The U.S. Food and Drug Administration (FDA) announced that an advisory panel will convene December 14-15, 2010, regarding the scientific issues of dental amalgam that may affect regulation. Dental amalgam is used used for direct filling in tooth restoration after decay. The panel meeting focuses on potential risk to vulnerable populations: pregnant women, fetuses, and young children.

Controversy over the health effects of dental amalgam has been ongoing for decades. The National Institute of Health cites several articles discussing concern over the mercury in the amalgam. Other metals and alloys are also in the amalgam mix. The Centers for Disease Control says amalgam can release small amounts of mercury vapor over time, but that use of amalgam is declining and no evidence of serious health risk has been documented.

In a 2009 final rule, the FDA reclassified dental mercury from a class I device to class II, classified dental amalgam as a class II device, and also designated special controls for dental amalgam, mercury and amalgam alloy. The special control guidance is "Class II Special Controls Guidance Document: Dental Amalgam, Mercury and Amalgam Alloy."
After the reclassification, the FDA received petitions relating to the final rule and special controls. The petitions request the FDA take actions including: banning the use of encapsulated mercury fillings; alternatively reclassifying mercury fillings to a class III device with restrictions in use; having warnings be given to patients undergoing dental restorations; and have mercury amalgam contraindicated for young children, pregnant or nursing mothers, and patients with certain health conditions.

Other concerns raised include the adequacy of the FDA's risk assessment method for classifying dental amalgam, and the clinical studies on amalgam. The FDA cites a National Academy of Sciences study, "Science and Decisions: Advancing Risk Assessment, NAP 2009," that proposes changes to risk assessments. The advisory committee may review the methods suggested in that study.

Details about the advisory panel meeting will be published in the Federal Register on Friday. The docket number is FDA2010N0268. The FDA will also be soliciting public comment on the issue.

Adapted in part from an FDA press release.

Link: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm215061.htm

More Industry Headlines