FDA Warns Companies Over Unapproved GLP-1 Drugs

(Reuters) – The U.S. Food and Drug Administration (FDA) announced on Tuesday that it has sent warning letters to four companies for selling unapproved versions of GLP-1 drugs, including semaglutide and tirzepatide, which are key ingredients in popular diabetes and weight-loss medications.

The letters were issued to Xcel Peptides, Swisschems, Summit Research, and Prime Peptides after a review of their websites conducted in October.

Although their websites labeled products as "research use only" or "not for human consumption or clinical use," the FDA gathered evidence showing these products are intended for human use.

Additionally, the FDA sent a warning letter to Veronvy, which sells unapproved and misbranded oral GLP-1 products, including one that falsely claims FDA approval.

The agency noted that the Veronvy website misleadingly suggests that its products are FDA-approved or endorsed.

The companies must respond within 15 business days of receiving the letter, detailing specific actions taken to rectify any violations. Failure to comply may lead to legal actions, including seizure and injunctions, according to the FDA.

Semaglutide is the active ingredient in Novo Nordisk's Wegovy and Ozempic, while Eli Lilly’s diabetes drug Mounjaro and weight-loss drug Zepbound contain tirzepatide. Some websites were also promoting retatrutide, Eli Lilly's experimental weight-loss drug.

Previously, these companies have sued various medical spas, compounding facilities, and clinics for selling products that claim to contain these active ingredients.