The U.S. Food and Drug Administration (FDA) has released two educational videos and a supplemental fact sheet covering information about the New Dietary Ingredient Notification (NDIN) process for dietary supplements. The materials are designed to help manufacturers correctly prepare and submit complete NDINs to the FDA.

As opposed to declaring an ingredient which is already in the food supply and can be declared as Generally Recognized as Safe (GRAS), new dietary ingredients must be subject to a premarket safety notification via the NDIN process, which is the agency’s only opportunity to evaluate the safety and identity of a new dietary ingredient in dietary supplements before it becomes available to consumers. Having a well-organized and scientifically-supported NDIN facilitates an efficient and timely review, FDA reported.

The first video, “Important Aspects of the NDIN Process,” and accompanying fact sheet outline several common issues the FDA has observed in the NDIN submission process that could result in unnecessary delays or a negative response from the agency.

The second video, “Correspondence Between FDA and the Notifier,” explains what manufacturers can expect after an NDIN has been submitted to the agency, including correspondence expected between the FDA and the notifier during the process.

FDA reported that additional questions can be submitted to the Office of Dietary Supplement Programs by email at NDITeam@fda.hhs.gov.