The U.S. Food and Drug Administration (FDA) has sent a letter to Hims & Hers Health (HIMS) CEO Andrew Dudum alleging that his company’s claims about its compounded semaglutide products that are used for weight loss are “false or misleading.”
The agency said that claims made on the Hims & Hers website about the semaglutide drugs are in violation of certain sections of the Federal Food, Drug, and Cosmetic Act.
Central to the FDA’s complaints are two specific statements made by the company in reference to its drugs: “Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy” and “Clinically proven ingredients.”
The FDA appears to interpret these statements as implying that the compounded semaglutide drugs being offered by Hims & Hers were approved by the agency in the same way that Novo Nordisk’s (NVO) Ozempic and Wegovy have been.
“Compounded drug products are not FDA-approved,” George Tidmarsh, director of the FDA’s Center for Drug Evaluation and Research wrote in his letter. “Your claims imply that your products are the same as an FDA-approved product when they are not.”
Tidmarsch gave Dudum 15 working days to send a written response detailing the steps that Hims & Hers are taking to prevent the recurrence of the violations. Or if Dudum doesn’t believe the company is in violation of the FDA’s regulations then he needs to explain why in his response.
“Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction,” Tidmarsch wrote.
However, while the Hims & Hers website still makes reference to its compounded GLP-1 drugs having “the same active ingredient as Ozempic,” it also includes a message indicating that compounded drugs “have not been approved by the FDA.”
The FDA temporarily allowed compounded GLP-1 drugs during a supply shortage, but now that the agency says the shortage is over, those alternatives are technically illegal.
Some companies found a legal loophole and continue selling them as “personalized medicine.”
That loophole allows a patient to be prescribed a modified version of a drug if they can’t tolerate the original but it’s being exploited, regulators warn.
Novo Nordisk terminated its collaboration with Hims & Hers in June after it said the latter had “failed to adhere to the law which prohibits mass sales of compounded drugs under the false guise of ‘personalization’ and are disseminating deceptive marketing that put patient safety at risk.”
Dulum fired back at Novo Nordisk in a post on X, accusing the management of “misleading the public.”
“In recent weeks, Novo Nordisk’s commercial team increasingly pressured us to control clinical standards and steer patients to Wegovy regardless of whether it was clinically best for patients,” he wrote at the time. “We refuse to be strong-armed by any pharmaceutical company’s anticompetitive demands that infringe on the independent decision making of providers and limit patient choice.”
Shares of HIMS fell nearly 6% on Tuesday but are still up 110.5% for the year.
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