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

Warning LetterOpen

Arthur G. Mikaelian CEO and President Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc. 632 S. Glenwood Place Burbank , CA 91506 United States info@aelia.com info@medolife.comIssued Apr 19, 2023Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateApr 19, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc.
Location: Arthur G. Mikaelian CEO and President Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc. 632 S. Glenwood Place Burbank , CA 91506 United States info@aelia.com info@medolife.com
FEI Number: N/A
Country: United States
Issue Date: April 19, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

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.

Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc. FDA Warning Letter, April 19, 2023