fda warning letter hims compounded semaglutide 2025 September 15, 2025: Telehealth company must stop implying its GLP-1 is FDA-approved, warns – Partnership for Safe Medicines From Crackdown to Collaboration: FDA

For example, if you started a GLP-1 in September 2024 with a BMI of 37, but in July 2026 you've lost weight and now have a BMI of 34, the prescriber should attest in the prior authorization request that you met the BMI criteria of 35 or over when the GLP-1 therapy started

FDA Sends Warning Letters to Novo Nordisk, Eli Lilly, and Hims Regarding Misleading Pharmaceutical Advertising

Prospective studies integrating body composition trajectories, structured dietary assessment, and redox-relevant biomarkers during GLP-1RA therapy may clarify whether preservation of rate-limiting substrate modules supports lean mass maintenance and metabolic stability

Vehicle-control mice were infused with normal saline for comparison

Using the same injection site every time