FDA: Find Out More About Cosmetics Registration

May 8, 2014
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The Food and Drug Administration (FDA) Philippines are strictly regulating the cosmetics products to ensure that it meets all the requirements and passed the FDA standard to assure its safety for human consumption. We are all aware that the role of the FDA is to protect and more importantly to promote public health and safety through the regulation and supervision of different products that may affect consumers’ health and living.

January this year, FDA released Advisory No. 2014-007 regarding the Public Caution Against Laboratory Reports on Levels of Lead (Pb) in Toys Using Handheld XRF Instrument. The administration is seriously concern over circulating laboratory reports generated by handheld X-ray fluorescence (XRF) instruments released to the public by well-meant organizations.
(image by: DOH- FDA Philippines)

Last February, a non-governmental-organization (NGO) submitted to FDA 36 samples of lipstick products, which were not FDA-notified, and subject of several reports published in newspapers allegedly containing prohibitive levels of lead (Pb), arsenic (As) or mercury (Hg) as measured by the XRF instrument. High level of said metals could put women at risk for health issues including stomach tumors and nervous system problems. Kids who experiment with makeup could also be at risk.

When FDA verified these samples, all reports made using the XRF instrument were confirmed to be true except for the 2 other lipstick samples which was within limits using XRF instrument but contained lead beyond the allowable limit according to the FDA Cosmetic Laboratory.

This discrepancy of results between standard laboratory methods and the handheld XRF instrument suggests that the use of the XRF instrument is not sufficient as a basis for alerting the public consumers.
According to FDA, it is important to remember that prudence should be exercised by all sectors and stakeholders before making any unsubstantiated claim or unfounded statement.

FDA Philippines provides standard requirements wherein products are being subjected to tests and analysis. The manufacturer, distributor, and/or importer’s biggest hurdle is to register their products because of the requirements they need to comply to assure that the product is safe to be used by the consumers.
The administration puts its metal hand and is very keen on the products circulating the market in to secure not only the consumers but the industry as well.

Triple I Consulting is headed by one of the most skilled and reliable FDA consultants who are willing to guide you in the licensing, and in preparing the legal requirements to ensure the safety and efficacy of your products. Our Regulatory Affairs Department is able to provide proper assistance in the preparation of documents to minimize certain incomplete requirements for regulatory approvals and to avoid rejection of registration or licensing. Do not hesitate to contact us.

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