inspire.clinic Warning Letter Details

Summary

inspire.clinic was cited for unlawfully selling unapproved and misbranded compounded drugs (semaglutide and tirzepatide) over the internet. The company made false or misleading claims that its compounded products were equivalent to FDA-approved drugs like Ozempic and Mounjaro by using comparative language such as "similar to" and "comparable to," thereby violating sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act. These misbranded products were introduced into interstate commerce without FDA approval, constituting a prohibited act under section 301(a) of the FDCA.