The US Food and Drug Administration (FDA) has issued warning letters to four companies selling unapproved glucagon-like peptide-1 receptor agonist (GLP-1RA) products, as the agency continues its crackdown on those illegally benefiting from the surge in popularity of diabetes and weight loss drugs.
Letters were issued to Xcel Peptides, Swisschems, Summit Research and Prime Peptides after an investigation by the FDA found they were selling semaglutide, tirzepatide and/or retatrutide products for human use despite marketing the drugs for research and chemical purposes.
Semaglutide is the active ingredient in Novo Nordisk's Ozempic and Ozempic while tirzepatide is in Eli Lilly’s Mounjaro and Zepbound. Retatrutide, Eli Lilly's experimental next-generation weight-loss drug, was also being advertised on some of the websites.
A separate letter was also sent to Veronvy – a company that went one stage further claiming to offer a GLP-1RA product approved by the FDA.
The implicated companies have 15 working days to take corrective steps and explain preventative action being taken to mitigate future violations.
In the letters to the online vendors, the FDA stated: “This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.”
The use of social media constituted a large part of traffic directed to the companies’ websites. For example: Summit Research Peptides wrote posts on Facebook with the title “Enhanced Weight Loss: Achieve superior weight reduction with the synergistic effects of Cagrilintide and Semaglutide”.
The FDA has not approved any treatment with cagrilintide, with the agency previously saying products containing the synthetic peptide are neither safe nor effective.
The FDA has already sent warning letters to separate companies selling unapproved and misbranded versions of semaglutide and tirzepatide earlier in the year. Synthetix and US Chem Labs. Synthetix’s website is not operational as of 18 December while US Chem Labs’ website no longer lists GLP-1RA products.
Along with the FDA, Novo Nordisk and Eli Lilly have been on the lookout for copied versions of their blockbuster weight loss and diabetes drugs. Both drugmakers have filed multiple lawsuits against online vendors and wellness spas selling products that claim to contain semaglutide or tirzepatide.
The World Health Organization (WHO) issued an alert earlier this year on falsified versions of Ozempic found circulating in Brazil, the UK and the US in late 2023. The alert recommended that patients using semaglutide should avoid buying products from unfamiliar or unverified sources such as online websites.
