The FDA has updated guidance warning telehealth companies that promoting compounded drugs, including GLP-1 receptor agonists, with false or misleading claims violates federal law and prevents patients from making informed decisions about their care.
The agency identified five prohibited practices it says remain common:
- Branding websites to imply the telehealth company is the compounder
- Describing a compounded drug as a generic or equivalent of an FDA-approved product
- Claiming FDA approval or safety review for a compounded drug
- Advertising clinical equivalence to a branded drug
- Stating a drug is sourced from an “FDA-approved” or “FDA-licensed” facility — a designation the agency says does not exist
The update is the latest step in an escalating enforcement campaign. In March, the FDA issued 30 warning letters to telehealth firms for the same category of violations — the second wave since the agency launched a broader crackdown in fall 2025, during which it sent more marketing enforcement notices than in the entire preceding decade. In April, the FDA moved to bar pharmacies from compounding GLP-1s once branded versions exit the shortage list and cited a facility for sterility failures in compounded semaglutide and tirzepatide production.
The stakes are significant. Compounded GLP-1s accounted for up to 30% of the U.S. market in 2024, fueled by sustained shortages of Novo Nordisk’s and Eli Lilly’s branded products and a wave of telehealth companies marketing them directly to consumers. No new enforcement actions accompanied the June 15 update, but the FDA said it will continue monitoring promotional materials and taking action to protect patients.
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