The agency once again signaled its determination to pursue a ban on nicotinamide mononucleotide (NMN), a key supplement that can help turn back the clock on degenerative disease. Action Alert!
While many may have given up on finding the mythical “Fountain of Youth,” emerging science is showing us strategies that can be used to help us stay healthy and vibrant as we age. An impressive array of animal research, coupled with a growing number of clinical studies, have shown NMN’s potential to combat age-related weight gain, improve energy, reduce age-related inflammation, counter premature ageing of the skin, fight cognitive decline, and protect the heart. But because FDA regulations are designed to benefit Big Pharma, this critical anti-aging nutrient is about to be banned as a supplement so that it can be pursued as an exorbitantly expensive drug. The threat to NMN is the latest example of a broken system that prioritizes expensive drugs (and the profits of the global mega-corporations that make them) over public health. Help us put a stop to it.
Last week, the FDA sent a letter denying a request from Representative Jeff Duncan (R-SC) for a public hearing to clarify the agency’s position on NMN. The agency stated that giving the public the ability to provide written comments is sufficient, even though NMN is a widely used ingredient in thousands of natural products that Americans use every day to optimize their health. We must continue to send messages to Congress educating members about the FDA’s attack on NMN.
In denying Rep. Duncan’s request for a public hearing, the FDA is hiding behind the fact that ANH-USA issued a joint Citizen’s Petition with the Natural Products Association (NPA) urging the agency to reverse its determination that NMN is not a legal dietary supplement. The agency states, “In light of this opportunity for the public to provide information and views that FDA will consider as part of our work in reviewing and responding to the citizen petition, we do not believe that it is in the public interest to hold a public hearing on this matter.”
Our translation: it is not in the FDA’s interest to hold a public hearing on the matter because then the agency would have to publicly answer for the fact that its actions promote pharmaceutical interests over the public’s health.
To recap how we got here: there is a back-channel 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 then 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 effectively creating a monopoly.
This back-channel allows Big Pharma to ransack nature, monopolizing beneficial compounds that should be available as supplements. It’s happening to CBD, and it could happen to n-acetyl-cysteine (NAC). For anyone who thinks we’re over-stating the risk, it has already happened to the naturally-occurring, pyridoxamine form of vitamin B6, which still remains banned in supplement form even though no drug ever came to market.
Without mass public and political pressure on the FDA, NMN could be the next domino to fall. 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.
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 help them live, grow, tolerate pests and diseases, and reproduce, but many of these can also benefit human health—just look at resveratrol and curcuminoids 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 potential to positively influence human health. There is a vast trove of bioactive compounds in plants, fungi, and algae 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, you can help 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! Write to Congress and tell your elected officials to support our Citizen’s Petition calling for a change in the law that allows the legal sale of NMN supplements. Your comment will also be posted on the public FDA regulatory docket for ANH’s petition supporting access to NMN in supplements. This alert is time-sensitive, so if freedom of choice in healthcare and continued access to NMN is important to you, please send your message immediately.