The Food and Drug and Administration (FDA) has warned the public not to use two face mask brands which did not go through the proper authorization process.
In an advisory released on Friday, FDA Director-General Rolando Enrique D. Domingo said a brandless product referred to as “Disposable Face Mask” and the AiDeLai Face Mask have not been certified by the agency.
Republic Act No. 9711 or the FDA Act of 2009 prohibits the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the agency’s evaluation.
“Since this unnotified medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety,” Mr. Domingo said.
The FDA official asked business establishments to stop distributing, advertising, or selling the said “violative” face masks until they are given a Product Notification Certificate. “Otherwise regulatory sanctions shall be strictly pursued.”
The FDA called on law enforcement agencies and local government units to “ensure that the products are not sold or made available in the market or within their areas of jurisdiction.” The Bureau of Customs has also been asked to stop the entry of these face masks.
Both products are available online for less than P100 for a box of 50.
The government has required the use of facemasks in public in an effort to control the spread of coronavirus disease 2019 (COVID-19). — Kyle Aristophere T. Atienza