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Comment on FDAAA provision

This article was originally published in The Tan Sheet

Executive Summary

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

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

AHPA comments on FDAAA

The American Herbal Products Association encourages FDA to implement carefully Sec. 912 of the FDA Amendments Act so it does not discourage investigations of the safety, functional effects or health benefits of substances that may be added to foods, the trade group says in comments submitted Nov. 25. FDAAA Sec. 912 prohibits interstate commerce of foods with an added approved drug or licensed biological product which is the subject of publicly disclosed substantial clinical investigations. If read strictly, this provision could block the sale of new and some existing dietary supplements and food ingredients, experts warn (1"The Tan Sheet" Aug. 11, 2008, In Brief). However, AHPA argues that the section does not replace or amend the Dietary Supplement Health and Education Act and does not affect dietary supplements

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