On May 19, the U.S. Food and Drug Administration has released a draft guidance outlining a proposed policy to give companies an opportunity to submit late new dietary ingredient (NDI) notifications. If finalized, the draft guidance will "advise the dietary supplement industry that FDA intends to exercise enforcement discretion, for a limited time and in limited circumstances, to encourage manufacturers and distributors to correct any past failures to submit a required NDI notification." Under the proposal, the enforcement discretion period to submit a late notification would start when the guidance is published, would last 180 days, and would apply only to products on the market when the Federal Register notice announcing the draft guidance was published.

FDA said giving the industry an opportunity "to correct past failures to submit required safety information," provides the agency with more safety information about the dietary supplement marketplace. “We remain committed to a flexible framework for dietary supplements that ensures the safety of these products for consumers,” said Cara Welch, Ph.D., Director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). “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.”

Among FDA's points:

  • The Dietary Supplement Health and Education Act of 1994 (DSHEA) requires manufacturers and distributors who wish to market a dietary supplement containing an NDI to notify the FDA before marketing, unless a legal exception applies.
  • The notification must contain the safety information that a manufacturer relied upon to conclude the dietary supplement containing the NDI is reasonably expected to be safe.
  • For dietary supplements that do not contain an NDI, the law does not require manufacturers to submit safety information to the FDA before marketing.
FDA added that theNDInotification process is the agency's only chance to evaluate the safety of a dietary supplement before it becomes available to consumers, but that in the 27-plus years since the requirement was established, some companies have marketed products for which a premarketNDInotification was required without submitting an NDI.

Steve Mister, President and CEO of theCouncil for Responsible Nutrition(CRN) applauded the idea of an amnesty period in which companies who have not filed an NDI notification with the agency can do so. “We encourage companies who have products in the market that are using clearly defined new ingredients to take advantage of this opportunity and submit to the agency their data demonstrating the safety of these products."

That said, Mister added, “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."

Mister added the the industry has tried to help in this regard. “Three years ago, CRN proposed a master file system to the agency to protect ingredient innovation and incentivize firms to submit NDI notifications with the assurance that their intellectual property would be protected—but FDA declined to provide the enforcement required to make the system work. Much uncertainty still exists as to when an ingredient is ‘new’ and subject to the notification requirement. 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. Enforcement discretion would be better enacted after the above issues are resolved."

The American Herbal Products Association (AHPA) noted that FDA will becollecting commentson the draft guidance until July 19, 2022.
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