A Federal judge has granted a stay in a β-nicotinamide mononucleotide (NMN) court case against the U.S. Food and Drug Administration (FDA), a move that could help decide the fate of NMN as a dietary supplement.
On August 28, 2024, the Natural Products Association (NPA) filed a complaint in Federal court against the FDA and other government agencies requesting that β-nicotinamide mononucleotide should not be excluded from the definition of a dietary supplement.
The FDA banned NMN as a dietary supplement in 2022, claiming the anti-aging compound is under investigation as a new drug and cannot be marketed in the United States as a supplement. The decision shocked the supplement industry and natural product advocates, as the FDA had previously accepted one company's request to market it in the U.S.
Metro International Biotech LLC, co-founded by Dr. David Sinclair, is working on a patented version of NMN called MIB-626, which, the FDA says, was in progress before supplement companies submitted NMN new dietary ingredient notifications (NDI) to the Agency.
The NPA's complaint, filed in the U.S. District Court for the District of Columbia, results from the FDA's failure to respond to a citizen petition submitted by the NPA and the Alliance for Natural Health in March 2023 asking the Agency to reverse its decision.
Judge pauses NMN legal proceedings
On October 24, the NPA and the U.S. Department of Justice (DOJ) requested that U.S. District Judge Paul L. Friedman order a stay on court proceedings while the FDA evaluates the citizen petition.
Supply Side Supplement Journal (formerly known as Natural Products Insider) reports that Judge Friedman granted the request. The court case will remain on hold until the FDA responds to the citizen petition, which is expected by July 31, 2025.
Judge Friedman also postponed all deadlines in the court case. However, the NPA must submit a response to Metro Biotech's motion to intervene in the lawsuit by November 13.
Metro requested a motion to intervene based on the potential fallout if the court rules in NPA's favor.
According to SupplySide Supplement Journal, the company's lawyers noted that if the court sides with the NPA, Metro Biotech will be "deprived of the protection of the preclusion clause and be at a great disadvantage compared to dietary supplement companies, undermining Metro's substantial investments in developing NMN as a drug. Metro accordingly is entitled to intervene to safeguard its private interests."
The pharmaceutical firm has until November 20 to file a reply to the NPA's response.
FDA explains inconsistencies in its NMN decisions
In an interview with the Journal, Cara Welch, Ph.D., director of the FDA's Office of Dietary Supplements Program (ODSP), said the FDA failed to immediately "connect the dots" when evaluating NMN as a new dietary ingredient as the Agency didn't realize NMN was the same as MIB-626.
"Once we were able to make that connection that NMN was the subject of an investigation new drug application (IND) under authorization, FDA verified it, checked all the boxes, and then we communicated that to the notifier," Welch said. "Because of the unfortunate situation, we felt it was really important to communicate that to everyone who had submitted a notification for that ingredient."
FDA’s NMN ban is paused
During the stay in court proceedings and while it considers the citizen's petition, the FDA said it would not prioritize enforcement actions related to the sale of NMN dietary supplements as long as they would be lawfully marketed products if the Agency eventually allowed NMN to be defined as a dietary supplement.
However, the FDA said it would reevaluate its enforcement priorities if it became aware of new NMN supplement safety concerns.
The NPA considers the court ruling and the FDA’s pause on enforcing its NMN ban a huge win.
“This is a monumental victory for NPA, our members, and American consumers,” said Daniel Fabricant, Ph.D., president, and CEO of the NPA, in a news release. “The court said plainly that FDA vastly exceeded their authority and needs to go back to the enforcement regime that follows the letter of the law.”
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