"The Food and Drug Administration on Tuesday posted more than 100 letters to various drugmakers and online prescribing companies, including Hims & Hers, which has built a multibillion-dollar business centered around lower-cost versions of blockbuster obesity injections. The FDA warned the company to remove "false and misleading" promotional statements from its website, including language claiming that its customized products contain "the same active ingredient" as FDA-approved drugs Wegovy and Ozempic. The formulations cited by regulators are produced by specialty compounding pharmacies and aren't reviewed by the FDA."
"It's the first FDA attempt to directly police online platforms like Hims, which have long argued they're not subject to traditional drug advertising rules. The FDA also posted separate warning letters to manufacturers of the so-called GLP-1 drugs, taking issue with a 2024 infomercial featuring Oprah Winfrey. Regulators said the 42-minute TV segment from Eli Lilly and Novo Nordisk gave a "misleading impression" about the safety of Zepbound, Wegovy and similar "drugs with multiple serious, potentially life-threatening risks.""
Federal health officials posted more than 100 warning letters to drugmakers and online prescribing companies, naming Hims & Hers among recipients. The FDA instructed Hims to remove "false and misleading" website claims that its customized compounded products contain "the same active ingredient" as FDA-approved drugs Wegovy and Ozempic. Regulators noted the cited formulations are produced by specialty compounding pharmacies and are not reviewed or approved by the FDA. Hims said it looks forward to engaging with the FDA and that its customer materials note compounded treatments are not approved or evaluated by the FDA. The FDA also challenged a 2024 GLP-1 infomercial for giving a misleading impression about safety of Zepbound, Wegovy and similar drugs with multiple serious risks.
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