In a remarkable reversal of policy and precedent, the Food and Drug Administration (FDA) last month rejected its own staff report that concluded mercury amalgam fillings used by millions of Americans are safe. The panel of FDA advisors said the report did not objectively and clearly present all current data about the fillings.
Members of the advisory panel - consisting of medical doctors, dentists, and health professionals - repeatedly questioned the impact of dental mercury on children and the fetuses of pregnant women. They also said that more study is needed on the health effects of vapors that are emitted from mercury fillings.
Dental amalgam, deceptively called silver fillings, is a remnant of 19th Century medicine. Today more than 100 million Americans have mercury/silver fillings. But the vast majority, according to a 2006 Zogby poll, is not aware that silver fillings consist of 50% mercury, one of the most toxic substances known to man.
The FDA has already taken numerous steps to limit human and animal exposure to mercury. To date, it has banned mercury in disinfectants and thermometers, warned against mercury in certain foods, and prohibited the presence of mercury in all veterinary products.
Many governments around the world, however, have gone a step further by either limiting the use of or banning mercury fillings. The UK, for example, prohibits pregnant and lactating women from receiving amalgam fillings, and Scandinavian countries are phasing out the product. Canada has also restricted its use.
Despite growing scientific evidence and public awareness of the dangers of exposure to even small amounts of mercury, the FDA, the federal agency charged with regulating dental amalgam, still permits the sale of a dental product that has not been proven safe and classified as the law requires and is used inches from the brain. It continues to sanction commerce in silver fillings without disclosing to the American people that they contain a significant amount of mercury and emit mercury vapor during the entire life of the filling.
The FDA's past silence on mercury amalgam is all the more curious given the fact that both the Centers for Disease Control, in 2005, identified amalgam as a source of "major exposure" to mercury, and the U.S. Public Health Service warned, in 1999, that mercury amalgam is one of the two greatest sources of mercury exposure to humans.
Dental amalgam is also a major environmental pollutant once it is removed from the mouth to such a degree that dental offices are the number one source of mercury in waste water. The FDA, however, has never written an environmental impact statement on dental amalgam as it is required to do by law. The environmental damage caused by the disposal of mercury amalgams makes no sense when alternative materials are now available for every kind of dental cavity.
The FDA's historic decision to reject its own staff report signals the beginning of the end of mercury amalgam's privileged sanctuary. It is a good first step. But more remains to be done.
The FDA must therefore move ahead post haste in the following four areas: (1) Disclosure: The FDA must immediately take the simple step of requiring dentists to inform their patients that amalgam is 50% mercury, it constitutes exposure to a neuro-toxin, and alternative fillings are available. (2) Environmental Impact: The FDA has the legal duty to conduct an environmental impact study of dental amalgam, which it has never done, before properly classifying the material. (3) Proof of Safety: Manufacturers of amalgam should have the burden of proving its safety. To date, they have never sought nor been given pre-market approval for their product. The FDA must hold amalgam manufacturers accountable. (4) Children and Pregnant Women: Ten years ago, Health Canada directed its dentists to cease placing mercury fillings in the teeth of children, pregnant women, and persons with kidney disease, mercury hypersensitivity, or braces. The FDA should implement a similar ban in the U.S.
Two short decades ago, health and public policy advocates embarked on a campaign to rid public areas of smokers and second-hand tobacco smoke. Today the U.S. is on the cutting-edge of educating and informing its citizens about the scourge of tobacco and eliminating tobacco smoke from public and common areas. A similar campaign is gathering momentum here and around the world to end the use of mercury amalgam. It is past time for the American dental profession to relinquish a practice that is as antiquated as it is dangerous.