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New Dietary Ingredient Submissions-Chapter 3:A Review of Past and Present

Elsevier Inc.
DOI: 10.1016/b978-012373901-8.00003-2


Publisher Summary When the new dietary ingredient notification requirements were originally published as part of DSHEA, it was thought the process itself was little more than a simple safety review. The reality is the process is more akin to a certification rather than a notification. Submitters are asked to qualify every aspect of the new ingredient without leaving any ambiguity. New products are introduced at a dizzying pace while new ingredients find their way into all kinds of product forms. Dietary ingredients are now within reach of most US consumers, eager to enjoy the health benefits afforded by the assortment of “functional” foods lining retain shelves. The Food and Drug Administration (FDA) has in place a safety review system for every new dietary ingredient before it enters the market, however, very few ingredients make it through the process successfully. There currently exists a fundamental disconnect between FDA and industry expectations on how to qualify safety for dietary ingredients. Whether future FDA guidance provides better clarification on the NDI process, a thorough understanding of the requirements should be part of any premarket strategy.

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