New Dietary Ingredients Notification Process

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.

Announcement: FDA invites comment on a new form it is developing, Form FDA 3880 - Electronic New Dietary Ingredient Notification (NDIN) Submission, that allows manufacturers and distributors to electronically submit premarket notifications of new dietary ingredients electronically. This electronic form could be used in lieu of submitting the same notification as a hard copy. View more information and provide us with your comments on Draft Form FDA 3880 - Electronic New Dietary Ingredient Notification (NDIN) Submission.

Page Last Updated: 11/13/2014
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