FDA’s “Final” Mercury Amalgam Ruling Effectively on Hold, New Panel to Discuss Issues in December
Posted on Friday, June 18th, 2010
On June 11, the Food and Drug Administration 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).
Concerns raised by the petitions 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.
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 International Academy of Oral Medicine and Toxicology 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.
In response to the news, IAOMT President, Dr. Michael Jackson, of Fort Worth said, “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. Once it has, you can submit comments 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.