Is cryotherapy approved by the FDA?

The most common argument against cryotherapy is that it is not approved by the FDA (The Food and Drug Administration). Meanwhile, ever since it was invented in the 1970’ as a treatment method for arthritis, it has been widely spread across Europe and became extremely popular in the US recently. 

The thing is that the FDA didn’t approve cryotherapy not because it is dangerous, but because the FDA doesn’t regulate cryotherapy. US regulations in matters of innovative technologies in medicine are too conservative.

“The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation” – says FDA mission.

Cryosauna is not a medical device and cryotherapy never claims to treat any disease or illness. It helps to reduce symptoms, improves blood circulation, and affects the body with positive stress with all the ensuing positive consequences.

At the same time, EU regulations are more progressive and flexible in the case of certification of cryotherapy devices. That is why all our cryosaunas have the necessary certifications and quality assurance documentation.