Breakthrough at FDA – Responding to Your Questions

[Guest guest]

I wonder how Platinum toxicity compares with Mercury

toxcitity? - Rogene

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Breakthrough at FDA – Responding to Your Questions

Hi. Never has an announcement from Consumers for

Dental Choice generated this kind of response -- and

with good reason. Four months ago, we announced that

the battle with FDA would be our “Norman invasion” --

we were taking on the American Dental Association’s

top ally inside our government. The good news -- and

this is to FDA’s real credit -- FDA agrees to start

over with amalgam, to kick out the “allergy” nonsense

and look at toxicity, especially neuro-toxicity. The

bad news -- FDA still won’t classify mercury fillings.

Why? Because they all know over there that no

scientist worth his or her salt would allow amalgam to

pass a safety test.

To respond to the many questions I got from this

e-mail:

1) It appears we mis-listed Associate

Commissioner Randall Lutter’s e-address; try

randall.lutter@...; for Associate Commissioner

Brodsky, it was correct, JBrodsky@...; I

again urge you to write & thank them – they are the

first two officials to insist that FDA address mercury

amalgam’s horrid neurological consequences.

2) Yes, you may you submit written comments – and

we encourage it. You have until August 23. Write

E. Adjodha, at either

.Adjodha@... or at Center for Devices

and Radiological Health (HFZ-480), FDA, 9200 Corporate

Blvd., Rockville, MD 20850. You may call Mr. Adjodha

at 301.827-5283.

3) Anyone may come to the hearing on September 6

and 7, and testify. BUT, while we need

consumers/patients to speak out, we must ensure that

key people have time to speak -- scientists, health

professionals, spokespersons for major organizations,

international visitors, and Members of Congress, for

example. We certainly hope for a gigantic turnout;

it’s in the Washington suburb of Gaithersburg, Md.

Details:

http://www.fda.gov/oc/advisory/accalendar/2006/cdrh12518dd09060706.html

Charlie Brown, 4/8/06

G. Brown, National Counsel

Consumers for Dental Choice

1725 K St., N.W., Suite 511, Washington, DC 20006

Ph. 202.822-6307; fax 822-6309

charlie@..., www.toxicteeth.org

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Breakthrough at FDA – hearings on mercury toxicity

from amalgam!!

In a dramatic break from its policy of

protecting pro-mercury dentistry, FDA has announced it

will hold public hearings about “potential mercury

toxicity” from amalgam, especially its

“neurotoxicity.” In addition, FDA has at last begun

to pry control of this issue away from the American

Dental Association -- a neurology-based advisory

committee has been added to hear the evidence on

neurotoxicity. FDA’s announcement:

http://www.fda.gov/oc/advisory/accalendar/2006/cdrh12518dd09060706.html

Until now, as you probably know, FDA has

been the silent partner to the American Dental

Association in protecting (even promoting) mercury

fillings. Disregarding the science and operating in

secret, FDA said amalgam’s mercury caused only

“allergies,” while it wrongly gave control of the

process to ADA dentists (plainly unqualified -- and

conflicted as well). But thanks to the involvement of

two high-ranking officials -- Associate Commissioner

Randall Lutter and Associate Commissioner

Brodsky -- this may change. These two Associate

Commissioners met with us last fall, agreed to take up

the issue more seriously, and, I guess, read my

barrage of letters. So here’s the good news:

FDA has opened its doors for two days of public

hearings, in Gaithersburg, Md. (a Washington suburb)

on Sept. 6 and 7.

FDA will conduct an inquiry into the “potential

mercury toxicity” from dental amalgam, “specifically

as it relates to neurotoxic effects.”

The emerging issue becomes not filling teeth but harm

to developing brains of children, to unborn babies,

and to all of us.

What you can do: Write and thank

Associate Commissioner Randall Lutter,

randall.lutter@..., and Associate Commissioner

Brodsky, JBrodsky@...; ask them to keep

the focus on mercury toxicity, and to remove dentists

from being in charge of regulating mercury fillings.

The breakthrough is historic, to be sure.

But let’s not be naïve … hearings can presage action …

or be a classic Washington stall tactic. To date, FDA

has not changed its official position on amalgam -- no

classifying, no pre-market approval, no warnings to

pregnant women and children, no disclosure of the

mercury. While we praise these FDA officials for

introducing the mercury toxicity issue, Consumers for

Dental Choice must still consider a challenge to FDA’s

regulation of amalgam.

Still, we must celebrate. By opening up

the mercury toxicity issue, it will be hard for FDA to

put that genie back into the bottle. For the two-day

hearing in September, we must make an unimpeachable

scientific record, bring in substantial public

participation, and encourage widespread press and

Congressional attention.

Charlie, 4/5/06

G. Brown, National Counsel

Consumers for Dental Choice

1725 K St., N.W., Suite 511, Washington, DC 20006

Ph. 202.822-6307; fax 822-6309

charlie@..., www.toxicteeth.org