149 
‘‘(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
150 
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
151 
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
152 
Determination’’ (61 Fed. Reg. 44619–45318 (Au-
gust 28, 1996)). 
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’’;
153 
(5) in subsection (g), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(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;