The U.S. Food and Drug Administration has issued 30 warning letters to telehealth companies for allegedly making false or misleading claims about compounded GLP-1 products on their websites, according to a March 3 announcement.  

The agency stated that the companies promoted compounded versions of GLP-1 medications in ways that implied "sameness" with FDA approved drugs and obscured the source of the products, including through branding practices that suggested the telehealth firms themselves were the compounders.  

FDA Highlights Enforcement Priorities

In the announcement, FDA Commissioner Dr. Marty Makary, MD, MPH, described the action as part of “a new era," noting increased attention to misleading claims made by telehealth and pharmaceutical companies across media platforms.

“Compounded drugs can be important for overcoming shortages or meeting unique patient needs — but compounders should not try to compound drugs in a way that circumvents FDA’s approval process,” Makary said.  

The FDA emphasized that compounded drugs are not FDA approved and therefore are not reviewed by the agency for safety, effectiveness, or quality before marketing. They are also not the same as generic drugs, which are FDA approved.  

Part of Ongoing FDA Crackdown on Misleading Drug Promotion

The FDA launched a broader crackdown in September on misleading direct to consumer pharmaceutical advertising. In the past six months, the agency stated it has sent thousands of letters to pharmaceutical and telehealth companies directing them to remove misleading advertisements, more than had been sent over the entire preceding decade. 

Among these were recent warnings to Novo Nordisk regarding a Wegovy TV ad's potentially misleading claims, and a February announcement of the agency's intent to restrict mass-marketed compounded GLP-1s such as those offered by Hims & Hers. Note, however, that major digital pharmacies Ro and Him & Hers were not among the telehealth companies selling compounded weight loss drugs that were issued letters on March 3.

Key Violations Identified

The FDA highlighted two primary issues in the letters:

1. Implying sameness with FDA approved products: The agency cited marketing claims suggesting compounded GLP-1 products were equivalent to approved medications.  
2. Obscuring product sourcing: Some companies allegedly advertised drug products under their own name or trademark without qualification, suggesting they were the compounder when they were not.  

What Medical Spas and Aesthetic Providers Should Know

While the FDA announcement did not specifically address medical spas, the agency's stated concerns apply broadly to any entity marketing compounded GLP-1 products:

• Compounded GLP 1s are not FDA approved and cannot be presented as equivalent to approved products.  
• Marketing materials must not obscure the identity of the compounding pharmacy or imply the marketer is the manufacturer.  
• The FDA is actively monitoring claims across all media platforms and is taking “swift action” against misleading promotion.  

The FDA’s announcement reiterated that compounded drugs should not be used or promoted in ways that circumvent the federal approval process or mislead consumers about their status. 

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