Big Pharma Strikes Back

…in the battle ANH and allies are waging to preserve access to NMN, a critical anti-aging supplement. Action Alert!

THE TOPLINE

• MetroBiotech’s aggressive response to our petition aims to force the FDA to ban the sale of NMN as a dietary supplement through its specific interpretation of rules surrounding the “back-channel” in FDA law that allows drug companies to turn nutrients into monopoly drugs.
• NMN is a natural product that’s found in small amounts in a number of foods, including broccoli, cabbage, avocados and tomatoes, and so should be able to be sold as a dietary supplement regardless of any consideration of when it was first sold as a dietary supplement or studied as drug.
• If MetroBiotech gets its way with the FDA, it will establish a very slippery slope that will incentivize Big Pharma to ransack nature to create monopoly drugs sold to the end consumer at much higher prices than their supplement equivalents.
• Massive grassroots and political pressure is needed now and is the only way we can close the FDA backdoor with Big Pharma – take action NOW!  

MetroBiotech, the drug company trying to turn NMN into a monopoly drug, issued a response to our Citizen’s Petition calling on the agency to allow continued access to NMN supplements. MetroBiotech — in true, bullish pharma style — is urging its friends in the FDA to reject our Petition and hand the company a monopoly on NMN. Given what we know about the revolving door between Big Pharma and the FDA, we have to keep up the grassroots pressure on Congress and the FDA to protect NMN but also fix the wider issue of Big Pharma being able to ransack nature to create monopoly drugs.

Let’s keep in mind what’s at stake. NMN, or nicotinamide mononucleotide, is not a fringe ingredient being used by eccentric billionaires. It is becoming widely recognized for its potential to reverse aging, likely because NMN is one of the most effective precursors to NAD⁺ , which is critical to longevity, healthy neurological function and energy production in the body. By middle age, our NAD levels plummet to half that of our youth, and stress further escalates the natural decline. Studies have shown that boosting NAD⁺ levels increases insulin sensitivity, reverses mitochondrial dysfunction, and extends lifespan. NAD is not absorbed well by cells, so we need precursors to raise blood levels of NAD. NMN is on the cutting edge of anti-aging, and we’re fighting so we can all have access to this compound at reasonable prices. MetroBiotech and the FDA are working to make sure that doesn’t happen. 

Those who are interested can read MetroBiotech’s letter for the details. Our petition and MetroBiotech’s letter get into the weeds about the exact dates NMN was sold as a supplement, when drug trials began and when these were made public. They are important points but to us the key is that this is a defective system that is designed to work to the advantage of drugs. What’s especially defective is that there is a back-channel at the FDA that allows companies to turn supplements into drugs. We explained how this 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 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.

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—only to reverse its stance after MetroBiotech stepped in.

NMN and vinpocetine are not the only supplement ingredients threatened by this back-channel to pharmaceutical monopoly. N-acetyl-cysteine (NAC), a precursor to glutathione and an important antioxidant, CBD supplements, and L-glutamine all face a similar fate; this is also why the naturally-occurring pyridoxamine form of vitamin B6 is no longer available as a supplement. What’s so important to understand is that if MetroBiotech gets its way with the FDA, it will be seen by other pharma companies as a precedent setting decision that will stimulate other pharma companies to further exploit nature and snatch from the hands of the public ever more health-giving, affordable, natural products that would otherwise be sold as dietary supplements.  

This back-channel creates a stacked deck in favor of Big Pharma. Drug companies can sit on confidential INDs 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.

MetroBiotech and the FDA keep ignoring one seminal, undeniable fact: NMN occurs naturally in small amounts in foods like broccoli, cabbage, cucumber and avocado so has every right to be sold as a concentrated food ingredient, namely a dietary supplement.

The FDA, but particularly Congress, need to decide who they care more about: consumer access to affordable NMN, but also a host of other natural compounds in supplement form, or the profits of drug companies. Send a message below to make sure they listen to YOUR voice on this issue, not just MetroBiotech’s.

Action Alert! Write to Congress and urge them to protect access to affordable NMN supplements. Please send your message immediately.