Before becoming FDA commissioner, Margaret Hamburg was on the board of Henry Shein, one of the largest distributors of dental amlgam filling materials. When Senator Enzi, as part of the confirmation process, asked Dr. Hamburg written questions about the upcoming amalgam rulemaking, she failed to disqualify herself or disclose her conflict even though she had been briefed on the issue enough that the conflict should have been apparent. She refuses to answer questions regarding her involvement in the decision making process and notified us of her recusal from the rule just 4 days prior to it being finalized in 2009.

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.

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.