Washington, D.C.—In a legal development for the natural products industry, a federal court has issued a ruling in favor of the Natural Products Association (NPA) in its lawsuit against the Food and Drug Administration (FDA) regarding the agency’s handling of Nicotinamide Mononucleotide (NMN). The court halted FDA's enforcement actions against NMN and is requiring FDA to review NPA's citizen's petition to clarify the legal status of NMN supplements.
As WholeFoods Magazine has reported, NPA's lawsuit follows earlier efforts by trade group on NMN, which became necessary after a November 2022 notification by FDA declared that NMN is not a legal dietary ingredient. In 2023, NPA and Alliance for Natural Health (ANH) responded by submitting a citizen petition requesting that FDA determine NMN is not excluded from the definition of a dietary supplement or commit to exercise enforcement discretion regarding the sale of NMN as a supplement. In July 2023, FDA rejected a Congressional Request for Public Hearing on NMN.
NPA reacts to the court ruling
Dr. Daniel Fabricant, NPA President and CEO, emphasized the significance of the court’s decision for both industry stakeholders and consumers. “This is a monumental victory for NPA, our members, and American consumers,” Dr. Fabricant stated. “The court clearly stated that FDA vastly exceeded its authority and must return to enforcing the law as written. This ruling serves as a reminder that the FDA should utilize its existing powers rather than seeking new ones it does not need.”
Dr. Fabricant also pointed out that FDA’s recent decisions regarding NMN have complicated the New Dietary Ingredient Notification (NDI) process: “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," he said. "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.”
The legal dispute over NMN, a supplement gaining popularity for its potential benefits in cellular health and healthy aging, highlights ongoing tensions between FDA and the natural products industry over regulatory clarity. NPA has also filed citizen petitions and lawsuits related to other controversial ingredients. NPA filed a citizen’s petition and lawsuit against the FDA on the regulatory status of N-Acetyl Cysteine (NAC), and the association stated that those actions established "significant precedent for the dietary supplement industry as the agency rendered enforcement discretion regarding drug preclusion for the first time in the Agency’s history." NPA also filed a petition on cannabidiol (CBD), calling for clearer guidance on its status as a dietary supplement.
This latest ruling compels FDA to address NPA’s citizen petition, which the agency had previously delayed due to "competing agency priorities." The petition was the third regulatory request from NPA aimed at resolving the NMN matter and follows years of efforts to secure regulatory clarity on emerging dietary ingredients. Find more background on NPA’s regulatory efforts here.
