The Food and Drug Administration (FDA) warns the general public NOT TO PURCHASE AND USE the unregistered health-related device product:
1. T33 CL10RO AIC-2 TASTE AND ODOR REMOVAL
The FDA verified through post-marketing surveillance that the above mentioned health- related device product is unregistered and no corresponding product registration certificate has been issued. Pursuant to the 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 health products without the proper authorization is prohibited.
Since this unregistered health-related device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety. The consumption of such violative product may pose potential health hazards to the consuming public. Health related device products especially water purification device/ system shall not bear any false, deceptive and misleading claims and promotional ploys on alkaline water, oxygenated water or ionized water (Please see FDA Advisory Nos. 2014-010-A, 2014-010 and 2011-013).
All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the product registration certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.
All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.
The Bureau of Customs is urged to restrain the entry of this unregistered product.
For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.
To report any sale or distribution of unregistered health-related device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.
Dissemination of this advisory to all concerned is hereby requested.