From: BULLELKMAN@aol.com
Sent: Thursday, September 12, 2002 2:05 PM
To: fdadockets@oc.fda.gov; jms@cdrh.fda.gov; rxf@cdrh.fda.gov;
brownchas@erols.com
Cc: Fourpawsca@aol.com; GRUFFY3@aol.com; l_tinsley@yahoo.com
Subject: Docket # 01N-0067 - Against FDA Proposal re Mercury Dental
Fillings

Dear FDA,

I am forwarding an e-mail message from Consumers for Dental Choice            
               that needs to be routed to Docket Number - 01N-0067.  Please 
post to the docket for 
Consumers for Dental Choice.

Thank you,
Mary Ann Newell
Manager of the Files for Consumers for Dental Choice

NOTE:  I am copying Ruth Fischer at RXF@CDRH.FDA.GOV on this e-mail. We 
appreciate Ruth Fischer's understanding for our need to copy her on this 
e-mail due to the deadline of September 16, 2002 for Docket Number - 
01N-0067.  We need to ensure that this e-mail is properly routed to Docket 
Number - 01N-0067.  The issue of mercury in dental fillings is too important 
to all of us to not allow everyone that submitted a comment to get on public 
record regarding the Reclassification of Dental Mercury.  THANK YOU.

Docket # 01N-0067 - Against FDA Proposal re Mercury Dental Fillings
Submitted to public record:  fdadockets@oc.fda.gov 
    May 23, 2002
Request for 
(1) Public Hearing
(2) Rebuttal and reply after new 60-day comment period
           
Joseph M. Sheehan, Chief, Regulations Staff
United States Food and Drug Administration
9200 Corporate Blvd.
Rockville, Maryland 20850
Via fax 301-594-4795, and email, jms@cdrh.fda.gov 

Dear Mr.. Sheehan:

Thank you, and Dr. Runner, for enlarging the public comment period on this 
extraordinarily important regulation.  On behalf of my client, Consumers for 
Dental Choice, Inc., I wish to elaborate on the e-mail request I sent you on 
Tuesday, asking for a public hearing and a period of rebuttal and reply.  If 
this decision in not within your authority, we ask that you forward it to the 
person making that decision.

Dentistry stands alone among health professions in advocating placing mercury 
in the mouths of children, pregnant women, and others.  Many other countries 
are abandoning mercury dental fillings.  We know now that poisonous vapors 
emanate from the filling to the rest of the body, including to the developing 
brains of children, and that mercury goes through the placenta to the 
developing child.  The politically powerful American Dental Association, the 
chief advocate for mercury fillings, fails to disclose that it receives money 
from amalgam manufacturers while calling amalgam "safe," and that it does not 
test the product for safety.  The ADA position that mercury fillings are good 
because they have been used for 150 years is scientifically preposterous, as 
any scientist at the FDA will recognize.

Public awareness of the risks of mercury has reached a step where states are 
adopting consumer protection laws.  These laws regulate the profession of 
dentistry, a step clearly assigned to the states in our constitutional 
system.  That the ADA would take the extraordinary step of pre-empting state 
regulation of the professions indicates the steps it will take to hide the 
risks of mercury dental fillings from the very patients whom their members 
serve.

The regulation, using the language "uniform disclosure," raises questions on 
whether the staff intends, or by consequence will, pre-empt state consumer 
protection laws.  (assuming arguendo the FDA has that power).  This is a 
matter of critical public policy interest, and needs a public airing.
The public is quite disadvantaged that you would be moving forward so rapidly 
without having a Commissioner in charge, leading to concerns that special 
interest groups such as the American Dental Association and the amalgam 
manufacturers have undue influence on the process.   Separately, we have 
filed a letter asking for a new Advisory Panel, one that includes consumer 
organizations interested in this issue.  Such a panel is needed to consider 
the plethora of developments of the past eight years, and do so openly with 
maximum opportunity for public input.

It is time that the FDA abandon a proposal championed by the special 
interests that so blatantly attempts to protect organized dentistry and fails 
to protect the public.  It is time to start examining the science, not the 
platitudes issuing from Chicago and from well-placed dentists inside federal 
agencies.  No one but the ADA and its advocates inside and outside government 
supports placing grams of mercury into the human body.  It is too late in the 
day to delegate these important issues to dentists.  It is time to put 
toxicologists and other scientists looking into this issue.

On behalf of my client, Consumers for Dental Choice, Inc., we requested:

(1) a reply opportunity to each side, one that begins immediately after the 
60-day extended public comment period, because it is essential we be given 
the chance to rebut the claims of organized dentistry, whom we believe lack 
any peer-reviewed studies about amalgam's safety.  Unless the FDA already has 
an agenda that it wants to put through a rule that ignores the emerging 
science, I believe you would welcome this reply period as providing useful 
information.

(2) a public hearing, so FDA officials will have the opportunity to question 
the assertions of scientists, dentists, and others about their position.  Too 
many questions are unanswered.  A public hearing is needed so the FDA may 
learn about scientific, public policy, legislative, and health-related 
developments of the past eight years.

Sincerely,
Charles G. Brown