New Dietary Ingredient (NDI) Notification Electronic Submissions
The following are system instructions for submitting a New Dietary Ingredient (NDI) Notification electronically.
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 (FDA) about these ingredients. Section 413(a)(2) of the FD&C Act requires that manufacturers and distributors who wish to market dietary supplements that contain "new dietary ingredients" notify FDA about the safety of the dietary supplement containing the new dietary 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.
For more information, see
- Background for Industry
- Information a Notification Must Contain - includes information on timeframe, format, and method of submission
FDA provides an ePortal (COSM) for electronic submissions. We encourage submitters to utilize the portal in order to receive confirmation of receipt by FDA and to facilitate their review.
Launch the New Dietary Ingredient Notification ePortal
(via the CFSAN Online Submission Module)
** instructions and account management information available **