MetroBiotech is in the process of creating a monopoly on a key anti-aging supplement, β-NMN (beta-nicotinamide mononucleotide, or simply NMN)—one of the best precursors of NAD (nicotinamide adenine dinucleotide), which is on the cutting edge of lifespan research. David Sinclair, Ph.D., a Harvard professor and popular author and lecturer, is a co-founder of the company and an outspoken proponent of NMN’s role in longevity, so it stands to reason that he played a large role in the company’s effort to create a monopoly. Previously, we reported on the FDA’s position stating that NMN cannot be sold as a supplement. Now we know that MetroBiotech is behind the FDA’s action. We must stop them and protect access to this vital nutrient.
In December 2021, MetroBiotech sent a letter to the FDA asking the agency to ban NMN supplements. Dr. Sinclair and MetroBiotech have published work demonstrating NMN works …and now the company is looking to cash in by asking the FDA to ban it as a supplement so they can charge what we assume will be exorbitant sums for an NMN drug. It’s shameful that millions of consumers will be denied access to a life-extending supplement due, in our opinion, to greed.
The bottom line is this: MetroBiotech is taking a nutrient that can extend your life and planning to turn it into a drug, thus removing supplement access for millions of people. By the letter of our broken law, the FDA will let it happen.
Further, Dr. Sinclair believes that aging should be considered a disease. In our view, this is part of the ploy to create a monopoly. If the FDA considers aging a disease (as they’ve done with “inflammation” and “hangovers”—see our related article on this topic), then no supplements, period—not just NMN—would be allowed to make anti-aging claims because only drugs can claim to prevent, treat, or mitigate diseases. Consumers would be denied knowledge about products that can help them live longer if the FDA considers aging a disease. Dr. Sinclair is interested in anti-aging, it seems to us, only insofar as he and his friends can turn a profit.
It is a contradictory and hypocritical position Dr. Sinclair is taking. He seems to enjoy media attention and acclaim for being a scientific pioneer yet his company is going to be responsible for taking away an important supplement from the public.
In October 2022, he joined a Hollywood talent agency. Reportedly, this move is geared towards “expanding his opportunities in TV, film, digital, books, speaking engagements, and other entertainment platforms.” He hosts shows on Instagram and YouTube with celebrity chef Serena Poon. Search his name, and it seems clear to us that he wants to be known as an anti-aging pioneer and to get all of the credit for “discovering” NMN and other anti-aging molecules like nicotinamide riboside. He wants to be in the limelight as an anti-aging hero, but is part of the company responsible for snatching away a supplement we care about.
NMN becoming a monopoly drug would be a huge loss to consumers. NMN is the most effective precursor to NAD, which represents the cutting edge of lifespan and health span research. NMN has been found to suppress age-associated weight gain, enhance energy metabolism and physical activity, improve insulin sensitivity, improve eye function, and improve mitochondrial health. This is a nutrient that should be widely available, not offered up to one company to monopolize.
The mechanism by which NMN is getting banned is called the “drug preclusion clause.” This is a back-channel at the FDA that allows companies to turn supplements into drugs. We explained how this back channel works in previous coverage: if a given supplement is considered “new”—that is, it came to the market after 1994—then the company selling it must submit a notification to the FDA proving safety. But here’s the issue: if a drug company files an investigational new drug application (IND) and studies that ingredient before the FDA receives a “new” supplement notification on it, it can no longer be sold as a supplement. MetroBiotech lists published studies on NMN and aging as far back as 2016, which predates the “new” supplement notifications the FDA has on file for NMN. Thus, MetroBiotech can ask the FDA to ban the supplement version of NMN.
It gets worse; this back-channel can apply retroactively. The FDA can accept a “new” supplement notification on a nutrient, only to flip flop years later when a drug IND is unearthed. This is what happened with vinpocetine, and the same thing is happening to NMN.
The FDA had previously acknowledged a “new supplement” notification on NMN, saying nothing about the ingredient’s preclusion from being a supplement because it was being studied as a drug. Now, the FDA is flip flopping now that MetroBiotech has stepped in with its IND, even though NMN has been sold as a supplement for a number of years.
It is through this mechanism that NAC is threatened, though we’ve had some good news on that front recently. It is why the fate of CBD supplements is also in limbo. It is why the pyridoxamine form of vitamin B6 is no longer available as a supplement, and why l-glutamine could suffer a similar fate. Once the FDA grants a monopoly and bans the supplement, there is no guarantee that a drug will even come to market, as in the case of pyridoxamine.
We think it’s important to bring those responsible for creating these monopolies out from the shadows because their actions will have a negative impact on patient access. We cannot let them get away with this without bringing wider attention to this issue. We’re asking members of Congress to sponsor a bill that would prevent NMN from being banned as a supplement. Help us get the word out far and wide to Congressional members!