The Food and Drug Administration (FDA) warns the public against the purchase and use of the adulterated and unnotified health product “ PURE PROTECT NATURAL SANITIZER 70% ETHYL ALCOHOL ”, which was tested and found to contain METHANOL.
An adulterated health product is composed, in whole or in part of, or contains any poisonous or deleterious substance which may render the contents injurious to health.
Acute and chronic exposure of humans to Methanol by inhalation or ingestion may result in visual disturbances, such as blurred or dimness of vision, leading to blindness, and neurological damage, specifically permanent motor dysfunction. Skin contact with methanol can also produce mild to severe dermatitis in humans. Furthermore, Methanol is not allowed to be part of a cosmetic product as per the Association of Southeast Asian Nations (ASEAN) Cosmetic Directive.
In light of the foregoing, the public is advised not to purchase the aforementioned violative cosmetic product. Always check if a product is notified with the FDA by using the FDA Verification Portal feature accessible at https://verification.fda.gov.ph. which may be used by typing in the name of the product before the purchase and/or using the cosmetic products..
All concerned establishments and/or entities are warned not to manufacture, distribute, sell, or offer for sale the adulterated health product/s. Pursuant to Section 11, subsections (a) and (b) of Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the following acts and the causing thereof: (a) 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; and (b) the adulteration or misbranding of any health product are prohibited.
All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and local government units, are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.
For more information or inquiries, please e-mail us at [email protected]. To report any sale or distribution of the above-mentioned product, kindly e-mail us via [email protected]. You may also call the Center for Cosmetics Regulation and Research (CCRR) at telephone number (02) 8857-1900 loc. 8113 or 8107.
Dissemination of this advisory to all concerned is hereby requested.