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 Dental Products Panel of the Medical Devices Advisory Committee in December 2010, 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.

Perhaps the hazard of using dental mercury in children was best acknowledged at this 2010 FDA Dental Products Panel when Dr. Suresh Kotagal, a pediatric neurologist at the Mayo Clinic, concluded, “…I think that there is really no place for mercury in children.”  Note that this transcript is only from the second day, December 15, 2010. The transcript includes statements from scientists, dentists, consumers, and the panel members.

Abstract / Excerpt:

“DR. JEFFCOAT: I would like to call this second day of the 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 my — and I am a periodontist and my expertise is in clinical studies. At this meeting the Panel will discuss and make recommendations on specific scientific issues raised in petitions received by the FDA concerning the final rule of the classification of dental amalgam, which was published in the Federal Register on August 4, 2009. Issues raised in the petitions include the adequacy of the risk assessment performed by the FDA in classifying dental amalgams in light of the new report on risk assessments issued by the National Academy of Sciences entitled ‘Science and Decisions Advancing Risk Assessment,’ and that is in the National Academy Press 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 15, 2010.  http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/DentalProductsPanel/UCM242363.pdf.