The mercury used in dental amalgam fillings is not at a level high enough to cause harm in patients, according to the FDA, which today issued its final regulation on the controversial tooth filling material.
However, the agency tightened its controls on mercury fillings, classifying the encapsulated amalgams now commonly sold to dentists as Class II devices, deemed a moderate risk, instead of the lower risk Class I devices.
Dental amalgams, the silver-colored material used to fill teeth after removal of a cavity, include liquid mercury and a powder that contains silver, tin, copper, zinc, and other metals. When the fillings are placed in the teeth or removed, or during chewing, mercury vapor is released, according to the FDA. At high levels, mercury can cause adverse health effects to the brain and kidneys.
A representative from an organization that opposes mercury fillings called the new ruling "an outrage," while the American Dental Association issued a statement agreeing with the decision.
In a disappointing move, the Food and Drug Administration (FDA) did an about face in issuing a final regulation classifying dental amalgam without calling for stringent precautions for pregnant women and children. Last June, a court settlement filed by the Consumers for Dental Choice required the FDA to withdraw claims of mercury amalgam's safety from its Web site and issue an advisory indicating: "Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses."
"FDA broke its contract and broke its word that it would put warnings for children and unborn children for neurological damage," said Charles G. Brown, National Counsel for Consumers for Dental Choice, who brought the lawsuit compelling today's action. "Bowing to the dental products industry, FDA for the first time in its history pulled a warning about neurological harm to children. This contemptuous attitude toward children and the unborn will not go unanswered. We will see FDA in court."
Most consumers, and most dentists, have already switched to the main alternative, resin composite. The FDA rule destroys a dental myth that the mercury becomes inert in the mouth; FDA says the vapors from dental mercury go into the human body. Due to mercury waste, amalgam is also increasingly targeted by environmentalists.
Intense interest in the rule exists on Capitol Hill. Congresswoman Diane Watson (D-CA) and Congressman Dan Burton (R-IN) co-authored a letter to FDA in May, signed by 19 Members of Congress, calling for a rule to protect children and young women from amalgam. In July, they introduced a resolution on the issue with 29 co-sponsors (H.Res. 648).
Amalgam has also become controversial because the middle-class has largely moved to non-toxic alternatives while the poor, minorities, and institutional recipients, such as soldiers and prisoners, still get amalgam.