## [Docket \# 01N-0067 - Against FDA Proposal re Mercury Dental Fillings]{.underline}

Submitted 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; e: dwf@cdrh.fda.gov*

and

Dr. Bernard Statland, Director

Office of Devise Evaluation

*fax 301-594-2510; e: 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]{.underline} 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*