TRYM Health, Inc. dba TRYM Health Warning Letter Details

Summary

TRYM Health sold unapproved and misbranded compounded drug products (semaglutide and tirzepatide) over the internet by making false or misleading claims that violated sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act. The company's website contained claims stating the products were "Clinically Proven to Work" and contained "the same active ingredient" as FDA-approved drugs like Ozempic, Wegovy, Mounjaro, and ZepBound, which falsely implied the compounded products were equivalent to approved medications despite lacking FDA approval. These misbranded products were introduced into interstate commerce in violation of section 301(a) of the FDCA.