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Today, the U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” This draft guidance responds to the dietary supplement industry’s requests for specific guidance on recommendations about Master Files for new dietary ingredient notifications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NDIN Master Files are not required by statute or regulation, but, as explained in today’s draft guidance, can be used to facilitate the submission of NDI-related identity, manufacturing, and/or safety information to the FDA for use in evaluating a potential future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 finalized, 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The recommendations in this draft guidance expand upon and replace the recommendations related to Master Files in the new dietary ingredient notifications (NDINs) in the 2016 FDA revised draft guidance.

To Submit Comments

Comments on the draft guidance should be submitted within 60 days (by 6/3/2024) after publication in the Federal Register to ensure that the FDA considers consider your comment on the draft guidance before working on the final version of the guidance. Submit electronic comments to www.regulations.gov to docket number FDA-2024-D-0706. Written comments should be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All written comments should identify the docket number FDA-2024-D-0706.

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Posted in Dietary Supplements, FDA and USDA Regulatory Update.