We win court fight--FDA must classify mercury fillings

[Guest guest]

----- Forwarded Message ----From: Brown <brownchas@...>

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