HHS asked the Department of Justice to investigate Hims & Hers over its cheaper compounded version of Wegovy. The FDA issued a warning letter to Hims & Hers on September 9, 2025 for misleading marketing claims such as "a weekly GLP-1 injection with the same active ingredient as Ozempic and Wego" or "clinically proven ingredients." These complex semaglutide products are not FDA approved and the labeling makes them misleading under sections 502(a) and 502(bb) of the FDCA. Hims & Hers offers a compounded pill version of Wegova for $49 the first month and then $99 a month, compared to Novo Nordisk's higher prices. Compounded medicines are authorized in the US in the absence of an original or for patient customization, but the FDA has announced since 2024 that GLP-1 medicines are not in short supply. Novo Nordisk has labeled the mass formulation of Hims & Hers as illegal and a threat to patient safety and is planning legal action. The FDA plans to take decisive action against the mass marketing of unapproved compounded versions of GLP-1 drugs.[1][2][3][6][8]