Hims & Hers Health (NYSE:HIMS) shares fell 3.2% after the FDA warned telehealth companies and compounding pharmacies over unapproved weight-loss drugs, including versions of semaglutide, tirzepatide and retatrutide.
The agency said retatrutide and cagrilintide cannot legally be used in compounding and that it has already warned companies marketing unapproved retatrutide directly to consumers.
As of May 31, the FDA had received 990 adverse-event reports linked to compounded semaglutide and more than 730 tied to compounded tirzepatide.
The agency also flagged dosing errors, fraudulent labels, improper refrigeration during shipping and questionable foreign-made ingredients among compounded GLP-1 products.
The FDA reiterated that compounded GLP-1 drugs are not FDA-approved and have not been reviewed for safety, effectiveness or quality before being marketed to consumers.