To amend the Federal Food, Drug, and Cosmetic Act to compel Food and Drug Administration compliance with the first amendment to the United States Constitution and to protect freedom of informed choice in the dietary supplement marketplace consistent with the decision of the United States Court of Appeals for the District of Columbia Circuit in Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), reh'g denied en banc, 172 F.3d 72 (D.C. Cir. 1999).
Requires the Secretary of Health and Human Services, within 100 days of receiving such a claim, to promulgate regulations authorizing such claims in a form that accurately reflects the degree of scientific evidence supporting the claim, unless the Secretary determines that no scientific evidence supports such claim and that the claim is inherently misleading. Allows judicial review of claims denied by the Secretary. Allows on such labeling statements made by a scientific body of the U.S. Government about the relationship between a nutrient and a health-related condition. Prohibits the Secretary from denying claims based on such statements.
Approves the health claims references in the decision of the U.S. Court of Appeals for the District of Columbia in Pearson v. Shalala. Directs the Secretary to publish a notice granting each of such claims with the following disclaimer: "The Food and Drug Administration has determined that the evidence supporting this claim is inconclusive." Makes null and void: (1) the interim final rules concerning health claims based on the authoritative statement published in the Federal Register of June 22, 1998; and (2) all orders issued by the FDA after April 20, 1999, and before this Act, that have denied health claims. Requires reevaluation of claims included under such orders.
Introduced in House
Introduced in House
Referred to the House Committee on Commerce.
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