Loading…
EvoLife Wellness sold unapproved and misbranded compounded semaglutide and tirzepatide products online to U.S. consumers in violation of the Federal Food, Drug, and Cosmetic Act. The company made false or misleading claims that its compounded drugs were "FDA-Approved" and "Clinically Proven," implying they were equivalent to FDA-approved products when compounded drugs cannot receive FDA approval. These misrepresentations violated sections 502(a) and 502(bb) of the FDCA and constituted prohibited introduction of misbranded drugs into interstate commerce under section 301(a).