The FDA's rules surrounding KN95 masks — masks made in China that were supposed to provide similar levels of protection as N95 masks — have allowed hundreds of mask brands to be sold with little oversight and few quality checks, leaving some states with stockpiles of the masks that they no longer trust as protective gear, The Wall Street Journal reported.
The agency made an emergency decision in April to allow importation of millions of KN95 masks, but 3,500 of the Chinese companies that have registered to sell the masks in the U.S. were never fully vetted by a U.S. agency, according to a Journal analysis.
State agencies have submitted orders for more than 180 million KN95 masks, many of which now sit in warehouses due to quality concerns, the Journal found.
The FDA has given some companies initial approval and later revoked that approval after finding the masks were of subpar quality. Some of the companies given initial approval were just weeks old or had posted incomplete mask quality tests.
The Journal also found that more than 60 percent of foreign made masks have failed basic U.S. quality tests and that nearly one-fifth of Chinese companies that make masks were just weeks old when the FDA gave their masks approval for medical use. Other companies used fake certifications or submitted incomplete tests to claim their masks met Chinese or European quality standards.
The FDA's website now includes lists of which KN95 masks are authorized and which are no longer authorized, but at least one model of mask was found to be included on both lists, the Journal reported.
The conflicting information has led to confusion for healthcare providers seeking masks to protect workers.
A Massachusetts eye doctor told the Journal he carefully checked the FDA's website in April before ordering 3,000 KN95 masks for his staff, but the brand was taken off the approval list the next month. He said the masks weren't legitimate products and that the FDA did a disservice by putting a lot of companies on the list without screening them.
Suzanne Schwartz, MD, a senior device regulator at the FDA, told the Journal that the agency has been constantly responding to new data and science during the pandemic and that the agency's main goal is to help hospitals obtain quality masks. She said the FDA has never told the general public to use KN95 masks.
Ms. Schwartz also said importers and distributors should also bear some responsibility to "do their own due diligence and take the appropriate steps to verify the product's authenticity prior to importing."
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