Alerta De Seguridad para Izumi 5P Antioxidant Alkaline Water Ionizer

Según Food and Drug Administration Philippines, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Philippines que fue producido por Izumi Ionizer.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Número del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
  • Notas adicionales en la data
  • Causa
    Fda advisory no. 2014-032 false, deceptive and misleading claims and strategies to promote "izumi 5p antioxidant alkaline water ionizer" the food and drug administration (fda) issued advisory no. 2014-010 dated 27 january 2014 warning consumers against false, deceptive and misleading claims regarding alkaline water and or water purification devices. despite issuance of the aforesaid advisory, the fda has monitored the newspaper advertisement of izumi 5p antioxidant alkaline water ionizer published in the philippine daily inquirer dated 31 march 2014 page a-25 entitled "the secret to a healthier, longer life" and philippine star, 4 april 2014 issue, page 13, allegedly comparing the benefits of drinking alkaline water produced by izumi ionizer, to that of a japanese guinness book of records holder oldest documented living person who was discovered to be drinking water from a preserved water source. the fda also monitored izumi website at http://izumilifestyle.Com and found that it is being used to advertise deceitful health and therapeutic claims, among others: a quick search at the fda website reveals that izumi alkaline water ionizer is not registered with the fda-center for device regulation, radiation health, and research. it is therefore a direct violation of ra 9711. otherwise known as the fda act of 2009, to sell or offer for sale or advertise the said purification device product that allegedly produce water known as "alkaline water" and make therapeutic claims unless covered by a certificate of product registration (cpr) and the importer/distributor is licensed by the fda. drinking alkaline water or ionized water does not change the blood ph level or remove every known chronic disease condition. there are no scientific and clinical studies that would support or back-up its health and therapeutic claims. consumers are, thus, strongly advised not to fall prey to these type of misleading, deceptive advertisements and are forewarned against buying and using unregistered izumi alkaline water ionizer since it is not an fda-approved water purification device. all consumers are advised to be more vigilant and critical about on-line and printed advertisements so as not to fall prey to the marketing schemes of unscrupulous companies. the importer and advertiser of izumi 5p antioxidant water ionizer is directed to immediately stop from further importing, advertising and selling the subject unregistered water purification device unless registered with the fda. for more information and inquiries, kindly email us at this email address is being protected from spambots. you need javascript enabled to view it. .  attachments: fa2014-032 - false deceptive and misleading claims and strategies to promote izu.



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