Rep. Jeff Duncan (R-SC) has called for a public hearing to clarify the agency’s position on NMN, a critical anti-aging supplement that the FDA is trying to ban. Action Alert!
Rep. Duncan’s letter to the FDA requesting the public hearing echoes many of the issues and questions we’ve been raising for the last few months regarding the FDA’s attack on nicotinamide mononucleotide (NMN), a NAD precursor that is on the cutting edge of anti-aging research. To protect access to affordable NMN, we must continue sending messages to Congress urging them to rein in the out-of-control FDA.
We’re delighted Rep. Duncan is leading the charge on this issue, as it is a critical one for health-conscious consumers. What’s at stake is our ability to turn back the clock on our age using natural supplements. Recall that the FDA has said that NMN is not a legal supplement because it was studied as a drug before it was sold in or as a supplement. This means that, technically speaking, the FDA could clear the market of NMN supplements, as it did a few years ago to pyridoxamine supplements under similar circumstances. This hasn’t happened yet, but it could at any time.
To recap how we got here: there is a backchannel at the FDA that allows drug companies to monopolize supplement ingredients. For supplements that are considered “new” under the law—that is, they weren’t sold “in or as a supplement” before 1994—companies must submit a notification to the FDA with studies to prove that it is safe before that ingredient can be marketed. This is the deeply problematic “new dietary ingredient” (NDI) notification process that we have written about extensively over the years. But here’s the issue: if a drug company files an Investigational new drug application (IND) and studies that ingredient before the FDA receives an NDI notification on it, it can no longer be sold as a supplement. This, of course, creates a stacked deck in favor of Big Pharma, which can sit on confidential IND’s for years while the supplement industry builds up a market for an ingredient before swooping in with their IND, kicking out the supplement competition, and creating a monopoly.
This is currently happening with NMN. MetroBiotech, a pharmaceutical company, sent a letter to the FDA late in 2021 asking the agency to remove all NMN supplements because it had begun clinical investigations on NMN which the FDA says predated any NDI’s the agency had received—meaning that, in the FDA’s view, NMN is not a legal supplement.
The case of NMN is particularly frustrating. For one, a supplement company filed an NDI on NMN in 2022, and the acknowledgement letter from the FDA contained no objections. As far as the law is concerned, at that point NMN is a legal dietary supplement. Just a few months later, though, the FDA reversed course after getting MetroBiotech’s letter, saying that “new information came to light” and that NMN is not a legal supplement.
The other irony is that NMN has had no bigger supporter than David Sinclair, PhD. Dr. Sinclair has publicly stated that he takes NMN supplements; many people listen to what he says and follow his anti-aging regimen. Yet Dr. Sinclair is the co-founder of MetroBiotech, the company trying to ban NMN supplements. Dr. Sinclair issued a statement on the NMN issue saying that he does not “manage or control” affairs at MetroBiotech but “the important work of bringing NMN to market as an FDA-approved medication is in the best interest of the tens of millions of people who suffer from and will succumb to aging-related diseases.”
Making NMN a monopoly drug is certainly in the best interest of MetroBiotech, but not for consumers. Just look at what happened with CBD, another natural supplement threatened by the FDA backchannel. It is (thankfully) still available in supplement form, and it’s a good thing because the FDA-approved drug costs $32,500 per year. We can expect similar monopoly prices if MetroBiotech’s NMN drug wins FDA approval—and if the agency bans NMN supplements, the drug will be consumers’ only choice.
Last month, ANH-USA filed a Citizen’s Petition with our allies, the Natural Products Association, calling for the FDA to issue a regulation stating that NMN is a lawful dietary supplement. You can read our previous coverage for more detail on the arguments contained in that submission.
We’re fighting for a carve-out in the law to allow the continued sale of NMN supplements, but the bigger problem must also be addressed— the loophole in the law that allows supplements to be turned into monopoly drugs in the first place. Consider that only one percent of plant phytonutrients have been characterized. These are chemicals produced by plants to live, grow, and reproduce, but they can also benefit human health—just look at resveratrol and curcumin for examples of how powerful these compounds can be— and we’re only scratching the surface. In fact, there are companies leveraging the power of machine learning and artificial intelligence to more efficiently isolate phytonutrients and determine their impact on human health. There is a vast trove of bioactive compounds in plants that could be harnessed for their healing powers, but when scientists find promising candidates to benefit our health, the system is rigged for these compounds to become monopoly drugs rather than supplements that more people could access.
We’re working on amending the law to close this backchannel. In the meantime, support our campaign to protect access to NMN by posting a comment on the public docket in favor of the FDA issuing a regulation allowing NMN’s sale as a supplement.
Action Alert! Post a comment to the public docket, with a copy to Congress, in support of our Citizen’s Petition to protect access to NMN supplements. Please send your message immediately.