Azar: FDA moved quickly to stop subpar Chinese masks from being sold in US

Health and Human Services Secretary Alex Azar said Tuesday that the Food and Drug Administration (FDA) moved quickly to stop subpar Chinese masks from being sold in the U.S.

During an interview on Fox Business’s “Mornings with Maria,” Azar responded to a Wall Street Journal analysis that determined the FDA allowed thousands of Chinese manufacturers to sell KN95 masks in the U.S. with little oversight or quality checks.

Azar said discussions on approving masks dated back to March as the coronavirus pandemic swept up New York, New Jersey and Connecticut, leaving medical workers without the necessary protective equipment. 

He commended FDA Commissioner Stephen Hahn for providing “alternative regulatory pathways” for the U.S. to obtain more masks, “if it was a reputable operator, if the product was approved in reputable countries other than China, or if there was independent data validation behind it.”

“What we found, though, was that on inspection, some of the manufacturers were not reliable and they had not actually gotten that independent test verification,” Azar said. “FDA quickly removed those products from the market.

“So I think it just shows that FDA has, under President Trump’s direction, been very nimble, very adaptable to meet this unprecedented pandemic,” he added. 

The FDA made an emergency decision to permit Chinese-made masks to be sold in the U.S., including to states, in April after public criticism over the lack of masks. But the administration ended up revoking its approval for some of the manufacturers, creating confusion among consumers.

The Journal found that state agencies bought more than 180 million KN95 masks from China, but many of them are unused because of quality concerns. Federal agencies also sent out millions of other KN95 masks to states, which could be less effective than expected.

The FDA currently publishes lists of Chinese-made respirators classified as “authorized” and “no longer authorized” for use.