II

106TH CONGRESS

2D SESSION S. 2333

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

and Drug Administration the authority to regulate the manufacture,

sale, and distribution of tobacco and other products containing nicotine,

tar, additives, and other potentially harmful constituents, and for other

purposes.

IN THE SENATE OF THE UNITED STATES

MARCH 30, 2000

Mr. REED (for himself and Mr. BINGAMAN) introduced the following bill;

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

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

grant the Food and Drug Administration the authority

to regulate the manufacture, sale, and distribution of

tobacco and other products containing nicotine, tar, additives, and other potentially harmful constituents, 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,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Tobacco Regulatory

5 Fairness Act of 2000’’.
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1 SEC. 2. FINDINGS.

2 Congress makes the following findings:

3 (1) Cigarette smoking and tobacco use cause

4 approximately 450,000 deaths each year in the

5 United States.

6 (2) Cigarette smoking accounts for approxi7 mately $65,000,000,000 in lost productivity and

8 health care costs.

9 (3) In spite of the well-established dangers of

10 cigarette smoking and tobacco use, there is no Fed11 eral agency that has any authority to regulate the

12 manufacture, sale, distribution, and use of tobacco

13 products.

14 (4) The tobacco industry spends approximately

15 $4,000,000,000 each year to promote tobacco prod16 ucts.

17 (5) Each day 3,000 children try cigarettes for

18 the first time, many of whom become lifelong ad19 dicted smokers.

20 (6) There is no minimum age requirement in

21 Federal law that an individual must reach to legally

22 buy cigarettes and other tobacco products.

23 (7) The Food and Drug Administration is the

24 most qualified Federal agency to regulate tobacco

25 products.
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1 (8) It is inconsistent for the Food and Drug

2 Administration to regulate the manufacture, sale,

3 and distribution of other nicotine-containing prod4 ucts used as substitutes for cigarette smoking and

5 tobacco use and not be able to regulate tobacco

6 products in a comparable manner.

7 SEC. 3. DEFINITIONS.

8 Section 201 of the Federal Food, Drug, and Cosmetic

9 Act (21 U.S.C. 321) is amended by adding at the end the

10 following:

11 ‘‘(kk) The term ‘tobacco product’ means cigarettes,

12 cigars, little cigars, pipe tobacco, smokeless tobacco, snuff,

13 and chewing tobacco.

14 ‘‘(ll) The term ‘tobacco additive’ means any sub15 stance the intended use of which results or may reasonably

16 be expected to result, directly or indirectly, in its becoming

17 a component or otherwise affecting the characteristics of

18 any tobacco product.

19 ‘‘(mm) The term ‘constituent’ means any element of

20 cigarette mainstream or sidestream smoke which is

21 present in quantities which represent a potential health

22 hazard or where the health effect is unknown.

23 ‘‘(nn) The term ‘tar’ means mainstream total articu24 late matter minus nicotine and water.’’.
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1 SEC. 4. ENFORCEMENT.

2 Section 301 of the Federal Food, Drug, and Cosmetic

3 Act (21 U.S.C. 331) is amended—

4 (1) in subsections (a), (b), (c), (g), and (k), by

5 striking ‘‘or cosmetic’’ and inserting ‘‘cosmetic, or

6 tobacco product’’; and

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

8 ‘‘(u) The manufacture, sale, distribution, and adver9 tising of tobacco products in violation of regulations pro10 mulgated by the Secretary pursuant to chapter X.’’.

11 SEC. 5. REGULATION OF TOBACCO PRODUCTS.

12 The Federal Food, Drug, and Cosmetic Act (21

13 U.S.C. 301 et seq.) is amended by adding at the end the

14 following:

15 ‘‘CHAPTER X—TOBACCO PRODUCTS

16 ‘‘SEC. 1000. REGULATION OF TOBACCO PRODUCTS.

17 ‘‘(a) REGULATIONS.—Not later than 1 year after the

18 date on which the Secretary receives the recommendations

19 described in section 1003(f), the Secretary shall promul20 gate regulations governing the manufacture, sale, and dis21 tribution of tobacco products in accordance with the provi22 sions of the chapter.

23 ‘‘(b) FOOD AND DRUG ADMINISTRATION.—Regula24 tions promulgated under subsection (a) shall designate the

25 Food and Drug Administration as the Federal agency that
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1 regulates the manufacture, distribution, and sale of to2 bacco products.

3 ‘‘(c) LIMITATION.—Regulations promulgated under

4 subsection (a) may not prohibit the manufacture, distribu5 tion, or sale of a tobacco product solely on the basis that

6 such product causes a disease.

7 ‘‘(d) SALE OR DISTRIBUTION.—Under regulations

8 promulgated under subsection (a) it shall be unlawful to—

9 ‘‘(1) sell a tobacco product to an individual

10 under the age of 18 years;

11 ‘‘(2) sell a tobacco product to an individual if

12 such tobacco product is intended for use by an indi13 vidual under the age of 18 years; and

14 ‘‘(3) sell or distribute a tobacco product if the

15 label of such product does not display the following

16 statement: ‘Federal Law Prohibits Sale To Minors’.

17 ‘‘(e) MANUFACTURING.—Regulations promulgated

18 under subsection (a) governing the manufacture of to19 bacco products shall—

20 ‘‘(1) require that all additives used in the man21 ufacture of tobacco products are safe; and

22 ‘‘(2) classify as a drug any nicotine-containing

23 product that does not meet the definition of a to24 bacco product.
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1 ‘‘SEC. 1001. ADULTERATED TOBACCO PRODUCTS.

2 ‘‘(a) IN GENERAL.—A tobacco product shall be

3 deemed to be adulterated—

4 ‘‘(1) if such product consists in whole or in part

5 of any filthy, putrid, or decomposed substance, or is

6 otherwise contaminated by any poisonous or delete7 rious substance that may render such product inju8 rious to health;

9 ‘‘(2) if such product has been prepared, packed,

10 or held under insanitary conditions in which such

11 product may have been contaminated with filth, or

12 in which such product may have been rendered inju13 rious to health; and

14 ‘‘(3) if the container for such product is com15 posed, in whole or in part, of any poisonous or dele16 terious substance that may render the contents of

17 such product injurious to health.

18 ‘‘(b) REGULATIONS.—The Secretary may by regula19 tion prescribe good manufacturing practices for tobacco

20 products. Such regulations may be modeled after current

21 good manufacturing practice regulations for other prod22 ucts regulated under this Act.

23 ‘‘SEC. 1002. MISBRANDED TOBACCO PRODUCTS.

24 ‘‘A tobacco product shall be deemed to be

25 misbranded—
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1 ‘‘(1) if the labeling of such product is false or

2 misleading in any particular;

3 ‘‘(2) if in package form unless such product

4 bears a label containing—

5 ‘‘(A) the name and place of business of the

6 tobacco product manufacturer, packer, or dis7 tributor; and

8 ‘‘(B) an accurate statement of the quantity

9 of the contents in terms of weight, measure, or

10 numerical count,

11 except that under subparagraph (B) of this para12 graph reasonable variations shall be permitted, and

13 exemptions as to small packages shall be established,

14 by regulations promulgated by the Secretary;

15 ‘‘(3) if any word, statement, or other informa16 tion required by or under authority of this chapter

17 to appear on the label or labeling is not prominently

18 placed thereon with such conspicuousness (as com19 pared with other words, statements or designs in the

20 labeling) and in such terms as to render it likely to

21 be read and understood by the ordinary individual

22 under customary conditions of purchase and use;

23 ‘‘(4) if such product has an established name,

24 unless its label bears, to the exclusion of any other

25 nonproprietary name, its established name is promi-
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1 nently printed in type as required by the Secretary

2 by regulation;

3 ‘‘(5) if the Secretary has issued regulations re4 quiring that the labeling of such product bear ade5 quate directions for use, or adequate warnings

6 against use by children, that are necessary for the

7 protection of users unless the labeling of such prod8 uct conforms in all respects to such regulations; and

9 ‘‘(6) if such product was manufactured, pre10 pared, propagated, or processed in an establishment

11 not duly registered as required under section 1004.

12 ‘‘SEC. 1003. ADVISORY COMMITTEE.

13 ‘‘(a) ESTABLISHMENT.—There is established in the

14 Food and Drug Administration a Tobacco and Nicotine

15 Products Advisory Committee (hereafter referred to as the

16 ‘advisory committee’).

17 ‘‘(b) PURPOSE.—The advisory committee shall assist

18 the Secretary in developing the regulations described in

19 section 1000.

20 ‘‘(c) MEMBERSHIP.—

21 ‘‘(1) IN GENERAL.—Not later than 60 days

22 after the date of enactment of this chapter, the Sec23 retary shall appoint to the advisory committee 10 in24 dividuals who are qualified by training and experi25 ence to evaluate and make recommendations regard-
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1 ing regulations governing the manufacture, distribu2 tion, sale, labeling and advertising of tobacco prod3 ucts.

4 ‘‘(2) EXPERTS.—The members described under

5 paragraph (1), not including the chairperson of such

6 advisory committee, shall consist of—

7 ‘‘(A) one expert in the field of nicotine ad8 diction;

9 ‘‘(B) one expert in the field of pharma10 cology;

11 ‘‘(C) one expert in the field of food and

12 drug law;

13 ‘‘(D) one expert in the field of public edu14 cation;

15 ‘‘(E) one expert in the field of toxicology;

16 ‘‘(F) two experts representing the interests

17 of family medicine, internal medicine, or pediat18 rics; and

19 ‘‘(G) two consumer representatives from

20 the public health community.

21 ‘‘(3) EX OFFICIO.—The advisory committee

22 shall have the following as ex officio members:

23 ‘‘(A) The Director of the National Cancer

24 Institute.
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1 ‘‘(B) The Director of the National Heart,

2 Lung, and Blood Institute.

3 ‘‘(C) The Director of National Institute on

4 Drug Abuse.

5 ‘‘(D) The Director of the Centers for Dis6 ease Control and Prevention.

7 ‘‘(E) The Surgeon General of the Public

8 Health Service.

9 ‘‘(4) CHAIRPERSON.—The chairperson of the

10 advisory committee shall be appointed by the Sec11 retary with the advice and consent of the Commis12 sioner of Food and Drugs.

13 ‘‘(d) FUNCTION.—The advisory committee shall—

14 ‘‘(1) review the available scientific evidence on

15 the effects of tobacco products on human health;

16 ‘‘(2) review the manufacturing process of to17 bacco products, including the use of additives,

18 sprayed on chemicals, product development, and

19 product manipulation;

20 ‘‘(3) review the role of nicotine as part of the

21 smoking habit, including its addictive properties and

22 health effects; and

23 ‘‘(4) review current Federal, State, and local

24 laws governing the manufacture, distribution, sale,

25 labeling and advertising of tobacco products.
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1 ‘‘(e) AUTHORITY.—The advisory committee may hold

2 hearings and receive testimony and evidence as the com3 mittee determines to be appropriate.

4 ‘‘(f) RECOMMENDATIONS.—Not later than 1 year

5 after the Secretary has appointed all members to the advi6 sory committee, such committee shall prepare and submit

7 recommendations regarding regulations to be promulgated

8 under section 1000 to the Secretary.

9 ‘‘SEC. 1004. REGISTRATION.

10 ‘‘Not later than 120 days after the date of enactment

11 of this chapter, any manufacturer directly or indirectly en12 gaged in the manufacture, distribution, or sale of tobacco

13 products shall register with the Secretary the name and

14 place of business of such manufacturer.

15 ‘‘SEC. 1005. ADVERTISING.

16 ‘‘(a) REGULATIONS.—The Federal Trade Commis17 sion, after consultation with the Secretary and upon re18 ceipt of approval by the Secretary, shall promulgate regu19 lations governing the advertising of all tobacco products.

20 ‘‘(b) LABELS.—The Federal Trade Commission,

21 after consultation with the Secretary and upon receipt of

22 approval by the Secretary, may promulgate regulations

23 that—

24 ‘‘(1) modify the warning labels required by the

25 Federal Cigarette Labeling and Advertising Act (15
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1 U.S.C. 1331 et seq.) and the Comprehensive Smoke2 less Tobacco Health Education Act of 1986 (15

3 U.S.C. 4401 et seq.) if the modification in the con4 tent of the label does not weaken the health message

5 contained in the label and is in the best interests of

6 the public health as determined by the Secretary;

7 and

8 ‘‘(2) increase the size and placement of such re9 quired labels.’’.

10 SEC. 6. CONFORMING AMENDMENTS.

11 (a) RECORDS.—Section 703 of the Federal Food,

12 Drug, and Cosmetic Act (21 U.S.C. 373) is amended—

13 (1) by striking ‘‘or cosmetics’’ each place it ap14 pears and inserting ‘‘cosmetics, or tobacco prod15 ucts’’; and

16 (2) by striking ‘‘or cosmetic’’ each place it ap17 pears and inserting ‘‘cosmetic, or tobacco product’’.

18 (b) FACTORY INSPECTIONS.—Section 704 of the Fed19 eral Food, Drug, and Cosmetic Act (21 U.S.C. 374) is

20 amended—

21 (1) in subsection (a)(1)—

22 (A) by striking ‘‘or cosmetics’’ each place

23 it appears and inserting ‘‘cosmetics, or tobacco

24 products’’; and
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1 (B) by striking ‘‘or restricted devices’’ each

2 place it appears and inserting ‘‘restricted de3 vices, or tobacco products’’; and

4 (2) in subsection (b), by striking ‘‘or cosmetic’’

5 and inserting ‘‘cosmetic, or tobacco product’’.

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