Background of NMN Applications

Nicotinamide mononucleotide (NMN) is a bioactive nucleotide naturally present in the human body and serves as a key precursor for synthesizing nicotinamide adenine dinucleotide (NAD+) in mammals. NAD+ plays a vital role in human health, participating in thousands of biochemical reactions. As people age, their nicotinamide adenine dinucleotide (NAD+) levels decrease, where depletion is associated with downregulation of energy production. NMN, a precursor to NAD+, reportedly slows the process by elevating NAD+levels in the body.

With a rapidly aging global population, there is increasing focus on age-related diseases such as atherosclerosis, osteoarthritis, Alzheimer's disease, and cancer. Anti-aging products are emerging rapidly, and NMN has become a research hotspot due to its anti-aging properties.

Regulatory Rollercoaster: NMN in the United States

• In May 2022, SyncoZymes’s NMN received the first NDI (New Dietary Ingredient) approval. However, the FDA withdraws the NDI status of NMN in November in the same year, and announced that it was excluding the ingredient from the definition of dietary supplements.
• In August 2024, the Natural Products Association (NPA) filed a lawsuit against the FDA to seek legal recognition of NMN as a dietary supplement in the U.S.
• In October 2024, according to documents from the U.S. District Court for the District of Columbia, the FDA announced it would temporarily refrain from restricting NMN sales and planned to issue an updated ruling on NPA’s petition by July 31, 2025.
• On July 29, 2025, NPA released an update on its litigation progress on its official website, indicating that the FDA’s response would be delayed due to significant staffing reductions implemented earlier this year. The agency now expects to issue a decision by September 30, 2025. In the meantime, NMN remains legally available for sale in the United States.

Source: https://www.npanational.org/wp-content/uploads/2025/07/Status-report.pdf 

Progressing Smoothly: NMN’s Novel Food Application in the EU

While the regulatory path in the U.S. remains uncertain, NMN’s application for novel food status in the European Union is progressing steadily. To date, the EU has received five NMN applications, with two Chinese companies’ NMN submissions already entering the risk assessment stage and being evaluated by the European Food Safety Authority (EFSA), as detailed in the table below.

*EFSA seek public comments during the risk assessment stage to ensure scientific and market-appropriate review conclusions.

If NMN gains official authorization as a novel food in the EU, it would mark a breakthrough in the global regulatory deadlock, transforming NMN from a “disputed ingredient” to a mainstream raw material and accelerating its global market expansion.

Will the FDA’s September ruling clear the way or set obstacles? Can Chinese companies be the first to bring NMN to the EU market? CIRS Group will continue to monitor developments and provide real-time updates and expert insights to help industry stakeholders navigate this evolving regulatory landscape with confidence.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.