By Brett J. Weiss
Published: 11:28 am PST Nov 29, 2022 | Updated: 3:53 p.m. PST Nov 29, 2022

The FDA has issued a statement saying that NMN may not be sold as a supplement, citing its status as being under investigation as a drug. This development is a reversal of the FDA’s previous decision to allow its sale as a new dietary supplement (NDI). Although many vitamin and supplement companies that sell NMN remain concerned with this news, banning NMN’s sale is not currently being enforced.

NMN is a precursor to a vital molecule involved in thousands of reactions for cell energy, DNA repair, and cell stress alleviation called nicotinamide adenine dinucleotide (NAD+). NAD+ levels significantly decline with age, correlating with the onset of age-related diseases like cardiovascular, neurological, and metabolic issues. Taking NMN has been shown to increase blood NAD+ levels in humans and mitigate age-related diseases in animal models. Due to its success in alleviating age-related ailments in animals, namely rodents, pharmaceutical companies like Metro International Biotech have begun trials investigating NMN as a drug for humans.

 

Pushback for Labeling NMN a Supplement from Pharma Companies Investigating NMN as a Drug

Pharmaceutical companies’ investigation of NMN as a drug may have spurred the FDA to ban its sale under the label of a supplement. For example, Metro International Biotech sent a letter to the FDA in December 2021 requesting that the FDA revise its classification of NMN to “protect the right of companies that have spent significant time and research to develop drugs products from competition from dietary supplements.” This request likely comes from their development of the NMN-based product MIB-626.