Rising Popularity of MedSpas Brings Increased Scrutiny Nationwide

Medical spas and aesthetic practices across the U.S. are experiencing unprecedented growth, drawing significant attention from investors and entrepreneurs alike. However, as the industry expands, so too does the complexity of the legal and regulatory landscape, presenting significant challenges for both new and established operators.

The aesthetic business is projected to grow to $28 billion by 2028, and licensing boards and regulators are ramping up enforcement actions.  From federal investigations to stepped-up state oversight, the takeaway is simple: compliance cannot be an afterthought.

INTENSIFYING SCRUTINY ACROSS THE COUNTRY

Federal agencies have recently issued warning letters targeting the use of unapproved or misbranded injectables and supplements in medspas. At the same time, state medical, nursing, cosmetology, and pharmacy boards are increasing their oversight through inspections, subpoenas, and disciplinary actions. Regulators are particularly focused on issues such as scope-of-practice violations, improper delegation of medical procedures, the corporate practice of medicine, ownership and control structures, insufficient physician supervision, telehealth compliance, and marketing practices, including the use of claims, testimonials, and “before and after” imagery. Compounding, IV hydration operations, and the handling of controlled substances are also under close watch.

Weight-loss medications like semaglutide and tirzepatide have become a focal point for enforcement in recent months. As shortages subside, providers are now required to fully comply with regulations governing compounding, sourcing, labeling, and promotion. Legal actions from manufacturers, cease-and-desist letters, payer interventions, and board warnings have already disrupted operations across the country.

Many states are also introducing new laws intended to specifically regulate medical aesthetics and IV hydration businesses. For example, on September 1, 2025, Texas House Bill 3749 (H.B. 3749), also known as Jenifer’s Law, was enacted in response to concerns highlighted by the death of a patient during an IV infusion at a Texas medical spa. The legislation introduces regulations specific to intravenous (IV) therapy provided outside of traditional healthcare settings, such as medical spas and IV hydration clinics.

COMMON PITFALLS AND CONSEQUENCES

Frequent missteps in the industry include improper delegation of injectables and laser device procedures, improper fee splitting, misleading advertising or outcome claims, inadequate informed consent and documentation, noncompliant ownership structures (for example, ownership of a medical spa by a non-clinician in states where physician ownership is required), and improper management agreements. Enforcement actions often originate from patient complaints, whistleblower reports, adverse events, competitors, or referrals from other agencies. The consequences can be severe, ranging from fines and license restrictions or suspensions to payment recoupments and even practice shutdowns. To add to these risks, when a medical spa is operating illegally, professional liability insurance claims related to adverse events at the spa may be denied by insurance carriers on the basis that the medical spa was operating illegally.

A PRACTICAL COMPLIANCE PLAYBOOK

To navigate this challenging environment, medspa operators should ensure that licensed physicians maintain control over all medical decision-making in accordance with state law and carefully scrutinize management service organization (MSO) and fee arrangements. Supervision protocols, chart reviews, and availability standards must align with each state’s requirements, with thorough documentation of training and competency. Standardizing consent forms and maintaining detailed records are essential, as is ensuring that all marketing materials, including claims, testimonials, images, endorsements, discounts, and loyalty programs, comply with regulatory and advertising standards.

Regular internal compliance audits, prompt remediation, and documentation of corrective actions are critical. Operators should seek independent healthcare counsel rather than relying solely on vendor or consultant assurances, and provide ongoing staff education while maintaining robust incident reporting and response protocols. Operators should also stay informed of new laws and regulations which may have an impact on their business, especially if operating in multiple jurisdictions where different legal frameworks may apply.

CONCLUSION

As the industry continues to evolve and expand, legislatures, licensing boards and regulators are passing more regulations and laws to combat the notion that medical spas are the “Wild West” where regulations are scant and enforcement actions a rarity.  Given this increased level of scrutiny, building a robust, verifiable compliance infrastructure and remaining informed of the legal landscape of the state(s) in which you operate is the most reliable way to protect patients, preserve licenses, and sustain enterprise value.

Guillermo J. Beades, Esq. 

• Partner, Frier Levitt

Brandon S. Zarsky, Esq.

• Partner, Frier Levitt