PLAQUE CLAIMS ARE DRUG CLAIMS

PLAQUE CLAIMS ARE DRUG CLAIMS, FDA's OTC Plaque Subcommittee decided in a 4-2 vote Dec. 7. The recommendation voted on by the subcommittee states that in classifying OTC plaque products, "all references to the control of dental plaque, or its equivalents, with or without qualification, will be interpreted as a drug claim."

The subcommittee considered three options submitted in a prepared statement by subcommittee members Max Listgarten, DDS, University of Pennsylvania and Robert Genco, DDS/PhD, State University of New York School of Medicine-Buffalo: (1) that all references to the control of dental plaque (or its synonyms) be avoided in products that make only a cosmetic claim, and that products making a therapeutic claim, with or without a cosmetic claim, be allowed to include such references; (2) that a plaque claim can be qualified and be a cosmetic claim; and (3) that qualified plaque claims would be allowed with a disclaimer stating that the claim has no effect on the reduction of oral disease.

After FDA liaison Jeanne Rippere pointed out that the regulation of cosmetics is outside the subcommittee's jurisdiction, option one was rephrased to exclude references to cosmetic products and to include statements on the link between plaque and gingivitis. Genco proposed that the wording include a reference to the "causal relationship between dental plaque and gingivitis" and a statement that any plaque-reducing agent "is intended for use in prevention or treatment of gingivitis."

Pointing to the tentative final monograph on oral hygiene products, subcommittee member Stanley Saxe, DMD, University of Kentucky College of Dentistry, remarked that Genco's suggested wording captured the pathogenic potential of plaque as it appears in the monograph. "If all plaques have pathogenic potential [as stated in the monograph], then anything that fights, lessens, or reduces plaque is, in a sense, treating or preventing oral disease," Saxe stated.

The final wording was crafted by Listgarten, who suggested a "simpler statement" with no specific reference to gingivitis but which maintained "plaque control" as a drug claim.

"The word 'plaque,' or its equivalent, implies a therapeutic product," Listgarten said. "In many people's minds, when you see plaque you associate it with some therapeutic effect," he noted. However, he mentioned, "There is no therapeutic effect" in many products making plaque claims. Plaque reduction claims on these products may be statistically significant but the amount of plaque removed "is clinically irrelevant," Listgarten asserted. "So clearly a therapeutic claim" for this type of product "is inappropriate because it doesn't make any difference to the clinical situation."

Agreeing with Listgarten, Genco said that although it is possible that such products could remove a small amount of plaque "...with some beneficial cosmetic effect, there would be absolutely no effect on gingivitis because you haven't removed the critical part, which is at the gingival margin."

In addition to Listgarten, Genco and Saxe, subcommittee member Eugene Savitt, DMD, voted for option one, while Christine Wu-Yuan, DDS/PhD, University of Iowa College of Dentistry, and Jorgen Slots, DDS/PhD, University of Southern California, voted against it, recommending further consideration of the third alternative, which would allow qualifying statements in cosmetic claims with a disclaimer.

"I don't think it's scientifically sound to state that anything that can remove plaque is a drug claim," Slots said. He said he was unsure whether the subcommittee should "reject the possibility of using the word 'plaque'" when it "can have some benefit for some people."

Cosmetic, Toiletry and Fragrance Association VP-Science Gerald McEwen, PhD, a non-voting industry representative, also voiced opposition to the classification of plaque claims as drug claims, calling the motion "unduly restrictive on the industry" and unable "to be supported by the science or by the law." He suggested that options one and two could be combined, which would allow some cosmetic claims with references to plaque "when it is clear from the label and the labeling that the intent of the manufacturer is cosmetic, not therapeutic benefits."

Listgarten expressed concern that coupling plaque claims with cosmetic claims would lead consumers to associate cosmetic benefits with plaque reduction, when in fact the cosmetic effects "of the mouthwash have nothing to do with plaque reduction," he said. "To couple plaque reduction with a sentence that deals with freshening the mouth...is misleading because this is not why the product freshens the mouth," he maintained. "The public is going to think that somehow there is a therapeutic benefit to this."