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New Dietary Ingredient (NDI) & NDI Notification

A "new dietary ingredient" is an ingredient that meets the definition of a "dietary ingredient" and was not marketed in the U.S. before Oct. 15, 1994.

If you plan to market a dietary supplement that contains a new dietary ingredient, you must submit to FDA, at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce, information that is the basis on which you have concluded that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe.

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