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Lawsuit Seeks FDA Response on Dental Amalgam Petition


Posted in Regulatory and Compliance by Jamie Hartford on April 1, 2014

The plaintiffs want FDA to ban dental amalgam or at least place it in the Class III device category.


By Jim Dickinson

                             

Several groups filed suit against FDA in March 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 III device category.

Despite “growing evidence of harm caused by dental amalgam, 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 had passed without an FDA response to the petitions, the suit complained, 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 2007 lawsuit, Moms Against Mercury v. Von Eschenbach, alleged that more than 30 years ago the agency was legally obligated to classify dental amalgam but that 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 II, assigning no controls or other measures intended to protect the public,” they said.

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 is MD+DI's contributing editor.

[image courtesy of ARZTSAMUI/FREEDIGITALPHOTOS.NET]


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