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FDA Flip Flops on Fatigue Supplement

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The FDA has said that an important supplement for energy and mitochondrial support can no longer be sold as a supplement because it is being studied as a drug—another gift to drug monopolists! Action Alert!

The FDA pulled a similar reversal a few years ago with vinpocetine, now it is happening again with β-NMN (beta-nicotinamide mononucleotide, or simply NMN), an important supplement for mitochondrial health that can help address fatigue and other aspects of aging. We must protect access to this important supplement.

If this decision stands, consumers lose, and drug company monopolists win. NMN has a number of documented benefits: it has been found to suppress age-associated weight gain, enhance energy metabolism and physical activity, improve insulin sensitivity, improve eye function, and improve mitochondrial health. Some of these benefits may be associated with the fact that NMN is a precursor to NAD+, another crucial nutrient that is found in every cell in the body and is essential to life. In fact, exposure to viruses like COVID have been found to deplete NAD+ levels, making supplements that boost NAD+ levels more important than ever.

In a batch of letters to supplement companies, the FDA communicated its position that NMN does not meet the definition of a supplement because it is being investigated as a drug. This is the infamous “back-channel” at the FDA that allows the drug industry to monopolize natural ingredients. 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 (IND) and studies that ingredient before the FDA receives an NDI notification on it, it can no longer be sold as a supplement.

This creates a stacked deck in favor of Big Pharma monopolies. IND applications are confidential. A drug company can file an IND on an ingredient and sit on it for 30 years. Meanwhile, an innovative supplement company could develop that nutrient into a great product, do the studies to comply with the FDA’s ridiculous notification process, and then create a market for that product—and then the drug company can swoop in with their 30-year-old IND, kick the supplements out of the market, and create a monopoly. Part of the solution to this problem is to make IND’s public so the FDA and Big Pharma can’t pull the rug out from under important supplements.

This isn’t hypothetical. In 2016, the FDA announced that vinpocetine, a brain health supplement which the agency had approved as a “new” supplement in the 1990s, couldn’t be a supplement anymore because a drug company had filed an IND on it in the 1980s.

Something similar happened to the pyridoxamine version of vitamin B6 in 2008. A drug company had an IND and cleared the market of pyridoxamine supplements—but then never even brought a drug to market. But that doesn’t matter—the supplement version remains banned. In 2018, an executive of the company that wanted pyridoxamine supplements removed from the market petitioned for the FDA to allow pyridoxamine supplements to be sold—to no avail. Once gone due to this mechanism, the supplement is lost forever.

What is especially outrageous about the FDA’s position is that the agency had previously acknowledged one “new supplement” notification on NMN—the agency said nothing about the ingredient’s preclusion from being a supplement because it was being studied as a drug.

As we said when the FDA pulled a similar stunt in banning vinpocetine: it is absurd that the FDA can retroactively and unilaterally decide that a supplement is not a dietary ingredient, after it has already said that it is. We argued at the time that such an action sets a dangerous precedent, and it looks like we were right. The FDA did the same thing last year to NAC supplements: after years of allowing them on the market, even reviewing and accepting structure/function claims on them, the FDA suddenly decided that it wasn’t a legal dietary supplement.

The FDA’s announcement comes on the heels of a study claiming that nicotinamide riboside (NR), a form of vitamin B3, is linked to cancer. NR is another nutrient that has proven effective at raising NAD+ levels. The study, like so many other studies claiming supplements are dangerous, suffers from a variety of shortcomings: it was an incredibly small mouse study that did not represent real world conditions—mice were injected with highly aggressive cancer cells. Measuring tumor formation in mice injected with breast cancer does not show that NR induces breast cancer. Further, NR has been heavily studied in animals, and no link to cancer has been found.

Our concern is that the FDA will use this study to attack NR supplements and further undercut our ability to naturally raise NAD+ levels to address fatigue, mitochondrial health, and more.

The crux of the problem is that 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. There’s also a belief that drug research needs to be incentivized, since the costs of bringing a drug to market can reach into the billions. But this ignores the fact that taxpayers heavily subsidize these costs: a recent analysis found that, of the drugs approved between 2010 and 2016, every one originated in government labs, or university labs funded by the government (i.e. taxpayers). Giving drug companies monopolies on natural compounds reduces consumer choice, drives up the cost of healthcare, and restricts access to products that could benefit public health.

We can’t let this most recent attempt to gift an important supplement as a monopoly to the drug industry succeed.

Action Alert! Write to Congress and the FDA, urging them to retain consumer access to NMN supplements. Please send your message immediately.

The post FDA Flip Flops on Fatigue Supplement first appeared on Alliance for Natural Health USA – Protecting Natural Health.

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