The FDA is taking steps to restrict GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies — including Hims & Hers and other compounding pharmacies — as similar alternatives to FDA-approved drugs. These actions are aimed to safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy. The FDA is also taking steps to combat misleading direct-to-consumer advertising and marketing following warning letters that were sent in the fall of 2025, were companies claimed that their non-FDA-approved compounded products were generic versions of FDA-approved products.
