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FDA Sees NDIN Master File Guidance Spurring Compliance, US Industry Looks For Enforcement

 
• By Malcolm Spicer

Some trade groups couldn’t agree more that spurring NDIN compliance will benefit the supplement industry, but few in industry are convinced the agency will strengthen enforcement of the requirement or across supplement sector generally.

• Source: Shutterstock

The Food and Drug Administration has agreement from some in the US dietary supplement industry that a master file system for new dietary ingredient notifications could spur compliance, but wider support could come with stronger enforcement of the NDIN requirement.

The FDA’s Office of Dietary Supplement Programs on 3 April published a draft guidance on compiling and submitting master files for NDINs compliant with Food, Drug and Cosmetic Act 413(a)(2) (

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