FDA Abandons Pro-Mercury Fillings Policy--To Propose New Rule

(Posted by Patrick Sullivan Jr.)

Wow!!  Can you say, "Progress!"  This is great news!!  In short, the FDA has agreed to leave the ADA high and dry.  Here's the rest from Charlie Brown, the National Counsel at Consumers for Dental Choice, of which I am a board member.

FDA Abandons Pro-Mercury Fillings Policy -- Will Propose New Rule

An intense set of interactions with FDA since the Court of Appeals opinion on April 13 has borne fruit.  On April 19, we advised FDA of liability exposure of key staff, then on May 2 notified FDA lawyers that we had the papers prepared to file another lawsuit unless FDA wanted to meet.  On May 10, top FDA officials met with food and drug law expert Jim Turner and me; we gave FDA a month to change course -- else we would return to court.

FDA responded -- favorably.  Hemmed in by its own scientific panel, facing another lawsuit from us, challenged by an increasingly aroused public, and unable to justify a policy that this mercury is somehow different from the mercury in medicines for dogs or fish for humans, FDA changed course.  On June 14, FDA’s lawyer notified me, by phone and in writing (e-mail is below) that FDA will write an entirely new regulation on mercury fillings. It is the harbinger of hope we may have been seeking from this powerful agency.

Here’s what it means: 

  1) The great news:  FDA abandons its policy (expressed in its proposed regulation of 2002) to write into law a sleazy special-interest rule prohibiting warnings, covering up the existence of mercury, and maintaining mercury exposure’s side effect is “allergies.”  After a five-year battle, we broke the A.D.A.’s stranglehold over FDA policy.

  2) The bad news:  Today, and tomorrow, the ugly status quo remains.  Dentists deceive parents by calling the fillings silver.  Toxic mercury fillings are still the choice of the assembly-line dentists working on our soldiers, our youth, our minorities, and our working poor.  FDA gives no timetable to propose its new regulation.

  3) The mystery:  With an in-house fight apparently going on between FDA reformers and FDA’s mercury protectors, the result is not predictable.  But at last, top officials are listening to our side -- Professor Boyd Haley, Dr. Rich Fischer, and Dr. Mike Fleming met June 22 with FDA’s Associate Commissioner for Science.  I have written FDA six questions about legally required steps.

We haven’t won – far from it.  But truly, the A.D.A. has lost.  FDA is no longer dancing to its tune.  The issue of mercury toxicity from amalgam will be the subject of a great national debate -- the news the A.D.A. and the pro-mercury dentists have long dreaded.

Let me not sugar-coat it: a major battle lies ahead as FDA determines its policy, and perhaps at FDA’s typical glacial speed.   We must vigilantly advocate our cause -- inside the agency, before the public, and if necessary back to the courts.  I welcome your views about our next step.  Grassroots activism by consumers, and speaking out by dentists and other health professionals, is more important than ever. 

Charlie Brown
24 June 2007

PS--Check our website, www.toxicteeth.org, for updates on FDA.

Charles G. Brown, National Counsel
Consumers for Dental Choice

NOTE OUR NEW ADDRESS as of 6/27/07:
316 F St., N.E., Suite 212
Washington, DC 20002
ph 202.246-7642

E-mail from FDA’s lawyer to [Charles] Brown

From: Vicente, Wendy [mailto:Wendy.Vicente@fda.hhs.gov]
Sent: Thursday, June 14, 2007 2:09 PM
To: Charlie Brown
Subject: RE: Legal and Policy Reasons to Exit Mercury Fillings

Mr. Brown, as you requested, I am writing to memorialize our conversation today.  I called you to let you know that the agency intends to issue an advanced notice of proposed rulemaking regarding the classification of dental amalgam.  I also told you that the agency cannot commit to a specific date certain when this will issue. 

Wendy S. Vicente
Food & Drug Division, OGC
Wendy.Vicente@fda.hhs.gov
301-827-7138
301-827-7145 (facsimile)   

Awesome news!  Great work Charlie and team!!

Related Posts:
Web poll of mothers with autistics: Only 8% never had a single mercury amalgam (aka. silver filling)
Ruling in Moms Against Mercury, et al vs. FDA