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
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.
This Act may be cited as the
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—
the claim is false and misleading in any material respect; and
there is no less speech restrictive alternative to claim suppression, such as use of disclaimers or qualifications, that can render the claim non-misleading.
Definition of drug
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
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
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.
Section 403(r) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)) is amended—
by striking clause (B) of subparagraph (1) and inserting the following:
by striking subparagraph (3);
in the first sentence of subparagraph (4)(A)(i)—
or (3)(B); and
by striking clause (C) of subparagraph (4);
by striking clause (D) of subparagraph (5); and
in subparagraph (6), by striking the second sentence.
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:
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—
names the specific food or dietary supplement sold by the person causing the publication to be distributed;
represents that the specific food or dietary supplement mitigates, treats, or prevents a disease; and
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.