Some states stop using KN95s to protect workers; agency cites ‘regulatory flexibility’

A Food and Drug Administration effort to address a shortage of protective masks has instead opened the floodgates to 3,500 Chinese manufacturers selling products of widely varying quality, potentially putting the public at risk and leaving some U.S. states with stockpiles of masks they no longer trust as protective gear, a Wall Street Journal analysis found.

Facing a severe shortage of N95 respirator masks in the early days of the coronavirus pandemic, the FDA made an emergency decision to allow importation of millions of Chinese-made masks, generally called KN95s, that were supposed to provide similar levels of virus protection.

But the FDA itself created confusion about which Chinese brands could be trusted for medical use, in part by giving—then revoking—its stamp of approval to masks that turned out to be subpar. Some of the companies given initial approval were just weeks old or posted incomplete mask-quality tests, the Journal found. Read more at WSJ