Biopolygen Corp.

Date: July 9, 2021 RE: Adulterated 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 website at the Internet address https://www.biopolygen.com on January 7, 2021, February 26, 2021, and June 30, 2021. The FDA has observed that your website offers the “COVIGEN AG-1 Covid-19 Self Detection Kit,” the “COVIDEX AB-1 Covid-19 Self Detection Kit,” and the “COVID-19 Antigen and Antibody Combo Set” (hereafter referred to collectively as “COVID-19 Self Detection Test Kits”) for sale in the United States. Based on our review, these products are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19[1] in people, and thus, are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).

The Covid-19 Self Detection Test Kits are offered for sale and distributed to consumers in the United States for self-testing without marketing approval, clearance, or authorization from FDA. Accordingly, the products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). Your products are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). The introduction or delivery for introduction of this product into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S.C. § 331(a). In addition, it is a prohibited act under section 301(k) of the Act, 21 U.S.C. § 331(k), to do any act with respect to a device while the device is held for sale after shipment in interstate commerce and results in the device being misbranded.

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, clearance, or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you offer for sale products that are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 in people. We request that you take immediate action to cease the sale of any unapproved, uncleared, and unauthorized products for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.

We also note that different and potentially serious public health risks are presented with specimen collection and testing in the home versus a healthcare setting. Risks may include, but are not limited to, whether a lay person has the ability to collect their specimen, run the test, and interpret the test result accurately. Your website (noted above), includes statements indicating that the COVID-19 Self Detection Test Kits may be purchased directly by consumers and are intended to be used for self-testing for COVID-19, including:

“ACCURACY BUT FAST, EFFICIENT; ANYTIME, ANYWHERE AT YOUR PRIVACY AND CONVENIENCE.” [https://www.biopolygen.com/shop/-Covid-19-antigen/c-p778]

“INSTANT AND EASY ACCESS TO SCREENING CAN BE LIFE OF[sic] DEATH. SCREENING FOR YOURSELF AND YOUR FAMILY TODAY AND REPEAT THE ROUTINE SCREENINGS TO PROTECT YOURSELF.” [https://www.biopolygen.com/shop/-Covid-19-antigen/c-p778]

A photograph of the “COVID-19 Antigen and Antibody Combo Set” includes the following language: “SELF-SCREENING METHOD FOR EALRY PREVENTION AND EARLY TREATMENT.” [https://www.biopolygen.com/shop/-Covid-19-antigen-antibodycombination/c-p783]

For more information about FDA’s regulation of devices used to mitigate, prevent, treat, diagnose, or cure COVID-19; frequently asked questions; and other helpful resources, visit our website at https://www.fda.gov/medical-devices/emergency-situations-medicaldevices/coronavirus-covid-19-and-medical-devices. In addition, the guidance titled “Policy for Coronavirus Disease 2019 Tests During the Public Health Emergency (Revised)”[4] provides information about FDA’s policies intended to help expand testing capacity by facilitating the development and use of COVID-19 tests during the public health emergency.

You should take immediate action to address the violations cited in this letter. This letter is not meant to be an all-inclusive list of violations that exist in connection with your products or operations. It is your responsibility to ensure that the products you sell are in compliance with the Act and its 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/or effective for a COVID-19-related use for which they have not been approved, cleared, or authorized by FDA and that you do not make claims that adulterate or misbrand the products in violation of the Act. Within 48 hours, please send an email to COVID-19-Task-Force-CDRH@fda.hhs.gov describing the specific steps you have taken to address these 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 correct any violations may result in legal action, including, without limitation, seizure and injunction.

FDA is advising consumers not to purchase or use certain products that are not in compliance with FDA requirements and are being misleadingly represented as safe and/or effective for the mitigation, prevention, treatment, diagnosis, or cure 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 Act. This list can be found at https://www.fda.gov/consumers/health-fraud-scams/fraudulentcoronavirus-disease-2019-covid-19-products. Once you have taken actions to address the sale of your unapproved, uncleared, 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 Act, include your reasoning and any supporting information for our consideration.

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