FDA Releases Draft Guidance on NDI Enforcement Discretion

Constituent Update

May 19, 2022

Today, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance on late submissions of new dietary ingredient (NDI) notifications. When finalized, the draft guidance will outline the FDA’s intent to exercise enforcement discretion, for a limited time and in limited circumstances, to encourage manufacturers and distributors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.

The FDA is aware that, in the years since the Dietary Supplement Health and Education Act of 1994 was enacted, some dietary supplement manufacturers and distributors have marketed ingredients and products for which a premarket NDI notification was required, but never submitted. In a February 2019 statement about new efforts to strengthen regulation of dietary supplements through modernization and reform, the FDA emphasized the need to ensure that our regulatory framework is flexible and comprehensive enough to adequately evaluate product safety, while promoting innovation. This draft guidance, when finalized, is an important step to foster the submission of NDI notifications and is key to this effort.

The goal of this policy, when finalized, is to encourage manufacturers and distributors to correct any past failures to submit a required NDI notification. Notifications submitted under the enforcement discretion policy will help increase the amount of safety information the FDA has about NDI-containing dietary supplements in the marketplace. The guidance also should help guide appropriate enforcement actions against those that remain out of compliance with the NDI notification requirements. The enforcement discretion policy outlined in the draft guidance relates solely to the failure to file an NDI notification; it will not apply to NDI-containing dietary supplements that would be adulterated (e.g., for safety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.

Along with this guidance, the FDA is developing a new submission type in the CFSAN Online Submission Module called a “Catch-up New Dietary Ingredient Submission.” Once the draft guidance is finalized, interested stakeholders will be able to electronically submit their late notifications to the FDA via a Catch-up New Dietary Ingredient Submission. Although notifiers may also submit late notifications on paper, the FDA encourages the use of this electronic system for late notifications submitted under the temporary enforcement discretion policy.

For additional questions regarding the FDA’s NDI notification process, please contact the Office of Dietary Supplement Programs by email at [email protected].

To Submit Comments:

Comments on the draft guidance should be submitted within 60 days after publication in the Federal Register. You may submit electronic comments to Regulations.gov. All written comments should be identified with the docket number FDA-2022-D-0281 and with the title of the guidance document.

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