The U.S. Food and Drug Administration (FDA) issued warning letters on Tuesday to four companies—Xcel Peptides, Swisschems, Summit Research, and Prime Peptides—for selling unapproved versions of GLP-1 drugs, including semaglutide and tirzepatide, active ingredients in widely used diabetes and weight-loss medications. The letters were sent last week after the FDA reviewed the companies’ websites in October.
While these companies label their products as “research use only” or “not for human consumption or clinical use,” the FDA found evidence indicating these products were intended for human use as drugs. The agency also sent a warning to Veronvy for selling unapproved oral GLP-1 products, including one that misleadingly claims FDA approval.
The FDA highlighted that these companies’ websites misbrand products by suggesting they are either FDA-approved or endorsed. The warning letters demand that the companies inform the FDA within 15 business days about the specific actions they have taken to address these violations. If the companies fail to adequately respond, legal action—including seizure and injunction—could follow.
Semaglutide, an active ingredient in Novo Nordisk’s Wegovy and Ozempic, and tirzepatide, used in Eli Lilly’s Mounjaro and Zepbound, were among the drugs targeted. Some of the websites also offered retatrutide, Eli Lilly’s experimental weight-loss drug. Previously, the companies have filed lawsuits against medical spas, clinics, and compounding facilities selling products falsely claiming to contain these active ingredients.
Also read: Senate Advances $895B Defense Bill with Transgender Care Limits
