Director's Note:You may be receiving some questions from patients regarding a recent settlement of a lawsuit filed against the U.S. Food and Drug Administration by some anti-amalgam groups. A coalition of anti-amalgamist groups filed the lawsuit against the FDA aimed, in effect, at forcing the agency to ban amalgam. The original suit was dismissed because it had been filed in the wrong court.
After the case was refiled, the anti-amalgamist plaintiffs and the FDA entered into a Settlement Agreement. That agreement obligates the FDA to set a date certain (July 28, 2009) to complete its reclassification of encapsulated amalgam and its component parts under the same FDA classification (Class II medical device), and to modify its Web page on dental amalgam.
The American Dental Association (ADA) is concerned and will seek clarification from the Food and Drug Administration (FDA) about recent quotes attributed to the FDA's Deputy Commissioner and a FDA spokesperson suggesting the agency has already decided on the outcome of the pending regulatory process on reclassification of dental amalgam.
The FDA officials' comments were in response to press inquiries about the recent settlement of a lawsuit filed against the federal agency by Moms Against Mercury, a group opposed to the use of dental amalgam fillings.
As part of the lawsuit settlement, the FDA revised information posted on its Web site about dental amalgam and the agency has agreed to set a definite deadline (July 28, 2009) to complete what it began in 2002 — a reclassification process for dental amalgam.
While the FDA's current reclassification proposal does not call for restrictions on the use of amalgam in any particular population group, a quote attributed to the FDA's Deputy Commissioner Randall Lutter, Ph.D., in a recent Associated Press article states, "...what this says is there's a clear intent on our part on labeling for sensitive subpopulations" which suggests that the FDA has already formed the intent to mandate some form of special labeling as a caution to groups purportedly sensitive to mercury.
The ADA does not believe that such action is supported by the best scientific studies published on this topic and intends to seek clarification from FDA, including any scientific support for the agency's recent statements.
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.
The ADA offers additional information about the various dental filling options at www.ada.org
