In a big win for safer dentistry, the Food and Drug Administration today effectively put on hold its rule declaring mercury?containing dental fillings to be safe for the entire population, in response to several ?petitions to reconsider,? including one filed by the International Academy of Oral Medicine and Toxicology (IAOMT). The Final Rule classifying dental mercury and dental amalgam was published in the Federal Register on August 4, 2009 (74 FR 38686).
FDA Grants iAOMT Petition to Reconsider Amalgam Rule
A spokesman for the FDA, noting that it is exceedingly rare for such petitions to be granted, made it clear that the petition submitted by the IAOMT was the one that influenced FDA policy makers to take this action. ?You confronted us based on the science,? he said, particularly on issues of risk assessment for mercury exposure from dental amalgam.
IAOMT President, Dr. Michael Jackson, of Fort Worth, Texas, said in response to today?s news, ?We believe the weight of scientific evidence demonstrates that there are unacceptable health risks posed by this product. The IAOMT position has always been that dental amalgam— the primary source of mercury exposure in the general population— should be discontinued, especially now that safer materials are so well established in dental practice.?
The FDA has scheduled a meeting of an advisory panel of scientists on December 14-15, 2010, to discuss and make recommendations concerning the scientific issues raised. A docket for public comment to the forthcoming panel will be open soon. Comments can be submitted at http://www.regulations.gov, docket number FDA2010N0268.
The panel meeting will focus particularly on the potential risk to vulnerable populations, such as pregnant women, fetuses, and young children.
The IAOMT (www.IAOMT.org) is an academy of medical, dental, and research professionals dedicated to integrity and safety in health care. Safer dentistry has been its main thrust since its founding in 1984.
