Information from the U.S. Food and Drug Administration (FDA):
The U.S. Food and Drug Administration (FDA) has released two educational videos and a supplemental fact sheet to broaden the dietary supplement industry’s awareness and understanding of the agency’s New Dietary Ingredient Notification (NDIN) review process. These educational materials are intended to help manufacturers and distributors of dietary supplements correctly prepare and submit complete NDINs to the FDA.
Section 413 of the Federal Food, Drug, and Cosmetic Act requires that manufacturers and distributors who wish to market certain new dietary ingredients submit a premarket safety notification to the FDA through the NDIN process. This process represents 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 FDA review.
The first video, titled “Important Aspects of the NDIN Process,” and the 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, titled “Correspondence Between FDA and the Notifier” explains what manufacturers can expect after an NDIN has been submitted to the agency, including the correspondence expected between the FDA and the notifier during the NDIN process.
These materials are intended to help simplify the process for manufacturers and distributors, resulting in more complete NDINs submitted to the FDA and facilitating the agency’s scientific review. For additional questions regarding the agency’s NDIN process, please contact the Office of Dietary Supplement Programs by email at NDITeam@fda.hhs.gov.
Additional Information:
How to Submit Notifications for a New Dietary Ingredient
New Dietary Ingredients in Dietary Supplements – Background for Industry
