Via Evidence Based Dentistry, blog of the International Academy of Oral Medicine and Toxicology:
On Tuesday, July 28, 2009, the FDA completed its classification of the traditional dental amalgam filling material by making it a Class II device, with minimal controls. Dr. Susan Runner, the acting director of the dental devices division, stated flatly that there are no serious concerns about the toxic mercury exposure from amalgam, that is in fact thoroughly documented in the scientific literature.
The International Academy of Oral Medicine and Toxicology (IAOMT), a group of dental, medical and research professionals dedicated to raising the standards of biocompatibility in dental practice, completely rejects the FDA’s action. Dental amalgam is universally acknowledged to expose people to mercury, but by making it a class II device, the FDA has passed on the opportunity to demand proof of safety from its manufacturers. Instead it has been declared safe by administrative fiat, in contradiction to the vast body of scientific evidence attesting to its hazardous nature, and in contradiction to its own expert panel, which voted in 2006 to reject claims of amalgam safety.
The FDA has obviously been influenced more by outside pressure than by the scientific standards that have produced other mercury warnings – about mercury from thermometers, or from excess consumption of fish – sources that clearly provide a lower risk of exposure in the general population than mercury dental filings.
The “controls” included in this classification have no force, and can be ignored at will by any dentist. There is no real protection from mercury exposure here for children and unborn fetuses.
The FDA actions of this past year have at least served the public by breaking open the old dirty secret about amalgam fillings – that they are composed mostly of mercury, and that they provide exposure and risk to children and other sensitive groups.
The IAOMT will continue to fight this unwise policy by all legal means.
Stephen M. Koral, DMD