- Medical Devices
- Issuing Office:
- Center for Devices and Radiological Health
Date: April 6, 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://sethilaboratories.com on March 19, 2021. We also reviewed your social media websites at https://www.facebook.com/sethilabs, https://www.instagram.com/p/CGC8yKEHXZO, and https://twitter.com/SethiLabsUS, where you direct consumers to your website, www.sethilaboratories.com, to purchase your products. The FDA has observed that your website offers a “Rapid COVID-19 Antibody Self Test Kit” (which your website also refers to as the “Novel Coronavirus Antibody Test Kit,” “COVID-19 ANTIBODY SELF TEST KIT,” and “AB Rapid Kit”) (hereafter referred to as the “COVID-19 Antibody Self Test Kit”) and a “Rapid COVID-19 Antigen Self Test Kit” (which your website also refers to as the “Novel Coronavirus Antigen Test Kit” and “Sethi Laboratories COVID-19 Antigen test”) (hereafter referred to as the “COVID-19 Antigen Self Test Kit”). Based on our review, the COVID-19 Antibody Self Test Kit and COVID-19 Antigen Self Test Kit are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-191 in people, and thus, they 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 Antibody Self Test Kit and COVID-19 Antigen Self Test Kit are offered for sale in the United States directly to consumers to self-test at home or outside of a healthcare setting without marketing approval, clearance, or authorization from FDA.2,3 Accordingly, your 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 these products 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.4 In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19.5 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 above, you sell 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.
Different and potentially serious public health risks are presented with sample collection and testing by lay users at home or outside of a healthcare setting versus collection and testing in a healthcare setting. Such risks 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, https://sethilaboratories.com, and social media websites indicate that your firm’s COVID-19 Antibody Self Test Kit and COVID-19 Antigen Self Test Kit may be purchased directly by consumers to self-test at home or outside of a healthcare setting, including:
• “RAPID COVID-19 ANTIBODY SELF TEST KITS…GREAT FOR BUSINESSES…Find out if you have Covid-19 without an appointment from the convenience of your home or business! . . . CONTAINS 25 SELF-ADMINISTERED TESTS” [https://sethilaboratories.com/novel-coronavirus-antibody-test-kit/]
• “RAPID COVID-19 ANTIGEN SELF TEST KITS . . . GREAT FOR BUSINESSES . . . Find out if you currently have Covid-19 without an appointment from the convenience of your home or business! . . . CONTAINS 20 SELF-ADMINISTERED TESTS” [https://sethilaboratories.com/novel-coronavirus-antigen-test-kit-new/]
• “Stay one step ahead with our COVID-19 Rapid Self Test Kits. Perfect for employers or families on the go that need to #staysafe...#test #testing #selftest #rapidtest #covid19 #coronavirus…#buynow...#order” [posted Oct. 7, 2020 to https://www.facebook.com/sethilabs]
• “RAPID COVID-19 SELF TESTS…KEEP YOUR EMPLOYEES SAFE…TEST WHEN NEEDED AND STAY SAFE AT WORK WITH OUR PACK OF 25 SELF TEST KITS!...www.sethilaboratories.com” [posted Oct. 7, 2020 to https://www.instagram.com/p/CGC8yKEHXZO/]
Your products are also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because your webpage represents that the COVID-19 Antibody Self Test Kit and COVID-19 Antigen Self Test Kit are “FDA Emergency Use Authorized” using the FDA logo. These representations create a false impression that your products have been authorized for emergency use by FDA and are misleading. As discussed above, your products have not been authorized by FDA. In addition, the FDA logo is for the official use of the FDA and not for use on private sector materials. Such use may send a misleading message that the FDA favors or endorses your products. Unauthorized use of the FDA logo may violate federal law and subject those responsible to civil and/or criminal liability.
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-medical-devices/coronavirus-covid-19-and-medical-devices. In addition, the guidance titled “Policy for Coronavirus Disease 2019 Tests During the Public Health Emergency (Revised)”6 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 FD&C Act. This list can be found at https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-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 FD&C 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.
Timothy T. Stenzel, M.D., Ph.D.
OHT7: Office of In Vitro Diagnostics and Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
1 As explained below, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
2 The “COVID-19 Antibody Self Test Kit” offered for sale on your website appears to be the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) manufactured by Healgen Scientific LLC. On May 29, 2020, FDA issued an Emergency Use Authorization (EUA) pursuant to section 564 of the Act, 21 U.S.C. § 360bbb-3, to permit emergency use of Healgen Scientific LLC’s COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform moderate and high complexity tests for qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in venous whole blood, plasma (Li+-heparin, K2-EDTA and sodium-citrate), and serum. However, this EUA does not authorize the sale of the Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) directly to consumers to self-test at home or outside of a healthcare setting.
3 The “COVID-19 Antigen Self Test Kit” offered for sale on your website appears to be the CareStart COVID-19 Antigen test manufactured by Access Bio, Inc. On February 1, 2021, FDA issued an EUA pursuant to section 564 of the Act, 21 U.S.C. § 360bbb-3, to permit emergency use of Access Bio, Inc.’s CareStart COVID-19 Antigen test by laboratories certified under CLIA that meet the requirements to perform, high, moderate, or waived complexity tests and in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation for qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset. However, this EUA does not authorize the sale of the Access Bio, Inc. CareStart COVID-19 Antigen test directly to consumers to self-test at home or outside of a healthcare setting.
4 Secretary of Health and Human Services Alex M. Azar II, 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.
5 President Donald J. Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) (Mar. 13, 2020), available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
6 Accessible at https://wwwfda.gov/media/135659/download.