FDA announces final guidance on NDIN procedures and timeframes for dietary supplement industry

• By: AHPA
• On: 03/06/2024 12:13:25
• In: Regulation / Legislation

AHPA welcomes the agency's shift to a section-by-section based approach to finalizing NDIN guidance

March 6, 2024

Yesterday, the U.S. Food & Drug Administration (FDA) announced the release of a final guidance titled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” Intended to help dietary supplement manufacturers and distributors prepare and submit new dietary ingredient notifications (NDINs), the guidance finalizes Section V (“NDI Notification Procedures and Timeframes”) of the 2016 revised draft guidance.
 
Using a Q&A format to provide information about the NDIN submission and review process, the guidance addresses topics such as:

• 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 Constituent Update from the Center for Food Safety and Applied Nutrition (CFSAN) announcing the final guidance confirmed that the “approach of separating the 2016 revised draft guidance into discrete sections for ease of use is responsive to comments received on the draft guidance.” This shift to finalizing guidance by section is a practical approach that the American Herbal Products Association (AHPA) has long thought FDA should take. 

“AHPA is pleased to see FDA finalize the section on ‘Notification Procedures and Timeframes' of the agency's guidance to industry on NDINs. This action is consistent with a suggestion AHPA made during an in-person meeting at FDA's office in 2012, specifically suggesting that FDA address the issue of NDIN guidance with a section-by-section based approach. We were told by FDA leadership at that time that such an approach would ‘be confusing,'” explained AHPA President Michael McGuffin. “However, the final guidance issued today – though still subject to detailed internal and member review – appears to be clarifying rather than confusing. We look forward to FDA's issuance of additional clarifying sections of guidance on this important regulatory matter.”