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FDA warns against use of unregulated face masks
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By Sola Ogundipe
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.
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Through post-marketing surveillance, the FDA said no Product Notification Certificates have been issued for the mentioned brands.
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Image from FDA January 18, 2021 THE Food and Drug Administration (FDA) has warned all healthcare professionals and the public not to purchase and use the unnotified medical device product AideLai Disposable Face Mask.
In an advisory, the FDA said it has verified through post-marketing surveillance that the AideLai Disposable Face Mask is not notified and no corresponding Product Notification Certificate has been issued.
Pursuant to Republic Act 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.