Cryotherapy has long been an at-home remedy for minor injuries and conditions. In recent years, the use of whole-body cryotherapy has gained popularity among athletes, fitness enthusiasts, and other individuals seeking alternative wellness and longevity treatments. Amid this rising consumer interest, many med spas, wellness clinics, and other providers are seeking to incorporate this sought-after service into their business model.
What Is Cryotherapy?
In general, cryotherapy is an extreme cooling of the body for therapeutic purposes. At home, cryotherapy can include the use of ice packs on a localized portion of the body to reduce pain or swelling. Medical cryotherapy involves the use of a medical device that is considered by the Federal Food and Drug Administration (FDA) to be both safe and effective for the treatment of one or more diseases, injuries, or conditions.
Whole-body cryotherapy involves exposing the human body to vapors that reach ultra-low temperatures, in one of two ways:
- A person stands alone for two to four minutes in an individual-size device that is open at the top. The person’s torso and legs are enclosed in the device and exposed to frigid temperatures while the person’s head remains above the enclosure at room temperature.
- One or more persons sit or stand in a chamber for two to four minutes. The entire body of each person, including each person’s head, is exposed to freezing temperatures.
Who Can Own a Cryotherapy Business?
Any individual or entity can own a cryotherapy business in Texas. There aren't specific restrictions on ownership based on profession or qualifications.
However, there are crucial legal and compliance considerations when forming and operating a cryotherapy business.
What Is the Best Entity for a Cryotherapy Business?
Given the potential liabilities associated with a cryotherapy business, an LLC is often considered a strong choice. It provides personal liability protection while offering flexibility in tax treatment.
Consult with a Texas business attorney to determine the best structure for your specific circumstances. Your attorney can help you weigh the pros and cons of each option and ensure compliance with state laws.
Is Cryotherapy Regulated by the FDA?
A medical device must be cleared or approved by the United States Food and Drug Administration (FDA), before device manufacturers and distributers may market the device for the treatment or prevention of any disease, injury, or condition, The FDA has not cleared or approved any whole-body cryotherapy devices.
Regulatory Compliance for Cryotherapy Businesses
The Federal Trade Commission (FTC) regulates certain healthcare claims and may take action against persons or entities that use false, misleading, or unsubstantiated claims in their marketing and advertisements. At the provider level, claims that a device treats, prevents, or reduces the risk of any disease, injury, or condition must be substantiated by reliable scientific evidence.
Should you claim – or even give the impression – that cryotherapy services can be used to treat a disease or condition, you could be in violation of FDA and FTC regulations, which can result in federal injunctions and substantial fines.
To avoid scrutiny by the FDA and FTC, many whole-body cryotherapy device sellers publish disclaimers stating that their devices are not intended to diagnose, treat, cure or prevent any disease or illness. You must be careful when using disclaimers for your business. A disclaimer that directly contradicts the rest of your marketing is not enough to avoid scrutiny by the FDA or FTC.
Texas Medical Board Rules and Cryotherapy
At the state level, Texas regulates the practice of medicine, which requires a professional license issued by the Texas Medical Board (TMB). The practice of medicine is defined broadly to encompass the exchange of money for any services that are offered as a treatment of any physical or mental disease, disorder, deformity, or injury. A person may be “practicing medicine” even if the services offered do not in fact provide treatment to the customer.
When you market whole body cryotherapy services as providing any kind of health benefit, you may be engaged in the practice medicine. The consequences of practicing medicine in Texas without a license include civil penalties and injunctive remedies enforced by the TMB and the Texas Attorney General, as well as criminal charges.
