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FDA issues consumer warning about whole body cryotherapy

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No whole body cryotherapy device — not a single one — has received FDA approval.

I’ve seen plenty of strange health fads come and go during my years as a health reporter, but none has been odder than the recent craze known as whole body cryotherapy.

An astonishing number of people — including, apparently, actor Daniel Craig and retired basketball player Kobe Bryant  — have paid good money to stand nearly naked in a chamber filled with freezing air (at temps as low as -300 degrees Fahrenheit) for two to four minutes.  

They are lured to those chambers by clever marketing, which touts whole body cryotherapy as a panacea for a host of diverse ailments, including migraines, rheumatoid arthritis, insomnia, sports injuries, fibromyalgia, multiple sclerosis, Alzheimer’s disease, stress and chronic pain.

It’s also hyped as being able to delay aging, lift depression, improve recovery after workouts, and help shed pounds.

Such a long list of health claims should always be a warning sign to consumers.

Unproven, unregulated

The Food and Drug Administration (FDA) certainly thinks so. On Tuesday, the agency released a consumer update on whole body cryotherapy that sharply warns people to “beware of misleading claims” regarding “this so-called ‘treatment.’ ”

“Based on purported health benefits seen in many promotions for cryotherapy spas, consumers may incorrectly believe that the FDA has cleared or approved [whole body cryotherapy] devices as safe and effective to treat medical conditions,” says Dr. Aron Yustein, a medical officer in the FDA’s Center for Devices and Radiological Health, in the update. “That is not the case.”

In fact, no whole body cryotherapy device — not a single one — has received FDA approval.

That means those chambers — and the “treatments” they offer — are unregulated.

The FDA examined the existing published scientific literature on whole body cryotherapy and found little evidence to support the idea that exposing the entire body to ultra-low temperatures in a confined space has any effect on the medical conditions cited by the companies and clinics marketing the treatments.

The FDA update does not point to specific studies. But I will. One of the most popular — and publicized — uses of whole body cryotherapy has been for the treatment of sports injuries. Yet, a 2014 study that reviewed the findings from 10 previous studies found that the evidence that whole body cryotherapy is effective for sports-injured joints or muscles is “weak” at best.

“Until further research is available,” the authors of that study wrote, “athletes should remain cognizant that less expensive modes of cryotherapy, such as local ice-pack application or cold-water immersion, offer comparable physiological and clinical effects to [whole body cryotherapy].” 

Serious safety concerns

Nor did the FDA find much information in the scientific literature that could answer questions about the procedure’s safety. 

Yet, whole body cryotherapy poses some serious risks.

One of those risks can be fatal — asphyxiation, especially when liquid nitrogen is used for cooling.

“The addition of nitrogen vapors to a closed room lowers the amount of oxygen in the room and can result in hypoxia, or oxygen deficiency, which could lead the user to lose consciousness,” the agency explains. “Moreover, subjects run the risk of frostbite, burns, and eye injury from the extreme temperatures.

Last October, a woman who worked in a cryotherapy clinic in Las Vegas suffocated to death when she apparently “treated” herself with the procedure after hours, when no one else was around. Her frozen body was found the next morning.

Caveat emptor

“If you decide to try [whole body cryotherapy], know that the FDA has not cleared or approved any of these devices for medical treatment of any specific medication conditions,” the agency says in its update.

“The FDA is also concerned that patients who opt for [whole body cryotherapy] treatment — especially in place of treatment options with established safety and effectiveness — may experience a lack of improvement or a worsening of their medical condition,” they add. 

Oh, and what I said at the top of this article about cryotherapy being the weirdest alternative health fad of recent years? I stand corrected: While writing this article, I learned that another current health craze (promoted by none other than that wondrous wellness guru Gwyneth Paltrow) is to let yourself be stung with bees. Or, if that sounds too painful, you can just spread a product with bee venom over your body.

Paltrow does it to reduce skin “inflammation and scarring.” But this bizarre “treatment” is also being promoted (with absolutely no scientific evidence) for the treatment of multiple sclerosis, wound and other injuries, Lyme disease, arthritis, pain, hay fever, gout, tendinitis, shingles, amyotrophic lateral sclerosis (ALS) and cancer. 

There’s that long list again.

FMI: You can read the FDA’s consumer update on cryotherapy on the agency’s website.

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