FDA warns consumers about whole body cryotherapy
By Ken Hedler | October 30, 2016
The U.S. Food and Drug Administration advises consumers it lacks the evidence necessary to say cryotherapy effectively treats a range of problems, and to be aware the agency does not back the therapy.
“Based on purported health benefits seen in many promotions for cryotherapy spas, consumers may incorrectly believe that the FDA has cleared or approved … devices as safe and effective to treat medical conditions,” said Aron Yustein, a medical officer in the FDA’s Center for Devices and Radiological Health. “That is not the case.”
The cryotherapy industry has not sought FDA approval because it would take 2 1/2 years to do a study, and cryotherapy machines would have to be taken off the market during that time frame, said Tommy Mitchell, who co-owns CryoLongview with his sister, Ruth Bowen. CryoLongview uses a machine called a Cryosauna, which resembles a vertical tanning bed.
FDA spokeswoman Stephanie Caccomo said in an email she could not comment about the length of a study because a device’s pre-market clearance or approval depends on the intended use of the device and whether the sponsor can demonstrate a new device is “substantially equivalent” to a “predicate device” in terms of its intended use.
“If the device requires pre-market approval, the sponsor must provide valid scientific evidence demonstrating reasonable assurance of safety and effectiveness for the device’s intended use,” she said.
In September, the FDA sent a warning letter to a Los Angeles doctor who was promoting and marketing the Cryosauna and other machines for treating medical conditions and providing therapy for a variety of conditions including injuries, insomnia, rheumatism, muscle and joint pain and multiple sclerosis.
“The FDA is not aware of any evidence to substantiate such claims,” the letter to Jonas Kuehne of Cryohealthcare Inc. stated.
The FDA advises consumers to talk to their doctors before undergoing cryotherapy.