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Location: Indianapolis, IndianaWarning Letter Date: September 9, 2025FDA Department Issuing Warning: Center for Drug Evaluation and Research (CDER)Type of Warning: False & Misleading Claims/Misbranded DrugsSubject of Violation: An Oprah Special: Shame, Blame, and the Weight Loss Revolution, regarding Zepbound (tirzepatide) and Mounjaro (tirzepatide)FDA Warning: In the program, which aired on television in 2024 and until recently was available continuously on the ABC website and through various streaming services, Eli Lilly promoted Mounjaro and Zepbound in a manner that failed to present the serious risks of these drug products in a truthful and nonmisleading manner, despite FDAs prior correspondence (advisory comments dated June 13, 2022 and June 21, 2022)

A 4 mg maintenance dose is also being studied alongside 9 mg and 12 mg