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The US drug regulator plans to crack down on copycat versions of popular weight-loss drugs sold by Hims & Hers, just hours after the US telehealth company said it would undercut Novo Nordisk on the price of its popular obesity products.
The Food and Drug Administration on Friday said it would take action to restrict the sales of the active ingredients in weight-loss drugs that are compounded and not approved by the agency. The FDA specifically mentioned Hims, a San Francisco-based telehealth company that sells treatments for weight-loss, hair-loss and other maladies. The regulator also said it would combat misleading advertisements.
“The FDA will use all available compliance and enforcement tools within its authorities to address unsubstantiated claims and associated public health concerns,” the agency said.
The announcement comes a day after Hims said its cheaper version of the Wegovy pill would retail at $49 a month and contain semaglutide, the same active ingredient as Novo’s drug. Denmark-based Novo began selling Wegovy in the US last month for $149 a month at the lowest dose after it became the first oral version of a weight-loss drug to be approved by regulators worldwide.
Novo denounced Hims’ pricing move, calling it “illegal mass compounding” and threatened legal action.
Novo on Thursday said: “This is another example of Hims & Hers’ historic behaviour of duping the American public with knock-off GLP-1 products, and the FDA has previously warned them about their deceptive advertising of GLP-1 knock-offs.”
The FDA’s move comes days before Hims is scheduled to run a television ad during the Super Bowl football game on Sunday, traditionally the most watched TV programme of the year. Last year, the FDA sent warning letters to drug companies about their ads, and said the enforcement threats were prompted in part by Hims’ 2025 Super Bowl commercial.
Hims said it complies with applicable laws and has a long history of working with regulators. “[We] look forward to continuing to engage with the FDA to ensure safe access to affordable healthcare.”
The company’s shares have plunged 43 per cent over the past month and traded down after the FDA’s announcement on Friday.
For months, investors had been asking why Novo had not sued Hims over its compounded product in which the Danish group still has a valid patent, Jefferies, the investment bank, wrote on Friday.
“Hims’s introduction of an oral version of Wegovy that they’re compounding in their pharmacies elicited a response and a threat of legal action from Novo that we believe intensifies the legal overhang on the stock.”
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