FDA Advisory No. 2020-553 || Public Health Warning Against the Purchase and Use of Cosmetic Products Containing Banned Ingredient/s as Reported in the ASEAN Post-Marketing Alert System (PMAS):

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The Food and Drug Administration (FDA) warns the public from purchasing and using the following adulterated cosmetic products, which tested positive for the presence of TRETINOIN, 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 (see attachement) indicates the particulars of the adulterated cosmetic products:

  1. 3RD SERIES YANKO WHITENING CREAM NIGHT CREAM
  2. 5TH SERIES YANKO WHITENING CREAM NIGHT CREAM
  3. 7TH SERIES YANKO WHITENING CREAM NIGHT CREAM

The aforementioned products have 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 these products are not compliant with the technical standards set forth by the ACD.

The aforementioned products were verified to contain Tretinoin, an ingredient that is not allowed to be part of cosmetic products as this is classified as drug product in the Philippines because of its multiple serious adverse effects 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 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 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, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-553