See the press release below the news article.

Related:            IAOMT editorial published in DrBicuspid.com

Lawsuit Seeks FDA Response on Petition on Dental Amalgam

03/05/2014

Several groups filed suit against FDA 3/5 in Washington, DC District Court seeking an order compelling the agency to respond to 2009 petitions calling for either a formal ban on dental amalgam use or its placement in the Class 3 device category. Despite “growing evidence of harm caused by dental amalgam, the FDA continues to delay its decision to protect public health against the dangers of mercury tooth fillings,” said one of the plaintiffs, the International Academy of Oral Medicine & Toxicology. Fifty-six months have passed without an FDA response to the petitions, the suit complains, adding that the agency’s own regulations require a response within 180 days.

Attorney James M. Love, who filed the lawsuit, said American consumers and dental professionals are being misled by the American Dental Association (ADA). “The ADA has misrepresented FDA’s lack of regulation as proof of safety, and continues to use this toxic dental filling, despite scientifically demonstrated risks,” Love said.  “Most individuals remain unaware that those ‘silver’ fillings, prevalently used as a dental restoration and covered by insurance policies, consist of 45-55% metallic mercury, and that there are health and environmental risks associated with those fillings.”

A previous 2007 lawsuit, Moms Against Mercury v. Eschenbach, alleged that more than thirty years ago the agency was legally obligated to classify dental amalgam, but it did not do so. That suit resulted in FDA agreeing to classify dental amalgam,” the plaintiffs said. “However, FDA classified the device in Class 2, assigning no controls or other measures intended to protect the public.”

Plaintiffs in the current lawsuit also include Moms Against Mercury, DAMS, Inc., CoMeD, Inc., and several individuals who were adversely affected by mercury in their amalgam fillings.

Jim Dickinson, Editor

 

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FOR IMMEDIATE RELEASE: March 5, 2014

 

Lawsuit Filed Today Against FDA for
Failing to Address Risks of Mercury in Dental Fillings

New Article in Peer-Reviewed Biometals
Indicates Children are Most at Risk

“Silver” Fillings Are 45-55% Metallic Mercury

(Washington, DC) — A lawsuit filed today in the DC District Federal Court claims that despite growing evidence of harm caused by dental amalgam, the FDA continues to delay its decision to protect public health against the dangers of mercury tooth fillings.

The case cites that the FDA has failed to respond within a reasonable time to petitions calling for either a formal ban of amalgam use, or placement in FDA’s Class III, which requires: 1) additional restrictions for vulnerable individuals; 2) more stringent proof of safety; and 3) an Environmental Impact Statement.

Meanwhile, according to attorney James M. Love, who filed the lawsuit today, American consumers and dental professionals are being misled by the American Dental Association (ADA) — the largest and most powerful advocate for continued amalgam use.

“The ADA has misrepresented FDA’s lack of regulation as proof of safety, and continues to use this toxic dental filling, despite scientifically demonstrated risks,” said Love.  “Most individuals remain unaware that those ‘silver’ fillings, prevalently used as a dental restoration and covered by insurance policies, consist of 45-55% metallic mercury, and that there are health and environmental risks associated with those fillings.”

Top scientists have repeatedly warned the FDA of the risk of harm caused by dental fillings:

  • In 2006, the FDA consulted a Joint Panel of physicians and dentists to review the FDA’s own White Paper on dental amalgam. The Panel ruled 13 to 7 that the White Paper did not demonstrate adequate proof of safety.
  • In 2009, in their position statement, the Scientific Advisory Board of the International Academy of Oral Medicine & Toxicology (IAOMT) stated, “[i]t is incompatible with current, valid scientific evidence to continue to endorse or otherwise condone the use of a permanently implanted material in teeth that continuously emits a very potent enzyme inhibitor and metabolic toxin.”
  • In 2010, at the urging of its own scientific advisory panel, the FDA agreed to review its amalgam rule based on current science.  The agency announced its intention to complete its review by 2011, but still has not acted.
  • A February 2014 study, “[n]ew science challenges old notion that mercury dental amalgam is safe,” published in the peer-reviewed journal, Biometals, uses the same studies cited by FDA in 2006, demonstrating that children are particularly at risk for mercury poisoning.
  • A 2013 study, “Woods et. al. 2013 – Neurobehavioral Data From CATs Reveals Greater Hg Effects In Boys With Metallothionein Gene Variant,” demonstrates that certain genetic factors make young boys more susceptible to adverse neurobehavioral effects from mercury.

Mercury is a persistent toxic chemical that can build up in the body.  It is particularly toxic to the kidneys and the nervous system.  Young children are more sensitive to mercury and are exposed to mercury through breast milk.   The fetus is exposed to mercury from placental transfer of mercury from a pregnant woman’s teeth containing amalgam.
More information on the health effects of mercury fillings can be seen in this video.
“We have banned mercury in disinfectants, thermometers, and many other consumer products,” said Griffin Cole, DDS, President of the IAOMT. “There is no magic formula that makes mercury safe when it’s put into our mouths.  It’s inexcusable to use mercury in dental fillings when there are much safer alternatives.”

A previous 2007 lawsuit, Moms Against Mercury v. Eschenbach, alleged that more than thirty years ago the FDA was legally obligated to classify dental amalgam, but did not do so.  In direct response to this lawsuit, the FDA agreed to classify dental amalgam.  However, FDA classified the device in Class II, assigning no controls or other measures intended to protect the public.

The largest user of dental amalgam is the U.S. government, which uses amalgam for welfare recipients, prisoners, those residing on Indian Reservations, and the military – serving largely low-income people, including women and children, who are given no other options.

Plaintiffs in the current lawsuit include: International Academy of Oral Medicine & Toxicology, Moms Against Mercury, DAMS, Inc., CoMeD, Inc., and several individuals who were adversely affected by the mercury from amalgam fillings. Plaintiffs submitted their first petitions in July 2009, which initially precipitated much promising activity, but have since been ignored by FDA. This lawsuit culminates the allegations set forth in the previous five petitions submitted to FDA.