Recent enforcement actions in Ohio, where four medical spa licenses were suspended due to improper handling of cosmetic drugs, highlight a growing trend throughout the country.
Sates are ramping up scrutiny and enforcement against medical and wellness spas that fail to comply with legal and regulatory requirements. The Ohio matters are the latest examples of the increasing risks faced by medical spas that do not comply with various standards regarding the sourcing, administration, and supervision of medical treatments, including the use of peptides.
As it pertains to the four Ohio licenses, Ohio’s state medical and pharmacy boards initiated investigations into multiple medical spas after receiving complaints and reports of adverse patient outcomes linked to the use of non-FDA-approved peptides. The investigations uncovered that these clinics were purchasing non-FDA approved peptides from unlicensed suppliers, often sourced from international vendors. These substances were then administered to patients without adequate medical supervision or proper recordkeeping, raising significant concerns about patient safety and regulatory compliance.
Risks of Grey Market Peptides
A growing concern in the medical aesthetics and wellness industry is the administering of “grey market peptides” on patients. These substances are often produced overseas, lack FDA approval, and are legally permitted only for research purposes—not for individual patient use. Utilizing these peptides in a clinical aesthetic setting exposes both patients and providers to serious risks, including unknown side effects, contamination, and legal liability to the providers. The lack of regulatory oversight in the production of these grey market peptides means that their safety, efficacy, and purity cannot be guaranteed. Providers who administer or prescribe non-FDA-approved peptides for patient use expose themselves to significant legal risks. Using substances not approved for human use outside of research settings can be considered a violation of state and federal law, potentially resulting in disciplinary action, loss of licensure, civil lawsuits, or even criminal charges. Providers may also face malpractice claims if patients are harmed by these unapproved products.
Importance of Proper Licensing and Supervision
Medical spas must ensure that all providers administering cosmetic drugs or performing medical aesthetic treatments—such as GLP-1 agonists—are properly licensed and supervised according to state law. The scope of practice for each provider, telehealth requirements, and state board of pharmacy regulations can vary significantly from state to state. Failure to comply with these requirements can result in severe penalties, including license revocation, fines, and reputational harm.
Best Practices and Recommendations for Medical Spas
- Scrutinize Vendors: Be wary of vendors offering access to “grey market” or research peptides for patient use. Such arrangements are often illegal and can put both patients and the business at risk.
- Maintain Vigilance: Regularly review and update compliance protocols, ensure all staff are properly trained and licensed, and stay informed about changes in state and federal regulations.
- Document Everything: Maintain thorough records of all drug sourcing, administration, and patient interactions to demonstrate compliance in the event of an audit or investigation.
- Stay Informed: Monitor changes in state and federal laws, press releases, and guidance from regulatory boards, to ensure ongoing compliance.
- Consult Healthcare Legal Counsel: Given the complexity and variability of state laws and unique vendors, medical spas should work closely with experienced healthcare legal counsel to confirm compliance with all applicable state and federal laws and regulations.
Conclusion
The recent enforcement actions in Ohio serve as a stark reminder that regulatory agencies are intensifying their oversight of medical and wellness spas, particularly regarding the use of non-FDA-approved peptides. Medical spas must prioritize compliance, patient safety, and proper supervision to avoid significant legal, financial, and reputational consequences.
How Frier Levitt Can Help
Frier Levitt offers essential support to medical and wellness spas across the country. Whether responding to complaints, investigations, or proactively seeking a compliance review and overhaul, Frier Levitt’s legal team can provide invaluable assistance. Contact us today to consult with an attorney and navigate the complex regulatory landscape of the medical spa industry.
Frier Levitt provides strategic, industry-focused legal counsel tailored to your needs. Contact our team today to learn how we can help you.
