Judge pauses court case against FDA over NMN supplements

October 30, 2024

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.

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.

Josh Long

Associate editorial director, SupplySide Supplement Journal , Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at SupplySide Supplement Journal (formerly known as Natural Products Insider), which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.