Today, the FDA announced the availability of a final guidance for industry titled “New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI.” This guidance is intended to help manufacturers and distributors of NDIs regarding the identity and safety information that should be included in a new dietary ingredient notification (NDIN). The guidance provides recommendations that may help industry comply with the requirements of the NDIN process, which is the agency’s only opportunity to evaluate the safety of NDIs in dietary supplements before they become available to consumers.
The guidance finalizes Section VI.A, Identity Information about the NDI and the Dietary Supplement, Section VI.B, History of Use or Other Evidence of Safety, and VI.C, Summary of the Basis for Your Conclusion of Safety, of the 2016 revised draft guidance. The guidance focuses on frequently asked questions about NDIN submissions, including the types of identity and safety information that should be included in an NDIN and when the FDA recommends submitting different types of studies.
This approach of finalizing discrete sections of the overall 2016 revised draft guidance is responsive to public comments received on that guidance and is intended to facilitate ease of use. As various sections of the guidance are finalized, the FDA will also update the existing 2016 revised draft guidance to indicate which sections have become final. The FDA understands the importance of providing the agency’s thinking on the topic of NDINs and continues to prioritize finalizing other parts of the 2016 revised draft guidance as the agency completes its review and analysis of those sections.
The public may submit electronic or written comments related to this final guidance at any time. Public comments can be submitted electronically to Regulations.gov with the docket number: FDA-2025-D-6501. Written comments should be identified with the docket number: FDA-2025-D-6501 and the title of the guidance document and submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852.
For questions regarding the FDA’s NDIN process, please contact the Office of Dietary Supplement Programs by email at NDIN@fda.hhs.gov.