FDA Cracks Down on Telehealth Companies promoting Unapproved Drugs

Key Takeaways

• The U.S. Food and Drug Management has sent over 100 warnings to drugmakers.
• Hims was flagged for its misleading claims about compounded Ozempic/Wegovy.
• The FDA says compounded drugs are not FDA-approved and may pose risks.

WEDNESDAY, Sept. 17, 2025 (HealthDay News) – Federal health officials are cracking down on telehealth companies’ promotion of unapproved versions of prescription drugs, including popular weight loss medications.

On Tuesday, the U.S. Food and Drug Administration (FDA) released more than 100 warning letters aimed at both drugmakers and online health companies. Among them: Hims was flagged for its misleading claims about compounded Ozempic/Wegovy.

The FDA emphasizes that compounded drugs are not FDA-approved. This means they haven’t undergone the same rigorous review for safety, effectiveness, and quality as approved medications. Compounded versions of drugs like Ozempic and Wegovy, used for weight loss and diabetes management, are raising concerns.

“Patients should be aware that compounded drugs may pose risks because of the way they are made, stored, and shipped,” the FDA stated. “There have been reports of adverse events associated with compounded versions of these drugs.”

the FDA’s warning letters aren’t just directed at Hims. They also target companies supplying the active pharmaceutical ingredients used in these compounded drugs. The agency is concerned about the quality and safety of these ingredients.

The FDA urges patients to discuss weight loss medications with their healthcare providers and to onyl obtain prescriptions from legitimate pharmacies. They also advise caution when considering medications advertised online, especially those claiming to be compounded versions of popular drugs.