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The FDA cited the telehealth company for making statements on its website that were false or misleading, including claims that its products were weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy and contained clinically proven ingredients. In the warning letter, dated September 9, the agency emphasized that compounded drug products are not FDA-approved, and Hims & Hers statements implied equivalency to FDA-approved medications, which is not accurate

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