Tuesday, June 17, 2008

American Dental Association Comments On FDA's Settlement Of Dental Amalgam Lawsuit

16 Jun 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.

A substantial body of peer-reviewed, scientific literature supports the safety of dental amalgam, including two clinical trials involving children published in the April 2006 Journal of the American Medical Association. The studies found that children with amalgam fillings do not experience adverse effects related to neurobehavioral, neuropsychological (IQ) and kidney function compared to a control group with composite (tooth colored) fillings. The ADA believes these studies support the existing scientific understanding that the minute amount of mercury released by amalgam does not adversely affect children's health.

"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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