i- On April 3, 2024, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” See 89 Fed. Reg. 23599 (Apr. 4, 2024). The draft guidance was published as a response to the dietary supplement industry’s requests for specific guidance on recommendations about Master Files for new dietary ingredient notifications (NDINS). The recommendations in the guidance expand upon and replace the recommendations concerning Master Files in FDA’s revised draft guidance “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues“.
- Although NDIN Master Files are not required by statute or regulation, they can be used to facilitate the submission of NDI-related identity, manufacturing, and/or safety information to FDA for use in evaluating a potential future NDIN. The intent of the guidance is to help industry comply more easily with the NDIN requirement by providing recommendations on the content, submission, and use of Master Files.
- Although some or all of the data in an NDIN Master File may be trade secret information
6or confidential commercial information (CCI) (and generally exempt from public disclosure), there is no presumption that any particular information in the Master File is trade secret information or CCI. A determination of whether specific data and information in an NDIN Master File is exempt from public disclosure is based on the status of the data and information under the Freedom of Information Act (FOIA) and FDA disclosure regulations at 21 CFR part 20, rather than on the type of file in which the data and information is stored. - Comments may be submitted by June 4, 2024.
FDA Publishes Draft Guidance on NDIN Master Files
Monday, April 8, 2024
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