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Supplement NDI Draft Guidance Discussions Snagged On Basic Criteria

 
• By Malcolm Spicer

FDA’s dietary supplement division is concerned that firms are not submitting NDI notifications in cases where they should be, while industry stakeholders assert the agency needs to clarify the criteria for determining which products should be the subject of notifications and what information is needed.

FDA supplement programs chief Dan Fabricant sees a gap between the agency and the dietary supplement industry over a draft guidance on new dietary ingredient notifications.

Fabricant and his associates in the Division of Dietary Supplement Programs in FDA’s Center for Food Safety and Applied Nutrition are concerned that firms are not

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