New Dietary Ingredient Notification Guidance

FDA has published a guidance, Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes, to help manufacturers and distributors of a new dietary ingredient to submit required premarket safety notifications, known as New Dietary Ingredient Notifications (NDIN). The document focuses on frequently asked questions about the NDIN submission and review process.

It finalizes a portion of a 2016 draft guidance that revised one published in 2011. The agency says it understands the importance of finalizing other parts of the 2016 revised draft guidance and plans to finalize other individual sections as it completes its review and analysis of the sections.

Topics included in this guidance are (1) who needs to submit an NDIN; (2) how the information should be organized and presented; (3) where an NDIN should be submitted; and (4) what happens after an NDIN is submitted.