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Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-0281

Under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350b(a)(2)), the manufacturer or distributor of a new dietary ingredient (NDI) that has not been present in the food supply as an article used for food, or a dietary supplement that contains the NDI, must submit a premarket safety notification to FDA at least 75 days before introducing the product into interstate commerce. If the required premarket notification is not submitted to FDA, section 413(a) of the FD&C Act (21 U.S.C. 350b(a)) provides that the dietary supplement containing the NDI is deemed to be adulterated under section 402(f) of the FD&C Act (21 U.S.C. 342(f)).

FDA is aware that some manufacturers and distributors have marketed products for which a premarket NDI notification under section 413(a)(2) of the FD&C Act was required, but never submitted. To increase the amount of safety information we have about NDI-containing dietary supplements in the marketplace and to promote risk-based regulation, we are informing manufacturers, distributors, and other interested persons of our intent to exercise enforcement discretion, for a limited time and in limited circumstances, to encourage firms to correct past failures to submit an NDI notification.

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