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May 07, 2020

FDA Bars Dozens of China Mask Makers From Exporting to U.S.

Previously, 80 China-based manufacturers were exporting N95-style masks to the U.S. Now, only 14 can.

By  Christopher Ruvo

More than 60 manufacturers in China can no longer export N95-style masks to the U.S. after federal officials determined that they were providing shoddy products that failed to meet standards.

N95 masks

On May 7, the U.S. Food and Drug Administration announced that only 14 mask makers in China are approved to produce N95-style masks for use in the United States. Previously, about 80 China-based manufacturers were able to make and export the masks to the U.S., The Wall Street Journal reported.

An N95 mask or N95 respirator is a particulate-filtering facepiece respirator that meets the U.S. National Institute for Occupational Safety and Health N95 classification of air filtration, meaning that it filters at least 95% of airborne particles. N95 masks are different than the non-medical grade cotton/cloth masks that many Americans have taken to wearing in public following advice from public heath officials that wearing such masks can help check the spread of COVID-19.

On April 3, the FDA had opened the door to allow N95-style mask imports from Chinese producers whose products U.S. officials had not tested. The idea was to help get more badly needed masks to the U.S., where there have been shortages because of the coronavirus pandemic.

Still, the May 7 decision reversed that leniency and reasserted tighter controls. The decision came after a report by The Wall Street Journal revealed that U.S. regulators and state officials had found that many imported N95-style masks were not making the grade.

For instance, the Journal reported that the National Institute for Occupational Safety and Health, which is part of the Centers for Disease Control and Prevention, found that about 60% of 67 different types of imported N95-style masks in at least one sample allowed in more tiny particles than U.S. standards typically permit.

In one instance, a China-based company’s masks only filtered out between 24% and 35% of particles. That’s below the 95% expected of N95 masks. The FDA has removed the company from the list of approved exporters of masks to the U.S.

The clampdown from the FDA comes a couple of days after U.S. Immigration and Customs Enforcement (ICE) announced that investigators are teaming up with corporations that include 3M, Amazon, Merck, Pfizer, Citi and Alibaba to stem the flow of counterfeit face masks, coronavirus tests and other PPE equipment/medical supplies into the U.S.

Investigators will work with the private companies to pinpoint suspect import shipments and root out bogus online listings for masks and other PPE gear. Crucial to the effort will be the private companies’ willingness to share important information and best practices, authorities said.