The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized adulterated cosmetic product SKIN REVOLUTION ACNE CLEARING SOLUTION which tested and found to contain BANNED INGREDIENTS (CLINDAMYCIN and METRONIDAZOLE) in cosmetic products, as reported in the ASEAN Post-Marketing Alert System (PMAS). These ingredients are not allowed to be part of a cosmetic product as per ASEAN Cosmetic Directive (ACD).
The aforementioned product has been tested by the National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia, as part of their post-marketing surveillance activities and results of the laboratory analyses show that the aforementioned product is not compliant with the technical standards set forth by the ACD.
Clindamycin, and Metronidazole are not allowed to be part of cosmetic products as these are classified as drug products in the Philippines because of their multiple serious adverse effects when used indiscriminately without medical supervision.
In light of the foregoing, the public is advised not to purchase the aforementioned unauthorized adulterated 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 are warned not to distribute adulterated cosmetic products.
All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of their jurisdiction.
To report any sale, distribution, complaint and/or adverse event on the use of the violative cosmetic product, the online reporting facility, eReport can be accessed at [email protected], or call us at the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) hotline (02) 8857-1900 loc. 8113 or 8107.
Dissemination of this advisory to all concerned is hereby requested.