FDA Advisory No. 2019-140 || Dissemination of ASEAN Post-Marketing Alert System (PMAS) Report on Adulterated Cosmetic Products With Reference No. (12)/MOH/DPS/PMAS/05/2019

The Food and Drug Administration (FDA) hereby issues this public health warning to inform the public on the report from ASEAN Post-Marketing Alert System (PMAS) on the following Cosmetic Products which were found to contain MERCURY:

BRAND / PRODUCT NAME

1. Glow Skin White French Technology Smart Pack — Whitening Cleanser

2. Glow Skin White French Technology Smart Pack — Whitening Cream
3. Glow Skin White French Technology Smart Pack — SPF 50 Cream

*Attached is a copy of the Brunei PMAS Report with Reference No. (12)/MOH/DPS/PMAS/05/2019

The aforementioned products have been tested by the Department of Pharmaceutical Services, Ministry of Health, Brunei Darussalam 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 ASEAN Cosmetic Directive (ACD).

The aforementioned products have been verified to contain Mercury, a naturally occuring heavy metal which is known to be severely hazardous to health even in small amount. People exposed to mercury exhibits symptoms including but not limited to tremors, numbness and tingling in hands and feet, gingivitis or inflammation of the gums, pink discolouration of the hands and feet especially in children, irritability, and photophobia or sensitivity to light. Nursing mothers are doubly vulnerable because mercury are passed on to nursing babies through breast milk which can affect the baby’s development.

Because of the hazards posed by the aforementioned products, the public is strongly advised to be vigilant and report to FDA, through any of the following channels, any encounter with these products:

  1. Send an e-mail via [email protected]
  2. Call the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8107 or 8113
  3. Utilize the agency’s online reporting facility, eReport, at www2.fda.gov.ph/ereport.

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines Trunk Line +63 2 857 1900 Fax +63 28070751 Website: www.fda.gov.ph Email: [email protected]

Furthermore, the public is also advised to only buy cosmetic products that have been notified with FDA. If unsure of a product’s notification status, consumers may verify whether the product is authorized by FDA through the Search engine embedded in the FDA website accessible at www2.fda.gov.ph. For more information and inquiries, please e-mail us at [email protected] or call the CCRR hotline.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-140

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-140 || Dissemination of ASEAN Post-Marketing Alert System (PMAS) Report on Adulterated Cosmetic Products With Reference No. (12)/MOH/DPS/PMAS/05/2019