Health Freedom Act - Prohibits the federal government from preventing the use of a claim describing any nutrient in a food or dietary supplement as mitigating, treating, or preventing any disease, disease symptom, or health-related condition unless, in a final order following a trial on the merits, a federal court 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 that can render the claim non-misleading. Defines the term "material" to mean that the Food and Drug Administration (FDA) 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.
Revokes all FDA rules prohibiting nutrient-disease relationship claims.
Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a food to be misbranded only when its label includes a claim adjudicated to be false and misleading under this Act. Removes limits on health claims on food provided for in the FFDCA.
Prohibits the government from preventing distribution of a publication concerning the sale of a food or dietary supplement unless: (1) it establishes that a claim contained in the publication names the specific food or supplement sold and represents that the food or supplement mitigates, treats, or prevents a disease; and (2) the claim is proven to be false and misleading in accordance with this Act.
[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2044 Introduced in House (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.
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.
(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.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Sponsor introductory remarks on measure. (CR E972)
Referred to the Subcommittee on Health.
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