FDA to Classify Mercury Fillings by Summer 2009

June 16, 2008

As part of a settlement in a lawsuit filed by Moms Against Mercury, the FDA has agreed to classify a controversial mercury-containing cavity filler by July 28, 2009.

The agency proposes to classify dental amalgam made of liquid mercury and metal powder as a Class II device. This would enable the agency to impose special controls to ensure the product’s safety and effectiveness. 

The FDA recently reopened the comment period on that proposed classification, specifically requesting information on appropriate labeling statements by July 28 of this year. After reviewing all comments, the FDA will issue a final rule classifying the product and possibly requiring revised labeling.

The suit, Moms Against Mercury v. Eschenbach, filed Dec. 28, 2007, in the U.S. District Court for the District of Columbia, alleged purposeful delays by the FDA in classifying the amalgam.

The FDA was required by the Medical Devices Amendments Act of 1976 to classify all medical devices on the market at the time of the act’s passage. In the 1980s, the agency classified all dental filling materials except mercury amalgam. In 2002, agency staff said the failure to classify mercury amalgam was “inadvertent” but later withdrew that claim, the suit said.

When amalgam fillings are installed or removed, they release mercury vapor. This vapor also is released during chewing. As part of its rulemaking, the FDA will review evidence on whether the vapor can cause health problems, including neurological disorders, in children and fetuses.