Categories: Blog
Published 7 May 2024

On June 10, 2022, the FDA issued a circular prohibiting the use of medical devices containing mercury, including thermometers, sphygmomanometers, dental amalgam capsules, and liquid mercury for dental restorative purposes. The World Health Organization (WHO) has identified mercury as one of the top ten chemicals of major public health concern. Even minimal exposure to mercury can lead to serious health issues, particularly affecting a child's development during pregnancy and early life. Various medical devices that use mercury pose a risk of exposure, including thermometers, sphygmomanometers, digestive devices, and dental amalgams.

The FDA's circular explicitly prohibits the manufacture, import, export, distribution, sale, donation, transfer, and promotional use of mercury-added thermometers and sphygmomanometers for dental purposes. This measure aims to safeguard human health from the adverse effects associated with mercury-laden medical devices.

The Food and Drug Administration (FDA) is empowered to protect public health and safety through the effective regulation of medical devices in the Philippines. This circular also addresses the growing concerns surrounding the sale of mercury-added medical devices on various digital platforms, seeking to completely ban such devices in the country.

To enforce this prohibition, the FDA is restricting the sale of used mercury-added thermometers and sphygmomanometers. Manufacturers, traders, distributors, importers, exporters, and wholesalers are responsible for conducting stock assessments and recalling their products to ensure the removal of all mercury-added thermometers and sphygmomanometers from the market. Companies found in violation of the provisions outlined in Republic Act No. 9711 and its Implementing Rules and Regulations (IRR) will face sanctions and penalties.

For more information, please refer to 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.