146 
any sample of a tobacco product to any individual who has 
not attained the minimum age established by applicable 
law for the purchase of such product.’’. 
(3) AMENDMENTS TO RULE.—Prior to making 
amendments to the rule published under paragraph 
(1), the Secretary shall promulgate a proposed rule in 
accordance with chapter 5 of title 5, United States 
Code. 
(4) RULE OF CONSTRUCTION.—Except as pro-
vided in paragraph (3), nothing in this section shall 
be construed to limit the authority of the Secretary to 
amend, in accordance with chapter 5 of title 5, 
United States Code, the regulation promulgated pur-
suant to this section, including the provisions of such 
regulation relating to distribution of free samples. 
(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 implementing 
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 quali-
fied adult-only facility (as such term is defined in 
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147 
section 897.16(d) of the final rule published under 
paragraph (1)) that is also a retailer and that com-
mits a violation as a retailer shall not be subject to 
the limitations in section 103(q) and shall be subject 
to penalties applicable to a qualified adult-only facil-
ity. 
(7) CONGRESSIONAL REVIEW PROVISIONS.—Sec-
tion 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 con-
stitute advisory opinions under section 10.85(d)(1) of title 
21, Code of Federal Regulations, except as they apply to 
tobacco products, and shall not be cited by the Secretary 
of Health and Human Services or the Food and Drug Ad-
ministration as binding precedent: 
(1) The preamble to the proposed rule in the doc-
ument titled ‘‘Regulations Restricting the Sale and 
Distribution of Cigarettes and Smokeless Tobacco 
Products to Protect Children and Adolescents’’ (60 
Fed. Reg. 41314–41372 (August 11, 1995)). 
(2) The document titled ‘‘Nicotine in Cigarettes 
and Smokeless Tobacco Products is a Drug and These 
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148 
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 Products 
are Nicotine Delivery Devices Under the Federal 
Food, Drug, and Cosmetic Act; Jurisdictional Deter-
mination’’ (61 Fed. Reg. 44619–45318 (August 28, 
1996)). 
SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GEN-
ERAL PROVISIONS. 
(a) AMENDMENT OF FEDERAL FOOD, DRUG, AND COS-
METIC ACT.—Except as otherwise expressly provided, when-
ever in this section an amendment is expressed in terms 
of an amendment to, or repeal of, a section or other provi-
sion, 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— 
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149 
(1) in subsection (a), by inserting ‘‘tobacco prod-
uct,’’ after ‘‘device,’’; 
(2) in subsection (b), by inserting ‘‘tobacco prod-
uct,’’ after ‘‘device,’’; 
(3) in subsection (c), by inserting ‘‘tobacco prod-
uct,’’ after ‘‘device,’’; 
(4) in subsection (e)— 
(A) by striking the period after ‘‘572(i)’’; 
and 
(B) by striking ‘‘or 761 or the refusal to 
permit access to’’ and inserting ‘‘761, 909, or 
921 or the refusal to permit access to’’; 
(5) in subsection (g), by inserting ‘‘tobacco prod-
uct,’’ after ‘‘device,’’; 
(6) in subsection (h), by inserting ‘‘tobacco prod-
uct,’’ after ‘‘device,’’; 
(7) in subsection (j)— 
(A) by striking the period after ‘‘573’’; and 
(B) by striking ‘‘708, or 721’’ and inserting 
‘‘708, 721, 904, 905, 906, 907, 908, 909, or 
921(b)’’; 
(8) in subsection (k), by inserting ‘‘tobacco prod-
uct,’’ after ‘‘device,’’; 
(9) by striking subsection (p) and inserting the 
following: 
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‘‘(p) The failure to register in accordance with section 
510 or 905, the failure to provide any information required 
by section 510(j), 510(k), 905(i), or 905(j), or the failure 
to provide a notice required by section 510(j)(2) or 
905(i)(3).’’; 
(10) by striking subsection (q)(1) and inserting 
the following: 
‘‘(q)(1) The failure or refusal— 
‘‘(A) to comply with any requirement prescribed 
under section 518, 520(g), 903(b), 907, 908, or 916; 
‘‘(B) to furnish any notification or other mate-
rial or information required by or under section 519, 
520(g), 904, 909, or 921; or 
‘‘(C) to comply with a requirement under section 
522 or 913.’’; 
(11) in subsection (q)(2), by striking ‘‘device,’’ 
and inserting ‘‘device or tobacco product,’’; 
(12) in subsection (r), by inserting ‘‘or tobacco 
product’’ after the term ‘‘device’’ each time that such 
term appears; and 
(13) by adding at the end the following: 
‘‘(oo) The sale of tobacco products in violation of a 
no-tobacco-sale order issued under section 303(f). 
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151 
‘‘(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 falsely 
representing, or without proper authority using any mark, 
stamp (including tax stamp), tag, label, or other identifica-
tion device upon any tobacco product or container or label-
ing thereof so as to render such tobacco product a counterfeit 
tobacco product. 
‘‘(2) Making, selling, disposing of, or keeping in posses-
sion, control, or custody, or concealing any punch, die, 
plate, stone, or other item that is designed to print, imprint, 
or reproduce the trademark, trade name, or other identi-
fying mark, imprint, or device of another or any likeness 
of any of the foregoing upon any tobacco product or con-
tainer or labeling thereof so as to render such tobacco prod-
uct 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 counter-
feit 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 Treas-
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152 
ury of their knowledge of tobacco products used in illicit 
trade. 
‘‘(tt) With respect to a tobacco product, any statement 
directed to consumers through the media or through the 
label, labeling, or advertising that would reasonably be ex-
pected to result in consumers believing that the product is 
regulated, inspected or approved by the Food and Drug Ad-
ministration, or that the product complies with the require-
ments of the Food and Drug Administration, including a 
statement or implication in the label, labeling, or adver-
tising of such product, and that could result in consumers 
believing that the product is endorsed for use by the Food 
and Drug Administration or in consumers being misled 
about the harmfulness of the product because of such regula-
tion, inspection, or compliance.’’. 
(c) SECTION 303.—Section 303(f) (21 U.S.C. 333(f)) 
is amended— 
(1) in paragraph (1)(A), by inserting ‘‘or to-
bacco products’’ after the term ‘‘devices’’ each place 
such term appears; 
(2) in paragraph (5)— 
(A) in subparagraph (A)— 
(i) by striking ‘‘assessed’’ the first time 
it appears and inserting ‘‘assessed, or a no- 
tobacco-sale order may be imposed,’’; and 
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153 
(ii) by striking ‘‘penalty’’ the second 
time it appears and inserting ‘‘penalty, or 
upon whom a no-tobacco-sale order is to be 
imposed,’’; 
(B) in subparagraph (B)— 
(i) by inserting after ‘‘penalty,’’ the 
following: ‘‘or the period to be covered by a 
no-tobacco-sale order,’’; and 
(ii) by adding at the end the following: 
‘‘A no-tobacco-sale order permanently pro-
hibiting an individual retail outlet from 
selling tobacco products shall include provi-
sions that allow the outlet, after a specified 
period of time, to request that the Secretary 
compromise, modify, or terminate the 
order.’’; and 
(C) by adding at the end the following: 
‘‘(D) The Secretary may compromise, modify, or ter-
minate, with or without conditions, any no-tobacco-sale 
order.’’; 
(3) in paragraph (6)— 
(A) by inserting ‘‘or the imposition of a no- 
tobacco-sale order’’ after the term ‘‘penalty’’ each 
place such term appears; and 
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154 
(B) by striking ‘‘issued.’’ and inserting 
‘‘issued, or on which the no-tobacco-sale order 
was imposed, as the case may be.’’; and 
(4) by adding at the end the following: 
‘‘(8) If the Secretary finds that a person has 
committed repeated violations of restrictions promul-
gated under section 906(d) at a particular retail out-
let then the Secretary may impose a no-tobacco-sale 
order on that person prohibiting the sale of tobacco 
products in that outlet. A no-tobacco-sale order may 
be imposed with a civil penalty under paragraph (1). 
Prior to the entry of a no-sale order under this para-
graph, a person shall be entitled to a hearing pursu-
ant to the procedures established through regulations 
of the Food and Drug Administration for assessing 
civil money penalties, including at a retailer’s request 
a hearing by telephone, or at the nearest regional or 
field office of the Food and Drug Administration, or 
at a Federal, State, or county facility within 100 
miles from the location of the retail outlet, if such a 
facility is available.’’. 
(d) SECTION 304.—Section 304 (21 U.S.C. 334) is 
amended— 
(1) in subsection (a)(2)— 
(A) by striking ‘‘and’’ before ‘‘(D)’’; and 
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155 
(B) by striking ‘‘device.’’ and inserting the 
following: ‘‘device, and (E) Any adulterated or 
misbranded tobacco product.’’; 
(2) in subsection (d)(1), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(3) in subsection (g)(1), by inserting ‘‘or tobacco 
product’’ after the term ‘‘device’’ each place such term 
appears; and 
(4) in subsection (g)(2)(A), by inserting ‘‘or to-
bacco product’’ after ‘‘device’’. 
(e) SECTION
505.—Section 505(n)(2) (21 U.S.C. 
355(n)(2)) is amended by striking ‘‘section 904’’ and insert-
ing ‘‘section 1004’’. 
(f) SECTION 523.—Section 523(b)(2)(D) (21 U.S.C. 
360m(b)(2)(D)) is amended by striking ‘‘section 903(g)’’ 
and inserting ‘‘section 1003(g)’’. 
(g) SECTION 702.—Section 702(a) (21 U.S.C. 372(a)) 
is amended by adding at the end of paragraph (1) the fol-
lowing: ‘‘For a tobacco product, to the extent feasible, the 
Secretary shall contract with the States in accordance with 
this paragraph to carry out inspections of retailers within 
that State in connection with the enforcement of this Act.’’. 
(h) SECTION 703.—Section 703 (21 U.S.C. 373) is 
amended— 
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(1) by inserting ‘‘tobacco product,’’ after the 
term ‘‘device,’’ each place such term appears; and 
(2) by inserting ‘‘tobacco products,’’ after the 
term ‘‘devices,’’ each place such term appears. 
(i) SECTION 704.—Section 704 (21 U.S.C. 374) is 
amended— 
(1) in subsection (a)(1)(A), by inserting ‘‘tobacco 
products,’’ after the term ‘‘devices,’’ each place such 
term appears; 
(2) in subsection (a)(1)(B), by inserting ‘‘or to-
bacco products’’ after the term ‘‘restricted devices’’ 
each place such term appears; 
(3) in subsection (b), by inserting ‘‘tobacco prod-
uct,’’ after ‘‘device,’’; and 
(4) in subsection (g)(13), by striking ‘‘section 
903(g)’’ and inserting ‘‘section 1003(g)’’. 
(j) SECTION 705.—Section 705(b) (21 U.S.C. 375(b)) 
is amended by inserting ‘‘tobacco products,’’ after ‘‘de-
vices,’’. 
(k) SECTION 709.—Section 709 (21 U.S.C. 379a) is 
amended by inserting ‘‘tobacco product,’’ after ‘‘device,’’. 
(l) SECTION 801.—Section 801 (21 U.S.C. 381) is 
amended— 
(1) in subsection (a)— 
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(A) by inserting ‘‘tobacco products,’’ after 
the term ‘‘devices,’’ ; 
(B) by inserting ‘‘or section 905(h)’’ after 
‘‘section 510’’; and 
(C) by striking the term ‘‘drugs or devices’’ 
each time such term appears and inserting 
‘‘drugs, devices, or tobacco products’’; 
(2) in subsection (e)(1), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; and 
(3) by adding at the end the following: 
‘‘(p)(1) Not later than 36 months after the date of en-
actment of the Family Smoking Prevention and Tobacco 
Control Act, and annually thereafter, the Secretary shall 
submit to the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives, a report regard-
ing— 
‘‘(A) the nature, extent, and destination of 
United States tobacco product exports that do not 
conform to tobacco product standards established pur-
suant to this Act; 
‘‘(B) the public health implications of such ex-
ports, including any evidence of a negative public 
health impact; and 
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158 
‘‘(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 redes-
ignated by section 101(b)) is amended— 
(1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and 
(2) inserting ‘‘, and tobacco products’’ after ‘‘de-
vices’’. 
(n) SECTION 1009.—Section 1009(b) (as redesignated 
by section 101(b)) is amended by striking ‘‘section 908’’ and 
inserting ‘‘section 1008’’. 
(o) SECTION 409 OF THE FEDERAL MEAT INSPECTION 
ACT.—Section 409(a) of the Federal Meat Inspection Act 
(21 U.S.C. 679(a)) is amended by striking ‘‘section 902(b)’’ 
and inserting ‘‘section 1002(b)’’. 
(p) RULE OF CONSTRUCTION.—Nothing in this section 
is intended or shall be construed to expand, contract, or 
otherwise modify or amend the existing limitations on State 
government authority over tribal restricted fee or trust 
lands. 
(q) GUIDANCE AND EFFECTIVE DATES.— 
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159 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall issue guidance— 
(A) defining the term ‘‘repeated violation’’, 
as used in section 303(f)(8) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 333(f)(8)) as 
amended by subsection (c), as including at least 
5 violations of particular requirements over a 
36-month period at a particular retail outlet 
that constitute a repeated violation and pro-
viding for civil penalties in accordance with 
paragraph (2); 
(B) providing for timely and effective notice 
by certified or registered mail or personal deliv-
ery to the retailer of each alleged violation at a 
particular retail outlet prior to conducting a fol-
lowup compliance check, such notice to be sent to 
the location specified on the retailer’s registra-
tion or to the retailer’s registered agent if the re-
tailer has provider such agent information to the 
Food and Drug Administration prior to the vio-
lation; 
(C) providing for a hearing pursuant to the 
procedures established through regulations of the 
Food and Drug Administration for assessing 
civil money penalties, including at a retailer’s 
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160 
request a hearing by telephone or at the nearest 
regional or field office of the Food and Drug Ad-
ministration, and providing for an expedited 
procedure for the administrative appeal of an al-
leged 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 out-
let; 
(E) establishing that civil money penalties 
for multiple violations shall increase from one 
violation to the next violation pursuant to para-
graph (2) within the time periods provided for 
in such paragraph; 
(F) providing that good faith reliance on 
the presentation of a false government-issued 
photographic identification that contains a date 
of birth does not constitute a violation of any 
minimum age requirement for the sale of tobacco 
products if the retailer has taken effective steps 
to prevent such violations, including— 
(i) adopting and enforcing a written 
policy against sales to minors; 
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161 
(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 compromise, 
modify, or terminate such an order, to consider 
whether the retailer has taken effective steps to 
prevent violations of the minimum age require-
ments for the sale of tobacco products, including 
the steps listed in subparagraph (F). 
(2) PENALTIES FOR VIOLATIONS.— 
(A) IN GENERAL.—The amount of the civil 
penalty to be applied for violations of restric-
tions promulgated under section 906(d), as de-
scribed in paragraph (1), shall be as follows: 
(i) With respect to a retailer with an 
approved training program, the amount of 
the civil penalty shall not exceed— 
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162 
(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. 
(ii) With respect to a retailer that does 
not have an approved training program, the 
amount of the civil penalty shall not ex-
ceed— 
(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; 
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163 
(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-
plies with standards developed by the Food and 
Drug Administration for such programs. 
(C) 
CONSIDERATION
OF
STATE
PEN-
ALTIES.—The Secretary shall coordinate with the 
States in enforcing the provisions of this Act 
and, for purposes of mitigating a civil penalty 
to be applied for a violation by a retailer of any 
restriction promulgated under section 906(d), 
shall consider the amount of any penalties paid 
by the retailer to a State for the same violation. 
(3) GENERAL
EFFECTIVE
DATE.—The amend-
ments made by paragraphs (2), (3), and (4) of sub-
section (c) shall take effect upon the issuance of guid-
ance described in paragraph (1) of this subsection. 
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164 
(4) SPECIAL EFFECTIVE DATE.—The amendment 
made by subsection (c)(1) shall take effect on the date 
of enactment of this Act. 
(5) PACKAGE LABEL REQUIREMENTS.—The pack-
age label requirements of paragraphs (2), (3), and (4) 
of section 903(a) of the Federal Food, Drug, and Cos-
metic Act (as amended by this Act) shall take effect 
on the date that is 12 months after the date of enact-
ment of this Act. The effective date shall be with re-
spect to the date of manufacture, provided that, in 
any case, 30 days after such effective date, a manu-
facturer shall not introduce into the domestic com-
merce of the United States any product that is not in 
conformance with section 903(a)(2), (3), and (4) and 
section 920(a) of the Federal Food, Drug, and Cos-
metic Act. 
(6) ADVERTISING
REQUIREMENTS.—The adver-
tising requirements of section 903(a)(8) of the Federal 
Food, Drug, and Cosmetic Act (as amended by this 
Act) shall take effect on the date that is 12 months 
after the date of enactment of this Act. 
SEC. 104. STUDY ON RAISING THE MINIMUM AGE TO PUR-
CHASE TOBACCO PRODUCTS. 
The Secretary of Health and Human Services shall— 
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165 
(1) convene an expert panel to conduct a study 
on the public health implications of raising the min-
imum age to purchase tobacco products; and 
(2) not later than 5 years after the date of the 
enactment of this Act, submit a report to the Congress 
on the results of such study. 
SEC. 105. TOBACCO INDUSTRY CONCENTRATION. 
(a) STUDY.—The Federal Trade Commission shall 
conduct a study on the causes and effects of concentration 
in the tobacco industry. 
(b) PUBLIC REPORT.—The Federal Trade Commission 
shall transmit to Congress a report not later than 5 years 
after the date of enactment of this Act, and a subsequent 
report on the date that is 10 years after the date of enact-
ment of this Act. Such reports shall include— 
(1) an analysis of trends in the market share of 
any dominant tobacco product manufacturer in any 
class of tobacco products; or 
(2) an analysis of trends in competition or the 
emergence of a monopoly; and 
(3) recommendations to Congress on any correc-
tive actions that should be taken to address tobacco 
industry concentration. 
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TITLE 
II—TOBACCO 
PRODUCT 
WARNINGS; 
CONSTITUENT 
AND 
SMOKE 
CONSTITUENT 
DISCLOSURE 
SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS. 
(a) AMENDMENT.—Section 4 of the Federal Cigarette 
Labeling and Advertising Act (15 U.S.C. 1333) is amended 
to read as follows: 
‘‘SEC. 4. LABELING. 
‘‘(a) LABEL REQUIREMENTS.— 
‘‘(1) IN GENERAL.—It shall be unlawful for any 
person to manufacture, package, sell, offer to sell, dis-
tribute, or import for sale or distribution within the 
United States any cigarettes the package of which 
fails to bear, in accordance with the requirements of 
this section, one of the following labels: 
‘‘WARNING: Cigarettes are addictive. 
‘‘WARNING: Tobacco smoke can harm your 
children. 
‘‘WARNING: Cigarettes cause fatal lung 
disease. 
‘‘WARNING: Cigarettes cause cancer. 
‘‘WARNING: Cigarettes cause strokes and 
heart disease. 
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‘‘WARNING: Smoking during pregnancy 
can harm your baby. 
‘‘WARNING: Smoking can kill you. 
‘‘WARNING: Tobacco smoke causes fatal 
lung disease in nonsmokers. 
‘‘WARNING: Quitting smoking now greatly 
reduces serious risks to your health. 
‘‘(2) PLACEMENT; 
TYPOGRAPHY; 
ETC.—Each 
label statement required by paragraph (1) shall be lo-
cated in the upper portion of the front and rear pan-
els of the package, directly on the package underneath 
the cellophane or other clear wrapping. 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 conspicuous and legible 17-point type, 
unless the text of the label statement would occupy 
more than 70 percent of such area, in which case the 
text may be in a smaller conspicuous and legible type 
size, provided that at least 60 percent of such area is 
occupied by required text. The text shall be black on 
a white background, or white on a black background, 
in a manner that contrasts, by typography, layout, or 
color, with all other printed material on the package, 
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