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FDA Advisory Panel to Review Dental Amalgam

06/12/2010 13:25:00 admin

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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.

The following is a petition requesting to act

CITIZEN PETITION

Action requested

The undersigned submits this petition under 21 CFR 10.30 of the Federal Food, Drug and Cosmetic Act or the Public Health Service Act or any other statutory provision for which authority has been delegated to the Commissioner of Food and Drugs under 21 CFR 5.10 to request the Commissioner of Food and Drugs to prepare informed consent brochures that dentists must give to their patients who receive dental restorations .

Statement of grounds

Amalgam restorative material generally contains 50% mercury (Hg) in a complex mixture of copper, tin, silver, and zinc . It has been well documented that this mixture continually emits mercury vapor, which is dramatically increased by chewing, eating, brushing, and drinking hot liquids . Mercury has been demonstrated to have damaging effects on the kidney, central nervous system, and cardiovascular system, and has been implicated in gingival tattoos . While mercury amalgams may result in detrimental exposure to the patient, they can also be danger in dental practices. In Europe, the federal governments of Norway (1), Finland (2), Denmark, and Sweden have enacted legislation requiring that dental patients receive informed consent information about the dental restorative material that will be used. In the United States, a few state governments have enacted informed consent legislation for dental patients receiving dental restorations. These state legislation's were enacted by Maine (3), California, Connecticut, and Vermont. It is a sad tragedy that mercury is causing such health damage to many people . The American Dental Association has said for the past 150 years that the mercury in amalgam is safe and does not leak; however, no clinical studies were ever done and the Food and Drug Administration approved amalgam under a grandfather clause . Subsequent studies have shown this claim of safety not to be true. Over ten years ago, the Federation of American Societies for Experimental Biology Journal published a comprehensive article calling mercury restorative material a major source of mercury exposure to the U.S . Population (4) . The authors of this Citizen's Petition recommend that the Food and Drug Administration require that informed consent brochures be given to all patients receiving silver-mercury amalgam restorative materials. The need for informed consent for dentist's who use mercury amalgam restorative material has been published in 2007(5) .

References

1 . A National Clinical Guideline for the Use of Dental Filling Materials .

Information for dental healthcare personnel . National Clinical Guidelines

Norway.

2. Ban On Mercury Amalgam Recommended By Swedish Committee. 1993

3 . Bureau of Health : Oral Health Program. Mercury Amalgam and Other

Filling Materials. Maine.gov.

4. Lorscheider FL, Vimy MJ, Summers AO. Mercury exposure from "silver"

tooth fillings; emerging evidence questions a traditional dental paradigm.

FASEB J . 1995 ;9 :504-8 .

5. Edlich R.F., Greene J.A., Cochran A.A ., Kelley A.R., Gubler K.D ., Olson

B.M., Hudson M.A., Woode D.R. Long III W.B ., McGregor W., Yoder C.,

Hopkins D.B ., Saepoff J.P Need for Informed Consent for Dentists Who

Use Mercury Amalgam Restorative Material as Well as Technical

Considerations in Removal of Dental Amalgam Restorations . Jenviron

Pathology Toxicology Oncology 2007 : 305-22 .

6. Hylander LD, Goodsite ME. Environmental cost of mercury pollution.

Sci Total Environ. 2006;368(1) :352-70.

Environmental Impact

The paper by Hylander and Goodsite (6) puts a tentative monetary value on Hg-polluted food sources in the Arctic, where local, significant pollution sources are limited, and relates this to costs for strategies avoiding Hg pollution and to remediation costs of contaminated sites in Sweden and Japan. The case studies are compiled to help policy makers and the public evaluate whether the benefits to the global environment from banning Hg and limiting its initial emission outweigh the benefits from its continues use or lack of control of Hg emissions.

The cases they studies are relevant for point pollution sources globally and their remediation costs ranged between 2,500 and 1 .1 million U.S . Dollars for mercury isolated from the biosphere. Therefore, regulations discontinuing mercury uses combined with extensive flue gas cleaning for all power plants and waste incinerators is cost effective in Sweden.

Economic Impact

Banning the use of mercury in dentistry would save the lives of Americans (5) . The discovery that amalgam releases mercury during chewing had led to concerns about the safety of this restorative material . It has been well documented that mercury amalgam continually emits mercury vapor, which is dramatically increased by chewing, eating, brushing, and drinking hot liquids.

Mercury has demonstrated to have damaging nonspecific psychological and somatic effects as well as specific pathological effects on the kidney and central nervous system (multiple sclerosis, autism, Alzheimer's disease) and has been implicated in adverse effects on the cardiovascular system . It must be emphasized that this amalgam also results in a muscosal tattoo adjacent to the restorative material .

Certification : The undersigned certify, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petition which are unfavorable to the petition .

Richard F. Edlich, MD, PhD

Distinguished Professor Emeritus of Plastic Surgery, Biomedical Engineering

and Emergency Medicine, University of Virginia Health System,

Charlottesville, VA.

22500 NE 1281'' Circle

Brush Prairie, WA 98606

360-944-7641

richardedlichgp-mail.com

Jill J . Dahlstrom

Research Assistant

Brush Prairie, WA 98606

Jamie J . Clark