Judge pauses court case against FDA over NMN supplements

A federal court in Washington, D.C., has granted a stay in a lawsuit against the U.S. Food and Drug Administration concerning the legality of a healthy aging ingredient marketed in dietary supplement products.

U.S. District Judge Paul L. Friedman ordered that all proceedings in the lawsuit are stayed until FDA answers a citizen petition filed by the plaintiff, the Natural Products Association (NPA).

NPA and FDA are at odds over the legality of β-nicotinamide mononucleotide (NMN) in dietary supplements.

Judge Friedman deferred all deadlines in the case except that he required NPA to submit to the court a response by Nov. 13 to a motion to intervene in the lawsuit. The motion was filed by Metro International Biotech LLC, a pharmaceutical company that has been investigating a proprietary form of NMN called MIB-626. Metro has until Nov. 20 to file a reply to NPA's forthcoming response.

FDA has concluded NMN cannot be lawfully marketed in supplements due to its authorization for investigation as a new drug — a position contested by NPA. Metro has sided with the federal government.

In an Oct. 24 court filing, NPA and the U.S. Department of Justice (DOJ) requested a stay of the legal proceedings while FDA evaluates a citizen petition related to NMN. FDA intends to answer the citizen petition by July 31, 2025, according to the filing in the U.S. District Court for the District of Columbia. The petition was filed in 2023 by NPA and the Alliance for Natural Health.

Related:FDA telegraphs enforcement strategy against NMN supplements amid NPA lawsuit

Meanwhile, as previously reported by SupplySide Supplement Journal (formerly known as Natural Products Insider), the government revealed its intent to not target NMN dietary supplements for enforcement actions under certain conditions.