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DENTAL MERCURY RECLASSIFICATION PROPOSAL SLATED FOR LATE SPRING

This article was originally published in The Gray Sheet

Executive Summary

DENTAL MERCURY RECLASSIFICATION PROPOSAL SLATED FOR LATE SPRING publication in the Federal Register, Lireka Joseph, acting director of the device center's office of training and assistance, told a Feb. 12 meeting of FDA's dental products advisory panel. The proposed rule would regulate the elemental mercury component of dental amalgam and the powder alloy component "as a single Class II product." Currently, the elemental mercury component is regulated in Class I, while the powder alloy, which is composed of silver, tin and copper, is regulated in Class II. The proposed rule follows the recommendation of the Public Health Service outlined in a report on dental amalgams released Jan. 21. The PHS committee maintained that "although sufficient data do not presently exist to establish dental amalgam as a human health hazard," the risk potential warrants further attention and the mercury component should be subject to a higher level of regulation ("The Gray Sheet" Jan. 25, p. 17). In conjunction with the Federal Register notice, the agency plans to send a letter to manufacturers of dental amalgam informing them of FDA's recommendation that "that the use of mercury in dental offices be confined to [use in a pre-mixed] encapsulated form." This letter is expected to be completed by the office of device evaluation by early April. In addition, dentists known to be using devices that titrate amalgam with mercury "will be strongly encouraged to switch to encapsulated forms," according to Joseph. FDA also plans to issue a regulation requiring producers of restorative dental devices containing metal alloys "to disclose their product ingredients" in the labeling, listing them "in descending order of percent of weight composition, but without listing the actual percentage of each component," Joseph said. PHS had recommended in the Jan. 21 report that labeling for all restorative dental materials list product ingredients. The labeling regulation would allow dentists to "shift to a substitute material if a reaction occurred, or avoid a substance if a pre-existing allergy condition was known" in a patient, according to Joseph. Prior to issuing the regulation, FDA will send a letter "to all manufacturers of dental devices that are composed of metal alloys which are intended to remain in the oral cavity for an extended period of time, strongly recommending" that the proposed changes in labeling be made voluntarily. Another PHS recommendation to be addressed by FDA involves an effort to improve the reporting of adverse incidents with dental products. Joseph said that FDA would try "to be more proactive in encouraging health professionals and patients to report adverse effects of all restorative material and devices." FDA plans to "more actively publicize" their problem reporting program "through journal articles, presentations, correspondence and discussions with professionals and consumers," she noted. Underreporting of adverse events related to dental devices also was addressed in a presentation made by FDA Commissioner David Kessler, who called for improved communication between the dental community and FDA as well as heightened enforcement.
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