II

106TH CONGRESS

1ST SESSION S. 1749

To require the Commissioner of Food and Drugs to issue revised regulations

relating to dietary supplement labeling, to amend the Federal Trade

Commission Act to provide that certain types of advertisements for

dietary supplements are proper, and for other purposes.

IN THE SENATE OF THE UNITED STATES

OCTOBER 19, 1999

Mr. CRAPO introduced the following bill; which was read twice and referred

to the Committee on Health, Education, Labor, and Pensions

A BILL

To require the Commissioner of Food and Drugs to issue

revised regulations relating to dietary supplement labeling, to amend the Federal Trade Commission Act to

provide that certain types of advertisements for dietary

supplements are proper, 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 ‘‘Dietary Supplement

5 Fairness in Labeling and Advertising Act’’.
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1 SEC. 2. LABELING OF DIETARY SUPPLEMENTS.

2 (a) SENSE OF CONGRESS.—It is the sense of Con3 gress that the proposed rule entitled ‘‘Regulations on

4 Statements Made for Dietary Supplements Concerning the

5 Effect of the Product on the Structure or Functions of

6 the Body’’, published in the Federal Register on April 29,

7 1998, 63 Fed. Reg. 23624 (to be codified at part 101 of

8 title 21, Code of Federal Regulations) would improperly

9 restrict use of appropriate labeling claims about the effect

10 of a dietary supplement or dietary ingredient on the struc11 ture or function of the human body.

12 (b) EFFECT OF REGULATIONS.—The proposed rule

13 described in subsection (a) shall not take effect.

14 (c) DIETARY SUPPLEMENT LABELING EXEMP15 TIONS.—Section 403B of the Federal Food, Drug, and

16 Cosmetic Act (21 U.S.C. 343–2) is amended by adding

17 at the end the following:

18 ‘‘(d) EXEMPTION FROM REGULATION AS LABEL19 ING.—A truthful and accurate summary of 1 or more of

20 the findings of a study or article that has appeared in a

21 peer-reviewed medical, nutritional, or other scientific pub22 lication, or in a bona fide medical, nutritional, or other

23 scientific textbook, shall not be subject to regulation as

24 labeling under this Act when used in connection with the

25 sale of a dietary supplement to consumers, even if the
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1 summary is included in written, printed, or graphic matter

2 that accompanies the dietary supplement.’’.

3 SEC. 3. ADVERTISING OF DIETARY SUPPLEMENTS.

4 Section 5 of the Federal Trade Commission Act (15

5 U.S.C. 45) is amended by adding at the end the following:

6 ‘‘(o) ADVERTISING OF DIETARY SUPPLEMENTS AND

7 DIETARY INGREDIENTS.—

8 ‘‘(1) DEFINITIONS.—In this subsection:

9 ‘‘(A) DIETARY SUPPLEMENT.—The term

10 ‘dietary supplement’ has the meaning given that

11 term by section 201(ff) of the Federal Food,

12 Drug, and Cosmetic Act (21 U.S.C. 321(ff)).

13 ‘‘(B) DIETARY INGREDIENT.—The term

14 ‘dietary ingredient’ means an ingredient listed

15 in section 201(ff)(1) (A) through (F) of the

16 Federal Food, Drug, and Cosmetic Act (21

17 U.S.C. 321(ff)(1) (A) through (F)) that is in18 cluded in, or that is intended to be included in,

19 a dietary supplement.

20 ‘‘(2) EXEMPTIONS FROM REGULATION AS AD21 VERTISING.—

22 ‘‘(A) LABELING.—Insofar as a publication

23 is exempt from regulation as labeling pursuant

24 to section 403B of the Federal Food, Drug, and

25 Cosmetic Act (21 U.S.C. 343–2) the publication
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1 is also exempt from regulation as advertising

2 under the Federal Trade Commission Act.

3 ‘‘(B) TRUTHFUL AND ACCURATE SUM4 MARY.—A truthful and accurate summary of 1

5 or more of the findings of a cited study or arti6 cle that has appeared in a peer-reviewed med7 ical, nutritional, or other scientific publication,

8 or in a bona fide medical, nutritional, or other

9 scientific textbook, when used in promotion for

10 a dietary supplement or dietary ingredient, shall

11 not be subject to regulation as advertising

12 under the Federal Trade Commission Act.

13 ‘‘(3) ADVERTISER ACCESS TO GOVERNMENT

14 SCIENTIFIC EXPERTS BEFORE A REGULATORY AC15 TION IS INITIATED.—Before the Commission files

16 any complaint that initiates any administrative or

17 judicial proceeding alleging that an advertisement or

18 advertiser is not in compliance with the Federal

19 Trade Commission Act with respect to any adver20 tising for a dietary supplement or dietary ingredient,

21 or for medical services or health treatments, the

22 Commission shall ensure that the advertiser first—

23 ‘‘(A) has been provided a full and fair op24 portunity to consult directly with all of the indi25 viduals whom the Commission or Commission
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1 staff have relied upon or intend to rely upon as

2 nutritional, medical, or other scientific experts

3 with respect to the particular allegations; and

4 ‘‘(B) has been provided a reasonable time

5 thereafter to communicate with the Commission

6 staff and the Commission with respect to the

7 merits of the experts’ views.

8 ‘‘(4) RELIANCE UPON SCIENTIFIC DATA OTHER

9 THAN CONCLUSIVE HUMAN CLINICAL STUDIES.—It

10 is not inherently or presumptively deceptive, unfair,

11 lacking in substantiation, or otherwise improper for

12 advertising about a dietary supplement or dietary in13 gredient, or about medical services or health treat14 ments, to describe, mention, or rely upon in vitro

15 laboratory studies, animal feeding studies, human

16 epidemiological studies, human clinical studies that

17 are of a preliminary nature and do not provide a

18 conclusive finding, meta-analyses, review articles, or

19 other bona fide medical, nutritional, or other sci20 entific texts if the advertising is truthful, not mis21 leading, and reveals the nature of the study or other

22 information.

23 ‘‘(5) CONSENT AGREEMENTS.—In any case in

24 which the Commission enters into a consent agree25 ment concerning advertising about a dietary supple-
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1 ment or dietary ingredient, or about medical services

2 or health treatments, the agreement shall apply only

3 to the particular dietary supplements/ingredients

4 and particular health-related conditions, or to the

5 particular medical services or health treatments, or

6 to other particular matters, that are subjects of the

7 complaint.’’.

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