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Eli Lilly distributed a false or misleading direct-to-consumer video promoting ZEPBOUND® (tirzepatide) that misrepresented the safety and effectiveness of the drug, which carries serious risks including a boxed warning for thyroid C-cell tumors. The company violated the Federal Food, Drug, and Cosmetic Act by failing to submit the promotional materials for FDA review prior to dissemination, as required by 21 CFR 314.81(b)(3)(i). The video, featuring company representatives and posted on a Fox25 affiliate website in July 2025, created a misleading impression about the drug's safety profile despite its multiple serious and potentially life-threatening risks.