110 HR 7120 IH: Science Free Speech U.S. House of Representatives 2008-09-26 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
I 110th CONGRESS 2d Session H. R. 7120 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.
1.
Short title
This Act may be cited as the Science Free Speech Act.
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..
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.
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:
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).
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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:
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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