The infographic provides a clear overview of the U.S. FDA regulatory pathways for ingredients used in food and dietary supplements, focusing on NDIN, GRAS, and FAP.

  • NDIN (New Dietary Ingredient Notification): Required if a dietary supplement contains a new ingredient not marketed in the U.S. before October 15, 1994. Submission to the FDA must be made 75 days prior to marketing with safety evidence. FDA may respond with a “No Objection” letter or concerns.

  • GRAS (Generally Recognized as Safe): A voluntary pathway to declare a food substance safe, based on scientific consensus or historical use before 1958. Companies can opt for self-affirmed GRAS or notify the FDA. If notified, the FDA may issue a “No Questions” letter.

  • FAP (Food Additive Petition): A formal request for FDA approval of new additives or new uses of existing ones not GRAS. Requires comprehensive data on safety, manufacturing, and labeling.

This guide helps businesses choose the right pathway for compliance.

ndin-gras-fap-us-fda-regulatory-pathways-for-ingredients-in-food-dietary-supplements-infographic-plaza

Source: https://www.freyrsolutions.com/infographics/ndin-gras-fap-us-fda-regulatory-pathways-for-ingredients-in-food-dietary-supplements

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