Coalition urges government to also regulate non-medical disposable face masks

The environmental health advocacy group EcoWaste Coalition has requested the government to regulate non-medical disposable masks that are enjoying brisk sales amid the COVID-19 pandemic.

Through a letter sent last Friday to the Food and Drug Administration (FDA), the EcoWaste Coalition signified the urgency of regulating single-use protective face masks flooding the market as the government enforces the use of face masks to help tackle the novel coronavirus pandemic.

“As most of the protective face masks that we have so far reported to the FDA are making high bacterial filtration efficiency and other health-related claims, we request the FDA to exercise regulatory flexibility and consider these products as de facto medical face masks for source control that should be regulated for consumer protection,” said Thony Dizon, Chemical Safety Campaigner, EcoWaste Coalition.

In addition, the group urged the agency to issue an advisory that will inform and educate the public about the differences between medical and non-medical disposable masks and the limitations and risks of using medical masks with no Certificate of Medical Device Notification (CMDN), which may not protect against pathogens, including SARS-COV-2, the virus that causes COVID-19.

The group had so far reported 33 brands of single-use protective face masks to the FDA, including four brands that explicitly call themselves as medical or surgical masks, of which not even one is listed in the FDA List of Notified Face Masks.

The products were purchased by the group from medical supplies stores in Sta. Cruz, Manila and from retail stores inside popular shopping malls in Binondo, Manila for P50 to P250 per box.  The test buys were conducted on August 22, 24, 26 and 27.

The Product Research and Standards Development Division of the FDA’s Center for Device Regulation, Radiation Health, and Research had earlier informed the EcoWaste Coalition that non-medical face masks are not regulated by the agency.

According to the FDA, “face masks intended for medical use are regulated by the FDA and can only be imported, manufactured and distributed by an FDA licensed establishment.” It added that “notified face masks are required to follow the labelling requirements which include reflecting the name and address of the manufacturer/ importer/distributor and FDA Registration Number in the form of CMDN.”

Aside from lacking CMDN, four brands were also found to carry the US FDA logo, which is not authorized.  “To the public, such use would send a message that FDA favors or endorses a private sector organization or the organization’s activities, products, services, and/or personnel (either overtly or tacitly), which FDA does not and cannot do,” the US FDA said.

The group also found three brands labeled in mostly foreign characters making them “misbranded” according to RA 3720, or the Food, Drug and Cosmetic Act  as amended by RA 9711, or the FDA Act.

Many of the products carry unverified health and safety claims such as “anti-droplets,” “anti-virus,” “anti-bacterial,” “high bacterial protection,” and “high filtration capacity” from 95 to 99%, the EcoWaste Coalition pointed out.