The Food and Drug Administration (FDA) advises the public against the purchase and use of the adulterated cosmetic product THE ORIGINAL PORCELANA® ASTRINGENT IMPROVED FORMULA which tested positive for the presence of HYDROQUINONE and TRETINOIN, ingredients that are not allowed to be part of a cosmetic as per Annex II Part 1 of the ASEAN Cosmetic Directive (refer to the image for the products’ particulars/details).
Products containing Hydroquinone and/or Tretinoin (Retinoic Acid) shall be classified as home remedy, over-the-counter, or prescription drug depending on the amount present as per Administrative Order No. 13 s. 1999.
Accordingly, because these products are not compliant with the existing standards, consumers should be vigilant against their purchase and use. The use of these products can pose potential health hazards to the consuming public and may result to adverse reactions including but not limited to skin irritation, itchiness, anaphylactic shock and organ failure.
In light of the above, the public is advised not to purchase the aforementioned violative products. Moreover, the public is also advised to be vigilant against cosmetic products that might not be duly notified with FDA. Always check if a cosmetic product has been notified with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.
All concerned establishments are warned not to distribute the above-identified violative cosmetic products until they have already been covered by the appropriate authorization (cosmetic notification), otherwise, regulatory actions and sanctions shall be strictly pursued.
All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.
To report any suspicious and/or illegal activity involving the said products, the public may contact FDA through its online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us at [email protected], or call the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8107/8113.
Dissemination of the information to all concerned is requested.