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AHPA comments on FDAAA

This article was originally published in The Tan Sheet

Executive Summary

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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