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‘‘(f) MEASUREMENT
OF GROSS DOMESTIC VOL-
UME.—
‘‘(1) IN
GENERAL.—Each manufacturer and 
importer of tobacco products shall submit to the 
Secretary a certified copy of each of the returns or 
forms described by this paragraph that are required 
to be filed with a Government agency on the same 
date that those returns or forms are filed, or re-
quired to be filed, with such agency. The returns 
and forms described by this paragraph are those re-
turns and forms related to the release of tobacco 
products into domestic commerce, as defined by sec-
tion 5702(k) of the Internal Revenue Code of 1986, 
and the repayment of the taxes imposed under chap-
ter 52 of such Code (ATF Form 500.24 and United 
States Customs Form 7501 under currently applica-
ble regulations). 
‘‘(2) PENALTIES.—Any person that knowingly 
fails to provide information required under this sub-
section or that provides false information under this 
subsection shall be subject to the penalties described 
in section 1003 of title 18, United States Code. In 
addition, such person may be subject to a civil pen-
alty in an amount not to exceed 2 percent of the 
value of the kind of tobacco products manufactured
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or imported by such person during the applicable 
quarter, as determined by the Secretary. 
‘‘(h) EFFECTIVE DATE.—The user fees prescribed by 
this section shall be assessed in fiscal year 2005, based 
on domestic sales of tobacco products during fiscal year 
2004 and shall be assessed in each fiscal year thereafter.’’. 
SEC. 102. INTERIM FINAL RULE. 
(a) CIGARETTES AND SMOKELESS TOBACCO.—
(1) IN GENERAL.—Not later than 30 days after 
the date of enactment of this Act, the Secretary of 
Health and Human Services shall publish in the 
Federal Register an interim final rule regarding 
cigarettes and smokeless tobacco, which is hereby 
deemed to be in compliance with the Administrative 
Procedures Act and other applicable law. 
(2) CONTENTS OF RULE.—Except as provided 
in this subsection, the interim final rule published 
under paragraph (1), shall be identical in its provi-
sions to part 897 of the regulations promulgated by 
the Secretary 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;
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(B) strike Subpart C—Labeling and sec-
tion 897.32(c); and 
(C) become effective not later than 1 year 
after the date of enactment of this Act. 
(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 the Administrative Procedures 
Act. 
(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 the Administrative 
Procedures Act, the regulation promulgated pursu-
ant to this section. 
(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 
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 entitled ‘‘Regulations Restricting the Sale
122
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 entitled ‘‘Nicotine in Ciga-
rettes 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 entitled ‘‘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 entitled ‘‘Nicotine in Ciga-
rettes and Smokeless Tobacco is a Drug and These 
Products are Nicotine Delivery Devices Under the 
Federal Food, Drug, and Cosmetic Act; Jurisdic-
tional Determination’’ (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 
COSMETIC ACT.—Except as otherwise expressly provided, 
whenever in this section an amendment is expressed in
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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), by striking ‘‘515(f), or 
519’’ and inserting ‘‘515(f), 519, or 909’’; 
(5) in subsection (g), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(6) in subsection (h), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(7) in subsection (j), by striking ‘‘708, or 721’’ 
and inserting ‘‘708, 721, 904, 905, 906, 907, 908, 
909, or section 921(b)’’; 
(8) in subsection (k), by inserting ‘‘tobacco 
product,’’ after ‘‘device,’’; 
(9) by striking subsection (p) and inserting the 
following: