In an effort to broaden the dietary supplement industry’s awareness and understanding of New Dietary Ingredient Notification (NDIN) review process, the U.S. Food and Drug Administration (FDA) released two educational videos and a supplemental fact sheet. FDA said the educational resources are intended to help dietary supplement manufacturers and distributors prepare and submit complete NDINs.
FDA’s Constituent Update explained that 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,” FDA said in the update. “Having a well-organized and scientifically supported NDIN facilitates an efficient and timely FDA review.”
FDA Resources for NDIN Process for Dietary Supplements
FDA shared a fact sheet and a video titled Important Aspects of the NDIN ProcessExternal Link Disclaimer. These outline common issues that FDA says it has observed in the NDIN submission process that could result in unnecessary delays or a negative response from the agency.
A second video, titled Correspondence Between FDA and the NotifierExternal Link Disclaimer, explains what manufacturers can expect after an NDIN has been submitted to the agency. This includes the correspondence expected between FDA and the notifier during the 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,” FDA said.
For additional questions regarding the NDIN process, FDA advises contacting the Office of Dietary Supplement Programs by email at NDITeam@fda.hhs.gov.
