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FDA Rules on Mercury Amalgam

Posted Jul 31 2009 11:45am

Via Medical News Today:

The US Food and Drug Administration (FDA) issued a final regulation today, Wednesday, saying that at the levels dentists use for tooth cavity filling, elemental mercury in dental amalgam does not harm patients, although adverse health effects are known to occur at higher exposures.

Dental amalgam is made by combining mercury with other metals such as silver, copper and tin.

Under the new regulation, dental amalgam is classified as Class II, denoting moderate risk. Devices in Class II can be made subject to special FDA safety and effectiveness controls (in addition to the manufacturing standards required of all medical devices regardless of their risk level).

The announcement has received a mixed response. While the American Dental Association said they agreed with the FDA decision, a consumer group that is against using mercury in dental fillings said it showed contempt for children and the unborn.

Here is the complete media release (via Medical News Today) from Consumers for Dental Choice, a nonprofit group working to “educate the public about the health and environmental dangers of mercury fillings, and to ensure more effective government oversight on amalgam”:

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.

“FDA remains alone in the world in failing to protect children and pregnant women from mercury fillings. Since 1996, Canadian dentists have been told not to put mercury amalgam in children or pregnant women. Since 1998, British dentists have been told the same for pregnant women. Norway and Sweden have banned amalgam altogether. Regrettably, this rule should have meant the end of two-tiered dentistry: mercury for the poor and choice for the rest. Instead the FDA has failed to carry out its mission of protecting the public health,” concluded Brown.


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Posted in mercury Tagged: amalgam fillings, Consumers for Dental Choice, dental amalgam, FDA, mercury, mercury fillings
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