From: Heartland Healing [heartlandhealingalt@earthlink.net]
Sent: Thursday, July 25, 2002 3:19 PM
To: fdadockets@oc.fda.gov
Cc: bullelkman@aol.com
Subject: Docket No. 01N-0067 - Against FDA Rule

Dockets Management Branch (HFA-305)

Food & Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20057

 

Dear FDA:

I have personally suffered from high mercury levels from dental amalgam fillings.  I have suffered in many ways from the adverse effects of this toxic poison that was, without my consent, placed into my mouth.  I have suffered from severe osteoarthritis and depression.  With the removal of the mercury from my mouth and a detoxification process, I have experienced improvement. 

Thousands of people have suffered ill effects from mercury from dental amalgam fillings, including children and the unborn, as well as adults.

 

The scientific evidence is clear as to the adverse effects of mercury in our bodies and it has also become clear that dental amalgams are the major source of mercury exposure for most people.  Your Rule uses selected old data and ignores all recent studies.  A Rule needs to alert the public to the scientific facts; your rule seriously fails to do that.  Your proposed Rule excludes the research, including a large body of newer research, that shows the harm that is done by mercury amalgam fillings.  This Rule hides the risks of mercury amalgam fillings.

 

Your Rule, with its classification of amalgam alloy and of encapsulated amalgam as class II devices, is unacceptable.  They should be classified in the most dangerous category, class III, where they would have to be proven safe!  That is only appropriate for a filling material that is half mercury and that is even put into the mouths of children and pregnant women!

 

Your proposed Rule calls fro weak uniform disclosures through a federal labeling requirement on all manufacturers.  This Rule appears to be an attempt to pre-empt the informed consent laws that have been enacted or are being considered in about a dozen states.

 

Furthermore, Your proposed labeling requirement does nothing to require that warning information be shown to the dental patient.  We need full disclosure, not a cover-up!

 

Citizens deserve to have public hearings on this important matter, around the country, with opportunities for rebuttal and reply after the public comment time.  I call for new members of the advisory panel that reviews the safety of dental amalgams, one that includes independent scientists and dental consumers from grassroots groups such as DAMS and Consumers for Dental Choice.

 

I am sending a copy of this message to  my Congressman (Bill Luther)  and Senators (Wellstone & Dayton)  urging them to scrutinize your conduct in this matter and also to support H.R. 4163, which will halt amalgam use in children, pregnant women and ban amalgams within five years.  FDA should extend its Rule process to see what Congressional intent is on this matter.

 

Sincerely,

 

 

Jody N. Ziegler NHD

Heartland Healing Alternatives, Ltd.

115 East 5th Street, Hastings MN  55033

651.480.8244(phone)  651.480.8293(fax)

heartlandhealingalt@earthlink.net

www.mbspirit.net/cm/jziegler 

If you have a body, I can help you balance it!