I

107TH CONGRESS

1ST SESSION H. R. 1097

To amend the Federal Food, Drug, and Cosmetic Act with respect to tobacco

products, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

MARCH 20, 2001

Mr. GANSKE (for himself, Mr. DINGELL, Mr. BALDACCI, Mr. BARTLETT of

Maryland, Mr. BEREUTER, Mr. BLUMENAUER, Mrs. BONO, Mrs. CAPPS,

Mr. DEFAZIO, Ms. DEGETTE, Mr. DOGGETT, Ms. ESHOO, Mr. EVANS,

Mr. FRANK, Mr. GALLEGLY, Mr. GILMAN, Mr. GREEN of Texas, Mr.

HANSEN, Mr. HINCHEY, Mr. HORN, Ms. KAPTUR, Mr. KIND, Mr.

KUCINICH, Mr. LAFALCE, Mr. LEACH, Mr. LIPINSKI, Mr. LUTHER, Mrs.

MALONEY of New York, Mr. MCDERMOTT, Mr. MCGOVERN, Mr. MEEHAN, Mr. MORAN of Virginia, Mrs. MORELLA, Mr. NADLER, Mr.

NETHERCUTT, Mr. OLVER, Mr. PALLONE, Mr. PAYNE, Ms. ROYBAL-ALLARD, Ms. SCHAKOWSKY, Mr. SNYDER, Mr. STARK, Mr. STUPAK, Mrs.

TAUSCHER, Mr. THOMPSON of California, Mr. UDALL of New Mexico,

Mr. UNDERWOOD, Mr. WAXMAN, Mr. WEINER, and Mr. WELLER) 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 with

respect to tobacco products, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
2

•HR 1097 IH

1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘FDA Tobacco Author3 ity Amendments Act’’.

4 SEC. 2. FINDINGS.

5 The Congress finds as follows:

6 (1) Tobacco products are addictive.

7 (2) Such products cause over 400,000 deaths

8 each year in the United States.

9 (3) The Supreme Court has held that there is

10 no congressional intent to provide the Food and

11 Drug Administration with the authority to regulate

12 tobacco products.

13 (4) The Congress should amend the Federal

14 Food, Drug, and Cosmetic Act to provide the Food

15 and Drug Administration with the authority to regu16 late tobacco products.

17 SEC. 3. DEFINITIONS.

18 (a) DRUG.—Section 201(g)(1) of the Federal Food,

19 Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)) is amend20 ed by inserting after the first sentence the following:

21 ‘‘Such term includes nicotine in a tobacco product.’’.

22 (b) DEVICES.—Section 201(h) of the Federal Food,

23 Drug, and Cosmetic Act (21 U.S.C. 321(h)) is amended

24 by adding at the end the following: ‘‘Such term includes

25 a tobacco product.’’.
3

•HR 1097 IH

1 (c) OTHER DEFINITIONS.—Section 201 of the Fed2 eral Food, Drug, and Cosmetic Act (21 U.S.C. 321) is

3 amended by adding at the end the following:

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

5 made or derived from tobacco that is intended for human

6 consumption.’’.

7 SEC. 4. AMENDMENTS TO CHAPTER V.

8 (a) MISBRANDING.—Section 502 of the Federal

9 Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amend10 ed by adding at the end the following:

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

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

13 (b) CLARIFICATION OF AUTHORITY REGARDING AD14 VERTISING AND PROMOTION; EQUAL TREATMENT OF RE15 TAIL OUTLETS.—Section 520(e) of the Federal Food,

16 Drug, and Cosmetic Act (21 U.S.C. 360j(e)) is amended

17 by adding at the end the following:

18 ‘‘(3) In the case of tobacco products:

19 ‘‘(A) The restrictions on sale and distribution

20 authorized by paragraph (1) shall include restric21 tions on advertising and promotion of tobacco prod22 ucts.

23 ‘‘(B) The Secretary shall ensure that such re24 strictions are applied uniformly to all entities that

25 make retail sales of tobacco products. For purposes
4

•HR 1097 IH

1 of the preceding sentence, such restrictions may not

2 exempt or apply differently to retail establishments

3 that predominantly or exclusively sell tobacco prod4 ucts.’’.

5 (c) PREEMPTION.—Section 521 of the Federal Food,

6 Drug, and Cosmetic Act (21 U.S.C. 360k) is amended—

7 (1) in subsection (a), by striking ‘‘Except as

8 provided in subsection (b)’’ and inserting ‘‘Except in

9 the case of tobacco products and as provided in sub10 section (b)’’; 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. SPECIAL PROVISIONS FOR TOBACCO PRODUCTS.

21 Chapter V of the Federal Food, Drug, and Cosmetic

22 Act (21 U.S.C. 351 et seq.) is amended by adding at the

23 end the following:
5

•HR 1097 IH

1 ‘‘Subchapter F—Special Provisions for

2 Tobacco Products

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

4 ‘‘In the case of tobacco products, an action that is

5 appropriate for the protection of public health shall be

6 deemed to provide a reasonable assurance of safety and

7 effectiveness.

8 ‘‘SEC. 566. WARNINGS REGARDING CIGARETTES AND

9 SMOKELESS TOBACCO; REGULATIONS.

10 ‘‘(a) IN GENERAL.—Not later than 18 months after

11 the date of the enactment of this subchapter, the Sec12 retary shall promulgate regulations to require warnings on

13 cigarette and smokeless tobacco labeling and advertise14 ments. The content, format, and rotation of warnings shall

15 conform to the specifications described in Title IB of the

16 Proposed Resolution entered into by the tobacco manufac17 turers and the State attorneys general on June 20, 1997.

18 ‘‘(b) REDUCED-RISK PRODUCTS.—No manufacturer

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

20 or advertisements of the tobacco product that the tobacco

21 product presents a reduced risk to health unless the Sec22 retary has determined that the tobacco product does

23 present a significantly reduced risk to public health.

24 ‘‘(c) SAVINGS PROVISION.—Subsection (a) or (b) may

25 not be construed as limiting the authority provided under
6

•HR 1097 IH

1 other provisions of this Act with respect to tobacco prod2 ucts.

3 ‘‘SEC. 567. RULE OF CONSTRUCTION REGARDING FARMERS

4 AND RELATED ENTITIES.

5 ‘‘The provisions of this Act relating to tobacco prod6 ucts shall not apply to tobacco leaf that is not in the pos7 session of the manufacturer, or to the producers of tobacco

8 leaf, including tobacco growers, tobacco warehouses, and

9 tobacco grower cooperatives, nor shall any employee of the

10 Food and Drug Administration have any authority what11 soever to enter onto a farm owned by a producer of to12 bacco leaf without the written consent of such producer.

13 Notwithstanding any other provision of this subparagraph,

14 if a producer of tobacco leaf is also a tobacco product man15 ufacturer or controlled by a tobacco product manufac16 turer, the producer shall be subject to this chapter in the

17 producer’s capacity as a manufacturer. Nothing in this

18 chapter shall be construed to grant the Secretary author19 ity to promulgate regulations on any matter that involves

20 the production of tobacco leaf or a producer thereof, other

21 than activities by a manufacturer affecting production.

22 For purposes of the preceding sentence, the term ‘con23 trolled by’ means a member of the same controlled group

24 of corporations as that term is used in section 52(a) of

25 the Internal Revenue Code of 1986, or under common con-
7

•HR 1097 IH

1 trol within the meaning of the regulations promulgated

2 under section 52(b) of such Code.’’.

3 SEC. 6. VALIDATION OF FDA RULE.

4 Effective one year after the date of the enactment

5 of this Act, all provisions of the regulations related to to6 bacco products promulgated by the Secretary of Health

7 and Human Services on August 28, 1996 (61 Fed. Reg.

8 44615–44618) shall take effect under authority of the

9 Federal Food, Drug, and Cosmetic Act as amended by this

10 Act. The Secretary shall amend the designations of au11 thorities in such regulations accordingly.

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 ‘‘(i) 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.’’.
8

•HR 1097 IH

1 SEC. 8. REPEALS.

2 Effective on the date the regulations described in sec3 tion 566(a) of the Federal Food, Drug, and Cosmetic Act

4 take effect—

5 (1) the Federal Cigarette Labeling and Adver6 tising Act (15 U.S.C. 1331 et seq.), other than sec7 tions 6, 8, 10, and 11, is repealed; and

8 (2) the Comprehensive Smokeless Tobacco

9 Health Education Act of 1986 (15 U.S.C. 4401 et

10 seq.), other than sections 3(f), 5, and 6, is repealed.

Æ