Mercury Dental FillingsDocket # 01N-0067 - Against FDA Proposal re Mercury Dental FillingsSubmitted to public record: fdadockets@oc.fda.gov May 23, 2002 Dr. David Feigal, Director Center for Devices and Radiological Health (CDRH) fax 301-594-1320; dwf@cdrh.fda.gov and Dr. Bernard Statland, Director Office of Devise Evaluation fax 301-594-2510; bes@cdrh.fda.gov Food and Drug Administration HFC 400 9200 Corporate Blvd. Rockville, Maryland 20850 Re: Request for New Advisory Panel re Mercury Dental Fillings Dear Dr. Feigal and Dr. Statland: I am counsel for Consumers for Dental Choice, Inc. We are informed that a new comment period will soon commence for the proposed rule protecting mercury dental fillings. We would request, and hereby put this request on the public record, that you re-create an Advisory Panel. Because the Panel met so long ago -- eight years, an eon in today’s world of constantly emerging science -- we believe our request is grounded not only in fairness and sound public policy, but as a legal requirement as well. The role of the Advisory Panel is, as you know, critical to writing a rule. You have relied on a panel that met eight years ago. In those eight years, a colossal amount of peer-reviewed studies, policy developments, laws, regulations, trends on mercury dental fillings have emerged – and they are virtually all negative to mercury in dental fillings. This rule blesses mercury dental fillings. It should not. Such fillings belong in a Class III category. An Advisory Panel is needed to take into account developments such as these, all of which have occurred since it met so long ago: The many peer-reviewed studies condemning mercury dental fillings, by Professors Haley, Lorscheider, Vimy, Summers, Aposhian, Chang, etc.; The Health Canada report, recommending no mercury fillings for children, pregnant women, and those with kidney problems, braces, or mercury allergies; The contraindication warnings by the manufacturer Dentsply, advising dentists to stop giving mercury fillings to children, pregnant women, and those with kidney problems, braces, or mercury allergies; The case directing that Proposition 65 warnings (California) issue for mercury dental fillings; The ending of mercury in other health care uses, such as in vaccines, thermometers and contact lenses. The Watson-Burton bill, H.R. 4163, with five more co-sponsors to date, which would abolish mercury dental fillings; State bills, similar to Watson-Burton, introduced in, to date, Alabama, Arizona, California, Georgia, and Illinois. The 1999 report of the Agency for Toxic Substance and Disease Registry. The resolution of the California Medical Association (2000) favoring phasing out of all health care products that contain mercury; The resolution of the American Public Health Association (1999) favoring phasing out of all health care products that contain mercury; The official paper of the American Pediatric Medical Association advising physicians to recommend mercury-free dentists to patients concerned about exposure to mercury; The emergence of Health Care Without Harm as an organization opposed to mercury in health care products; The creation of Consumers for Dental Choice (1996), a consumer group favoring, first, informed consent, and second, an end to mercury dental fillings; The creation of the Coalition to Abolish Mercury Dental Fillings (2001), an umbrella group supporting policies ending mercury in dentistry; State laws directing specific warnings issue: Arizona (2000), Maine (2001), and New Hampshire (2002); The implementation of a 1992 California statute requiring a “fact sheet” on the risks of mercury fillings, so blithely ignored by the Dental Board that the Legislature shut down the Board in 2001; The constituency make-up of such a panel needs to reflect current realities, not those of a decade ago. Two national consumer organizations need to be consulted about the consumer members – Consumers for Dental Choice, Inc., and Dental Amalgam Mercury Syndrome, Inc., two major consumer groups focused primarily on mercury in dentistry. We hereby request the right to recommend members. We have no idea from the record when the Advisory Panel met, who was on it, when they had public sessions. Public confidence cannot exist in such a closed environment as existed to formulate this proposed rule. 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, 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. It is time the FDA abandoned its efforts to protect organized dentistry and starts examining the science. Sincerely, Charles G. Brown cc: Joseph M. Sheehan, Chief, Regulations Staff, fax 301-594-4795; jms@cdrh.fda.gov Dr. Susan Runner, Branch Chief, Dental Devices, Division of Dental Infection Control and General Hospital Devices, fax 301.480-3002 Public record: fdadockets@oc.fda.gov |