In a letter dated September 9, the FDA alleged that the company’s claims concerning compounded Semaglutide products are “false or misleading.”
Shares of Hims & Hers Health (HIMS) slumped 7% on Tuesday after the U.S. Food and Drug Administration (FDA) sent a letter to the company CEO regarding the sale of compounded drug products.
In the letter dated September 9, the agency alleged that the company’s claims concerning compounded Semaglutide products, used for weight loss, are “false or misleading.” The FDA also noted that this is a violation of certain sections of the Federal Food, Drug, and Cosmetic Act.
The FDA pointed out that compounded drug products are not approved by it. “Your claims imply that your products are the same as an FDA-approved product when they are not,” the letter said, while urging the company to take immediate action to address violations. A failure to adequately address any violation may result in legal action without further notice, it added.
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