PLAQUE SUBCOMMITTEE MAY CONSIDER EFFECTIVENESS OF COSMETIC CLAIMS

PLAQUE SUBCOMMITTEE MAY CONSIDER EFFECTIVENESS OF COSMETIC CLAIMS such as oral malodor, tooth stain and "mouth feel," subcommittee members indicated at a Dec. 17 meeting of FDA's Plaque Subcommittee. "I do not know if we have to limit ourselves to drug attributes," Jorgen Slots, DDS, PhD, University of California, contended. "I believe that we can also come up with recommendations how the effectiveness can be performed in a cosmetic setting. I do not feel that we have a limitation given to us from FDA only to consider, in a narrow sense, drug attributes," he stated.

Slots' comments were in response to a suggestion by industry representative Gerald McEwen, PhD, of the Cosmetic, Toiletry & Fragrance Association, to insert a disclaimer within the definition of dental plaque. The disclaimer would have limited committee discussion to anti-plaque "drug" issues and would have meant that the subcommittee would not consider the effectiveness of plaque products for cosmetic uses.

McEwen proposed the disclaimer: "Plaque has been reported to contribute to a number of cosmetic conditions, for example, oral malodor, tooth stain or 'mouth feel.' While acknowledging that these conditions may correctly further characterize oral plaque, the subcommittee does not intend to address the cosmetic attributes of the ingredients being reviewed in this report."

McEwen suggested that such a disclaimer would be useful to the committee to help focus discussion on issues related to "Category I conditions in a final monograph." In determining whether plaque products can make drug claims, McEwen said, "we are not taking away the product's ability to make [cosmetic] claims as long as they are truthful and not misleading." He suggested that "all the [disclaimer] is doing is saying -- 'this is not a drug claim' -- [and that] we are not going to go through and identify tests that have to be done so that you can determine -- 'Okay. What is oral malodor? How does it have to be tested?'"

Slots noted that oral malodor can come from either benign bacteria or could be an indication of a disease. In response, McEwen asserted: "You cannot sit on this subcommittee and determine that oral malodor itself is a disease or is a condition that falls under this monograph or any other because then you would be determining, for example, that chewing gum with retsyn ...is a drug."

While agreeing with McEwen that "oral malodor is not our mission," Slots added that he saw no "reason to limit" the committee with a disclaimer. "We do not know where the discussion can bring us. What is our gain of stating that we will limit ourselves?" Slots asked. Concurring with Slots, Stanley Saxe, DMD, University of Kentucky, added, "This [disclaimer] may be quite correct but at this early stage, to push aside an area and say we won't look at it -- I don't feel comfortable [with that]. We may want to revisit that area."

The subcommittee's mission on the second day of the two-day meeting was to discuss definitions related to plaque ("The Rose Sheet" Dec. 20, p. 5). "Plaques are organized, coherent, gel-like or mucoid masses consisting of microorganisms that adhere to the teeth, prosthesis and other oral surfaces," the committee's revised definition reads. The definition also includes several qualifiers, or "bullets," which detail, for example, plaque structure, bacterial composition and distinctions of location and composition.

During the revisions of the working definition of dental plaque, subcommittee members determined that "oral malodor" and "tooth stain" warrant treatment with distinct, separate definitions. The subcommittee originally planned to consider them within the definition of plaque.

With respect to dental plaque, subcommittee members disagreed on how significantly dental plaque contributes to oral malodor. Subcommittee Chair William Bowen, DSC, University of Rochester, suggested that there are "causes for malodor other than dental plaque. It merits a separate section. Obviously...it includes 'plaque bacteria' and 'plaque.'"

Subcommittee members also decided that it would be useful to deal with tooth staining as a separate issue. Max Listgarten, DDS, University of Pennsylvania, noted that tooth staining is "not an essential part of dental plaque." Deciding that both the tooth and plaque can be stained, Listgarten added that handling tooth staining separately would allow the group to "elaborate about what can be stained and where these stains come from."

Subcommittee members also decided that the "tactile sense of plaque in the early stages" does not belong within the definition of dental plaque. "There is no evidence that sensory perception of plaque is related to amount of plaque on teeth surfaces," Listgarten explained. He suggested that to "make that kind of determination, you have to run trials."

The group also decided that the definition of dental plaque should include a statement explaining that ephedrines may cause gingival enlargement, which is considered a risk factor for periodontitis. Bowen also requested that the dental plaque definition include the bullet: "Dental plaques are not readily removed by rinsing."

In addition, Bowen said the subcommittee also would discuss the public's perception of plaque reduction and "urged" industry to submit "structured research" on the topic. Emphasizing "structured," Bowen warned that a "collection of anecdotes" would "not be helpful." Both the Nonprescription Drug Manufacturers Association and the American Dental Association agreed to compile consumer prevention data for the subcommittee at its inaugural meeting in August ("The Rose Sheet" Aug. 9, p. 3).

In general, Bowen urged subcommittee members not to get caught up in the details of each definition, noting that definitions would be revisited at a later meeting. Several subcommittee members said they expected the definitions to be revised at least one more time before being submitted to the panel and, subsequently, to the Federal Register for comment.

Bowen also announced that the March 1994 meeting date would have to be rescheduled because of subcommittee member conflicts. Bowen announced that topics for the next meeting will include: toxicology, with the assistance of an FDA toxicologist, as it pertains to OTC products; plaque indices and plaque measurements; and, at FDA's request, the role of alcohol in mouthwash.