Will the U.S. FDA ban amalgam in children?

In the dental amalgam arena, the United States Food and Drug Administration (FDA) – which is charged with regulating amalgam – prefers to sit and watch from the sidelines: 

  • Scientists on FDA’s own advisory panels told FDA that mercury dental fillings pose a risk to children and other sensitive populations.  As one expert explained in no uncertain terms, “definitely not in pregnant women and definitely not in those below 6 years of age.”  But FDA just sat and watched.
  • Amalgam manufacturers in other countries warned against amalgam use in children and pregnant women.  They caution that amalgam is “not suitable for use in children and during pregnancy” in the United Kingdom, nor is it appropriate for children and women of childbearing age in Germany.  But FDA just sat and watched.
  • Other governments implemented policies that discourage, restrict, or prohibit the use of amalgam in children, pregnant women, and other sensitive populations.  Sweden, Denmark, Finland, Germany, Canada, Australia, the United Kingdom, and Norway have all taken at least some steps to protect their children from dental mercury.  But FDA just sat and watched.

Now comes an event that FDA cannot just sit and watch: the European Union has voted to ban amalgam for children under 15, pregnant women, and breastfeeding mothers in response to the game-changing Minamata Convention on Mercury.

The European Union is FDA’s chief rival for supremacy as the world’s leading health regulator.  As FDA has boasted, “Under the EU system, the public are being used as guinea pigs….We don’t use our people as guinea pigs in the U.S.”


In its amalgam rule, FDA itself concedes that “The developing neurological systems in fetuses and young children may be more sensitive to the neurotoxic effects of mercury vapor.”  FDA also admits that there is no scientific proof that amalgam is safe for these populations: “Very limited to no clinical information is available regarding long-term health outcomes in pregnant women and their developing fetuses, and children under the age of six, including infants who are breastfed.”

Yet FDA promotes subjecting children to this risky, unproven mercury product like guinea pigs….while the European Union is withdrawing its children from this toxic experiment.

So the U.S.-based Consumers for Dental Choice is challenging FDA to catch up with the European Union – and the many scientists, manufacturers, and other governments that already take steps to keep amalgam out of children’s mouths.  They filed a formal citizen petition and are also organizing an online petition.

FDA needs to stop sitting in the grandstands – it’s time to go to bat for America’s children.