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Novo Nordisk was cited for false and misleading promotional claims in a direct-to-consumer video titled "An Oprah Special: Shame, Blame, and the Weight Loss Revolution" that promoted Wegovy, Ozempic, and Victoza without adequately communicating serious safety risks, including a boxed warning for thyroid C-cell tumors. The company violated FDA regulations by failing to submit the promotional materials for review prior to dissemination, as required by 21 CFR 314.81(b)(3)(i), and the video created a misleading impression regarding drug safety in a vulnerable patient population. The violations were deemed particularly concerning because obesity, excessive weight, and type 2 diabetes are significant public health issues affecting millions of Americans and vulnerable populations including children.