FDA Advisory No. 2017-289
Public Health Warning Against the Use of Unnotified Cosmetic Products Found to Contain Toxic Mercury (Hg) Levels (Batch 2)
The Food and Drug Administration (FDA) advises the public against the purchase and use of the following cosmetic products which tested and found to contain toxic mercury (Hg) levels beyond the 1 ppm (parts per million) limit set by the FDA, and as published in the ASEAN Cosmetic Directive (refer to the attached annex for the product particulars/details):
1. RENOW-D NEW FACIAL CREAM FORMULA-ONE
2. GOREE® DAY & NIGHT WHITENING CREAM OIL FREE
3. GOREE® BEAUTY CREAM WITH LYCOPENE WITH SPF 30 AVOCADO & ALOEVERA
FDA post-marketing surveillance (PMS) activities have verified that the abovementioned cosmetic products have not gone through the verification process of the agency and have not been issued the proper authorization in the form of acknowledged cosmetic notifications. Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.
Mercury salts in cosmetic products inhibits the formation of skin melanin which will result to lighter skin tone. Adverse health effects brought about by highly toxic mercury in cosmetics products include kidney damage, skin rashes, skin discoloration and scarring. Chronic use reduces the skin’s normal resistance against bacterial and fungal infections. Other effects include anxiety, depression or psychosis and peripheral neuropathy. The transfer of mercury to fetuses of pregnant women may manifest as neurodevelopment deficits later in life.
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.
Dissemination of the information to all concerned is requested.