- On June 3, Charlie Brown, chief counsel of Consumers
for Dental Choice sent this announcement. It's a great historic victory,
but the fight to ban dental mercury now proceeds to the next stage -- getting
the FDA to classify it in Class III. This makes it all the more important
for us all to submit comments to the FDA docket.
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- We Win -- FDA Must Classify Mercury Fillings
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- 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.
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- 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.
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- 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 amalgamÕs
safety. Instead -- see <http://www.fda.gov/cdrh/consumer/amalgams.html>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:
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- Dental amalgams contain mercury, which may have neurotoxic
effects on the nervous systems of developing children and fetus.
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- 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.
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- Perfect? No. A 180-degree reversal from FDA's 30-year
policy of protecting mercury fillings? Absolutely.
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- 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.
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- 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.
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- Charlie Brown 3 June 2008
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- 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.
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- 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.
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- 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, <http://www.toxicteeth.org>www.toxicteeth.org
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