The Food and Drug Administration (FDA) has advised healthcare professionals and the public not to purchase AiDeLai disposable face masks, since the product was found to be without required authorization.
“The FDA verified through post-marketing surveillance that the above mentioned medical device product is not notified and no corresponding Product Notification Certificate has been issued,” the FDA said in its advisory.
Under Republic Act No. 9711 or the “Food and Drug Administration (FDA) Act of 2009,” the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization is prohibited.
“Since this unnotified medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety,” FDA said.
Without Product Notification Certificate, establishments cannot distribute, advertise, or sell the said “violative” face mask brand.
Violators will face sanctions since the agency reminded establishments to regularly check if a certain product has been approved by the agency through www.fda.gov.ph.
FDA Registration numbers can also be found on the label in the form of CMDN-xxx.
Meanwhile, the FDA has advised the Bureau of Customs to ban the further influx of the unnotified product. Ronald dela Cruz