Dental Amalgam, FDA Docket 03N-0169

The following is a summary of all submissions to the FDA amalgam review panel, with detail provided on a web page for all submissions by the ADA and DAMS, Inc. A listing of all submissions to the panel is also provided on a web page. The submissions, including that of the ADA, overwhelmingly document that amalgam is the largest source of mercury exposure in most people, and commonly causes chronic health prolbem; which are often cured or significantly improved by amalgam replacement.

Review of articles on 14 pages submitted by ADA to FDA amalgam review panel:

(most science articles they submitted are strongly anti-amalgam use and support warnings or phasing out use of mercury)

Categorization based on my analysis of the studies(see note at bottom):

very strongly anti-amalgam use(A+) 8

strongly anti-amalgam use(A) 29

anti-amalgam use, but poorly done(A-) 27

anti-amalgam use, environmental (AE) 2

Neutral (N) 8

Neutral, poorly done study (N-PDS) 12

Mechanical issues, not health related 10

Not related to amalgam use 7

pro-amalgam use, PDS (P-PDS) 4 (I documented what is poorly done in the studies)

Dental publications, Reviews

pro-amalgam use, opinion, review (P/R/O/D) 29 opinion or review article in dental journal

neutral, opinion, review 9

anti-amalgam use, review 2

The abstracts of these articles with my review and references regarding the articles can be found at www.flcv.com/adaabsr.html

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Dental Amalgam, FDA Docket 03N-0169

(Submissions to Food & Drug Admininstration(FDA) Amalgam Review Panel- 4 volumes)

Summary of submissions with assessment of content of each submission(notation):

A = medical or science article(s) with evidence of significant mercury exposure or significant adverse health effects

A+ = large number of science article(s) with evidence of significant mercury exposure or significant adverse health effects

P = science articles with no evidence of significant mercury exposure or significant adverse health effects

RD = review or opinion article in journal without open review by scientists

NS= letter or article with no relevant science content or clinical experience

C = clinical case with evidence of adverse health effects due to mercury

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Individual submissions by category(Summary Count)

A+ 83

A 78

C 10 (note: most individual case histories were included on another disk not assessed here)

P 3

RD 1 (for details of ADA submission see the ADA submission summary)

NS 13

Full listing of all submissions to FDA amalgam review panel can be found at: www.flcv.com/fdarevl.html

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Full summary with abstracts and references for over 3000 peer-reviewed studies submitted by DAMS to the FDA amalgam review panel can be found at: www.flcv.com/fdarev.html

The studies document that amalgam is the largest source of mercury exposure for most people and the levels of exposure are significant and commonly higher than U.S. government health guidelines for mercury.

The studies also document the mechanisms by which mercury from amalgam causes over 30 chronic health conditions, and document over 50,000 clinical cases of recovery or significant improvement from all of those chronic conditions after amalgam replacement. For some conditions the majority show significant improvement or recovery after amalgam replacement.

The studies also document that amalgam is the largest source of mercury in sewers and sewer sludge, with the level in most sewers and sewer sludge being documented to be causing widespread damage and harm. Mercury in sewers goes into water bodies and thus into fish and wildlife, being documented to be a major source of such mercury. Over 33 % of all U.S. lakes have fish consumption warnings for mercury, 15% of all river miles, and over 90% of coastal miles on the Gulf and East coasts. Mercury in sewer sludge has been documented by Government agencies to be transfered into crops when landspread, and to be methylated to methyl mercury by soil bacteria and outgased when the sun shines from landspread or landfill areas - being a factor in high levels of mercury in rain all over the U.S.

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A CD ROM of all submissions to the FDA amalgam review panel can be obtained for $20 by contacting Mary Ann Newall at

B. Windham, President DAMS, Inc.