FDA Regulatory "Oversight" of Dental Amalgam - A Timeline -

FDA Regulatory "Oversight" of Dental Amalgam
- Timeline -

2011-2019: Eight 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. 

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.

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[1] http://iaomt.org/wp-content/uploads/FDA-2012-safety-communication-mercury.pdf

[2] http://mpp.cclearn.org/wp-content/uploads/2008/08/transcript051508momsvfda.pdf

FDA Safety Communication: Reducing Exposure to Mercury Vapor Released From Dental Amalgam (Draft Jan 2012)

FDA Amalgam Safety Proposal

In January 2012, the FDA prepared a “Safety Communication” that recommended reducing the use of mercury amalgam in the general population, and avoiding it in susceptible subpopulations:

• pregnant and nursing women
• children under six years of age
• people with allergy to mercury or other components
• people with neurological disease
• people with renal disease

It also recognized the risk of occupational exposure for dental personnel.

The recommendations were never made public, and in January 2015, the FDA issued another statement saying that amalgam was unequivocally safe for everyone. Somehow, somewhere in the reaches of government and the Health and Human Services Administration, this amendment to the FDA rule was killed.

Here is the full text of the original, 2012 proposed rule:

FDA Safety Communication: Reducing Exposure to Mercury Vapor Released From Dental Amalgam (“Silver Fillings”)

HHS has not allowed FDA to release this safety warning. The most vulnerable continue to be harmed by a hidden river of mercury poisoning installed without our knowledge or consent.

Please sign the Petition for Medical and Dental Device Safety Urgent Reform (MEDDSURGE).

MD+DI DeviceTalk: Lawsuit Tells How Politics Trump FDA's 'Gold Standard' on Mercury Fillings

MD+DI: Lawsuit Tells How Politics Trump FDA’s “Gold Standard”

Jim Dickinson August 3, 2015

FDA tarnishes its reputation as the regulatory "gold standard" with its stance on mercury-based dental amalgam.

..."Copiously documented with legal, regulatory, and scientific exhibits, the 28-page Washington complaint supplements a 16-month-old lawsuit that FDA has been trying to ignore from the International Academy of Oral and Medical Toxicology and other mercury-opposed plaintiffs who, on other fronts, are winning as the archaic amalgam market in U.S. dentistry dwindles in favor of non-mercury composite resin alternatives.

The darkest tarnish on FDA’s illusory gold glitter could be the new complaint’s discovery that after the agency in 2012 dutifully sent to its political bosses at HHS a scientifically-based final decision restricting mercury amalgam’s use in dentistry, FDA mysteriously reversed course.

That final decision remained a secret, internal document until by a process unexplained in the complaint, it came into the hands of the plaintiffs’ lawyers, enabling them to compare what FDA had decided to tell the world about amalgam and what it was diverted from above to say instead. It did this last January in deceptive responses to three petitions from plaintiffs for a ban on amalgam."...