Longevity Supplement in Peril

The FDA’s inaction on this critical supplement that can extend life is all part of the plan. Action Alert!

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THE TOPLINE

• The FDA claimed in 2022 that NMN was illegal because it was studied as a drug first. But instead of enforcing a ban, it has continued to allow NMN supplements to remain in a legal grey area. This discourages reputable companies from investing in NMN products, while shady businesses may sell fraudulent versions, ultimately reducing the quality and choice of supplements for consumers.
• By fostering a narrative that supplements are unregulated and unsafe, the FDA aims to gain more oversight power. Historical and recent examples show a pattern of non-enforcement or selective enforcement to undermine the supplement industry, encouraging bad actors to justify more crack-downs and potentially leading to more restrictive regulations and less consumer access to beneficial natural products.

Nicotinamide mononucleotide (NMN) is a precursor to the coenzyme NAD+ that declines with age and is involved in cellular/DNA repair and protection, immune system function, and many key metabolic processes. A growing body of evidence suggest NMN supplementation may have multi-system benefits, including reducing age-related inflammation and related processes, while boosting cardiovascular and brain health, and supporting metabolism.

So, how do you take something good, like NMN, away from people without causing a public outcry?

The FDA has quite a playbook when it comes to eliminating natural medicines, but the strategy used against NMN, an exciting anti-aging compound found in nature, is tried and tested. It’s akin to boiling a frog slowly.  Like CBD before it, the FDA has said that NMN did not meet the definition of a supplement because it was studied as a drug first—meaning that NMN supplements are technically illegal. Now the devious part: do nothing. No sweeping ban of NMN supplements, no feds swarming vitamin shops. The FDA says, in so many words, that NMN supplements are illegal, and then does nothing.

This accomplishes several things. NMN supplements now exist in a grey area: they’re still available in some places from reputable companies, but there aren’t many options. Amazon won’t sell it. Merchant service providers won’t partner with companies selling NMN. Its questionable legal status may attract shady companies to enter the scene and sell fraudulent, mislabeled, or inferior quality products. It becomes hard to trust what you’re getting.

At the same time, what supplement company would invest the time and resources into creating better or more innovative NMN products when the FDA has said they’re illegal, and could eliminate products anytime it wants?

And just like that, without having really to do anything, the FDA kills the market for NMN supplements. Not overnight, but gradually.

This same playbook has been applied, in varying degrees, to homeopathy, peptides and laboratory developed tests (LDTs). Remember when the FDA said that all homeopathic products and 22 different compounded peptides were illegal? But don’t worry, we’re told, because the agency will only focus its attention on certain categories of products—that is, until it changes its mind!

The same is happening in the field of laboratory developed tests. This is not exactly solid ground on which to build a business or invest in new and innovative products, which will make it much more difficult for the sector to grow and flourish—ultimately depriving consumers of the best products.

In our view, the FDA deliberately cultivates the idea that supplements are unregulated, unsafe, “grey area” products in order create legal uncertainty and gain more power over them. When you create a narrative that the supplement industry is the Wild West, you’re more likely to get Congress to give you additional oversight, as Senator Dick Durbin (D-IL) is doing with his anti-supplement policy. Never mind the data that clearly show existing laws, many of which are not enforced, ensure supplements are already considerably safer than conventional foods.

Just recently, Representative Jeff Duncan (R-SC) sent a letter to the FDA asking why the agency refused to follow up on testing submitted by supplement company NOW Foods finding widespread fraud and mislabeling in commonly sold supplements on e-commerce platforms. The FDA’s response? In a nutshell, the agency said it doesn’t take enforcement action based on third party reports.

But this is really nothing new. After the Dietary Supplement Health and Education Act (DSHEA) was passed in 1994, the FDA commissioner at the time, Dr. David Kessler, was reportedly “so infuriated by the enactment of DSHEA that he ordered the FDA not to enforce the new law.” Former FDA officials subsequently admitted that the goal of this policy of non-enforcement was to allow the worst aspects of the supplement industry to run wild in hope that the law would be repealed.

What happens to NMN will be incredibly important for our access to products moving forward. If a NMN ban goes through, it would create a situation that defies common sense where the closely-related NAD precursor, nicotinamide riboside, is accepted as GRAS and a legal supplement because it has no prior challenge from a company claiming it as an investigational new drug (IND).  A ban would also send a warning signal to supplement companies: don’t bother innovating, or doing the legwork to find and develop new and exciting natural compounds into products that can support our health.

We cannot let that happen.

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