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This article was originally published in The Tan Sheet

Executive Summary

ANTI-PLAQUE PRODUCTS' REGULATION AS OTC DRUGS RECOMMENDED by American Dental Association Council on Dental Therapeutics Assistant Director Clifford Whall, PhD, at a Dec. 16 meeting of FDA's Plaque Subcommittee. In a presentation on behalf of ADA, Whall argued that "anti-plaque claims are inexorably linked to therapeutic claims, regardless of whether plaque control is by mechanical or chemotherapeutic means." Whall explained that ADA "[supports] the widely held belief that dental plaque is the etiologic agent for most gingivitis and periodontitis. Because of this, daily plaque control is the method recommended by the ADA, by other dental organizations . . . and by dentists as an important step in controlling gingivitis." As a result, he said, "the public now readily associates plaque with oral disease." "If it is an active therapeutic agent that is responsible for the plaque control, then this is a drug product and anti-plaque claims are drug claims," Whall told subcommittee members. He maintained that this is true "even when [references to plaque are] not used in anti-gingivitis or anti-caries claims." Whall suggested that, like the ADA, the Plaque Subcommittee will "want to see data to support safety and efficacy" for these products. In guidelines published in 1986 on chemotherapeutic dental products, ADA determined that it did "not believe that OTC products are able to control subgingival plaque . . . to affect periodontitis . . . [or] that OTC products can control subgingival calculus" or tartar, according to Whall. "If clinical studies are not able to demonstrate a concomitant gingivitis reduction, then anti-plaque claims should not be permitted, because such claims would be misleading to the public," Whall concluded. He called for studies with that endpoint in mind. Whall contended that industry arguments at the Aug. 2 inaugural meeting of the Plaque Subcommittee stating that plaque may be a cosmetic issue ("The Tan Sheet" Aug. 9, p. 5) were "contrary to our knowledge about plaque, and contrary to the massive educational efforts that the ADA and the dental industry have put forth in recent years." He cited a September 1990 Federal Register notice in which FDA characterized plaque as a "colorless bacterial layer" and said that "plaque removal is not considered a cosmetic purpose. Plaque reduction or removal is intended to prevent disease." The Nonprescription Drug Manufacturers Association and the Cosmetic, Toiletry, and Fragrance Association in a joint presentation to the subcommittee reiterated their position that the regulation of anti-plaque rinses should depend upon the type of claims made by the manufacturer on the label. "Plaque can be associated with disease-related endpoints -- e.g., gingivitis -- and cosmetic conditions, both of which are amenable to amelioration according to the 'intended use' of the particular product," NDMA Senior VP-Science & Technology William Soller, PhD, stated. He said that modifying phrases shaped a claim more than the mention of plaque, because "plaque is not a claim per se" and "plaque is not a disease." "The FDA's OTC review of plaque-related claims should focus on drug-related claims, leaving those claims that are cosmetic- related to the current available and effective compliance that FDA is capable of imposing on products making such cosmetic claims," Soller argued. He also quoted "verbatim comments" from consumers who participated in one-on-one interviews sponsored by Procter & Gamble about the meaning of a "clean mouth." Consumers, Soller reported, interpreted the phrase to mean a "fresh feeling; smooth and clean; no bad taste," "don't have ugly build-up," "white teeth, feels smooth," "not gummy or fuzzy," "breath is better," "no stains; clean teeth don't feel scummy." CTFA Associate General Counsel James Skiles maintained that if an anti-plaque product makes only cosmetic claims, it must be regulated as a cosmetic under current law. A cosmetic is defined as a product "intended . . . for cleansing," a definition that applies to products claiming to "clean" or "whiten" teeth or "freshen breath," according to Skiles. "Claims for a product determine its regulatory status, not whether an anti-plaque agent is in the product," he said. On Dec. 17, the second day of the panel meeting, the Plaque Subcommittee discussed working definitions of dental terms in preparation for the report being prepared for the Dental Products Panel, including such terms as: "plaque"; "tartar"; "supragingival"; "subgingival"; "gingivitis"; "pellicle"; "periodontitis"; and "oral hygiene." The subcommittee also discussed the relationship of gingivitis to plaque and whether the age and amount of plaque is a precursor to gingivitis. Subcommittee Chairman William Bowen, DSC, University of Rochester, urged the panel to resolve the issue early in the subcommittee's proceedings because, he predicted, "somewhere down the road" the panel may have to deal with an ingredient claiming "40% plaque reduction." The subcommittee decided that plaque may be "causally related to gingivitis" although subcommittee members differed on the significance of the relationship.

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