Federal Government

Charles Brown, National Counsel

1725 K St., N.W., Suite 511, Washington, DC 20006
Ph. 202.822-6307; fax 822-6309
April 5, 2006

Breakthrough at FDA – hearings on mercury toxicity from amalgam!!

In a dramatic break from its policy of protecting pro-mercury dentistry, FDA has announced it will hold public hearings about “ potential mercury toxicity” from amalgam, especially its “neurotoxicity.”  In addition, FDA has at last begun to pry control of this issue away from the American Dental Association -- a neurology-based advisory committee has been added to hear the evidence on neurotoxicity.  FDA’s announcement: http://www.fda.gov/oc/advisory/accalendar/2006/cdrh12518dd09060706.html

Until now, as you probably know, FDA has been the silent partner to the American Dental Association in protecting (even promoting) mercury fillings.  Disregarding the science and operating in secret, FDA said amalgam’s mercury caused only “allergies,” while it wrongly gave control of the process to ADA dentists (plainly unqualified -- and conflicted as well).  But thanks to the involvement of two high-ranking officials -- Associate Commissioner Randall Lutter and Associate Commissioner Jason Brodsky -- this may change.  These two Associate Commissioners met with us last fall, agreed to take up the issue more seriously, and, I guess, read my barrage of letters.  So here’s the good news:

  • FDA has opened its doors for two days of public hearings, in Gaithersburg, Md. (a Washington suburb) on Sept. 6 and 7.
  • FDA will conduct an inquiry into the “potential mercury toxicity” from dental amalgam, “specifically as it relates to neurotoxic effects.”
  • The emerging issue becomes not filling teeth but harm to developing brains of children, to unborn babies, and to all of us.

What you can do:  Write and thank Associate Commissioner Randall Lutter, RLutter@oc.fda.gov, and Associate Commissioner Jason Brodsky, JBrodsky@oc.fda.gov ; ask them to keep the focus on mercury toxicity, and to remove dentists from being in charge of regulating mercury fillings.

The breakthrough is historic, to be sure.  But let’s not be naïve … hearings can presage action … or be a classic Washington stall tactic.  To date, FDA has not changed its official position on amalgam -- no classifying, no pre-market approval, no warnings to pregnant women and children, no disclosure of the mercury.  While we praise these FDA officials for introducing the mercury toxicity issue, Consumers for Dental Choice must still consider a challenge to FDA’s regulation of amalgam. 

Still, we must celebrate.  By opening up the mercury toxicity issue, it will be hard for FDA to put that genie back into the bottle.  For the two-day hearing in September, we must make an unimpeachable scientific record, bring in substantial public participation, and encourage widespread press and Congressional attention.

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