If You're Using This Mask for Protection, Throw It Out Now, FDA Warns
The agency is asking people to stop using one specific mask.
Virus experts have gone back and forth about the need for masks over the last few months, with the spread of the highly transmissible Delta variant complicating the situation. In July, the Centers for Disease Control and Prevention (CDC) made a major reversal of its mask guidance, recommending that vaccinated individuals once again mask up in indoor spaces. The current variant of COVID is so contagious that many experts have even recommended that the general public don N95 respirators, which were largely reserved for health care workers during the height of the pandemic.
"Quality of mask is going to make a difference with a variant that spreads more aggressively like Delta does, where people are more contagious and exude more virus, and trying to get in N95 masks into the hands of vulnerable individuals in places where this is really epidemic, I think is going to be important, even in cases where they're vaccinated," Scott Gottlieb, MD, former commissioner of the Food and Drug Administration (FDA), told CBS News. But despite the added protection these masks provide, not every N95 mask is safe for you to use right now.
On Aug. 25, the FDA released an announcement requesting that people "stop using certain N95 respirators" manufactured by Shanghai Dasheng, a Chinese-based mask manufacturer. The company had previously earned approval for its respirators by the CDC's National Institute for Occupational Safety and Health (NIOSH), but the institute has revoked all of the respirator approvals. According to the announcement, "the company did not implement, maintain, and control a quality management system."
Consequently, Shanghai Dasheng has lost authorization from the FDA for its N95 masks. "All previously authorized Shanghai Dasheng respirators are no longer authorized for emergency use as a result of the loss of NIOSH-approval," the agency stated in the announcement.
According to the warning, affected respirators can be identified by cross-referencing approval numbers that are no longer NIOSH-approved with the NIOSH approval label on any respirator manufactured by Shanghai Dasheng. There are nearly 40 affected approval numbers, and the numbers can typically be found in red print on or within the packaging, per NIOSH.
"The FDA is alerting health care facility risk managers, procurement staff, and health care personnel about serious concerns with the quality of certain N95 respirators manufactured by Shanghai Dasheng," the agency said.
This is not the first time Shanghai Dasheng has been involved with controversy with its respirators in the U.S. In March 2020, boxes of low-quality, counterfeit N95 masks bearing the Dasheng logo were shipped to front-line health care workers in Los Angeles, California. But the company maintained that it did not export these masks to the U.S., as the counterfeit masks had ear loops on them.
"The N95 masks exported by the company to the U.S. market are all headband masks (with bands) that stretch across the back of the head. We have never exported N95 masks with ear loops to the United States," Wu Shengrong, chairman of Shanghai Dasheng, told the China Internet Information Center at the time.