I

107TH CONGRESS

1ST SESSION H. R. 1043

To amend the Federal Food, Drug, and Cosmetic Act to provide the Food

and Drug Administration jurisdiction over tobacco.

IN THE HOUSE OF REPRESENTATIVES

MARCH 15, 2001

Mr. WAXMAN (for himself, Mr. HANSEN, Mr. MEEHAN, Mr. GANSKE, Mr.

DINGELL, Mrs. MORELLA, Mr. BROWN of Ohio, Mr. DOGGETT, Mr.

BONIOR, Ms. DEGETTE, Mrs. CAPPS, Ms. DELAURO, Mr. LANTOS, Mr.

MARKEY, Ms. ESHOO, Mr. STARK, Mr. ALLEN, Mr. MCDERMOTT, Mrs.

MINK of Hawaii, Ms. SCHAKOWSKY, Mr. OLVER, Mr. HINCHEY, Ms.

NORTON, Mrs. TAUSCHER, Mr. OBERSTAR, Mr. GEORGE MILLER of California, Ms. RIVERS, Mr. BALDACCI, Mr. PAYNE, Mr. BORSKI, Ms. ROYBAL-ALLARD, Mr. LAFALCE, Mr. DEFAZIO, Ms. SLAUGHTER, Ms.

PELOSI, Mr. COYNE, Mr. BLUMENAUER, Mrs. MALONEY of New York,

and Mr. WEXLER) introduced the following bill; which was referred to the

Committee on Energy and Commerce

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to

provide the Food and Drug Administration jurisdiction

over tobacco.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘FDA Tobacco Juris5 diction Act of 2001’’.
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1 SEC. 2. REFERENCE.

2 Whenever in this Act an amendment or repeal is ex3 pressed in terms of an amendment to, or repeal of, a sec4 tion or other provision, the reference shall be considered

5 to be made to a section or other provision of the Federal

6 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

7 SEC. 3. DEFINITIONS.

8 (a) DRUG.—Section 201(g)(1) (21 U.S.C. 321(g)(1))

9 is amended by striking ‘‘; and (D)’’ and inserting ‘‘; (D)

10 nicotine in tobacco products; and (E)’’.

11 (b) DEVICES.—Section 201(h) (21 U.S.C. 321(h)) is

12 amended by adding at the end the following: ‘‘Such term

13 includes a tobacco product.’’.

14 (c) OTHER DEFINITIONS.—Section 201 (21 U.S.C.

15 321) is amended by adding at the end the following:

16 ‘‘(kk) The term ‘tobacco product’ means any product

17 made or derived from tobacco that is intended for human

18 consumption.’’.

19 SEC. 4. AMENDMENTS TO CHAPTER V.

20 (a) MISBRANDING.—Section 502 (21 U.S.C. 360) is

21 amended by adding at the end the following:

22 ‘‘(u) In the case of a tobacco product, if it does not

23 comply with a requirement under subchapter F.’’.

24 (b) CLARIFICATION OF AUTHORITY.—Section 520(e)

25 (21 U.S.C. 360j(e)) is amended by adding at the end the

26 following:
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1 ‘‘(3) In the case of tobacco products, the restrictions

2 on sale and distribution authorized by paragraph (1) shall

3 include restrictions on advertising and promotion of to4 bacco products.’’.

5 (c) PREEMPTION.—Section 521(a) (21 U.S.C.

6 360k(a)) is amended—

7 (1) by striking ‘‘Except as provided in sub8 section (b)’’ and inserting ‘‘Except in the case of to9 bacco products and as provided in subsection (b)’’;

10 and

11 (2) by adding at the end the following:

12 ‘‘TOBACCO PRODUCTS

13 ‘‘(c) If the package or advertisement of a tobacco

14 product is required to bear a warning under this Act, no

15 statement relating to the use of the tobacco product and

16 health, other than a statement required under this Act,

17 may be required by any State or local statute or regulation

18 to be included on any package or in any advertisement

19 of such tobacco product.’’.

20 SEC. 5. VALIDATION OF THE FDA RULE.

21 (a) IN GENERAL.—All provisions of the regulations

22 related to tobacco products promulgated by the Secretary

23 of Health and Human Services on August 28, 1996 (61

24 Fed. Reg. 44396) shall be considered to be lawful, and

25 to have been lawfully promulgated, under the Federal

26 Food, Drug, and Cosmetic Act.
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1 (b) EFFECTIVE DATE.—All provisions of such regula2 tions shall take effect upon the expiration of 1 year after

3 the date of the enactment of this Act.

4 SEC. 6. SPECIAL PROVISIONS FOR TOBACCO PRODUCTS.

5 Chapter V is amended by adding at the end the fol6 lowing:

7 ‘‘Subchapter F—Special Provisions for

8 Tobacco Products

9 ‘‘SEC. 565. SPECIAL STANDARD FOR TOBACCO PRODUCTS.

10 ‘‘In the case of tobacco products, an action that pro11 vides appropriate protection of public health shall be

12 deemed to provide a reasonable assurance of safety and

13 effectiveness.

14 ‘‘SEC. 566. IMPLEMENTATION OF THE PROPOSED RESOLU15 TION.

16 ‘‘(a) ADDITIONAL RESTRICTIONS ON MARKETING,

17 ADVERTISING, AND ACCESS.—Not later than 18 months

18 after the date of the enactment of this subchapter, the

19 Secretary shall revise the regulations related to tobacco

20 products promulgated by the Secretary on August 28,

21 1996 (61 Fed. Reg. 44396) to include the additional re22 strictions on marketing, advertising, and access described

23 in Title IA and Title IC of the Proposed Resolution en24 tered into by the tobacco manufacturers and the State at25 torneys general on June 20, 1997, except that the Sec-
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1 retary shall not include an additional restriction on mar2 keting or advertising in such regulations if its inclusion

3 would violate the First Amendment to the Constitution.

4 ‘‘(b) WARNINGS.—

5 ‘‘(1) CIGARETTES AND SMOKELESS TOBACCO.—

6 Not later than 18 months after the date of the en7 actment of this subchapter, the Secretary shall pro8 mulgate regulations to require warnings on cigarette

9 and smokeless tobacco labeling and advertisements.

10 The content, format, and rotation of warnings shall

11 conform to the specifications described in Title IB of

12 the Proposed Resolution entered into by the tobacco

13 manufacturers and the State attorneys general on

14 June 20, 1997.

15 ‘‘(2) PROHIBITION.—It shall be unlawful to ad16 vertise tobacco products on any medium of electronic

17 communication subject to the jurisdiction of the

18 Federal Communications Commission.

19 ‘‘(c) INGREDIENTS.—

20 ‘‘(1) IN GENERAL.—Not later than 18 months

21 after the date of enactment of this subchapter, the

22 Secretary shall promulgate regulations relating to

23 ingredients in tobacco products. Except as provided

24 in paragraph (2), such regulations shall conform to

25 the specifications described in Title IF of the Pro-
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1 posed Resolution entered into by the tobacco manu2 facturers and the State attorneys general on June

3 20, 1997.

4 ‘‘(2) FAILURE TO ACT.—If the Secretary fails

5 to approve or disapprove an ingredient’s safety with6 in the review period prescribed under the regulations

7 under paragraph (1), such failure shall not be con8 sidered an approval of such ingredient.

9 ‘‘(d) REDUCED-RISK PRODUCTS.—No manufacturer

10 of a tobacco product may state or imply in the labeling

11 or advertisements of the tobacco product that the tobacco

12 product presents a reduced risk to health unless the Sec13 retary has determined that the tobacco product does

14 present a significantly reduced risk to health.

15 ‘‘(e) OTHER AUTHORITY.—This section does not

16 limit the authority the Secretary has under other provi17 sions of this Act with respect to tobacco products.

18 ‘‘SEC. 567. STATE TOBACCO CONTROL PROGRAMS.

19 ‘‘(a) IN GENERAL.—Effective 2 years after the date

20 of the enactment of this subchapter, a State may not re21 ceive funds under this Act for tobacco control activities

22 unless the State has put into law a State tobacco control

23 program that conforms to the model State program estab24 lished by the Secretary under subsection (b).

25 ‘‘(b) MODEL STATE PROGRAM.—
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1 ‘‘(1) GENERAL RULE.—Within one year of the

2 date of the enactment of this subchapter, the Sec3 retary shall establish a model State tobacco control

4 program.

5 ‘‘(2) PROGRAM CONTENT.—The model State to6 bacco control program established under paragraph

7 (1) shall—

8 ‘‘(A) require persons who sell tobacco

9 products to individuals for personal consump10 tion to obtain a license from the State;

11 ‘‘(B) require licensed retailers to comply

12 with the requirements under this Act that are

13 applicable to tobacco product retailers;

14 ‘‘(C) prohibit any individual from pur15 chasing tobacco products for resale or distribu16 tion to individuals under the age of 18;

17 ‘‘(D) include minimum requirements for

18 the conduct and frequency of compliance in19 spections of licensed retailers;

20 ‘‘(E) include State performance objectives,

21 including objectives for reducing the level of vio22 lations observed during compliance inspections;

23 ‘‘(F) include provisions for appropriate

24 penalties for violations of the program require-
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1 ments, including provisions for license suspen2 sion and revocation; and

3 ‘‘(G) include such other provisions as the

4 Secretary determines are appropriate to protect

5 public health.

6 ‘‘(c) FAILURE TO IMPLEMENT.—If a State fails to

7 effectively implement a State tobacco control program

8 which conforms to the Model State program established

9 under subsection (b) or if a State fails to achieve the per10 formance objectives applicable to the State under the

11 Model State program, the Secretary shall withhold up to

12 20 percent of the funds made available under this Act to

13 the State for tobacco control activities.

14 ‘‘(d) FEDERAL LICENSING PROGRAM.—Within one

15 year of the date of the enactment of this subchapter, the

16 Secretary shall establish Federal licensing requirements

17 for—

18 ‘‘(1) tobacco product retailers operating on

19 Federal property;

20 ‘‘(2) tobacco product retailers operating in a

21 State which does not put into law or effectively im22 plement a State tobacco control program which con23 forms to the Model State Program; and

24 ‘‘(3) such other tobacco product retailers as the

25 Secretary may specify.
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1 The Federal tobacco control requirements shall conform

2 to the licensing requirements of the Model State Program.

3 ‘‘(e) FEDERAL AUTHORITY.—The Secretary may

4 order a retailer licensed by a State to suspend or cease

5 selling tobacco products if the tobacco product retailer is

6 in violation of a requirement under this Act related to to7 bacco products.

8 ‘‘(f) INDIAN TRIBES.—In the case of tobacco product

9 retailers operating on Indian reservations, the governing

10 Indian tribe or tribal organization shall be treated as a

11 State.’’.

12 SEC. 7. GENERAL PROVISIONS.

13 (a) ENFORCEMENT.—Section 301 (21 U.S.C. 331) is

14 amended by adding at the end the following:

15 ‘‘(bb) The violation of any requirement under this Act

16 relating to tobacco products.’’.

17 (b) ACCESS TO INFORMATION.—Section 701 (21

18 U.S.C 371) is amended by adding at the end the following:

19 ‘‘(h) To acquire information related to tobacco prod20 ucts, the Secretary may administer oaths and require the

21 testimony of witnesses and the production of documents

22 and other materials. The Secretary may disclose to the

23 public information acquired under this subsection if the

24 Secretary determines that disclosure is appropriate to pro25 tect public health.’’.
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1 SEC. 8. REPEAL.

2 The Federal Cigarette Labeling and Advertising Act

3 (15 U.S.C. 1331 et seq.) and the Comprehensive Smoke4 less Tobacco Health Education Act of 1986 (15 U.S.C.

5 4401 et seq.) are repealed on the date the regulations de6 scribed in section 566(b) of the Federal Food, Drug, and

7 Cosmetic Act take effect.

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