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CHPA, CRN Remind US FDA About Enforcement In Comments On NDIN Master File Draft Guidance

 
• By Malcolm Spicer

CRN is “disappointed the draft guidance was not accompanied with an announcement by FDA of its commitment to rigorously enforce the NDI notification requirement.” CHPA says NDIN “requirement is only meaningful if FDA consistently takes enforcement action against manufacturers and distributors” noncompliant with the requirement.

• Source: Shutterstock

Comments on the US Food and Drug Administration’s draft guidance on master files for new dietary ingredient notifications suggest the agency clarify some details while also clarifying that the industry pushes for increased enforcement against NDIN violations.

The Council for Responsible Nutrition states that it is “disappointed the draft guidance was not accompanied with an announcement by FDA of its commitment to rigorously enforce the NDI notification...

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