American Dental Association Update
July 1, 2007
Dr. Behm's comments are in purple italics.
"The FDA has been contemplating regulatory action for several years to reclassify dental amalgam as either a Class II or III material.
Components of encapsulated amalgam currently are classified separately.
This is a way the ADA has snuck by the FDA up to this point is by categorizing each component of the filling (tin, copper, silver, zinc) separately; not the amalgamated mixture as a whole. The word "amalgam" actually means mercury mixed with other metals. The ADA makes it the individual dentist's responsibility that he mixes a powder of the above metals with liquid mercury, this is the way the ADA circumvents responsibility for millions of plugs of deadly toxin STILL being placed in the mouths of Americas every year.
The FDA divides medical substances up into classes.
Class I may be sold to anyone without controls. The manufacturer needs to give FDA notice of the product coming on the market, but does not need FDA's approval. It is called Pre-Market Notification.
Class II may be sold, but subject to "special controls," which range from quite strict or meaningless. Again, though, the manufacturer need only give FDA notice of the product coming on the market, but does not need FDA's approval. It is called Pre-Market Notification.
Class III means that the manufacturer must first prove to FDA that the device is safe before it can be sold. It is called Pre-Market Approval. A "III" classification will sink mercury fillings, because they can't be proven safe. Even the ADA's lawyer acknowledges that a III means curtains for amalgam. See FDA Regulatory Requirements.
So, as you can see, we are fighting for a III. If not a III, then we want a II with strict controls, like prohibited for children & young women; that will mean its gradual end.
"The ADA has supported classifying dental amalgam as a Class II device in the past. We expect the FDA will issue an Advanced Notice of Proposed Rulemaking (ANPR) this summer, seeking input from interested parties.
"An ANPR is the beginning of the regulatory process. After consideration of input generated by the ANPR, the FDA will likely issue a notice of proposed rulemaking, setting forth a specific proposal for public comment.
"Only after that would a new regulation be issued. At this point, we don't know the direction the FDA will take. The agency could simply reclassify amalgam as a Class II material, adding special controls to its use, such as a mandatory brochure or even limited warnings, or classify it as a Class III material, which could result in a ban. We don't expect the latter.
"We're closely monitoring these developments and of course will offer appropriate advocacy comments and develop strategies for addressing the ANPR. We'll also keep you updated as this process plays out."
