Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc.
FDA issued a warning letter to Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc. (CEO Arthur Mikaelian) in April 2023 after reviewing their websites and finding that five 'Escozine' products — marketed as homeopathic remedies containing polarized blue scorpion venom — were being sold with claims to treat, cure, or mitigate serious conditions including cancer, HIV, and COVID-19. FDA determined these products are unapproved new drugs under section 505(a) of the FD&C Act, as no approved application is in effect for any of them. The agency warned that failure to correct violations could result in seizure and injunction, and required a written response within fifteen working days.
Flagged claims (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
Escozine has shown promising results, in proof-of-concept clinical studies for Covid-19 patients.
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.
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.
Preliminary research has been conducted on various types of Cancers, where Escozine has induced apoptosis (programmed cancer cell death).
Research show that Escozine has the ability to reverse Chemotherapy drug resistance in Cancer patients, which is common up to 30%.
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.
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. The product's unique blend of polarized ingredients created with patented technology help relieve common side-effects of chemotherapy, such as . . . Relieves pain[,] Relieves inflammation[,] Improves energy[,] Improves sleep[, and] Improves appetite
Required actions (2)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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