KEY POINTS

  • FDA said none of the at-home test kits available in the market has yet been approved and authorized by it
  • It said it will issue warning letters, seizures or injunctions against the companies that were selling the fraudulent products
  • FDA said it was “stepping up enforcement at ports of entry, including International Mail Facilities” to deter import of fraudulent products

The US Food and Drug Administration (FDA) on Friday dismissed the at-home coronavirus tests available in the market as “unauthorized fraudulent test kits.”

FDA said it “actively and aggressively” surveyed the market for firms dealing in “fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims” in an effort to protect public health at the onset of the viral pandemic, which led the agency to the identification of several such unproven products.

“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,” it said in its consumer alert, adding that the agency was mulling over the inclusion of at-home kits for COVID-19 in its future inventory of safer and accurate tests.

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

It said it will take needful action against companies that were capitalizing on the ongoing crisis by deceiving the public into buying tests that pose risk to their health. Earlier this month, the agency and the Federal Trade Commission (FTC) jointly issued warning letters to seven companies that were promoting fraudulent products citing a cure for COVID-19.

The agency said additional actions will be forthcoming, this time in conjunction with “seizures or injunctions.” Additionally, it said it was “stepping up enforcement at ports of entry, including International Mail Facilities” to clamp down on the import of fraudulent products originated in foreign countries.

It urged people to report any fraudulent test kits for COVID-19 that they chance upon. “We will continue to aggressively pursue those who place the public health at risk and hold bad actors accountable,” the statement added.