Urgent Attention --The FDA has announced that it is reopening public comments on a rule first proposed in 2002 that would place precapsulated amalgam in Class II, with "special controls."  The rule was then 26 years overdue, since the FDA was mandated by Congress to make these classifications in 1976, and the special control proposed was, incredibly, a warning about exposure to zinc from amalgam! No action has been taken since.

Under intense lobbying by IAOMT, and under pressure from a lawsuit brought by our allies at Consumers for Dental Choice, the FDA has reopened public comments on ways to amend the rule for 90 days. Whether they are just bluffing again, or actually mean to bring the rule forward, it is imperative that every one of us, and all our friends, submit a comment, based on our own knowledge and experience.  Amalgam should be placed in Class III, and the manufacturers forced to prove that it is safe, not in Class II, where old assumptions of its safety can live on. 

Below is a letter from Charlie Brown of Consumers for Dental Choice, with talking points, and information on just how to submit your comment.

Dear Doctor:
Due to the deadlines imposed upon it by our lawsuit Moms Against Mercury et al, v. Von Eschenbach et al., the Food and Drug Administration has stopped stonewalling on mercury fillings.  FDA has created a 90-day window to comment on how it should classify mercury fillings, and what special controls (restrictions on use) it should adopt.
 
Now is the time for all mercury-free dentists to comment.  Whether FDA is making a feint to delay action once more, or whether FDA has had a real change of heart -- your comments are important.  If the former, your comments help build a record to nail them in court later.  If the latter, we educate FDA to take action.
 
Talking points:
            1) Ask FDA to put a total ban on mercury fillings --- or at least a ban for children 18 & under, for women of childbearing age, and for persons with kidney problems --- or at the very least, pregnant women, nursing mother, and children 18 and under.  Tell them why, in your own words.
            2) Advise FDA that mercury fillings are completely unnecessary in 21st-century dentistry.  This is quite important, that general dentists say that they can fill any cavity, big or small, in a child or adult, in an able-bodied or a disabled person, with alternatives like resin.
            3) An entire generation has grown up getting mercury implants solely because FDA refuses to do its job.  No more delays, FDA --- this lawlessness must end.
 
You may comment three different ways:
1) Electronic: Federal Rulemaking Portal: http://www.regulations.gov
               In category "Search," insert: FDA-2008-N-0163
               Follow instructions to submit comments.
2) Fax: 301-827-6870.
3) Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]:
Division of Dockets Management (HFA-305),
Food and Drug Administration,
5630 Fishers Lane, rm. 1061,
Rockville, MD 20852
 
Charlie Brown, National Counsel
Consumers for Dental Choice
28 April 2008
 
PS--Doctor, be assured we are not letting up in pressure in the courtroom.  On May 16, in Washington DC, I will argue for our motion for a preliminary injunction to take mercury fillings off the market until and unless FDA classifies it.
PPS--Thank you!  Call me if you have questions--202.544-6333