FDA: Mercury Fillings Not Harmful
FDA Rules Mercury in Dental Fillings Doesn't Cause Harm, but Tightens Controls
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FDA's Final Rule on Amalgams continued...
Included in the final regulation is the decision to classify dental amalgam as a Class II or moderate risk device, giving the FDA authority to impose special controls with the goal of ensuring safety and effectiveness.
The special controls are spelled out in a guidance document that includes recommendations on labeling and other parameters. Among the labeling recommendations:
• A warning against the use of the filling material in those with a known mercury allergy
• A warning to dentists and other dental professionals to use adequate ventilation when handling the dental amalgam
• A statement talking about the risk and benefit of the dental amalgams, including the risks of inhaled mercury vapor. The statement is meant to help patients and dentists make informed decisions.
Previously, the FDA had classified the two separate parts of the amalgam, including elemental mercury and the metal powder alloy. Now the product is purchased in a different form than in previous years, Runner says. ''Many years ago, dentists would purchase the alloy and the mercury separately and mix it in the office."
These days, she says, they purchase it in an encapsulated form. "That was the form not classified before," she says.
FDA Ruling: Reactions
In a statement issued Tuesday, the American Dental Association said: "The American Dental Association (ADA) agrees with the U.S. Food and Drug Administration's (FDA) decision not to place any restriction on the use of dental amalgam, a commonly used cavity-filling material."
Leaving the decision up to patients and their dentists is the correct approach, according to the ADA. "The FDA has left the decision about dental treatment right where it needs to be -- between the dentist and the patient," ADA President John Findley, DDS, says in the statement.
Not everyone agrees, however. ''The final rule is an outrage," says Charles Brown, national counsel for Consumers for Dental Choice, a group against the use of mercury amalgams. ''It puts mercury 1 inch from a child's brain. It puts mercury directly to the fetus.''
Ideally, he says, the agency should have warned against the filling use for children, pregnant women, and nursing mothers.