FDA issues warning letters to 30 telemedicine companies over false advertising of GLP-1 drugs

Investing.com – The U.S. Food and Drug Administration (FDA) issued warning letters to 30 telemedicine companies on Tuesday for making false or misleading claims about compounded GLP-1 products on their websites.

FDA Commissioner Dr. Robert M. Califf said the agency is monitoring misleading promotions by telemedicine and pharmaceutical companies across all media platforms and taking action. Califf noted that compounded medications can help address drug shortages or meet specific patient needs, but compounding companies should not attempt to bypass FDA approval processes.

This is the second batch of warning letters sent to telemedicine companies since the agency began cracking down on misleading direct-to-consumer drug advertising in September last year. Over the past six months, the agency has sent thousands of warning letters to pharmaceutical and telemedicine companies, requiring them to remove misleading advertisements—more than the total number of warnings issued in the previous ten years.

In February, Hims & Hers received a stern warning from the FDA for large-scale marketing of compounded GLP-1 drugs.

The main violations cited in the warning letters include claims of equivalent efficacy to FDA-approved products and promoting drugs by using the telemedicine company’s own name or trademark to obscure the source of the product, implying they are the compounding manufacturer.

Unapproved compounded drugs mean the FDA will not review their safety, efficacy, or quality before they are marketed. Compounded drugs are also different from generic drugs, which are approved by the FDA.

FDA-approved GLP-1 drugs are developed by Novo Nordisk and Eli Lilly.

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