FDA Advisory No. 2017-223
Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 50)
The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unnotified cosmetic products whose particulars/details are provided in the attached annex:
1. PROFESSIONAL SKIN CARE FORMULA REJUVENATING (MORNING & NIGHT)
A. PROFESSIONAL SKIN CARE FORMULA KOJIC ACID SOAP
B. PROFESSIONAL SKIN CARE FORMULA REJUVENATING TONER
C. PROFESSIONAL SKIN CARE FORMULA SUNBLOCK CREAM SPF 30 PA++
D. REJUVENATING CREAM
2. SKIN MAGICAL™ REJUVENATING SET KIT #1
A. SKIN MAGICAL REJUVENATING FACIAL TONER 1
B. SKIN MAGICAL EXTRA STRENGTH REJUVENATING SOAP
C. SKIN MAGICAL REJUVENATING CREAM
D. SKIN MAGICAL AGE ERASER COLLAGEN CREAM
E. SKIN MAGICAL SMOOTHENING SUNBLOCK
3. SKIN MAGICAL GLYCOLIC SOAP
4. BANILA CO. PRIME PRIMER CLASSIC
5. BANILA CO. THE KISSEST SATIN FIT THE KISSEST LIP LACQUER SATIN FIT SRD301
6. BANILA CO. KISS COLLECT MOISTURE KISS COLLECTOR MOISTURE LIPTSTICK MPK502
7. BANILA CO. CLEAN IT ZERO RESVERATROL
8. BANILA CO. CLEAN IT ZERO
9. AMC PLUS AMAZING FACIAL MIST
10. AMC PLUS AMAZING TOPICAL MIST
11. SECRETS OF PROFESSIONALS GLUTA BLEACH SOAP WHITENING & MOISTURIZING
12. SECRETS OF PROFESSIONALS CALAMANSI SOAP PURE EXTRACT
13. WET TISSUE YELLOW (LABEL IS IN FOREIGN LANGUAGE)
14. WET TISSUE GREEN (LABEL IS IN FOREIGN LANGUAGE)
15. WET TISSUE PINK (LABEL IS IN FOREIGN LANGUAGE)
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.
Accordingly, because unnotified cosmetic products have not gone through the verification process of the FDA, the agency cannot guarantee their quality and safety. The use of such violative products may pose potential health hazards to the consuming public. Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals such as mercury especially in whitening cosmetic products. The use of substandard and possibly adulterated cosmetic products 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.
Dissemination of the information to all concerned is requested.