FDA Reverses Course, Legalizing NMN in Dietary Supplements
September 29, 2025 — A bombshell rocked the U.S. health-and-nutrition world: after nearly three years of relentless pressure from the Natural Products Association (NPA), the Food and Drug Administration has reversed its position and formally recognized β-nicotinamide mononucleotide (NMN) as a lawful dietary-supplement ingredient. The decision, forged in a multi-front battle, is poised to reshape the industry.
Years earlier, the agency had tried to shut NMN out of the supplement marketplace, arguing the compound was first studied as a new drug. The NPA refused to accept the rationale, hitting back with a citizen petition, a federal lawsuit filed in Washington, D.C., and a nationwide mobilization of manufacturers and consumers. Confronted with mounting evidence that NMN was already sold as a supplement in the United States by 2017, the FDA could no longer insist it fell outside the statutory definition.
In its response to the petition, the agency spelled out a new reading of the "drug-exclusion" or "marketing-clause" provisions in the 1994 Dietary Supplement Health and Education Act. While the NPA still disagrees with parts of FDA's legal analysis, it welcomes the agency's retreat from the stance that marketing of a dietary supplement must be "lawful" to trigger the clause.
"FDA's decision today confirms NMN's legality in supplements," said NPA President & CEO Dr. Daniel Fabricant. "We now call on every e-commerce platform to restore NMN products to virtual shelves immediately."
*Special note - This article is for informational purposes only and cannot replace a doctor's treatment diagnosis and advice. It should not be regarded as a recommendation or proof of efficacy of the medical products involved. If it involves disease diagnosis, treatment, and rehabilitation, please be sure to go to a professional medical institution to seek professional advice.
by GSHWORLD
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