I 111th CONGRESS 1st Session H. R. 3395 IN THE HOUSE OF REPRESENTATIVES July 29, 2009 Mr. Paul (for himself and Mr. Burton of Indiana) 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 concerning claims about the effects of foods and dietary supplements on health-related conditions and disease, and for other purposes.

1.

Short title

This Act may be cited as the Health Freedom Act.

2.

Limitation on suppression by Federal Government of claims in food and dietary supplements

The Federal Government may not take any action to prevent use of a claim describing any nutrient in a food or dietary supplement (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) as mitigating, treating, or preventing any disease, disease symptom, or health-related condition, unless in a final order of a Federal court following a trial on the merits finds clear and convincing evidence based on qualified expert opinion and published peer-reviewed scientific research that— (1)the claim is false and misleading in any material respect; and (2)there is no less speech restrictive alternative to claim suppression, such as use of disclaimers or qualifications, that can render the claim non-misleading.

3.

Definition of drug

(a)

In general

Subparagraph (1) of section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) is amended by striking the second and third sentences and inserting the following: A food or dietary supplement for which a claim is made in accordance with section 403(r)(1)(B) is not a drug solely because of such claim.. (b)

Rules

All rules of the Food and Drug Administration in existence on the date of the enactment of this Act prohibiting nutrient-disease relationship claims are revoked.

4.

Misbranded food

Section 403(r) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)) is amended— (1)by striking clause (B) of subparagraph (1) and inserting the following: (B) describes any nutrient as mitigating, treating, or preventing any disease, disease symptom, or health-related condition if, and only if, the claim has been adjudicated false and misleading in any material respect by final order of a Federal court of competent jurisdiction in accordance with section 2 of the Health Freedom Protection Act. ; (2)by striking subparagraph (3); (3)in the first sentence of subparagraph (4)(A)(i)— (A)by striking or (3)(B); and (B)by striking or (1)(B); (4)by striking clause (C) of subparagraph (4); (5)by striking clause (D) of subparagraph (5); and (6)in subparagraph (6), by striking the second sentence.

5.

Dietary supplement labeling exemptions

Section 403B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343–2) is amended to read as follows:

403B.

Food and dietary supplement labeling

The Federal Government shall take no action to prevent distribution of any publication in connection with the sale of a food or dietary supplement to consumers unless it establishes that a claim contained in the publication— (1)names the specific food or dietary supplement sold by the person causing the publication to be distributed; (2)represents that the specific food or dietary supplement mitigates, treats, or prevents a disease; and (3)proves the claim to be false and misleading in any material respect by final order of a Federal court of competent jurisdiction in accordance with section 2 of the Health Freedom Protection Act.

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