The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that manufacturers and distributors who wish to market dietary supplements that contain "new dietary ingredients" notify the Food and Drug Administration about these ingredients. Generally, the notification must include information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling.
New Dietary Ingredient Notification ePortal Submission
- Electronic New Dietary Ingredient Notification (NDIN) Submission Portal
(accessed via FDA Industry Systems)
- How to Submit Notifications
Information on how to submit a notification including timeframe, format, and method of submission.
- Step-by-Step System Instructions