ADA Caves In - FDA Under Fire For Protecting Mercury Fillings

ADA Caves In - FDA Under Fire For Protecting Mercury Fillings
August 1, 2007
Chris Gupta

Paragraph from ADA Update, July 1, 2007 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 donÌt 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 donÌt expect the latter. WeÌre closely monitoring these developments and of course will offer appropriate advocacy comments and develop strategies for addressing the ANPR. WeÌll also keep you updated as this process plays out.Ó