FDA Agrees to Review Amalgam Dental Filling Dangers

The U.S. Food and Dug Administration (FDA, Rockville, MD, USA) has agreed to complete a regulatory review on the dangers of Mercury amalgam dental fillings by July 2009, as part of the settlement of a lawsuit--filed in December 2007 in U.S. District Court in Washington (DC, USA)--by a collection of environmental groups, consumers, and U.S. state officials. The FDA is awaiting more short-term data exposure from certain patient groups before it makes a final decision on the regulatory review, which began in 2002. The process could result in a requirement that prescribing information of dental amalgam warn dentists and pregnant women of nervous system dangers to fetuses and young children with neurological brain development.

"Gone are all of FDA's claims that no science exists that amalgam is unsafe,” said Michael Bender of Vermont (USA), a plaintiff in the lawsuit. "The FDA has moved to a more neutral course, while still recognizing the serious health risks posed by amalgam in particular for children and unborn children, for pregnant women, and for those with mercury immuno-sensitivity.”

As part of the same settlement, the FDA has also updated some of the safety concerns regarding amalgam stating, "Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses. When amalgam fillings are placed in teeth or removed from teeth, they release mercury vapor. Mercury vapor is also released during chewing. FDA's rulemaking will examine evidence concerning whether release of mercury vapor can cause health problems, including neurological disorders, in children and fetuses.”

The dental amalgam controversy, which has been raging for decades, centers around the long-term health effects of toxicity or allergy which may be associated with constant mercury exposure, particularly as a potential cause of chronic illnesses, autoimmune disorders, neurodegenerative diseases, birth defects, and mental disorders. Scientists agree that mercury amalgam fillings expose the bearers to a daily dose of mercury, but different studies have concluded that this exposure may be as low as 1-3 µg/day, or as high as 27µg/day. The American Dental Association (ADA, Chicago, Il, USA) reviewed 34 studies and found no evidence that the fillings release mercury vapor when chewing. In addition, they say that the fillings pose no more risk than the mercury found in fish and other food.


Related Links:
U.S. Food and Dug Administration
American Dental Association