Federal Register #2026-21453

FDA Final Guidance on New Dietary Ingredient Notifications

The U.S. Food and Drug Administration issued final guidance on information for new dietary ingredient notifications, not a procurement solicitation. - Government buyer: None; the notice is from the Food and Drug Administration (FDA), within the Department of Health and Human Services (HHS). - The guidance is for manufacturers and distributors preparing new dietary ingredient notifications (NDINs) for dietary ingredients and supplements containing them. - It addresses identity and safety information, use of a single safety narrative, when additional safety evidence may be needed, and recommended supporting studies. - No OEMs, vendors, products, services, quantities, or part numbers are identified; there are no procurement line items.

Description

The Food and Drug Administration announces the availability of a final industry guidance on new dietary ingredient notification (NDIN) submissions. It provides recommendations to manufacturers and distributors of new dietary ingredients and dietary supplements containing an NDI about the identity and safety information to include in an NDIN. The guidance also addresses use of a single safety narrative, when additional safety evidence should be submitted, and recommended types of studies. This is a notice of guidance availability, not a procurement opportunity.

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