Justin Marti, attorney and principal at Marti Law Group, provides information on the four areas of concern that medical spa providers must be aware of when considering adding weight loss drugs to their list of services.
Semaglutide and other GLP-1 receptor agonists for weight loss are skyrocketing in popularity, and medical spas throughout the country have responded to the phenomenon by adding weight loss programs to their service mix. For many practices, weight loss treatments can be a high-performing profit center. However, the more we learn about these drugs, the more risks to patients and legal landmines for providers reveal themselves. The FDA and various state regulators are beginning to weigh in with warnings and advisory opinions on how and when these drugs can be used for weight loss (if at all). Below are four areas of concern that providers should be aware of.
Adverse Reactions and Contraindications
FDA-approved semaglutide, as well as unregulated compounds, come with risks to patients. As with any prescription medication, authorized prescribers should be well-versed in potential adverse reactions and contraindications for weight loss drugs. The medication guides for all approved semaglutide (Ozempic®, Wegovy®, and Rybelsus®) and tirzepetide (name brand includes Mounjaro®) include contraindications and adverse reactions. In order to best prevent patients from suffering adverse reactions and to inform them of potential risks, medical spas should have a few crucial protocols in place for prescribing weight loss treatments: Start with a comprehensive Good Faith Exam to determine candidacy for treatment; have a legal team review your informed consents; and understand the risks and regulation of off-label use and compounded weight loss drugs.
Off-Label Use of Semaglutide for Weight Loss
Currently, Wegovy® is the only drug that is FDA approved specifically for weight loss. Ozempic®, a treatment for diabetes, is often used off-label as a treatment for weight loss, as popularized through social media and pop culture. However, the off-label use of Ozempic® and other drugs for weight loss is new and the long-term impact under-researched. Some state regulators are cracking down on off-label use of semaglutide. Prescribers in these states cannot utilize the drug if the FDA has not approved it for weight loss. What does this mean for prescribers? Essentially, only Wegovy® (not Ozempic®, Rybelsus®, or non-approved semaglutide compound) can be prescribed solely as a medical weight loss treatment. If your state hasn’t issued a statement about off-label use, stay tuned. We believe that more regulators will follow suit to begin prohibiting off-label use of these drugs in the near future.
Risks of Using Compounds
No compounded form of semaglutide is FDA-approved, and the FDA has warned against their use because of some adverse event reports. Compounded drugs can only be used in a shortage and must meet requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This omits all salt-forms of semaglutide. Some state regulators reiterate the FDA’s warning, stating that even when compounding of a semaglutide drug is allowable under the FD&C Act, the use of salts is prohibited. Compounding things further for medical spa owners and providers is the prevalence of fraudulent or defective medicines onlines and across the industry as a whole. The FDA has found illegally marketed forms of semaglutide on the web and counterfeit Ozempic in the U.S. Knowing and vetting the source of drugs is just as critical as proper use and administration. Medical spas should proceed with extreme caution in prescribing compounds, to remain aware of both federal and state warnings, and to be vigilant in working with compounding pharmacies.
Legal Action from Novo Nordisk
Novo Nordisk (the manufacturer of Ozempic® and Wegovy®) has taken legal action against medical spas across the country for “false advertising, trademark infringement and/or unlawful sales of non-FDA approved compounded products claiming to contain semaglutide.” The threat of lawsuits from major manufacturers is something that should be kept in careful consideration when developing marketing content. Providers should refrain from referencing the brand names if they are not, in fact, offering them.