Newman Clinic, PLLC dba Newman Clinic Warning Letter Details

Summary

Newman Clinic was cited for marketing compounded semaglutide and tirzepatide products with false or misleading claims and labeling that violated the Federal Food, Drug, and Cosmetic Act. The clinic's website falsely represented that Newman Clinic was the compounder of these drugs when it was not, and made unsubstantiated claims equating the compounded products to FDA-approved drugs like Ozempic®, Wegovy®, Mounjaro®, and Zepbound®, implying FDA approval that did not exist. These violations rendered the products misbranded under sections 502(a) and 502(bb) of the FDCA and constituted introduction of misbranded drugs into interstate commerce.