Regulatory and Safety Notice BPC-157, TB500, and growth hormone secretagogues lack FDA approval for performance enhancement or aesthetic applications
Some early reports did describe the occurrence of chronic liver disease that was associated with the long-term use of Tylenol in recommended doses
IgE, mast cells, basophils, and eosinophils
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
