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

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

These products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a).

Passage 2

your “Escozine-HP,” “Escozine Immunapen,” “Escozine Immunapen Anti Anxiety,” “Escozine Immunapen Energy & Focus,” and “Escozine Immunapen Stress Relief” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.

Passage 3

These products are especially concerning from a public health perspective because they claim to cure, mitigate, treat, or prevent serious and/or life-threatening conditions including, but not limited to, cancer, HIV, and COVID-19.

Passage 4

“Escozine-HP . . . This OTC homeopathic remedy combines polarized blue scorpion venom with renown homeopathic ingredients Bryonia alba and Echinacea purpurea for cancer patients undergoing or recovering from chemotherapy.

Passage 5

“Blue scorpion venom . . . All Medolife RX Immunapens contain a patented polarized solution of Rhopalurus princeps scorpion venom. Current pharmaceuticals utilize snakes, scorpions, snails, and sea anemone venom components. These highly regarded medicines are used to treat cancer, high blood pressure, autoimmune disease, MS and HIV.”

Passage 6

“Escozine has shown promising results in helping patients to overcome many viral infections, including COVID-19 as well as eliminating multiple cancer cell lines in clinical trials and has shown to have quality of life enhancement capabilities that could be marketed as an independent drug.”

Passage 7

“Escozine has shown promising results, in proof-of-concept clinical studies for Covid-19 patients.”

Passage 8

“Escozine/ Covid-19: Data on Escozine has been filed under pre-IND with US FDA as a potential COVID1-19. [sic] Clinical studies showing efficacy and safety of product”

Passage 9

“Escozine has shown promising results in proof-of-concept clinical studies. In the United States, Medolife Rx is currently in the Pre-Approval pathway for the Covid -19 therapy drug (FDA PIND #150335), where the company expects to move into the Investigational New Drug (IND) status.”

Passage 10

“In the Domonican [sic] Republic, the company has an exclusive licence [sic] with the minister of health, allowing Escozine to become the first registered treatment for COVID-19.”

Passage 11

“Preliminary research has been conducted on various types of Cancers, where Escozine has induced apoptosis (programmed cancer cell death).”

Passage 12

“Research show that Escozine has the ability to reverse Chemotherapy drug resistance in Cancer patients, which is common up to 30%.”

Passage 13

Your “Escozine-HP,” “Escozine Immunapen,” “Escozine Immunapen Anti Anxiety,” “Escozine Immunapen Energy & Focus,” and “Escozine Immunapen Stress Relief” products are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).

Passage 14

No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for “Escozine-HP,” “Escozine Immunapen,” “Escozine Immunapen Anti Anxiety,” “Escozine Immunapen Energy & Focus,” and “Escozine Immunapen Stress Relief.”