103
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 
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 (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)—
‘‘(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
105
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 102 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). 
‘‘(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
106
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 
(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
107
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, 
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
108
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 a 
11-member advisory committee, to be known as the ‘To-
bacco Products Scientific Advisory Committee’. 
‘‘(b) MEMBERSHIP.—
‘‘(1) IN GENERAL.—
109
‘‘(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; 
‘‘(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.
110
‘‘(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; 
‘‘(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
111
‘‘(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. 
‘‘(2) ADMINISTRATIVE
SUPPORT.—The Sec-
retary shall furnish the Advisory Committee clerical 
and other assistance.
112
‘‘(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 
‘‘(3) review and consider the evidence for addi-
tional indications for nicotine replacement products, 
such as for craving relief or relapse prevention.
113
‘‘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 2005, 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.—
‘‘(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
114
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; 
‘‘(vi) 0.06 percent shall be assessed on 
manufacturers and importers of pipe to-
bacco; and
115
‘‘(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—
‘‘(A) for fiscal year 2005 shall be 
$85,000,000; 
‘‘(B) for fiscal year 2006 shall be 
$175,000,000;
116
‘‘(C) for fiscal year 2007 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 
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
117
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-
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.
118
‘‘(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; 
‘‘(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.