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Structure/function notification burden queried

This article was originally published in The Tan Sheet

Executive Summary

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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