We know that the FDA banned the sale of NMN as a dietary supplement in October 2022. Therefore, as a dietary supplement factory, NMNH, which is more efficient, is launched to replace NMN. Can NMNH completely replace NMN? 

'FDA Bans NMN as a Dietary Supplement: Why and What Happened?"

the U.S. Food and Drug Administration (FDA) banned NMN in 2022 from being sold as a dietary supplement after initially allowing one company to market it as a dietary supplement, sending shockwaves through the supplement industry and organizations that support natural health products.

Will NMNH replace NMN? Is it safe? Will it be banned like NMN?

NMNH, a new alternative to NMN (which the FDA "banned"), is now available on Amazon and other retail sites.

Nicotinamide mononucleotide (NMN) is a derivative of vitamin B3 (niacin) and one of several precursors to nicotinamide adenine dinucleotide (NAD+), a compound essential for cellular processes in the body. As people age, NAD+ levels tend to drop significantly, which scientists believe may contribute to age-related health conditions.

Studies have shown that NMN supplements can increase NAD+ levels, help reduce age-related inflammation, support cardiovascular health, and enhance brain function.

Despite its potential anti-aging effects, the U.S. Food and Drug Administration (FDA) recently banned the sale of NMN as a supplement. The ban, which came after the agency had already allowed companies to sell it, sparked outrage among natural health advocates and the dietary supplement industry.

However, another compound — dihydronicotinamide mononucleotide (NMNH) — is being sold on Amazon and other retail sites as an alternative to NMN, a move by supplement companies that could raise the same legal issues as NMN.

Although more research is needed to determine its safety, experts say NMNH may work better than NMN as an NAD+-boosting compound.

But NMNH is really good ? 

NMNH is a non-natural molecule. NMN can be converted into NMNH by some artificial means. Its safety and stability in the human body have not been studied and confirmed.

According to Dr. Robert Verkerk, founder and executive scientific director of the Natural Health Alliance, NMNH is the reduced form of NMN. It works similarly to NMN in that they are both NAD+ precursors, but there appear to be some differences in the enzyme pathways involved.

“Some recent laboratory studies suggest that NMNH may be more effective than NMN in increasing NAD+ levels in the body,” Dr. Verkerk said.

Dr. Andrew Shao, senior vice president of global regulatory and scientific affairs at ChromaDex, told CNN that NMNH may be 5-10 times more potent than NMN in animals.

While research is limited, a 2021 study found that NMNH was a better NAD+ enhancer than NMN in laboratory studies and studies of organisms.

Results of a study published in 2021 also showed that NMNH increased NAD+ levels faster and more than NMN or nicotinamide riboside (NR), another NAD+ precursor. Scientists found that mice given the compound had a rapid and sustained surge of NAD+ detected in their blood.

But NMNH is Safe ?

Dr. Shao said the safety of oral NMNH is not clear because there are no studies on its safety in animals or humans. Studies examining its NAD-boosting effects have been conducted by injecting NMNH. Therefore, its safety, efficacy, and stability in oral form are not yet clear.

“It is still early in the research of this molecule,” said Dr. Verkerk. “Although there have been no safety signals, it is reasonable to assume that NMNH will have a similar safety profile to NMN due to the similarity of the molecules.”

But NMNH Legal issues ?

When a company wants to market a new ingredient as a supplement, it must voluntarily submit a New Dietary Ingredient (NDI) application to the FDA.

Although the FDA initially accepted NMN as a dietary supplement, it later changed its decision and essentially deemed the sale of NMN illegal. The FDA stated that since NMN has been authorized for investigation as a new drug, it cannot be sold in the US market.

NMN and other technical issues may eventually affect NMNH, which is currently being sold online and in stores.

“Although the FDA’s decision only applies to NMN, NMNH is chemically different from NMN, which makes it a new dietary ingredient that requires notification to the FDA,” Shao explained. “As of today, no NDI notification has been submitted to the FDA for NMNH. This means that NMNH on the market is technically not legal.”

Dr. Verkerk agrees that the FDA will likely consider NMNH a new dietary ingredient. Companies that want to sell NMNH will have to comply with the requirements of an NDI application in order to be considered legal. “Supplement companies also use the Generally Recognized As Safe (GRAS) process to bring new products to market.”

Will NMNH be banned like NMN?

Dr. Verkerk said that what happened to NMN could also happen to NMNH if a pharmaceutical company filed an Investigational New Drug application (IND) before NMNH was marketed as a supplement.

“The frustrating thing about this legal loophole is that INDs are confidential, so pharmaceutical companies can hold onto their INDs for years while the supplement industry paves the market for an ingredient, and then pharmaceutical companies come in with their INDs and drive out supplement competition, effectively creating a monopoly,” Dr. Verkerk said.

Shao thinks it’s unlikely that the FDA will ban NMNH at this stage.

“However, given that there are no published studies examining the safety or efficacy of oral NMNH and no company has submitted an Investigational New Drug Application (NDI) to the FDA, NMNH is still in the research stage and has a long way to go,” Shao said.

What can we do between NMN and NMNH ?

NMNH is currently under development and testing. There is no problem with its safety, and its functional efficiency is stronger than NMN.

After 3-5 years of development, NMN has evolved from raw materials to finished product manufacturers, from the market to individuals, from FDA allowed to be sold to not allowed to be sold as a nutritional supplement, and has risen to NDI as an over-the-counter drug, indicating that there is no problem with its safety and reliability. The function of NMN has also been confirmed, and the annual sales of more than 200 billion US dollars indicate that the market has accepted the anti-aging effect of NMN.

AIDEVI is a top 10 Seller, NMN 18000 contains a compound formula of 300mg NMN, which increases the efficiency of NMN conversion to NAD+ by 3-4 times. It is completely comparable to the function of NMNH. Recommended to buy!

NMN News Updates 

1.

Natural health and product advocates are contemplating suing the FDA to reverse its determination that NMN is not a legal dietary supplement.

"Lawsuits Against FDA's NMN Ban Could Be Coming Soon"

2. FDA Face A Lot Questions To NMN

FDA’s takedown of NMN raises fairness, transparency concerns

Article References

1.https://healthnews.com/

2.https://www.nutraingredients-usa.com/

3.1. Zapata-Pérez, R., Tammaro, A., Schomakers, B. V., Scantlebery, A. M. L., Denis, S., Elfrink, H. L., Giroud-Gerbetant, J., Cantó, C., López-Leonardo, C., McIntyre, R. L., van Weeghel, M., Sánchez-Ferrer, Á., & Houtkooper, R. H. (2021). Reduced nicotinamide mononucleotide is a new and potent nad+ precursor in mammalian cells and mice. FASEB Journal, 35(4), 1-17. Article e21456. https://doi.org/10.1096/fj.202001826R