State Department Urged to Press FDA to Curb Mercury Dental Fillings

Washington – Sixty US and foreign environmental groups say the Food and Drug Administration is dragging its feet in complying with an international treaty that calls for scaling back the use of dental fillings containing highly toxic mercury and want the State Department to pressure the agency to comply.

In 2013, the United States was the first of 128 signatories to the treaty, the Minamata Convention on Mercury, putting the country on record in support of a phaseout of the use of mercury compounds, known as amalgams, to treat decayed teeth.

But despite mounting numbers of dental patients who say mercury fillings have afflicted them with serious illnesses, senior federal health officials have thwarted the Food and Drug Administration from curbing their use on grounds it would be too costly for the poor, McClatchy reported in July.

The nonprofit groups, including the Natural Resources Defense Council, Clean Water Action and the Sierra Club’s National Toxics Committee, petitioned Secretary of State John Kerry in a letter on Monday to direct the State Department to “take a leadership role in encouraging FDA to reduce amalgam use.”

A State Department spokesman declined immediate comment on the letter.

The groups’ focus is on halting the flow of mercury dental waste into waterways, where it can enter the food chain by biologically accumulating in fish. The Environmental Protection Agency has formally proposed a rule aimed at requiring dentists to contain the damage.

Mercury is often called the most toxic non-radioactive substance on the planet. Once in the blood stream, it attacks the central nervous system and has been linked to an array of health problems, including nerve damage, memory loss, depression, autoimmune diseases including multiple sclerosis and lupus, kidney failure, autism and foggy thinking.

A 2013 report by the US Geological Survey said dental mercury fillings now account for 35 percent to 57 percent of the nation’s end-use mercury products. One study found an estimated 28.5 tons of mercury dental waste had been released to the environment, the geological agency said.

The Minamata treaty aims to protect people around the world by limiting environmental emissions and releases of mercury into the environment from sources including power plants, instrument manufacturing, gold mining and dental offices. Its name stems from a disaster in the 1950s when more than 1,700 people who lived near Japan’s Minamata Bay died after eating fish contaminated by mercury-laden wastewater from a chemical plant.

Reports for the European Commission and the World Health Organization found that eight countries already have reduced the use of mercury fillings by at least 95 percent. The countries are Norway, Sweden, Japan, the Netherlands, Finland, Estonia, Italy and Denmark.

Mercury fillings have been used in dentistry worldwide for about 160 years and are defended by the American Dental Association as a “durable, safe, effective cavity-filling material.”

The association says its last survey on the subject, in 2009, indicated that 54 percent of US dentists still use mercury fillings, though that figure is believed to have slid considerably over the last six years as alternatives such as composite resins have improved and become more affordable.

The dental association said in response to a query that it is pleased with language in the Minamata treaty because it aligns with the association’s “long commitment to capture and recycle” mercury waste with “best management practices (that) can prevent up to 99 percent of waste amalgam from entering the environment.”

However, many dentists haven’t adopted those practices, prompting the EPA’s current rule making.

The Food and Drug Administration has yet to impose tough regulations on mercury fillings. After its creation more than 80 years ago, the agency effectively grandfathered approval of mercury dental compounds without a safety review. Even in finally classifying the compounds as a medical device in 2009, the agency said no environmental impact study was necessary. It did not consider the environmental costs of the compounds’ continued use.

Its 2009 designation of mercury fillings as a Class II medical device, rather than a riskier Class III device, spared manufacturers from proving their products’ safety before marketing them.

The 2009 rule expressly objected to “any change away from use of dental amalgam” on grounds it would lead low-income patients who can’t afford alternatives to delay or avoid treatment.

The environmental and consumer groups said that language shows the FDA is “fundamentally at odds” with the treaty’s goals.

“The FDA is speaking out of both sides of its mouth, on the one hand participating as part of the US delegation supporting the amalgam phase-down, and on the other hand standing behind their 2009 rule,” said Michael Bender, director of the Mercury Policy Project, who helped draft the letter to Kerry.

Over the last six years, the FDA has navigated a somewhat confusing path on the issue while waging a 23-year legal battle with consumer groups seeking a ban on mercury fillings.

In late 2011, FDA officials drafted a public safety communication advising dentists that they should not implant mercury fillings in the teeth of vulnerable populations, including pregnant women and small children, and to try to avoid use of the compounds altogether, McClatchy disclosed in a story on July 21.

The communication won approval from top agency officials but was shelved sometime over the ensuing three years after a cost-benefit analysis at the Department of Health and Human Services cited its impact on low-income people, said a knowledgeable administration official who lacked authorization to publicly discuss the decision.

Then in 2013, an FDA representative was supportive when the State Department adopted language calling for the “phase down, with the goal of eventual phase out.”

FDA spokesman Jeff Ventura said the agency could not comment on the letter to Kerry because of ongoing litigation on the issue.

“FDA will continue to evaluate the safety of dental amalgams and will take any further actions that are warranted,” he said.