139 
that a substantial reduction in morbidity or 
mortality among individual tobacco users is 
likely; 
‘‘(B) include validated biomarkers, inter-
mediate clinical endpoints, and other feasible 
outcome measures, as appropriate; 
‘‘(C) establish minimum standards for post 
market studies, that shall include regular and 
long-term assessments of health outcomes and 
mortality, intermediate clinical endpoints, con-
sumer 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; and 
‘‘(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. 
‘‘(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 
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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 
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 for which the applicant 
seeks approval as a modified risk tobacco product 
under this section. 
‘‘(m) DISTRIBUTORS.—No distributor may take any 
action, after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act, with respect to a to-
bacco product that would reasonably be expected to result 
in consumers believing that the tobacco product or its 
smoke may present a lower risk of disease or is less harm-
ful than one or more commercially marketed tobacco prod-
ucts, or presents a reduced exposure to, or does not con-
tain or is free of, a substance or substances. 
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‘‘SEC. 912. JUDICIAL REVIEW. 
‘‘(a) RIGHT TO REVIEW.— 
‘‘(1) IN
GENERAL.—Not later than 30 days 
after— 
‘‘(A) the promulgation of a regulation 
under section 907 establishing, amending, or 
revoking a tobacco product standard; or 
‘‘(B) a denial of an application for ap-
proval under section 910(c), any person ad-
versely affected by such regulation or denial 
may file a petition for judicial review of such 
regulation or denial with the United States 
Court of Appeals for the District of Columbia 
or for the circuit in which such person resides 
or has their principal place of business. 
‘‘(2) REQUIREMENTS.— 
‘‘(A) COPY OF PETITION.—A copy of the 
petition filed under paragraph (1) shall be 
transmitted by the clerk of the court involved to 
the Secretary. 
‘‘(B) RECORD OF PROCEEDINGS.—On re-
ceipt of a petition under subparagraph (A), the 
Secretary shall file in the court in which such 
petition was filed— 
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‘‘(i) the record of the proceedings on 
which the regulation or order was based; 
and 
‘‘(ii) a statement of the reasons for 
the issuance of such a regulation or order. 
‘‘(C) DEFINITION
OF
RECORD.—In this 
section, the term ‘record’ means— 
‘‘(i) all notices and other matter 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-
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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 
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 
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is the sale of tobacco products comply with any advertising 
restrictions applicable to retail establishments accessible 
to individuals under the age of 18. 
‘‘SEC. 914. JURISDICTION OF AND COORDINATION WITH 
THE FEDERAL TRADE COMMISSION. 
‘‘(a) JURISDICTION.— 
‘‘(1) IN
GENERAL.—Except where expressly 
provided in this chapter, nothing in this chapter 
shall be construed as limiting or diminishing the 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 232 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 (15 U.S.C. 45(a)) 
and shall be considered a violation of a rule promul-
gated under section 18 of that Act (15 U.S.C. 57a). 
‘‘(b) COORDINATION.—With respect to the require-
ments of section 4 of the Federal Cigarette Labeling and 
Advertising Act (15 U.S.C. 1333) and section 3 of the 
Comprehensive Smokeless Tobacco Health Education Act 
of 1986 (15 U.S.C. 4402)— 
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‘‘(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 
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. CONGRESSIONAL REVIEW PROVISIONS. 
‘‘In accordance with section 801 of title 5, United 
States Code, Congress shall review, and may disapprove, 
any rule under this chapter that is subject to section 801. 
This section and section 801 do not apply to the regula-
tions referred to in section 232 of the Family Smoking 
Prevention and Tobacco Control Act. 
‘‘SEC. 916. REGULATION REQUIREMENT. 
‘‘(a) TESTING, REPORTING, AND DISCLOSURE.—Not 
later than 24 months after the date of enactment of the 
Family Smoking Prevention and Tobacco Control Act, the 
Secretary, acting through the Commissioner of the Food 
and Drug Administration, shall promulgate regulations 
under this Act that meet the requirements of subsection 
(b). 
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‘‘(b) CONTENTS OF RULES.—The regulations pro-
mulgated under subsection (a) shall require testing and 
reporting of tobacco product constituents, ingredients, and 
additives, including smoke constituents, by brand and sub- 
brand that the Secretary determines should be tested to 
protect the public health. The regulations may require 
that tobacco product manufacturers, packagers, or import-
ers make disclosures relating to the results of the testing 
of tar and nicotine through labels or advertising or other 
appropriate means, and make disclosures regarding the re-
sults 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 mislead consumers about the 
risk of tobacco related disease. 
‘‘(c) AUTHORITY.—The Food and Drug Administra-
tion shall have the authority under this chapter to conduct 
or to require the testing, reporting, or disclosure of to-
bacco product constituents, including smoke constituents. 
‘‘SEC. 917. PRESERVATION OF STATE AND LOCAL AUTHOR-
ITY. 
‘‘(a) IN GENERAL.— 
‘‘(1) PRESERVATION.—Nothing in this chapter, 
or rules promulgated under this chapter, shall be 
construed to limit the authority of a Federal agency 
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(including the Armed Forces), a State or political 
subdivision of a State, or the government of an In-
dian tribe to enact, adopt, promulgate, and enforce 
any law, rule, regulation, or other measure with re-
spect 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, possession, exposure to, access to, ad-
vertising and promotion of, or use of tobacco prod-
ucts by individuals of any age, information reporting 
to the State, or measures relating to fire safety 
standards for tobacco products. No provision of this 
chapter shall limit or otherwise affect any State, 
Tribal, or local taxation of tobacco products. 
‘‘(2) PREEMPTION
OF
CERTAIN
STATE
AND 
LOCAL REQUIREMENTS.— 
‘‘(A) IN GENERAL.—Except as provided in 
paragraph (1) and subparagraph (B), no State 
or political subdivision of a State may establish 
or continue in effect with respect to a tobacco 
product any requirement which is different 
from, or in addition to, any requirement under 
the provisions of this chapter relating to to-
bacco product standards, premarket approval, 
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adulteration, misbranding, labeling, registra-
tion, good manufacturing standards, or modi-
fied risk tobacco products. 
‘‘(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 554(b)(4) of title 5, United States Code, 
shall be treated as trade secret and confidential 
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. 918. TOBACCO PRODUCTS SCIENTIFIC ADVISORY 
COMMITTEE. 
‘‘(a) ESTABLISHMENT.—Not later than 1 year after 
the date of enactment of the Family Smoking Prevention 
and Tobacco Control Act, the Secretary shall establish an 
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11-member advisory committee, to be known as the ‘To-
bacco Products Scientific Advisory Committee’. 
‘‘(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 the 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; 
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‘‘(iv) 1 individual as a representative 
of the interests in the tobacco manufac-
turing industry; and 
‘‘(v) 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) and (v) of subparagraph (A) shall serve as 
consultants to those described in clauses (i) 
through (iii) of subparagraph (A) and shall be 
nonvoting representatives. 
‘‘(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 of the Advisory Committee 
to serve as chairperson. 
‘‘(c) DUTIES.—The Tobacco Products Scientific Ad-
visory Committee shall provide advice, information, and 
recommendations to the Secretary— 
‘‘(1) as provided in this chapter; 
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‘‘(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.— 
‘‘(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 for level 4 of the Senior Executive 
Schedule under section 5382 of title 5, United 
States Code, for each day (including travel time) 
they are so engaged; and while so serving away from 
their homes or regular places of business each mem-
ber 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. 
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‘‘(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 (5 U.S.C. 
App.) 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 
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. 919. DRUG PRODUCTS USED TO TREAT TOBACCO DE-
PENDENCE. 
‘‘The Secretary shall— 
‘‘(1) at the request of the applicant, consider 
designating nicotine replacement products as fast 
track research 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 
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‘‘(3) review and consider the evidence for addi-
tional indications for nicotine replacement products, 
such as for craving relief or relapse prevention. 
‘‘SEC. 920. USER FEE. 
‘‘(a) ESTABLISHMENT OF QUARTERLY USER FEE.— 
The Secretary shall assess a quarterly user fee with re-
spect to every quarter of each fiscal year commencing fis-
cal year 2007, calculated in accordance with this section, 
upon each manufacturer and importer of tobacco products 
subject to this chapter. 
‘‘(b) FUNDING OF FDA REGULATION OF TOBACCO 
PRODUCTS.—The Secretary shall make user fees collected 
pursuant to this section available to pay, in each fiscal 
year, for the costs of the activities of the Food and Drug 
Administration related to the regulation of tobacco prod-
ucts under this chapter. 
‘‘(c) ASSESSMENT OF USER FEE.— 
‘‘(1) AMOUNT
OF
ASSESSMENT.—Except as 
provided in paragraph (4), the total user fees as-
sessed each year pursuant to this section shall be 
sufficient, and shall not exceed what is necessary, to 
pay for the costs of the activities described in sub-
section (b) for each fiscal year. 
‘‘(2) ALLOCATION OF ASSESSMENT BY CLASS 
OF TOBACCO PRODUCTS.— 
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‘‘(A) IN GENERAL.—Subject to paragraph 
(3), the total user fees assessed each fiscal year 
with respect to each class of importers and 
manufacturers shall be equal to an amount that 
is the applicable percentage of the total costs of 
activities of the Food and Drug Administration 
described in subsection (b). 
‘‘(B) 
APPLICABLE
PERCENTAGE.—For 
purposes of subparagraph (A) the applicable 
percentage for a fiscal year shall be the fol-
lowing: 
‘‘(i) 92.07 percent shall be assessed 
on manufacturers and importers of ciga-
rettes; 
‘‘(ii) 0.05 percent shall be assessed on 
manufacturers and importers of little ci-
gars; 
‘‘(iii) 7.15 percent shall be assessed 
on manufacturers and importers of cigars 
other than little cigars; 
‘‘(iv) 0.43 percent shall be assessed on 
manufacturers and importers of snuff; 
‘‘(v) 0.10 percent shall be assessed on 
manufacturers and importers of chewing 
tobacco; 
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‘‘(vi) 0.06 percent shall be assessed on 
manufacturers and importers of pipe to-
bacco; and 
‘‘(vii) 0.14 percent shall be assessed 
on manufacturers and importers of roll- 
your-own tobacco. 
‘‘(3) DISTRIBUTION OF FEE SHARES OF MANU-
FACTURERS AND IMPORTERS EXEMPT FROM USER 
FEE.—Where a class of tobacco products is not sub-
ject to a user fee under this section, the portion of 
the user fee assigned to such class under subsection 
(d)(2) shall be allocated by the Secretary on a pro 
rata basis among the classes of tobacco products 
that are subject to a user fee under this section. 
Such pro rata allocation for each class of tobacco 
products that are subject to a user fee under this 
section shall be the quotient of— 
‘‘(A) the sum of the percentages assigned 
to all classes of tobacco products subject to this 
section; divided by 
‘‘(B) the percentage assigned to such class 
under paragraph (2). 
‘‘(4) ANNUAL
LIMIT
ON
ASSESSMENT.—The 
total assessment under this section— 
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‘‘(A) for fiscal year 2007 shall be 
$85,000,000; 
‘‘(B) for fiscal year 2008 shall be 
$175,000,000; 
‘‘(C) for fiscal year 2009 shall be 
$300,000,000; and 
‘‘(D) for each subsequent fiscal year, shall 
not exceed the limit on the assessment imposed 
during the previous fiscal year, as adjusted by 
the Secretary (after notice, published in the 
Federal Register) to reflect the greater of— 
‘‘(i) the total percentage change that 
occurred in the Consumer Price Index for 
all urban consumers (all items; United 
States city average) for the 12-month pe-
riod ending on June 30 of the preceding 
fiscal year for which fees are being estab-
lished; or 
‘‘(ii) the total percentage change for 
the previous fiscal year in basic pay under 
the General Schedule in accordance with 
section 5332 of title 5, United States 
Code, as adjusted by any locality-based 
comparability payment pursuant to section 
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5304 of such title for Federal employees 
stationed in the District of Columbia. 
‘‘(5) TIMING OF USER FEE ASSESSMENT.—The 
Secretary shall notify each manufacturer and im-
porter of tobacco products subject to this section of 
the amount of the quarterly assessment imposed on 
such manufacturer or importer under subsection (f) 
during each quarter of each fiscal year. Such notifi-
cations shall occur not earlier than 3 months prior 
to the end of the quarter for which such assessment 
is made, and payments of all assessments shall be 
made not later than 60 days after each such notifi-
cation. 
‘‘(d) DETERMINATION OF USER FEE BY COMPANY 
MARKET SHARE.— 
‘‘(1) IN GENERAL.—The user fee to be paid by 
each manufacturer or importer of a given class of to-
bacco products shall be determined in each quarter 
by multiplying— 
‘‘(A) such manufacturer’s or importer’s 
market share of such class of tobacco products; 
by 
‘‘(B) the portion of the user fee amount 
for the current quarter to be assessed on manu-
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facturers and importers of such class of tobacco 
products as determined under subsection (e). 
‘‘(2) NO FEE IN EXCESS OF MARKET SHARE.— 
No manufacturer or importer of tobacco products 
shall be required to pay a user fee in excess of the 
market share of such manufacturer or importer. 
‘‘(e) DETERMINATION
OF VOLUME
OF DOMESTIC 
SALES.— 
‘‘(1) IN
GENERAL.—The calculation of gross 
domestic volume of a class of tobacco product by a 
manufacturer or importer, and by all manufacturers 
and importers as a group, shall be made by the Sec-
retary using information provided by manufacturers 
and importers pursuant to subsection (f), as well as 
any other relevant information provided to or ob-
tained by the Secretary. 
‘‘(2) MEASUREMENT.—For purposes of the cal-
culations under this subsection and the information 
provided under subsection (f) by the Secretary, gross 
domestic volume shall be measured by— 
‘‘(A) in the case of cigarettes, the number 
of cigarettes sold; 
‘‘(B) in the case of little cigars, the num-
ber of little cigars sold; 
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‘‘(C) in the case of large cigars, the num-
ber of cigars weighing more than 3 pounds per 
thousand sold; and 
‘‘(D) in the case of other classes of tobacco 
products, in terms of number of pounds, or 
fraction thereof, of these products sold. 
‘‘(f) MEASUREMENT
OF GROSS DOMESTIC VOL-
UME.— 
‘‘(1) IN
GENERAL.—Each manufacturer and 
importer of tobacco products shall submit to the 
Secretary a certified copy of each of the returns or 
forms described by this paragraph that are required 
to be filed with a Government agency on the same 
date that those returns or forms are filed, or re-
quired to be filed, with such agency. The returns 
and forms described by this paragraph are those re-
turns and forms related to the release of tobacco 
products into domestic commerce, as defined by sec-
tion 5702(k) of the Internal Revenue Code of 1986, 
and the repayment of the taxes imposed under chap-
ter 52 of such Code (ATF Form 500.24 and United 
States Customs Form 7501 under currently applica-
ble regulations). 
‘‘(2) PENALTIES.—Any person that knowingly 
fails to provide information required under this sub-
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section or that provides false information under this 
subsection shall be subject to the penalties described 
in section 1003 of title 18, United States Code. In 
addition, such person may be subject to a civil pen-
alty in an amount not to exceed 2 percent of the 
value of the kind of tobacco products manufactured 
or imported by such person during the applicable 
quarter, as determined by the Secretary. 
‘‘(g) EFFECTIVE DATE.—The user fees prescribed by 
this section shall be assessed in fiscal year 2007, based 
on domestic sales of tobacco products during fiscal year 
2006 and shall be assessed in each fiscal year thereafter.’’. 
SEC. 232. INTERIM FINAL RULE. 
(a) CIGARETTES AND SMOKELESS TOBACCO.— 
(1) IN GENERAL.—Not later than 30 days after 
the date of enactment of this Act, the Secretary of 
Health and Human Services shall publish in the 
Federal Register an interim final rule regarding 
cigarettes and smokeless tobacco, which is hereby 
deemed to be in compliance with the Administrative 
Procedures Act and other applicable law. 
(2) CONTENTS OF RULE.—Except as provided 
in this subsection, the interim final rule published 
under paragraph (1), shall be identical in its provi-
sions to part 897 of the regulations promulgated by 
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161 
the Secretary of Health and Human Services in the 
August 28, 1996, issue of the Federal Register (61 
Fed. Reg., 44615–44618). Such rule shall— 
(A) provide for the designation of jurisdic-
tional authority that is in accordance with this 
subsection; 
(B) strike Subpart C—Labeling and sec-
tion 897.32(c); and 
(C) become effective not later than 1 year 
after the date of enactment of this Act. 
(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 the Administrative Procedures 
Act. 
(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 the Administrative 
Procedures Act, the regulation promulgated pursu-
ant to this section. 
(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 
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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 entitled ‘‘Regulations Restricting the Sale 
and Distribution of Cigarettes and Smokeless To-
bacco Products to Protect Children and Adoles-
cents’’ (60 Fed. Reg. 41314–41372 (August 11, 
1995)). 
(2) The document entitled ‘‘Nicotine in Ciga-
rettes 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 entitled ‘‘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 entitled ‘‘Nicotine in Ciga-
rettes and Smokeless Tobacco is a Drug and These 
Products are Nicotine Delivery Devices Under the 
Federal Food, Drug, and Cosmetic Act; Jurisdic-
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tional Determination’’ (61 Fed. Reg. 44619–45318 
(August 28, 1996)). 
SEC. 233. 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 
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), by striking ‘‘515(f), or 
519’’ and inserting ‘‘515(f), 519, or 909’’; 
(5) in subsection (g), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(6) in subsection (h), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
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(7) in subsection (j), by striking ‘‘708, or 721’’ 
and inserting ‘‘708, 721, 904, 905, 906, 907, 908, 
909, or section 921(b)’’; 
(8) in subsection (k), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(9) by striking subsection (p) and inserting the 
following: 
‘‘(p) The failure to register in accordance with section 
510 or 905, the failure to provide any information 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)(2).’’; 
(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)(8), or 908, or 
condition 
prescribed 
under 
section 
903(b)(6)(B)(ii)(II); 
‘‘(B) to furnish any notification or other mate-
rial or information required by or under section 519, 
520(g), 904, 909, or section 921; or 
‘‘(C) to comply with a requirement under sec-
tion 522 or 913.’’; 
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(11) in subsection (q)(2), by striking ‘‘device,’’ 
and inserting ‘‘device or tobacco product,’’; 
(12) in subsection (r), by inserting ‘‘or tobacco 
product’’ after ‘‘device’’ each time that it appears; 
and 
(13) by adding at the end the following: 
‘‘(aa) The sale of tobacco products in violation of a 
no-tobacco-sale order issued under section 303(f). 
‘‘(bb) The introduction or delivery for introduction 
into interstate commerce of a tobacco product in violation 
of section 911. 
‘‘(cc)(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. 
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166 
‘‘(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. 
‘‘(dd) The charitable distribution of tobacco products. 
‘‘(ee) The failure of a manufacturer or distributor to 
notify the Attorney General of their knowledge of tobacco 
products used in illicit trade.’’. 
(c) SECTION 303.—Section 303 (21 U.S.C. 333(f)) 
is amended in subsection (f)— 
(1) by striking the subsection heading and in-
serting the following: 
‘‘(f) CIVIL
PENALTIES; NO-TOBACCO-SALE
OR-
DERS.—’’; 
(2) in paragraph (1)(A), by inserting ‘‘or to-
bacco products’’ after ‘‘devices’’; 
(3) in paragraph (2)(C), by striking ‘‘paragraph 
(3)(A)’’ and inserting ‘‘paragraph (4)(A)’’; 
(4) by redesignating paragraphs (3), (4), and 
(5) as paragraphs (4), (5), and (6), and inserting 
after paragraph (2) the following: 
‘‘(3) 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 
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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).’’; 
(5) in paragraph (4) as so redesignated— 
(A) in subparagraph (A)— 
(i) by striking ‘‘assessed’’ the first 
time it appears and inserting ‘‘assessed, or 
a no-tobacco-sale order may be imposed,’’; 
and 
(ii) by striking ‘‘penalty’’ and insert-
ing ‘‘penalty, or upon whom a no-tobacco- 
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 
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(C) by adding at the end, the following: 
‘‘(D) The Secretary may compromise, mod-
ify, or terminate, with or without conditions, 
any no-tobacco-sale order.’’; 
(6) in paragraph (5) as so redesignated— 
(A) by striking ‘‘(3)(A)’’ as redesignated, 
and inserting ‘‘(4)(A)’’; 
(B) by inserting ‘‘or the imposition of a 
no-tobacco-sale order’’ after ‘‘penalty’’ the first 
2 places it appears; and 
(C) by striking ‘‘issued.’’ and inserting 
‘‘issued, or on which the no-tobacco-sale order 
was imposed, as the case may be.’’; and 
(7) in paragraph (6), as so redesignated, by 
striking ‘‘paragraph (4)’’ each place it appears and 
inserting ‘‘paragraph (5)’’. 
(d) SECTION 304.—Section 304 (21 U.S.C. 334) is 
amended— 
(1) in subsection (a)(2)— 
(A) by striking ‘‘and’’ before ‘‘(D)’’; and 
(B) by striking ‘‘device.’’ and inserting the 
following: ‘‘, (E) Any adulterated or misbranded 
tobacco product.’’; 
(2) in subsection (d)(1), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
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169 
(3) in subsection (g)(1), by inserting ‘‘or to-
bacco product’’ after ‘‘device’’ each place it appears; 
and 
(4) in subsection (g)(2)(A), by inserting ‘‘or to-
bacco product’’ after ‘‘device’’ each place it appears. 
(e) SECTION
702.—Section 702(a) (21 U.S.C. 
372(a)) is amended— 
(1) by inserting ‘‘(1)’’ after ‘‘(a)’’; and 
(2) by adding at the end thereof the following: 
‘‘(2) For a tobacco product, to the extent feasible, 
the Secretary shall contract with the States in accordance 
with paragraph (1) to carry out inspections of retailers 
within that State in connection with the enforcement of 
this Act.’’. 
(f) SECTION 703.—Section 703 (21 U.S.C. 373) is 
amended— 
(1) by inserting ‘‘tobacco product,’’ after ‘‘de-
vice,’’ each place it appears; and 
(2) by inserting ‘‘tobacco products,’’ after ‘‘de-
vices,’’ each place it appears. 
(g) SECTION 704.—Section 704 (21 U.S.C. 374) is 
amended— 
(1) in subsection (a)(1)(A), by inserting ‘‘to-
bacco products,’’ after ‘‘devices,’’ each place it ap-
pears; 
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170 
(2) in subsection (a)(1)(B), by inserting ‘‘or to-
bacco product’’ after ‘‘restricted devices’’ each place 
it appears; and 
(3) in subsection (b), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’. 
(h) SECTION
705.—Section 705(b) (21 U.S.C. 
375(b)) is amended by inserting ‘‘tobacco products,’’ after 
‘‘devices,’’. 
(i) SECTION 709.—Section 709 (21 U.S.C. 379) is 
amended by inserting ‘‘or tobacco product’’ after ‘‘device’’. 
(j) SECTION 801.—Section 801 (21 U.S.C. 381) is 
amended— 
(1) in subsection (a)— 
(A) by inserting ‘‘tobacco products,’’ after 
‘‘devices,’’ the first time it appears; 
(B) by inserting ‘‘or section 905(j)’’ after 
‘‘section 510’’; and 
(C) by striking ‘‘drugs or devices’’ each 
time it appears and inserting ‘‘drugs, devices, 
or tobacco products’’; 
(2) in subsection (e)(1), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; and 
(3) by adding at the end the following: 
‘‘(p)(1) Not later than 2 years after the date of enact-
ment of the Family Smoking Prevention and Tobacco 
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171 
Control Act, and annually thereafter, the Secretary shall 
submit to the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Committee on Energy 
and Commerce of the House of 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.’’. 
(k) SECTION 1003.—Section 1003(d)(2)(C) (as re-
designated by section 231(a)) is amended— 
(1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and 
(2) inserting a comma and ‘‘and tobacco prod-
ucts’’ after ‘‘devices’’. 
(l) GUIDANCE AND EFFECTIVE DATES.— 
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(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) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 333(f)) as 
amended by subsection (c), by identifying the 
number of violations of particular requirements 
over a specified period of time at a particular 
retail outlet that constitute a repeated violation; 
(B) providing for timely and effective no-
tice to the retailer of each alleged violation at 
a particular retail outlet; 
(C) providing for an expedited procedure 
for the administrative appeal of an alleged vio-
lation; 
(D) providing that a person may not be 
charged with a violation at a particular retail 
outlet unless the Secretary has provided notice 
to the retailer of all previous violations at that 
outlet; 
(E) establishing a period of time during 
which, if there are no violations by a particular 
retail outlet, that outlet will not be considered 
to have been the site of repeated violations 
when the next violation occurs; and 
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173 
(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. 
(2) GENERAL EFFECTIVE DATE.—The amend-
ments made by subsection (c), other than the 
amendment made by paragraph (2) of such sub-
section, shall take effect upon the issuance of guid-
ance described in paragraph (1). 
(3) SPECIAL
EFFECTIVE
DATE.—The amend-
ments made by paragraph (2) of subsection (c) shall 
take effect on the date of enactment of this Act. 
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174 
PART II—TOBACCO PRODUCT WARNINGS; CON-
STITUENT AND SMOKE CCONSTITUENT DIS-
CLOSURE 
SEC. 235. CIGARETTE LABEL AND ADVERTISING WARNINGS. 
Section 4 of the Federal Cigarette Labeling and Ad-
vertising Act (15 U.S.C. 1333) is amended to read as fol-
lows: 
‘‘SEC. 4. LABELING. 
‘‘(a) LABEL REQUIREMENTS.— 
‘‘(1) IN GENERAL.—It shall be unlawful for any 
person to manufacture, package, sell, offer to sell, 
distribute, or import for sale or distribution within 
the United States any cigarettes the package of 
which fails to bear, in accordance with the 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 dis-
ease 
‘‘ ‘WARNING: Cigarettes cause cancer 
‘‘ ‘WARNING: Cigarettes cause strokes and 
heart disease 
‘‘ ‘WARNING: Smoking during pregnancy can 
harm your baby 
‘‘ ‘WARNING: Smoking can kill you 
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‘‘ ‘WARNING: Tobacco smoke causes fatal lung 
disease in non-smokers 
‘‘ ‘WARNING: Quitting smoking now greatly 
reduces serious risks to your health’. 
‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.— 
‘‘(A) IN GENERAL.—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 under-
neath the cellophane or other clear wrapping. 
Except as provided in subparagraph (B), each 
label statement shall comprise at least the top 
30 percent of the front and rear panels of the 
package. The word ‘WARNING’ shall appear in 
capital letters and all text shall be in con-
spicuous and legible 17-point type, unless the 
text of the label statement would occupy more 
than 70 percent of such area, in which case the 
text may be in a smaller conspicuous and leg-
ible type size, provided that at least 60 percent 
of such area is occupied by required text. The 
text shall be black on a white background, or 
white on a black background, in a manner that 
contrasts, by typography, layout, or color, with 
all other printed material on the package, in an 
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