The American Dental Association sends out an ADA Update to its members only, but of course we have several Fifth Columnists who wheel it on to us.
Gone is the old
ADA braggadocio about the Food & Drug Administration finding mercury fillings to be safe. Gone is the time-worn assurance to its members that the good old
ADA will take care of any problems those “anti-amalgamists” are stirring up. Instead, the
ADA meekly advises its members that warnings are likely, and a ban is conceivable.
Below is their entire message on this issue. Note the quotations – again, folks, this is straight from the American Dental Association:
We don’t know the direction the FDA will take,”
FDA could issue “a mandatory brochure or even limited warnings,”
FDA could even issue “a ban,” though “we don’t expect the latter.”
“The FDA has been contemplating regulatory action for several years to reclassify dental amalgam as either a class 2 or 3 material. (Components of encapsulated amalgam currently are classified separately.) The
ADA has supported classifying dental amalgam as a Class 2 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 2 material, adding special controls to its use, such as a mandatory brochure or even limited warnings, or classify it as a Class 3 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.”