Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc. Warning Letter Details

Summary

Medolife Rx, AELIA, Inc., and Quanta Inc. were cited for marketing unapproved new drugs under sections 301(d) and 505(a) of the FD&C Act, including products named Escozine-HP, Escozine Immunapen, and several Immunapen variants sold through their websites. The company made disease claims for serious conditions including cancer, HIV, and COVID-19 without FDA approval, establishing these products as drugs under section 201(g)(1) rather than the dietary supplements or cosmetics they may have been presented as. The violations were identified during an April 2023 FDA review of the company's websites offering these products for sale in interstate commerce.