United States: FDA releases draft guidance on late submissions of new dietary ingredient (NDI) notifications

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As the FDA is aware that some manufacturers and distributors have marketed dietary supplements for which a premarket new dietary ingredient (NDI) notification was required, but never submitted, on May 19, 2022, the FDA announced the availability of a draft guidance on late submissions of NDI notifications, titled “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Premarket Notification: Guidance for Industry“. When finalized, the draft guidance will outline the FDA’s intent to exercise enforcement discretion, for a limited time and in limited circumstances, to encourage manufacturers and distributors to correct any past failures to submit a required NDI notification.

FDA intends to exercise enforcement discretion if the NDI notification required is submitted within 180 days following the publication of a notice in the Federal Register announcing that the final version of this guidance document is available, and if the dietary supplement that is the subject of the notification was marketed in the United States as of May 20, 2022. Upon the release of a finalized guidance, companies will be able to electronically submit late NDIs to FDA for a set period without penalty.

The enforcement discretion policy outlined in the draft guidance relates solely to the failure to file an NDI notification; it will not apply to NDI-containing dietary supplements that would be adulterated (e.g., for safety reasons) even if an NDI notification had been timely submitted, or to any other regulatory requirements that pertain to dietary supplements.

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