On March 5, the FDA issued the final guidance “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.”

Under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350b(a)(2)), the manufacturer or distributor of a new dietary ingredient (NDI) that has not been present in the food supply as an article used for food, or of a dietary supplement that contains the NDI, must submit a premarket safety notification to FDA at least 75 days before introducing the product into interstate commerce. The new guidance is intended to help manufacturers and distributors of NDIs and dietary supplements prepare and submit new dietary ingredient notifications (NDINs) to the FDA.

The guidance provides information about the NDIN submission and review process in a Q&A format. Topics include:

• Who needs to submit an NDIN?
• How should the information be organized and presented?
• Where should an NDIN be submitted?
• What happens after an NDIN is submitted?

Download the final guidance here.