We have won our ten-year battle to get the Food and Drug Administration to comply with the law and set a date to classify mercury amalgam.

On Monday, we settled our lawsuit, Moms Against Mercury et al. v. Von Eschenbach, Commissioner, et al. FDA will finish classifying within one year of the close of the public comment period on its amalgam policy, that is, by July 28, 2009.

There’s more good news. During a several hour negotiation session, FDA agreed to change its website on amalgam -- dramatically. Gone, gone, gone are all of FDA’s claims that no science exists that amalgam is unsafe, or that other countries have acted for environmental reasons only, or that the 2006 Scientific Panel vote affirmed amalgam’s safety. Instead -- see http://www.fda.gov/cdrh/consumer/amalgams.html -- FDA has moved to a neutral course, while recognizing the serious health concerns posed by amalgam in particular for children and unborn children, for pregnant women, for those with mercury immuno-sensitivity or high mercury body burdens.

FDA now states, for example: “Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetus.”

“Pregnant women and persons who may have a health condition that makes them more sensitive to mercury exposure, including individuals with existing high levels of mercury bioburden, should not avoid seeking dental care, but should discuss options with their health practitioner.”

Perfect? No. A 180-degree reversal from FDA’s 30-year policy of protecting mercury fillings? Absolutely.

To change FDA policy, we tried petitions, Congressional hearings, state fact sheet laws, Scientific Advisory Committee hearings, and letters galore -- to no avail. So in the great American tradition, we sued. The case came to a head this spring. On April 22, working with Johann Wehrle and Gwen Smith, I filed a motion for an injunction before Judge Ellen Huvelle. Three sets of briefs later, the government and I presented our oral arguments on May 16. In a crucial ruling, Judge Huvelle ruled that our 11 plaintiffs -- the diverse group listed below -- have standing. She said FDA should classify, and invited the two sides to mediate. On May 30, before Magistrate Judge John Facciola, Bob Reeves (who flew in from Lexington KY) and I hammered out an agreement with FDA officials and lawyers.

The impact of the re-writing of its position on amalgam can hardly be understated. FDA’s website will no longer be cited by the American Dental Association in public hearings. FDA shows awareness of the key issues involved. As it prepares to classify amalgam, FDA has moved to a position of neutrality. Indeed, having repeatedly raised the question of amalgam’s risk to children, young women, and the immuno-sensitive persons in its website, I find it inconceivable that FDA will not in some way protect them in its upcoming rule.

Charlie Brown 3 June 2008

PS 1: Our talented (and pro bono publico) legal team includes Consumers for Dental Choice president Sandy Duffy, Bob Reeves, Johann Wehrle, Sandra Keech, Mike McClory, and Gwen Smith; Larry Pilot served as legal advisor on the FDCA.

PS 2: Great appreciation to our gutsy plaintiffs, a team of four nonprofit groups, two public officials, three dental professionals, and two consumer victims: Moms Against Mercury (Amy Carson and Angela Medlin), Connecticut Coalition for Environmental Justice (Dr. Mark Mitchell), Oregonians for Life (Mary Starrett), mercury expert Michael Bender (in his capacity as Commissioner of a Vermont advisory board on mercury), Arizona Senator Karen Johnson, Dr. Andy Landerman, Dr. Corrie Crowe, dental assistant Karen Palmer, consumer advocates Linda Brocato and Anita Vazquez Tibau, and (of course) Consumers for Dental Choice.

Charles G. Brown,
National Counsel Consumers for Dental Choice
316 F St., N.E., Suite 210,
Washington, DC 20002
Ph. 202.544-6333;
fax 202.544-6331
charlie@toxicteeth.org ,
www.toxicteeth.org

Fact Sheet

Scientific Studies Concerning Mercury Dental Fillings Prepared by the International Academy of Oral Medicine and Toxicology www.iaomt.org

1. Mercury is a very toxic substance-- more toxic than lead, cadmium, or arsenic.
 
Sharma, RP; Obersteiner, EJ., Metals and Neurotoxic Effects: Cytotoxicity of Selected Metallic Compounds on Chick Ganglia Cultures, J Comp Pathol, 91(2):235-44 (1981).

2. At least seventeen separate studies have confirmed that dental patients absorb a daily dose of mercury derived from their mercury fillings. Mercury is not rendered chemically inert in dental fillings.

These studies were recently summarized in the following paper: Richardson, G.M., Inhalation of Mercury-Contaminated Particulate Matter by Dentists: An Overlooked Occupational Risk, Human and Ecological Risk Assessment, 9:1519-1531 (2003). A fact sheet on ADA's website says, "Minute amounts of mercury vapor (between 1-3 micrograms per day) may be released from amalgam under the pressure of chewing or grinding." http://www.ada.org/public/media/releases/0207_release01.asp

3. On average, eighty percent of the mercury inhaled into the lungs is absorbed into the bloodstream.

Kudsk, F.N., Absorption of Mercury Vapour from the Respiratory Tract in Man, Acta Pharmacol. et Toxicol. 23:250-262 (1965).

4. The general population in America absorbs more mercury from dental fillings than from any other source. Studies demonstrate that two-thirds of the mercury absorbed by non-occupationally exposed populations is derived from amalgam fillings.

Aposhian, H.V., et al., Urinary mercury after administration of 2,3-dimercap-topropaane-1-sufonic acid: correlation with dental amalgam score, FASEB J, vol. 6 (April 1992), pp. 2472-2476. See also, Sandborgh-Englund, et al., Mercury in Biological Fluids After Amalgam Removal, J Dent Res, 77(4): 615-24 (Apr. 1998); World Health Organization, Environmental Health Criteria 118: Inorganic Mercury (1991) p. 36; Clarkson, T.W.; et al., Biological Monitoring of Toxic Metals: The Prediction of Intake of Mercury Vapor From Amalgams (1988) p. 256. (“The release of mercury from dental amalgams makes the predominant contribution to human exposure to inorganic mercury including mercury vapor in the generalpopulation.”); Lorscheider, FL; et al., Mercury Exposure from Silver Tooth Fillings: Emerging Evidence Questions a Traditional Dental Paradigm, FASEB J., 9:504-8 (1995). (“[D]ental amalgam tooth fillings are the major source of Hg exposure for the general population.”)

5. The mercury absorbed from dental fillings exceeds published government toxic thresholds for mercury. The Agency for Toxic Substances & Disease Registry minimum risk level for mercury is 2.4 µgs/day. (ATSDR, Toxicological Profile for Mercury.) The EPA’s reference dose for mercury is 3.84 µgs/day. (U.S. EPA. "Health Effects Assessment Summary Tables: FY-1997 Update" (1997).) Health Canada’s tolerable daily intake for mercury is 1.4 ugs/day. (Health Canada, Assessment of Mercury Exposure and Risks From Dental Amalgam: Final Report, Medical Devices Bureau, Environmental Health Directorate.) The World Health Organization, Environmental Health Criteria 118: Inorganic Mercury (1991) p. 36, concludes that persons with mercury fillings absorb 3 to 17 micrograms of mercury per day. This document reflects that the concensus average estimate of 10 µgs absorbed per day, an uptake corroborated by a more recent daily estimate of 12 µgs/day.

Skare, I, et al., Human Exposure to Mercury and Silver Released from Dental Amalgam Restorations, Archives of Environmental Health, vol. 49, no. 5, pp. 384-394 (Sept.-Oct. 1994). Levels for some individuals may be as high as 100 µgs/day. Lorscheider, FL; et al., Mercury Exposure from Silver Tooth Fillings: Emerging Evidence Questions a Traditional Dental Paradigm. FASEB J., 9:504-8 (1995).

6. A specific no-observed-effect level (NOEL) cannot be established, meaning that no level can be established at which mercury does not adversely affect the body.

World Health Organization, Environmental Health Criteria 118: Inorganic Mercury (1991) p. 36.

7. Peer-reviewed studies have established that adverse health affects have been associated with mercury vapor derived from amalgam fillings. Summarized in:

Lorscheider, FL; et al., Mercury Exposure from Silver Tooth Fillings: Emerging Evidence Questions a Traditional Dental Paradigm. FASEB J., 9:504-8 (1995). Ziff, M.F., Documented Clinical Side-Effects to Dental Amalgam, Advanced Dental Research, 6:131-4, 1992. An extensive list of diseases that have been linked to amalgam in the peer-reviewed scientific literature, including periodontal disease (gum disease). http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1292453&dopt=Abstract