FDA fails to reach decision on NMN citizen petition filed by NPA and ANH

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The U.S. Food and Drug Administration (FDA) has responded to a citizen petition from the Natural Products Association (NPA; Washington, D.C.) and the Alliance for Natural Health (ANH; Edinburg, VA) requesting that FDA reevaluate its position on nicotinamide mononucleotide. Specifically, the petition requested FDA to determine that NMN is not excluded from the definition of dietary supplements and to commit to exercising enforcement discretion with products marketed and sold as dietary supplements.

In its letter, FDA simply informed the petitioners that the agency has not reached a decision in the allotted 180 days “due to competing agency priorities,” but that FDA staff was evaluating the petition. NPA’s president and CEO, Daniel Fabricant, PhD, criticized the agency’s letter as “woefully inadequate.”

“The FDA’s negligence has and will continue to cause severe economic damage to a growing sector of the dietary supplement industry,” said Fabricant, in a press release. “This decision to kick the can down the road after six months of deliberation will absolutely threaten the NMN sector, but also weakens the New Dietary Ingredient (NDI) process for manufacturers seeking to bring emerging and innovative ingredients for other dietary supplements to American consumers.”

Notably, FDA retroactively rejected a new dietary ingredient notification for an NMN ingredient the agency had initially acknowledged without objection, citing drug preclusion. “FDA is using the NDI process as de facto pre-market approval,” stated Fabricant. “They get 75 days, no more/no less, to determine whether something is a dietary ingredient and understand the company’s safety data, not forever. Even in the unlikely occurrence where they find a problem after that window, they have appropriate authorities for action. However, the FDA is avoiding that work here all in the name of rolling back DSHEA to protect the pharmaceutical industry’s intellectual property.”

Fabricant was also critical of FDA’s proposed reorganization. “FDA has literally left the building when it comes to regulating dietary supplements. Instead of protecting Americans and working with stakeholders to bring more products to consumers safely and efficiently, it is wasting time, effort, and taxpayer money pushing a reorganization plan that is dead on arrival,” said Fabricant.