The Food and Drug Administration (FDA) warns the public from purchasing and using the following adulterated cosmetic products which tested and found to contain o-AMINOPHENOL as reported in the ASEAN Post-Marketing Alert System (PMAS). This ingredient is not allowed to be part of a cosmetic product as per ASEAN Cosmetic Directive (ACD). The table below indicates the particulars of the violative cosmetic product/s:
1. SEEDBEE WATER COLORING WINE BROWN
2. SEEDBEE WATER COLORING MEDIUM BROWN
The aforementioned cosmetic products have been tested by the Thailand, Food and Drug Administration, as part of their post-marketing surveillance activities and results of the laboratory analyses show that the aforementioned products are not compliant with the technical standards set forth by the ACD.
o-Aminophenol is included in the list of substances which must not form part of the composition of cosmetic products as per Annex II of the 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 are warned not to distribute violative 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. 8107.
Dissemination of this advisory to all concerned is hereby requested.