Location: Plainsboro, New JerseyWarning 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 Wegovy (semaglutide) injection, for subcutaneous use, Ozempic (semaglutide) injection, for subcutaneous use, and Victoza (liraglutide) injection, for subcutaneous use.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, Novo Nordisk promoted Wegovy, Ozempic, and Victoza in a manner that failed to present the serious risks of these drug products in a truthful and nonmisleading manner
Author contributions FC: Writing original draft
Assignment is random and determined by study protocols overseen by federal regulators
Concerns with Unapproved GLP-1 Drugs Used for Weight Loss and Diabetes The FDA has documented over 600 adverse event reports related to compounded semaglutide by mid-2025, highlighting important safety concerns with non-approved alternatives
All the participants completed the general questionnaire, and information on anthropometric factors (height and weight) was collected at the beginning of the study
You may be asked to continue with this treatment for a period after becoming pregnant