NDI Guidance Sparks Questions Even From Firms Ready To Comply
This article was originally published in The Tan Sheet
Executive Summary
FDA’s new dietary ingredient notification draft guidance draws questions even from firms that expect compliance will not require drastic changes in their processes.
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FDA Revision Of NDI Draft Guidance Starts With Grandfathered List
Trade groups say FDA committed to revisiting issues in the NDI draft guidance including how firms prove ingredients’ grandfathered status, notifications required for ingredients or finished products and data necessary to demonstrate NDI safety. The agency’s decision followed a meeting between industry allies Sens. Hatch and Harkin and FDA Commissioner Hamburg.
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