New Draft Guidance on FDA Enforcement Discretion for Past-Due NDI Notifications
The Dietary Supplement Health and Education Act of 1994 (DSHEA) requires manufacturers and distributors who wish to market a dietary supplement containing 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, to notify the FDA at least 75 days before marketing. A successful notification must show there is a history of use or other evidence of safety establishing that the NDI, when used as labeled, will reasonably be expected to be safe. If the required premarket notification is not submitted to FDA, the dietary supplement containing the NDI is deemed to be adulterated under the Federal Food, Drug, and Cosmetic Act. FDA estimates that more than 4,600 notifications should have been submitted since 1994 but to date only approximately 1,200 have been.
On May 20, 2022, FDA published notice of a new draft guidance titled, “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-Market Notification.” FDA’s new enforcement discretion policy will provide a 180-day window after the guidance is finalized for those who, before May 20, 2022, have marketed products that are subject to the premarket notification requirement, without having submitted such notification, to submit a late NDI notification without risk of FDA taking enforcement action against their product solely on account of the lateness of the notification. While FDA has provided a dedicated pathway in the CFSAN Online Submission Module for this new type of submission and intends to prioritize the review of theses notifications, FDA does not anticipate being able to complete the scientific evaluation and provide a response within 75 days after receipt. FDA’s enforcement discretion policy would not extend to NDI-containing dietary supplements that are adulterated for safety reasons or that violate any other applicable regulatory requirements. FDA expects this temporary policy should help facilitate enforcement actions against those that remain out of compliance with the NDI notification requirements after the enforcement discretion period ends.
Comments on FDA’s new draft guidance that are submitted to the Docket No. FDA-2022-D-0281 before July 19, 2022 will be considered before FDA begins work on the final version of the guidance.