ANTI-PLAQUE INGREDIENT REVIEW BY FDA'S PLAQUE SUBCOMMITTEE

ANTI-PLAQUE INGREDIENT REVIEW BY FDA'S PLAQUE SUBCOMMITTEE initially will include 12 single ingredients and four combinations, OTC Plaque Products Subcommittee Acting Chair Robert Genco, DDS/PhD, State University of New York School of Medicine, reported at a June 28-29 meeting. The subcommittee is charged with reviewing the safety and efficacy and risk/benefit of anti-plaque ingredients ("The Rose Sheet" Aug. 9, 1993, p. 1). Genco said the committee plans to review single ingredients when used in combination products at a later date.

To expedite the ingredient review, the panel decided to look at those ingredients that clearly are marketed as drugs at its next meeting, tentatively scheduled for Oct. 11-12. The industry representative on the subcommittee, Cosmetic, Toiletry and Fragrance Association VP-Science Gerald McEwen, PhD/JD, suggested that the panel focus on "those [ingredients] that have been acknowledged to be drugs" in order to avoid ingredients that may be determined to be cosmetics and, therefore, outside the panel's purview.

FDA liaison to the plaque subcommittee, Jeanne Rippere, offered to "look through the submissions" to the agency to determine for the group which ingredients are acknowledged to be drugs.

In conjunction with the ingredient review, the subcommittee plans to "summarize the last three meetings with respect to [proposing] some recommendation" to the Dental Products Panel on how to distinguish between "drug" and "cosmetic" claims for anti- plaque products, Genco stated. Subcommittee member Max Listgarten, DDS, University of Pennsylvania, and Genco will draft the proposal, which will be presented for the subcommittee's approval at an upcoming meeting tentatively set for early December.

The subcommittee also heard presentations on consumer perception studies conducted for the Nonprescription Drug Manufacturers Association and Colgate-Palmolive. Panel members had asked for consumer perception data at the inaugural meeting of the subcommittee in August 1993 ("The Rose Sheet" Aug. 9, 1993, p. 3).

NDMA Senior VP-Science and Technology William Soller, PhD, reported on a "mall intercept" study commissioned by his association and the Cosmetic, Toiletry and Fragrance Association and conducted by Indianapolis-based Walker Research. In the study, researchers presented 2,073 subjects with one of seven anti-plaque statements and, after asking two "open-ended" questions about the statement, classified consumer responses as either cosmetic, therapeutic or unspecified. Soller asserted that "modifying [anti- plaque statements] provides the consumer with sufficient information to appropriately interpret the statement as cosmetic- or therapeutic-related."

"When presented with different plaque-related statements," Soller maintained, "consumers generally do not take away more than what is stated" in the product claim.

After reading cosmetic anti-plaque statements, such as "clean away plaque for a whiter smile," 82-87% of subjects responded with cosmetic statements about the product's activity. When provided with drug-type anti-plaque claims, such as "helps remove plaque to prevent gingivitis," 84-90% of the respondents found the claims to be therapeutic. Unqualified anti-plaque claims such as "helps remove plaque" prompted mostly unqualified responses, Soller said.

Interpreting the study results as supportive of NDMA's contention that products making anti-plaque claims need not fall under FDA's purview as OTCs, Soller held that "plaque is not a claim per se." Anti-plaque product claims convey "generally understood benefits to consumers by modifying phrases that describe the intended use of the products," he asserted.

However, Colgate-Palmolive VP-Product Safety David Richardson, PhD, who presented the results of a similar mall intercept study with 1,600 respondents, came up with a different finding. Richardson said the "overwhelming majority associated [anti- plaque] actions with therapeutic endpoints." When consumers were asked what they perceived as the benefits of removing plaque, 92% associated a therapeutic benefit with plaque removal and 5% named cosmetic benefits only. Asked the consequences of not removing plaque, 2% referenced cosmetic endpoints exclusively.

"Anti-plaque claims are inexorably linked with therapeutic benefits as a matter of science, of regulation, and of the promotional history of anti-plaque products," Richardson asserted. "We believe the consumer has come to associate the term 'anti- plaque' with therapeutic benefits" as a result of "broad-scale education by the dental profession and by pervasive advertising," he continued. The Colgate-Palmolive study also found that dentists are the primary source of information about plaque for 53% of consumers, while 33% cited television ads as their first source of information.