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H.R. 3395

BillFederalHouseIn Committee
Health Freedom Act
About This Bill
Committee
Latest Action · July 30, 2009
Referred to the Subcommittee on Health.
Congress
111th (2009–2011)
Introduced
July 29, 2009
Cosponsors (2)
0D 2R
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Summary

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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 any material respect; and (2) there is no less speech restrictive alternative to claim suppression that can render the claim non-misleading. Amends the Federal Food, Drug, and Cosmetic Act to deem a food or dietary supplement for which a claim characterizing the relationship of a nutrient to a disease or health-related condition not to be included in the definition of "drug" solely because of such claim. Revokes all Food and Drug Administration (FDA) rules prohibiting nutrient-disease relationship claims. Revises the criteria for deeming a food misbranded when a claim for a nutrient is made. Revises dietary supplement labeling exemptions to prohibit 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 any material respect by final order of a federal court in accordance with this Act.

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