Washington, DC—The U.S. Food and Drug Administration’s (FDA) has confirmed that Beta (β) Nicotinamide Mononucleotide (NMN) is lawful for use in dietary supplements. The Natural Products Association (NPA) shared news of FDA’s reversed course on NMN, as outlined in a letter to the association on September 29.
Outlining the timeline, NPA explained that FDA had previously attempted to block NMN from the supplement market, claiming it was first investigated as a new drug. As WholeFoods Magazine has reported, FDA declared in a November 2022 notification that NMN is not a legal dietary ingredient. In 2023, NPA and Alliance for Natural Health (ANH) submitted a citizen petition requesting that FDA determine 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. In July 2023, FDA rejected a Congressional Request for Public Hearing on NMN. NPA later launched a federal lawsuit against the agency, and mobilized 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 a letter to NPA, FDA explained, “FDA is aware of evidence that NMN was marketed as a dietary supplement in the United States as early as 2017. This preceded the authorization of NMN for investigation as a new drug. Accordingly, we now conclude that NMN is not excluded from the dietary supplement definition under section 201(ff)(3)(B).”
NPA reported that, 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 noted that while it continues to disagree with certain legal interpretations by FDA, the association is pleased that FDA reconsidered its position that dietary supplement marketing must be “lawful” in determining the race-to-market clause.
NPA, which will celebrate its 90th anniversary in 2026, said the “NMN victory underscores its unmatched record of holding FDA accountable, defending consumer choice, and delivering results where others fall short.” Daniel Fabricant, Ph.D., President and CEO of NPA, noted, “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. We will continue pressing Congress, the courts and the Administration until FDA stops abusing the drug preclusion clause once and for all.”
Calls for more action
The Council for Responsible Nutrition (CRN) also had filed a Citizen Petition in 2023, focused on Drug Preclusion. The trade association argued that the Drug Preclusion Clause has been, and will likely continue to be, misapplied to dietary supplement ingredients that the agency has previously acknowledged as lawfully marketed. This, CRN said, threatens future innovation in the supplement marketplace. CRN said its 2023 petition (as well as a supplemental filing in March 2025) “sought a practical, common-sense framework that aligns with Congressional intent, provides regulatory certainty, and preserves consumer access to safe, beneficial supplements.”
Following FDA’s September 29 response clarification that NMN may be marketed as a dietary supplement, CRN said the agency did not fix the underlying policies that created uncertainty in the first place.
CRN reported that, in addition to clarifying that NMN was marketed as a dietary supplement prior to the date that an Investigational New Drug (IND) went into effect, FDA’s September 29 responses (to CRN and to the parallel petition from NPA) indicate that:
- FDA continues to treat the confidential effective date of an Investigational New Drug (IND) as the operative trigger, rather than when substantial clinical investigations for the article become public. CRN said this fuels uncertainty for supplement innovators.
- FDA appears to have broadened “substantial clinical investigations,” which CRN said suggests that “even early-phase or limited studies can confer drug companies with a monopoly for an ingredient if FDA deems them qualitatively important for drug development.” CRN was seeking a clear delineation from FDA regarding what constitutes a “substantial” investigation. “Basically,” CRN said, “FDA claims it will know it when it sees it.”
- FDA is rejecting foreign marketing of an ingredient as either a food or a supplement as relevant to the race-to-market, even though it puts drug companies on notice of supplement interest in an ingredient. CRN said drug companies may seize on articles marketed elsewhere before they are marketed in the U.S. and prevent their sale as a supplement here.
- FDA acknowledges that “marketing” need not be “legal” to count; CRN said this technical concession offers little practical relief for most ingredients.
“The agency’s reliance on non-public IND dates and an expansive view of ‘substantial clinical investigations’ creates a moving target that businesses cannot reliably plan around,” said Megan Olsen, Senior Vice President and General Counsel, CRN. “Yes, NMN can be marketed today. But the same unstable framework remains in place for the next ingredient, inviting repeat uncertainty.”
Steve Mister, President & CEO, CRN, noted, “FDA missed a pivotal opportunity to bring clarity and balance to the line between pharmaceuticals and dietary supplements. At every juncture where FDA had the opportunity to choose between two interpretations of the statute, it chose one that favors pharmaceutical development over supplements. Consumer access to affordable and accessible healthcare products will be stymied as a result.”
Mister also stated that, collectively, FDA’s response does one thing: “It allows FDA to dodge the bullet with respect to NMN and escape a potential legal battle over its status. But FDA has aggressively declined to provide any real guidance to the supplement or pharmaceutical industries. Without transparent, publicly knowable triggers and workable guidance, companies will continue to face unnecessary conflict with drug development rather than a coherent policy that advances public health.”
CRN is urging FDA to revisit its interpretation and issue clear guidance. If the agency will not act, CRN said, the next step would be for Congress to “restore balance so that consumers retain access to beneficial supplements while legitimate drug innovation proceeds.”
