In the rush to meet demand for face masks and respirators during the COVID-19 pandemic, some manufacturers have turned out poor quality products while falsely claiming approval by the U.S. Food and Drug Administration, a new investigation has found.
A “mix of first-time manufacturers and first-time buyers has led to confusion and concerns about quality,” according to a report from National Public Radio.
Mask shipments from alternative suppliers have arrived damaged, of poor quality, dirty, made of odd materials, and ill fitting, according to complaints from healthcare providers. Yet many sellers claim that their products have FDA certificates of registration, supply chain sources told the news outlet. These often include an FDA logo and a cartoon eagle.
When NPR examined top surgical mask wholesale listings in early July, all 21 included an image of an FDA registration certificate. They also had valid registrations for their facilities. Yet none had undergone FDA inspection or were cleared for selling surgical masks.
The certificates usually include fine print explaining that the FDA doesn’t honor such proof of approval. In fact, no such regulatory standard exists. Even though the agency requires medical products manufacturers to register their facilities for tracking purposes, it does not issue these certificates, NPR reported.
The certificates “are completely commercially meaningless, of absolutely no value whatsoever,” said a U.S. attorney who represents importers.
To complicate matters, government agencies have attempted to ease sourcing problems by forgoing normal product scrutiny during the pandemic. Surgical masks, for instance, typically need FDA clearance before going on the market, but the agency has temporarily waived that requirement.
Meanwhile, the FDA has received at least 37 reports of mask malfunctions and injuries involving surgical masks, N95 respirators, KN95 respirators and face shields. And in early June, it provided a list of manufacturers whose masks could not withstand decontamination and reuse. Respirators manufactured in China — where many masks originate — vary in design and performance, the agency announced at the time.
A continuing care community in Auburn, Washington told NPR that it had opted not to use the oddly manufactured masks it received from FEMA. Instead, community residents sewed better masks and gave them to the staff.