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FDA Warns Consumers About Fraudulent At-Home COVID-19 Test Kits

NEW YORK – The US Food and Drug Administration on Friday warned consumers to watch out for companies marketing unproven products for diagnosing, preventing, or treating COVID-19.

"We will continue to aggressively pursue those who place the public health at risk and hold bad actors accountable," the agency said in the March 20 consumer alert.

In particular, the agency said it is aware of companies selling unauthorized kits for at-home COVID-19 testing. The agency hasn't authorized any at-home test kits for this purpose, but is currently working with test developers to advance authorized kits that can enable at-home sample collection.

Earlier this month, the agency and the Federal Trade Commission jointly sent warning letters to seven companies who were marketing teas, essential oils, tinctures and colloidal silver for the treatment of COVID-19. "We expect additional such actions will be forthcoming," the agency told consumer in the latest alert.

In addition to warning letters, the agency can also issue injunctions against companies making fraudulent claims and seize unauthorized products. "We are 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 our borders," the agency said, asking members of the public to report fraudulent test kits to the FDA.

To ensure that disciplined entities aren't continuing to sell products under a different name, the agency has said it will monitor social media and online marketplaces. A cross agency task force is also watching out for fraudulent COVID-19 drugs and tests, and has already worked with major retailers and online marketplaces to remove more than three dozen listings.  

The agency cautioned that using fraudulent tests and other healthcare products can result in serious harm and keep some patients from seeking the medical treatment they need. The FDA advised consumers to follow the Centers for Disease Control and Prevention's guidelines and if they think they have COVID-19 symptoms, to speak to a doctor, who in turn will provide further guidance regarding testing if needed. 

"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 agency warned.