DOJ Charges Chinese Manufacturer With Making, Exporting Misbranded Masks
The Department of Justice charged a Chinese manufacturer with making and sending to the U.S. “nearly half a million misbranded and defective masks that falsely purported to be N95 respirators,” the DOJ said in a June 5 news release. The manufacturer, King Year Packaging and Printing Co. Ltd., faces “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,” the DOJ said. CBP seized a shipment of more than 95,000 masks at JFK Airport in New York City from China, according to the complaint.
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CBP found several labeling issues with the seized masks that were made by King Year. “Among other things: (i) the packaging for the Subject Respirators displayed the NIOSH logo prominently in two places, falsely implying the Subject Respirators were NIOSH-approved (they were not); (ii) the labeling on the Subject Respirators included the FDA logo, implying the Subject Respirators were FDA-approved, cleared, or authorized (they were not); and (iii) the Subject Mask were embroidered with “N95” in their fabric (they did not meet the N95 standard),” the DOJ said. The complaint was filed in the Eastern District of New York.