MANILA - The Food and Drug Administration (FDA) warned healthcare professionals and the general public against buying two disposable face mask brands that are “unnotified” or have not gone through the agency’s evaluation.
In an advisory dated Nov. 6, 2020, the FDA identified these brands as “Day Maker Disposable Face Mask” and “AINBEI Disposable Protective Masks”.
“Since these unnotified medical device products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety," the advisory read.
“All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until the Product Notification Certificates are issued, otherwise, regulatory actions and sanctions shall be strictly pursued,” it said.
FDA director general Eric Domingo told ABS-CBN News on Monday that “AINBEI” and “Day Maker” masks need to be registered with the FDA because they are being sold as medical-grade masks or for use in medical settings.
“Karamihan po inirereport sa atin ng mga consumers na nagdududa at 'yung iba naman namo-monitor natin (“AINBEI”, “Day Maker” masks) sa mga online sellers, lalo na ng mga nagtitinda na wala naman silang lisensya to operate as medical device distributors or sellers," he said.
“Pag po yung mga personal protective equipment ay ibinibenta para sa ospital or para sa medical setting, kailangan po medical grade 'yun — ibig sabihin, natest siya at pumasa siya sa standards na protective siya sa tao na gagamit nito lalo na sa setting na maraming merong sakit, may infection o kaya nagaalaga sa may sakit.
“So pag po ibinibenta ang mga mask as a medical device, kailangan po talaga yan ay inirerehistro sa FDA para po nasusuri natin at nasisigurado natin na sumusunod siya sa mga standards,” Domingo said.
Masks worn for reasons other than medical purposes need not be registered with the FDA, according to Domingo.
The FDA urged the Bureau of Customs (BOC) to restrain the entry of unevaluated and uncertified products.
BOC Assistant Commissioner Jet Maronilla told ABS-CBN News all airports and seaport customs personnel have been alerted.
“Immediately, the Commissioner of Customs (Rey Leonardo Guerrero) instructed already the Enforcement Group, Intelligence Group, and the district offices of the [BOC] to take note of these brands and not to allow the importation ng mga brand na ‘to," said Maronilla.
“Lahat kasi dapat idaan natin sa FDA sa tamang pagsusuri para at least alam natin na safe gamitin, especially that this advisory also advises medical practitioners who might not be able to validate yung potency nito or effectiveness nitong mask na to, so sila din part din sila ng winawarningan ng FDA,” he said.
The FDA has approved the sale of 63 face mask brands, as of posting.
Since last March when the COVID-19 pandemic began, Maronilla said the BOC and National Bureau of Investigation (NBI) have jointly conducted at least 10 operations against unregistered face masks and other medical items, especially on Bambang St. in Manila, home of medical supply stores.
Two warehouses full of unnotified face masks have also been raided so far, he said.
Bambang vendors and medical supply operators said they are not selling “AINBEI” and “Day Maker” masks.
“Wala po kaming ganoon, ni hindi pa po namin nasalubong yung ganoong face mask… sumusunod naman po kami sa kung ano po ang dapat ibenta, yun lang po,” Glena Tejeras, who manned the counters at Beljas Medical Supplies Trading, told ABS-CBN News
To report any sale or distribution of the unnotified face masks, the FDA’s online reporting portal, eReport, may be accessed at www.fda.gov.ph/ereport.
The FDA said violators will be slapped with administrative cases and fined.