Dental Amalgam Final Regulation Issued by FDA

Posted on Wednesday, August 5th, 2009 and is filed under Health. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

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The Food and Drug Administration (FDA) classify dental amalgam as Class II (moderate risk). This chemical is used in dental fillings.

The component parts of dental amalgam are elemental mercury and powder alloy. Elemental mercury has been known to be of a health risk at high levels, but the FDA states that at low levels, its risks are low.

The organization, Mercury Policy Project, states that until now, dentists didn’t have to disclose to patients the ingredients of dental fillings. Now, they say, the result of a lawsuit has forced the FDA’s hand. “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.”

Even though the FDA acknowledges that dental amalgam can pose a low-level health risk, they do not place any restrictions on its use. The American Dental Association (ADA) agrees with this. “The FDA has left the decision about dental treatment right where it needs to be–between the dentist and the patient,” said ADA President Dr. John Findley. “This decision underscores what the ADA has long supported–a discussion between dentists and patients about the full range of treatment options to help patients make educated decisions regarding their dental care.”

The ADA points out in a press release that numerous studies have been conducted on dental amalgam and the results of those studies–two published in the April 2006 issue of the Journal of the American Medical Association–have shown that dental amalgam is safe.

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