FDA Should Allow "Qualified" Plaque-Only Cosmetics Claims, WhiteHill Says

Plaque-only claims "qualified with cosmetic benefits" should be included in the eventual OTC monograph for antiplaque/antigingivitis drugs, WhiteHill Oral Technologies urges in recent comments to FDA. Examples of "qualified plaque claims" include "Reduces plaque for a cleaner mouth"; "Reduces plaque for cleaner teeth"; or "Reduces plaque associated with bad breath," WhiteHill says.

Those statements, the company maintains, "will not confuse the consumer into believing that reduction of plaque results in reduction of gingivitis or any other therapeutic benefit."

The Hazlet, N.J.-based Microdent oral preparation ingredient manufacturer submitted its comments in response to FDA's Dental Plaque Advisory Subcommittee draft report. The draft was made available for comment in November. Release of the final report is expected this spring.

WhiteHill's suggestions run counter to the recommendations proffered by the subcommittee. In its report, the panel proposes "any reference to the control of dental plaque or its equivalents, with or without qualifications, will be interpreted as a drug claim."

An OTC drug "making any reference to the reduction or prevention of dental plaque also must demonstrate a clinically significant effect on gingivitis," the subcommittee adds, concluding, "plaque and plaque-related claims should not stand alone."

WhiteHill's position is consistent with data it presented in support of Microdent's plaque-only claims at a May 1997 subcommittee meeting. The short-term studies focused on the ingredient's plaque reduction abilities and did not address gingivitis reduction or prevention ("The Rose Sheet" May 12, 1997, p. 19).

The company said it sought only a plaque reduction claim, but subcommittee Chair Robert Genco, PhD/DDS, SUNY-Buffalo, explained the panel's primary focus is gingivitis reduction. At the May meeting, Microdent was voted by the subcommittee to be Category I (safe and effective) for safety and Category III (insufficient data) for efficacy.

WhiteHill also challenges the subcommittee's determination that all plaque-related claims are therapeutic, which it says is an "incorrect" statement. Plaque-only statements are "structure and function" claims, the firm says, adding, "FDA should recognize this distinction."

The draft report, in its section on the regulatory status of antiplaque products, cites American Dental Association and American Academy of Periodontology positions that "the control of dental plaque is a therapeutic procedure basic to the prevention of caries and periodontal diseases, particularly the latter."

"The claim that a product significantly reduces dental plaque (statistically speaking) may easily mislead consumers into thinking that the reduction is therapeutically significant," the draft states. "Thus, the consumer may purchase a product with the mistaken notion that a therapeutic benefit may be derived from its use, instead of seeking effective care for potential signs and symptoms of disease."

WhiteHill argues, however, that products carrying plaque-related claims can be classified either under the therapeutic definition of a drug or the structure/ function definition. The firm cites two categories as examples - tobacco and antiperspirants - where the products "need not have any therapeutic endpoint, or benefit to consumer" to be classified as drugs.

In regulatory actions, FDA has decreed that both nicotine in cigarettes and antiperspirant products "affect the structure and function of the body" but provide no therapeutic effect, WhiteHill maintains. The "only effect" of antiperspirants is to "reduce perspiration (affect a function)," the company adds, "and their benefit to the consumer is entirely cosmetic."

Therefore, WhiteHill concludes, "plaque reduction is under the same 'structure and function' classification as the precedents cited above. Reducing plaque affects a function of the body, thus satisfying the statutory definition of a drug, but its benefit to the consumer can be entirely cosmetic."

The firm also suggests the subcommittee categorizes product forms too narrowly. The draft's definition - "traditional dosage forms" - refers to dentifrices, gels, pastes or rinses. WhiteHill maintains this definition "would limit future new product developments that could benefit the consuming public."

WhiteHill asks that the final report remove or expand the dosage form "to allow any dosage that complies with the safety and efficacy requirements for drugs as regulated" in the FD&C Act.