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WARNING LETTER

Date: November 7, 2022

RE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

This is to advise you that the United States Food and Drug Administration (FDA) reviewed your websites at the Internet addresses https://www.todosmedical.com, https://www.mytollovid.com and https://www.tollovid.myshopify.com on June 23, 2022. We also reviewed your social media websites at https://www.facebook.com/todosmedical and https://www.youtube.com/channel/UCWsJLl1iB9qlZUSicQ9e-Mg, where you direct consumers to your websites https://www.mytollovid.com and https://www.todosmedical.com, respectively, to purchase your products. Additionally, we reviewed your product listings on your Amazon storefront at https://www.amazon.com/s?ie=UTF8&marketplaceID=ATVPDKIKX0DER&me=A1DTBIYVC3OVND. The FDA has observed that your websites and your Amazon storefront offer the product Tollovid 3CL Protease Inhibitor Delayed Release (Tollovid) for sale in the United States and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19¹ in people. Based on our review, this product is an unapproved new drug sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).

There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.² In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19.³ Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell a product that is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.

Some examples of the claims on your websites that establish the intended use of your product and misleadingly represent it as safe and/or effective for the treatment or prevention of COVID-19 include:

• “3CL Protease Inhibitors: The Potential Key to Combating the SARS-CoV-2 Virus Life Cycle . . . Studies have shown … that by using protease inhibitors, we can stop the virus’ ability to replicate itself, halting the spread in it [sic] tracks.” [from your website https://todosmedical.com/3cl- protease-inhibitors?hsLang=en]

• Under the heading “Protease Inhibitors”:
“Todos has acquired exclusive distribution rights to the immune boosting, dietary supplement Tollovid™ and is developing Tollovir,™ a highly potent 3CL protease inhibitor as a COVID-10 antiviral.” [from your homepage at https://www.todosmedical.com]

• "What is a 3CL Protease?
Formally known as C3 Endopeptidase, the main protease found in coronaviruses." [from https://mytollovid.com/a/faq]

• "Todos Medical featured in a new Seeking Alpha article: Pfizer's #3CL #Protease #Inhibitor May Cut the Achilles’ Heel of #COVID19
. . .
Todos . . .has a promising pipeline of products . . . Its 3CL protease inhibitor is called Tollovir. It is an antiviral, but it is also designed to support immune function. They also have a dietary supplement made of the same active ingredient that supports immune function.” [from a September 8, 2021 post on your social media webpage https://www.facebook.com/todosmedical]

Your website https://www.mytollovid.com also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Tollovid for the cure, mitigation, treatment, or prevention of disease (https://mytollovid.com/pages/testimonials). Examples of such testimonials include:

J. Reese on November 14, 2021
“A 5-day dosing regimen of Tollovid, from all the research I have done on 3CL Protease inhibitors, should keep the [infection] from replicating to the point I need hospitalization. A small price to pay for my health.”

Anonymous on September 27, 2021
“Excited to boost my immune system and not worry anymore in unmasked situations!! Work in retail and desired extra protection against illness during uncertain times.”

Keegan B. on January 12, 2021
“I believe Tollovid helps … When I found out I tested positive, I immediately ordered a bottle of Tollovid. I took 6 capsules a day, and I believe it helped me in the fight against this disease. I am fortunate to have known about this product because I do believe it gave me an advantage to a quick recovery . . .”

Michael B. on December 8, 2020
“My family and I were directly exposed a few weeks ago, we had just started taking Tollovid and no one in my family contracted it while the other family we were with all ended up positive and sick. While there is no way of proving it was because of taking Tollovid, I’m grateful we were on it and will continue to take it.‘"

You should take immediate action to address this matter. This letter is not meant to be an all-inclusive statement of violations that may exist in connection with your products or operations. It is your responsibility to ensure that the products you sell are in compliance with the FD&C Act and FDA's implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a COVID-19-related use for which they have not been approved by FDA and that you do not make claims that misbrand the products in violation of the FD&C Act. Within 48 hours, please send an email to COVID-19-Task-Force-CFSAN@fda.hhs.gov describing the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of any 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.

FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and that are being misleadingly represented as safe and/or effective for the treatment or prevention of COVID-19. Your firm will be added to a published list on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the FD&C Act. This list can be found at http://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-covid-19-products.

Once you have taken actions to address the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and any appropriate corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken such corrective actions.

This letter notifies you of our concerns and provides you with an opportunity to address them. If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. 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 are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission if they are offered for importation into the United States. We may advise the appropriate regulatory officials in the country from which you operate that FDA considers your product(s) referenced above to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.

Please direct any inquiries to FDA at COVID-19-Task-Force-CFSAN@fda.hhs.gov.

Sincerely,
/S/
Ann M. Oxenham Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration

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1 As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).

2 Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.

3 Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency- concerning-novel-coronavirus-disease-covid-19-outbreak/.