The Food and Drug Administration (FDA) is warning against misleading claims about whole body cryotherapy to treat various diseases or conditions.
Cryotherapy, or “super-cooling” of the body has been linked to conditions such as asthma Alzheimer’s, anxiety, chronic pain, depression, fibromyalgia, insomnia, migraines, multiple sclerosis, osteoarthritis, rheumatoid arthritis; claims of weight loss benefits, improvement in blood circulation and metabolism have also been circulating on the internet.
However, cryotherapy has not demonstrated efficacy for any of these conditions and no whole body cryotherapy device has been FDA-approved for these claims. Aron Yustein, MD, a medical officer in the FDA’s Center for Devices and Radiological Health, added “Based on purported health benefits seen in many promotions for cryotherapy spas, consumers may incorrectly believe that the FDA has cleared or approved WBC devices as safe and effective to treat medical conditions. That is not the case.”
Cryotherapy can include using ice packs on localized areas of the body, such as the lower back. Whole body cryotherapy usually involves exposing the body to vapors that reach temperatures ranging from –200 to –300 degrees Fahrenheit. People undergoing whole body cryotherapy are enclosed in confined spaces for 2–4 minutes either by: standing alone in a can-like enclosure while the head remains above or in a chamber with several people where the entire body is exposed to the freezing temperatures.
FDA scientific reviewer Anna Ghambaryan, MD, PhD explained that the healing benefits of cryotherapy are unconfirmed but the potential risks are very apparent, such as asphyxiation when liquid nitrogen is used for cooling. Further, users are at risk for hypoxia, frostbite, burns, and eye injury.
The Agency has expressed concern that users who choose whole body cryotherapy as treatment may actually experience a lack of improvement or a worsening of their conditions. Patients should discuss whole body cryotherapy with their physician prior to trying it.
For more information call (888) 463-6332 or visit FDA.gov.