FDA Warns Companies Over Misleading Claims of GLP-1 Copycats

The US Food and Drug Administration issued 25 warning letters to telehealth companies for marketing false and misleading claims about compounded GLP-1s, cracking down on several businesses selling copycat weight loss and diabetes drugs.

The letters posted Tuesday, signed off by the Center for Drug Evaluation and Research, were sent to several telehealth companies including Ready Med, Roen Health Inc., Maximus Health Inc., and Medica Weight Loss in early June.

Some of the companies claimed on their websites that their compounded semaglutide and tirzepatide products were clinically studied ingredients, or that the compounded drug products are sourced from an “FDA-approved pharmacy,” according to the agency’s letters.

The agency made clear in its social media post that compounded products are not FDA-approved.

“Protecting consumers from false and misleading claims about compounded drugs is a priority for CDER,” Michael Davis, acting director of CDER, said Tuesday in a social media post. “Patients deserve to know what they’re getting—compounded GLP-1 products have not been proven safe, effective, or of consistent quality like FDA-approved drugs.”

Pharmaceutical giants Novo Nordisk A/S and Eli Lilly & Co. have filed a series of lawsuits against telehealth platforms, alleging they engaged in misleading marketing of compounded versions of their blockbuster GLP-1 drugs.

Novo is the only drugmaker that holds FDA approval for semaglutide, a diabetes and obesity treatment sold under brand names Ozempic and Wegovy. Lilly is the only manufacturer with FDA-approved tirzepatide, another a diabetes and obesity treatment branded as Mounjaro and Zepbound.