FDA issues draft guidance on dietary ingredient notification master files

Published: 4-Apr-2024

The updated guidance on dietary ingredients for supplementation purposes facilitates the submission of manufacturing and safety information

The US Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry titled "New Dietary Ingredient Notification Master Files for Dietary Supplements."  

This draft guidance responds to the dietary supplement industry’s requests for specific guidance on recommendations about master files for new dietary ingredient notifications (NDINs).

NDIN Master Files are not required by statute or regulation, but, as explained in today’s draft guidance, can be used to facilitate the submission of NDI-related identity, manufacturing and/or safety information to the FDA for use in evaluating a potential future NDIN.

The intent of the guidance, once finalised, will be to help industry comply more easily with the NDIN requirement by providing recommendations on the content, submission and use of master files.

The recommendations in this draft guidance expand upon and replace the recommendations related to Master Files in the FDA’s revised draft guidance, "Dietary Supplements: New Dietary Ingredient Notifications and Related Issues." 

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