Gov't urged: Check safety claims, product registration of face masks
MANILA, Philippines — As the government continues to enforce the mandatory wearing of face masks outdoors, it should also regulate single-use and non-medical disposable masks flooding the market amid the coronavirus pandemic, a chemical safety watchdog said Sunday.
In a letter addressed to the Food and Drug Administration, the EcoWaste Coalition reported that many of the products enjoying high sales advertise unverified health and safety claims including being "anti-droplets," "anti-virus," "anti-bacterial," "high bacterial protection, and "high filtration capacity" from 95 to 99%.
According to the group, at least 33 brands of single-use protective face masks have been making questionable claims, four of which even explicitly label themselves as medical or surgical masks despite not being included in the FDA List of Notified Face Masks. Three were labeled in mostly foreign characters.
According to Republic Act No. 3720, or the Food, Drug and Cosmetic Act as amended by Republic Act No. 9711, or the FDA Act:
"(jj) 'Misbranding' means, in addition to definitions in existing laws, misinformation or misleading information on the label or other information materials authorized by the FDA. It shall not refer to copyright, trademark, or other intellectual property-like instruments.
"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," Thony Dizon, chemical safety campaigner at the EcoWaste Coalition said in a statement.
In a string of test buys conducted by the group in late August, the products were purchased at medical supplies stores in Sta. Cruz, Manila, and even retail stores inside popular shopping malls in Binondo, Manila for P50 to P250 per box.
The Product Research and Standards Development Division of the FDA’s Center for Device Regulation, Radiation Health, and Research earlier informed the EcoWaste Coalition that non-medical face masks are not regulated by the agency.
The coalition said in its statement that 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."
The FDA also said that "notified face masks are required to follow the labeling 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 without authorization.
"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.
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