FDA Says Cryotherapy Lacks Evidence, Poses Risks Save

Cryotherapy is a non-FDA approved treatment that has been promoted to treat post-athletic injury, osteoarthritis,rheumatoid arthritis, fibromyalgia, alzheimers, migraines, asthma, multiple sclerosis, etc. Cryotherapy may be as simple as ice packs on a localized portion of the body, such as the lower back, or may involve whole body cryotherapy exposing the body to vapors that reach ultra-low temperatures ranging from minus 200 to minus 300 degrees Fahrenheit, typically for 2-4 minutes at a time.

But according to the FDA, cryotherapy may pose serious health risks and does not have the evidence to substantiate many of its claims. Whole body cryotherapy (WBC) is starting to pop up in a number of gyms, spas and wellness centres. 

Despite the growing availability of WBC, cryotherapy hasn't been cleared or approved by the FDA to treat any conditions. An FDA scientific reviewer said potential hazards of cryotherapy include asphyxiation, frostbite and burns.

What are the effects of these super low temperatures on the body, blood pressure, heart rate, and metabolism?  “We simply don’t know,” says FDA scientific reviewer Anna Ghambaryan, MD, PhD. “At this time, there’s insufficient publicly available information to help us answer these questions.”

While the benefits of cryotherapy are uncertain, the potential risks are readily 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.

The FDA has informally reviewed the medical literature available on this subject,” Yustein says. “We found very little evidence about its safety or effectiveness in treating the conditions for which it is being promoted.”