The Food and Drug Administration is targeting misleading promotional practices in pharmaceutical advertising, focusing on weight loss medications and telehealth services.
Why it matters: This marks the first direct attempt by the FDA to police companies like Hims & Hers, which have long argued they’re not subject to traditional drug advertising rules.
The details:
- The FDA posted more than 100 letters to various drugmakers and online prescribing companies, addressing misleading promotional practices.
- Hims & Hers was warned to remove “false and misleading” promotional statements from its website, including claims that its customized products contain “the same active ingredients” as FDA-approved drugs Wegovy and Ozempic.
- The FDA also issued separate warning letters to manufacturers of GLP-1 drugs, critiquing a 2024 infomercial featuring misleading safety information about Zepbound, Wegovy, and similar drugs with serious, potentially life-threatening risks.
- A memo signed by President Donald Trump directed government agencies and the FDA to ensure that advertisements, social media, and other websites are “truthful and non-misleading.”
The new FDA letters utilize “cease and desist” language, differing from the agency’s usual practice of citing specific regulations in more bureaucratic terms.
The background: Hims & Hers has been under scrutiny from Washington for some time. Earlier this year, an advertisement from the company touted the benefits of its weight-loss medications but failed to list their side effects or potential harms. FDA rules require advertisements to present a balanced view of drug risks and benefits.
The bottomline: The new FDA crackdown signals a heightened effort to ensure that pharmaceutical advertising practices adhere to the agency’s strict guidelines, providing consumers with accurate and truthful information.
