[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7120 Introduced in House (IH)]







110th CONGRESS
  2d Session
                                H. R. 7120

   To amend the Federal Food, Drug, and Cosmetic Act concerning the 
  distribution and citation of scientific research in connection with 
         foods and dietary supplements, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 26, 2008

  Mr. Cannon 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 the 
  distribution and citation of scientific research in connection with 
         foods and 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,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Science Free Speech Act''.

SEC. 2. DEFINITION OF A DRUG.

    Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321(g)(1)) is amended by adding at the end the following: ``A 
food or dietary supplement, for which a claim regarding legitimate 
scientific research is made in accordance with section 403B, is not a 
drug solely because of such claim.''.

SEC. 3. MISBRANDED FOOD.

    Section 403(r)(1)(B) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 343(r)(1)(B)) is amended by striking ``unless the claim is 
made in accordance with subparagraph (3) or (5)(D)'' and inserting 
``unless the claim is made in accordance with subparagraph (3) or 
(5)(D) or is a claim regarding legitimate scientific research made in 
accordance with section 403B''.

SEC. 4. FOOD AND 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:

``SEC. 403B. FOOD AND DIETARY SUPPLEMENT LABELING EXEMPTION.

    ``(a) Legitimate Scientific Research.--The use of truthful and not 
misleading information on legitimate scientific research in connection 
with the sale or distribution of a food or dietary supplement to 
consumers shall not be treated as a violation of this Act and shall not 
be deemed evidence of an intent to sell a drug.
    ``(b) Actions by Secretary.--The Secretary--
            ``(1) shall not restrict in any way the distribution of 
        truthful and not misleading information on legitimate 
        scientific research described in subsection (a); and
            ``(2) shall not prohibit manufacturers or distributors of 
        foods or dietary supplements from including citations to 
        legitimate scientific research in the labeling of a food or a 
        dietary supplement, even if the citation expressly or 
        implicitly references a disease or a disease condition.
    ``(c) Burden of Proof.--In any administrative or judicial 
proceeding in which the Secretary contests the use of material being 
disseminated or cited as legitimate scientific research, the burden of 
proof shall be on the Secretary to disprove that the material is 
truthful and not misleading information on legitimate scientific 
research.
    ``(d) Definition.--In section 201(g) and this section, the term 
`legitimate scientific research' means scientific research, whether 
performed in vitro, in vivo, in animals, or in humans, that is--
            ``(1) conducted in accordance with sound scientific 
        principles; and
            ``(2) evaluated and accepted by a scientific or medical 
        panel or published in--
                    ``(A) a recognized scholastic textbook or a peer-
                reviewed scientific publication or database;
                    ``(B) any publication of the United States 
                Government (including publications by or at the request 
                of any Federal department, agency, institute, center, 
                or academy); or
                    ``(C) an accurate balanced summary or scientific 
                review of information published in accordance with 
                subparagraph (A) or (B).''.

SEC. 5. DIAGNOSTIC TESTS.

    Chapter III of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
331 et seq.) is amended by inserting after section 301 the following:

``SEC. 301A. PERMITTED ACTS.

    ``The Secretary shall not prohibit or restrict a retailer or 
wholesaler of any agricultural product, including fresh produce, in any 
way from--
            ``(1) testing any of its agricultural products for any 
        pathogens, including bacteria, viruses, protozoa, fungi, or 
        parasites, that may--
                    ``(A) potentially be transmitted to humans; or
                    ``(B) potentially cause illness or disease in 
                humans; or
            ``(2) communicating the results of the tests described in 
        paragraph (1) to the public.''.
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