For over 33 years the FDA dodged properly classifying dental mercury amalgam as it was grandfathered in without proof of safety. In 2007 the FDA lost a lawsuit which forced them to classify dental amalgam. The final rule of the FDA classification was a huge disappointment as it declared mercury amalgam to be safe for anyone and everyone, without regard to age, reproductive status, or any of the known factors that make a person unusually susceptible to the effects of mercury exposure.

FDA’s August 4, 2009, Final Rule classifying dental amalgam in Class II and concomitant failure to prepare an Environmental Impact Statement, or at least, and Environmental Assessment under the National Environmental Protection Act (“NEPA.”)

This Petition pertains to dental mercury capsules (herein after sometimes referred to as “mercury fillings” or “dental amalgam.”) It is hereby requested that the Commissioner of the Food and Drug Administration (“FDA”) take the following actions with respect to mercury fillings:

On July 28, 2009, FDA announced that it was classifying dental amalgam for the first time in Class II without requiring any significant special controls. FDA’s Final Rule on this issue was published on August 4, 2009. FDA also published an Addendum in support of its Final Rule, in which it explained its attempts to address the recommendations of the Joint Panels that convened in September 2006 and rejected the conclusions in the FDA White Paper on amalgam fillings.

Mercury, we now know, concentrates in the kidneys, and experimental evidence shows that it can inhibit kidney function. In one experiment, the organ that accumulated the greatest amount of mercury following amalgam placement was the kidneys.