The Food and Drug Administration (FDA) Philippines strictly regulates cosmetic products to ensure they meet all requirements and pass FDA standards, assuring their safety for human consumption. Cosmetics registration is a crucial step in this process, ensuring that products comply with regulatory guidelines before reaching the market. We are all aware that the role of the FDA is to protect and, more importantly, 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. This is particularly relevant in processes like cosmetics registration, where accuracy and regulatory compliance are crucial.
According to the 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 subjected to tests and analysis. The manufacturer, distributor, and/or importer’s biggest hurdle is cosmetics registration due to the numerous requirements they must comply with to ensure product safety for consumers.
The administration enforces strict regulations and closely monitors products in the market to protect both consumers and the industry.
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.
