Alerte De Sécurité sur Biocera Alkaline Antioxidant Stick

Safety alert

2017-298

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/473926-fda-advisory-no-2017-298

Fda advisory no. 2017-298  reiteration of fda advisory no. 2017-212 entitled “public health warning against the purchase and use of unregistered health related device (water purification device) biocera alkaline antioxidant stick, fda advisory no. 2014-032 entitled “false, deceptive and misleading claims and strategies to promote “izumi 5p antioxidant alkaline water ionizer” and fda advisory no. 2014-010 entitled “consumer warning against false, deceptive and misleading claims and promotional ploys on “alkaline water” and “oxygenated water” the food and drug administration (fda) advises the public against the purchase and use water purification devices that allegedly produce water known as “alkaline”, “oxygenated”, “ionized”, “hydrogenated” and all claims that are therapeutic in nature as a ploy to promote and market water purification devices. consumers are advised not to fall prey to these false, deceptive and misleading claims. therapeutic claims made on drinking water as a ploy to promote and market water must be substantiated through valid clinical trials. fda observed proliferation of device products promoted and offered for sale or use of purification devices with claims stated above has not gone through the registration process of the agency and has not been issued with proper authorization in the form of certificate of product registration. pursuant to the provisions of 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 any health product that is adulterated, unregistered or misbranded are prohibited. the products that did not undergo the evaluation process of the fda cannot guarantee its quality and safety. all concerned establishments and/or entities are warned not to advertise, sell or distribute products with such claims until such have been issued by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued. all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that water purification device product is not sold or made available in their localities or areas of jurisdiction without proper authorization. for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it. or call the product research and development division - center for device regulation, radiation health and research of the fda at telephone no. (02) 857-1900 loc. 8301. dissemination of the information to all concerned is requested. attachments: fda advisory no. 2017-298.Pdf.