REGULATORY UPDATE | The FDA Philippines Prohibits the Dental Restorative Use of Sphygmomanometer, Dental Amalgam Capsules, Mercury Thermometer, and Liquid Mercury

On June 10, 2022, the FDA Philippines issued a circular regarding the prohibition of the use of medical devices containing mercury, such as Mercury Thermometer, Mercury sphygmomanometer, Dental Amalgam Capsule dan Liquid Mercury (for use for dental restorative purposes). According to the World Health Organization (WHO) data regarding mercury and health, WHO considers mercury to be one of the top ten chemicals or group of chemicals of major public health concern. Exposure to even small amounts of mercury can cause serious health problems for a child's development in utero and early life. There are various medical devices that use mercury that may cause mercury exposure, such as thermometers, tensimeters, digestive devices, and dental amalgams.

The Food and Drug Administration Philippines (FDA) states in their circular that they prohibit the manufacture, import, export, distribution, sale, offer for sale, donation, transfer and where applicable, the promotional, advertising, or sponsorship use of mercury-added thermometers and sphygmomanometers for use in dental restorative purposes to protect human health from the adverse effects of mercury-added medical devices.The FDA is authorized to protect public health and safety through effective regulation of medical devices in the Philippines. This circular is also issued with the intention of addressing the current issues arising from the rampant sales of mercury-added medical devices through various digital platforms and to completely baned such devices in the Philippines.

PRODUCT RECALL

The FDA Philippines is restricting the sale or seller of used mercury add-on thermometers and sphygmomanometers. Manufacturers, traders, distributors, importers, exporters, and wholesalers are responsible for conducting stock investments and recalls of their products to ensure that all thermometers and tensimeters with added mercury are removed from the market and that these products are no longer available in the market. Companies found to have violated the provisions stipulated in RA 9711 and their IRR will be subject to sanctions and penalties.

Read more at the original source: FDA Circular No.2022-003 || Banning of all Mercury-Added Thermometers, Sphygmomanometers, Dental Amalgam Capsules and Liquid Mercury for Use in Dental Restorative Purposes – Food and Drug Administration