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WARNING LETTER

April 19, 2023

RE: 651522

Dear Arthur Mikaelian:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses www.medolife.com and www.medoliferx.com in April 2023. The FDA has observed that your websites offer “Escozine-HP,” “Escozine Immunapen,” “Escozine Immunapen Anti Anxiety,” “Escozine Immunapen Energy & Focus,” and “Escozine Immunapen Stress Relief” for sale in the United States. Based on our review, 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). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Based on a review of your websites, 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. 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. Examples of claims from your websites www.medolife.com and www.medoliferx.com that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:

On your firm’s website www.medolife.com:

• “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”

On your firm’s website www.medoliferx.com:

• “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.”

On your firm’s webpage https://medoliferx.com/clinical-strategy/:

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

On your firm’s webpage https://medoliferx.com/focus-areas/:

• “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.”
• “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%.”

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). With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). 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.”¹ Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

We recognize that your “Escozine-HP,” “Escozine Immunapen,” “Escozine Immunapen Anti Anxiety,” “Escozine Immunapen Energy & Focus,” and “Escozine Immunapen Stress Relief” products are labeled as homeopathic drugs with active ingredient(s) measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

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. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Please direct any inquiries to FDA at [email protected].

Sincerely,
/S/

Jill Furman
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

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1 Your website www.medoliferx.com references that a pre-investigational new drug application (pre-IND) has been filed with the FDA (PIND 150335); however, we note a pre-IND is neither an approved new drug application nor an IND. Even if you had an IND on file, a sponsor or investigator must adhere to the applicable statutory requirements in the FD&C Act and applicable regulations contained in 21 CFR Part 312.