The Food and Drug Administration (FDA) warns the public from purchasing and using the adulterated cosmetic product which tested and found to contain BETAMETHASONE 17-VALERATE 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:
The aforementioned cosmetic 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.
Betamethasone 17-Valerate is not allowed to be part of cosmetic product as this was classified as drug product in the Philippines because of the 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 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 email us at [email protected].
Dissemination of this advisory to all concerned is hereby requested.