The Food and Drug Administration (FDA) warns the public from purchasing and using the following unauthorized and adulterated cosmetic products, which tested positive for the presence of HYDROQUINONE and/or TRETINOIN, respectively, 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 table below indicates the particulars of the unauthorized and adulterated cosmetic products:
1. BLEACHING SKIN BY NINA – BLEACHING LIQUID
2. ERASE WHITENING LOTION SPF 50
3. SHANTAHL REJUVENATING SET – REJUVENATING TONER
4. SHANTAHL REJUVENATING SET – NIGHT CREAM
The aforementioned products have been tested by the Department of Pharmaceutical Services, Brunei Darussalam, 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 and Tretinoin 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, such as sensitivity to light, skin redness and permanent skin discoloration, when used indiscriminately. Additionally, tretinoin may also cause harm to developing fetus. Women planning to get pregnant or are already expecting are strongly advised to avoid using products containing tretinoin.
In light of the foregoing, the public is advised not to purchase the aforementioned unauthorized and adulterated products. 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.