FDA Regulatory "Oversight" of Dental Amalgam
- Timeline -
- Timeline -
- 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.
Federal judge Ellen Huvelle told the FDA that, "the probability of harm is enormous,"
and called the agency's 32-year foot-dragging, "government at its worst."[2]
- 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 three decades. The FDA also declined to exempt it from classification.
- 1987: FDA developed a new definition for an element to add to the periodic table, “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.
