December 10, 2025
Agency Confirms that NMN Can be Marketed As Supplement
Washington, D.C. — In a significant victory for the dietary supplement industry and a reversal from a 2022 determination, the U.S. Food and Drug Administration this month confirmed that nicotinamide mononucleotide (NMN) can be marketed as a dietary supplement.
Just last week, FDA clearly referenced its Sept. 29, 2025, conclusion that NMN is not excluded from the dietary supplement definition in letters to companies that previously submitted new dietary ingredient notifications to the agency. The premarket notifications are required under the Dietary Supplement Health and Education Act of 1994 (DSHEA) to establish the identity and safety of new dietary ingredients. In a Dec. 2 letter to SyncoZymes (Shanghai) Co. Ltd., whose distributor CellMark USA LLC is an NPA member, FDA reinstated a previous response in May 2022 that acknowledged its NDI notification, otherwise known in industry parlance as a good day letter.
This is a significant development as it follows actions taken by FDA in September, when the agency reversed its previous determination that the investigation of NMN as a drug precluded its use in supplements. FDA’s determination came in response to an amended citizen petition and a lawsuit against FDA brought by NPA.
“FDA’s recent letters — including its response to our amended citizen petition — represent a massive U-turn, and we’re proud that we were able to help shape the outcome. NPA strongly objected when FDA made the wrong decision on NMN three years ago, and we fought it in the regulatory arena, in conversations with congressional offices, and ultimately in the courts,” said Daniel Fabricant, Ph.D., president and CEO of NPA.
“While others sat on the sidelines, NPA’s efforts delivered an unequivocal victory on this specific issue,” Dr. Fabricant added. “Furthermore, because of our actions, FDA has now provided extremely valuable and additional clarity on the drug preclusion clause in DSHEA, so this is in a sense a two-fer. NPA will use this opening to advance a legislative solution to the drug preclusion clause, which has been inconsistently interpreted and applied in ways that threaten lawful supplement ingredients long after they have been safely marketed to consumers.”
Following FDA’s response to NPA’s citizen petition in September, which successfully resolved the NMN controversy, the association filed a notice to voluntarily dismiss (without prejudice) its lawsuit against FDA in Federal District Court.
“NPA’s successful effort to establish the legitimacy of NMN required extraordinary investments, including the filing of a formal citizen petition and subsequent litigation against FDA,” Dr. Fabricant said. “Absent congressional action, the same uncertainty now looms over peptides and other next-generation ingredients that may become entangled in investigational new drug applications, chilling research, deterring investment, undermining innovation and limiting consumer choice. Regulatory clarity is essential to ensure that DSHEA continues to function as Congress intended by providing a predictable, science-based framework that protects consumers while allowing innovation to flourish.”
