US files charges against Chinese mask manufacturer
Masks had filtration efficiency of 22%, well below 95% filtration called for in N95 masks
Federal prosecutors accused a Chinese manufacturer of selling 140,000 defective masks to a U.S. distributor, the latest case brought against a company for allegedly selling substandard products that could put wearers at risk amid the coronavirus pandemic.
U.S. Customs and Border Protection agents stopped the masks for inspection at John F. Kennedy International Airport in New York in early May, according to a complaint filed Wednesday by the U.S. attorney's office for the District of New Jersey.
Prosecutors alleged that Shenzhen, China-based Crawford Technology Group (HK) Co. sold masks that claimed to meet regulations which require them to filter out at least 95% of very small particles, including droplets containing viruses. The company claimed the masks were KN95s, which are similar to N95 masks in the U.S., according to the 13-page complaint. Such masks are widely used by health-care workers.
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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.
Crawford Technology didn't immediately respond to a request for comment Wednesday.
As the coronavirus spreads across the U.S., hospitals and state governments have faced a severe shortage of protective equipment needed to prevent health-care workers from getting sick. Many of these institutions bought N95-style masks from abroad produced by unproven foreign manufacturers that later turned out to be low-quality when tested.
Earlier this month prosecutors charged a different mask maker with selling masks that falsely claimed to be N95 respirators.
Prosecutors charged Crawford Technology with making false claims about the filtration efficiency of its masks in violation of the Federal Food, Drug and Cosmetic Act. The unnamed distributor paid Crawford Technology about $150,000 for the masks, according to the complaint.
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Crawford Technology initially registered with the Food and Drug Administration using CCTC Service Inc. as its legally-mandated U.S. representative to sell medical products in the U.S. during the pandemic, according to the complaint. A Wall Street Journal investigation found that more than 1,300 Chinese companies used CCTC and a false Delaware address and nonworking phone number when registering with the FDA.
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CCTC didn't immediately respond to a request for comment. The FDA said it is actively monitoring the U.S. for fraudulent products.
"Defective and misbranded personal protection equipment is a danger to all who unwittingly purchase and use it," said New Jersey U.S. Attorney Craig Carpenito.
Write to Austen Hufford at austen.hufford@wsj.com
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