FDA warns against use of 2 brands of disposable face masks
MANILA, Philippines — The Food and Drug Administration (FDA) on Friday warned healthcare professionals and the public against the use and purchase of two brands of “unnotified” disposable face masks.
In separate advisories, FDA director-general Eric Domingo said the “Disposable Medical Mask” and the “Aidelai Disposable Face Mask” are “unnotified medical device products.”
Domingo said the FDA has verified through post-marketing surveillance that Product Notification Certificates have not been issued for the two brands of face masks.
“Pursuant to the Republic Act No. 9711, otherwise known as the Food and Drug Administration Act of 2009, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without proper authorization is prohibited,” he said.
He added that since the products have not gone through the evaluation process of the FDA, the agency cannot assure the products’ quality and safety.
Domingo warned concerned establishments not to distribute, advertise, or sell the said face masks until Product Notification Certificates are issued.
“Otherwise, regulatory actions and actions shall be strictly pursued,” the FDA chief said.
He then advised the public to always check on the FDA’s website if a certain product has been evaluated by the agency before purchasing it.
All law enforcement agencies and local government units were also requested to ensure that the said face masks are not sold or made available in the market in their areas of jurisdiction.
The Bureau of Customs is likewise urged to restrain the entry of the products to the country.
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