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Law firm asks for structure/function petition decision

This article was originally published in The Tan Sheet

Executive Summary

The dietary supplement industry would have no reporting burden for structure/function claim notifications if FDA affirmed a citizen petition to revoke the claim notification rule, A. Wes Siegner says. The Hyman, Phelps & McNamara attorney reminded FDA in a Nov. 23 1letter that the agency has not responded to HPM's Feb. 4, 2000, petition, which asked FDA to rescind its disclaimer requirement for structure/function claims and its requirement that supplement firms notify FDA of such claims, as long as the claims are "truthful, non-misleading and derive[d] from nutritive value." Siegner's letter responds to FDA's June 2 Federal Register notice seeking comment on the burden of claim notification - estimated at 1,650 total hours annually (2"The Tan Sheet" June 8, 2009)

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