Court dismisses suit seeking new FDA restrictions on amalgam
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Posted April 16, 2007 |
By Craig Palmer Washington— A federal appeals court dismissed a suit seeking new Food and Drug Administration restrictions on the use of dental amalgam fillings and said the court lacks jurisdiction. The American Dental Association was not a party to the litigation.
ADA statements on dental amalgam for dental professionals and the public are available on ADA.org. The Association bases its policies and recommendations to dentists and consumers on the best available science. ADA President Kathleen Roth said the Association welcomes the ruling in a statement posted online.
"A number of advocacy organizations and individuals seek review of regulatory inaction by the Food and Drug Administration," Judge David B. Sentelle wrote for the U.S. Court of Appeals for the District of Columbia three-judge panel, which unanimously dismissed the suit. "They assert that the FDA should classify, under the Federal Food, Drug and Cosmetic Act, a material commonly used for dental fillings.
"The material, they contend, must be regulated by the FDA in order to protect consumers against its deleterious health effects. We hold that we lack jurisdiction over the subject matter and thus dismiss the petition." The case was filed on April 27, 2006, argued March 27 and decided April 13. The decision is posted at the court's Web site in PDF format  .
The court under certain "hypothetical" circumstances could later assert jurisdiction, said the court's written opinion. But in the absence of FDA regulation of encapsulated amalgam, there is no jurisdiction. "FDA's failure to classify a device does not directly give rise to judicial review in this court under the Federal Food, Drug and Cosmetic Act."
The government in oral arguments said the FDA "has proceeded appropriately" to regulate encapsulated amalgam alloy and dental mercury (EAADM), which are currently regulated separately by the FDA and typically used by dentists in one capsule combining the components to create the material used to fill cavities.
The plaintiffs have no standing to sue and the court lacks jurisdiction, said the U.S. Department of Justice brief filed in the case. "This is not a case where the agency has been neglecting its duty to classify; rather the agency has been steadily working towards classification but has been slowed, in part, by the lack of literature and definitive scientific evidence on which its decision will be based."
The FDA convened public hearings last year on dental amalgam (ADA News Today Sept. 11, 2006, ADA provides testimony to FDA panel on amalgam safety).
The suit challenging FDA regulation of dental amalgam was filed by four organizations and five individuals. The U.S. Court of Appeals held that they "failed to carry their burden of demonstrating that this court has subject matter jurisdiction over their claim."
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