Events

Safety Alert for Hydrogen Water Generator

According to Food and Drug Administration Philippines, this safety alert involved a device in Philippines that was produced by N/A.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event Number
    2018-176
  • Event Country
    Philippines
  • Event Source
    FDAP
  • Event Source URL
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/508923-fda-advisory-no-2018-176
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    Fda advisory no. 2018-176 public health warning against non-certified therapeutic claims on the advertisement and promotion of hydrogen water generator the food and drug administration (fda) warns the public against non-certified therapeutic claims on the advertisement and promotion of hydrogen water generator: among the unsubstantiated health claims used on the said product are as follows: helps cure and fight wide range of diseases, boosts immune system; anti-aging, anti-wrinkle; act as therapeutic antioxidant; helps prevent brain injuries, heart disease and age related memory loss; improves concentration; prevents cancer and diabetes; strengthen immune system; and enhance immune system of children  therapeutic claims made on drinking water must be substantiated through valid clinical trial. the above health claims used in the advertisement of the said product have not been validated and approved by the fda. sale, distribution and advertisement of health products without prior approval from the fda is a violation of the provisions of republic act 9711 or the food and drug administration (fda) act of 2009.  the public is hereby advised not to fall prey to distributors and retailers of the said product and to be vigilant and observe precautionary measures in purchasing products with misleading and deceptive health claims.  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 center for device regulation, radiation health and research hotline at (02) 857-1900 local 8301.  dissemination of the information to all concerned is requested. attachments: fda advisory no. 2018-176.Pdf.

Device

Hydrogen Water Generator
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP