FDA warns Hims & Hers and other weight loss drugmakers to remove ‘false and misleading’ advertising

Core Viewpoint - Federal health officials are targeting telehealth companies for promoting unofficial versions of prescription drugs, particularly weight loss medications, as part of a crackdown on pharmaceutical advertising initiated by the Trump administration [1][6]. Regulatory Actions - The FDA issued over 100 warning letters to drugmakers and online prescribing companies, including Hims & Hers, which has developed a multibillion-dollar business around lower-cost obesity medications [2][9]. - Hims & Hers received a warning to remove misleading promotional statements from its website, specifically claims that their products contain the same active ingredients as FDA-approved drugs like Wegovy and Ozempic [3][4]. Company Responses - Hims stated it looks forward to engaging with the FDA and emphasized that its materials indicate compounded treatments are not FDA-approved [4]. - The company has faced scrutiny for its advertising practices, including a Super Bowl ad that failed to disclose side effects of its weight-loss medications [7][9]. Industry Context - The FDA's recent actions mark a shift towards more direct regulation of online platforms, which have previously argued they are not bound by traditional drug advertising rules [4][6]. - The FDA has determined that GLP-1 drugs no longer meet the criteria for shortage, which impacts the compounding practices of companies like Hims [8]. Market Impact - Following the FDA's warning letters, shares of Hims & Hers Health Inc. fell by more than 6.47% [9].