U.S. files charges against Chinese manufacturer for exporting defective masks falsely claiming to be KN95 respirators; 140,000 masks failed to meet standards

First China exported coronavirus to countries around the world, and now the country is exporting fake masks to the United States. Today, U.S. Federal prosecutors charged a Chinese manufacturer of selling defective and substandard masks that could put wearers at risk amid the coronavirus pandemic.

In a criminal complaint filed by U.S. Attorney Craig Carpenito, the U.S. Department of Justice (DOJ) accused the Chinese manufacturer of selling producing and exporting to the United States in the midst of the COVID-19 pandemic over 140,000 misbranded and defective masks that falsely purported to be KN95 respirators.

According to a complaint filed Wednesday by the U.S. attorney’s office for the District of New Jersey, Chinese manufacturer Crawford Technology Group (HK) Co. LTD. (Crawford) is charged by complaint with violating the Federal Food, Drug and Cosmetic Act (FDCA) for causing misbranded and substandard respirators that falsely purported to meet various filtration efficiency standards to be imported into the United States.

“Defective and misbranded personal protection equipment is a danger to all who unwittingly purchase and use it,” U.S. Attorney Carpenito said. “The Department of Justice and our partners remain committed to finding the unscrupulous companies that sell dangerous gear and stopping them from further endangering health care workers and first responders.”

“It is not enough that this pandemic has upended lives around the world and caused countless suffering and hundreds of thousands of deaths,” Jason Molina, Special Agent in Charge, Homeland Security Investigations (HSI), Newark, said. “In the midst of that, we have companies like this that exploited this tragedy for financial gain and in the process put millions of lives at risk. This case is a good reminder that the combined efforts of the agencies involved in Attorney General Barr’s Task Force have a very long reach to track and charge those who commit such wrongdoing. In addition, for HSI this fulfills the mission of Operation Stolen Promise to rout out COVID related fraud in all its many forms.”

According to tests conducted by the main U.S. mask regulator, the National Institute for Occupational Safety and Health, the masks had filtration efficiency of 22%, well below the 95% filtration called for in N95 masks.

“U.S. Customs and Border Protection is proud of the expertise we bring to support and assist investigations that result in the seizure of illicit products,” Troy Miller, Director New York Field Office, said. “It is through interagency partnerships and collaborative efforts, like the one leading to today’s criminal charges, that law enforcement successfully combats today’s criminal organizations.”

“The FDA is actively monitoring the marketplace for fraudulent products related to our battle against COVID-19 that are marketed and distributed to Americans. The agency will continue to collaborate with our fellow law enforcement partners to bring to justice those who place profits above the public health during this pandemic,” Special Agent in Charge Jeffrey J. Ebersole, FDA Office of Criminal Investigations New York Field Office, said. “We will take appropriate action against those who jeopardize the health of Americans and take advantage of a crisis.”

According to documents filed in this case and statements made in court:

In May 2020, Crawford, a digital electronics company based in Shenzhen, China, manufactured and sold 140,400 adulterated and misbranded KN95 filtering face piece respirators to Company-1 for import into the United States.

The packaging for the respirators, as well as the respirators themselves, falsely indicated that they were 95 percent efficient at filtering harmful airborne particles. The respirators and their packaging also claimed that they complied with established standards in the European Union and China, which require at least 94 percent or 95 percent filtering efficiency, respectively. Crawford also advertised the respirators on its website under a tab labeled “epidemic” and claimed that their respirators have “4 layers of protection” and “Passed the national standard 2626-2000 test.” The page also says “KN95 Filtration reaches 95%,” “KN95 Filter Effect 95%,” and states that their respirators protect against “Severe Haze,” “Bacteria,” and “Dust.” These claims were false and misleading because the average filtering efficiency for the Crawford respirators was 22.33 percent, far below the required thresholds.

The charge in the complaint carries a maximum fine of $200,000.