FDA Issues Final Guidance on New Dietary Ingredient Notification Procedures and Timeframes

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) announced the availability of a final guidance for industry titled “Dietary Supplements:  New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” The guidance is intended to help manufacturers and distributors of new dietary ingredients (NDIs) and dietary supplements prepare and submit new dietary ingredient notifications (NDINs) to the FDA.

The guidance provides information in a questions and answers format about the NDIN submission and review process. Topics include:

• Who needs to submit an NDIN?
• How should the information be organized and presented?
• Where should an NDIN be submitted?
• What happens after an NDIN is submitted?

The guidance finalizes Section V (“NDI Notification Procedures and Timeframes”) of the 2016 revised draft guidance, in addition to several related questions from other sections of the draft guidance. This approach of separating the 2016 revised draft guidance into discrete sections for ease of use is responsive to comments received on the draft guidance.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 said it 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thinking on the topic of NDINs and related issues and plans to prioritize finalizing other parts of the 2016 revised draft guidance as the agency completes its review and analysis of those sections.

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-2023-D-5280. Written comments should be identified with the docket number: FDA-2023-D-5280 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, contact the Office of Dietary Supplement Programs by email at NDIN@fda.hhs.gov.