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

Source: https://www.keypedia.com/records/warning_letter/medolife-rx-dba-medolife-corp-aelia-inc-and-quanta-inc/37aca560-0acf-48c4-8421-967d37db67f8

> FDA WARNING_LETTER for Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc. on April 25, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc.
- Inspection Date: 2023-04-25
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

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- [Director](https://www.keypedia.com/people/jill-p-furman/984bfbfc-3f4e-46bc-8d3b-3d82e56c6ac9)

Company: https://www.keypedia.com/companies/medolife-rx-dba-medolife-corp-aelia-inc-and-quanta-inc/646f1569-c4b7-499c-884a-624d89886e77

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c