- Medical Devices
Recipient NameSteve Utley
- Anytime COVID Test LLC
6615 West Boynton Beach Blvd., #181
Boynton Beach, FL 33437
- Issuing Office:
- Center for Devices and Radiological Health
Date: April 13, 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 websites at the Internet addresses https://www.anytimecovidtest.com and http://www.mycovidtester.com, http://www.gotcovidtests.com, http://www.covidtestyou.com, and http://www.buymycovidtest.com, which resolve to https://www.anytimecovidtest.com, on October 9, 2020, and April 2, 2021. The FDA has observed that https://www.anytimecovidtest.com offers for sale a “Covid-19 Test Kit” (also referred to as the “Anytime Covid Test”) (hereinafter “COVID-19 Test Kit”), for sale in the United States directly to consumers for at-home use. Based on our review, your COVID-19 Test Kit is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-191 in people, and thus, it is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).
The COVID-19 Test Kit is offered for sale and distributed directly to consumers for at-home testing in the United States without marketing approval, clearance, or authorization from FDA. Accordingly, your product is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). Your product is 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 device 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 herein, you sell a product that is intended for use in mitigation, prevention, treatment, diagnosis, or cure COVID-19 in people. We request that you take immediate action to cease the sale of such 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, https://www.anytimecovidtest.com, includes statements that indicate that the COVID-19 Test Kit may be purchased directly by consumers and is intended to be used for at-home testing for COVID-19, including:
• “GET BACK TO WHAT’S IMPORTANT
Order Your Covid-19 Test Today!”
“Results in 15 Minutes or Less in the privacy of your home. No waiting on labs”
The page also includes a link to “ORDER NOW.” [https://www.anytimecovidtest.com]
• “At-Home Covid-19 Antibodies Rapid Test No Doctor Office or Lab Visit Needed” [https://www.anytimecovidtest.com]
• “Anytime Covid Test, LLC is working with individuals, community organizations, employers, groups and agencies to offer an at home pre-screening test for COVID-19 antibodies that gives private and confidential results in 15 minutes or less in the privacy of your home or office. This test helps to determine whether you have been exposed to the virus within the past 4 to 24 days. This rapid test cassette reliably identifies IgG and IgM antibodies specific to SARS-CoV-2 in a sample of blood drawn with a finger prick, without exposing yourself to this or other viruses with an unnecessary trip to the lab, doctors [sic] office or field visit.”
• “At Home Test. At Home Results.” [https://www.anytimecovidtest.com]
• “Order your ‘at home’ rapid test kit with ‘at home” results in 15 minutes.” [https://www.anytimecovidtest.com/shop]
In addition, the COVID-19 Test Kit is also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because its labeling is false or misleading. The COVID-19 Test Kit is not authorized, so statements on your website that imply that the product is authorized are false. In addition, your website, https://www.anytimecovidtest.com, displays a large FDA logo near the top of the page. The FDA logo is positioned near images of and information about the COVID-19 Test Kit. The unauthorized use of the FDA logo4 alongside product information is misleading because it implies FDA approval, clearance, authorization, endorsement, or other evaluation of the COVID-19 Test Kit. Your website also displays a “Clinical Trials Number” (embedded within the FDA logo) that is positioned alongside images of and information about the product. Based on our review of your website and as described above, you are marketing the COVID-19 Test Kit for use at home as opposed to merely providing information about its investigational status. Further, your display of the clinical trial number is misleading because the representation fails to convey to consumers that the product is investigational and lacks approval, clearance, or authorization, and it also implies FDA approval, clearance, authorization, endorsement, or other evaluation of the product. The representations and unauthorized display of the FDA logo on your website are especially concerning from a public health perspective because consumers rely on information provided by sellers to determine whether to purchase a device and your presentation conveys the misimpression that the product has been approved, cleared, authorized, endorsed, or otherwise evaluated by FDA. We note that the 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)”5 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 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/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 emails 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/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 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 product is 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.
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
CC: Steve Utley, CEO
Health Alliance Network, LLC
3810 Inverrary Blvd. Suite 305
Fort Lauderdale, FL 33319
1 As explained below, 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/.
4 FDA logo is for official use by FDA and not for private use on labeling of FDA-regulated products. See FDA Logo Policy (available at: https://www.fda.gov/about-fda/website-policies/fda-logo-policy).
5 Accessible at https://www.fda.gov/media/135659/download.