June 16, 2025Policy & Regulation, Health Care, Regulatory, Food and Drug Administration (FDA)
Last week, the U.S. Food and Drug Administration (FDA) released two educational videos and a supplemental fact sheet to guide dietary supplement manufacturers and distributors through the New Dietary Ingredient Notification (NDIN) review process. Under Section 413 of the Federal Food, Drug, and Cosmetic Act, manufacturers and distributors must submit an NDIN to notify FDA before marketing a dietary supplement with a new dietary ingredient. These resources offer guidance on structuring submissions and outline what to expect during the agency’s review. Ultimately, they are intended to enhance the quality of NDIN submissions and minimize common pitfalls, with the goal of avoiding delays or unfavorable results in the agency’s review.
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