HR 2044 IH
112th CONGRESS
1st Session
H. R. 2044
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.
IN THE HOUSE OF REPRESENTATIVES
May 26, 2011
Mr. PAUL 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.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
SEC. 2. LIMITATION ON SUPPRESSION BY FEDERAL GOVERNMENT OF CLAIMS IN FOOD AND DIETARY SUPPLEMENTS.
(a) In General- 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 a Federal court in a final order 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 a 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.
(b) Definition- In this section, the term ‘material’ means that the Food and Drug Administration has identified a competent consumer survey demonstrating that consumers decided to purchase the food or dietary supplement based on the portion of the claim alleged to be false or misleading.
SEC. 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.
SEC. 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 a material respect by final order of a Federal court of competent jurisdiction in accordance with section 2 of the Health Freedom 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), in the matter following clause (C), by striking the first sentence.
SEC. 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:
‘FOOD AND DIETARY SUPPLEMENT LABELING
‘Sec. 403B. 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 a material respect by final order of a Federal court of competent jurisdiction in accordance with section 2 of the Health Freedom Act.’.
U.S. Congress - Text of H.R.2044 as Introduced in House Health Freedom Act
