The U.S. Food and Drug Administration today announced the issuance of 30 warning letters to telehealth companies for making false or misleading claims regarding compounded GLP-1 products offered on their websites.
“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, M.D., M.P.H. “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.”
This is the second group of warning letters sent to telehealth firms since the agency launched in September a crackdown on misleading direct-to-consumer pharmaceutical advertisements. Over the past six months, the agency has sent thousands of letters warning pharmaceutical and telehealth firms to remove misleading ads, more than had been sent over the entire preceding decade.
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. This means the agency does not review their safety, effectiveness or quality before they are marketed. Compounded drugs are also not the same as generic drugs, which are FDA-approved.