November 30, 2023

Environmental group lauds DOH-FDA for banning mercury use in medical devices and dental procedures

Environmental watchdog group BAN Toxics lauds the Department of Health (DOH) and the Food and Drug Administration (FDA) Philippines for issuing the FDA Circular which totally bans mercury-added thermometers, sphygmomanometers, dental amalgam capsules, and liquid mercury use in dental restorative procedures in the country.

FDA Circular No. 2022-003 aims for “the total ban of the manufacture, importation, exportation, distribution, sale, offer for sale, donation, transfer, and where applicable, the use, promotion, advertising, or sponsorship of mercury-added thermometers and sphygmomanometers along with dental amalgam capsules and liquid mercury for use in dental restorative purposes to protect human health from the adverse effects of mercury-added medical devices.”[1]

In addition, the storage, transport, and disposal of the banned medical devices shall comply with the existing implementing rules and regulations of the Department of Environment and Natural Resources (DENR).

Any establishment found to violate the provisions of the circular shall be subjected to sanctions and penalties as prescribed by Republic Act 9711, otherwise known as the Food and Drug Administration (FDA) Act of 2009, and its corresponding Implementing Rules and Regulations (IRR). Penalties for the violation include imprisonment ranging from one (1) year but not more than ten (10) years or a fine of not less than Fifty thousand pesos (P50,000.00) but not more than Five hundred thousand pesos (P500,000.00), or both, at the discretion of the court.[2]

Mercury is used in numerous medical devices, including thermometers, sphygmomanometers, gastrointestinal devices, and dental amalgams. Users of the previously mentioned devices may be at risk of mercury exposure and its corresponding adverse effects.

The World Health Organization (WHO) considers mercury as one of the top chemicals of concern due to its toxicity in nature. Exposure to mercury and mercury compounds may cause serious health problems and can cause harm to human’s nervous, digestive, and immune systems.

BAN Toxics is a non-governmental organization that strongly supports the protection of the environment and advocates for an environmentally sustainable future through the promotion of sound chemicals and wastes management practices.

In their efforts to raise public awareness on the adverse effects of mercury, particularly from mercury-containing medical measuring devices (MCMMDs), the organization recently conducted research on the Situation Assessment of Mercury-Containing Medical Measuring Devices in the Philippines assessing the effectivity of the Administrative Order that bans the use of MCMMDs in healthcare facilities and encouraged the shift to mercury-free alternatives. The research was funded by the Government of Japan and was published by the Asian Institute of Technology Regional Resource Centre for Asia and the Pacific.[3]

The assessment is part of the Philippines’ efforts to comply with the Minamata Convention on Mercury which the country ratified in 2020.

“We welcome the FDA’s strong stance towards the liberation of the Filipinos from mercury-added products which ultimately harms both human health and the environment. To better protect the Filipinos from mercury, the strict implementation and regulation of mercury-added products is needed,” says Jam Lorenzo, Policy and Research Associate of BAN Toxics.

“We further recommend to the regulatory agency, including local government officials, to comply with and strictly implement the issuance, and conduct information dissemination efforts to raise awareness about the new circular,” BAN Toxics added.