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This article was originally published in The Gray Sheet

Executive Summary

FDA DENTAL MATERIALS LABELING REG PROPOSAL is expected to be completed by the next meeting of the agency's dental products panel, scheduled for December, FDAers say. The agency is in the process of deciding whether it will be sufficient for the reg to require that dental restorative materials labeling list product components in order of percent composition. Another possibility would be to require that the labeling also include the exact weight composition of each component. At an Aug. 2 meeting of the dental products panel, Greg Singleton, senior dental officer in FDA's office of device evaluation, described the two options. "One possibility is to include all components in the order of percent composition without requiring placement of the exact composition of the components in order to protect proprietary information." Trace quantities also would be listed "since sensitivity reactions can occur in the presence of very small quantities of material." He continued: "Another possibility would be to list the exact [quantity] by weight of all components based on the potential for dose-specific reactions." At a February meeting of the dental products panel, FDA indicated that it would not take this step ("The Gray Sheet" Feb. 22, p. 11), and agency staffers say it is still unlikely that the proposal will require that manufacturers list quantities. The effort to develop a labeling regulation for dental materials was undertaken after a Public Health Service committee that explored the safety of dental amalgam concluded that "industry disclosure of product ingredients" in all dental restorative materials "would provide dentists with useful information with which to diagnose the cause of sensitivity reactions, and would facilitate their selection of a substitute material." In addition to discussing labeling issues, Singleton updated the advisory panel on FDA's efforts to draft a new classification reg for amalgam. Also expected to be drafted by December, the rule would regulate the elemental mercury component of dental amalgam and the powder alloy component as a single Class II product. Currently, the mercury component is in Class I, and the powder alloy is in Class II. The single reg is designed to encourage dentists to use premixed amalgam instead of mixing it in-office, which would result in exposure to potentially harmful materials. Singleton noted that the agency has not yet determined whether it will eliminate the current individual regs for mercury and alloy, which would effectively disallow their use in an unmixed form. "That action may actually have some effect on the dental industry and for those practitioners who actually prefer to... buy those separate entities." He added that FDA will have to balance this concern with "the potential benefits that could be derived from less exposure in the dental office for dental personnel and patients."

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