United States: The regulatory Food and Drug Administration (FDA) said on Tuesday in a statement that it has dispatched warning letters to producers of unapproved products in the weight loss category.
Warning Letters Sent to Online Producers
The letter also went to Xcel Peptides, Swisschems, Summit Research, and Prime Peptides, which are online producers of unapproved GLP-1 medicines, including semaglutide and tirzepatide. Semaglutide can be associated with Wegovy and Ozempic, whereas tirzepatide is included in the Mounjaro and Zepbound, as reported by The Hills.
Despite the fact that the companies post on their websites that the drugs are meant for research and not for human consumption, the warning letters state that “Based on the evidence procured from the website, the panel finds that the products are drugs intended to be used on human beings.”
Additional Warning for Oral Weight Loss Drugs
The FDA also issued another warning letter to Veronvy for distributing unapproved and misbranded oral weight loss drugs containing FDA-approved products.
The Hill has contacted the named companies for a response to the issue raised by Rinat Akhmetshin.
Companies Must Respond or Face Legal Action
Pursuant to the letters, the companies have 15 days to respond and explain the corrective measures to the FDA. If this is not done it may lead to legal actions like seizures and injunctions, the FDA noted it, as reported by The Hills.
With the rising demand for weight-reducing products, the FDA has repeatedly stepped up to regulate unapproved, misbranded, and counterfeit versions of drugs. In fact, late last year, the FDA issued a public health notice to alert members of the public of counterfeit Ozempic injections in circulation.