United States hesitates to import Chinese N95 Alternative Amid Face Mask Shortage

United States hesitates to import Chinese N95 Alternative Amid Face Mask Shortage


The U.S. is experiencing a horrific shortage of N95 face masks, so it would only get tougher to obtain as COVID-19 events begin to escalate so suppliers fail to keep up with that demand. 

Big retailers, including Home Depot, have stopped selling such masks in store to free up more inventory for healthcare employees and those working in high-risk environments; smaller vendors with restricted supplies run rates through the roof; and the federal government has almost exhausted its stocks of N95s as well as other personal protective equipment (PPE).

Luckily, there are a variety of N95 alternatives on the international market. But face masks, like other medical products, can not be marketed in the U.S. without permission from the Food and Drug Administration. 

And on March 28, the FDA released an emergency authorization for five international countries (Australia, Brazil, Japan, Korea and Mexico) approved N95 alternatives plus the European Union. The emergency permit, though, significantly excluded a Chinese-made mask named KN95, which has an ample supply in the U.S. that would "greatly alleviate the scarcity," published BuzzFeed News on Sunday.

N95 alternatives authorized by the FDA.

The FDA did not specifically state that KN95 is banned in the U.S., but the omission caused importers and health workers to refuse to purchase and use it, while both the U.S. endorse the equipment. Centers for Disease Control and Prevention and 3 M, the world's biggest producer of the original N95. 

At the end of February, the CDC said that KN95 is one of the "suitable alternatives" to N95 masks "when supplies are short." And 3 M said that KN95 "can be expected to function very similar" to N95 masks.

A top FDA official explained Thursday that KN95 imports would not be barred by the federal agency. "The FDA is not blocking KN95 mask imports," said Anand Shah, the deputy commissioner for medical and scientific affairs at the department, in an interview with BuzzFeed News. Yet he noted that, because KN95 is not licensed in the U.S., importers must buy them "at their own risk" without federal government legal safeguards.

The story of Buzz News has drawn broad interest across industries. The petition launched earlier this week to persuade the U.S. government to allow KN95 to be imported has so far gathered almost 3,000 signatures.


Preview Image:A worker produces face masks in China’s Shandong province on Wednesday.