The agency's latest move follows a lengthy debate on the supposed dangers of these fillings, which was capped by a lawsuit filed in 2006 against the FDA by several consumer groups, including Moms Against Mercury and Consumers for Dental Choice.
As part of that settlement, the FDA agreed to classify mercury fillings, also known as dental amalgam, by July 28, 2009, and posted a notice on its Web site that said: "Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses."
The American Dental Association (ADA), one of the organizations that had expected a Class II classification, supported the FDA action.
"The FDA has left the decision about dental treatment right where it needs to be -- between the dentist and the patient," the ADA's president, Dr. John Findley, said in a prepared statement. "This decision underscores what the ADA has long supported -- a discussion between dentists and patients about the full range of treatment options to help patients make educated decisions regarding their dental care."
"Right now, it's confusing because [amalgam] is classified according to its different components. The encapsulated amalgam functions as a unit, so it just makes sense," Dr. Edmond Hewlett, an ADA consumer advisor and an associate professor at the UCLA School of Dentistry, said before the ruling. "And it's reasonable to expect special controls such as precautions for people who are hypersensitive or are allergic to amalgam as well as proper handling guidelines for dental personnel."
Encapsulated amalgam contains two parts, a metal alloy as well as mercury, which are delivered in separate sections that are mixed after they have been delivered to the de
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