US EditionFDA Warns 30 Telehealth Companies Over Misleading Compounded GLP-1 Advertising
The FDA targets misleading advertising by 30 telehealth firms marketing compounded GLP-1 drugs without approval, continuing a crackdown launched last year.
- The FDA sent warning letters to 30 telehealth companies accusing them of illegally marketing compounded GLP-1 formulations as part of a direct-to-consumer advertising initiative launched last September.
- Last year regulators began a crackdown targeting companies selling compounded versions of in‑patent drugs, including warnings to prominent telehealth company Hims & Hers.
- Smaller firms named in the letters include Strut Health, PharmaZee, Lean Rx and GoodGirlRx, which marketed compounded semaglutide, liraglutide and tirzepatide, while transgressions include implying FDA approval and using `clinically proven`.
- The FDA's campaign has prompted thousands of warning letters, and Novo Nordisk's Wegovy U.S. sales shrank 2% in the final three months of 2025, affecting branded makers and telehealth programs.
- Regulatory and commercial tensions suggest the FDA’s move will delight Novo Nordisk and Eli Lilly, highlighting conflicts between branded manufacturers and compounded competitors under Section 503A since last year.
9 Articles
9 Articles
FDA Warns 30 Telehealth Firms Over Misleading Compounded GLP-1 Ads
The Food and Drug Administration (FDA) has issued 30 warning letters to companies that the agency said are making false or misleading claims about compounded GLP-1 products being offered on their websites. In its March 3 announcement, the FDA said that compounded drugs are not FDA-approved, which means the agency does not review their safety, effectiveness, or quality before they are marketed to the public. Compounded drugs are different from ge…
FDA sends warning to 30 telehealth companies selling ‘illegal’ GLP-1s
The Food and Drug Administration (FDA) on Tuesday sent 30 telehealth companies warning letters about their “illegal” sales of compounded GLP-1s, building off increasing pressure to tamp down on the sale of these unapproved medications. According to the FDA, the companies they contacted made “false or misleading claims” about the GLP-1 products they sold on…
FDA Warns 30 Telehealth Firms Over Compounded GLP-1 Medications
(MedPage Today) -- Thirty warning letters were issued to telehealth companies for false and misleading claims about compounded GLP-1 receptor agonist products, the FDA announced on Tuesday. The letters primarily targeted claims implying "sameness...
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