Dec 17 (Reuters) - The U.S. Food and Drug Administration said on Tuesday it has sent
warning letters to four companies for selling unapproved versions of GLP-1 drugs including
semaglutide and tirzepatide, the active ingredients in popular diabetes and weight-loss drugs.
The letters were issued to Xcel Peptides, Swisschems, Summit Research and Prime Peptides
last week after the U.S. health regulator conducted a review of their respective websites in
October.
The websites indicate that their products are labeled as "research use only" or "not for
human consumption or clinical use." However, evidence gathered by the FDA establishes that these
products are actually intended to be used as drugs for humans.
The agency also sent a warning letter to Veronvy, which offers unapproved and misbranded
oral GLP-1 products, including one that claims to be approved by the FDA.
The FDA has observed that the website offers misbranded products that misleadingly suggest
that the drug products are approved or endorsed by the agency in some way.
The companies must inform the agency within 15 business days of receiving the letter,
outlining the specific actions taken to address any violations. Failure to adequately address
the violations may result in legal action including, without limitation, seizure and injunction,
the FDA said.
Semaglutide is an active ingredient in Novo Nordisk's Wegovy and Ozempic, while
Eli Lilly's ( LLY ) diabetes drug sold as Mounjaro and weight-loss drug Zepbound use the
ingredient tirzepatide.
Some of the websites were also offering retatrutide, Eli Lilly's ( LLY ) experimental next
generation weight-loss drug.
The companies have previously sued various medical spas, compounding facilities and clinics
for selling products purporting to contain the active ingredients.