Coalition worried over proliferation of unnotified protective face masks

An environmental health organization has raised concerns over the unregulated sale of disposable face masks that may not offer protection from the novel coronavirus disease (COVID-19), while adding to growing COVID-related wastes.

In a letter to the Food and Drug Administration-Center for Device Regulation, Radiation Health and Research (FDA-CDRRHR), the EcoWaste Coalition alerted government regulators about the widespread sale in the local market of protective face masks that are not included in the FDA List of Notified Face Masks.

The group conducted test buys on August 22 and 23 of protective face masks, including those marketed for children’s use, that are being sold by retailers at 168 Shopping Mall, 999 Shopping Mall and Divisoria Mall in Binondo, Manila for P100 to P200 per box.

Of the 12 brands of protective face masks purchased by the group, not a single one was on the FDA List of Notified Face Masks as of 17 August 2020; none provided complete labeling information; none specified the names of their local importers/distributors and their addresses; and six failed to indicate their manufacturer’s details.

One product for children’s use provided most of the labeling information in foreign characters, which makes it “misbranded” as per Section 19(c) of RA No. 3720, or the Food, Drug, and Cosmetic Act  as amended by RA 9711, or the FDA Act.

The group also noted the misuse of the US FDA logo wrongly sending the message that it is FDA-approved.  As per US FDA logo policy, the agency’s logo is “not for use on private sector materials.” Three other products arbitrarily carried the “CE” marking, a certification mark indicating that items were manufactured based on the high safety, health and environmental protection standards in the European Economic Area.

“We are concerned that the above products may not be compliant to essential quality and safety requirements, particularly on filtration efficiency, and may not offer adequate defense against COVID-19 infection if not combined with other protective measures,” wrote Thony Dizon, Chemical Safety Campaigner, EcoWaste Coalition, to FDA Director General Rolando Enrique Domingo and CDRRHR Director Maria Cecilia Matienzo.

Some products claim to possess effective filtering capacity that is not duly certified by a designated body.  The group cited the following as examples of uncertified product claims as written on the product packaging:  “effectively block the inhalation of bacteria and viruses,” “high bacterial filtration efficiency,” “effective filtration,” “high efficiency filtration,” “3-layer filtration,” and “3 layers of care.”

“We are worried that some of these products are passed off as medical-grade masks and used by those who are advised by health authorities to wear such masks, especially frontline health workers,” said Dizon.

According to the WHO, “medical masks (also known as surgical masks) should be worn by health workers, people who have COVID-19 symptoms and those who take care of someone suspected or confirmed with COVID-19.”

“We are also concerned that enterprising individuals are sourcing unnotified face masks from wholesalers in Binondo/Divisoria and selling them elsewhere or online. A quick check of face mask advertisements on popular online shopping platforms will show rampant sale of products not found in the FDA List of Notified Face Masks,” Dizon pointed out.

The EcoWaste Coalition is further concerned that the unchecked importation, distribution and sale of unnotified protective face masks is leading to non-judicious consumption of single-use, non-recyclable and non-biodegradable plastic face masks and their irresponsible disposal, which causes recklessly discarded masks to flow out to the canals, rivers and into the oceans.

To address this problem, the EcoWaste Coalition requested the FDA to issue a public health warning against the purchase and use of unnotified protective face masks and to undertake other measures to prevent and control the proliferation of such products in the local market and in online shopping sites.