The FDA has decided that NMN can no longer be considered a dietary supplement. Does this mean that NMN will disappear from store shelves?
In late October 2022, the anti-aging world went into a frenzy about a possible NMN (nicotinamide mononucleotide) ban. NMN had long been one of the most popular anti-aging supplements on the market — until the FDA revoked NMN’s NDI (New Dietary Ingredient) classification. This means that companies in the US are not allowed to market this product any longer. So why is it suddenly prohibited and does it have anything to do with the supplement’s properties?
This article gives objective information about what is happening!
What Is NMN?
NMN is a precursor of the essential vitamin B3 that can repair DNA cells in the body, increase energy levels, improve heart health, and perform various other functions that can enhance overall longevity. Recent studies show that this substance has a rejuvenating and regenerating effect on the whole body.
Why Is FDA Certification Important?
The Food and Drug Administration (FDA) is one of the US federal departments serving as a part of the Department of Health. The agency investigates the safety of a wide variety of products, from food and tobacco products to medicines, cosmetics, dietary supplements, medical equipment, and personal care devices. The FDA is also promoting healthy lifestyles in the United States, gradually reaching the global level.
It is believed that the quality standards of this department are the most stringent, so the FDA approval of the product immediately increases its popularity and the trust of buyers around the world.
First of all, approval guarantees the safety of the product’s composition — none of its components can be harmful to humans. Technological, chemical, and microbiological characteristics are subjected to analysis, and the radioactive safety of the product is also checked. The presence of an FDA certificate allows you to enter the market not only in the United States but also in more than a dozen countries (including Australia, Canada, etc.)
What Happened to NMN’s FDA Status?
NMN was previously acknowledged as a dietary supplement by the FDA. However, when in July 2022 the FDA received a notification about marketing a new NMN product from Inner Mongolia Kingdomway Pharmaceutical Ltd. (Kingdomway), the administration suddenly decided that NMN could no longer be considered a dietary supplement as it was under investigation as a prescription drug.
The thing is, a company called Metro International Biotech LLC is currently studying and looking to market MIB-626 as a prescription drug. MIB-626 is a proprietary formula and version of β-Nicotinamide Mononucleotide β-NMN (beta-NMN). Beta NMN is a form of NMN commonly sold by companies in the US and abroad.
The founder of Metro International Biotech is David Sinclair — a person responsible for making NMN popular with his extensive research and numerous publications on the matter. Having created insane demand for the substance, Sinclair is now basically pushing to get it off the shelves, making space on the market for his new MIB-626 drug. It surely looks like his motives are less than honorable.
However, the FDA does not disclose the date on which a company submits an Investigational New Drug (IND) application. Therefore, it is unclear whether the new drug investigation for MIB-626 began before or after NMN was marketed as a supplement. The FDA rules state that if the ingredient has already been marketed as a dietary supplement before the authorization for its investigation as a new drug, then it cannot be excluded from the supplement list.
So far, the NDA has deemed all evidence stating that NMN had been previously marketed as a supplement unsubstantial. At the same time, they did not formally ban NMN completely for the whole industry — they simply answered a notification of one company that was looking to market NMN as a supplement. What comes next for NMN is this debacle remains to be seen as we’re waiting for additional comments from the FDA.
History Repeating Itself? NAC Case Explained
A similar situation has already taken place during the withdrawal of N-acetyl-L-cysteine (NAC) in 2020. It is a supplement that is also widely used to slow down aging. It was deemed no longer a supplement or dietary ingredient by the FDA because it was first approved for research as a new drug.
But then, the indignant NAC producers defended their right to sell their product as a biologically active supplement and filed a lawsuit against the FDA. On November 4, 2022, the FDA dismissed the lawsuit without prejudice. And, while the FDA stated that NAC did not meet the definition of a dietary supplement, in the final guidance, they adopted a policy of “enforcement discretion” that essentially allows companies to continue to sell NAC in the US.
Hopefully, the same scenario can happen with NMN. This would allow NMN to continue being sold as a supplement in the United States. Right now, the substance in limbo since it is currently widely available online and in retail stores. We hope that a product with such powerful and beneficial properties will stay accessible for everyone looking to purchase it.
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