Background: Under section 413 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.350b), the manufacturer or distributor of an NDI that has not been present in the food supply as an article used for food, or the manufacturer or distributor of a dietary supplement containing such an NDI, must submit an NDIN to FDA at least 75 days before introducing the product into interstate commerce. The NDIN must contain the information, including any citation to published articles, which provides the basis on which the manufacturer or distributor of the NDI or dietary supplement (the notifier) has concluded that the dietary supplement containing the NDI will reasonably be expected to be safe (21 U.S.C. 350b).

This FDA provides recommendations to the industry on Master Files for new dietary ingredient notifications (NDINs). A master file (NDIN Master File or Master File) is a file containing identity, manufacturing, and/or safety information relating to a new dietary ingredient (NDI) that the Master File owner submits to FDA for use in evaluating a potential future NDIN by the Master File owner or by another person designated by the owner (e.g., business partner, supplement manufacturer). 

A Master File contains information about an NDI, a dietary supplement containing an NDI, or both. The Master File owner may refer to the Master File in an NDIN or may grant written authorization to other parties to incorporate information from the Master File by reference in NDINs. A written authorization granting a right of reference to a Master File in an NDIN does not include the right to see or copy the Master File. The recommendations in this guidance expand upon and replace the recommendations related to Master Files in FDA’s revised draft guidance, Dietary Supplements: New Dietary Ingredient