FDA Reaffirms Amalgam is Safe

Jennifer GoodrumFeatured News

July 29, 2009

Yesterday, July 28, after years of careful investigation and review of over 200 scientific studies, the U.S. Food and Drug Administration (FDA) reaffirmed its view that dental amalgam is a safe, effective material for use in dental restorations.

The FDA ruling categorizes encapsulated dental amalgam as a class II medical device, placing it in the same class as gold and composite fillings. The ADA has supported a class II designation for dental amalgam since 2002, when first proposed by the FDA.

Dr. Susan Runner spoke on behalf of the FDA during yesterday’s news conference. She stated, “The best available scientific evidence supports the conclusion that patients with dental amalgam fillings are not at risk for mercury-associated adverse health effects.” She also noted that the FDA explored potential health effects of dental amalgam in developing fetuses, breast-fed infants and children under age six. Although the research on these populations is more limited, she said, “the scientific evidence that is available suggests that these populations also are not at risk.”

To address the needs of patients with an allergy or sensitivity to mercury or other metals in dental amalgam, the FDA is placing special controls on dental amalgam to help provide “reasonable assurance” of its safety and effectiveness. These controls include recommended performance tests to ensure that essential information is provided to the FDA when devices are submitted for evaluation.

The special controls also instruct manufacturers to add language to their product labeling that:

  • Warns against the use of amalgam in patients with mercury allergies
  • Advises dental professionals to use adequate ventilation when handling amalgam
  • Reviews the benefits and risks of amalgam

Dental amalgam is made by combining mercury with other metals such as silver, copper and tin. Numerous scientific studies conducted over the past several decades, including two large clinical trials published in the April 2006 Journal of the American Medical Association, indicate dental amalgam as a safe, effective cavity-filling material for children and others. In its 2009 review of the scientific literature on amalgam safety, the ADA’s Council on Scientific Affairs reaffirmed that the scientific evidence continues to support amalgam as a valuable, viable and safe choice for dental patients.

Click here to read the FDA’s complete media statement on amalgam.