FDA issues 30 warning letters to telehealth firms over GLP-1 claims

The U.S. Food and Drug Administration issued 30 warning letters to telehealth companies for making false or misleading claims about compounded GLP-1 products on their websites.

The warning letters represent the second group sent to telehealth firms since the FDA launched a crackdown on misleading direct-to-consumer pharmaceutical advertisements in September. Over the past six months, the agency has sent thousands of letters warning pharmaceutical and telehealth firms to remove misleading ads, exceeding the number sent over the entire preceding decade.

"It's a new era. We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms—and taking swift action," said FDA Commissioner Marty Makary. "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."

The primary violations identified in the letters included making claims implying sameness with FDA-approved products and obscuring product sourcing by advertising drug products branded with the telehealth firm's name or trademark without qualification, implying they are the compounder.

Compounded drugs are not FDA-approved, meaning the agency does not review their safety, effectiveness or quality before they are marketed. The FDA noted that compounded drugs are also not the same as generic drugs, which are FDA-approved.

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