The FDA has concluded that NMN is excluded from the dietary supplement definition and may not be marketed as or in a dietary supplement in the US. This isn’t about any safety issue, as NMN has been proven safe and has shown tremendous health benefits in 12 human studies released in 2021/22. The reason behind this withdrawal ("ban") of NMN as a nutritional supplement is the registration as a drug and a re-evaluation by the FDA. The GRAS status (" generally recognised as safe") is unaffected. the successful lobbying from Metro International Biotech LLC, a company co-founded by Dr. David Sinclair, who’s aim is to sell their patented NMN form (MIB-626) as a prescription drug, which would be way more profitable.
At this point, all American brands offering NMN and many NMN manufacturers as well as suppliers are coming together, gathering evidence to overturn FDA’s conclusions.
We are closely monitoring the situation in Europe/the UK, but have not received any new directives from the authorities for now. We will notify our customers and all relevant stakeholders when we have more clarity and if any change in the regulations occurs.
At Avea, we believe that good health and longevity should be accessible to everyone and deplore that the FDA, as a famously pharma-friendly “regulatory” body, wishes to make this beneficial ingredient out of reach for all but the few.
Meanwhile, our supplier Effepharm who produces our Uthever™ NMN (Shanghai, CN) conducted the clinical trails and applied NDI in USA and Novel food in EU.