September 29, 2025 — After nearly three years of pressure from the Natural Products Association (NPA), the U.S. Food and Drug Administration (FDA) has reversed course and confirmed that Beta (β) Nicotinamide Mononucleotide (NMN) is lawful for use in dietary supplements.
FDA had previously attempted to block NMN from the supplement market, claiming it was first investigated as a new drug. NPA refused to accept that interpretation, filing a citizen petition with FDA, launching a federal lawsuit against the agency in the nation’s capital, and mobilizing industry and consumer support to challenge FDA. In response to the petition and lawsuit, FDA acknowledged evidence that NMN was marketed as a dietary supplement in the United States as early as 2017 and consequently is not excluded from the definition of a dietary supplement.
In its response to the citizen petition, FDA elaborated on its interpretations of the “drug preclusion” or race-to-market clause in the Dietary Supplement Health and Education Act of 1994 (DSHEA). NPA continues to disagree with certain legal interpretations by FDA, but the association is pleased that the agency reconsidered its position that dietary supplement marketing must be “lawful” in determining the race-to-market clause.
“FDA’s decision today confirms NMN is lawful in supplements, and we now call on e-commerce platforms to immediately restore NMN products to the market,” said Daniel Fabricant, Ph.D., president and CEO of NPA. “We will continue pressing Congress, the courts and the Administration until FDA stops abusing the drug preclusion clause once and for all.”
This is not the first time that FDA has changed course in response to NPA actions. In 2022, after NPA filed a citizen petition and lawsuit over FDA’s attempt to exclude NAC (N-acetyl-L-cysteine) from supplements, the agency ultimately issued a final guidance — or policy of enforcement discretion — that allowed NAC products back on the market.
As NPA prepares to celebrate its 90th anniversary in 2026, the NMN victory underscores its unmatched record of holding FDA accountable, defending consumer choice, and delivering results where others fall short.
For media inquiries, contact Josh Long at jlong@npanational.org.
