Group wants public warned about face masks being sold without FDA approval

Published August 25, 2020, 1:01 PM

by Ellalyn De Vera-Ruiz

An environmental health organization is calling on government regulators to address the proliferation of unregulated and mislabeled protective face masks in the local market.


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

All 12 brands of protective face masks purchased by the group were not on the FDA List of Notified Face Masks as of August 17.

The group also noted that none provided complete labeling information and names of their local importers/distributors and their addresses; while 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 a “misbranded” product as stated under Section 19(c) of the Republic Act (RA) 3720, or the Food, Drug, and Cosmetic Act as amended by RA 9711, or the FDA Act.

EcoWaste also noted the misuse of the US FDA logo on these products, 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.  

EcoWaste Coalition sent a letter to the FDA-Center for Device Regulation, Radiation Health and Research (CDRRHR) last Monday as it raised concerns over the matter.

It 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.

“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,” EcoWaste chemical safety campaigner Thony Dizon wrote to FDA Director-General Rolando Enrique Domingo and CDRRHR Director Maria Cecilia Matienzo, noting some of the products claim to possess effective filtering capacity that is not duly certified by a designated body.

Some of the claims as written on the product packaging were “effectively block the inhalation of bacteria and viruses,” “high bacterial filtration efficiency,” “effective filtration,” “high efficiency filtration,” “three-layer filtration,” and “three 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,” Dizon said.

“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,” he added.