[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
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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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