FDA Takes Aim at Hims & Hers, Weight-Loss Drugs in New Advertising Blitz

""the same active ingredient""

""Your claims imply that your products are the same as an FDA-approved product when they are not,""

""looks forward to engaging with the FDA.""

""Our website and our customer-facing materials note that compounded treatments are not approved or evaluated by the FDA,""

Federal regulators posted more than 100 warning letters targeting drugmakers and online prescribing companies for promoting unapproved compounded versions of prescription medications, including GLP-1 weight-loss injections. The FDA warned Hims & Hers to remove statements claiming its customized products contain "the same active ingredient" as FDA-approved semaglutide, noting those formulations are produced by compounding pharmacies and are not reviewed by the FDA. The agency stated that such claims imply compound products are the same as approved drugs when they are not. The FDA also flagged a 2024 GLP-1 infomercial for giving a misleading impression about drug safety. Hims said it will engage with the FDA and that its customer-facing materials note compounded treatments are not FDA-approved or evaluated.

Read at Medpagetoday