- Yesterday, the U.S. Food and Drug Administration (FDA) unveiled two educational videos and a supplemental fact sheet to help the dietary supplement industry with the New Dietary Ingredient Notification (NDIN) review process. These educational materials are the latest release among several resources the FDA has put forth since the 1997 Final Rule: Premarket Notification for a New Dietary Ingredient. The full list of resources for the NDIN process can be found here.
- The NDIN review process follows the Federal Food, Drug, and Cosmetic Act (the FD&C Act) requirement that manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” notify the FDA about these ingredients (subject to a narrow exception).
- The new supplemental fact sheet lists 5 commonly observed issues FDA sees manufacturers and distributors make during the NDIN submission process. FDA hopes highlighting these issues will make it easier for manufacturers and distributors to successfully file an NDIN and avoid delays or negative responses that often follow submission issues.
- The new educational videos titled, “Important Aspects of the NDIN Process” and “Correspondence Between FDA and the Notifier,” work together to provide an overview of the entire NDIN process. The first video, “Important Aspects of the NDIN Process,” walks through what an NDIN should and should not include, and common mistakes made during the NDIN submission process. The second video, “Correspondence Between FDA and the Notifier,” explains what the notifier can expect following the submission of an NDIN.
- Keller and Heckman will continue to monitor developments related to the NDIN process.
