FDA Issues Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements

The U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” This draft guidance responds to the dietary supplement industry’s requests for specific guidance on recommendations about Master Files for new dietary ingredient notifications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NDIN Master Files are not required by statute or regulation, but, as explained in today’s draft guidance, can be used to facilitate the submission of NDI-related identity, manufacturing, and/or safety information to the FDA for use in evaluating a potential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The recommendations in this draft guidance expand upon and replace the recommendations related to Master Files in the FDA’s revised draft guidance, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.

To Submit Comments:

Comments on the draft guidance should be submitted within 60 days after publication in the Federal Register to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance.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.

Additional Information:

Federal Register Notice for the Draft Guidance

New Dietary Ingredient (NDI) Notification Process

Information for Industry on Dietary Supplements