An ongoing NMN update may be useful to track the FDA’s plan to disallow the over-the-counter access to NMN (nicotinamide mononucleotide), a molecule that boosts the body’s production of NAD+, an essential coenzyme that diminishes as we age.
This is significant, because NMN is very popular with people seeking to slow down their biological aging rate, although that has not been proven.
This table of content will help you get to the information you want:
- What is NMN?
- Why is NMN Popular?
- Why is the FDA targeting NMN?
- Two explanatory videos
- Can you still buy NMN?
Let’s dig in…
NMN, or nicotinamide mononucleotide, is one of the forms of vitamin B3 (niacin) that has been shown to enhance the levels of the coenzyme NAD+ (Nicotinamide Adenine Dinucleotide) in the cells of the body.
Boosting NAD+ levels has been shown to significantly reduce cellular senescence, a process whereby a variety of cellular stresses lead to a state of irreversible growth arrest. Senescent cells accumulate during aging, increase baseline inflammation in the body, and have been implicated in promoting a variety of age-related diseases.
NAD+ plays crucial roles in cellular reactions that generate energy, repair DNA, and counter cell stress. Studies show that NAD+ levels fall as we grow older, which likely leads to age-associated diseases such as neurodegenerative, cardiovascular, and metabolic conditions.
To maintain cell NAD+ concentrations and prevent age-related ailments, researchers have developed NAD+ boosters, such as NNM and a similar molecule NR (Nicotinamide Riboside).
Both NMN and NR are sold over-the-counter by supplement companies who typically offer them in capsule or powder form. They are considered safe to consume. Some mouse studies indicate that NMN consumption may extend healthspan or lifespan.
Various human trials of NMN have recently been completed or are ongoing. Small human trials of NR were sponsored by Chromadex (an NR manufacturer) and by Elysium Health (an NR seller). Completed studies of both NMN and NR indicate that these molecules can upregulate NAD+ in humans to some extent; however, they are currently considered inconclusive.
Both NMN and NR have been popular “anti-aging” supplements for several years — so much so that many companies have sprung up to sell them, often offering products that do not contain the amount of supplement printed on the label, or are sullied by contaminants.
The motivation, of course, is to cash in on the trend. Given that NMN and NR are expensive, there’s ample opportunity to attract buyers by offering much lower prices on fraudulent products.
One of the biggest promoters of NMN has been the ubiquitous longevity scientist, Dr. David Sinclair. He and his lab have researched it, and he has promoted its use in hundreds of social media mentions, podcasts and interviews. Interestingly, Dr. Sinclair’s postdoc advisor, Dr. Leonard Guarantee, is a co-founder of Elysium Health, a seller of NR.
Each of these scientists suggest that their respective favorites are superior to the other in boosting NAD+
Apparently, the FDA wants NMN off the shelves because of its prior investigation as a drug. This determination is surprising, given NMN’s market history, and has raised questions of fairness and transparency.
Also surprising is Dr. Sinclair’s role in the FDA push to disallow NMN. To begin to understand that, it’s useful to know a bit about the difference between regulatory procedures between a supplement and a drug.
A New Dietary Ingredient (NDI), allows a natural product to be sold as a dietary supplement. The FDA had previously approved an NDI for NMN, allowing it to be sold as a dietary supplement. But, in an unprecedented action, they revoked the NDI on October 11, 2022.
A quote from that notice:
“NMN is excluded from the dietary supplement definition under section 201(ff(3)(B)(ii) of the FD&C Act (21 U.S.C. § 321(ff)(3)(B)(ii)) and may not be marketed as or in a dietary supplement.”
The FDA stated their reason for excluding NMN from being classified as a dietary supplement is because it was previously investigated as a drug. This is where Dr. Sinclair enters the fray. He is a co-founder of Metro International Biotech LLC, a pharmaceutical company that has been trying to get MIB-626 classified as a drug.
MIB-626 is a proprietary formulation and a version of β-NMN Beta-Nicotinamide Mononucleotide (Beta NMN), which is the fancy name for the NMN commonly sold by companies in the U.S. and abroad.
Metro International Biotech sent this letter to the FDA on December 1st, 2021, regarding the FDA’s ban on NAC.
If three criteria are met with the Federal Food, Drug and Cosmetic Act (FDCA), then they can exclude NMN from being used as a supplement in the U.S.
- The ingredient must be authorized for investigation as a new drug.
- Substantial clinical investigations must have been instituted.
- The clinical investigations must have been publicized.
If the product was previously marketed as a supplement or food prior to authorization for investigation as a new drug, then it does not cause an exclusion, even if the three criteria are met.
Update 2/18/2023: Amazon pulls NMN
Amazon announced that on March 13, 2023 it will no longer offer NMN for sale.
A letter from ProHealth, one of the largest sellers of NMN in the United States said this:
We received a notice from Amazon stating NMN sales will be discontinued starting March 13th, so it’s possible that the FDA has begun to enforce their NMN ruling. We don’t know if Amazon changed their NMN policy because they received an enforcement letter from the FDA or because of an internal review. Walmart.com also discontinued the sale of NMN, so it’s likely that enforcement letters are going out and NMN will become unavailable as a supplement. ProHealth hasn’t received any communication from the FDA, and we plan to continue to sell NMN until the FDA tells us that we have to stop. NMN is critical to many people’s quality of life, so at this time we’re advising customers to consider stocking up on NMN.
A video produced by Renue and one by Dr. Brad Stanfield will give you a clearer understanding of what’s going on with the FDA and NMN, and what Dr. Sinclair’s role in this might be.
I’ve already summarized what’s in Renue’s video, but check it out anyway:
This is Dr. Brad Stanfield’s NMN update:
In case you didn’t watch it, here’s a summary of Dr. Brad Stanfield’s video:
- The FDA banned NMN supplements in response lobbying efforts by Dr David Sinclair’s company Metrobiotech, so they could extinguish competition for Metro’s proprietary blend.
- NMN sellers are trying to get the same exception for NMN that was obtained for NAC, which also was banned but subsequently reinstated.
- NMN continues to be sold.
Click here for a short blurb about NAC
Parenthetically, a similar ban was enacted by the FDA on a supplement called NAC (N-acetyl-L-cysteine) in 2020. At that time the FDA deemed that it was no longer a supplement or dietary ingredient because it was first authorized for investigation as a new drug before it was sold as a supplement. Various organizations and companies with vested interests in NAC fought back, it was reinstated, and can now be purchased over the counter.
As of November 21, 2022, yes, you can still buy NMN over-the-counter, as well as NR, which so far has not been reevaluated by the FDA.
But, as I said earlier, Amazon, Walmart, and probably others will discontinue selling it soon, so stock up now.
Be careful about which NMN product you choose. Select a brand that’s been around for some number of years, and tests its product for quality and contamination.
I favor ProHealth Longevity’s NMN for three reasons:
- I’ve consulted for the company and thus have seen first-hand their commitment to quality (I’m also friends with the Founder);
- They routinely test the product and show lab certifications; and
- Their prices are very competitive, usually the lowest among verifiable NMN-selling brands.
Last Updated on February 18, 2023 by Joe Garma