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