Thursday, June 05, 2008

ADA Comments on FDA's Settlement of Dental Amalgam Lawsuit

WASHINGTON, June 5, 2008—The American Dental Association (ADA) believes the recent settlement between the U.S. Food and Drug Administration (FDA) and the group Moms Against Mercury simply sets a definite deadline (July 28, 2009) for the FDA to complete what it began in 2002—a reclassification process for dental amalgam, a commonly-used cavity filling material. As far as the ADA is aware, the FDA has in no way changed its approach to, or position on, dental amalgam

Contrary to some assertions, the FDA’s current reclassification proposal does not call for restrictions on the use of amalgam in any particular population group. It merely restates FDA’s ongoing call for public comments on that issue, as well as the findings of the most current scientific studies on amalgam.

"People depend on the FDA and other government health agencies to help protect their health. It’s critically important that public health recommendations are based on sound scientific evidence," states ADA President Mark J. Feldman, DMD. "The ADA will continue to advocate for the best oral health of the public as part of the FDA regulatory process."

Presently, FDA has different classifications for encapsulated amalgam and its component parts, dental mercury and amalgam alloy. The FDA’s proposed reclassification, which the ADA has supported since 2002, would place encapsulated amalgam and its components under one classification.

Based on extensive studies and scientific reviews of dental amalgam by government and independent organizations worldwide, the ADA believes that dental amalgam remains a safe, affordable and durable cavity filling choice for dental patients.

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