FDA warns companies over unapproved weight loss drug sales

The Food and Drug Administration (FDA) said Tuesday in a statement it has sent warning letters to companies selling unapproved weight loss drugs.

The letter went to Xcel Peptides, Swisschems, Summit Research and Prime Peptides, four online companies it said were selling unapproved GLP-1 drugs, including semaglutide and tirzepatide. Semaglutide is known for its use in Wegovy and Ozempic, while tirzepatide is found in Mounjaro and Zepbound.

Although the companies put on their websites that the drugs are only intended for research purposes and not human use, the warning letters claim that “evidence obtained from your website establishes that your products are intended to be drugs for human use.”

The FDA also sent an additional warning letter to Veronvy for sending unapproved and misbranded oral weight loss drugs that claimed to be FDA-approved.

The Hill has reached out to the named companies for comment.

According to the guidelines of the letters, the companies have fifteen days to address the concerns and explain their corrective procedures to the FDA. Failure to do so may result in legal action including, without limitation, seizure and injunction, the FDA said.

As weight loss drugs become increasingly popular, the FDA has repeatedly cracked down on regulating unapproved, misbranded and counterfeit versions of the drugs. Last December, the FDA warned public consumers about fake Ozempic injections in the supply chain.

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