By Cynthia L. Meyer and Justine E. Lenehan
The U.S. Food and Drug Administration (FDA) announced on May 19, 2022, the availability of a draft guidance intended to increase the submission to the agency of safety information for dietary supplements currently on the market. Specifically, the draft guidance, entitled “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification,” outlines FDA’s proposed policy of enforcement discretion to encourage the submission of new dietary ingredient (NDI)[1] notifications by dietary supplement manufacturers and distributors who have not previously submitted such notifications to FDA.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) requires that manufacturers or distributors of a dietary supplement containing an NDI submit a premarket safety notification (also known as an NDI notification) to FDA at least 75 days prior to the dietary supplement’s introduction into interstate commerce. 21 U.S.C. § 350b(a)(2). The notification must detail the basis upon which the manufacturer/distributor has concluded that the NDI-containing dietary supplement will reasonably be expected to be safe. Failure to do so renders the dietary supplement adulterated under the Federal Food, Drug, and Cosmetic Act (FDCA). 21 U.S.C. § 342(f). However, FDA is aware of dietary supplements currently on the market for which an NDI notification was required but never submitted and estimates that roughly 3,400 additional NDI notifications should have been submitted since DSHEA’s enactment.
Accordingly, FDA proposes to establish a limited period of enforcement discretion with respect to the premarket safety notification under certain circumstances to allow manufacturers and distributors to submit late NDI notifications without penalty. In order to take advantage of FDA’s enforcement discretion policy as proposed under the draft guidance, manufacturers or distributors would need to submit all information required under 21 C.F.R. § 190.6 (regarding NDI notifications) and the information recommended under section III.B of the draft guidance within 180 days of the Federal Register notice announcing the availability of the final guidance document. Additionally, the dietary supplement would need to have been marketed in the United States as of May 20, 2022.
Section III.B of the draft guidance recommends that NDI notifications submitted in response to this policy include the following information (in addition to the information required pursuant to FDA’s implementing regulations under 21 C.F.R. § 190.6):
- Documentation that the dietary supplement was marketed in the United States as of May 20, 2022;
- A copy of the dietary supplement’s current label;
- Information to support that the product is reasonably expected to be safe (e.g., a history of safe use, safety studies, etc.); and
- Evidence related to the product’s history of safe use since it has been on the market (including any consumer complaints or adverse events).
Notably, if finalized, FDA’s enforcement discretion policy will relate only to section 350b(a)(2)’s requirement regarding the timing for filing an NDI notification. That is, the enforcement discretion policy will not extend to NDIs or NDI-containing dietary supplements that would otherwise be adulterated under the FDCA or to any other regulatory requirements applicable to dietary supplements.
FDA would plan to acknowledge receipt of a submission within 75 days of receipt but explicitly stated that it does not expect to complete its scientific evaluation and provide a response within that timeframe.
Manufacturers or distributors may also be unsure whether an ingredient constitutes an NDI or whether DSHEA requires the submission of an NDI notification. For over a decade, FDA has been working to finalize a guidance document addressing these issues and topics related to the submission of an NDI notification. FDA issued a revised draft guidance in 2016 entitled “New Dietary Ingredient Notifications and Related Issues” (superseding a 2011 draft guidance on the same topic) which has not yet been finalized. Consequently, and perhaps sympathetic to the lack of guidance provided to industry on this topic, FDA in this latest 2022 draft guidance encourages manufacturers and distributors to contact the Agency within the first 90 days of the enforcement discretion period if they are uncertain as to whether their products are subject to the premarket safety notification requirement.
Comments on the draft guidance are due by July 19, 2022.
[1] A new dietary ingredient means a dietary ingredient that was not marketed in the U.S. prior to October 15, 1994. See 21 U.S.C. § 350b(d).