The FDCA defines labeling broadly to mean all labels and other written, printed or graphic matter.[26] The FDA and the Supreme Court have broadly interpreted labeling to apply to marketing and advertising materials, including advertisements.[27] We look forward to further dialogue with you both regarding the urgent need for FDA to take action against compounded drug advertisements that fail to comply with FDA laws, regulations, and guidance
Major US medical organizations including ACOG, The Menopause Society, and NASEM have concluded that compounded bioidentical hormone therapy claims of superior safety or effectiveness over FDA-approved hormone therapy are not substantiated by evidence from well-designed clinical studies, and that FDA-approved hormone therapy products are generally recommended over compounded alternatives when an FDA-approved formulation appropriate to the patient is available
GLP-1 medications and online weight loss programs GLP-1based medications, including GLP-1 agonists and GLP-1/GIP medications, have become central to medical weight loss, with one in eight adults currently taking a GLP-1 drug for weight loss or chronic conditions
Strengths of this study included the sizable nondiabetic population in the database
