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‘‘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’). 
‘‘(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; 
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‘‘(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; 
‘‘(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. 
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‘‘(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, 
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; 
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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 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. 
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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 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. 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 
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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. 
‘‘(b) REPORT ON INNOVATIVE PRODUCTS.— 
‘‘(1) IN
GENERAL.—Not later than 3 years 
after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act, the Secretary, 
after consultation with recognized scientific, medical, 
and public health experts (including both Federal 
agencies and nongovernmental entities, the Institute 
of Medicine of the National Academy of Sciences, 
and the Society for Research on Nicotine and 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. 
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‘‘(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. 
‘‘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: 
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‘‘(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. 
‘‘(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-
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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. 
‘‘(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 
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HR 1256 PCS 
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 
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-
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HR 1256 PCS 
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 
particular class of tobacco products of the total user 
fee to be paid by all manufacturers or importers of 
that class of tobacco products shall be the percent-
age determined for purposes of allocations under 
subsections (e) through (h) of section 625 of Public 
Law 108–357. 
‘‘(5) 
ALLOCATION
FOR
CIGARS.—Notwith-
standing paragraph (4), if a user fee assessment is 
imposed on cigars, the percentage share of each 
manufacturer or importer of cigars shall be based on 
the excise taxes paid by such manufacturer or im-
porter during the prior fiscal year. 
‘‘(6) TIMING OF ASSESSMENT.—The Secretary 
shall notify each manufacturer and importer of to-
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HR 1256 PCS 
bacco products subject to this section of the amount 
of the quarterly assessment imposed on such manu-
facturer or importer under this subsection for each 
quarter of each fiscal year. Such notifications shall 
occur not later than 30 days prior to the end of the 
quarter for which such assessment is made, and pay-
ments of all assessments shall be made by the last 
day of the quarter involved. 
‘‘(7) MEMORANDUM OF UNDERSTANDING.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
request the appropriate Federal agency to enter 
into a memorandum of understanding that 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 
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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-
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 
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HR 1256 PCS 
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). 
‘‘(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 
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HR 1256 PCS 
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 
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-
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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 
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 
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HR 1256 PCS 
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); 
(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 
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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 
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 
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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); 
‘‘(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 
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‘‘(III) any combination of words that 
would imply to a reasonable observer that the 
manufacturer, distributor, or retailer has a 
sponsorship 
that 
would 
violate 
section 
897.34(c). 
‘‘(D) Distribution of samples of smokeless tobacco 
under this subparagraph permitted to be taken out of the 
qualified adult-only facility shall be limited to 1 package 
per adult consumer containing no more than 0.53 ounces 
(15 grams) of smokeless tobacco. If such package of 
smokeless tobacco contains individual portions of 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 
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‘‘(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-
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 
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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. 
(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 
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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-
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 
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‘‘(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: 
‘‘(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-
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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. 
‘‘(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 
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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’’. 
(n) SECTION 1009.—Section 1009(b) (as redesig-
nated by section 101(b)) is amended by striking ‘‘section 
908’’ and inserting ‘‘section 1008’’. 
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(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); 
(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 
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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; 
(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; 
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(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 
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.— 
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(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 
(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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(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. 
(B) TRAINING PROGRAM.—For purposes of 
subparagraph (A), the term ‘‘approved training 
program’’ means a training program that com-
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