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ADA: No scientific reason to revisit amalgam regulation

Washington—The American Dental Association “strongly urges” a Food and Drug Administration advisory panel to support the current regulation of dental amalgam when the advisors meet Dec. 14-15.

The FDA will convene a dental advisory panel to review “scientific issues that may affect the regulation of dental amalgam,” the agency announced in June.  The panel can advise the FDA but has no authority to change amalgam regulations adopted just a year ago and supported by the Association. The FDA can accept or reject any recommendations that may issue from the panel’s public review. The FDA regulates amalgam as a medical device.

“There is no scientific reason to revisit the 2009 FDA amalgam ruling,” the Association said in comments filed for the dental products panel of FDA’s medical devices advisory committee. “The state of the science on the issue of the safety of dental amalgam is clear. The best scientific evidence continues to support the safety of dental amalgam.”

The Association’s comments include an update of the scientific literature by ADA’s Council on Scientific Affairs covering studies published between Jan. 1, 2004 and June 15, 2010.

“Overall, studies continue to support the position that dental amalgam is a safe restorative option for both children and adults,” the ADA’s scientific experts concluded.

The 17-member ADA council “has no interest in the outcome of scientific debate other than to provide dentists with the best available scientific information on which to base their treatment decisions,” the Association said.

“The ADA is a science-based organization and bases its comments solely on the scientific evidence. Based on that evidence, the ADA strongly urges the FDA advisory panel to support the well researched and thoughtful conclusions reached by the FDA only last year, after years of study.”

The FDA concluded in 2009 that dental amalgam was a safe and effective restorative treatment and issued a final rule, which the Association supported, that reclassified dental mercury and amalgam components for regulatory purposes.

But on June 10, 2010 the FDA called for a new review after receiving petitions “raising various issues relating to the [2009] final rule and special controls,” the agency said. The FDA announcement and related Federal Register notice are posted at FDA advisory panel.

“The scientific evidence regarding the safety of dental amalgam is well established and has not changed since FDA’s 2009 ruling,” the Association said.