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103D CONGRESS

1ST SESSION H. R. 2923

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

of dietary supplements.

IN THE HOUSE OF REPRESENTATIVES

AUGUST 6, 1993

Mrs. COLLINS of Illinois 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

revise the regulation 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; REFERENCE.

4 This Act may be cited as the ‘‘Dietary Supplement

5 Consumer Protection Act of 1993’’.

6 (b) REFERENCE.—Whenever in this Act an amend7 ment or repeal is expressed in terms of an amendment

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

9 shall be considered to be made to a section or other provi10 sion of the Federal Food, Drug, and Cosmetic Act
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1 SEC. 2. DEFINITIONS.

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

3 at the end the following:

4 ‘‘(gg) The term ‘dietary supplement’ means an article

5 that is—

6 ‘‘(1) intended to supplement the diet,

7 ‘‘(2) is, or contains, a vitamin, mineral, or an

8 herb or similar nutritional substance, including a

9 concentrate or extract of a vitamin, mineral, or other

10 nutritional substance, and

11 ‘‘(3)(A) is intended for ingestion in a form de12 scribed in paragraph (1)(B)(i) or (2) of section

13 411(c) or in another similar form, or

14 ‘‘(B) complies with section 411(c)(1)(B)(ii).

15 ‘‘(hh) The term ‘dietary ingredient’ means a vitamin,

16 mineral, or herb or other similar nutritional substance the

17 intended use of which results, or may reasonably be ex18 pected to result, directly or indirectly, in its becoming a

19 component or otherwise affecting the characteristics of

20 any dietary supplement.’’.

21 SEC. 3. DEFINITIONS AND STANDARDS OF IDENTITY.

22 Section 401 (21 U.S.C. 341) is amended—

23 (1) in the first sentence, by inserting ‘‘or die24 tary supplement’’ after ‘‘establishing for any food’’,

25 and
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1 (2) in the fourth sentence, by inserting ‘‘or die2 tary supplement’’ after ‘‘any food’’ and by inserting

3 ‘‘or dietary supplements’’ after ‘‘class of food’’.

4 SEC. 4. ADULTERATION.

5 Section 402 (21 U.S.C. 342) is amended—

6 (1) by inserting ‘‘or dietary supplement’’ after

7 ‘‘food’’ before paragraph (a), and

8 (2) by adding at the end the following:

9 ‘‘(f) If it is a dietary supplement and it is, or con10 tains, any dietary ingredient which is unsafe within the

11 meaning of section 413.

12 ‘‘(g) If it is a dietary supplement and it does not meet

13 the quality factor requirements prescribed by the Sec14 retary under this paragraph. The Secretary shall, by regu15 lation, establish requirements for quality factors for die16 tary supplements as appropriate.

17 ‘‘(h)(1) If it is a dietary supplement and the process18 ing of such dietary supplement is not in compliance with

19 the good manufacturing practices and the quality control

20 procedures established by the Secretary under subpara21 graph (2).

22 ‘‘(2) The Secretary shall, by regulation, establish

23 good manufacturing practices for dietary supplements, in24 cluding quality control procedures that the Secretary de-
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1 termines are necessary to assure that a dietary supple2 ment—

3 ‘‘(A) provides the vitamin, mineral, or herb or

4 other nutritional substance it claims to provide in its

5 label or labeling, and

6 ‘‘(B) is manufactured in a manner designed to

7 prevent adulteration.’’.

8 SEC. 5. MISBRANDING.

9 Section 403 (21 U.S.C. 343) is amended—

10 (1) by inserting ‘‘or dietary supplement’’ after

11 ‘‘food’’ before paragraph (a),

12 (2) in paragraph (a)(2), by inserting ‘‘or die13 tary supplement’’ after ‘‘food’’,

14 (3) in paragraph (b), by inserting ‘‘or dietary

15 supplement’’ after ‘‘another food’’,

16 (4) in paragraph (g), by inserting ‘‘or dietary

17 supplement’’ after ‘‘food’’ each place it occurs,

18 (5) in paragraph (h), by inserting ‘‘or dietary

19 supplement’’ after ‘‘food’’ each place it occurs,

20 (6) in paragraph (i)(1), by inserting ‘‘or dietary

21 supplement’’ after ‘‘food’’,

22 (7) in paragraph (r)(1), by inserting ‘‘or dietary

23 supplement’’ after ‘‘food’’ each place it occurs and

24 by inserting ‘‘or dietary ingredient’’ after ‘‘nutrient’’

25 each place it occurs,
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1 (8) in paragraph (r)(1)(B), by inserting ‘‘or any

2 dietary supplement’’ after ‘‘food’’ and by striking

3 out ‘‘or (5)(D)’’,

4 (9) in paragraph (r)(3)(A)(ii), by inserting ‘‘or

5 dietary supplement’’ after ‘‘food’’ each place it oc6 curs and by inserting ‘‘or dietary ingredient’’ after

7 ‘‘nutrient’’,

8 (10) in paragraph (r)(3)(B)(ii)(I), by inserting

9 ‘‘or dietary supplements’’ after ‘‘food’’ and by insert10 ing ‘‘or dietary ingredient’’ after ‘‘(q)(2)’’,

11 (11) in paragraph (r)(3)(B)(ii)(II), by inserting

12 ‘‘or dietary ingredient’’ after ‘‘nutrient’’,

13 (12) in paragraph (r)(5), by striking out clause

14 (D), and

15 (13) by adding at the end the following:

16 ‘‘(s) If it is a dietary supplement, unless its label and

17 labeling contain the date after which it should no longer

18 be consumed as prescribed by the Secretary by regulation.

19 ‘‘(t) If it is a dietary supplement, unless its label and

20 labeling contain, where appropriate, a statement regarding

21 possible adverse effects as prescribed by the Secretary by

22 regulation. Such a statement shall indicate the level, if

23 any, at which a dietary supplement can cause adverse ef24 fects and the specific nature of any adverse effects and
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1 shall identify segments of the population, including the el2 derly and children, that may be affected.’’.

3 SEC. 6. SAFETY PROVISIONS AND NOTIFICATION REQUIRE4 MENTS FOR DIETARY INGREDIENTS.

5 Subchapter IV of chapter 4 is amended by adding

6 at the end the following:

7 ‘‘DIETARY INGREDIENTS SAFETY

8 ‘‘SEC. 413. (a) A dietary ingredient shall, with re9 spect to any particular or intended use of such ingredient,

10 be deemed unsafe for the purposes of section 402(f) un11 less—

12 ‘‘(1) there is in effect, and it and its use or in13 tended use are in conformity with, a regulation is14 sued under this section prescribing the conditions

15 under which such dietary ingredient may be safely

16 used,

17 ‘‘(2) such ingredient is generally recognized,

18 among experts qualified by adequate training and

19 experience to evaluate its safety, as having been ade20 quately shown through scientific procedures to be

21 safe under the conditions of its intended use, or

22 ‘‘(3) in the case of a dietary ingredient in use

23 in a dietary supplement before August 5, 1993, it

24 has been adequately shown, through either scientific

25 procedures or experience based on common use in a

26 dietary supplement, to be safe under the conditions
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1 of its intended use pending completion of the review

2 required by subsection (f).

3 ‘‘(b) Any person may with respect to any intended

4 use of a dietary ingredient file with the Secretary a peti5 tion proposing the issuance of a regulation prescribing the

6 conditions under which such ingredient may be safely

7 used. The Secretary shall by regulation establish require8 ments for petitions submitted under this subsection.

9 ‘‘(c) The Secretary shall by order—

10 ‘‘(1) establish a regulation (whether or not in

11 accord with the regulation proposed by the peti12 tioner) prescribing, with respect to one or more pro13 posed uses of the dietary ingredient involved, the

14 conditions under which such ingredient may be safe15 ly used, including specifications as to the—

16 ‘‘(A) particular dietary supplement or

17 classes of dietary supplements in which such in18 gredient may be used,

19 ‘‘(B) the maximum quantity which may be

20 used or permitted in the dietary supplement,

21 ‘‘(C) the manner in which such ingredient

22 may be added to or used in the dietary supple23 ment, and

24 ‘‘(D) any directions or other labeling or

25 packaging requirements for such ingredient
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1 deemed necessary by the Secretary to assure

2 the safety of its use, and

3 notify the petitioner of such order and the reasons

4 for it, or

5 ‘‘(2) deny the petition and notify the petitioner

6 of such order and the reasons for it.

7 ‘‘(d) The Secretary may at any time, upon the Sec8 retary’s own initiative, propose the issuance of a regula9 tion prescribing, with respect to any particular use of a

10 dietary ingredient, the conditions under which such ingre11 dient may be safely used and the reasons therefor.

12 ‘‘(e) Each person who proposes to begin the introduc13 tion or delivery into interstate commerce of a dietary in14 gredient that it determines to be subject to subsection

15 (a)(2) shall, at least 90 days before making such introduc16 tion or delivery, notify the Secretary, in such form and

17 manner as the Secretary shall by regulation prescribe, of

18 such introduction or delivery.

19 ‘‘(f) The Secretary shall commence a safety review

20 of those dietary ingredients subject to subsection (a)(3)

21 within 60 days of the date of the enactment of this

22 section.’’.

23 ‘‘NOTIFICATION

24 ‘‘SEC. 414. If the manufacturer, distributor, or re25 tailer of a dietary supplement or ingredient has knowledge

26 which reasonably supports the conclusion that a dietary
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1 supplement or ingredient may be adulterated or mis2 branded, such manufacturer, distributor, or retailer shall

3 promptly notify the Secretary of such knowledge.’’.

4 SEC. 7. ADVISORY COMMITTEE.

5 The Secretary of Health and Human Services shall

6 establish an advisory committee, in accordance with the

7 Federal Advisory Committee Act, to assist in the imple8 mentation of the amendments made by this Act.

9 SEC. 8. RESEARCH.

10 (a) ESTABLISHMENT.—The Director of the National

11 Institutes of Health shall expand and intensify programs

12 with respect to research and related activities regarding

13 dietary supplements.

14 (b) AUTHORIZATION OF APPROPRIATIONS.—For the

15 purpose of carrying out subsection (a), there are author16 ized to be appropriated $10,000,000 for fiscal year 1994

17 and such sums as may be necessary for each of the fiscal

18 years 1995 through 1997.

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