After declaring that NMN is lawful to be sold as a dietary supplement ingredient in September, the U.S. Food and Drug Administration (FDA) provided companies that have filed New Dietary Ingredient Notifications seeking to bring NMN ingredients to the market with additional confirmation.

The NMN saga began in 2022, when FDA declared that NMN was authorized as an investigational new drug prior to being marketed as a supplement, thereby precluding it from being sold in supplements. After citizen petitions from the Natural Products Association (NPA) and Council for Responsible Nutrition (CRN), NPA filed a lawsuit against the agency, and the case was stayed on the condition that FDA would provide a final determination on the ingredient via response to the trade groups’ citizen petitions.

In letters to companies that previously submitted new dietary ingredient notifications to the agency, seeking to bring NMN products to the market, the agency confirmed that NMN is not excluded from dietary supplements.

For instance, in a Dec. 2 letter to SyncoZymes Co. Ltd., FDA reinstated a previous response from May 2022, at which point it acknowledged the NDI notification with no objections, which is known in industry parlance as a “good day letter.”

“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, PhD, president and CEO of NPA.

“While others sat on the sidelines, NPA’s efforts delivered an unequivocal victory on this specific issue,” Fabricant continued. “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, the association filed notice to voluntarily dismiss its lawsuit against FDA without prejudice.

“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,” said Fabricant. “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, and 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.”