FDA Ruling On Mercury Fillings Falls Short

Main Category: Dentistry
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 29 Jul 2009 - 2:00 PDT

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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.

Source: Consumers for Dental Choice