FDA Reluctantly Admits Mercury Fillings Have Neurotoxic Effects on Children

In 2002, the FDA began a regulatory review of amalgam that was expected to be complete within a few years. In 2006, with the review still incomplete, an independent FDA advisory panel of doctors and dentists rejected the agency's position that there is no reason for concern about the use of amalgam. While the panel agreed that the majority of people receiving such fillings would not be harmed, panel members expressed concern for the health of certain sensitive populations, including children under the age of six.

The panel recommended that the FDA conduct further studies on the risks to children from dental amalgam, and that it consider a policy of informed consent for children and pregnant: that is, warning those groups of the risks associated with the fillings before installing them.

Part of the lawsuit centered on the FDA's failure to respond to these recommendations in a timely fashion.

"This is your classic failure to act," federal judge Ellen Segal Huvelle told the agency.

As part of the lawsuit settlement, the FDA must reach a final decision on the regulation of amalgam by July 28, 2009.



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