
| 7/29/2009 |
Re: FDA Final Regulation on Dental Amalgam
On July 28, 2009, the FDA issued its final regulation on dental amalgams. Other than making some changes to the labeling on Kerr dental amalgam products, the final regulations will not impact the manner in which Kerr manufactures, packages or sells dental amalgam products.
In addition to issuing final regulations, the FDA changed their website on dental amalgams to include the following statement:
FDA has reviewed the best available scientific evidence to determine whether the low levels of mercury vapor associated with dental amalgam fillings are a cause for concern. Based on this evidence, FDA considers dental amalgam fillings safe for adults and children ages 6 and above. The amount of mercury measured in the bodies of people with dental amalgam fillings is well below levels associated with adverse health effects. Even in adults and children ages 6 and above who have fifteen or more amalgam surfaces, mercury exposure due to dental amalgam fillings has been found to be far below the lowest levels associated with harm. Clinical studies in adults and children ages 6 and above have also found no link between dental amalgam fillings and health problems.
There is limited clinical information about the potential effects of dental amalgam fillings on pregnant women and their developing fetuses, and on children under the age of 6, including breastfed infants. However, the estimated amount of mercury in breast milk attributable to dental amalgam is low and falls well below general levels for oral intake that the Environmental Protection Agency (EPA) considers safe. FDA concludes that the existing data support a finding that infants are not at risk for adverse health effects from the breast milk of women exposed to mercury vapor from dental amalgam. The estimated daily dose of mercury vapor in children under age 6 with dental amalgams is also expected to be at or below levels that the EPA and the Centers for Disease Control and Prevention (CDC) consider safe. Pregnant or nursing mothers and parents with young children should talk with their dentists if they have concerns about dental amalgam.
Kerr intends to continue offering dental amalgams as a restorative material because, like the American Dental Association, Kerr continues to believe that dental amalgam is a valuable and safe choice for dental patients. Kerr remains, as it has throughout its history of over 100 years, devoted to providing the dental profession with products that assist the profession in providing safe and effective dental treatment.