IAOMT’s Press Release Regarding The FDA’s Response to Citizens’ Petitions Concerning the Mercury in Dental Fillings
(Washington, DC) — In response to a lawsuit filed on March 5, 2014, FDA agreed to submit responses to three citizens’ petitions filed with FDA in September 2009 challenging FDA’s position on the safety of mercury tooth fillings. The citizens’ petitions allege that the published scientific literature demonstrates that the absorption of mercury from these filings presents an unacceptable risk to the health of those in whom this material is placed. The lawsuit alleges that FDA has failed to respond to these petitions within the six-month period provided by regulation. In December 2010, the FDA announced its intention to complete its review by the end of 2011, but it did not actually respond until January 27.
The petitions call for either a formal ban on amalgam use, or classification of these fillings in FDA’s Class III. Such classification would require: 1) additional restrictions for vulnerable individuals; 2) more stringent proof of safety; and 3) an Environmental Impact Statement. In August 2009, FDA classified this dental device in Class II, prescribing no controls or other measures intended to protect the public.