FDA Issues A New Draft Guidance On New Dietary Ingredient Notification Master Files For Dietary Supplements

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to announce that on April 3, FDA issued the New Dietary Ingredient Notification Master Files for Dietary Supplements draft guidance. In a related constituent update, FDA explained that the draft guidance responds to the dietary supplement industry's requests for specific guidance regarding Master Files for new dietary ingredient notifications (NDINs).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