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 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