FDA Warnings on Mercury Tooth Fillings Expected Today: New Regulation Result of Lawsuit Settled Last Year
WASHINGTON, July 28 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration is expected to issue a new regulation today calling for special controls on the placement of mercury tooth fillings. Until now, dentists who used amalgam have not had to disclose the type of materials used in dental fillings or advise patients, and particularly sensitive populations, of its use.
The ruling results from a lawsuit settled last year by the plaintiffs in the case of Moms Against Mercury v. Von Eschenbach. The settlement required FDA to withdraw claims of amalgam’s safety from its web site and reclassify its use by July 28, 2009.
“After 32 years of delays, FDA finally warned Americans about neurotoxic effects from amalgam to the nervous systems of developing children and fetus,” said Michael Bender, a plaintiff in the lawsuit and director of the Mercury Policy Project. “This breakthrough corresponds to the one in 2004 when FDA first warned pregnant women and children to limit consumption of certain tuna.”
As reflected in the May 2008 court transcripts, Judge Ellen Huvelle stated that the “…probability of harm is enormous,” and asked the FDA: “How could you drag your feet for 32 years? Do what you are supposed to do.” Judge Huvelle also said that she couldn’t “. . .order a ban, but can compel to act,” observing that this was “government at its worst” and that she wanted this “public safety issue to be resolved.” (See link to court transcript at the end of release.)
As part of the settlement, FDA agreed to change its website — dramatically. In addition to recognizing that amalgam contains a neurotoxin that may present a risk to children, the FDA website now says, for example, that: “Some other countries follow a “precautionary principle” and avoid the use of dental amalgam in pregnant women.”
These warnings are similar to those from manufacturers. Amalgam arrives at a dentist’s office with skull and cross bones affixed next to the words “POISON, CONTAINS METALLIC MERCURY.” Manufacturers advise dentists against placing amalgam in pregnant women, nursing mothers, children under six, and anyone with kidney disease. For example, Dentsply has warned: “Contraindication In children 6 and under” and “In expectant mothers.”
However, most Americans are not aware of these warnings, according to a poll conducted for the Mercury Policy Project by Zogby International. The poll indicates that most Americans (76%) don’t know mercury is the primary component of amalgam, but when informed, almost all (92%) want to be informed prior to treatment. The poll also found that most Americans (77%) would choose higher cost mercury-free fillings — given the choice — and a large majority (69%) support a ban on placement of mercury fillings in pregnant women and children.
May 16, 2008 court transcripts:
Results of Zogby poll:
June 10, 2008 Mercury Policy web post:
SOURCE Mercury Policy Project