FDA announces intent to act against mass-marketed non-approved compounded GLP-1 drugs
Intent announced · Policy statement
FDA announced intended enforcement steps involving GLP-1 active pharmaceutical ingredients used in mass-marketed non-approved compounded drugs and misleading direct-to-consumer promotion. The statement named Hims & Hers among the companies in scope but was not itself a final adjudication against that company.
Compounds: Semaglutide, Tirzepatide
