FDA’s Efforts to Monitor Manufacturers of COVID-19 Products

The Food and Drug Administration (FDA) provided an update on its efforts to combat the sale of fraudulent products during the COVID-19 pandemic through written testimony before the U.S. Senate Subcommittee on Manufacturing, Trade, and Consumer Protection on July 21, 2020.

The FDA has uncovered more than 780 fraudulent COVID-19 products, including substandard personal protective equipment (PPE), diagnostic tests, and purported vaccines being offered for sale. The FDA found that the Internet is the primary mechanism for the sale of fraudulent COVID-19-related products, which presents unique challenges because of the speed at which sellers can post, change, move or remove listings for fraudulent products. According to Catherine Hermsen, Assistant Commissioner, Office of Criminal Investigations, Office of Regulatory Affairs, the FDA “has already contacted numerous parts of the online ecosystem to request that they be vigilant in removing unapproved, unauthorized, and uncleared products with false and misleading COVID-19 claims from their Internet sites.” The FDA has issued more than 80 warning letters, taken action to remove internet listings for more than 195 unapproved, uncleared, or unauthorized products that claimed to diagnose, cure, mitigate, treat, or prevent COVID-19 from online marketplaces, and the FDA has issued more than 260 abuse complaints to domain name registrars, resulting in those registrars taking 189 websites offline.

The FDA is also putting efforts toward preventing the import of unproven products, including adulterated and misbranded testing kits. In one instance, the FDA intercepted test kits from the United Kingdom labeled as “Trinity COVID-19 SARS Antipathogenic Treatment” kits, even though there is no specific antiviral treatment for COVID-19 and no vaccine to prevent coronavirus infection. The kits had not been approved by the FDA to treat COVID-19 – or for any other use. The investigation, which was conducted in collaboration with U.S. and international law enforcement agencies resulted in a British man being criminally charged.

“We are committed to protecting Americans from unsafe products, and will continue our efforts to find and stop those selling unproven products that fraudulently claim to diagnose, cure, mitigate, treat, or prevent COVID-19,” said Hermsen. “Unscrupulous actors must not be permitted to take advantage of a pandemic to increase their profits while jeopardizing the public health.”

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