Cryotherapy Regulations

 

• Non-medical cryotherapy is generally unregulated in the US.  This includes commercial operation of Whole Body Cryotherapy chambers and saunas.
• 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 must be non-medical.  Your equipment manufacturer should be able to advise you of language you can and can not use in any claims you make.

General state regulations for cryotherapy are minimal because the FDA does not classify whole-body cryotherapy chambers as medical devices unless medical claims are made. However, some states have more specific guidelines, while common requirements where regulations exist include operator training, client consent, and safety measures like protective gear and time limits. Other applicable rules often include local building, fire, and mechanical codes, as well as any licenses required for the specific procedures being performed

Several states have stronger positions:

California:

• California has no statewide cryotherapy-specific law, but it enforces strict consumer safety laws that can be applied to cryotherapy.
• Medical use must be overseen by a licensed practitioner, while wellness centers must provide clear disclaimers. 

Colorado:

• The Department of Regulatory Agencies considers cryotherapy a medical procedure when medical claims are made and requires oversight by a licensed doctor.
• However, if it is offered purely as a non-medical wellness treatment, it may not require specific regulation.

Connecticut:

• Cryotherapy businesses in Connecticut are subject to general health regulations. Medical oversight is required if providers make therapeutic claims about the service.

Nevada: Following a high-profile death, Nevada's State Health Division issued specific safety guidelines for cryotherapy businesses. These guidelines recommend:

• Maximum session times of 3 minutes per day.
• Prohibitions on use by minors under 18 or people under five feet tall.
• Requiring operators to check blood pressure before and after a session
• Mandating that staff are trained in CPR.
• Implementing safety measures like on-site emergency kits, defibrillators, and nitrogen monitors

Texas:

• The Texas Medical Board can regulate cryotherapy services that are marketed with health benefits, as this may be classified as the unlicensed practice of medicine.
• Operators must be careful about marketing claims that could trigger oversight by the medical board.

Avoid any appearance of medical application of the equipment and avoid terms like "treatments" or patients.

Local building codes governing equipment installations apply and should be observed.

Many states may require businesses to carry liability or malpractice insurance to protect both patients and staff.

Due to the variation in laws, it is crucial for cryotherapy business owners to consult with a local attorney to ensure full compliance with specific state and local requirements