Thursday, August 27, 2015

Regulatory Timeline for Dental Amalgam

2011-2015: Five Years of Denial and Delay

  • 2011-2014: James S. Woods et. al. publish four retractions of their findings of amalgam safety in children, finding neurobehavioral deficits in boys with four gene types.
  • 2011: At FDA regional public hearings around the country, many dental professionals and patients testified of harm and many diseases caused by mercury in dental amalgam. 
  • 2012: HHS quashed a planned FDA Safety Communication in an election year. The FDA called for reducing the use of amalgam, recognizing the risk of occupational exposure for dental personnel, and avoiding its use in susceptible sub-populations: Pregnant and nursing women; Parents and guardians of infants and children under age 6; People with mercury allergy or sensitivity; People with neurological disease; and People with kidney disease.[1] 
  • 2014: FDA and HHS were sued for failure to respond to multiple petitions for reconsideration.
  • 2015: FDA response to lawsuit is to take no action. McClatchy DC, Medscape and MD+DI Device Talk all report on HHS cover-up. FDA and HHS are sued for third time.

    2006-2010: Five Years of Wrong Action

    •       2006: FDA issued a White Paper concluding dental amalgam was safe. However, the FDA’s Dental Products Panel rejected the FDA’s position 13-7. The FDA did not act.
    •       2008: a number of organizations and plaintiffs sued the FDA for its failure to classify amalgam. The FDA settled the lawsuit, published a website warning, and agreed to issue a final rule within a year. FDA Commissioner Hamburg came in after a six year board seat on dental products distributor Henry Schein; the website warning was removed. 

    • 2009: FDA classified dental amalgam as Class II, with warning labels only to dentists.
    • 2010: After strong objections, FDA reconvened a Dental Products Panel. FDA did not take a vote. Dentists, patients and an expert risk assessment testified of risk and harm.

    1976-2005: Thirty Years of Inaction

    • 1976: Congress passed legislation to add medical, dental and radiological devices to the Food and Drug Administration (FDA).  Certain materials were ‘grandfathered’ as generally recognized as safe (GRAS) initially, including cigarettes, asbestos, and dental amalgam, but were to be reviewed and classified. The FDA declined to classify dental amalgam for decades. The FDA also declined to exempt it from classification.
    • 1987: FDA developed a new definition for the element mercury, “dental mercury.” The FDA ruled “dental mercury” to be Class I – generally recognized as safe.
    • 2002: FDA announced a proposal to reclassify dental amalgam as Class II with special controls related to dentists. Then it was put on the back burner again.


    1. In America, the dispute
      between those dentists who would use amalgam and those who would not
      became extremely polemical, leading to the so-called umalgam wars. In fact,
      there was an early professional body, the American Society of Dental
      Surgeons, whose express purpose was to unite ethical dentists (i.e. those
      refusing to use amalgam) against the ‘unethical’ ones.

    2. Yes, the Amalgam Wars are the longest war in the United States, and it is still going on, sapping too many in our nation of health, vitality, balance, memory, and more.