[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3395 Introduced in House (IH)]

111th CONGRESS
  1st Session
                                H. R. 3395

  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

                             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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Health Freedom Act''.

SEC. 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.

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 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.

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 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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