Growing Bipartisan Support for Cracking Down on Counterfeit Masks

The Biden Administration has continued to ignore wide bipartisan calls to protect the intellectual property rights of essential COVID-19-related goods. This time, even radical Senator Elizabeth Warren joined in calls for the executive branch to more effectively deter the trade of counterfeit facemasks. Additional efforts to defend crucial IP rights should be pursued in order to protect Americans from the numerous health risks that come with counterfeit medical products.

Sen. Warren (D-Mass.), Sen. Ed Markey (D-Mass.), and Sen. Richard Blumenthal (D-Conn.) sent a letter to Attorney General Merrick Garland on Feb. 1 requesting that the Department of Justice open an investigation into the trade of counterfeit masks in the United States. They further requested that the DOJ must “take all necessary steps to deter… the proliferation of fraudulent and counterfeit masks sold by retailers.”

Republican and Democratic representatives alike have repeatedly raised concerns about counterfeit facemasks at congressional hearings throughout the COVID-19 pandemic. In late 2021 Senator Mike Braun (R-Ind.) and Senator Chris Murphy (D-Conn.) also jointly introduced S.3416, the Protecting Patients from Counterfeit Medical Devices Act, which would “expand the enforcement authority of the Food and Drug Administration with respect to counterfeit devices” including facemasks.

“The number of counterfeit medical devices have been on the rise during the pandemic, posing a serious risk to the safety and health of Americans. This legislation would bring greater protection for patients and consumers of medical devices by increasing enforcement penalties against fraudulent medical device manufacturers,” said Sen. Braun.

The proliferation of counterfeit facemasks and other counterfeit personal protective equipment (PPE) has remained at extreme levels throughout the pandemic. The Centers for Disease Control and Prevention (CDC) estimates that as many as 60% of KN95 masks analyzed in the United States in 2020 and 2021 were counterfeit, ineffective, and failed to meet the standards of the National Institute for Occupational Safety and Health (NIOSH).

U.S. Customs and Border Protection (CBP) had already seized 34 million counterfeit N95 and KN95 masks just between the beginning of the pandemic and April 2021, and distributions of these counterfeits have only continued into 2022, along with distributions of counterfeit COVID-19 test kits, vaccines, and vaccine cards.

Many other countries around the world have also faced issues of abundant counterfeit facemasks over the last two years. For example, in just one month in 2021, Canadian authorities detained or seized almost 700,000 counterfeit 3M-branded N95 masks from importers and distributors.

Counterfeit masks pose a health risk during the pandemic primarily because they are highly ineffective at preventing the spread of COVID-19. While a wearer of a fake N95 or KN95 mask may believe that he or she has an 83% lower risk of infection in indoor settings, the counterfeit version will actually provide little to no protection against the virus. As long as counterfeits remain a dominant force in the U.S. market, the coronavirus will continue to spread more easily among Americans, especially among the frontline medical providers who typically wear the tight-fitting KN95 models.

The Biden administration should heed Congress’s repeated warnings about the proliferation of counterfeit masks in the United States and take more action to combat this illicit trade through its powers in the DOJ, FDA, and Department of Homeland Security/CBP. Protecting the patents and trademarks of PPE producers is important not only to the companies who own the intellectual property, but to the public health of the nation at large.


Photo Credit: CDC on Pexels