ADA News

Washington—The U.S. Food and Drug Administration will convene a dental advisory panel Dec. 14-15 to review "scientific issues that may affect the regulation of dental amalgam. The panel meeting will focus particularly on the potential risk to vulnerable populations such as pregnant women, fetuses and young children," said the FDA's June 10 announcement.

For more information, visit www.ada.org, which offers amalgam resources and materials for the profession and the public.

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. The dental products panel of FDA's medical devices advisory committee can advise the agency but has no authority to overrule FDA's 2009 decision.

Since that decision, the FDA has received several petitions "raising various issues relating to the final rule and special controls," the agency said in the announcement posted at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm215061.htm.

"The concerns raised include the adequacy of the risk assessment method used by the FDA in classifying dental amalgam, the bioaccumulative effect of mercury, the exposure of pediatric populations to mercury vapor, and the adequacy of the clinical studies on dental amalgam," said the agency's explanation for the new review. "In addition, a recent report on risk assessments issued by the National Academy of Sciences, titled 'Science and Decisions: Advancing Risk Assessment, NAP 2009,' proposes new approaches to conducting risk assessments. These may be some of the issues the agency asks the advisory committee to review," the announcement said.

The FDA will amplify this announcement with a notice scheduled for publication June 11 in the Federal Register, the official record of government regulatory activity. The FR notice will announce the opening of a docket titled FDA2010N0268 and invite public comment on amalgam regulation. The docket will close Dec. 3. The advisory panel meeting Dec. 14-15 will be open to the public.