I

104TH CONGRESS

1ST SESSION H. R. 1951

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

dietary supplement manufacturers to communicate truthful,

nonmisleading information to consumers concerning the nutritional content and disease prevention benefits of their products, to repeal or clarify

rules enacted by the Dietary Supplement Health and Education Act

of 1994, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

JUNE 28, 1995

Mr. PALLONE (for himself, Mr. HASTERT, Mr. RICHARDSON, Mr. FRISA, and

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

Committee on Commerce

A BILL

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

allow food and dietary supplement manufacturers to communicate truthful, nonmisleading information to consumers concerning the nutritional content and disease prevention benefits of their products, to repeal or clarify

rules enacted by the Dietary Supplement Health and

Education Act of 1994, 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,
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1 SECTION 1. SHORT TITLE; REFERENCE.

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

3 ‘‘Food and Dietary Supplement Consumer Information

4 Act of 1995’’.

5 (b) REFERENCE.—Whenever in this Act an amend6 ment or repeal is expressed in terms of an amendment

7 to, or repeal of, a section or other provision, the reference

8 shall be considered to be made to a section or other provi9 sion of the Federal Food, Drug, and Cosmetic Act.

10 SEC. 2. AUTHORIZING TRUTHFUL CLAIMS THAT ARE NOT

11 MISLEADING.

12 (a) CLAIMS PERMITTED.—Section 403B (21 U.S.C.

13 343–2) is amended to read as follows:

14 ‘‘FOOD AND DIETARY SUPPLEMENT LABELING RULE

15 ‘‘SEC. 403B. If the labeling or advertising for a food

16 or dietary supplement contains a claim or other informa17 tion that characterizes the relationship of such food or die18 tary supplement to a disease or health-related condition,

19 or characterizes the relationship of the presence or ab20 sence of any substance in such food or dietary supplement

21 to a disease or health-related condition, such food or die22 tary supplement may not be deemed to be adulterated or

23 misbranded by reason of such claim or other information,

24 if such claim or other information is truthful and not mis25 leading.’’.
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1 (b) CONFORMING REPEALER.—Section 403(r)(6) (21

2 U.S.C. 343(r)(6)) (pertaining to allowable statements of

3 nutritional support) is repealed.

4 SEC. 3. REPEAL OF RULE ENACTED BY THE DIETARY SUP5 PLEMENT HEALTH AND EDUCATION ACT OF

6 1994 PERTAINING TO A FOOD OR DIETARY

7 SUPPLEMENT THAT IS ALSO MARKETED AS A

8 NEW DRUG, ANTIBIOTIC, OR BIOLOGIC.

9 Section 201(ff) (21 U.S.C. 321(ff)) is amended—

10 (1) in paragraph (1), by inserting ‘‘and’’ after

11 the semicolon at the end;

12 (2) in paragraph (2)(C), by striking ‘‘; and’’

13 and inserting a period; and

14 (3) by striking paragraph (3).

15 SEC. 4. REPEAL OF DIETARY INGREDIENT RULE.

16 (a) Section 413 (21 U.S.C. 350b) is repealed.

17 (b) Section 402(f) (21 U.S.C. 342(f)) is amended by

18 striking subparagraph (B) and redesignating subpara19 graphs (C) and (D) as subparagraphs (B) and (C), respec20 tively.

21 SEC. 5. FOODS AND DIETARY SUPPLEMENTS NOT TO BE

22 TREATED AS DRUGS.

23 (a) Section 201(g)(1) (21 U.S.C. 321(g)(1)) is

24 amended—
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1 (1) by striking the last two sentences and in2 serting, ‘‘Neither a food nor a dietary supplement

3 shall be deemed to be a drug.’’; and

4 (2) in clause (C), by striking ‘‘(other than

5 food)’’.

6 (b) Section 201(ff)) (21 U.S.C. 321(ff)), as amended

7 by section 3, is further amended by striking the last sen8 tence (pertaining to the deeming of a dietary supplement

9 to be a food).

10 SEC. 6. ADULTERATED DIETARY SUPPLEMENT: CLARIFICA11 TION OF TEST.

12 Section 402(f) (21 U.S.C. 342(f)), as amended by

13 section 4, is further amended in paragraph (1)(A) by

14 striking ‘‘significant or unreasonable risk’’ and inserting

15 ‘‘substantial and unreasonable risk’’.

16 SEC. 7. REGULATION OF FOODS AND DIETARY SUPPLE17 MENTS UNDER STATE LAW.

18 Chapter IV (21 U.S.C. 341 et seq.) is amended by

19 inserting after section 403B the following:

20 ‘‘STATE REGULATION OF FOOD AND DIETARY

21 SUPPLEMENTS

22 ‘‘SEC. 403C. (a) No State or political subdivision of

23 a State may deem a food or dietary supplement to be a

24 drug, or directly or indirectly establish under any author25 ity, or continue in effect, a requirement applicable to such

26 food or dietary supplement as though it were a drug.
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1 ‘‘(b) If the labeling or advertising of a food or dietary

2 supplement contains a claim or other information that

3 complies with section 403B, no State or political subdivi4 sion of a State may deem such food or dietary supplement

5 to be adulterated, misbranded, or otherwise rendered out

6 of compliance with the law of such State or political sub7 division, by reason of such claim.’’.

8 SEC. 8. COMMISSION ON DIETARY SUPPLEMENT LABELS

9 ABOLISHED.

10 The Commission on Dietary Supplement Labels, es11 tablished under the Dietary Supplement Health and Edu12 cation Act of 1994, Public Law 103–417, is abolished, and

13 section 12 of that Act is repealed.

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