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Road To 'New' From FDA 'Old' Dietary Ingredient Discussion Has Doubters

This article was originally published in The Rose Sheet

Executive Summary

CFSAN hosts a discussion at its College Park, Md., headquarters on developing a list of dietary ingredients available in the US food supply before Congress passed DSHEA. Food and drug law attorneys Todd Harrison and Wes Siegner make arguments that FDA is heading in the wrong direction to keep violative ingredients off the market.

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Compiling Pre-DSHEA Ingredient List Relies On Bridging FDA-Industry Gap

"Nobody said these are easy questions, if they were they would have been answered a long time ago," says Steve Tave, director of FDA's Office of Dietary Supplement Programs. Industry stakeholders at a public meeting recommend a reasonable threshold for evidence that verifies a dietary ingredient was available in the US before Congress passed DSHEA.

Supplement Industry Critics On Agenda For FDA's Ingredient List Meeting

FDAs Oct. 3 meeting agenda includes Pieter Cohen, Harvard Medical School professor; Consumers Union Programs Director Chuck Bell; Laura MacCleery, Center for Science in the Public Interest regulatory affairs director; and Stephanie Scarmo, Pew Charitable Trusts Health Care Products Project officer.

Lack Of Supplement NDI Notification Guidance Not A Market Pass For Industry

Manufacturers, ingredient suppliers and other parties submitting NDI notifications can improve the industry's outlook by "anticipating future products that haven't been brought to market yet" and proposing the highest concentration of an ingredient for the broadest variety of uses, says ODSP senior advisory Cara Welch.

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