NMN (beta-nicotinamide mononucleotide) has been shown to enhance the levels of nicotinamide adenine dinucleotide (NAD+) in the cells of the body. Boosting these levels has in turn demonstrated significant benefits in staving off cellular aging.
In late 2022, FDA informed SyncoZymes (NDIN 1247) and Inner Mongolia Kingdomway Pharmaceutical Limited (NDIN 1259) that NMN was not allowed as a dietary ingredient because of its prior investigation as a drug.
The Natural Products Association (NPA) and the Alliance for Natural Health USA (ANH) filed a joint Citizen Petition on March 7, 2023, requesting that the FDA determine that NMN is not excluded from the definition of a dietary supplement or commit to exercise enforcement discretion regarding the sale of NMN as a supplement.
FDA stated in September 2023 that it had been unable to reach a decision on the requests made in a citizen petition about NMN due to “competing agency priorities.”
In August 2024, NPA filed a lawsuit against the agency, but the association and the U.S. Department of Justice (DOJ) then came together to seek a temporary break in the battle over NMN. As first reported by NutraIngredients on Oct. 30, U.S. District Judge Paul L. Friedman granted the stay of legal proceedings to allow FDA to evaluate the NMN citizen petition.
That stay was accompanied by FDA instigating a period of enforcement discretion related to the sale and distribution of NMN-containing products that are labeled as dietary supplements.
The FDA finally responded to the Citizen Petition in September of this year, with the agency changing its interpretation and stating clearly that the ingredient is legal for use in dietary supplements.
SyncoZymes and Inner Mongolia Kingdomway have both now received letters from the FDA confirming that it had reconsidered its stance and NMN is no longer excluded from the dietary supplement definition.
NPA: ‘An unequivocal victory on this specific issue’
Commenting on the new development, Daniel Fabricant, PhD, president and CEO of NPA, stated: “The Natural Products Association welcomes FDA’s Dec. 2, 2025, letters, reiterating that NMN may be lawfully marketed as a dietary supplement. While others remained on the sidelines, NPA’s efforts led to an unequivocal victory on this specific issue. Furthermore, in response to our actions in the executive and judicial branches, FDA has provided more clarity on the drug preclusion clause in DSHEA than ever before.”
NPA stated that it will continue to work closely with congressional offices to advance a targeted legislative fix to the drug preclusion clause, which it says has been inconsistently interpreted and applied in ways that threaten lawful supplement ingredients long after they have been safely marketed to consumers.
“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 added.
“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 responsible innovation to flourish.”
