FDA of Philippines enacts Circular banning mercury-added thermometers, sphygmomanometers, and dental restorative materials 
On June 10, 2022, the Food and Drug Administration (FDA) of the Philippines enacted FDA Circular No. 2022-003: Banning of all Mercury-Added Thermometers, Sphygmomanometers, Dental Amalgam Capsules and Liquid Mercury for Use in Dental Restorative Purposes. This Circular prohibits the manufacture, importation, exportation, distribution, sale, offering for sale, donation, transfer, and where applicable, the use, promotion, advertising, or sponsorship of mercury-added thermometers and sphygmomanometers, dental amalgam capsules and liquid mercury for use in dental restorative purposes. This Circular will take effect 15 days following its publication in the Official Gazette or in a newspaper of general circulation and upon filing copies with the Office of the National Administrative Register (ONAR).
This Circular can be downloaded from the following URL.
https://www.fda.gov.ph/wp-content/uploads/2022/06/FDA-Circular-No.2022-003-1.pdf
Main Provisions
- The manufacture, distribution, importation, exportation, sale, offering for sale, donation, transfer, and where applicable, the use, promotion, advertising, or sponsorship of mercury-added thermometers and sphygmomanometers are strictly prohibited.
- Sale and offering for sale of mercury-added thermometers and sphygmomanometers through different digital platforms including social media or through online shopping platforms are strictly prohibited.
- The importation, distribution, sale or offering for sale of liquid mercury and dental amalgam capsules for use in dental restorative purposes shall not be allowed.
- FDA shall not accept any application nor issue any authorization for the manufacture, distribution, importation, exportation, sale, offering for sale, donation, transfer, and where applicable, the use, promotion, advertising, or sponsorship of mercury-added thermometers and sphygmomanometers, and liquid mercury and dental amalgams for use in dental restorative purposes.
- Sale and offering for sale of second-hand mercury-added thermometers and sphygmomanometers are likewise strictly prohibited.
- It shall be the responsibility of the manufacturer, trader, distributor, importer, exporter and wholesaler to check inventory and recall their products to ensure that all mercury-added thermometers and sphygmomanometers are removed from the market and that such products shall no longer be made available to the market.
- The storage, transport, and disposal of these banned medical devices shall comply with the existing implementing rules and regulations of the Department of Environment and Natural Resources.
Any establishment found to be in violation of the provisions of this Circular shall be subject to the sanctions and penalties as prescribed under the Food and Drug Administration Act of 2009 (Republic Act No. 9711) and its implementing rules and regulations.
The draft of this Circular published on July 14, 2021, allowed authorized distributors and retailers of dental amalgam capsules to sell their remaining stocks in the market until June 6, 2023. Also, a 30-day grace period was included for compliance with this Circular for mercury-added thermometers and sphygmomanometers. However, these transitional provisions have been eliminated in the Circular promulgated this time.
The FDA’s announcement on this matter can be viewed at the following URL.
https://www.fda.gov.ph/fda-circular-no-2022-003-banning-of-all-mercury-added-thermometers-sphygmomanometers-dental-amalgam-capsules-and-liquid-mercury-for-use-in-dental-restorative-purposes/
