FDA WARNING_LETTER - Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc. - April 25, 2023

The FDA issued a Warning Letter to Arthur Mikaelian regarding products sold on www.medolife.com and www.medoliferx.com, specifically "Escozine-HP," "Escozine Immunapen," "Escozine Immunapen Anti Anxiety," "Escozine Immunapen Energy & Focus," and "Escozine Immunapen Stress Relief." The FDA reviewed these websites in April 2023.

These products are deemed unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), and their introduction into interstate commerce violates sections 301(d) and 505(a). The products are classified as drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), due to claims of intended use in diagnosing, curing, mitigating, treating, or preventing disease, or affecting body structure/function.

Of particular concern are claims to treat serious conditions like cancer, HIV, and COVID-19. The products are not generally recognized as safe and effective (GRASE) for their claimed uses, making them "new drugs" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). No FDA