After 32 years of delay, the Food and Drug Administration has finally agreed to comply with the law and set a date to classify mercury amalgam as a substance that poses a health risk to pregnant women and unborn babies, and children. This about-face resulted from settling, earlier this week, our lawsuit, Moms Against Mercury et al. v. Von Eschenbach, Commissioner, et al. (see Press Release) Stating it was an “unreasonable delay” and “an reasonable case of failure to act.” As reflected in the May 16, 2008 court transcripts, Judge Ellen Huvelle states that the “probability of harm is enormous,” and asked the FDA: “How could you drag your feet for 32 years? Do what you are supposed to do.” (see full transcript) Judge Huvelle also states that she couldn’t “order a ban, but can compel to act,” observing that this was “government at its worst” and that she wanted this “public safety issue to be resolved.” The FDA must now finish classification within one year of the close of the public comment period on its amalgam policy, that is, by July 28, 2009.
As part of the settlement, the FDA agreed to and, with uncharacteristic speed, has already changed its website— dramatically. The Updated June 3, 2008 FDA website now states, for example:
“Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetus.” “Pregnant women and persons who may have a health condition that makes them more sensitive to mercury exposure, including individuals with existing high levels of mercury bioburden, should not avoid seeking dental care, but should discuss options with their health practitioner.”
The FDA website also now states that “Some other countries follow a “precautionary principle” and avoid the use of dental amalgam in pregnant women” and provides links to advice about amalgams from regulatory agencies in other countries, including Canada , France and Sweden. These warnings are similar to those sent from the manufacturers. Encapsulated dental amalgam arrives at a dentist’s office with skull and cross bones affixed next to the words “POISON, CONTAINS METALLIC MERCURY.” Amalgam manufacturers – Kerr, Vivadent and Dentsply – advise dentists against placing amalgam in pregnant women, nursing mothers, children under six, and anyone with kidney disease. Dentsply warns: “Contraindication (N.B.: “Contraindication” is a directive to forbid, not just a “warning.”) “In children 6 and under” and “In expectant mothers.” However, these warnings appear not to have been passed to the public, based on the results of a national poll conducted for MPP by Zogby International whereby most Americans (76 percent) don’t know mercury is the primary component of amalgam fillings; 92 percent of Americans overwhelmingly want to be informed of their options with respect to mercury and non-mercury dental filling materials prior to treatment; and 77 percent of Americans would choose higher cost fillings that do not contain mercury if given the choice.