Premarket Notification for a New Dietary Ingredient

This information collection supports the premarket notification requirements for a new dietary ingredient (NDI). Respondents include manufacturers, distributors, packagers, holders, labelers, exporters, and importers of dietary supplements that contain NDIs who must report product information to FDA at least 75 days before an NDI or a dietary supplement that contains an NDI can be introduced or delivered into interstate commerce.

The latest form for Premarket Notification for a New Dietary Ingredient expires 2027-02-28 and can be found here.