On May 20, FDA’s (U.S. Food and Drug Administration) 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Food Safety and Applied Nutrition (CFSAN) published a notice in the Federal Register announcing the availability of a draft guidance, “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification.” Under the new policy described in this draft guidance, FDA intends to exercise limited enforcement discretion with respect to companies that are required to submit, but have not yet submitted, a new dietary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 a dietary ingredient marketed on or after Oct. 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. 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.
The policy noted that it does not extend to NDIs and NDI-containing dietary supplements that would be adulterated under section 402(f) of the FD&C Act (21U.S.C. 342(f) even if an NDI notification had been submitted, nor to any other regulatory requirements that pertain to dietary supplements.
In comments sent to the FDA on June 14, Ullman, Shapiro & Ullman, LLP, a boutique law firm representing clients in the natural products industry, challenged the purpose of the policy. “We question how, in cases where FDA has not received the NDIN for a new dietary ingredient, the agency can form any basis to determine that adequate safety data exists meaning that the ingredient would be adulterated even if the NDIN had been submitted and, therefore, not subject to enforcement discretion?”
The letter concluded, “We believe that the Draft Guidance serves no purpose and for the agency to finalize it as a waste of time and resources. In essence it acknowledges that FDA has failed to enforce the law relating to NDIs for a quarter century, that FDA intends to continue this failure to enforce and does not even commit FDA to start enforcement at any time in the future. FDA should withdraw the Draft Guidance and begin actual enforcement against violators as soon as possible.”
The Council for Responsible Nutrition (CRN) initially applauded FDA’s announcement, regarding the amnesty period for companies to file an NDI notification with the agency if they have previously failed to do so. However, CRN President and CEO Steve Mister pointed out, “Unfortunately, the concerns the agency expressed are partially of its own making by failing to provide a clear direction for when an NDI notification is required and failing to enforce the existing requirements. FDA has refused to develop an authoritative list of grandfathered ingredients—or to accept as authoritative—the well-documented lists developed by the industry. Eleven years after FDA first proposed a draft guidance to clarify when an ingredient qualifies as ‘new,’ consumers and industry alike are still waiting for the agency to finalize that guidance.”
