Thursday, December 12, 2019
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Calls for Action on Dental Amalgam at FDA Advisory Committee Meeting

Thursday, December 12, 2019

A scientific advisory committee convened by the Food and Drug Administration (FDA) recommended that the agency provide information to patients about the risks of dental amalgam, especially for vulnerable populations.  Dental amalgam is a controversial filling material that is 50% mercury.  Committee members expressed particular concern about the disproportionate use of amalgam in disadvantaged populations, including communities of color and low-income communities that are already exposed to higher levels of toxins.

The panel adjourned November 14 after convening for two days of hearings in Gaithersburg, Maryland, the advisory committee re-examined FDA policy on dental amalgam, as well as metal implants.  A diverse array of experts from national and state organizations converged to call for FDA action to protect the public from amalgam, a major source of mercury exposure.

“The European Union virtually forbids amalgam use in children under 15 and in pregnant and breastfeeding women, and entire countries have phased out all amalgam use,” said Charles Brown of the World Alliance for Mercury-Free Dentistry.

“Dentistry has become two-tiered in America, with the majority of people receiving mercury-free dentistry while many soldiers and sailors and their families, prisoners, residents of Indian reservations, and Medicaid families are getting mercury fillings,” said Mark A. Mitchell. M.D., Co-Chair of the Commission on Environmental Health of the National Medical Association and lead author of the commentary Is Amalgam Toxic to Children of Color? [1] “FDA must end amalgam for children and pregnant women without delay.”

“FDA’s silence on dental amalgam is deafening – and it must end,” said Kristie Trousdale Deputy Director of the Children’s Environmental Health Network.   Ms. Trousdale testified as well for the Learning Disabilities Association of America and the Alliance of Nurses for Healthy Environments.

Dr. Rueben Warren, Director of the National Center for Bioethics in Research and Health Care at Tuskegee University, called continued use of amalgam in children “unethical” when there are safer alternatives available, in light of other major health questions. Dr. Warren said, “dental caries is a preventable disease that disproportionately and adversely impacts African American and Hispanic children, and low-income children, regardless of race or ethnicity.” [2] It is noteworthy that FDA’s Center for Devices allows the use of amalgam in children without any warning to their parents – but does not even know whether it is safe for use in children. [3]

“We applaud the scientific advisory committee for urging action by FDA’s Center for Devices, and we thank Director Jeff Shuren for adding immunological and neurological impacts of amalgam to the advisory committee’s agenda.  We look forward to working with FDA on implementing the committee’s recommendations,” said Eric Uram, who organized the Chicago Declaration to End Mercury Use in the Dental Industry, whose signatories include 50 national and state-based environmental, parents, health, and consumer organizations working to phase out amalgam use in the United States. [4]


References

[1] Published in the Journal of the National Medical Association (2018), https://www.sciencedirect.com/science/article/abs/pii/S002796841830258X?via%3Dihub

[2] US Dept. of Health and Human Services. Oral Health America: A Report of the Surgeon General, Executive Summary, Report Rockville, Maryland:  US Dept. of Health and Human Services, National Institute of Dental and Craniofacial Research, National Institutes of Health.

[3] 2009 FDA amalgam rule, Federal Register, Vol. 74, No. 148, 8/4/2009, pp. 38706-07, http://www.gpo.gov/fdsys/pkg/FR-2009-08-04/pdf/E9-18447.pdf

[4] https://mercuryfreedentistry.files.wordpress.com/2018/04/chicago-declaration-to-end-dental-industry-mercury-use-4-18-18.pdf

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