The U.S. Food and Drug Administration has issued warning letters to 30 telehealth companies for making false or misleading claims regarding compounded GLP-1 products offered on their websites.
This marks the second group of such letters sent to telehealth firms since the agency launched a crackdown in September on misleading direct-to-consumer pharmaceutical advertisements. Over the past six months, the FDA has sent thousands of letters warning pharmaceutical and telehealth firms to remove misleading ads — more than it issued during the entire preceding decade.
FDA Commissioner Marty Makary, M.D., M.P.H., said the agency is stepping up its oversight.
“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,” Makary said. “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 involved claims implying the compounded products were the same as FDA-approved drugs and obscuring product sourcing by advertising the medications under the telehealth companies’ own brand names or trademarks without qualification.
Compounded drugs are not FDA-approved. This means the agency does not review their safety, effectiveness, or quality before they are marketed. Compounded drugs are also not the same as FDA-approved generic drugs.
