“Whole body cryotherapy has been used in Europe and Japan for more than three decades!” the website exclaims. “Multiple research studies have been published in medical journals about the effects of whole body cryotherapy, and in many European countries the treatments are covered by medical insurance policies.”

It’s the typical sales pitch for just another scientifically unsubstantiated alternative health technique that providers claim can cure everything from Alzheimer’s and asthma to rheumatoid arthritis and multiple sclerosis.

The only problem is that none of it is true.

The U.S. Food and Drug Administration (FDA) has just issued a warning stating that contrary to what spas and wellness centers around the country are advertising, there is no evidence that whole body cryotherapy (WBC) can treat anything. Even worse, it could actually harm you.

For those who never heard of it, WBC is a technique which uses liquid nitrogen to lower a person’s skin surface temperature anywhere from 30 to 50 degrees Fahreneheit for two to three minutes. This is done either by using a multi-person Cryochamber, which is a walk-in device similar to a shower stall, or a single-person Cryosauna. Both devices are open at the top which allows the client’s head to remain above the cooling vapors where the person can continue to breathe room-temperature air.

“The skin reacts to the cold and sends messages to the brain that acts as a stimulant to the regulatory functions of the body,” this site explains. “It produces the scanning of all areas that may not be working to their fullest potential. The skin exposure to the extreme temperatures also triggers the release of anti-inflammatory molecules and endorphins.”

The release of these endorphins in turn makes the client feel energetic afterward. Practitioners claim these mood-enhancing effects can last for days after each session.

Practitioners also claim that it’s completely safe (except if persons enter the machine wearing wet clothing because it freezes immediately). Clients are encouraged to wear dry cotton garments, socks, slippers, and gloves to protect the extremities, as well as a bestmask face-mask and earmuffs or a hat to cover their ears.

People with health conditions such as arthritis, migraines, fibromyalgia and a host of other serious illnesses are encouraged to participate in multiple sessions in one of these machines. A single 3-4 minute session will set you back $65. You can purchase three sessions for $175 or a package of 10 for $450. This site offers the “Ultimate Freeze Week” package for $269 which gives you 2 treatments per day for a week. An unlimited monthly membership costs $299 per month.

It all sounds wonderful, especially because practitioners claim to be relying on “multiple research studies.” Even though the studies look impressive to the untrained eye, experts at the FDA say “not so fast!”

“Given a growing interest from consumers in whole body cryotherapy, the FDA has informally reviewed the medical literature available on this subject,” says Aron Yustein, M.D., a medical officer in the FDA’s Center for Devices and Radiological Health. “We found very little evidence about its safety or effectiveness in treating the conditions for which it is being promoted.”

What actually happens physiologically to the body when a person stays within these chambers for two to four minutes? What effects do such cold temperatures have on the blood pressure, heart rate, and metabolism?

“We simply don’t know,” says FDA scientific reviewer Anna Ghambaryan, M.D., Ph.D. “At this time, there’s insufficient publicly available information to help us answer these questions.”

However, she notes that while the healing benefits of cryotherapy remain unconfirmed, the potential risks are apparent.

“Potential hazards include asphyxiation, especially when liquid nitrogen is used for cooling,” says Ghambaryan. 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. Moreover, subjects run the risk of frostbite, burns, and eye injury from the extreme temperatures.

For this reason, the FDA is warning consumers that their agency, which is tasked with consumer safety, has been unable to clear or approve WBC devices as being safe and effective for use.

However, if a consumer insists on using one, the FDA is advising that they notify their physician before trying it, or if they are already using it.