Author: United States Food and Drug Administration.
Source: United States of America Department of Health and Human Services Food and Drug Administration, Center for Devices and Radiological Health Medical Devices Committee.
Year: 2010
Comment:
At this meeting, the Dental Products Panel encouraged the FDA to consider limiting dental mercury amalgam use in pregnant women and children and to consider labeling that would warn consumers about the risks of this mercury-containing product. This transcript contains testimonies from dental consumers to the FDA and information from risk assessment expert Dr. G. Mark Richardson, who was invited by the FDA to present the results of a major risk assessment analysis of dental mercury amalgam fillings at this meeting. Note that this transcript is only from the first day, December 14, 2010.
Abstract / Excerpt:
“DR. JEFFCOAT: Good morning. I would like to call this meeting to order. And thank you all for coming out on a very cold day. I’m Dr. Marjorie Jeffcoat and I’m officially calling this meeting of the Dental Products Panel to order. I’m Dr. Marjorie Jeffcoat, Chairperson of the Panel. I’m a professor at the University of Pennsylvania and the former dean. I have expertise in clinical studies, especially related to systemic diseases and oral health. At this meeting, the Panel will discuss and makerecommendations on scientific issues raised in the petitions received by the
FDA concerning the final rule on the classification of dental amalgam, which was published in the Federal Register on August 4th, 2009. Issues raised in the petitions include the adequacy of the risk assessment performed by the FDA in classifying dental amalgam, in light of a new report on risk assessment issued by the National Academy of Sciences entitled ‘Science and Decisions: Advancing Risk Assessment.’ And that was in the National Academy Press in 2009.”
Citation:
United States of America Department of Health and Human Services Food and Drug Administration, Center for Devices and Radiological Health Medical Devices Committee. Dental Products Panel [transcript]. December 14, 2010. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/DentalProductsPanel/UCM242357.pdf