Structure/function notification burden queried
This article was originally published in The Tan Sheet
FDA asks for dietary supplement firms' comments on the reporting burden of notifying the agency about structure/function claims. In a June 2 Federal Register 1notice, the agency estimates, based on submissions received in the past two years, that 2,200 firms will make the reports per year and each will require 0.75 hours to report the necessary information, for a total annual industry burden of 1,650 hours. The Dietary Supplement Health and Education Act requires manufacturers making structure/function claims on supplements to notify FDA of the claims within 30 days of a product reaching the market. The deadline for comments is Aug. 3, according to the notice
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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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