New Dietary Ingredient (NDI)
The Federal Food, Drug, and Cosmetic Act mandates that manufacturers and distributors intending to market dietary supplements containing new dietary ingredients (NDIs) notify the U.S. Food and Drug Administration (FDA) at least 75 days before introducing the product into interstate commerce. This notification must include evidence supporting the safety of the NDI under the recommended conditions of use.
An NDI is defined as a dietary ingredient not marketed in the U.S. before October 15, 1994. The notification should provide detailed information, including the identity and composition of the NDI, the manufacturing process, specifications, and the basis for the conclusion that the dietary supplement will reasonably be expected to be safe.
For detailed instructions on submission procedures, including timeframes, format, and methods, refer to the FDA's guidance on how to submit notifications for a new dietary ingredient. FDA.GOVBy adhering to these guidelines, stakeholders can facilitate the FDA's evaluation process, ensuring that dietary supplements containing NDIs are safe for consumer use.
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