Azar Confirms FDA Struck Down Sale of Subpar Chinese Masks Being Sold in the US

Department of Health and Human Services Secretary Alex Azar is offering details about a federal probe into subpar, KN95 masks from China being sold in the United States.

During an interview on Fox News’ “Mornings with Maria,” Azar weighed in on the Wall Street Journal’s recent analysis that suggested the Food and Drug Administration (FDA) initially allowed Chinese-manufactured, low-quality KN95 masks to be sold in the U.S., which created “confusion about which Chinese brands could be trusted for medical use.” The FDA has since revoked the approval.

According to Azar, the investigative findings determined that some of the manufacturers were not reliable. He also noted that the quality of the masks had not been verified.

He also noted FDA Commissioner Stephen Hahn’s role in determining “alternative regulatory pathways” for the country to acquire more masks.

However, those pathways would be contingent on whether or not there is “a reputable operator, if the product was approved in reputable countries other than China, or if there was independent data validation behind it.”

Azar added, “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. 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,” Azar said.

See Azar’s remarks below (starting at 4:30):

Azar’s latest comments come months after shortages of both N95 and KN95 masks.

According to Dr. Anthony Fauci, at the beginning of the pandemic, the Centers for Disease Control and Prevention (CDC) opted not to recommend face coverings for everyone due to the shortage of personal protective equipment (PPE) and prioritization of healthcare workers, as previously reported on IJR. He said:

“Well, the reason for that is that we were concerned, the public health community and many people were saying this, … that it was at a time when personal protective equipment, including the N95 masks and the surgical masks, were in very short supply.”

However, the surge in coronavirus cases over the last several weeks has led to mask mandates in multiple states which has increased the demand for masks yet again. As of Tuesday afternoon, there are more than 4.8 million confirmed coronavirus cases across the United States.