Healthy Living Clinic Warning Letter Details

Summary

Healthy Living Clinic was cited for unlawfully selling unapproved and misbranded compounded semaglutide drugs over the internet, in violation of the Federal Food, Drug, and Cosmetic Act. The company's website contained false or misleading claims that its compounded semaglutide products were "available under brand names like Wegovy, Ozempic, and Rybelsus," implying equivalence to FDA-approved drugs when compounded products are not FDA-approved. This misrepresentation constituted violations of sections 502(a) and 502(bb) of the FDCA, which prohibit false or misleading labeling and advertising of drugs, and resulted in misbranded products being introduced into interstate commerce in violation of section 301(a) of the FDCA.