Maryland: The U.S. Food and Drug Administration (FDA) has issued warning letters to two online vendors, Semaspace and Gorilla Healing, for selling unapproved versions of semaglutide and tirzepatide. These active ingredients are found in popular GLP-1 class medications such as Novo Nordisk’s weight-loss drug Wegovy.
The FDA clarified that the only approved semaglutide products are Wegovy, as well as Novo’s diabetes drugs Ozempic and Rybelsus. Similarly, tirzepatide, found in Eli Lilly’s Mounjaro, is only approved for diabetes treatment. The FDA emphasized the importance of halting the sale of unapproved medicines to protect the public from potential harm. Unapproved drugs lack the same safety and effectiveness assurances as regulated drugs, and they may be contaminated or contain varying active ingredients.
The FDA also highlighted that Semaspace and Gorilla Healing violated U.S. law by selling semaglutide and tirzepatide without ensuring customers had prescriptions from licensed healthcare practitioners. Failure to comply with FDA warnings may result in legal actions such as seizures and injunctions.
Semaspace has already shut down its website in response, but Gorilla Healing is still operating and continues to list semaglutide and tirzepatide for sale.
In a separate letter, the FDA also addressed www.alphamedstore.com, warning them to cease selling unapproved and misbranded opioid drug products. The FDA emphasized the urgent need to address the immense public health crisis arising from opioid addiction and abuse.
These warnings from the FDA come after previous legal action taken by pharmaceutical companies, including Novo Nordisk and Eli Lilly, against various medical spas, wellness centers, and compounding pharmacies. These companies were found to be selling products falsely claiming to contain tirzepatide and semaglutide.
Overall, the FDA’s actions aim to ensure that patients have access to only regulated and approved medications, protecting their health and well-being.
