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Relative to the issuance of the FDA Advisory No. 2014-010 regarding the false, deceptive and misleading claims and promotional ploy on “Alkaline Water” and “Oxygenated Water”.

The Food and Drug Administration (FDA) reissues this advisory to inform the general public that any distributors that are promoting and offering for sale or use equipment or devices that would change tap water or bottled water into “alkaline” or “oxygenated” water shall be substantiated through valid clinical trials. It is a violation of RA 9711, otherwise known as the FDA Act of 2009, to sell or offer for sale or use purification devices that allegedly produce water known as “alkaline water” or “oxygenated water” and make therapeutic claims without a Certificate of Product Registration (CPR). Vendo-type outlets or refilling stations, and those engaged in the manufacture, importation and distribution of water with therapeutic claims shall secure a License to Operate from FDA before applying for a CPR.

Consumers are advised not to fall prey to these unscrupulous vendors and peddlers. Drinking alkaline, oxygenated or ionized water does not change the blood pH level.

The FDA warns all companies engaged in the business of supplying drinking waters in containers with specific claims, such as “alkaline water” or “oxygenated water” to secure LTO from FDA and apply for a CPR. The FDA Act of 2009 (RA 9711) prohibits selling, offering for sale, distribution, advertisement, and promotion, among other marketing and advertisement activities, of unregistered health products.

All local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that this kind of products are not sold or made available in localities or areas of jurisdiction.

To check if a health product is registered with FDA, please log in at www.fda.gov.ph and type in the name of the product in the Search bar.

For more information and inquiries, please e-mail us at [email protected] To report continuous sale or distribution of the above health related device, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or email us via [email protected], or call us at the Center for Device Regulation, Radiation Health, and Research (CDRRHR) hotline (02) 857-1900 local 8301.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2014-010-A