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FDA 100-Day Health Claim Review Provided In House Bill

This article was originally published in The Tan Sheet

Executive Summary

FDA would be required to authorize general health claims and "claims based on government statements" within 100 days of receipt under the "Consumer Freedom Protection Act." Currently, the agency has 540 days to review a proposed health claim.

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Consumer Freedom Protection Act

Bill to amend FD&C Act to allow broad range of health claims introduced in House June 8 by Rep. Helen Chenoweth-Hage (R-Idaho). The measure, HR 4604, would eliminate the current "significant scientific agreement" review standard for health claims, substituting a First Amendment standard allowing verbatim and accurately paraphrased quotes of health claims and nutrient content claims published in statements by federal governmental bodies. Under the First Amendment standard, FDA would be prohibited from denying any health or nutrient content claims unless it determines "no scientific evidence supports the claim and that the claim is inherently misleading." An attempt by the Pearson v. Shalala plaintiffs to secure a preliminary injunction against FDA's ban on four proposed health claims was denied May 24 (1"The Tan Sheet" June 5, p. 14)

FDA Pearson Implementation Faces Further Congressional Criticism

FDA's progress in implementing the Pearson v. Shalala court decision is sharply criticized by Republican Reps. Helen Chenoweth-Hage (Idaho), Ron Paul (Texas) and Bob Stump (Ariz.) in a March 17 letter to the agency.

Authoritative Statements For Health Claims Up To Agency Heads - Yetley

Appropriate authoritative statements for dietary supplement health claims should be determined by the director of the agency from which the claim originates, Center for Food Safety & Applied Nutrition Office of Special Nutritionals Director Elizabeth Yetley, PhD, asserted at a Nonprescription Drug Manufacturers Association meeting on dietary supplements in Washington, D.C. Jan. 15.





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