FDA Advisory No. 2017-092
Public Health Warning Against the Use of Unnotified Toy and Childcare Article (TCCAs) Products (Batch 3)
The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unnotified TCCA products whose particulars/details are provided in the attached annex:
- BONBON PACIFIER (GREEN)
- BONBON PACIFIER (BLUE)
FDA post-marketing surveillance (PMS) activities have verified that the abovementioned TCCA products have not gone through the verification process of the agency and have not been issued the proper authorization in the form of acknowledged TCCA notifications. Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.
Accordingly, because unnotified TCCA products have not gone through the verification process of the FDA, the agency cannot guarantee their quality and safety. The use of such violative products may pose potential health hazards to the consuming public. Potential hazards may come from materials that are not allowed to be part of a TCCA product or being exposed to chemicals that can leach out from the product such as pthalates and nitrosamines. Based on some international studies, these chemicals may cause allergy and cancer.
In light of the above, the public is advised not to purchase the aforementioned violative products. Moreover, the public is also advised to be vigilant against TCCA products that might not be duly notified with FDA. Always check if a TCCA product has been notified with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.
All concerned establishments are warned not to distribute the above-identified violative TCCA products until they have already been covered by the appropriate authorization (TCCA notification), otherwise, regulatory actions and sanctions shall be strictly pursued.
All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.
Dissemination of the information to all concerned is requested.