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103D CONGRESS

1ST SESSION H. R. 2147

To amend the Federal Food, Drug, and Cosmetic Act to regulate the manufacture, labeling, sale, distribution, and advertising and promotion of

tobacco and other products containing nicotine, tar, additives and other

potentially harmful constituents, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

MAY 18, 1993

Mr. SYNAR (for himself, Mr. DURBIN, Mr. ANDREWS of Texas, Mr. WYDEN,

Mrs. COLLINS of Illinois, Ms. SCHENK, Mr. BLACKWELL, Mr. WHEAT,

Mr. HUFFINGTON, and Mr. EVANS) 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

regulate the manufacture, labeling, sale, distribution, and

advertising and promotion 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; REFERENCE.

4 (a) SHORT TITLE.—This Act may be cited as the

5 ‘‘Fairness in Tobacco and Nicotine Regulation Act of

6 1993’’.
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1 (b) REFERENCE.—Whenever in this Act (other than

2 sections 5(b)(1) and 5(b)(2)) an amendment or repeal is

3 expressed in terms of an amendment to, or repeal of, a

4 section or other provision, the reference shall be consid5 ered to be made to a section or other provision of the

6 Federal Food, Drug, and Cosmetic Act.

7 SEC. 2. FINDINGS.

8 The Congress finds that—

9 (1) Cigarette smoking and tobacco use account

10 for approximately 450,000 deaths each year in the

11 United States.

12 (2) Cigarette smoking accounts for approxi13 mately $65 billion in lost productivity and health

14 care costs.

15 (3) Environmental tobacco smoke is a cause of

16 disease in nonsmokers.

17 (4) In spite of well established dangers of ciga18 rette smoking and tobacco use, no Federal regu19 latory agency has the authority to regulate the man20 ufacture, sale, distribution, labeling, and advertising

21 of such products.

22 (5) Tobacco is as addictive as cocaine and

23 heroin.

24 (6) The tobacco industry spends approximately

25 $4 billion each year to promote its products.
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1 (7) The tobacco industry’s voluntary advertising

2 code which was enacted to prohibit the use of images

3 of sexual attraction, sophistication, and athletic

4 abilities and the making of implied health claims has

5 for the last 30 years not been followed or enforced.

6 (8) Each day 3,000 children try cigarettes for

7 the first time and many become life-long addicted

8 smokers.

9 (9) There is no Federal minimum age of sale of

10 cigarettes and tobacco products.

11 (10) The labeling of tobacco products is inad12 equate as to provide smokers and nonsmokers alike

13 with full and complete information about tobacco

14 products.

15 (11) The tobacco industry adds chemical addi16 tives to their products that are neither disclosed to

17 the public or tested for health and safety in a com18 parable manner to food.

19 (12) There is no listing of chemical constituents

20 found in mainstream and sidestream smoke (includ21 ing benzene, arsenic, cyanide, etc.).

22 (13) The Food and Drug Administration is the

23 most qualified Federal agency to comprehensively

24 regulate tobacco products.
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1 (14) It is inconsistent for the Food and Drug

2 Administration to regulate the manufacture, sale,

3 distribution, labeling, advertising, and promotion of

4 other nicotine containing products used as sub5 stitutes for cigarette smoking and tobacco use and

6 not be able to regulate tobacco products in a com7 parable manner.

8 SEC. 3. DEFINITIONS.

9 Section 201 (21 U.S.C. 321) is amended by adding

10 at the end thereof the following new paragraphs:

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

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

13 and chewing tobacco.

14 ‘‘(hh) 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 ‘‘(ii) 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 ‘‘(jj) The term ‘tar’ means mainstream total articu24 late matter minus nicotine and water.
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1 SEC. 4. ENFORCEMENT.

2 Section 301 (21 U.S.C. 331) is amended by adding

3 at the end thereof the following new subsection:

4 ‘‘(u) The manufacture, labeling, sale, distribution,

5 advertising, and promotion of tobacco products in violation

6 of regulations of the Secretary pursuant to section 701.’’

7 SEC. 5. REGULATION OF TOBACCO PRODUCTS.

8 (a) REGULATION.—The Federal Food, Drug, and

9 Cosmetic Act is amended by redesignating chapters VII,

10 VIII, and IX as chapters VIII, IX, and X, respectively,

11 and by adding after chapter VI the following:

12 ‘‘CHAPTER VII—TOBACCO PRODUCTS

13 ‘‘REGULATIONS

14 ‘‘SEC. 701. (a) PROMULGATION.—The Secretary

15 shall promulgate regulations governing the manufacture,

16 distribution, sale, labeling, and advertising and promotion

17 of tobacco products which are consistent with the manner

18 in which other products which are ingested into the body

19 are regulated, except that the Secretary may not promul20 gate a regulation which prohibits the sale and distribution

21 of a tobacco product solely on the basis of the fact that

22 tobacco causes disease. Such regulations shall be promul23 gated not later than 12 months after the date the Sec24 retary receives the recommendations of the Tobacco and

25 Nicotine Products Advisory Committee under section

26 702(e).
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1 ‘‘(b) MINIMUM REQUIREMENTS.—

2 ‘‘(1) SALE OR DISTRIBUTION.—Regulations

3 under subsection (a) shall with respect to the sale or

4 distribution of tobacco products make unlawful—

5 ‘‘(A) the sale of a tobacco product intended

6 for use by man to any person under the age of

7 18 years or under such other age greater than

8 18 years as the State in which the sale occurs

9 may establish by law,

10 ‘‘(B) the distribution of a tobacco product

11 as a free sample or the distribution of a tobacco

12 product as a result of coupons or other mate13 rials which allow for the obtaining of free or

14 discounted tobacco products, or

15 ‘‘(C) the sale or distribution of a tobacco

16 product if the label fails to carry the following

17 statement: ‘‘Federal Law Prohibits Sale To

18 Minors’’.

19 The Secretary shall enforce this paragraph in a

20 manner that can reasonably be expected to ensure

21 that tobacco products are not made available to indi22 viduals under the age of 18 years.

23 ‘‘(2) LABELING.—

24 ‘‘(A) IN GENERAL.—Regulations under

25 subsection (a) with respect to the labeling of to-
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1 bacco products shall require that a tobacco

2 product shall be deemed misbranded if—

3 ‘‘(i) it is not in compliance with the

4 labeling requirements of the Federal Ciga5 rette Labeling and Advertising Act and the

6 Comprehensive Smokeless Tobacco Health

7 Education Act of 1986,

8 ‘‘(ii) it does not include a warning and

9 information about the dangers associated

10 with environmental tobacco smoke,

11 ‘‘(iii) it does not provide a list of

12 chemical additives and constituents found

13 in tobacco products and tobacco smoke, or

14 ‘‘(iv) it contains any implied or direct

15 health claim, including the use of such

16 terms as light, lower tar, medium, lowest,

17 or nicotine free, unless such terms have

18 been approved by the Secretary on the

19 basis of sound scientific data and the Sec20 retary determines that such terms will

21 have a significant impact on the health

22 consequences associated with cigarette

23 smoking and other tobacco use.

24 ‘‘(B) SPECIFIC INFORMATION.—The Sec25 retary may include in regulations under sub-
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1 section (a) relating to labeling of tobacco prod2 ucts labeling requirements requiring manufac3 turers of tobacco products to provide to con4 sumers by way of labeling of packages, package

5 inserts, or other means—

6 ‘‘(i) information about the adverse ef7 fects of tobacco products,

8 ‘‘(ii) adequate warnings and directions

9 for use,

10 ‘‘(iii) contraindications,

11 ‘‘(iv) adequate warnings against use

12 in pathological conditions, and

13 ‘‘(v) any other information deemed

14 necessary by the Secretary.’’.

15 ‘‘(3) ADVERTISING AND PROMOTION.—

16 ‘‘(A) CONSISTENCY.—Regulations under

17 subsection (a) with respect to the advertising

18 and promotion of tobacco products shall be con19 sistent with regulations governing the advertis20 ing and promotion of prescription drugs, espe21 cially such drugs which contain nicotine.

22 ‘‘(B) SPONSORSHIP.—In such regulations,

23 the Secretary shall make it unlawful for any

24 sporting event, cultural event, or any other

25 event or function open to the public to be spon-
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1 sored by a tobacco manufacturer who at such

2 event or function displays the name or logo of

3 any brand of cigarettes or tobacco product of

4 such manufacturer.

5 ‘‘(C) CONSTRUCTION.—Such regulations

6 and the authority provided the Secretary does

7 not repeal or modify the authority of the Fed8 eral Trade Commission in carrying out its

9 responsibilities.

10 ‘‘(4) MANUFACTURING.—Regulations under

11 subsection (a) governing the manufacture of tobacco

12 products shall—

13 ‘‘(A) require that all additives used in the

14 manufacture of tobacco products are safe,

15 ‘‘(B) classify as a drug any nicotine con16 taining product which does not meet the defini17 tion of a tobacco product, and

18 ‘‘(C) have the authority to subpoena any

19 document which relates to the manner in which

20 tobacco products are manufactured.

21 ‘‘ADVISORY COMMITTEE

22 ‘‘SEC. 702. (a) ESTABLISHMENT.—To assist in the

23 development of regulations required by section 701, there

24 is established in the Food and Drug Administration a To25 bacco and Nicotine Products Advisory Committee (herein-
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1 after in this section referred to as the ‘‘advisory commit2 tee’’).

3 ‘‘(b) MEMBERSHIP.—

4 ‘‘(1) SECRETARIAL APPOINTMENTS.—The Sec5 retary shall appoint to the advisory committee 10 in6 dividuals who are qualified by training and experi7 ence to evaluate and make recommendations for the

8 issuance of regulations governing the manufacture,

9 distribution, sale, labeling, and advertising and pro10 motion of tobacco products which, to the greatest ex11 tent practical, promote and protect the public’s

12 health without banning the product. The 10 mem13 bers shall consist of—

14 ‘‘(A) one expert in the field of nicotine

15 addiction,

16 ‘‘(B) one expert in the field of pharmacol17 ogy,

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

19 drug law,

20 ‘‘(D) one expert in the field of marketing

21 and promotion of products,

22 ‘‘(E) one expert in the field of public

23 education,

24 ‘‘(F) one expert in the field of toxicology,
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1 ‘‘(G) two representing the interests of fam2 ily medicine, internal medicine, or pediatrics,

3 and

4 ‘‘(H) two consumer representatives from

5 the public health community.

6 ‘‘(2) EX OFFICIO.—The Directors of the Na7 tional Cancer Institute, the National Heart, Lung,

8 and Blood Institute, the National Institute of Drug

9 Abuse, the Centers for Disease Control and Preven10 tion, and the Surgeon General of the United States

11 shall serve as ex officio members of the advisory

12 committee.

13 ‘‘(3) CHAIRMAN.—The chairman of the advisory

14 committee shall be appointed by the Secretary with

15 the advice and consent of the Commissioner of Food

16 and Drugs.

17 ‘‘(4) APPOINTMENT DATE.—The Secretary shall

18 make appointments to the advisory committee within

19 60 days of the date of the enactment of this section.

20 ‘‘(c) FUNCTION.—The advisory committee shall give

21 specific consideration to—

22 ‘‘(1) reviewing the available scientific evidence

23 on the effects of tobacco products on human health,

24 including the effects of environmental tobacco smoke

25 on nonsmokers,
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1 ‘‘(2) reviewing the manufacturing process of to2 bacco products, including the use of additives,

3 sprayed on chemicals, product development, and

4 product manipulation,

5 ‘‘(3) reviewing the role of nicotine as part of

6 the smoking habit, including its addictive properties

7 and health effects,

8 ‘‘(4) reviewing the marketing and promotional

9 techniques used by tobacco manufacturers in selling

10 their products, and

11 ‘‘(5) reviewing current Federal, State, and local

12 laws governing the manufacture, distribution, sale,

13 labeling, and advertising and promotion of tobacco

14 products.

15 ‘‘(d) AUTHORITY.—The advisory committee may for

16 the purpose of carrying out its functions hold such hear17 ings, sit and act at such times and places, take such testi18 mony, and receive such evidence as the advisory committee

19 deems appropriate.

20 ‘‘(e) RECOMMENDATIONS.—The advisory committee

21 shall make recommendations respecting the issuance of

22 regulations under section 701 within 12 months of the ap23 pointment of the 10 members of the advisory committee.

24 ‘‘REGISTRATION

25 ‘‘SEC. 703. Each tobacco product manufacturer shall

26 register with the Secretary. Any such manufacturer who
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1 is in business on the date of the enactment of this Act

2 shall register with the Secretary not later than 120 days

3 after the date of the enactment of this section.

4 ‘‘TOBACCO PRODUCT MANUFACTURER FEE

5 ‘‘SEC. 704.(a) FEE PURPOSE.—For the purpose of

6 paying the costs of implementing this chapter, each to7 bacco product manufacturer shall pay an annual fee estab8 lished pursuant to paragraph (2). Such fee shall be pay9 able on or before January 31 of each year.

10 ‘‘(b) ESTABLISHMENT BY THE SECRETARY.—Subject

11 to the amount established in appropriation Acts, the an12 nual tobacco product manufacturer fee shall be deter13 mined by the Secretary based upon the total market share

14 for each brand of tobacco product.

15 ‘‘(c) CREDITING AND AVAILABILITY OF FEES.—

16 ‘‘(1) IN GENERAL.—Fees collected for a fiscal

17 year pursuant to subsection (a) shall be credited to

18 the appropriation account for salaries and expenses

19 of the Food and Drug Administration and shall be

20 available in accordance with appropriation Acts until

21 expended without fiscal year limitation.

22 ‘‘(2) COLLECTIONS AND APPROPRIATION

23 ACTS.—The fees authorized by subsection (a)—

24 ‘‘(A) shall be collected in each fiscal year

25 in an amount equal to the amount specified in

26 appropriation Acts for such fiscal year, and
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1 ‘‘(B) shall only be collected and available

2 to defray the costs of implementing this chap3 ter.’’.

4 (b) CONFORMING AMENDMENTS.—

5 (1) TOBACCO LABELING AND ADVERTISING.—

6 The Federal Cigarette Labeling and Advertising Act

7 (15 U.S.C. 1331 et seq.) is amended—

8 (A) in section 4 (15 U.S.C. 1333) by strik9 ing out ‘‘SURGEON GENERAL’S WARN10 ING: Cigarette Smoke Contains Carbon Mon11 oxide’’ each place it appears and inserting in

12 lieu thereof ‘‘SURGEON GENERAL’S WARN13 ING: Smoking is Addictive. Once You Start

14 You May Not Be Able to Stop’’, and

15 (B) by repealing sections 5(b) and 7 (15

16 U.S.C. 1334(b), 1335a).

17 (2) SMOKELESS TOBACCO.—The Comprehensive

18 Smokeless Tobacco Health Education Act of 1986 is

19 amended—

20 (A) in section 3(a)(1) (15 U.S.C.

21 4402(a)(1)), by striking out the close quotation

22 marks and the period following at the end and

23 inserting the following:
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1 ‘‘WARNING: THIS PRODUCT IS AD2 DICTIVE. ONCE YOU START YOU MAY

3 NOT BE ABLE TO QUIT’.’’,

4 (B) in section 3(b)(1) (15 U.S.C.

5 4402(b)(1), by inserting in the matter in sub6 paragraph (B) the following:

7 (3) RECORDS OF INTERSTATE SHIPMENT.—Sec8 tion 703 (21 U.S.C. 373) is amended—

9 (A) by striking out ‘‘or cosmetics’’ and in10 serting in lieu thereof ‘‘cosmetics, or tobacco

11 products’’, and

12 (B) by striking out ‘‘or cosmetic’’ and in13 serting in lieu thereof ‘‘cosmetic, or tobacco

14 product’’.

15 (4) FACTORY INSPECTION.—Section 704 (21

16 U.S.C. 374) is amended—
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1 (A) in subsection (a)(1), by striking out

2 ‘‘or cosmetics’’ and inserting in lieu thereof

3 ‘‘cosmetics, or tobacco products’’,

4 (B) in subsection (a)(1), by striking out

5 ‘‘or restricted devices’’ each place it appears

6 and inserting in lieu thereof ‘‘, restricted de7 vices, or tobacco products’’, and

8 (C) in subsection (b), by striking out ‘‘or

9 cosmetic’’ and inserting in lieu thereof ‘‘cos10 metic, or tobacco product’’.

11 (5) REDESIGNATIONS.—Sections 701 through

12 711 are redesignated as sections 801 through 811,

13 respectively, section 721 is redesignated as section

14 821, sections 731 through 736 are redesignated as

15 sections 831 through 836, respectively, sections 801

16 through 803 are redesignated as sections 901

17 through 903, respectively, sections 901 through 903

18 are redesignated as sections 1001 through 1003, re19 spectively, and the references to the redesignated

20 sections are changed to refer to the sections as

21 redesignated.

22 (c) SECRETARIAL AUTHORITY.—The Secretary of

23 Health and Human Services may, by regulation—

24 (1) modify the warning labels required by the

25 Federal Cigarette Labeling and Advertising Act and
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1 the Comprehensive Smokeless Tobacco Health Edu2 cation Act of 1986 if the modification in the content

3 of the label does not weaken the health message con4 tained in the label and is in the best interests of the

5 public health, and

6 (2) increase the size and placement of such re7 quired labels.

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