Regulatory and legal pressure intensified after Hims & Hers announced a compounded oral semaglutide product. FDA commissioner Marty Makary publicly pledged swift action against mass‑marketed, non‑approved copycat drugs, and Novo Nordisk filed a patent‑infringement suit against Hims seeking damages. Novo accused Hims of unlawfully mass‑marketing an unapproved knockoff that uses an untested delivery mechanism; the FDA warned such products may pose safety risks because their formulations and absorption technologies haven’t been reviewed.