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).
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 FDA-2010-N-0268- (The docket is not ready for viewing at this time. We will let you know as soon as we get this information).
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.
FDA webview writes:
FDA Panel to Re-review Dental Amalgam Rule
06/10/2010
Opponents of FDA's position on dental amalgam are moving one step closer to a possible agency redress of last August’s controversial final rule (see earlier story) declaring mercury-based dental amalgam safe. FDA says it is holding an advisory committee meeting 12/14-15 to discuss several scientific issues that may affect the dental amalgam regulation.
A Federal Register notice publishing 6/11 acknowledges several petitions the agency has received about the rule raising concerns on the adequacy of the risk assessment method used to classify 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, titled "Science and Decisions: Advancing Risk Assessment, NAP 2009," proposes new approaches to conducting risk assessments, the agency says, adding that "(t)hese may be some of the issues the agency asks the advisory committee to review."
Last month, FDA Webview reported that FDA might be preparing to admit its mistake on the final rule. One big factor shaping the agency's advisory committee review is "new" data that were not available when the final rule went to press. The data reportedly aren’t really that new — they just weren’t considered by FDA’s amalgam rule lead reviewer Susan Runner before the rule was finalized. These data, on extreme toxicity reactivity in infants implanted with amalgam — underpinned a Health Canada decision to recommend against amalgam use in 1995, according to a 9/15/09, 47-page petition, one of two against dental amalgam that are under review at the agency.
Speaking for the International Academy of Oral Medicine and Toxicology, Oklahoma attorney Jim Love (Titus Hills), author of one of the pending petitions, told FDA Webview 6/10 that while "sorely disappointed in the FDA’s final rule issued in July 2009, we are pleased and encouraged that FDA has seen fit to reconsider its position by a holding new hearing before an advisory panel of experts. We believe there is already adequate science available to demonstrate the unacceptable health risks posed by the use of this product. As we have said for many years, dental amalgam — the primary source of mercury in the general population — is unsuitable for use as a dental restorative material and should be discontinued."
FDA NOTE TO CORRESPONDENTS
For Immediate Release: June 10, 2010
Media Inquiries: Dick Thompson, 301-796-7566, dick.thompson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Advisory Panel to Review Dental Amalgam
Agency to consider risks to vulnerable populations
The U.S. Food and Drug Administration today announced plans to hold an advisory panel on Dec. 14-15, 2010, to discuss several scientific issues that may affect the regulation of dental amalgam, used for direct filling of carious lesions or structural defects in teeth. The panel meeting will focus particularly on the potential risk to vulnerable populations, such as pregnant women, fetuses, and young children.
Used to treat tooth decay, dental amalgam is a mixture of metals, composed of liquid mercury and a powdered amalgam alloy, composed primarily of silver, tin, and copper.
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 titled, “Class II Special Controls Guidance Document: Dental Amalgam, Mercury and Amalgam Alloy.”
Since that time, the agency has received several petitions raising various issues relating to the final rule and special controls.
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. 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.
Details about the advisory panel meeting will be published in the Federal Register on June 11, 2010 and is available for advanced viewing today only.
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