As promised last month, we are happy to announce that on April 3, FDA issued the New Dietary Ingredient Notification Master Files for Dietary Supplements draft guidance. In a related constituent update, FDA explained that the draft guidance responds to the dietary supplement industry's requests for specific guidance regarding Master Files for new dietary ingredient notifications (NDINs). The guidance expands upon and replaces the recommendations related to NDIN Master Files outlined in FDA's revised draft 2016 guidance, Dietary Supplements: New Dietary Ingredients Notifications and Related Issues.
NDIN Master Files are not required by statute or regulation. As explained in the guidance, a Master File is a file containing identity, manufacturing, and/or safety information relating to a new dietary ingredient (NDI) that the Master File owner can submit to FDA for use in evaluating a potential future NDIN by the Master File owner or by another person designated by the NDIN Master File owner. A Master File can contain information about an NDI, a dietary supplement containing an NDI, or both.
The guidance also explains how a Master File owner can, without disclosing the information in the Master File itself, authorize another party, such as a business partner or supplement manufacturer, to reference this information. It states that Master Files benefit NDIN submitters with a right of reference by allowing them to refer to data already on file, instead of having to develop the data themselves and resubmit it in each NDIN for the same ingredient. FDA plans to include a list of Master Files that are referenced in published NDINs on its website and expects to update the list quarterly. The list will include the subject and Master File Owner. FDA hopes that by describing how to submit and use Master Files, the guidance will help industry to "more easily comply with the requirement to submit NDINs."
Other highlights in the draft guidance include recommendations on how to establish, submit, update, and close a Master File. Further, the guidance explains the effect of an NDIN Master File on trade secrets and confidential commercial information (CCI) and how to identify this information. The guidance also explains FDA's review process regarding Master Files.
Comments on the draft guidance are due by June 3, 2024. Consider talking to your lawyer to learn more about the comment process and the agency's current emphasis on the requirement to submit NDINs.
