The FDA did in fact settle a lawsuit with opponents of dental amalgam in June of 2008. The group was seeking a complete and outright ban of dental amalgam. The ADA and FDA have differing views on what transpired; the ADA considers it to be a changing of policy and warnings rather than a call to stop using the material. Opponents claim it to be dangerous and unfit for use in treatments.

The outcome of the settlement has prompted new warnings on the dental amalgam, not an industry ban. The FDA has issued warnings against using the product on “developing children and fetuses” a more specialized distinction in the use of amalgam. Many newspaper headlines and articles have not or do not warn pregnant moms and children directly. An indirect statement such as “Pregnant women and persons who may have a health condition that makes them more sensitive to mercury exposure….” The FDA was accepting comments on this issue until the end of July 2008.

Regardless of the comments submitted to the FDA, the new regulations will not likely remove dental amalgam from the market. Pepper Long, an FDA spokes person, said “We might perhaps be more likely to have more warnings.” It will fall in the hands of the dentist and their patients to decide what the best solution is, the same as it ever was. Charles C. Brown, chief counsel for the Consumers for Dental Choice, encourages lawsuits against dentist using the material. “If a dentist wants to keep his yacht or second home, he better stop giving this to people.”

Brown believes these new “warnings” and “statements” on the FDA website are the start of a complete ban on amalgam use in the United States. The final decision by the FDA he hopes will include all women of child bearing age, all children, not just those under 6 years of age, and even older children. The FDA started this reclassification of dental amalgam back in 2002, and it sees these warnings and statements as the end result of this process.

The ADA makes no reference to the FDA statements on this issue and has declined to talk or speak with reporters and websites covering this topic. If the new rule or warnings are implemented by the FDA, they will, more than likely, be accompanied by proper use instructions, how to handle instructions and standards for the packaging. Most of the research conducted on this issue supports the continued use of the product, not the ban of its use. Other studies conducted in Portugal and New England showed that children with amalgam restorations showed no signs of harming the children. No signs of neurological concerns or problems have ever been recorded.

A portion of the opponents even agree that there is no direct evidence of harm using amalgam, but James S. Woods, Ph.D., M.P.H, a chemist who participated in the study in Portugal, want the use of dental amalgam stopped. Being a heavy metals researcher he says different people can be affected by mercury based materials, especially those with developing brains and bodies. This is not a concern founded in concrete data, and is speculative at best.
Although the powers at large are still deciding what to do, they have set a date to make their decision. In the next 12 months the FDA will issue its statement on this issue, so we at least will have a decision by next year.