Stem Cell Med Spa Treatments: How to Avoid Legal Pitfalls
While you might associate stem cell therapy as a treatment for people with serious diseases, stem cell therapy has actually become a buzzworthy trend in the aesthetics industry. Many med spas across the country are offering stem cell treatments, attracting clients with promises of skin rejuvenation, thicker hair, anti-aging, and pain relief. However, med spas that offer or are considering offering stem cell treatments must understand the complex legal and regulatory landscape. This is what med spas interested in offering stem cell treatments need to understand to not run into legal issues.
What Are Stem Cell Med Spa Treatments?
Stem cells are cells in the body that have the ability to change into various cell types. They are often used in regenerative medicine to repair damaged tissues, treat chronic conditions, and promote healing. In the med spa industry, stem cell treatments are marketed primarily for aesthetic and anti-aging purposes.
These are just a few examples of stem cell med spa treatments:
Facial Rejuvenation
Stem cell-based facials promise to rejuvenate the skin, reduce wrinkles, and promote a youthful appearance. These treatments often combine microneedling or platelet-rich plasma (PRP) with stem cells to boost collagen production and enhance skin elasticity. A med spa may offer a Stem Cell Microneedling Facial, where stem cells derived from adipose tissue are applied to the skin after microneedling to accelerate healing and improve texture.
Hair Restoration
Stem cell therapy is also used for treating hair loss. By injecting stem cells into the scalp, these treatments aim to stimulate dormant hair follicles and promote hair growth. This procedure is popular among individuals seeking a non-surgical solution for thinning hair. A patient experiencing early-stage hair loss may undergo a series of stem cell scalp injections, often combined with PRP, to stimulate new hair growth.
Joint Pain Relief and Regenerative Therapy
Some med spas offer stem cell injections for joint pain relief and injury recovery. These treatments aim to reduce inflammation and promote tissue regeneration. A client with chronic knee pain may receive stem cell injections to help regenerate cartilage and improve mobility without surgery.
Legal Considerations for Stem Cell Therapy
The above examples highlight just what stem cell therapy can do for clients and can make it enticing for med spa owners to offer them. However, the big challenge for med spas offering stem cell therapy is concerns about the legal size. This is a highly-evolving area of law. Regenerative medicine, especially stem cell therapy, is an emerging field with many uncertainties. The use of stem cells in anti-aging treatments remains largely experimental, and the legal regulations surrounding these therapies are still evolving. A med spa law attorney can assist you in ensuring you are compliant with all rules and regulations. Here are some of the top things that they will advise you on:
Monitoring the Food and Drug Administration’s Position
The Food and Drug Administration (FDA) oversees the regulation of biological products, including stem cells and PRP. Many regenerative therapies are still considered experimental and have not received full FDA approval for aesthetic use. Medical spas must carefully follow FDA guidelines and ensure that all treatments comply with current regulations, as most stem cell products used for cosmetic purposes lack FDA approval.
Getting Informed Consent From Patients
Patient consent and liability issues are critical for med spas offering stem cell therapy. Because many stem cell treatments are considered experimental or investigational, the informed consent process is even more important. Consent documents must go beyond basic treatment explanations, clearly outlining the experimental nature of the therapy, potential risks, expected outcomes, and alternative treatment options. Patients should fully understand that results are not guaranteed and the therapy may not be FDA-approved for their specific condition. A well-crafted informed consent form should also address potential complications, the possibility of limited long-term data on safety and efficacy, and the patient’s voluntary participation in the treatment. Taking the time to have thorough discussions with patients about these factors can reduce the risk of misunderstandings and disputes down the road.
Be Extra Careful With Advertising
Med spas must be especially cautious about how they advertise through websites, social media, and promotional events. Marketing and advertising practices for stem cell therapy at med spas carry significant legal risks, and missteps can lead to serious consequences. Any claims regarding the efficacy of these stem cell treatments must be backed by credible scientific evidence. Statements that suggest or imply that stem cell therapy is a guaranteed cure or effective for unapproved conditions can quickly result in regulatory investigations, fines, or even lawsuits for false advertising or consumer fraud.
Using patient testimonials, before-and-after photos, or anecdotal success stories without clear disclaimers can be misleading and potentially violate advertising regulations. Phrases like “proven results,” “FDA-approved,” or “risk-free” should be avoided unless they are accurate and well-supported by clinical data.
A recent case can highlight stiff penalties in this area. In January 2025, three Georgia companies were ordered to pay $5.155 million in civil penalties and refunds to patients. The companies also made false or unsubstantiated claims, according to the FTC, that their treatments were as effective as—or superior to—surgery, steroid injections, and painkillers. Additionally, they falsely advertised their therapies as being approved by both the FTC and FDA. Many of these patients were elderly or disabled. They are permanently banned from making “bogus claims” that their stem cell therapy could treat arthritis, joint pain, neuropathy, and other conditions.
Consult an Experienced Med Spa Attorney
Stem cell treatments in med spas offer exciting possibilities for anti-aging and regenerative therapies, but they also come with significant legal and regulatory challenges, particularly in areas of patient consent and the advertising of these services. An attorney specializing in med spa law can also provide guidance on best practices for patient care, risk management, and avoiding any potential legal pitfalls.