Food

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.

New Dietary Ingredient Notification ePortal Submission 

New Dietary Ingredient Notification ePortal Submission Screenshot

 

Page Last Updated: 01/13/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.