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(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 
constitute advisory opinions under section 10.85(d)(1) of 
title 21, Code of Federal Regulations, except as they apply 
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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 
Determination’’ (61 Fed. Reg. 44619–45318 (Au-
gust 28, 1996)). 
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SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GEN-
ERAL PROVISIONS. 
(a) AMENDMENT OF FEDERAL FOOD, DRUG, AND 
COSMETIC ACT.—Except as otherwise expressly provided, 
whenever in this section an amendment is expressed in 
terms of an amendment to, or repeal of, a section or other 
provision, the reference is to a section or other provision 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.). 
(b) SECTION 301.—Section 301 (21 U.S.C. 331) is 
amended— 
(1) in subsection (a), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(2) in subsection (b), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(3) in subsection (c), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(4) in subsection (e)— 
(A) by striking the period after ‘‘572(i)’’; 
and 
(B) by striking ‘‘or 761 or the refusal to 
permit access to’’ and inserting ‘‘761, 909, or 
920 or the refusal to permit access to’’; 
(5) in subsection (g), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
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(6) in subsection (h), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(7) in subsection (j)— 
(A) by striking the period after ‘‘573’’; and 
(B) by striking ‘‘708, or 721’’ and insert-
ing ‘‘708, 721, 904, 905, 906, 907, 908, 909, 
or 920(b)’’; 
(8) in subsection (k), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(9) by striking subsection (p) and inserting the 
following: 
‘‘(p) The failure to register in accordance with section 
510 or 905, the failure to provide any information re-
quired by section 510(j), 510(k), 905(i), or 905(j), or the 
failure to provide a notice required by section 510(j)(2) 
or 905(i)(3).’’; 
(10) by striking subsection (q)(1) and inserting 
the following: 
‘‘(q)(1) The failure or refusal— 
‘‘(A) to comply with any requirement prescribed 
under section 518, 520(g), 903(b), 907, 908, or 916; 
‘‘(B) to furnish any notification or other mate-
rial or information required by or under section 519, 
520(g), 904, 909, or 920; or 
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‘‘(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-
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 
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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 
being misled about the harmfulness of the product because 
of such regulation, inspection, or compliance.’’. 
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(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 
(ii) by striking ‘‘penalty’’ the second 
time it appears and inserting ‘‘penalty, or 
upon whom a no-tobacco-sale order is to be 
imposed,’’; 
(B) in subparagraph (B)— 
(i) by inserting after ‘‘penalty,’’ the 
following: ‘‘or the period to be covered by 
a no-tobacco-sale order,’’; and 
(ii) by adding at the end the fol-
lowing: ‘‘A no-tobacco-sale order perma-
nently prohibiting an individual retail out-
let from selling tobacco products shall in-
clude provisions that allow the outlet, after 
a specified period of time, to request that 
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the Secretary compromise, modify, or ter-
minate the order.’’; and 
(C) by adding at the end the following: 
‘‘(D) The Secretary may compromise, modify, or ter-
minate, with or without conditions, any no-tobacco-sale 
order.’’; 
(3) in paragraph (6)— 
(A) by inserting ‘‘or the imposition of a 
no-tobacco-sale order’’ after the term ‘‘penalty’’ 
each place such term appears; and 
(B) by striking ‘‘issued.’’ and inserting 
‘‘issued, or on which the no-tobacco-sale order 
was imposed, as the case may be.’’; and 
(4) by adding at the end the following: 
‘‘(8) If the Secretary finds that a person has 
committed repeated violations of restrictions promul-
gated under section 906(d) at a particular retail out-
let then the Secretary may impose a no-tobacco-sale 
order on that person prohibiting the sale of tobacco 
products in that outlet. A no-tobacco-sale order may 
be imposed with a civil penalty under paragraph (1). 
Prior to the entry of a no-sale order under this para-
graph, a person shall be entitled to a hearing pursu-
ant to the procedures established through regula-
tions of the Food and Drug Administration for as-
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