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FDA new guidance on "New Dietary Ingredient Notification Procedures and Timeframes"


Mar 03, 2024

The U.S. Food and Drug Administration announced the availability of a final guidance for industry titled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” This guidance is intended to help manufacturers and distributors of new dietary ingredients (NDIs) and dietary supplements to 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, among others:

  • 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?

For further information (in English), click on the Link

Check the full text of the documents (in English), click on the Link

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