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Congress Did Not Intend FDAAA Sec. 912 To Apply To Supplements – Industry

This article was originally published in The Tan Sheet

Executive Summary

FDA should not subject dietary supplements to an FDA Amendment Act of 2007 provision that, if interpreted broadly, would block supplement sales, restrict innovation and discourage pre-market safety and efficacy tests, industry leaders say

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Technical Hurdles, Commercial Limits Complicate Supplement-To-Drug Moves

Firms should investigate regulatory hurdles and gauge the commercial appeal of a finished product before moving dietary supplement ingredients into the pharmaceutical realm, say manufacturing and testing consultants

Senate Puts FDA On Notice To Solve FDAAA Sec. 912 Puzzle

Senate appropriators say FDA must decide how it will implement a provision of the FDA Amendments Act of 2007 that could substantially stifle innovation in the dietary supplement industry

Comment on FDAAA provision

FDA requests industry help to interpret a provision in the FDA Amendments Act of 2007 that could block the sale of new and some existing dietary supplements and food ingredients if read strictly. A provision of FDAAA amended the Food, Drug and Cosmetics Act to prohibit the sale of any drug or biological product for which "substantial clinical investigations" were conducted and publicized, and any food product to which an approved drug or licensed biological has been added (1"The Tan Sheet" March 10, 2008, p. 3). In a July 29 Federal Register notice, the agency asks industry how to interpret clinical investigations and how the provision will impact supplements and self-determined GRAS status. The amendment has no legislative history or grandfather clause for existing products. FDA also seeks comments on whether the provision is a disincentive to study conventional foods and dietary supplements and, if so, how to minimize that impact. Comments are due by Oct. 27...

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