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OTC DENTURE PRODUCTS MAY BE REQUIRED TO LIST INGREDIENTS

This article was originally published in The Tan Sheet

Executive Summary

OTC DENTURE PRODUCTS MAY BE REQUIRED TO LIST INGREDIENTS in product labeling under an upcoming FDA proposal, according to a preliminary list of products presented to the agency's dental products advisory panel for comment at a Dec. 3 meeting. Among a number of materials that may come in long-term contact with human tissue, the preliminary list includes OTC denture cleansers, denture pads and cushions, denture reliners and denture repair kits. FDA announced its intent to require ingredient labeling for dental materials at a February meeting of the dental products panel. The labeling effort follows recommendations made in January by a Public Health Service committee that explored the safety of dental amalgam. The PHS committee concluded that disclosure of the 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." The agency hopes to have a proposal for the first phase of labeling requirements by the next meeting of the dental panel in April 1994. FDA initially hoped to have a proposal ready for the panel's December meeting. Outlining the agency's strategy for implementing ingredient labeling for dental materials, Greg Singleton, senior dental officer in FDA's Division of General and Restorative Devices, said "the first step would be to require manufacturers of alloy and mercury and the combination of the two materials to provide the ingredients of their products in their labeling." "The next step," Singleton added, "will be to require manufacturers of all other dental materials contacting human tissue to provide ingredient labeling." Agency staffers said requirements for warnings, precautions and adverse effects on labeling are likely much further down the road. Singleton noted that eventually, "requirements instituted for dental materials will be extended to all implanted medical devices and those intended to remain in contact with human tissue for extended periods of time." The agency is looking to the panel to give advice to the agency on "the most specific information to be included in the labeling for each [dental] device" that is intended for long-term contact with human tissue, Singleton said. In addition to OTC denture products, the list includes implant materials, filling materials, crown and bridge alloys and resins, root canal materials, and orthodontic materials. FDA emphasized that the list of materials and product categories presented to the panel is 11 preliminary." The agency asked the panel to provide input on the list, which could be revised before the requirements are implemented. Although the panel did not reach any conclusions on the issue at the meeting, Chairman Paul Robertson, DDS, University of Washington School of Dentistry, listed five questions members should be prepared to discuss at the April session: (1) Is labeling a benefit to the patient and provider?; (2) What groups of devices should be included in such an effort?; (3) How comprehensive should a list of ingredients be?; (4) Should labeling include hazards, warnings, side effects and cautions?; and (5) Who should be responsible for determining specific labeling requirements? In a presentation to the panel, American Dental Trade Association Special Counsel on Regulatory Affairs Thomas Fise maintained that the currently available data "suggests that there is not a very large volume of complaints of allergic reactions." The complaints that are made, Fise continued, "are not so severe as to trigger FDA's own criteria of the type of device incident that requires filing a report with the agency." He said the ADTA "urged the panel to recommend against instituting new regulatory controls" requiring dental ingredient labeling, "which we believe are not necessary to protect the public health." Fise raised a number of arguments for why FDA "should exercise restraint" in imposing ingredient labeling requirements. A key concern for manufacturers is that labeling, whether by percentage of composition or by declining magnitude of composition, "presents a recipe for the product for anyone who cares to copy it," he noted. In addition, he suggested that labeling requirements would make U.S. standards different from other countries, creating barriers to international marketing. The requirements would also create a lag time for implementing ingredient changes and raise costs, he added. The American Dental Association, represented at the meeting by P. L. Fan, interim director for the Council on Dental Materials, Instruments and Equipment, commented that labeling products with at least major ingredients would be useful to practitioners and the public.
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