FDA advisory panel to review dental amalgam

Jun 9, 2010

After receiving several petitions raising concerns about the safety of dental amalgam and the adequacy of the clinical studies used to determine how it should be regulated, the U.S. Food and Drug Administration (FDA) announced that it will hold an advisory panel meeting December 14-15, 2010, to discuss scientific issues that may affect the regulation of amalgam.

The meeting, which is open to the public, will focus particularly on the potential risk to vulnerable populations, such as pregnant women, fetuses, and young children, the agency said.

On July 28, 2009, the FDA issued a final rule that reclassified dental mercury from a class I device to class II, classified dental amalgam as a class II device, and designated special controls for dental amalgam, mercury, and amalgam alloy. The special control for the devices is a guidance, "Class II Special Controls Guidance Document: Dental Amalgam, Mercury and Amalgam Alloy."

Since that time, the FDA said it has received several petitions raising issues related to the final rule and special controls, including 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.

In addition, a recent report on risk assessments issued by the National Academy of Sciences, "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.

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before December 6, 2010. Oral presentations from the public will be scheduled at 1 p.m. on December 14, 2010, and 8 a.m. on December 15, 2010.

Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 29, 2010.

Further details about the advisory panel meeting will be published in the Federal Register on June 11, 2010.