April 3, 2024
FDA Issues Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements

Today, the U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” This draft guidance responds to the dietary supplement industry’s requests for specific guidance on recommendations about Master Files for new dietary ingredient notifications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NDIN Master Files are not required by statute or regulation, but, as explained in today’s draft guidance, can be used to facilitate the submission of NDI-related identity, manufacturing, and/or safety information to the FDA for use in evaluating a potential future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The recommendations in this draft guidance expand upon and replace the recommendations related to Master Files in the FDA’s revised draft guidance, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.”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Comments on the draft guidance should be submitted within 60 days after publication in the Federal Register to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance.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:

Contact us
Thank you for your interest in Garg Law PLLC.
Our commitment to understanding your regulatory questions and business goals, and helping you achieve results starts here.
If you are looking for representation on a new matter, please fill out the form below to request a free consultation. The form enables us to conduct a preliminary check for potential conflicts of interest and to determine if we can proceed with the free consultation.
Garg Law Global Icon

News & Insights

Get the latest news on FDA regulatory delivered straight to your inbox.