Following recent FDA ruling, Restricted Products Team of online retail giant issues notice to NMN sellers.
Back in November, we covered the news that the FDA had ruled that the popular longevity supplement ingredient beta-nicotinamide mononucleotide (NMN) could no longer be sold as a dietary supplement in the US because it “has been authorized for investigation as a new drug”.
The company conducting the research in question is clinical-stage pharma company Metro International Biotech. It is currently is working on “small-molecule NAD+ enhancers that leverage the NAD+ cycle to treat rare diseases and pursue significant improvements in human health to combat the adverse conditions of aging.”
Longevity.Technology: NMN is an enormously-popular supplement – and with good reason. It is a precursor of critical coenzyme nicotinamide adenine dinucleotide (NAD+), a molecule that plays a key role in myriad metabolic processes, including generating biological energy from glucose and oxygen, helping proteins regulate cellular functions, DNA repair and mitochondrial maintenance. NAD+ levels decline with age not only because we produce less, but because we use it up at a faster rate, and this double whammy can lead to accelerated aging and increased risk of heart disease, Alzheimer’s disease and type 2 diabetes.
No wonder supplements that boost NAD+ have become increasingly popular, promising to keep us younger and fitter for longer and stave off age-related decline; now it seems that the convenience of ordering them with Amazon’s famous one-click process might be off the table for the moment.
According to the notice from Amazon, sellers may continue to offer products that contain NMN until 13 March 2023 and after that date, they may only sell products that contain NMN if you they upload labeling with a National Drug Code (NDC) clearly present and legible.
“This latest example of the FDA misinterpretation of the law is wreaking havoc on the marketplace and causing confusion and significant economic harm,” said Daniel Fabricant, PhD, President and CEO of the Natural Products Association (NPA) .
“This the first time in history that FDA reversed itself on an acknowledgement letter for a new dietary ingredient without a shred of evidence that safety was at risk,” he added. “It is setting a new precedent in that an announcement of Generally Recognized as Safe no longer constitutes evidence of the marketing of NMN as a food before the ingredient was authorized for investigation as a new drug.”
Of course, pending communication from the FDA to the contrary, many sellers are likely to continue to sell from their own websites, and it is only the US that is affected by the FDA’s decision.
Nevertheless, supplement companies are keeping a close eye on proceedings; Longevity.Technology reached out to a couple to find out their thoughts…
Wonderfeel told us that based on the feedback they had received from the former Directors at FDA and other experts, they find the FDA’s decision controversial and unprecedented, creating disruption in the market where “tens of thousands of Americans have been safely benefiting from the use of NMN supplements”.
However, there is an upside.
“On the subject of safety, one silver lining according to the industry watchdogs is that a large number of imposter brands from overseas manufacturers will be eliminated,” Baran Dilaver, Co-founder and CEO of Wonderfeel told us. “A majority of these brands produce low-grade NMN products in chemical plants with poor purity levels. The Amazon ban will prevent these non-GMP certified NMN manufacturers from taking advantage of unsuspecting customers by removing their direct and often only sales channel in the US.
“We expect that consumers will still be able to find NMN and we encourage them to source their NMN directly from reputable companies that can back their products by clinical research and verifiable third party lab results.
Founded in San Francisco, Wonderfeel boasts Harvard MD Andrew Salzman as its Chief Medical Officer, and is all about the science, having previously partnered with Abinopharm, to analyse, interpret and release the preliminary encouraging findings from a large double blind study on the effects of NMN, as well as carrying out in vitro studies of its novel supplement, Youngr™ NMN.
“While we advocate for the protection of drug development, we believe that such efforts shouldn’t deprive the public of safe and readily used supplements,” Dilaver told us. “As part of our current preclinical and clinical studies, we are laying the groundwork for pharma development of our NMN formulations to run parallel to our nutraceutical pursuits.
“Various consumer groups and trade associations are rightfully questioning FDA’s announcement and we encourage NMN users to do the same. Write or call your local member of Congress and let them know what you think about the FDA revoking your access to NMN.”
According to New Zealand-based supplement company SRW, this is a unique situation; given the popularity of NMN and its clear importance as a molecule that many Americans rely on to boost NAD levels and support youthful cell function, SRW feels demand is likely to shift from US brands to international ones.
“Americans will be able to import NMN from offshore for personal use,” Greg Macpherson, Founder of SRW Laboratories told us. “We see a significant advantage for companies outside of America to fill the demand that current local brands have been offering. But … American consumers will need to be careful. Recent tests of NMN purity on supplements sold on Amazon showed that many did not have the stated amount of NMN in the formulation. For this reason consumers need to choose their NMN supplier carefully and identify brands they trust.
We asked Macpherson whether he felt the FDA’s decision reflected the Chinese administration’s decision to ban NMN.
He told us there are quite different drivers regarding the regulation of NMN in both markets.
“In China, NMN is yet to be approved – this is quite different to the reason FDA has made its decision to remove the supplement status of NMN,” he explained. “The change in status from supplement to drug is due to a technicality identified because NMN was listed as an investigational drug prior to it being on the market as a supplement. In this situation the law says the molecule has to be a drug and can’t be a supplement.”
This begs the question as to whether, scientifically, there is any evidence that NMN should be considered a therapeutic as opposed to a food supplement.
“With the rapid advancement in our understanding of the pathways and cellular mechanisms that certain supplements modulate it is becoming very clear that there is good science indicating therapeutic benefit across a wide range of natural compounds, this includes NMN,” said Macpherson. “If you look at clinicaltrials.gov there are many supplements that are being clinically tested for therapeutic effect. Examples are fisetin, curcumin and 2-hoba. A supplement being involved in a clinical trial is incredibly important as it builds evidence that a supplement has benefit for human health but does not mean it should be reclassified as a therapeutic.
Although SRW has now been forced to withdraw its product from Amazon.com, it will continue to supply NMN-based supplements to American residents from its New Zealand-based website.
If you are thinking the FDA-NMN-Amazon hoohah sounds familiar, you’d be right. The FDA decided NAC, a supplement form of key amino acid cysteine, was excluded from the dietary supplement definition because it was approved as a new drug before it was marketed as a dietary supplement or as a food.
When Amazon also removed NAC (N-acetyl-L-cysteine) from its platform in May 2021, there was uproar – especially as it had been on the shelves as a supplement for over 30 years. Following a lawsuit filed by the NPA, the FDA published its final guidance and stated it will exercise enforcement discretion for NAC – basically turning a blind eye to supplement sales, so long as no-one is claiming NAC is a wonder cure. Amazon duly reinstated NAC products on its .com website.
We would imagine the same state of affairs will come to pass for NMN, but for now, watch this space.