The discretion period would last 180 from the time a final guidance is published.
FDA today issued draft guidance stating that the agency will, “for a limited time and in limited circumstances,” exercise enforcement discretion while companies submit overdue new dietary ingredient (NDI) notifications. The discretion period would last 180 from the time a final guidance is published. The agency is now accepting public comments on the draft guidance until July 19, 2022.
Section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that manufacturers or distributors of a new dietary ingredient that has not been present in the food supply or has not been on the market in a dietary supplement before October 15, 1994, (the date the Dietary Supplement Health and Education Act passed creating the requirement for NDI notification) must first submit an NDI notification to FDA containing data on the ingredient’s “reasonable expectation of safety” at least 75 days before introducing the NDI into interstate commerce.
FDA has said for years that it believes a large number of supplement companies have not submitted required NDI notifications. The new draft guidance states, “In 1994, there were about 4,000 products on the market; according to recent estimates, there are over 50,000—and possibly as many as 80,000 or more—products available to consumers. Although not every dietary supplement requires an NDI notification, we estimate that more than 4,600 notifications should have been submitted and were not. Despite the expanded marketplace, however, we have received only about 1,200 NDI notifications since DSHEA’s enactment.”
FDA says it will now exercise a 180-day enforcement discretion period, once final guidance is published in the Federal Register, to allow companies that should have submitted notifications time to submit them. This enforcement discretion period is meant to “encourage firms to correct past failures to submit an NDI notification,” the guidance says.
Companies submitting late notifications are required to submit the required NDI notification information as well as “a copy of the current label for the dietary supplement,” the guidance states. Also, it adds, “Since your product is already on the market, we suggest that you also include any evidence related to the history of your product’s use since it has been on the market, including any customer complaints, adverse events (whether serious or non-serious) associated with the product.”
FDA’s draft guidance says that, “In general, FDA intends to exercise enforcement discretion if you submit to us the NDI notification required by 21 CFR 190.6…within 180 days following the publication of a notice in the Federal Register announcing that the final version of this guidance document is available, and if you can show that the dietary supplement that is the subject of your notification was marketed in the United States as of May 20, 2022.
It expands: “This enforcement discretion policy relates solely to the timing of the requirement to fil an NDI notification…In other words, we generally do not intend to take enforcement action based on a failure to comply with the requirement to file an NDI notification in a timely fashion against firms marketing products within the scope of this enforcement discretion policy.” Notably, it says, the discretion period does not extend to ingredients FDA considers to be adulterated or non-supplement ingredients.
In an FDA press release, Cara Welch, PhD, director of the Office of Dietary Supplement Programs in FDA’s Center for Food Safety and Applied Nutrition (CFSAN), stated, “We remain committed to a flexible framework for dietary supplements that ensures the safety of these products for consumers. The resulting notifications the agency receives through this period of enforcement discretion will help increase the amount of safety information we have about NDI-containing dietary supplements in the marketplace.”
FDA also said it is creating a “new submission type through the CFSAN Online Submission Model” where companies can submit these “late notifications.”
The draft guidance adds: “FDA recognizes that not every dietary supplement containing an NDI is subject to the notification requirement in section 413(a)(2) of the FD&C Act. However, we are aware that some manufacturers and distributors have marketed ingredients and products that are subject to this requirement without having submitted the required notification. A number of firms have told us informally that they realize they should have previously submitted notifications and have this information ready to be submitted, but they are afraid of drawing attention to themselves with a late submission. As part of our ongoing efforts to manage safety risks and to promote risk-based regulation and transparency, we are informing manufacturers, distributors, and other interested persons that we intend to implement a limited enforcement discretion period regarding the requirement to file an NDI notification…”
The draft guidance also warns that FDA might not be able to respond within 75 days of receiving an NDI notification. By law, companies that submit the required notifications can proceed to market after 75 days of notifying FDA, regardless of whether the agency has sent a response. The guidance states that “although we expect to confirm receipt of your submission within 75 days after we receive it, we do not anticipate being able to complete our scientific evaluation and provide a response within 75 days after receipt.”
The Council for Responsible Nutrition (CRN; Washington, D.C.) is applauding FDA for giving companies an amnesty period, though notes that FDA is not without fault when it comes to a lack of a lack of NDINs. "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," said Steve Mister, CEO of CRN, in a press release. "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."
As a solution, CRN reiterated its support for a master file system to "to protect ingredient innovation and incentivize firms to submit NDI notifications with the assurance that their intellectual property would be protected."
CRN proposed this solution alongside the Consumer Healthcare Products Association (CHPA; Washington, D.C.) and the United Natural Products Alliance (UNPA; Salt Lake City, UT), but FDA declined to provide the enforcement necessary to make the system work.
"FDA cannot expect firms to submit their safety dossiers and manufacturing processes for possible objection when it provides neither meaningful consequences for the failure to file nor a clear roadmap for when an NDI notification is necessary," said Mister. "Enforcement discretion would be better enacted after the above issues are resolved.”
Updated on Thursday, May 19 at 5:29 PM EST