Hims falls after FDA posts warning letter
The agency’s letter took issue with the claims made in Hims’ marketing materials.
Hims & Hers fell by more than 5% after the US Food and Drug Administration posted a warning letter it sent the company over its compounded weight-loss drugs.
In a letter dated September 9, the FDA took issue with how Hims has marketed its compounded semaglutide, which uses the active ingredient in Novo Nordisk’s Ozempic and Wegovy but in “personalized” doses. Compounded drugs are not evaluated or approved by the FDA.
In its marketing materials, Hims says its products use “clinically proven ingredients,” among other assertions. “Your claims imply that your products are the same as an FDA-approved product when they are not,” the FDA said.
A Hims spokesperson declined to comment on the letter. In a post on X, Hims CEO Andrew Dudum emphasized that Hims was not the only company to receive a letter from the FDA.
"With this industry-wide push, the FDA is demonstrating its commitment to ensuring individuals can make informed choices about their care – a commitment we share and something Hims & Hers was built to do," he said.
Last week, President Donald Trump issued an executive order directing the Secretary of Health and Human Services to crack down on drug ads. It was initially unclear whether that order would extend to telehealth companies that also sell compounded drugs, which operate in a regulatory gray area and have historically not been held to the same standards as drugmakers.
Last week, FDA Commissioner Marty Makary authored an opinion piece in the JAMA Network on pharmaceuticals in which he called out Hims’ Super Bowl ad. In the piece, he called it out as the “most overt” example of “brazen” marketing tactics from drug companies.
The FDA also sent warning letters to other compounders, including BlueChew and Zealthy, over their compounded erectile dysfunction and weight loss drugs, respectively. It also sent letters to Novo and Eli Lillyover claims made in marketing of their branded weight loss drugs.
Still, Novo and Lilly nudged up on the news. Compounders have nibbled away at drugmakers' marketshare and until now the FDA has not weighed in on the issue.
