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FDA Standing in the Way of Longer Life

FDA Standing in the Way of Longer Life
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Once again, the feds are about to hand a ground-breaking, life-extending supplement to Big Pharma so it can be turned into an expensive monopoly drug. Action Alert!

For a few months now, we’ve been telling you about the threat to nicotinamide mononucleotide (NMN) supplements, which are on the cutting edge of lifespan research. NMN supplements are on the verge of an FDA ban after a drug company, MetroBiotech, claimed it studied NMN as a drug before it was sold as a supplement. In a recent letter to the Natural Products Association (NPA), a supplement industry trade group, the FDA has maintained its adversarial stance towards NMN. We must maintain grassroots pressure on Congress and the FDA to protect our access to this critical anti-aging supplement.

In the letter, the FDA denied a request from NPA that the agency open a public docket on NMN. The FDA makes clear that it only wants to communicate with a small number of supplement companies, like those that submitted “new supplement” (NDI) notifications on NMN. To us, this move is a clear sign that the agency does not want grassroots activists involved. The FDA would much prefer this ban to happen in the shadows, without much fanfare. But we’re here to shine a big bright light on the agency’s plans to hand another drug monopoly to Big Pharma.

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. NAD can be administered intravenously, but there is a lack of data on its effectiveness; at the very least it is impractical for the majority of people since infusions would be needed every few days to sustain increased NAD levels. 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.

Why is this miraculous molecule with such promising health benefits on the verge of being banned? As we explained previously, it all has to do with the backchannel at the FDA that allows drug companies to take natural ingredients and turn them into drugs while banning the supplement version. This is what famously happened to the pyridoxamine version of vitamin B6, and that supplement is still not available even though a drug never came to market.

Here’s how it works. 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 and studies that ingredient before the FDA receives an NDI notification on it, it can no longer be sold as a supplement.

In other words, the law allows drug companies to create monopolies on natural ingredients that have been sold in the marketplace for years. Part of the reason this happens is that our system gives priority to drugs: the FDA has, and continues to, distrust, attack, and undermine medicines that are not “FDA-approved” like supplements, homeopathic medicines, and compounded drugs. This adversarial stance is not based on any safety concerns, but economics: drug companies, through the user fees they pay for drug approvals, fund a substantial portion of the FDA’s activities. As a result, the FDA sees the drug industry as its client who’s interest it serves. Supplements and other natural medicines are the competition, so they must be throttled, banned, or delegitimized.

There is another unfortunate wrinkle to this story. The company asking for the NMN ban, MetroBiotech, was co-founded by David Sinclair, PhD, an anti-aging guru who has touted the benefits of NMN supplementation for years. 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. You can read more about Dr. Sinclair’s comments on the NMN ban here

We must pressure Congress to step in since we know the FDA is on the side of the drug companies.

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

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