We Win -- FDA Must Classify Mercury Fillings

[Guest guest]

http://www.toxicteeth.org/

We Win -- FDA Must Classify Mercury Fillings

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 , 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 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, Keech, Mike McClory, and Gwen ; 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

Medlin), Connecticut Coalition for Environmental Justice (Dr. Mark

), Oregonians for Life ( Starrett), mercury expert

Bender (in his capacity as Commissioner of a Vermont advisory

board on mercury), Arizona Senator , Dr. Andy Landerman,

Dr. Corrie Crowe, dental assistant Palmer, consumer advocates

Brocato and Anita Vazquez Tibau, and (of course) Consumers for

Dental Choice.

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@..., www.toxicteeth.org

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Sheri Nakken, former R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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