NPA’s lawsuit against FDA on NMN stayed pending agency’s decision on citizen petition
The court has granted a joint motion for stay filed by NPA and FDA, pending the agency's decision on the citizen petition asking FDA to reverse its stance on NMN's status as a dietary ingredient.
Photo © iStockphoto.com/KLH49
The Natural Products Association (NPA; Washington, D.C.) has announced that the court has granted a joint motion for a stay in the legal proceedings of NPA’s lawsuit against the U.S. Food and Drug Administration on the question of beta-nicotinamide mononucleotide’s (NMN) status as a dietary supplement ingredient. FDA has concluded that NMN is not a dietary ingredient, citing the drug preclusion clause, and retroactively rejecting a new dietary ingredient notification (NDIN) for the ingredient that was previously acknowledged.
Prior to the lawsuit, NPA submitted a citizen petition on March 9, 2023, asking FDA to reverse its decision. The agency failed to reach a decision on that petition within the allotted 180 days due to “competing agency priorities.” FDA is still evaluating the petition and according to the joint motion for stay, since the complaint against them contains arguments beyond those asserted in the petition, FDA is allowing NPA to supplement its petition to include those arguments to be considered as part of the petition.
“The parties request a stay of the proceedings because they believe that FDA’s response to the Citizen Petition may make it possible to resolve this case without further litigation or, at a minimum, narrow the issues for the Court’s consideration,” the motions read. “A stay of proceedings in this matter until FDA answers the Citizen Petition thus will conserve the time and resources of the Court and the parties.”
FDA expects that they will be able to answer the petition by July 31, 2025. In the meantime, the agency has represented that it does not intend to prioritize enforcement action related to NMN unless there are safety concerns or unlawful claims.
“Fundamentally, FDA’s past decisions have weakened the integrity of the New Dietary Ingredient Notification (NDI) process for members of the NPA who want to bring twenty-first-century consumer health products to the market,” said Daniel Fabricant, PhD, president and CEO of NPA, in a press release. “While we believe the FDA could have solved this and other similar cases without litigation, we are pleased with the outcome and will continue to hold the FDA accountable when the agency misapplies the law.”
