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...
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