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.
See How to Submit Notifications for details on how to submit a notification including timeframe, format, and method of submission.
FDA provides an ePortal for electronic submissions.
New Dietary Ingredient Draft Guidance
FDA issued a revised draft guidance for industry on dietary ingredient notifications and related issues. The revised draft guidance supersedes FDA's July 2011 draft guidance on the same topic. The revised draft guidance, when finalized, will help industry in evaluating whether to submit a premarket safety notification for a new dietary ingredient (NDI), or for a dietary supplement containing an NDI, and in preparing such premarket safety notifications (also referred to as NDI notifications).
Read and Comment on the Draft Guidance: New Dietary Ingredient Notifications and Related Issues.