I

103D CONGRESS

1ST SESSION H. R. 509

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

regarding the composition and labeling of dietary supplements.

IN THE HOUSE OF REPRESENTATIVES

JANUARY 21, 1993

Mr. GALLEGLY (for himself, Mr. INHOFE, Mr. SHAYS, Mr. COX, Mr. TAYLOR

of North Carolina, Mr. STUMP, Mr. BURTON of Indiana, Mr. HANSEN,

Mr. HUNTER, Mr. HASTERT of Illinois, Mr. UPTON, and Mr. SCHIFF introduced the following bill; which was referred to the Committee on Energy and Commerce

AUGUST 23, 1993

Additional sponsors: Mr. STEARNS, Mr. KLUG, Mr. EMERSON, Mr.

MANZULLO, Mr. HANCOCK, Mr. ARMEY, Mr. HERGER, Mr. BAKER of

Louisiana, Mr. DELAY, Mr. THOMAS of California, Mr. SKEEN, Mr.

BARTLETT of Maryland, Mr. SCHAEFER, Mr. GINGRICH, Mr. FIELDS of

Texas, Mr. DREIER, Mr. BOEHNER, Mr. FISH, Mrs. THURMAN, Mr.

HEFLEY, Mr. GOSS, Mr. WALSH, Mr. CRANE, Mr. KIM, Mr. MCKEON,

Mr. DOOLITTLE, Mr. ROTH, Mr. HYDE, Mr. SMITH of Oregon, Mr. SENSENBRENNER, Mr. SPENCE, Mr. PACKARD, Mr. CALVERT, and Mr.

ROYCE

JANUARY 5, 1994

Additional sponsors: Mr. DUNCAN, Mr. CUNNINGHAM, Mr. DORNAN, Mr.

PORTMAN, Mr. QUILLEN, Mr. ISTOOK, Mr. THOMAS of Wyoming, Mr.

CAMP, Mr. LINDER, Mr. FRANKS of Connecticut, Mr. PETRI, Mr. WOLF,

Mr. RAVENEL, Mr. ROHRABACHER, Mr. ARCHER, Mr. POMBO, and Mr.

CRAPO

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to
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establish provisions regarding the composition and labeling of dietary supplements.

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 ‘‘Health Freedom Act

5 of 1993’’.

6 SEC. 2. DEFINITIONS.

7 (a) DIETARY SUPPLEMENT.—Section 201 of the

8 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)

9 is amended by adding at the end the following new para10 graph:

11 ‘‘(ff) The term ‘dietary supplement’ means an article

12 that—

13 ‘‘(1) includes, and is intended to supplement

14 the diet with—

15 ‘‘(A) a vitamin;

16 ‘‘(B) a mineral;

17 ‘‘(C) an herb; or

18 ‘‘(D) another similar nutritional substance,

19 including a concentrate or extract of an item

20 described in clause (A), (B), or (C); and

21 ‘‘(2)(A) is intended for ingestion in a form de22 scribed in paragraph (1)(B)(i) or (2) of section

23 411(c), or another similar form; or

24 ‘‘(B) complies with section 411(c)(1)(B)(ii).’’.
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1 (b) DRUG.—Section 201(g)(1) of such Act is amend2 ed by adding at the end the following: ‘‘A dietary supple3 ment shall not be considered to be a drug solely because

4 of the potency of a substance in the dietary supplement.

5 A dietary supplement shall not be considered to be a drug

6 under clause (B) solely because the labeling or advertising

7 for the supplement contains a claim, or provides informa8 tion, that is described in section 413(b) and meets the re9 quirements specified in paragraphs (1) and (2) of such

10 section, or that concerns the potency of a substance in

11 the supplement.’’.

12 (c) FOOD ADDITIVE.—Section 201(s) of such Act is

13 amended—

14 (1) by redesignating subparagraphs (1) through

15 (5) as clauses (A) through (E), respectively;

16 (2) by inserting ‘‘(1)’’ after ‘‘(s)’’; and

17 (3) by adding at the end the following:

18 ‘‘(2) A substance in a dietary supplement is not a

19 food additive if the substance is identified in the labeling

20 of the dietary supplement as a substance provided by the

21 product to supplement the diet.’’.

22 SEC. 3. DIETARY SUPPLEMENTS.

23 (a) IN GENERAL.—Chapter IV of the Federal Food,

24 Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amend25 ed by adding at the end the following new section:
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1 ‘‘SEC. 413. LABELING AND ADVERTISING OF DIETARY SUP2 PLEMENTS.

3 ‘‘(a) DESCRIPTION.—Notwithstanding any other pro4 vision of this Act, an article that is a dietary supplement

5 may be described as a dietary supplement in labeling or

6 advertising.

7 ‘‘(b) RELATIONSHIP TO DISEASE OR HEALTH-RE8 LATED CONDITION.—Notwithstanding any other provision

9 of this Act, labeling or advertising for a dietary supple10 ment may include a claim or other information that char11 acterizes the relationship of the dietary supplement, or of

12 one or more of the substances provided by the dietary sup13 plement, or of the absence of one or more of the sub14 stances, to a disease or health-related condition, if—

15 ‘‘(1) such claim or other information is truthful

16 and not misleading; and

17 ‘‘(2) there is scientific evidence, whether pub18 lished or unpublished, that provides a reasonable

19 basis for such claim or other information.

20 ‘‘(c) PROHIBITION ON PRIOR APPROVAL OR REGULA21 TION.—Notwithstanding any other provision of this Act,

22 the Secretary shall not establish any requirement that

23 such a claim or other information that meets the require24 ments specified in paragraphs (1) and (2) of subsection

25 (b) shall be approved by or conform to a regulation issued
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1 by the Secretary before the claim or information may be

2 used.

3 ‘‘(d) ACTIONS.—

4 ‘‘(1) RIGHT OF ACTION.—If the Secretary as5 serts that labeling or advertising for a dietary sup6 plement includes such a claim or other information

7 that fails to comply with paragraph (1) or (2) of

8 subsection (b), whether the Secretary makes the as9 sertion in a warning letter issued by an officer or

10 employee of the Department, or in connection with

11 another action to enforce a provision of this Act, the

12 manufacturer, processor, packer, distributor, or re13 tailer, of the dietary supplement, or other person to

14 whom the assertion is addressed, may—

15 ‘‘(A) bring an action in a United States

16 district court in any appropriate judicial district

17 under section 1391 of title 28, United States

18 Code, to secure a declaratory judgment regard19 ing the validity of the assertion; and

20 ‘‘(B) obtain any other means of judicial re21 view authorized by law.

22 ‘‘(2) INFERENCE.—The absence of any action

23 described in subparagraph (A) or (B) in paragraph

24 (1) with respect to an assertion shall not establish

25 any inference that the assertion is valid.’’.
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1 (b) CONFORMING AMENDMENT.—Section 403(r)(5)

2 of such Act (21 U.S.C. 343(r)(5)) is amended by striking

3 clause (D).

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