FDA Intends to Exercise Enforcement Discretion for Past-Due NDI Notifications

FDA Intends to Exercise Enforcement Discretion for Past-Due NDI Notifications

May 20, 2022, Covington Alert

Today, May 20, 2022, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) published a notice in the Federal Register announcing the availability of a draft guidance, “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification.” Under the new policy described in this draft guidance, FDA intends to exercise limited enforcement discretion with respect to companies that are required to submit, but have not yet submitted, a new dietary ingredient (NDI) notification. This policy of enforcement discretion applies to dietary supplements marketed as of May 20, 2022. The policy is intended to incentivize companies to submit past-due NDI notifications, thereby increasing FDA’s visibility into the safety of dietary ingredients on the market. Enforcement discretion would extend to 180 days after the guidance is finalized.

An NDI is dietary ingredient marketed on or after October 15, 1994, i.e., “new” because it was not on the market prior to the enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA). An NDI notification contains the basis for the manufacturer’s or distributor’s safety determination. When an NDI notification is required, a company must submit it 75 days prior to marketing a dietary supplement containing the NDI.[1] Companies commonly wait for FDA to respond to the notification prior to marketing, even if the response takes longer than 75 days. For companies that proceeded to market without an NDI notification, FDA’s new policy could offer an opportunity to fulfill this regulatory requirement without drawing undue attention to the delayed submission.

Under DSHEA, a manufacturer or distributor must submit an NDI notification to FDA 75 days prior to marketing a dietary supplement containing the NDI unless the ingredient satisfies either of two exclusions:

1. The dietary ingredient is a “pre-DSHEA” dietary ingredient, i.e., an ingredient “marketed” in the United States prior to October 15, 1994.[2]
2. The dietary ingredient has been “present in the food supply as an article used for food in a form in which the food has not been chemically altered.”[3]

For many companies, it remains uncertain whether an NDI notification is required, and FDA has yet to finalize its guidance on this subject. FDA issued draft guidance on the circumstances under which NDI notifications are required in 2011, and later updated this draft in 2016. Both documents have elicited significant criticism from industry (see our client alert on the 2016 revised NDI draft guidance). Nearly six years have passed and FDA has yet to publish final guidance providing clear direction to industry, though FDA has shared its intention to do so by the end of 2022. This lack of certainty, coupled with the complexity of the notification process and the historically low rate of success, has resulted in a relatively low number of submissions. FDA reports that it has received only about 1,200 NDI notifications since DSHEA’s enactment. In contrast, FDA estimates that it should have received more than 4,600.

FDA’s enforcement discretion policy acknowledges the uncertainty that industry faces and offers companies the opportunity to contact CFSAN for guidance on whether premarket notification is required. Companies can do so within the first 90 days of the enforcement discretion period, which will begin when the guidance is finalized.

Under this new policy of enforcement discretion, if a company determines that an NDI notification is required for dietary supplements that are currently marketed (as of May 20, 2022), the company may submit it within 180 days after the guidance is finalized without risking enforcement action for late submission. FDA reserves the right to take enforcement action if a dietary ingredient does not meet the safety standard, meaning there is not a history of safe use or other evidence of safety establishing that the NDI will reasonably be expected to be safe under the intended conditions for use. In this respect, companies submitting past-due NDI notifications could still face enforcement for the underlying safety of the marketed ingredient.

The draft guidance specifically encourages companies to submit evidence of safety gathered while the supplement was marketed without a required NDI. Such safety information can include customer complaints and adverse event information for the product. Perhaps anticipating a flood of filings, FDA expects to confirm receipt within 75 days after filing, but does not expect to complete its scientific evaluation within this period.

Covington will continue to monitor this development and provide strategic advice regarding NDI submissions. Comments on this guidance can be submitted to Docket Number FDA-2022-D-0281 by July 19, 2022.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.