Try Nova Warning Letter Details

Summary

Try Nova was cited for unlawfully selling unapproved and misbranded compounded drug products, including semaglutide, over the internet to U.S. consumers. The company violated FDA regulations by claiming its compounded semaglutide products contained the "same active ingredient as Wegovy & Ozempic," a false or misleading statement that implied equivalence to FDA-approved drugs when compounded products are not FDA-approved. This marketing claim violated sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act, resulting in the introduction of misbranded drugs into interstate commerce in violation of section 301(a).