Hello Cake, Inc. dba Hello Cake Warning Letter Details

Summary

Hello Cake, Inc. was cited for unlawfully selling unapproved and misbranded compounded drugs containing sildenafil and tadalafil over the internet, violating sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act. The company made false or misleading claims that its compounded products were equivalent to FDA-approved branded medications (Viagra and Cialis) while costing less, implying bioequivalence that does not exist for unapproved compounded formulations. The FDA determined these marketing claims rendered the products misbranded and prohibited under section 301(a) of the FDCA, as compounded drugs are not FDA-approved and cannot be legally promoted as interchangeable with approved pharmaceuticals.