section 8439(c) the amount of the investment 
management fees, administrative expenses, and any 
other fees or expenses paid with respect to each in-
vestment fund and option under the Thrift Savings 
Plan. Any such statement shall also provide a state-
ment notifying participants as to how they may ac-
cess 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 pro-
viding the information required under this sub-
section, the Executive Director may provide a rea-
sonable and representative estimate of any fees or 
expenses described in paragraph (1) and shall indi-
cate 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— 
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(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 es-
tablished under section 8439 of title 5, United 
States Code. 
SEC. 406. ACKNOWLEDGEMENT 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 acknowledge-
ment’’ and inserting ‘‘any investment fund or option 
under this chapter, other than the Government Se-
curities Investment Fund,’’; and 
(2) by striking ‘‘either such Fund’’ and insert-
ing ‘‘any such fund or option’’. 
(b) COORDINATION WITH PROVISIONS RELATING TO 
INVESTMENTS IN THE ABSENCE OF AN ELECTION.—Sub-
section (d) of section 8439 of title 5, United States Code 
(as amended by subsection (a)) is further amended— 
(1) by redesignating subsection (d) as sub-
section (d)(1); and 
(2) by adding at the end the following: 
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‘‘(2)(A) In the case of an investment made under sec-
tion 8438(c)(2) in any fund or option to which paragraph 
(1) would otherwise apply, the participant involved shall, 
for purposes of this subsection, be deemed— 
‘‘(i) to have elected to invest in such fund or 
option; and 
‘‘(ii) to have executed the acknowledgement re-
quired under paragraph (1). 
‘‘(B)(i) The Executive Director shall prescribe regu-
lations under which written notice shall be provided to a 
participant whenever an investment is made under section 
8438(c)(2)(B) on behalf of such participant in the absence 
of an affirmative election described in section 8438(c)(1). 
‘‘(ii) The regulations shall ensure that any such no-
tice shall be provided to the participant within 7 calendar 
days after the effective date of the default election. 
‘‘(C) For purposes of this paragraph, the term ‘par-
ticipant’ has the meaning given such term by section 
8471(3).’’. 
(c) COORDINATION WITH PROVISIONS RELATING TO 
FIDUCIARY RESPONSIBILITIES, LIABILITIES, AND PEN-
ALTIES.—Section 8477(e)(1)(C) of title 5, United States 
Code, is amended— 
(1) by redesignating subparagraph (C) as sub-
paragraph (C)(i); and 
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(2) by adding at the end the following: 
‘‘(ii) A fiduciary shall not be liable under subpara-
graph (A), and no civil action may be brought against a 
fiduciary— 
‘‘(I) for providing for the automatic enrollment 
of 
a 
participant 
in 
accordance 
with 
section 
8432(b)(2)(A); 
‘‘(II) for enrolling a participant in a default in-
vestment 
fund 
in 
accordance 
with 
section 
8438(c)(2)(B); or 
‘‘(III) for allowing a participant to invest 
through the self-directed investment window or for 
establishing restrictions applicable to participants’ 
ability to invest through the self-directed investment 
window.’’. 
SEC. 407. CREDIT FOR UNUSED SICK LEAVE. 
(a) IN GENERAL.—Section 8415 of title 5, United 
States Code, is amended— 
(1) by redesignating the second subsection (k) 
and subsection (l) as subsections (l) and (m), respec-
tively; and 
(2) in subsection (l) (as so redesignated by 
paragraph (1))— 
(A) by striking ‘‘(l) In computing’’ and in-
serting ‘‘(l)(1) In computing’’; and 
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(B) by adding at the end the following: 
‘‘(2) Except as provided in paragraph (1), in com-
puting an annuity under this subchapter, the total service 
of an employee who retires on an immediate annuity or 
who dies leaving a survivor or survivors entitled to annuity 
includes the days of unused sick leave to his credit under 
a formal leave system, except that these days will not be 
counted in determining average pay or annuity eligibility 
under this subchapter. For purposes of this subsection, in 
the case of any such employee who is excepted from sub-
chapter I of chapter 63 under section 6301(2)(x)-(xiii), 
the days of unused sick leave to his credit include any un-
used sick leave standing to his credit when he was ex-
cepted from such subchapter.’’. 
(b) EXCEPTION FROM DEPOSIT REQUIREMENT.— 
Section 8422(d)(2) of title 5, United States Code, is 
amended by striking ‘‘section 8415(k)’’ and inserting 
‘‘paragraph (1) or (2) of section 8415(l)’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply with respect to annuities computed 
based on separations occurring on or after the date of en-
actment of this Act. 
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