CryoTherapy Regulations - US

Cryotherapy Regulations in the United States

Non-medical cryotherapy is mostly unregulated in the US.  This includes commercial operation of Whole Body Cryotherapy chambers and saunas.

The FDA does not regulate cryotherapy devices unless the manufacturer makes medical claims such as removing fat, reducing muscle injury recovery time or increasing circulation; they have no mandate to regulate cryotherapy.  

Any claims you make should be non-medical.  Your equipment manufacturer is able advise you of claims language that you may use and may not use.

Several states have stronger positions:

The Colorado Department of Regulatory Agencies puts cryotherapy in a medical category that requires oversight by a licensed doctor.

The Nevada State Health Department has guidelines that recommend that the devices not be used by clients that are:

  • younger than 18.
  • less than five feet tall. 
  • have health conditions including high blood pressure, seizures, infections, or who are pregnant.

Several states have medical code mentions of cryotherapy as used by therapists (apparently referring to ice baths and plunge pools):

  • New Jersey for occupational therapists.
  • Colorado for athletic trainers.

You want to avoid any appearance of medical application of the equipment and should avoid terms like "treatments" or patients.

Be aware that there are medical cryotherapy procedures.  These include removal of skin lesions including warts and some forms of skin cancer.  These procedures can only be performed by licensed medical professionals.

Local building codes governing equipment installations apply in almost all places and should be carefully observed.

Last modified: Wednesday, November 17, 2021, 10:11 PM