FDA Warns Against Use Of Unregulated Face Masks
The general public has been warned against the purchase and use of certain brands of face masks that lack product notification certificates.
The face masks in question, according to the FDA include Cherub Daily Protective Mask, Just Mask Anti Viral Face Mask, Health Master Disposable Protective Mask, Aidelai Disposable Face Mask, and Disposable Medical Mask.
The agency had published in a number of advisories that the brands did not pass through its regulatory evaluation process.
Through post-marketing surveillance, the FDA said no Product Notification Certificates have been issued for the mentioned brands.
According to the agency: “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 the proper authorization is prohibited.”
The agency said it cannot assure the quality and safety of the mask brands as the products have not gone through their evaluation process.
“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,” the FDA said
The agency also advised the public to always check if a product has been issued FDA certifications before use.
