Legal Issues to Consider When Implementing GLP-1 and Other Weight Loss Drugs into Your Medical Aesthetics Business

Now, more than ever, medical aesthetics practices and spas across the country are considering implementing glucagon-like peptide 1 (GLP-1) and other weight loss drug service lines into their practices. The global GLP-1 receptor agonist market was estimated to be worth $47.4 billion in 2024 and could reach $471.1 billion by 2032.¹ While the addition of GLP-1 and other weight-loss drugs into your aesthetic business may offer significant financial incentives, they also bring a plethora of legal risks and considerations that medical aesthetics practices, spas, and any affiliated management services organizations (MSOs) should be aware of prior to implementation.

In this article, we provide a high-level overview of some key legal compliance and risk management considerations medical aesthetics businesses should be aware of when implementing GLP-1 and other weight-loss drug service lines to help reduce risk when incorporating this promising and life-changing line of revolutionary new drugs.

MARKETING CONSIDERATIONS

Marketing and advertising are a major area of concern with GLP-1s. Specifically, Eli Lilly has filed about two dozen lawsuits claiming inter alia false and deceptive advertising, trademark infringement, and/or violation of various state Food, Drug and Cosmetic Acts, asserting that an inferior or counterfeit compounded GLP-1 was improperly advertised. In addition, many cease-and-desist and restraining orders by pharmaceutical companies against prescribers, clinics, and medical spas have been successful, and we anticipate most companies will continue to aggressively file lawsuits to try to prevent problematic advertisements and defend their relevant trademarks. For that reason, businesses integrating GLP-1s should carefully consider the US Food and Drug Administration, Federal Trade Commission, and US Patent and Trademark Office laws and regulations applicable to GLP-1 marketing material.

TELEHEALTH AND TELEMEDICINE REQUIREMENTS

Aesthetic practices planning to utilize telehealth services in conjunction with their GLP-1 treatment programs should consult their state-specific telehealth laws prior to implementation to ensure their proposed telehealth model complies with state laws and regulations. All jurisdictions contain state-specific limitations on provider scope of practice in the context of telehealth, and often apply different requirements to different provider types. For example, in certain jurisdictions physicians may be able to provide certain services such as GLP-1 consultations via telehealth, while mid-level providers may be more limited. Certain jurisdictions may also require an in-person physical assessment, rather than a telehealth assessment, prior to prescribing GLP-1s or other weight-loss medications.

SCOPE OF PRACTICE AND SUPERVISION REQUIREMENTS

Similar to telemedicine laws and regulations, each state has its own unique scope of practice and supervision limitations. These limitations include, but are not limited to, whether certain providers need to be supervised by a medical doctor/doctor of osteopathy, or a nurse practitioner or physician’s assistant, when providing certain treatments or prescribing certain drugs, including GLP-1 and other weight-loss drugs. For this reason, it is important to research your state’s specific scope of practice requirements for prescribing and monitoring GLP-1 weight loss drugs before providing treatment to ensure the correct type of provider(s) are conducting the initial physical examination, prescribing the drug, developing treatment plans, and conducting patient follow-ups.

OTHER STATE-SPECIFIC LAWS AND REGUALTIONS

Another area of law that can impact businesses implementing GLP-1s into their business are state-specific laws that pertain to the payment of “kickbacks” in exchange for referrals of business, as well as state laws that prohibit physicians “splitting fees” with non-physicians. Specifically, businesses should consider whether their state’s laws apply to cash-based GLP-1 models, and whether they create any other limitations on the types of permissible payment models. For example, in some states, single-patient subscription fee structures can be problematic if improperly structured.

Finally, business owners should also be cautious of any arrangements where payments are made to marketing companies in exchange for patient referrals or leads.

COMPOUNDING CONSIDERATIONS

To be produced and sold, compounded drugs must meet conditions to qualify for exemptions under sections 503A and 503B of the Federal Food, Drug and Cosmetic Act. This means that compounding GLP-1 drugs may be permissible at some times in certain circumstances, and not in others. While this topic could easily take up its own article, one simple rule to follow if utilizing compounded GLP-1 products is to consult with legal counsel to confirm the viability of utilizing compounded medications in the short and long term. Relationships with compounding pharmacies and 503B outsourcing facilities should also be carefully reviewed to ensure compliance with state and federal law.

1. Research and Markets. Global GLP-1 Analogues Market Report 2024-2032: Market Expansion Driven by Innovation and Efficacy in Diabetes and Obesity Treatment - Single Dose and Zepbound Drive Market Domination. GlobeNewswire News Room. Published August 30, 2024. Accessed December 17, 2024. https://www.globenewswire.com/news-release/2024/08/30/2938346/0/en/Global-GLP-1-Analogues-Market-Report-2024-2032-Market-Expansion-Driven-by-Innovation-and-Efficacy-in-Diabetes-and-Obesity-Treatment-Single-Dose-and-Zepbound-Drive-Market-Domination.html