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."...

Storify: White House Champions of Change for Precision Medicine July 8, 2015

Click here for highlights, comments, questions and tweets from White House Champions of Change for Precision Medicine July 8, 2015. Also attended Pre-Meeting on Regulations with FDA. 

Key points: 
Reboot FDA device regulations for patient safety 
Recognize genetic variation in tolerance vs. toxicity
Patient labels, Informed consent, Precision Devices 
Pretest "right for you" before they are installed
Include in medical (not just dental) record
Add dental section to MedWatch Report Forms 
Integrate dental into healthcare, insurance, records

MEDDSURGE: Is Your Medical/Dental Device "Right for You?"

Medical and Dental Device Safety Urgent Regulatory Reform

MEDDSURGE: Top Priority for FDA Reform

Is Your Medical/Dental Device “Right for You”? Keep Pace with Science, Reduce Harm, Lower Costs

 For All Medical and Dental Devices, Congress should require:

·         Written information for patients on what materials devices contain, like for Rx & OTC.

·         One-time pretest to determine which devices are “right for you” in advance.

·         Immediate full implementation of the new system of Universal Device Indicators (UDIs).
·         Redirect device tax to Medical & Dental Device Illness Compensation (MEDDIC) Fund, and end federal preemption so ill and injured patients can seek redress in the courts.

Additionally for Dental Materials:

·         Written informed consent for dental fillings.

·         Medical records to include dental devices, fillings and materials information to allow physicians, epidemiologists and Big Data to assess the potential for health impacts.

·         FDA MedWatch Form 3500B to include a section tailored for dental fillings and devices.

·         Order HHS to release FDA January 2012 Safety Communication on Dental Amalgam.

Thousands of Patients Are Harmed by Medical and Dental Devices:

·         According to MedWatch & DENS, over 1,000 complaints have been filed on dental amalgam. Over 100,000 people have sought volunteer counseling from DAMS to find dentists qualified and able to work with patients ill from dental mercury toxicity.

·         FDA’s MAUDE shows thousands of women have filed complaints for medical devices such as Essure contraceptive coils, vaginal mesh, morcellators, and breast implants.

·         FDA’s MAUDE shows thousands of men and women have filed complaints for cardiac devices, implants, joints, stents, etc. If they are “right for you” is learned after the fact.

We Need Precision Medical and Dental Devices
MEDDSURGE Can Improve Health, Reduce Diseases and Lower Healthcare Costs By:

·         People react differently to foods, prescription drugs, and medical devices and materials.

·         Medical and dental devices provide 24/7/365 exposure to sources of inflammation.

·         Inflammation is at the root of many chronic diseases, from autoimmune to neurological.

·         Ensuring devices are ‘right for us’ will lower chronic disease rates and health care costs.

·         Tailoring medical devices selected for treatment to the characteristics of patients.

·         Conducting clinical trials run as “basket studies” by major genetic variants to determine which device materials are safer for which patients, and which should not be used.

·         Making sure any device used is “right for you” before it is installed.

·         Enabling patients to be reimbursed for uncovered medical, dental and supportive treatments by a Medical & Dental Device Illness Compensation (MEDDIC) Fund, and for patients to recover lost income and care expenses when needed.

Sign MEDDSURGE Petition here.

Medscape: Did HHS Cancel Proposed FDA Limits on Mercury Fillings?

Robert Lowes  July 29, 2015

"In January 2012, the US Food and Drug Administration (FDA) appeared ready to prohibit the use of mercury-based dental fillings, or dental amalgam, in pregnant women, nursing mothers, children aged less than 6 years, and other groups considered sensitive to the metal's neurotoxic vapors.

The agency also was ready to advise dentists that "alternative materials would best be offered as the first line of restorative care minimizing the use of dental amalgam," according to a draft FDA safety communication dated "January XX, 2012."

The proposed FDA guidance, stemming more from cautious uncertainty than clear evidence on dental amalgam's effects on health, would have represented a sea change in the government's regulation of the controversial filling material.

However, as part of the US Department of Health & Human Services (HHS), the FDA needed a green light from higher-ups to issue this guidance. The green light never came.

"We were unable to obtain clearance from HHS," an FDA official told an attorney in February 2012 in a lawsuit seeking to either ban or limit the use of dental amalgam. "We are still working on securing that clearance. When or even if it will happen I cannot say."...

Breaking News: Four Stories on HHS Cover-Up of FDA Safety Warning on Dental Amalgam

Health officials kill proposal to curb mercury dental fillings
Greg Gordon, McClatchy DC, July 21, 2015

Proposed warnings have been kept secret more than three years
Safety communication could have affected millions of patients
Scientist says one in 10 with mercury fillings could be very ill

Six lives upended by mercury-filled teeth
Greg Gordon, McClatchy DC, July 21, 2015

Dental patients describe battles with mercury
Combing the Internet to find a cause
‘The brain fog in my head lifted’

Things to know about mercury fillings
Greg Gordon, McClatchy DC, July 21, 2015

A risk assessment said 122 million Americans exposed to unsafe mercury levels
Scientist says he can trace sources of mercury in hair, blood and urine
Worried about your mercury fillings? Don’t detox until they’re gone

Mercury-free dentists shoot back at national association
Greg Gordon, McClatchy DC, July 21, 2015

Audio: Rob Moir's Environmental Dialogues with Laura Henze Russell

Audio: Moir's Environmental Dialogues

Listen to Dr. Rob Moir and Laura Henze Russell discuss mercury poisoning and safer alternatives in dentistry.

March 20,2014 Episode  - Dental Assistant Karen Palmer of Bethlehem, PA talks about her occupational mercury poisoning.

March 6, 2014 Episode - Laura Henze Russell talks about the Campaign for Good Health, Call for a Surgeon General's Report, and IAOMT Lawsuit Against the FDA and HHS.

November 29, 2012 Episode - Laura Henze Russell talks about the upcoming Sharon, MA Town Warrant Articles.

Hidden River Health Challenge on YouTube - Watch Us!

Hidden River Health Challenge on YouTube - Watch Us!

March 2014 Resolution for Surgeon General Report to Sharon Finance Committee for May Town Meeting, and IAOMT Lawsuit vs. FDA in a Nutshell (14 min)


December 2012 Articles at Sharon Town Meeting to Learn About, Share and Act on Health Risks of Mercury Dental Amalgam for Genetically Susceptible Children and Adults (14 min)

November 2012 Cable TV Show FYI with Colleen Tuck

October 2012 Presentation to Board of Selectmen on Articles for Town Meeting Dec 2012

Oct. 2012 Presentation to Sharon Finance Committee on Articles for Town Meeting Dec. 2012

July 2012 Presentation to Sharon Board of Health on Health Risks for Dental Mercury Amalgam for Genetically Susceptible Children and Adults