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Dietary Supplement Health and Education Act of 1994
Public Law 103-417
103rd Congress

An Act

To amend the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

1. Short Title; Reference; Table Of Contents. This Act may be cited as the "Dietary Supplement Health and Education Act of 1994".

(b) Reference.

Whenever in this Act an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act.

(c) Table of Contents.

The table of contents of this Act is as follows:

Sec. 1. Short title; reference; table of contents.
Sec. 2. Findings.
Sec. 3. Definitions.
Sec. 4. Safety of dietary supplements and burden of proof on FDA.
Sec. 5. Dietary supplement claims.
Sec. 6. Statements of nutritional support.
Sec. 7. Dietary supplement ingredient labeling and nutrition information labeling.
Sec. 8. New dietary ingredients.
Sec. 9. Good manufacturing practices.
Sec. 10. Conforming amendments.
Sec. 11. Withdrawal of the regulations and notice.
Sec. 12. Commission on dietary supplement labels.
Sec. 13. Office of dietary supplements.

2. Findings.

Congress finds that -

(1) improving the health status of United States citizens ranks at the top of the national priorities of the Federal Government;

3. Definitions.

Except for purposes of section 201(g), a dietary supplement shall be deemed to be a food within the meaning of this Act.

4. Safety of Dietary Supplements and Burden of Proof on FDA.

Section 402 (21 U.S.C. 342) is amended by adding at the end the following:

5. Dietary Supplement Claims.

Chapter IV (21 U.S.C. 341 et seq.) is amended by inserting after section 403A the following new section:

DIETARY SUPPLEMENT LABELING EXEMPTIONS

"Sec. 403B. (a) IN GENERAL.- A publication, including an article, a chapter in a book, or an official abstract of a peer-reviewed scientific publication that appears in an article and was prepared by the author or the editors of the publication, which is reprinted in its entirety, shall not be defined as labeling when used in connection with the sale of a dietary supplement to consumers when it -

6. Statements of Nutritional Support.

Section 403(r) (21 U.S.C. 343(r)) is amended by adding at the end the following:

7. Dietary Supplement Ingredient Labeling and Nutrition Information Labeling.

8. New Dietary Ingredients.

Chapter IV of the Federal Food, Drug, and Cosmetic Act is amended by adding at the end the following:

"NEW DIETARY INGREDIENTS

9. Good Manufacturing Practices.

Section 402 (21 U.S.C. 342), as amended by section 4, is amended by adding at the end the following:

10. Conforming Amendments.

11. Withdrawal of the Regulations and Notice.

The advance notice of proposed rulemaking concerning dietary supplements published in the Federal Register of June 18, 1993 (58 FR 33690-33700) is null and void and of no force or effect insofar as it applies to dietary supplements. The Secretary of Health and Human Services shall publish a notice in the Federal Register to revoke the item declared to be null and void and of no force or effect under subsection (a).

12. Commission on Dietary Supplement Labels.

13. Office of Dietary Supplements.

Approved October 25, 1994.

 

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