FDA Delays Response to Citizen Petition on NMN

While the dietary supplements industry expected that FDA would deliver a response this week to citizen petitions filed by the Council for Responsible Nutrition (CRN) and Natural Products Association (NPA) and Alliance for Natural Health (ANH), respectively, the agency told NPA in a status report that it was short-staffed, and would need more time.  

NMN is a popular ingredient in the longevity supplements market, as it is a precursor to NAD+, which is a critical component of energy production in cells and is considered a key marker of biological age.

A Lengthy Saga

The NMN saga began  in 2022, when FDA rejected a New Dietary Ingredient (NDI) notification seeking a pathway to market for NMN, claiming that it was first investigated as a new drug, precluding it from use in dietary supplements. FDA came under fire from supplement industry experts due to its lack of transparency with regard to how it interprets the drug preclusion rule within the Dietary Supplements Health and Education Act (DSHEA), specifically with ingredients like NAC, CBD, and NMN.

In the time since, CRN submitted a Citizen Petition to FDA requesting that the agency provides more clarity on how FDA interprets drug preclusion and the exact date upon which an Investigational New Drug study precludes an “article” from being marketed as a supplement.

NPA sued FDA on the matter, demanding that the agency “cease its unlawful retroactive application of the Food, Drug, and Cosmetic Act against nicotinamide mononucleotide,” but the case was stayed in October last year to allow FDA to respond to NPA’s citizen petition, which specifically calls for clarity on its NMN decision.

Response Expected in the Fall

FDA reported that it “has been working consistently and diligently on its response to the Citizen Petition, but, due to unforeseen circumstances, the agency will not be able to complete its response by the end of July 2025. Among other things, FDA experienced a significant reduction in force (RIF) on April 1, 2025, including in the Human Foods Program (HFP) and Center for Drug Evaluation and Research (CDER) offices that are primarily responsible for developing the agency’s Citizen Petition response.”

As a result, the remaining employees in these offices had to absorb the work of those who were laid off, which included “subject matter experts knowledgeable on the specific issues raised in the Petition and those charged with coordinating CDER’s input on the response,” FDA said.

The agency now expects to respond to NPA’s Citizen Petition on September 30.