FDA has developed a new set of requirements for documenting the safety of dietary supplement ingredients. Manufacturers are able to market products with new ingredients without preapproval as long as they can prove they are safe, including creating and maintaining a file supporting the safety of the new ingredient.
To that end FDA is creating new guidance related to such files. The eventual final guidance entitled “New Dietary Ingredient Notification Master Files for Dietary Supplements” will contain recommendations to the industry about what Master Files should contain and how they will be reviewed. The goal of the guidance is to assist the industry with compliance with the new dietary ingredient notification requirement as it relates to Master Files that contain identity, manufacturing, or safety data used to support a new dietary ingredient notification.
A Master File (NDIN Master File or Master File) is a file containing 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 owner. The draft guidance contains information on establishing an NDIN Mater File, updating or closing an NDIN Master File, the use of data from an NDIN Master File by the owner and other parties authorized by the owner, and FDA’s role in reviewing and administering NDIN Master Files.
Why This Matters
Properly prepared Master Files can significantly streamline the NDI notification process, ensuring compliance with FDA regulations and expediting the introduction of new dietary ingredients to the market.
