The U.S. Food and Drug Administration announced that it is actively monitoring the market for any firms offering products with fraudulent coronavirus (Covid-19) diagnostic, prevention and treatment claims as part of the agency’s efforts to protect public health during this pandemic.
The FDA wants to alert the public that, at this time, it has not authorized any test that is available to purchase for testing Covid-19 at home. The FDA does see 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 in this space.
The agency warns that 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 reminds consumers to follow the Centers for Disease Control and Prevention’s guidelines and speak to their medical provider if they have symptoms of Covid-19. A medical provider will advise a patient about whether they should get tested and the process for being tested with an appropriate test.
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.
This may include issuing warning letters, seizures or injunctions. The agency has already identified and issued warning letters to companies found selling and promoting fraudulent items, and it expects additional such actions will follow.
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 no enter through U.S. borders. The FDA asks all citizens to report any fraudulent test kits they are aware of to the agency.