Texas Cryotherapy Clinic Lawyers

Legal Compliance for Cryotherapy Services

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.

The health law attorneys at Hendershot Cowart P.C. have extensive experience establishing and counseling health and wellness providers on establishing and operating compliant healthcare businesses, including cryotherapy clinics.

Well-versed on both federal and Texas law, our business and health law attorneys can guide you through ownership models and entity selection, regulatory compliance, and operational best practices that will help your medical business thrive while protecting your clients’ safety and well-being.

Contact our Houston-based law firm today to help set up your cryotherapy and wellness clinic.

On This Page:

• What Is Cryotherapy?
• Who Can Own a Cryotherapy Business?
• What Is the Best Entity for a Cryotherapy Business?
• Is Cryotherapy Regulated by the FDA?
• Regulatory Compliance for Cryotherapy Businesses
• Texas Medical Board Rules and Cryotherapy
• How Our Attorneys Can Help

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:

1. 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.
2. 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.

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.

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.

However, it's crucial to 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.

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.

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.

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 theTexas Attorney General, as well as criminal charges.

A healthcare attorney can review your cryotherapy business’s procedures, marketing guidelines, agreements, disclosures, and waivers to ensure that you are protecting your client’s safety as well as maintaining compliance with Texas law and federal regulations.

Hendershot Cowart P.C. is a business and healthcare law firm, uniting both practices under one firm, giving you access to the expertise you need to establish and manage a thriving, compliant healthcare business.

Our attorneys can help you:

• Decipher state and federal regulations and licensing requirements so you can start and manage your clinic with confidence;
• Structure partnerships, management services organizations, or shareholder arrangements;
• Set up entities with the Texas Secretary of State;
• Draft management services agreements, employment agreements, client contracts and forms, and marketing guidelines;
• Review franchise agreements and franchise disclosure documents (FDDs) if you are considering investing in a cryotherapy franchise; and
• Help you protect intellectual property, including your business name and brand.

Established in 1987, our Houston-based law firm proudly serves healthcare professionals and medical business owners throughout the state of Texas and beyond.

We want to be your one-stop legal shop for structuring a compliant and successful cryotherapy and wellness clinic. Contact our Texas healthcare law firm to help set up your cryotherapy business today.