The Food and Drug Administration (FDA) hereby issues this public health warning to inform the public of the ASEAN Post-Marketing Alert System (PMAS) report on the following cosmetic products.
|BRAND / PRODUCT NAME||FINDINGS|
|1.||Deeja Cosmetic Star Cream||Product tested and found to contain hydroquinone and tretinoin|
|2.||Deeja Cosmetic Vogue Cream||Product tested and found to contain high level of mercury|
|3.||Deeja Krim Nano (Night)||Product tested and found to contain high level of mercury|
|4.||Miracle White – Brightening Cream||Product tested and found to contain high level of mercury|
|5.||Deluxe Beauty – Ultra Lightening Cream||Product tested and found to contain high level of mercury|
*Attached is a copy of the Malaysian PMAS Report with Reference No. ASEAN ALERT 12-16/2018/K
The aforementioned products have been tested by the National Pharmaceutical Regulatory Agency, Ministry of Health, Malaysia as part of its post-marketing surveillance activities and results of the laboratory analysis show that these products are not compliant with the technical standards set forth by the ASEAN Cosmetic Directive (ACD). Thus, the cosmetic notifications issued by the National Pharmaceutical Regulatory Agency to the said products have been cancelled.
Product #1 has been found to contain hydroquinone and tretinoin, both of which are no longer allowed to be part of a cosmetic product and are classified as drug products in the Philippines because of its multiple serious adverse effects (i.e. sensitivity to light, skin redness and permanent skin discoloration) when used indiscriminately. Additionally, tretinoin may also cause harm to developing fetus. Women planning to get pregnant or are already expecting are strongly advised to avoid using products containing tretinoin.
Products #2 to #5, on the other hand, have been verified to contain mercury exceeding the maximum allowed limit of 1 part per million (ppm). Mercury is 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:
- Send an e-mail via [email protected]
- Call the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8107 or 8113
- Utilize the agency’s online reporting facility, eReport, at fda.gov.ph/ereport.
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 has been authorized by FDA through the Search engine embedded in the FDA website accessible at www.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.