Dental Tribune America

Amalgam opponents file lawsuit against FDA

By Dental Tribune International
March 09, 2014

WASHINGTON, USA: Last week, several groups advocating for mercury-free dentistry fillings filed a lawsuit against the Food and Drug Administration, accusing the state agency of failing to address the risk of mercury in dental fillings properly. The plaintiffs are demanding either a formal ban on dental amalgam use or a risk reclassification of dental amalgam by the FDA.

According to nonprofit health organization the International Academy of Oral Medicine and Technology (IAOMT), the FDA failed to respond within a reasonable time to petitions calling for a ban or placement in a higher risk class with additional restrictions and more stringent proof of safety.

The FDA currently lists dental amalgam as a Class II device, a class of higher risk devices that require greater regulatory control to provide safety and effectiveness, such as condoms. However, the agency does not prescribe control or other measures intended to protect the public although the risks of dental amalgam fillings have been demonstrated scientifically by a number of studies, IAOMT stated.

Among other findings, it has been documented that mercury, which can accumulate in the body, is associated with adverse effects in the nervous system and the kidneys. Children in particular are more susceptible to the effects of mercury from dental amalgam fillings. Therefore, many countries advise against the placement of mercury fillings in children and pregnant women. Owing to its toxicity, the chemical has been banned in disinfectants, thermometers and many other consumer products.

According to IAOMT, a joint panel of physicians and dentists reviewed the FDA's white paper on dental amalgam in 2006 and found that it did not demonstrate adequate proof of safety. In addition, the FDA's scientific advisory panel urged the agency to review its amalgam recommendations based on current science in 2010. However, the FDA has not revised its statement to date.

The academy also stated that the U.S. government is the largest user of dental amalgam. It is provided to welfare recipients, prisoners, people residing on American Indian reservations and the military, serving predominately low-income patients, including women and children.

The lawsuit was filed on March 5 at the U.S. District Court for the District of Columbia by several nonprofit organizations dedicated to raising awareness of and educating the public on the dangers of mercury, including IAOMT, Moms Against Mercury, Dental Amalgam Mercury Solutions and the Coalition for Mercury-free Drugs, as well as individuals who claim to have suffered adverse effects of mercury.

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