CONSUMER PERCEPTION DATA ON ANTI-PLAQUE PRODUCT CLAIMS

CONSUMER PERCEPTION DATA ON ANTI-PLAQUE PRODUCT CLAIMS will be compiled by the Nonprescription Drug Manufacturers Association and the American Dental Association for review by FDA's new Plaque Subcommittee of the Dental Products Panel at its next meeting, tentatively set for Dec. 16-17. Both NDMA and ADA agreed to provide the data at the Aug. 2-3 inaugural meeting of the Plaque Subcommittee. Consumer representative Jean Frazier, PhD, offered to supply the panel with "large literature reviews up to the very present" consumer impressions of advertising and labeling in order to assist the subcommittee in determining "what the consumer perceives or needs." The subcommittee also indicated interest in discussing definitions of the terms "plaque," "tartar," "gingivitis" and "periodontitis," which are included in the labeling of many OTC products that make anti-plaque claims. Subcommittee members also were asked at the Aug. 2-3 meeting to "give considerable thought to" whether products that claim to control plaque should be marketed as drugs or as cosmetics in preparation for the next meeting. "It is clear" that there are "two distinct camps" of thought on this issue, observed William Bowen, DSc, University of Rochester, who served as acting chairman during the subcommittee's first meeting. Subcommittee member Robert Genco, DDS/PhD, State University of New York School of Medicine, asked FDA to compile a list of labeling claims made for anti-plaque products in time to be included on the December meeting agenda. "It might help [the subcommittee] to look at some of the specific claims," he noted. "For example, 'it leaves your mouth feeling clean'" could be a cosmetic claim, he suggested, whereas "one could make the argument that . . . 'Helps prevent gingivitis'" is a drug claim. Commenting on industry presentations that some plaque claims should be considered "cosmetic" claims rather than "drug claims" (see following story), Bowen noted that "these are the issues that we will discuss when we get down to what we mean by plaque control -- is plaque [control] cosmetic or is plaque a drug claim? That's what we are trying to resolve."