FDA Advisory No. 2019-139 || Dissemination of ASEAN Post-Marketing Alert System (PMAS) Report on Adulterated Cosmetic Product With Reference No. HSA074310052019

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 Cosmetic Product ELIXIR OF LUMOS MASK which was found to contain ARSENIC.

The aforementioned product has been tested by the Health Sciences Authority, Singapore as part of their post-marketing surveillance activities and results of the laboratory analysis show that this product is not compliant with the technical standards set forth by the ASEAN Cosmetic Directive (ACD).

The aforementioned product was found to contain Arsenic, a substance that is not allowed to be part of a cosmetic product based on the ACD. According to the World Health Organization (WHO), acute arsenic poisoning includes vomiting, abdominal pain and diarrhea, followed by numbness and tingling of the extremities, muscle cramping and death, in extreme cases. The International Agency for Research on Cancer (IARC) has classified arsenic and arsenic compounds as carcinogenic to humans. Skin lesions and skin cancer are the most characteristic long-term effects of arsenic.

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

  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.

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. 2019-139

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