The Food and Drug Administration (FDA) warns the public from purchasing and using the following unauthorized and adulterated cosmetic product, which tested positive for the presence of HYDROQUINONE, as reported in the ASEAN Post-Marketing Alert System (PMAS). This ingredient not allowed to be part of a cosmetic product as per ASEAN Cosmetic Directive (ACD). The table below indicates the particulars of the unauthorized and adulterated cosmetic product:
1. OBAGI NU-DERM CLEAR FX SKIN BRIGHTENING CREAM
The aforementioned products have been tested by the Health Sciences Authority (HSA), Singapore, as part of their post-marketing surveillance activities and results of the laboratory analyses show that these products are not compliant with the technical standards set forth by the ACD.
Hydroquinone is not allowed to be part of cosmetic products as this is classified as a drug product in the Philippines because of its multiple serious adverse effects, such as sensitivity to light, skin redness and permanent skin discoloration, when used indiscriminately.
In light of the foregoing, the public is advised not to purchase the aforementioned unauthorized and adulterated product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.
All concerned establishments are warned not to distribute unauthorized and 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 jurisdiction.
Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8113 or 8107.
To report any sale or distribution of the afore-mentioned cosmetic product, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.
Dissemination of this advisory to all concerned is hereby requested.
Attachment:-> FDA-Advisory-No.2020-2084