Commissioner of Food and Drugs - Food and Drug AdministrationToday, the U.S. Food and Drug Administration is announcing its intent to take decisive 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. We take seriously any potential violations of the Federal Food, Drug, and Cosmetic Act. In promotional materials, companies cannot claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA. They also cannot state compounded drugs use the same active ingredient as the FDA-approved drugs or that compounded drugs are clinically proven to produce results for the patient.