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Chuck...
Posted: Sun Jun 29, 2008 10:17 pm
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Dental Mercury Victory

AAHF is pleased to announce that the Food and Drug Administration must
now classify mercury fillings! We congratulate Consumers for Dental
Choices, Moms Against Mercury, International Academy of Oral and Metal
Toxicology, and all other groups and individuals who have dedicated
years to the issue of the dangers of dental mercury.
This is a successful end to a 10-year battle to get the FDA to comply
with the law and set a date to classify mercury amalgam.
On Monday, June 2, Consumers for Dental Choice announced that they
settled the lawsuit, Moms Against Mercury et al. v. Von Eschenbach,
Commissioner, et al and that the 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.
Charlie Brown, General Council for Consumers for Dental Choice stated,
“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.”
As Charlie says, this isn’t a perfect win but it is a 180-degree
reversal from FDA’s 30-year policy of protecting mercury fillings.
This win also shows that health freedom can make a difference even
when going against Goliath.
This wasn’t a one-prong approach -- these groups (including AAHF)
developed strategies, built a united voice, and relied on credible
information. To change the policy, there were petitions,
Congressional hearings, state fact sheet laws, Scientific Advisory
Committee hearings, and support letters, all setting the stage for the
lawsuit.
The impact of the re-writing of FDA’s position on amalgam can hardly
be understated. Their 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, it is inconceivable that FDA will
not in some way protect them in its upcoming rule.
Please join us in celebrating this victory and consider giving a
donation to the Consumers for Dental Choice to help off-set their
costs of taking the lead on this issue.

Visit: www.toxicteeth.org for more information.

#2: From: Dr. Diane Meyer B.S.D.D.S

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 at (no spam) toxicteeth.org, www.toxicteeth.org
 
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