"Based on purported health benefits seen in many promotions for cryotherapy spas, consumers may incorrectly believe that the FDA has cleared or approved [these] devices as safe and effective to treat medical conditions," Dr. Aron Yustein, a medical officer in the FDA's Center for Devices and Radiological Health, said in an agency news release. "That is not the case."
Cryotherapy involves freezing abnormal tissue; it is often used to kill early skin cancers, according to the U.S. National Cancer Institute.
During whole body cryotherapy, the entire body is enclosed in a chamber and exposed to cold vapors for several minutes. The vapors are generated by liquid nitrogen and can reach ultra-low temperatures, the FDA said.
The benefits of whole body cryotherapy are still under investigation, although proponents claim it can ease symptoms of fibromyalgia, migraines, rheumatoid arthritis, multiple sclerosis, stress, anxiety or chronic pain.
But the FDA says there are many risks associated with the treatment.
"Potential hazards include asphyxiation, especially when liquid nitrogen is used for cooling," said FDA scientific reviewer Dr. Anna Ghambaryan.
Being exposed to nitrogen vapors in an enclosed space can deprive people of oxygen and cause them to lose consciousness. Other risks associated with these extreme temperatures include frostbite, burns and eye injuries, the FDA said.
The treatment could also worsen existing medical conditions, the agency added.
The FDA advises people considering whole body cryotherapy to check with their doctor first.
Some whole body cryotherapy operators also claim the treatment improves circulation, boosts metabolism, speeds recovery and soreness following workouts and eases joint pain, the agency said.
It remains unclear how whole body cryotherapy affects people's blood pressure, heart rate or metabolism, the FDA said.
The U.S. Food and Drug Administration provides consumer updates on cryotherapy and other products and treatments.
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