Posted June 20, 2020

FDA Warns Companies Selling Unapproved COVID-19 Tests

On June 17, the FDA issued warning letters to three companies for marketing unapproved, adulterated or misbranded antibody tests for coronavirus (COVID-19). The agency also emphasized to consumers that there are no diagnostic or antibody COVID-19 test kits that are authorized, cleared or approved to be used completely at home.

The companies that received a warning letter are as follows (use the links below to read the full warning letter):
Some of the test kits were being sold in the US directly to consumers for at-home use without FDA authorization and/or included labels that falsely claim FDA approval or bear the FDA logo, which is for the official use by the FDA only, and not for use on private sector materials.

The tests were promoted with statements such as "Our diagnostic tests can be used anywhere, anytime, making it possible to provide simple, quick, accurate, and affordable results" and "MyCOVID19 Testing Club includes 15 minute Covid tests for the whole family!"

An FDA director spoke out against companies committing fraud to take advantage of the pandemic, stating, "When tests are marketed inappropriately, with inaccurate or misleading claims -- such as the ability to perform the test completely at home, or that the test is authorized, cleared, or approved when it is not -- they put the health of Americans at risk. Such conduct will not be tolerated by the FDA, and we will continue to monitor tests marketed in the U.S., taking appropriate action as warranted."

See ConsumerLab's answer to the question How can I get tested for the coronavirus? Can I get a home-test for COVID-19? Which are the best tests? Are any tests free?

See Related Warnings:

Seller of Silver and Vitamin C Lozenges & More Warned for Coronavirus Claims

FTC Warns 35 More Companies for Coronavirus Claims

FDA Warns Sellers of CBD, Colloidal Silver, Essential Oils, and More Promoted to Treat Coronavirus

Seller of Vitamin and CBD "NoronaPak" Warned for Coronavirus Claims

FTC Warns 50 More Companies for Coronavirus Claims

FDA Warns Sellers of CBD, Kratom, Vitamin C, and More for Coronavirus Claims

Plum Dragon Herbs Warned for Coronavirus Claims

For more information, use the link below.