On October 19, 2026, final guidance from the United States Food & Drug Administration came out. Its title is New Dietary Ingredient (NDI) Notifications and Related Issues: Identity and Safety Information About the NDI. It has recommendations for identity and safety information. Manufacturers and distributors should use them in New Dietary Ingredient Notifications (NDINs). The guidance talks about crucial questions about the information required to support the safety of those dietary supplements that have new dietary ingredients.
The announcement strengthens the FDA’s continuous effort to finalize sections of its 2016 revised draft guidance on NDINs. The newly finalized guidance covers three areas. Companies developing or marketing dietary supplements in the United States should know the additional direction for preparing NDIN submissions. They can learn to present information supporting a product’s expected safety under its intended conditions of use.
What Does the FDA’s New NDI Guidance Cover?
The final guidance addresses three sections of the FDA’s 2016 revised draft guidance on NDINs.
Identity Information About the NDI and Dietary Supplement
The guidance finalizes Section VI.A, which concerns identity information about the new dietary ingredient and the dietary supplement containing it. This section addresses the identity information manufacturers and distributors should include in an NDIN. Establishing the ingredient’s identity is an important part of presenting a notification because the FDA needs information about the ingredient being assessed and the dietary supplement in which it will be used. Companies preparing an NDIN should consult the final guidance for the FDA’s recommendations on the information to include in this section.
History of Use or Other Evidence of Safety
Section VI.B addresses the history of use or other evidence of safety supporting the ingredient. The guidance discusses the information that should be presented to support the notifier’s safety assessment. Manufacturers and distributors should review the FDA’s recommendations when they want to document the proof used to back the proposed conditions of operation. The guidance also has frequently asked questions about when the FDA recommends submitting different types of studies.
Summary of the Basis for the Safety Conclusion
Section VI.C concerns the summary of the basis for the notifier’s conclusion of safety. The FD&C Act says that an NDIN that applies must have details to strengthen the conclusion. It should clarify that the dietary supplement with the new dietary ingredient will reasonably be expected to be safe under the use cases it’s intended for. Thus, the final guidance recommends how to present the basis for this conclusion as part of the notification.
Why Is an NDI Notification Important?
A pre-market notification is required. It’s under the FD&C Act. It’s for some dietary supplements containing new dietary ingredients. A new dietary ingredient is something that has not been present in the food supply as an article used for food. A manufacturer or distributor of this ingredient, or of a dietary supplement with that ingredient, must submit an NDIN to the FDA. They must do so at least 75 days before introducing the product into interstate commerce, unless a statutory exception applies.
The notification must have information that supports the conclusion that the product will reasonably be expected to be safe under the intended use conditions. The NDIN process, as per FDI, is an opportunity to evaluate the safety of new dietary ingredients in dietary supplements before they become available to consumers. The statutory days for the notification are 75 days.
Changes from the 2016 Revised Draft Guidance
The last guidance finalizes the recommendations. It does so in Sections VI.A, VI.B, and VI.C of the 2016 revised draft guidance. The FDA explained that finalizing discrete sections separately is intended to make the guidance easier to use and reflects public comments received on the earlier draft. The agency will update the existing 2016 revised draft guidance to identify the sections that have become final as additional portions are completed.
The FDA’s still reviewing the remaining sections of the 2016 revised draft guidance. The recent announcement does not finalize the entire 2016 guidance. There’s also separate final guidance by the FDA issued in March 2024. It covers NDI notification procedures and timeframes. That document provides the procedural areas of the notification process.
Are Comments on the Final Guidance from Stakeholders Accepted?
Yes. The public may submit electronic or written comments on the final guidance at any time. They can do so through Regulations.gov using docket number FDA-2025-D-6501. Written comments should find the docket number. Also, the title of the guidance document. Send them to:
Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852, USA
The FDA has the Office of Dietary Supplement Programs as the contact point for questions about the NDIN process. Reach them at NDIN@fda.hhs.gov.
Conclusion
The final guidance by the FDA provides clarity to three important parts of the New Dietary Ingredient Notification process. With other sections still under review, manufacturers and distributors should consult the relevant final guidance documents and the FDA’s current NDIN process information when preparing submissions.
For companies planning to introduce dietary supplements containing new dietary ingredients into the US market, understanding the notification requirement, the 75-day statutory timeframe where it applies, and the FDA’s recommendations for presenting identity and safety evidence remains an important part of regulatory planning.
