On September 29, 2025, the Natural Products Association (NPA) announced that the U.S. Food and Drug Administration (FDA) reversed course and confirmed that Beta (β) Nicotinamide Mononucleotide (NMN) is lawful for use in dietary supplements — ending nearly three years of regulatory uncertainty. This marks a historic breakthrough in NMN’s regulatory landscape.
NMN is a naturally occurring bioactive nucleotide in the human 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.
01 Background
NMN’s path to legalization in the U.S. faced setbacks, leading to legal disputes
In May 2022, SyncoZymes’s NMN received the first NDI (New Dietary Ingredient) approval. However, the FDA withdrew the NDI status of NMN in November of the same year and announced that it was excluding the ingredient from the definition of dietary supplements.
In August 2024, NPA filed a lawsuit against the FDA to seek legal recognition of NMN as a dietary supplement in the U.S.
As of September 29, 2025, this three-year-long compliance battle has finally reached its conclusion.
In addition to the regulatory progress in the United States, CIRS has also tracked a detailed follow-up of NMN’s application status in the European Union.
02 Current Status
FDA reverses its course — NMN now legally permitted in dietary supplements
Previously, the FDA has stated that NMN cannot be marketed as a dietary supplement because it has been authorized for investigation as a new drug. However, the NPA rejected this rationale, filing a citizen petition and a federal lawsuit in Washington, while rallying support from industry stakeholders and consumers.
In response to these petitions and legal actions, the FDA acknowledged that evidence shows NMN had been sold in the U.S. as a dietary supplement as early as 2017, and therefore should not be excluded from the definition of dietary supplements.
Daniel Fabricant, Ph.D., president and CEO of NPA stated:
“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 the FDA stops abusing the drug preclusion clause once and for all.”
This course reversal by the U.S. FDA reaffirms NMN’s legal status as a dietary supplement, marking a major positive milestone for global NMN compliance.
CIRS Group will continue monitoring NMN regulatory developments across the EU, China, and other regions, providing timely professional insights to help companies navigate evolving regulations with confidence.
About CIRS
The Food Division of CIRS Group was established in 2012 and has a professional team specializing in US GRAS notices. The Food Division has extensive experience in various fields, covering GRAS, new food ingredients, new food additives, food contact materials, synthetic biology foods, EU Novel Foods, dietary supplements, and special dietary foods.
CIRS operates a fully-owned subsidiary in the US. By leveraging the expertise of the CIRS USA and the international teams, it can provide enterprises with various US food services, including but not limited to:
- US FDA GRAS Notice;
- US FDA Dietary Supplement Structure/Function Claim Notification;
- US New Dietary Ingredient (NDI) Notification;
- US FDA Registration of Food Facilities; and
- US Food Label/Advertisement Information Review.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
