Semaglutide and other GLP-1 receptor agonists for weight loss are skyrocketing in popularity. Medical spas throughout the country have responded to the phenomenon by adding weight loss programs to their service mixes. For many practices, weight loss treatments can be a high-performing profit center.
Of course, regulators, providers, and patients are still learning about these drugs, compounded versions, and their off-label (weight loss) use. The more we learn, the more the risks to patients and legal landmines for providers reveal themselves. Practice owners scramble for guidance to make sure their weight loss treatments remain safe and compliant. In the already ambiguous field of medical aesthetic laws and regulations, weight loss drugs are a new wild west.
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). What does it all mean for practice owners and providers?
We’ve slogged through the FDA approved medical guides, various states’ advisory opinions, and other emerging statements to make sense of it all. Before we jump in, here are some key takeaways for medical spas nationwide. (We’ll break these down further below):
Key Takeaways, Risks, and Legal Landmines for Medical Weight Loss Treatments
Adverse Reactions and Contraindications: FDA-approved semaglutide as well as unregulated compounds come with risks to patients. This emphasizes the importance of a proper Good Faith Exam (GFE) to identify potential contraindications.
Off-label use: The Boards of Pharmacy in some states (such as Mississippi) have prohibited off-label use for semaglutide, which means providers in those states cannot prescribe it solely for weight loss treatment.
Compounds: No compounded form of semaglutide is FDA-approved. Compounded drugs can only be used in a shortage and MUST meet requirements of the Federal Food, Drug, and Cosmetic Act. This omits all salt-forms of semaglutide.
Counterfeits: Counterfeit and fraudulent forms of semaglutide have been discovered at medical spas working with compounding pharmacies. It is critical to properly vet pharmacies with whom you intend to work.
Legal Action: Novo Nordisk (the manufacturer of Ozempic® and Wegovy®) has taken legal action against medical spas for “false advertising, trademark infringement and/or unlawful sales of non-FDA approved compounded products claiming to contain semaglutide.” The key takeaway here is to be careful that you are not marketing brand names if your medspa is offering a compounded or generic version.
Medical Risks of Semaglutide Weight Loss Treatments
As with any prescription medication, authorized prescribers should be well-versed in potential adverse reactions and contraindications for weight loss drugs. (Of course, prescribers should take even more caution if prescribing them off-label or prescribing a compound that is not FDA approved.)
The medication guides for all approved semaglutide (Ozempic®, Wegovy® and Rybelsus®) and tirzepetide (name brand includes Mounjaro®) include contraindications and adverse reactions. This one for Ozempic notes how it causes thyroid C-Cell tumors in rodents (it is unknown whether it causes them in humans). Ozempic is contraindicated in patients with personal family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2.
There are reports of adverse reactions to semaglutide compounds as well (more on compounds later in the article). 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 (GFE). Your initial one-on-one consult with a patient seeking medical weight loss treatment needs to be thorough enough to get to know a patient’s medical history and vet them for candidacy for treatments.
Have a legal team review your informed consent. Ensure that your practice’s informed consent is aligned to your specific treatment plan and educates the patient on potential reactions or contraindications. Make sure to obtain a signed Informed Consent from a patient before he or she begins weight loss treatment.
Understand the risks and regulation of off-label use and compounded weight loss drugs. We cover this thoroughly in the next two sections.
Off-Label Use of Semaglutide
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 these drugs for weight loss is new and the long-term impact under-researched.
State Regulation of Off-Label Use:
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. Here’s a statement from the Mississippi State Board of Licensure prohibiting off-label use:
"Off-label use of any medication that does not have Food and Drug Administration approval for use in the treatment of weight loss is prohibited if administered solely for the purpose of 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 Compounded Drugs in Your Weight Loss Program
What is compounded semaglutide?
Compounded semaglutide is an alternative to FDA-approved branded products (Ozempic® injection, Rybelsus® tablets, Wegovy® injection) using the same active ingredient, semaglutide. Providers may prescribe a compounded drug in appropriate cases when the FDA-approved products are in a shortage (Ozempic and Wegovy are, as of publication of this article), “if they meet certain requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act.” Compounded products are not identical to FDA-approved products, and they have not been evaluated by the FDA for safety or quality.
What does the FDA warn against compounded semaglutide?
The U.S. Food and Drug Administration (FDA) has issued a warning for providers and patients on potential adverse effects of compounded semaglutide. In pertinent part, the FDA stated, “Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality.”
What other key facts are in the FDA warning?
The FDA has received adverse event reports of patients using semaglutide.
Some compounders are using salt forms of semaglutide, which are “different active ingredients than (are) used in the approved drugs.” These do not meet FD&C requirements and should not be prescribed, although some compounders may be using them.
Finally, the FDA has found illegally marketed forms of semaglutide online and counterfeit Ozempic in the US.
How do individual states weigh in on compounding?
Some state regulators, like the Alabama Board of Medical Examiners, New Jersey Office of the Attorney General, and an identical statement from the North Carolina Board of Pharmacy 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. The Mississippi State Board of Licensure, however, took it one step further: “The Board strongly advises medical licensees to refrain from prescribing, dispensing, or administering any compounded semaglutide until further notice.”
The takeaway here is that we advise medical spas to 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.
More Resources for Navigating Compliance for Weight Loss Drugs
What’s next for providers, regulators, semaglutide, and patients seeking weight loss treatments? Stay tuned as we do our best to add clarity and context to this emerging conversation. Scroll down to subscribe to our newsletter to be the first to know about updates to this topic.
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