Regulatory policy

Draft Guidance for Industry: Policy Regarding Certain New Food Ingredients and Dietary Supplements Subject to Premarket Notification Requirement

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Although you may comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before beginning work on the guide, submit either online or written feedback on the draft guide by the closing date.

If you cannot submit comments online, please send your written comments to:

Records Management
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5630 Fisherman’s Lane, Room 1061
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All written comments should be identified by the file number of this document: FDA-2022-D-0281

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Guidance Dissemination Office

Center for Food Safety and Applied Nutrition, Office of Dietary Supplement Programs

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

The FDA is aware that some manufacturers and distributors have marketed products for which an FD&C Section 413(a)(2) premarket NDI notification was required but was never submitted. To increase the amount of safety information available to us about dietary supplements containing NDI on the market and to promote risk-based regulation, we inform manufacturers, distributors and other interested persons of our intention to exercise enforcement discretion, for a limited time and in limited circumstances, to encourage companies to correct past failures to submit an NDI notification.

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