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GUIDANCE DOCUMENT

Guidance for Industry: New Dietary Ingredient Notification Procedures and Timeframes - Dietary Supplements March 2024

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2023-D-5280
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition

This guidance finalizes Section V (“NDI Notification Procedures and Timeframes”) of the 2016 revised draft guidance (Draft Guidance for Industry: New Dietary Ingredient Notifications and Related Issues) in addition to several related questions from other sections of the draft guidance. This approach of separating the 2016 revised draft guidance into discrete sections for ease of use is responsive to comments received on the draft guidance. The FDA understands the importance of providing the agency’s thinking on the topic of NDINs and related issues and plans to prioritize finalizing other parts of the 2016 revised draft guidance as the agency completes its review and analysis of those sections. For more information, see Constituent Update: FDA Issues Final Guidance on New Dietary Ingredient Notification Procedures and Timeframes.

Under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. End of
Translation Click to Translate text after this point 350b(a)(2)), the manufacturer or distributor of a new dietary ingredient (NDI) that has not been present in the food supply as an article used for food, or of a dietary supplement that contains the NDI, must submit a premarket safety notification to FDA at least 75 days before introducing the product into interstate commerce.  This guidance is intended to help manufacturers and distributors of NDIs and dietary supplements (you) prepare and submit such premarket safety notifications, commonly referred to as New Dietary Ingredient Notifications (NDINs).

This guidance focuses on frequently asked questions about the NDIN submission and review process.  We encourage you to consult this guidance when you are ready to submit your NDIN.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities.  Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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All written comments should be identified with this document's docket number: FDA-2023-D-5280.

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