The FDA has sent warning letters to two online vendors — US Chem Labs and Helix Chemical Supply — for selling unapproved and misbranded versions of semaglutide and tirzepatide.
Federal regulators sent the letters Feb. 7, notifying the companies they have 15 working days to confirm receipt and list steps to address any identified violations. The FDA said it had reviewed both companies' websites and found unapproved and misbranded semaglutide and tirzepatide products. The FDA also flagged US Chem Labs for offering unapproved and misbranded thymalin products.
"Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction," the FDA said in its warnings.
Semaglutide is the active ingredient in Novo Nordisk's Wegovy, which is approved for weight loss, and Ozempic, which is approved to treat Type 2 diabetes. Tirzepatide is the active ingredient in Eli Lilly's weight loss drugs known as Zepbound and Mounjaro.
In October, the FDA announced it had started investigating online sales of semaglutide and tirzepatide. The agency also said it was probing schemes to sell counterfeit versions of Ozempic to unsuspecting pharmacies.