The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that Just Essentials Distribution Inc., the distributor of Just Mask – Anti-Viral Face Mask had complied to the FDA rules and regulations. The company removed the misleading claims of “anti- viral face mask and any other similar terminology” and added disposable face masks on the packaging of the aforementioned product.
Accordingly, the warning against the purchase and use of the subject product as mentioned in FDA Advisory No. 2020-2217 is herby lifted.
The provisions of FDA Advisory No. 2020-2217 indicating unnotified medical device product is still in effect.
The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to existing laws, rules, and regulations.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected] or call (02) 8857-1900 loc. 8301.
To report any sale or distribution of unregistered medical device products, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.
Dissemination of this advisory to all concerned is hereby requested.
Attachment:-> FDA Advisory No.2020-2217-A