FDA Announces Release of First Final Guidance Section for NDIN – NDI Notification Procedures and Timeframes

The FDA recently announced final guidance for industry on “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes.” This 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 including

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The guidance finalizes Section V (“NDI Notification Procedures and Timeframes”) of the 2016 revised draft guidance in addition to several related questions from other sections of the draft guidance. This approach of separating the 2016 revised draft guidance into discrete sections for ease of use is responsive to comments received on the draft guidance.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thinking on the topic of NDINs and related issues and plans to prioritize finalizing other parts of the 2016 revised draft guidance as the agency completes its review and analysis of those sections.