By Evie Liu
Shares of Hims & Hers Health tumbled more than 12% on Friday in after-hours trading, as the company faced increased scrutiny from federal regulators.
The Department of Health and Human Services referred the consumer wellness company to the Department of Justice for investigation, wrote HHS general counsel Mike Stuart in a post on X Friday afternoon.
Stuart said the referral was for investigation of potential violations by Hims of the Federal Food, Drug, and Cosmetic Act -- the main U.S. drug law enforced by the Food and Drug Administration -- and applicable Title 18 provisions, which covers federal crimes.
"Hims & Hers has always operated with a deep commitment to the safety and best interests of consumers and in compliance with applicable law. We have a long history of successfully working with regulators, and look forward to continuing to engage with the FDA to ensure safe access to affordable healthcare," Hims said in a statement to Barron's.
The announcement came after Hims announced this week that it had begun offering a compounded version of popular weight-loss medicine Wegovy, sold by Danish drugmaker Novo Nordisk, at a sharply discounted price -- starting at $49 per month compared to Wegovy at $149.
Stuart's post on Friday did not explicitly name Hims' copycat drug.
Unlike Wegovy, the Hims product has not been reviewed or approved by the FDA for safety or effectiveness. While U.S. law allows compounded drugs under limited circumstances, regulators have warned that they run the risk of misleading advertising if the marketing implies that they have similar effects as FDA-approved drugs.
Novo Nordisk said in a statement on Thursday that Hims' product is "illegal" and "poses a significant risk to patient safety."
Hims said in a post on X on Thursday, "This is not the first time (nor will it be the last time) a big pharma company has suggested taking an accessible, customer-first approach to healthcare is dangerous, illegal, or bad for the marketplace."
On Thursday, FDA's commissioner Dr. Marty Makary said in a post on X that the agency would "take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products."
Makary didn't refer to Novo or Wegovy by name. Still, Hims stock dropped 2% on Friday during the regular session, while Novo shares rallied 10%. Novo shares jumped 4.2% in after-hours trading.
Investors will be watching closely for any public statements from federal agencies as the situation develops. If the DOJ opens a formal investigation or brings charges, Hims could face costly litigation and threat of enforcement actions.
George Glover contributed to this article.
Write to Evie Liu at evie.liu@barrons.com
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February 06, 2026 20:22 ET (01:22 GMT)
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