Mercury Amalgam Tooth Fillings: FDA Changes Stance - Review to Take Place - Dec. 2010

The US Food and Drug Administration (FDA) seems to have changed its stance on dental amalgam fillings. In a legal settlement signed in 2009, the FDA has changed the information on its Web site about amalgam fillings to say that they “may have neurotoxic effects on the nervous systems of developing children and fetus” and that pregnant women “should not avoid seeking dental care, but should discuss options with their health practitioner.” Till now they were not so harsh on the neurotoxic effects of mercury fillings. FDA’s rule making body will examine evidence concerning whether release of mercury vapor can cause health problems, including neurological disorders, in children and fetuses. The FDA also agreed to decide by next year whether mercury fillings need more regulation.

Dental amalgams contain mercury, when amalgam fillings are placed in teeth or removed from teeth, they release mercury vapor. Mercury vapor is also released during chewing. There have been routine warnings about not using the amalgam in patients known to be allergic to the amalgam. This is because of the  relatively high percentage of mercury it contains (almost as much as in a mercury thermometer). Mercury is a known neurotoxin which may have harmful effects on the nervous systems of developing children and fetuses. The manufacturers say it should not be used in children age 6 and under, or in pregnant women.

Anti-mercury activists have for long been engaged in pushing the industry to develop substitutes like composites or resins and several other types of dental fillings, that are now available in the market. They've also been persuading people to have their fillings ripped out  and replaced by substitutes. But they've been lacking support from official government agencies.  The FDA's new approach is just what they wanted for it is sure to give strength to their battle against mercury tooth fillings.

Detailed information on the topic is available at FDA's official website.

More recently, on June 11, 2010 the Dental Products Panel of the Medical Devices Advisory Committee of the FDA announced that it is planning meetings in the Washington, D.C. area in December 2010 (Dec. 14-15). These discussions are centered on developing recommendations related to scientific issues raised in petitions received by the FDA concerning last year's final ruling.

The petitions submitted to the FDA question the adequacy of the risk assessment performed by the FDA at the time the dental amalgam was classified as a Class II medical device. The petitioners would like to see dental amalgam banned.

FDA release:
June 10, 2010
FDA Advisory Panel to Review Dental Amalgam
Agency to consider risks to vulnerable populations

"The U.S. Food and Drug Administration today announced plans to hold an advisory panel on Dec. 14-15, 2010, to discuss several scientific issues that may affect the regulation of dental amalgam, used for direct filling of carious lesions or structural defects in teeth. The panel meeting will focus particularly on the potential risk to vulnerable populations, such as pregnant women, fetuses, and young children.

Used to treat tooth decay, dental amalgam is a mixture of metals, composed of liquid mercury and a powdered amalgam alloy, composed primarily of silver, tin, and copper.

On July 28, 2009, the FDA issued a final rule that reclassified dental mercury from a class I device to class II, classified dental amalgam as a class II device, and designated special controls for dental amalgam, mercury and amalgam alloy. The special control for the devices is a guidance titled, "Class II Special Controls Guidance Document: Dental Amalgam, Mercury and Amalgam Alloy."

Since that time, the agency has received several petitions raising various issues relating to the final rule and special controls.

The concerns raised include the adequacy of the risk assessment method used by the FDA in classifying dental amalgam, the bioaccumulative effect of mercury, the exposure of pediatric populations to mercury vapor, and the adequacy of the clinical studies on dental amalgam. In addition, a recent report on risk assessments issued by the National Academy of Sciences, titled "Science and Decisions: Advancing Risk Assessment, NAP 2009," proposes new approaches to conducting risk assessments. These may be some of the issues the agency asks the advisory committee to review."