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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)

FDA-Approved Tirzepatide : Mounjaro and Zepbound are produced under highly controlled conditions with consistent dosing, purity, and efficacy

Hold duration: Keep the liquid under the tongue for at least two minutes

Store Tirzepatide in the freezer, thaw for 30 min-1 hr prior to injection, and return to the freezer until the next dose is due.

The goal is to keep it below 25% of total weight lost, which is the threshold where cardiometabolic benefits remain largely preserved