FDA Warns Consumers About Fraudulent COVID-19 Tests

As researchers continue to develop faster and more accurate tests for the novel coronavirus (COVID-19), officials with the FDA have said they are beginning to see unauthorized test kits marketed for consumers to test for the virus at home.¹

Currently, no COVID-19 test has been FDA-approved for at-home testing.¹

“The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space,” said FDA Commissioner Stephen Hahn, MD, in a statement.¹

Several companies had plans to market at-home testing kits, including Scanwell Health, which released a statement March 19 saying they were planning to launch the first clinical-grade rapid at-home test for COVID-19. According to the company, the test takes 15 minutes using their app, and a health professional will then follow up with the results and next steps.²

According to The Wall Street Journal, however, the company has announced they will not ship the test until they’ve obtained FDA clearance under an emergency use authorization, which can take 6-8 weeks.³

Updated FDA regulations have specified that the policies for COVID-19 diagnostic testing do not apply to at-home testing, including self-collection of samples to be sent to a laboratory.⁴

The FDA has also issued warnings to several companies for fraudulent products claiming to treat or prevent the virus, including teas, essential oils, tinctures, and colloidal silver.⁵

“There already is a high level of anxiety over the potential spread of coronavirus,” said Federal Trade Commission Chairman Joe Simons, in a statement from the FDA. “What we don’t need in this situation are companies preying on consumers by promoting products with fraudulent prevention and treatment claims.”⁵

Fraudulent or unapproved tests can post serious public health risks, according to the FDA. They may lead patients not to seek professional care or to delay medical treatments, thereby allowing the virus to potentially spread further.¹

FDA actions for fraudulent tests or treatments may include warning letters, seizures, or injunctions.¹

REFERENCE

• Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kids [news release]. Food and Drug Administration; March 20, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-alerts-consumers-about-unauthorized-fraudulent-covid-19-test-kits. Accessed March 24, 2020.
• Murphy J. First Clinical-Grade Rapid At-Home Test to Aid in COVID-19 Crisis. Pharmacy Times; March 24, 2020. https://www.pharmacytimes.com/news/first-clinical-grade-rapid-at-home-test-to-aid-in-covid-19-crisis. Accessed March 24, 2020.
• Burton T, Winkler R. FDA Warns Consumers Against At-Home Coronavirus Tests. The Wall Street Journal; March 23, 2020. https://www.wsj.com/articles/fda-warns-consumers-against-at-home-coronavirus-tests-11585005915. Accessed March 24, 2020.
• Food and Drug Administration. FAQs on Diagnostic Testing for SARS-CoV-2. Updated March 23, 2020. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2#offerhometest. Accessed March 24, 2020.
• Coronavirus Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19 [news release]. FDA; March 9, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-update-fda-and-ftc-warn-seven-companies-selling-fraudulent-products-claim-treat-or. Accessed March 24, 2020.