Executive Summary

OTC ANTICARIES RINSE LABEL STATEMENT "NOT A MOUTHWASH" should not be required on anticavity or fluoride treatment rinses, the Proprietary Association (P-A) maintained in Dec. 30 comments to FDA on the Anticaries Tentative Final Monograph. Noting that the TFM requires "treatment rinses" to carry the statement "This is a]n[ 'anticavity' and/or 'fluoride' treatment rinse, not a mouthwash," P-A requested that the "'not a mouthwash' . . . language be deleted from" the proposed regulation on the grounds that treatment rinses might also be mouthwashes, i.e., breath fresheners. P-A argued that "a mouthwash that delivers an anticavity fluoride ingredient to the teeth may be identified and represented both to freshen breath . . . and to prevent cavities." The association maintained that "it is illogical and contrary to . . . long-established legal principles for a dental rinse truthfully represented to prevent cativies -- drug claims -- and also truthfully represented to freshen breath or relieve oral malodor -- cosmetic claims -- to be required to state in labeling that the product is 'not a mouthwash' when in fact it is." The requested "not a mouthwash" labeling deletion is part of P-A's broader argument that OTC products should be allowed to make cosmetic as well as drug claims. "As long as the labeling is truthful and not misleading, statements combining drug and cosmetic claims and properties of a product should be allowed to appear anywhere on the product's label, and FDA has no legal authority to prevent such integrated drug/cosmetic labeling representations," the association asserted. Addressing the same issue, Warner-Lambert, in Dec. 19 comments to FDA, said the required labeling statement "is not consistent with ]the agency's[ well established position regarding OTC drug products which claim both a therapeutic and cosmetic benefit." As an example, the firm cited the antiperspirant TFM (published in the Aug. 20, 1982 Federal Register) which "does not prohibit the labeling of an antiperspirant drug product from making cosmetic claims" for deodorant activity. Products which are "promoted for both antiperspirant and deodorant properties are no different from oral health product claiming anticavity and breath freshening properties," Warner-Lambert said. The proposed regulation also requires that concentrated treatment rinse products contain the statement: "Warning: Do not use before mixing with water. Read the directions carefully." Noting this, P-A commented that "this information should be listed under directions for use, rather than included as a 'warning' since it concerns proper use of a product, rather than cautioning to prevent possible dangers of misuse." P-A also objected to the term "treatment" as the only recommended identifier in the TFM for anticavity OTCs. Asserting that "other equally truthful and non-misleading identifiers are also appropriate for many kinds of marketed dental care products," the association recommended "that 'treatment' be retained . . . as an optional statement of identity for gels, rinses, concentrated rinses, rinse powders or rinse effervescent tablets." P-A urged "that 'dental' also be listed as an optional term," as in the term "dental treatment gel."