A number of non-profit organizations and individuals have filed a declaratory action against the U.S. Food and Drug Administration (FDA), claiming that it has failed to act on their petition for rulemaking to “formally ban the use of dental amalgam as a dental restorative material.” Int’l Acad. of Oral Med. & Toxicology, Inc. v. FDA, No.14-0356 (U.S. Dist. Ct., D.D.C., filed March 5, 2014). According to the complaint, more than four years have passed since the plaintiffs asked the agency to reconsider its action classifying dental fillings with mercury as Class II medical devices, “essentially finding that mercury fillings are safe.” Alleging that these fillings are not safe or should be placed in Class III “so that the amalgam manufacturers are required to prove that they are safe,” the plaintiffs point to a number of other mercury-containing products
that are no longer available, due to safety concerns, on the market. The plaintiffs seek an order declaring that FDA’s failure to “promptly” take meaningful action on their petitions for reconsideration violates the Administrative Procedure Act and an order requiring an FDA response “as soon as reasonably practicable.”