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FDA Ransack of Nature Ongoing with NMN Attack

FDA Ransack of Nature Ongoing with NMN Attack
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Stop drug companies from stealing products that give us years on our lives. Action Alert!

Earlier this year, ANH-USA and the Natural Products Association (NPA) submitted a Citizen’s Petition to the FDA urging the agency to reverse its determination that nicotinamide mononucleotide (NMN) is not a legal dietary supplement. Late in August, the agency responded to our petition…saying it needs more time to reach a decision. This inaction is disappointing, but not surprising. NMN is part of a wider landscape of supplements that are being stolen by the drug industry via FDA regulations. Without Congressional intervention, it looks likely that legal action will be needed to rein in the FDA’s bias against natural products.

For our readers who haven’t been following this story, here’s how we got here.

NMN is one of the most effective precursors to NAD, which is critical to longevity. By middle age, our NAD levels plummet to half that of our youth. 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. There is some debate as to which precursor is most effective, but NMN is one of the most promising NAD options available with a proven ability to raise NAD levels.

Famed anti-aging researcher David Sinclair, PhD of Harvard University is one of the individuals that helped put NMN on the map as a longevity compound. Many people listen to what he says and follow his anti-aging regimen, which includes NMN. Yet a pharmaceutical company that Dr. Sinclair co-founded, MetroBiotech, is the very company that has petitioned the FDA to ban NMN supplements.

That’s right: Dr. Sinclair proselytizes about the benefits of NMN, while the company he co-founded is working to ban the supplement form so they can turn a profit on their NMN drug—a drug that isn’t even on the market yet, and is not guaranteed to ever be on the market. In a statement Dr. Sinclair released earlier this year, he seemed to distance himself from MetroBiotech, but also stated his support for NMN coming to the market as a drug—presumably because he is an investor in the company and likely stands to make a fortune if NMN comes to market as a monopoly drug.

The bigger issue at play here is the mechanism used by pharmaceutical companies like MetroBiotech to monopolize natural compounds like NMN 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.

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.

NMN and vinpocetine are not the only supplement ingredients threatened by this back-channel to pharmaceutical monopoly. It is through this mechanism that N-acetyl-cysteine (NAC), a precursor to glutathione and an important antioxidant, is threatened, though we’ve had some good news on that front. It is why the fate of CBD supplements is also in limbo. It is why the naturally-occurring pyridoxamine form of vitamin B6 is no longer available as a supplement, and why L-glutamine could suffer a similar fate.

We need to shine a spotlight on this issue both to protect our access to a critical longevity supplement in NMN and to fix the wider problem of drug companies being able to ransack nature and claim a monopoly on these compounds.

Action Alert! Write to Congress, urging them to protect access to NMN supplements. Please send your message immediately.

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