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FDA Revision Of NDI Draft Guidance Starts With Grandfathered List

This article was originally published in The Tan Sheet

Executive Summary

Trade groups say FDA committed to revisiting issues in the NDI draft guidance including how firms prove ingredients’ grandfathered status, notifications required for ingredients or finished products and data necessary to demonstrate NDI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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