FDA has issued the final regulation on dental amalgam (silver mercury fillings)

August 11, 2009
Category: Uncategorized

The FDA reclassification moves dental amalgams from low risk (Class I) to moderate risk (Class II). Many dentists have already abandoned dental amalgam fillings, perhaps ringing the death knell for mercury fillings.

In 1976 the FDA was given broad powers to regulate medical devices. But certain devices in use prior to that year, including the dental mercury/silver/amalgam filling (hereafter referred to as a mercury filling), were termed “pre-amendment devices.”  Although the FDA had separately classified the elemental mercury and the metal powder alloy parts of the mercury filling, for years there was no regulation of the combination of the two, which was in common use in U.S. dental offices (75 percent of fillings in Americans’ mouths presently contain mercury).
In 2006, the FDA invited experts in dentistry, neurology and toxicology to a landmark advisory-committee meeting to review the existing scientific data on mercury fillings. It is important to note that the FDA in 2002 had ruled zero tolerance for mercury in any product used to treat an animal. Forbidding the use on horses of ointments containing mercury, the FDA ruled that mercury is so toxic to mammals, the agency had no duty to prove that mercury could actually harm a horse.  In stark contrast, the FDA told critics of mercury that actual and widespread harm must be proven in disallowing mercury fillings in human mouths.
Consumers for Dental Choice, under the legal counsel of attorney Charles Brown, sued the FDA. The result was a court order directing the agency to classify mercury fillings. These are now classified as “medical devices with moderate risk” (Class II out of a I, II, III system). In addition, the FDA recommends that labels include:

  • A warning against the use of dental amalgam in patients with mercury allergy;
  • A warning that dental professionals use adequate ventilation when handling dental amalgam;
  • A statement discussing the scientific evidence on the benefits and risks of dental amalgam, including the risk of inhaled mercury vapor. This statement should help dentists and patients make informed decisions about the use of dental amalgam.

A JP Morgan analysis of the dental industry predicts the FDA will finally forbid the use of mercury fillings in children and pregnant women.
It is crucial that we make intelligent choices about dental health, especially as it is now widely recognized that dental health affects total body health.

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