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FDA Issues Alert Over Fake COVID-19 Test Kits

The agency takes action over unapproved home testing kits.


The Food and Drug Administration has issued a statement on how it is “actively and aggressively” on alert for fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims.

In particular, the agency is beginning to see unapproved home testing kits.

The FDA stated that, “We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19.”

Fraudulent tests and products are seen as posing serious health risks in that they could keep some patients from seeking care, or delaying treatment. 

The FDA also promised to take appropriate action against bad actors who are taking advantage of a crisis. This could include seizures or injunctions. 

The agency has already issued nearly a dozen warning letters to companies found selling and promoting fraudulent items.

Consumers who become aware of fraudulent test kits for COVID-19 are asked to report them to the FDA by sending an email to [email protected]

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