FDA Finalizes Section v Of The 2016 Revised Draft NDI Guidance

On March 4, FDA announced the availability of a final guidance, Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes – Guidance for Industry. The guidance finalizes Section V: NDI Notification Procedures and Timeframe of the 2016 revised draft NDI guidance and several related questions from other sections of the draft guidance. According to FDA, the guidance is intended to help manufacturers and distributors of new dietary ingredients (NDIs) prepare and submit new dietary ingredient notifications (NDINs) to FDA.

As did the draft, the final guidance covers topics such as who must submit an NDIN, how the information should be organized and presented, information regarding the submission process, and what happens after an NDIN is submitted. Importantly, the finalized guidance reiterates FDA's position that an NDIN submitted by an ingredient manufacturer does not necessarily eliminate the need for a manufacturer or distributor of a dietary supplement containing the NDI to submit its own notification.

Highlights of the final guidance include the fact that FDA has provided additional clarity on how to prepare and submit an NDIN. For example, botanicals grown under controlled, specific conditions to concentrate or increase specific constituents should be identified. Furthermore, FDA explained how to voluntarily request feedback on a potential NDIN, should a submitter wish to meet with the agency.

Overall, the final guidance is not very different from the draft, at least with respect to notification procedures and timing. However, its publication does demonstrate that FDA is focused on NDIs and intends to dedicate resources to ensuring compliance with the NDIN process. To that end, FDA acknowledges the need to finalize other sections of the 2016 revised draft guidance and intends to prioritize the review of ingredient identity, safety, and master files for finalization.

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Up Next: The "New Dietary Ingredient Notification Master Files for Dietary Supplements" draft guidance is under development. See: Foods Program Guidance Under Development. Plan to hear from us as it progresses.

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