WARNING LETTER
DermaCare Biosciences, LTD.
MARCS-CMS 617910 —
December 01, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Rich Butler
Recipient Title
Managing Director
DermaCare Biosciences, LTD.
301 W. Atlantic Avenue Suite #05
Delray Beach
,
FL
33444
United States
rich@dermacarepkg.com
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
Date: December 1, 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) has reviewed your websites at the Internet addresses https://www.easyrapidnow.com/ and https://www.dermacarepkg.com/, on February 2, 2021, on September 20, 2021, and on October 22, 2021. We also reviewed your social media websites at https://www.linkedin.com/company/dermacare-packaging-private-label/, https://www.facebook.com/dermacarepkg/, and https://Instagram.com/easyrapidcovidtestkits where you direct consumers to your website, https://www.easyrapidnow.com, to purchase your products. The FDA has observed that your website offers for sale the Easy Rapid Now COVID-19 Nasal Swab Antigen Test (Colloidal Gold) (hereinafter referred to as “COVID-19 Test”) in the United States. Based on our review, your COVID-19 Test 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 is offered for sale and distributed to consumers 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.
Your website, https://www.easyrapidnow.com/, as well as social media websites, include statements that indicate that your firm’s COVID-19 Test is intended for screening or diagnosis
4
of COVID-19, including:
“Mass Surveillance. Protect Classrooms, Workplaces, and Other Populations.” [https://easyrapidnow.com/]
“I was part of a surveillance screening at work. I was feeling symptoms and I took the EasyRapidNow™ test. It showed “positive”. I went for a PCR test and sure enough, it confirmed I had COVID. These really work!” [https://easyrapidnow.com/testimonials]
“Routine Coronavirus surveillance gives you an early warning of infection, allowing targeted measures to be taken to stop the spread.” [https://easyrapidnow.com/]
“These EasyRapidNow™ tests will be super easy for you to perform and I have firsthand experience. My wife came home Monday evening with a cough and not feeling well. In 15 minutes, we confirmed that she was positive, and we were able to take the appropriate precautions. She works in a doctor’s office and was able to get a PCR test the next day, which confirmed that she was positive. My son and I tested negative and have no symptoms so far. Two days later my son and I tested again, and I was positive, he was negative. We are grateful to have the early warning. This type of early warning will assist you in keeping your workplace and employees safer resulting in fewer business interruptions.” [https://easyrapidnow.com/testimonials]
“Rapid detection of SARS-CoV-2 nucleocapsid antigen in less than 15 minute [sic]” [https://easyrapidnow.com/wp-content/uploads/EasyRapidNow-Brochure_Ja25_U.S.pdf]
COVID-19 Nasal Swab Tests Available Now! Test results in as little as 5 minutes! Simple Easy Fast Affordable! Scan QR Code to buy now!” [https://www.linkedin.com/company/dermacare-packaging-private-label/]
Your firm’s websites include a disclaimer that your tests “enable[] surveillance screening at a population level” are “not intended for diagnostic use or home use.”
5
However, these disclaimers are inconsistent with the statements identified above on your firm’s websites that indicate these tests are intended to be used to identify individuals infected with COVID-19 so that individual decisions can be made based on the test results (e.g., quarantine or confirmatory testing). Furthermore, FDA has observed that your business offers for sale the COVID-19 Test directly to consumers in the United States. Based on the statements identified on your website above and your sale of these tests directly to consumers, the FDA has determined that your test is intended for diagnosis of COVID-19 including screening for COVID-19 in asymptomatic individuals without known exposure with the intent of making individual decisions based on the test results (e.g., who may return or what protective measures to take on an individual basis).
We also note that your social media LinkedIn site, https://www.linkedin.com/company/dermacarepackaging-private-label/, displays a large FDA logo at the top right of the page alongside information about your COVID-19 test and other products. The FDA logo is for the official use of the FDA and not for use on private sector materials.
6
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)
7
” 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.
Sincerely,
/S/
Timothy T. Stenzel, M.D., Ph.D.
Director
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
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
Screening for COVID-19 is looking for occurrence at the individual level even if there is no individual reason to suspect infection such as a known exposure. Examples of screening include testing plans developed by a workplace to test all employees returning to the workplace regardless of exposure or signs and systems and testing plans developed by a school to test all students and faculty returning to the school regardless of exposure or signs and symptoms, with the intent of using the results to determine who may return or what protective measures to take on an individual basis. Diagnostic testing for COVID-19 is also looking for occurrence at the individual level but is performed when there is a particular reason to suspect that an individual may be infected. Examples of diagnostic testing include testing symptomatic individuals presenting to their healthcare provider, testing individuals who indicate that they were exposed to an individual with a confirmed or suspected case of COVID-19, and testing all individuals present at an event where an attendee was later confirmed to have COVID-19.
See
COVID-19 Test Uses: FAQs on Testing for SARS-CoV-2,
available
at
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-uses-faqs-testing-sars-cov-2
.
5
Surveillance testing is primarily used to gain information at a population level, rather than an individual level. Surveillance testing may be a random sampling of a certain percentage of a specific population to monitor for increasing or decreasing prevalence and determining the population effect from community interventions such as social distancing. An example of surveillance testing is a testing plan developed by a State Public Health Department to randomly select and sample 1% of all individuals in a city on a rolling basis to determine local infection rates and trends.
See
COVID-19 Test Uses: FAQs on Testing for SARS-CoV-2,
available at
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-uses-faqs-testing-sars-cov-2
.
6
FDA Logo Policy (available at:
https://www.fda.gov/about-fda/website-policies/fda-logo-policy
).
7
Accessible at
https://www.fda.gov/media/135659/download
.
Content current as of:
12/21/2021
Regulated Product(s)
Medical Devices