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.
“Your claims imply that your products are the same as an FDA-approved product when they are not,” states the warning letter, dated Sept. 9.
Hims said Tuesday that it “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,” the company said in a statement.
The new FDA letters each contain “cease and desist” language. That’s a different approach for the agency, which typically drafts its letters in highly bureaucratic language citing specific FDA regulations.
Hims has been under scrutiny from Washington for some time.
Makary singled out the ad in last week’s Journal of the American Medical Association, calling it a “brazen” example of how advertising is “contributing to America’s culture of overreliance on pharmaceuticals for health.”
Hims and similar companies initially sold cheap generic versions of drugs for hair loss, erectile dysfunction and other health issues. But booming demand for obesity medications opened the door to selling cheaper copies.
The FDA permits so-called compounding, or customized production, when there is a shortage of the official versions of FDA-approved medications.
Hims and other companies have taken to offering “personalized” dosages and formulations for certain patients, arguing they offer extra benefits.
Shares of San Francisco-based Hims & Hers Health Inc. fell more than 6.47% in trading Tuesday.
The letters posted Tuesday come from FDA’s drug center.
Researchers and consumer advocates have long complained that the upbeat TV images of patients enjoying life with family and friends often overshadow discussions of side effects.
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