FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits

The U.S. Food & Drug Administration (FDA) released an announcement that warns consumers about unauthorized fraudulent coronavirus tests that are being marketed to test for COVID-19 in the home. 

At this time, the FDA has not authorized any test that is available to purchase for testing at home for COVID-19.

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 is actively working with test developers to bring this to fruition.

Fraudulent health claims, tests, and products can pose serious health risks. They may keep some patients from seeking care or delay necessary medical treatment.

The FDA will take appropriate action to protect consumers from bad actors who take advantage of a crisis to deceive the public by marketing tests that pose risks to patient health.

The FDA has already identified and issued warning letters to companies found selling and promoting fraudulent items and expects additional such actions will be forthcoming.

Additionally, the FDA is stepping up enforcement at ports of entry, including International Mail Facilities, to ensure these fraudulent products that originate outside the country do not enter through the nation’s borders.

If a resident is aware of fraudulent test kits for COVID-19, please report them to the FDA. Reports may be sent via email to FDA-COVID-19-Fraudulent-Products@fda.hhs.gov.

The FDA will continue to pursue those who place the public health at risk. Actions may include issuing warning letters, seizures or injunctions.