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  5. Trask and Roth Inc. dba Trask & Roth Research and Manufacturing - 609565 - 10/29/2020
  1. Warning Letters

WARNING LETTER

Trask and Roth Inc. dba Trask & Roth Research and Manufacturing MARCS-CMS 609565 —

Product:
Medical Devices
Recipient:
Recipient Name
Kodi Bethay-Roth
Recipient Title
President
Trask and Roth Inc. dba Trask & Roth Research and Manufacturing

2441 E. Erie Drive
Tempe, AZ 85282
United States

aaron@traskandroth.com
erica@traskandroth.com
benjamin@traskandroth.com
Issuing Office:
Center for Devices and Radiological Health

United States

WARNING LETTER

Date:  October 29, 2020

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 website at the Internet address www.traskandroth.com on September 22, 2020. We also reviewed your social media page at www.facebook.com/trashkandroth/ where you direct consumers to www.traskandroth.com to purchase your products. The FDA has observed that your website, www.traskandroth.com, offers a “Lateral Flow Testing Device” for sale in the United States. Based on our review, your “Lateral Flow Testing Device” is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19[1] 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).

Our review of your websites revealed statements that establish that your “Lateral Flow Testing Device” is intended for the prevention, diagnosis, mitigation, and/or treatment of COVID-19, including:

  • On July 14, 2020, you posted: “RAPID LATERAL FLOW COVID-19 TEST KITS FOR SALE NOW!” [from your www.facebook.com/trashkandroth/]
  • “Lateral flow testing is fast, easy, and detects IgG and IgM antibodies.  Trask & Roth are devoted to manufacturing rapid test kits in the United States for all major pathogens affecting the population, including SARS CoV-2 . . . .” [www.traskandroth.com]
  • “Trask & Roth use the colloidal gold test strips to detect IgG and IgM antibodies.” [www.traskandroth.com]
  • “Lateral Flow rapid testing is cost effective, very quick and easy, and does not require a traditional medical laboratory for results.  Patients experience more comfort with a simple finger prick rather than a venipuncture.” [www.traskandroth.com]

The “Lateral Flow Testing Device” is offered for sale and distributed 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, the President declared 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.[4] As described above, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.

You should take immediate action to correct 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 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, cleared, or authorized by FDA and that you do not make claims that 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 correct these violations.  Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.  Failure to immediately correct the violations cited in this letter 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 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 corrective actions to cease the sale of your unapproved, uncleared, and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and such actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken appropriate corrective action.

If you cannot complete corrective action within 48 hours, state the reason for the delay and the time within which you will complete the corrections. 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.

Sincerely,

/S/

Timothy T. Stenzel, M.D., Ph.D.
Director
OHT7: Office of In Vitro Diagnostics and Radiological Health
Office of 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] Secretary of Health and Human Services Alex M Azar, Determination that a Public Health Emergency Exists.  Jan. 31, 2020.  (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx). The declaration has been renewed for an additional 90 days twice.  The most recent renewal went into effect on July 25, 2020.  Secretary of Health and Human Services Alex M. Azar, Renewal of Determination that a Public Health Emergency Exists. July 23, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-21.aspx).

[3] President Donald J. Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19).  Mar. 13, 2020.  (Accessible at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/).

[4] 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) (Accessible at https://www.fda.gov/media/135659/download) 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.

 
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