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Whitepaper

New Dietary Ingredient Notification Procedures and Timeframes

According to section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350b(a)(2)), manufacturer or distributor of a new dietary ingredient (NDI) which has not been present in food supply as an article used for food, or of a dietary supplement containing NDI, must submit a premarket safety notification to FDA at least 75 days before introducing product into interstate commerce.

This Whitepaper focusses on:

  • NDIN Procedures
  • Information in NDIN
  • Submission of NDIN
  • Review of NDIN
WP-New-Dietary-Ingredient-Notification-Procedures-and-Timeframes


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