I

103D CONGRESS

1ST SESSION H. R. 3650

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

to dietary supplements and to amend the Dietary Supplement Act of

1992 to extend the moratorium with respect to the issuance of regulations on dietary supplements, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

NOVEMBER 22, 1993

Mr. WAXMAN (for himself and Mr. DINGELL) 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

assure access to dietary supplements and to amend the

Dietary Supplement Act of 1992 to extend the moratorium with respect to the issuance of regulations on dietary supplements, 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 Access and Claims Moratorium Act of 1993’’.

6 SEC. 2. FINDINGS.

7 The Congress finds the following:
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1 (1) Many consumers use vitamins, minerals,

2 herbs, amino acids, and other dietary supplements.

3 (2) There has been a public campaign to con4 vince consumers that the Food and Drug Adminis5 tration intends to require prescriptions for many die6 tary supplements, or that the FDA will otherwise

7 act to take these products off the market.

8 (3) Due to public concern, it is appropriate for

9 Congress to assure consumers that they will have ac10 cess to the dietary supplements that are currently on

11 the market.

12 (4) The dietary supplement industry is con13 cerned that the Nutrition Labeling and Education

14 Act of 1990 will prohibit health claims on dietary

15 supplements. Congress shall extend the moratorium

16 on FDA actions under such Act with respect to

17 dietary supplements.

18 TITLE I—ACCESS TO DIETARY

19 SUPPLEMENTS

20 SEC. 101. REFERENCE.

21 Whenever in this title an amendment or repeal is ex22 pressed in terms of an amendment to, or repeal of, a sec23 tion or other provision, the reference shall be considered

24 to be made to a section or other provision of the Federal

25 Food, Drug, and Cosmetic Act.
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1 SEC. 102. ACCESS TO DIETARY SUPPLEMENTS.

2 (a) FDA MAY NOT REQUIRE PRESCRIPTIONS FOR

3 DIETARY SUPPLEMENTS.—Section 503(b) (21 U.S.C.

4 353(b)) is amended by adding at the end the following:

5 ‘‘(6) For a dietary supplement marketed on or before

6 November 15, 1993, the Secretary may not, after Novem7 ber 15, 1993, require a prescription . For a dietary supple8 ment first marketed after November 15, 1993, this sub9 section as it was in effect on the date of the enactment

10 of the Dietary Supplement Access and Claims Moratorium

11 Act of 1993 shall apply.’’.

12 (b) FDA MAY NOT REQUIRE PREMARKET APPROVAL

13 FOR DIETARY SUPPLEMENTS.—

14 (1) FOOD ADDITIVES.—Section 201(s) (21

15 U.S.C. 321(s)) is amended—

16 (A) by striking out the period at the end

17 of subparagraph (5) and inserting in lieu there18 of ‘‘; or’’; and

19 (B) by adding after subparagraph (5) the

20 following:

21 ‘‘(6) any dietary ingredient in a dietary supple22 ment.’’.

23 (2) DRUGS.—Section 201(g)(1) (21 U.S.C.

24 321(g)(1)) is amended by adding at the end the fol25 lowing: ‘‘A dietary supplement which was on the
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1 market on or before November 15, 1993, and for

2 which no claim is made is not a drug.’’.

3 (c) BURDEN OF PROOF ON FDA.—

4 (1) IN GENERAL.—Section 402 (21 U.S.C. 342)

5 is amended by adding at the end the following:

6 ‘‘(f) If it contains a dietary ingredient at a level that

7 may be injurious to health or is a dietary supplement

8 which when used in accordance with the conditions of use

9 may be injurious to health.’’.

10 (2) CONFORMING AMENDMENT.—Section 402

11 (21 U.S.C. 342) is amended by striking ‘‘food’’ in

12 the matter preceding paragraph (a) and inserting

13 ‘‘food or dietary supplement’’.

14 (d) DEFINITIONS.—

15 (1) IN GENERAL.—Section 201 (21 U.S.C. 321)

16 is amended by adding at the end the following:

17 ‘‘(gg) The term ‘dietary ingredient’ means—

18 ‘‘(1) a vitamin,

19 ‘‘(2) a mineral,

20 ‘‘(3) an herb,

21 ‘‘(4) an amino acid, or

22 ‘‘(5) other ingredient,

23 contained in a product marketed in the United States as

24 a dietary supplement on or before November 15, 1993.
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1 ‘‘(hh) The term ‘dietary supplement’ means a product

2 which contains one or more dietary ingredients and—

3 ‘‘(1) which is marketed to supplement the diet,

4 ‘‘(2) which is intended for use in tablet, cap5 sule, powder, softgel, or liquid form and if in liquid

6 form is formulated in a fluid carrier and is intended

7 for ingestion in daily quantities measured in drops

8 or similar small units of measure,

9 ‘‘(3) which is not represented for use as conven10 tional food or as a sole item of a meal or of the diet,

11 and

12 ‘‘(4) which does not include any ingredient

13 other than a vitamin or mineral which has been ap14 proved as the active ingredient of a drug.’’.

15 (2) SECRETARIAL ACTION.—For purposes of

16 the definitions added by paragraph (1), the Sec17 retary of Health and Human Services shall, not

18 later than 180 days after the date of the enactment

19 of this Act, issue a regulation identifying the dietary

20 ingredients which were marketed on or before No21 vember 15, 1993.
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1 TITLE II—MORATORIUM ON

2 DIETARY SUPPLEMENT CLAIMS

3 SEC. 201. REFERENCE.

4 Whenever in this title an amendment or repeal is ex5 pressed in terms of an amendment to, or repeal of, a sec6 tion or other provision, the reference shall be considered

7 to be made to a section or other provision of the Prescrip8 tion Drug User Fee Act of 1992.

9 SEC. 202. PROHIBITION OF IMPLEMENTATION.

10 Section 202(a)(1) (21 U.S.C. 343 note) is amended—

11 (1) by striking ‘‘December 15, 1993’’ and in12 serting ‘‘June 30, 1994’’, and

13 (2) by inserting ‘‘amino acids,’’ after ‘‘herbs,’’.

14 SEC. 203. ISSUANCE OF REGULATIONS.

15 The amendments made by sections 202(a)(2)(B)(i)

16 and 202(a)(2)(B)(ii) (21 U.S.C. 343 note) are each

17 amended—

18 (1) by striking ‘‘December 31, 1993’’ and in19 serting ‘‘June 30, 1994’’, and

20 (2) by inserting ‘‘amino acids,’’ after ‘‘herbs,’’.

21 SEC. 204. STATE ENFORCEMENT.

22 The amendment made by section 202(a)(3) (21

23 U.S.C. 343 note) is amended by striking ‘‘to such dietary

24 supplement on December 31, 1993’’ and inserting ‘‘to die25 tary supplements of vitamins, minerals, herbs, amino
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1 acids, or other similar nutritional substances on June 30,

2 1994’’.

3 SEC. 205. CLAIM APPROVAL.

4 Section 202(b) (21 U.S.C. 343 note) is amended—

5 (1) by striking ‘‘December 15, 1993’’ and in6 serting ‘‘June 30, 1994’’, and

7 (2) by inserting ‘‘amino acids,’’ after ‘‘herbs,’’.

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