Washington, D.C. – December 10, 2025 – A landmark announcement from the U.S. Food and Drug Administration (FDA) has sent ripples through the global anti-aging and wellness industry: nicotinamide mononucleotide (NMN) is officially reinstated as a legal dietary supplement. This decisive reversal marks the end of a three-year regulatory standoff that began in 2022, delivering a major win for manufacturers, retailers, and consumers alike.
The breakthrough follows relentless advocacy by the
Natural Products Association (NPA), which filed a lawsuit and an amended citizen petition challenging the FDA’s prior stance that NMN’s classification as an investigational drug barred its use in supplements. The pivotal shift happened this September, the FDA revised its position, acknowledging that drug research status does not automatically exclude a substance from the dietary supplement category.
The week before the FDA officially restored NMN's status as a dietary supplement, the FDA solidified this change by issuing letters to companies that had submitted New Dietary Ingredient (NDI) notifications for NMN. Notably, the agency reinstated its 2022 responses to
previously frozen NDI submissions from affected enterprises—documents widely recognized in the industry as "good day letters" that formally validate product compliance with regulatory standards.
“FDA’s recent actions represent a massive U-turn, and we’re proud to have driven this outcome,” stated
Dr. Daniel Fabricant, President and CEO of the NPA. “Three years ago, we objected to the FDA’s flawed decision, and we fought it tirelessly—in regulatory forums, on Capitol Hill, and in the courts.”
The ruling carries dual milestone significance for the industry:
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Clears Market Access Hurdles: For three years, regulatory uncertainty had stifled corporate R&D investment and market expansion. With NMN’s status now confirmed, businesses can operate confidently, and consumers retain access to this in-demand wellness supplement.
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Establishes Clear Regulatory Precedent: The FDA’s clarification of DSHEA’s “drug preclusion clause” sets a critical standard for future ingredients. It ensures that substances under drug investigation are not automatically disqualified as supplements, preventing regulatory ambiguity from derailing innovation.
The decision is already triggering ripple effects across the global market. For U.S. manufacturers, the removal of trade barriers will spur production and sales growth. For cross-border e-commerce platforms, reduced compliance risks will stabilize supply chains for American consumers. As a global regulatory bellwether, the U.S. ruling is also expected to influence policy adjustments in other regions, paving the way for harmonized international standards for NMN.
“Beyond resolving the NMN dispute, this victory delivers much-needed clarity for next-generation ingredients like peptides,” Dr. Fabricant added. “Without congressional action, these substances face the same regulatory uncertainty—chilling research, deterring investment, and limiting consumer choice. Regulatory predictability is key to ensuring DSHEA works as Congress intended: protecting consumers while fostering innovation.”
As the three-year regulatory saga concludes, the global NMN industry stands at a new starting line. Backed by clear rules, businesses can accelerate innovation and global expansion, while consumers gain greater assurance in their supplement choices. The NPA’s advocacy and the FDA’s policy shift have set a powerful example of regulatory-industry collaboration—proving that science-based, transparent rules are the foundation of a thriving wellness market.
References
“FDA Reinstates NMN as Dietary Supplement after NPA Lawsuit | Natural Products Association.” Natural Products Association, 10 Dec. 2025, www.npanational.org/news/fda-reinstates-nmn-as-dietary-supplement-after-npa-lawsuit/. Accessed 22 Dec. 2025.
