FDA Warns Against 5 Face Mask Brands: Here Is A List That Is FDA-Approved

On Sunday, January 17, the Philippines reached the 500,000 mark for COVID-19 positive cases, with 4.9% or 24,691 as active cases.

With our numbers continuing to rise with each passing day, the Food and Drug Administration (FDA) warned the public against five face mask brands that have not been certified for public use.

The brands are as follows:

• Aidelai Disposable Face Mask
• Cherub Daily Protective Mask
• Just Mask Anti-Viral Face Mask
• Health Master Disposable Protective Mask
• Disposable Medical Mask

The AideLai face mask, commonly sold online, markets itself as a disposable protective mask that can filter PM (particulate matter) 2.5 pollutants. But according to the FDA these products lack product notification certificates and have not gone through the evaluation process of the FDA. Thus, the agency cannot assure its quality and safety.

“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 FDA said in its advisory.

It also warned establishments 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 supplied a list of registered face masks that are specifically designed for medical use. These comply with global regulatory requirements.

 

For more information on the list of notified face masks brands, you may view the advisory here.

As a precaution, always check if your product has been notified with the FDA before making a purchase. Use the search feature on their website at www.fda.gov.ph or look for the FDA registration number on the product label in the form of CMDN-xxx.

PH pediatricians warn agains the use of face shields and masks for newborns. Read the story here.