Chinese Manufacturer Charged with Exporting Misbranded and Defective Masks Falsely Purporting to be N95 Respirators
For Immediate Release
U.S. Attorney's Office, District of New Jersey
NEWARK, N.J. – A Chinese manufacturer was charged today with producing and exporting to the United States in the midst of the COVID-19 pandemic nearly half a million misbranded and defective masks that falsely purported to be N95 respirators, U.S. Attorneys Craig Carpenito, District of New Jersey, and Richard P. Donoghue, Eastern District of New York, announced.
King Year Packaging and Printing Co. Ltd. (King Year) is charged by complaint with three counts of violating the Federal Food, Drug and Cosmetic Act (FDCA) for causing misbranded and substandard respirators that falsely purported to meet the N95 standard to be imported into the United States. The complaint also charges the defendant with one felony count of making a false statement by filing misleading registration documents with the U.S. Food and Drug Administration (FDA). The criminal complaint was filed in Brooklyn federal court.
“These charges demonstrate the continued commitment of the Department of Justice and our partners to aggressively pursue those who sell misbranded and defective personal protective equipment, whether they are located here or abroad,” Carpenito said. “We will aggressively investigate and charge manufacturers that put our medical professionals and first responders at risk in fighting this crisis.”
“The charges alleged in this complaint show a blatant disregard for the safety of American citizens,” Acting FBI-Newark Special Agent in Charge Douglas Korneski said. “Had it not been for the actions of the investigative team, this defendant would have put first responders, hospital employees, and other front line workers directly in harm’s way with faulty equipment just to make a buck. The defendant tried to bypass the government's regulations by misbranding the quality of the equipment being peddled. The FBI remains vigilant in the pursuit of criminals trying to exploit the current crisis.”
Attorney General William P. Barr created the COVID-19 Hoarding and Price Gouging Task Force, led by U.S. Attorney Carpenito, who is coordinating efforts with the Antitrust Division and U.S. Attorneys across the country wherever illegal activity involving protective personal equipment occurs. The Secretary of Health and Human Services has issued a notice designating categories of health and medical supplies that must not be hoarded or sold for exorbitant prices.
“U.S. Customs and Border Protection is proud of the expertise we bring to support and assist investigations by our law enforcement partners,” Troy Miller, Director, CBP New York Field Office, said. “It is through interagency partnerships and collaborative efforts, like the one leading to today’s charges that we send a message to foreign manufacturers on the importance of understanding and complying with US health, safety, and import laws.”
“The FDA is actively monitoring the marketplace for fraudulent products related to our battle against COVID-19. 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,” Jeffrey J. Ebersole, Special Agent in Charge, FDA Office of Criminal Investigations’ New York Field Office, said. “Today’s announcement should serve as a reminder that we will take appropriate action against those who jeopardize the health of Americans while taking advantage of a crisis.”
According to the complaint:
From April 6, 2020, to April 21, 2020, King Year manufactured 495,200 defective and misbranded masks that claimed to be N95 respirators, and caused those defective products to be imported into the United States. King Year stamped the NIOSH and FDA logos on the packaging for its respirators, appealing directly to healthcare personnel, when in fact, its respirators were not NIOSH-approved, nor were they approved, cleared, or otherwise authorized by the FDA. King Year’s respirators also were embroidered with “N95,” even though they fell well below the minimum 95 percent filtration standard.
King Year’s misbranded and defective products had the potential to deceive U.S. consumers, including healthcare workers and first responders, into believing they were purchasing authentic N95 respirators, and put them at risk. To cover up the poor quality of its respirators, King Year disseminated false documents attesting to their authenticity and filed a fraudulent registration statement with the FDA.
Each charge carries a maximum fine of $500,000 or the greater of twice the gross gain or twice the gross loss from the offense.
Please report COVID-19 fraud, hoarding or price-gouging to the National Center for Disaster Fraud’s National Hotline at (866) 720-5721, or e-mail: firstname.lastname@example.org.
The government is represented by Assistant United States Attorney Jonathan Fayer of the Economic Crimes Unit for the U.S. Attorney’s Office for the District of New Jersey.
The charges in the complaint are merely allegations, and the defendant is presumed innocent unless and until proven guilty.
Updated June 5, 2020
Press Release Number: 20-170