Story at a glance
- At the onset of the coronavirus pandemic, American health workers faced a shortage of personal protective equipment.
- In response, the Food and Drug Administration relaxed certain standards and allowed for KN95 masks to be imported from China.
- An analysis by the Wall Street Journal found that these masks vary widely in quality.
The shortage of personal protective equipment (PPE) at the beginning of the coronavirus outbreak in the United States led public health officials to hold off on recommending that most Americans use face masks. But the Food and Drug Administration’s (FDA) response allowed low-quality masks from China into the country, according to a Wall Street Journal (WSJ) analysis, and created confusion.
Online, the Centers for Disease Control and Prevention lists manufacturers of N95 respirators approved by the National Institute for Occupational Safety and Health (NIOSH), which are intended for use by medical professionals and workers. Under an emergency use authorization (EUA) issued in early April, the FDA permitted importing non-NIOSH-approved N95 respirators and some KN95 respirators made in China.
One month later, the FDA revised the EUA after NIOSH tests found that about 60 percent of 67 different types of imported masks tested allowed in more tiny particles in at least one sample than U.S. standards normally permit.
"Nearly one-fifth of Chinese mask makers were just weeks old when the FDA initially approved them for medical use, while others used fake certifications or incomplete tests to claim their masks met Chinese or European standards, according to a review of Chinese corporate registries and company marketing materials," the WSJ reported.
But state agencies had already placed orders for more than 180 million KN95 masks, according to public records analyzed by the WSJ, some of which are now sitting unwanted and unused in warehouses. Others are on sale, leaving consumers vulnerable to low-quality products.
Suzanne Schwartz, a senior FDA device regulator, told the WSJ in a statement that the agency has been constantly responding to new data and science during the pandemic.
“We have provided regulatory flexibility where it is needed most,” she told the WSJ.