10th June 2008 - FDA Must Classify Mercury Fillings

Last june a group of no-profit organizations won a ten-year battle to get the Food and Drug Administration to comply with the law and set a date to classify mercury amalgam.  The team of nonprofit groups was made of Against Mercury, Connecticut Coalition for Environmental Justice, Oregonians for Life, Consumers for Dental Choice and mercury expert Michael Bender,  Arizona Senator Karen Johnson, and other dentists and dental assistant.

After the lawsuit Mum against Mercury et al. v. Von Eschenbach, Commissioner, et al.  FDA will finish classifying within one year of the close of the public comment period on its amalgam policy, that is, by July 28, 2009.

To change FDA policy, the team had tried petitions, Congressional hearings, state fact sheet laws, Scientific Advisory Committee hearings, and letters galore -- to no avail.  So eventually they sued.  The case came to a head this spring. The presentation of the oral arguments was on May 16.  In a crucial ruling, Judge Huvelle ruled that the 11 no profit organizations have standing.  She said FDA should classify, and invited the two sides to mediate.  On May 30, before Magistrate Judge John Facciola, Bob Reeves and  Charles G. Brown, National Counsel from Consumers for Dental Choice hammered out an agreement with FDA officials and lawyers.

The FDA agreed to change its website on amalgam -- dramatically.  There is no sign of the FDA's claims that no science exists that amalgam is unsafe, or that other countries have acted for environmental reasons only, or that the 2006 Scientific Panel vote affirmed amalgam's safety.  Instead -- see http://www.fda.gov/cdrh/consumer/amalgams.html -- FDA has moved to a neutral course, while recognizing the serious health concerns posed by amalgam in particular for children and unborn children, for pregnant women, for those with mercury immuno-sensitivity or high mercury body burdens.  FDA 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."

For example, now the American Dental Association will not cite the FDA website in public hearings to state the amalgam safety.