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New dietary ingredient notifications

This article was originally published in The Tan Sheet

Executive Summary

FDA should issue a guidance to explain when new dietary ingredient notifications are necessary, as well as the type of information they should include, NNFA says in May 9 letter to the agency. Guidance should establish "whether, and under what conditions, a dietary ingredient that is a component of food (i.e. lycopene in tomatoes) would be exempt" from notification, as well as the quantity, quality of information required to satisfy the "history of use or other evidence of safety" standard. NNFA's comments respond to March 19 FDA notice requesting public feedback on premarket notification process for new dietary ingredients...

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