NMNH, a new alternative to FDA-banned NMN, is available on Amazon and other retail websites. But is it safe? And will it be banned like NMN? Healthnews talked to experts about this new anti-aging supplement.
Nicotinamide mononucleotide (NMN) is a derivative of vitamin B3 (niacin) and one of several precursors to nicotinamide adenine dinucleotide (NAD+), a compound necessary for cellular processes in the body. As people age, NAD+ levels tend to decline significantly, which scientists think may lead to age-related health conditions.
Research suggests that NMN supplements can increase NAD+ levels and help reduce age-related inflammation, support cardiovascular health, and boost brain function.
Despite its potential anti-aging effects, the U.S. Food and Drug Administration recently put a halt to NMN supplements when it banned the sale of NMN in the United States. The ban came after the agency had already allowed companies to sell it, which triggered outrage among natural health advocates and the dietary supplement industry.
However, another compound — dihydronicotinamide mononucleotide (NMNH) — is being sold as an alternative to NMN on Amazon and other retail sites, a move by supplement companies that could trigger legal issues similar to those that occurred with NMN.
Still, while more research is needed to determine its safety, experts say NMNH may be superior to NMN as an NAD+ boosting compound.
What is NMNH and is it better than NMN?
According to Robert Verkerk, Ph.D., founder and executive and scientific director of the Alliance for Natural Health, NMNH is the reduced form of NMN. It works similarly to NMN in that both are NAD+ precursors, but there appear to be some differences in the enzymatic pathways involved.
"There have been some recent laboratory studies suggesting that NMNH may be more effective than NMN at increasing NAD+ levels in the body," Verkerk says.
While research is limited, a 2021 study found that NMNH was a better NAD+ enhancer than NMN in lab studies and research on living organisms.
Results from a study also published in 2021 suggest that NMNH increases NAD+ levels faster and to a much greater extent than NMN or nicotinamide riboside (NR), another NAD+ precursor. The scientists found that mice given the compound experienced a rapid surge of sustained NAD+ in their bloodstreams.
Is NMNH considered safe?
Shao says that the safety of orally administered NMNH is unknown as there are no published studies on its safety in animals or humans. Studies examining its NAD-boosting effects have administered NMNH by injection. So, its safety, efficacy, and stability in oral form are unknown.
"Research on this molecule is in its early stages," Verkerk says. "While no safety signals have arisen yet, it's a reasonable assumption that the extreme safety profile of NMN will be shared with NMNH given the similarity of the molecules."
Legal issues with NMNH
When a company wants to market a new ingredient as a supplement, it must voluntarily submit a New Dietary Ingredient (NDI) form to the FDA.
While the FDA initially accepted NMN as a dietary supplement, it reversed its decision later, essentially making the sale of the compound illegal. The agency said NMN could not be marketed in the U.S. because it had been authorized for investigation as a new drug.
"The Alliance for Natural Health-USA is working with allied organizations to raise the requisite funds needed to challenge the FDA legally regarding its position on NMN. We are also educating Congressional offices on the issue to pressure the FDA to permit NMN in dietary supplements," Verkerk tells Healthnews.
The legal issues with NMN and other technicalities may eventually impact its NAD+ boosting alternative, NMNH, which is currently for sale online and in stores.
"Although the FDA's decision only applies to NMN, NMNH is chemically distinct from NMN, which renders it to be a new dietary ingredient, which requires it to be notified to the FDA," Shao explains. "As of today, there is no NDI Notification filed with the FDA on NMNH. This means that NMNH on the market is technically not legal."
Verkerk agrees that the FDA will likely consider NMNH a new dietary ingredient.
"Firms wishing to sell NMNH would, therefore, need to comply with NDI requirements for pre-market notification with the FDA to be considered legal," Verkerk explains. "Supplement companies have also used the Generally Recognized as Safe (GRAS) process to bring new products to market."
Will NMNH be banned like NMN?
Verkerk says if a pharmaceutical company submits an investigational new drug application (IND) on NMNH before it is sold as a supplement, then the same thing that happened to NMN could happen to NMNH.
"The frustrating part of this legal loophole is that INDs are confidential, so drug companies can sit on INDs for years while the supplement industry builds up a market for an ingredient before swooping in with their IND, kicking out the supplement competition, and effectively creating a monopoly," Verkerk tells Healthnews.
Shao believes that the FDA is unlikely to ban NMNH.
"However, given that there are no published studies examining the safety or efficacy of oral NMNH and no NDI filed with the FDA, the agency may take enforcement action," Shao says.
The bottom line
The FDA does not "approve" dietary supplements before they are marketed — including supplements like NMNH. Instead, it monitors supplements by inspecting manufacturing facilities and watching for reports of adverse events related to the product after it is sold to consumers.
So, until scientists understand more about the safety and effectiveness of NMNH, consumers should consider using caution when purchasing the supplement online or in retail stores.
2 resources
- Journal of Proteome Research. Reduced nicotinamide mononucleotide (NMNH) potently enhances NAD+ and suppresses glycolysis, the TCA cycle, and cell growth.
- Federation of American Societies for Experimental Biology. Reduced nicotinamide mononucleotide is a new and potent NAD+ precursor in mammalian cells and mice.
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