The US Food and Drug Administration (FDA) has reversed its position on beta-nicotinamide mononucleotide (NMN), confirming the ingredient is lawful for use in dietary supplements.
In two letters issued on September 29th, 2025, the agency concluded that NMN meets the definition of a dietary supplement.
This overturns its earlier interpretation that excluded the ingredient under the drug preclusion clause of the Food, Drug and Cosmetic Act (FD&C).
The reversal stems from the FDA’s analysis of the “race to market” provision, which governs whether a substance can be sold as a supplement if it is also investigated as a drug.
The agency determined there was sufficient evidence that NMN was marketed as a dietary supplement in the US before being authorised for drug investigation, meaning it can remain available to consumers.
A key factor in this landmark decision was the recognition that NMN is a naturally occurring molecule produced by the body as part of the NAD+ biosynthesis pathway.
This fundamental characteristic underscores NMN's appropriate classification as a dietary supplement rather than a pharmaceutical drug.
The decision follows years of advocacy from industry groups including the Natural Products Association (NPA), Alliance for Natural Health USA and the Council for Responsible Nutrition.
Whilst the FDA granted parts of these petitions, it did not clarify what constitutes “substantial” clinical investigation, leaving uncertainty for future ingredients.
Industry leaders welcomed the policy shift as a win for consumer access.
However, some criticised the FDA for continuing to provide limited guidance on how it interprets the drug preclusion clause.
"This is a historic day for both the supplement industry and the consumers we serve," said Bryan Nettles, CEO of Renue by Science.
"The FDA's reversal confirms what we've known all along, that NMN is a safe, effective and lawful supplement for promoting healthy ageing and vitality."
"This decision protects consumers from inflated pharmaceutical pricing while safeguarding the pathways for future innovation in the supplement industry."
"We are grateful for the efforts of industry advocates and remain committed to providing innovative, science-backed products that support people's wellness journeys."