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Executive Summary

FLUORIDE LEVEL INFORMATION IN TOOTHPASTE LABELING is the subject of a Nov. 24 FDA Federal Register notice, which reopens the administrative record for the OTC dental caries product monograph. Specifically, FDA is asking whether there is "consumer benefit in having OTC fluoride-containing drug products labeled to state their fluoride levels." If so, FDA would like comments on the "best way(s) to provide this information to consumers." FDA is seeking comments by Jan. 25, 1993. The agency said it "plans to discuss identification of fluoride levels" in labeling in the final monograph for OTC dental caries products. * The agency is considering a requirement that information on fluoride levels be included in toothpaste packaging in response to a February 1991 report from HHS' Ad Hoc Subcommittee on Fluoride that recommended that toothpaste manufacturers be "encouraged to make the fluoride levels in their products easily known" ("The Pink Sheet" Feb. 25, 1991, T&G-7). The subcommittee was convened in 1990 to look into a National Toxicology Program carcinogenicity study that found "equivocal" evidence of osteosarcoma in rats given fluoride over their lifetimes. However, the subcommittee's concern with fluoride toothpaste use focused solely on an increased risk of mild fluorosis. The report suggested that FDA "review the labeling required for toothpaste and other fluoride-containing products to ensure that the public has adequate knowledge to make informed decisions about their use, especially for young children." FDA sent letters to the American Dental Association, the Nonprescription Drug Manufacturers Association and the Cosmetic, Toiletry and Fragrance Association in April 1991 asking them for suggestions on providing fluoride information to consumers. The ADA suggested listing fluoride concentration expressed as percent weight to volume. The professional association suggested that such an approach would allow comparisons of fluoride levels between products with different fluoride compound concentrations. In addition, the association pointed out that toothpaste is dispensed by volume rather than weight and noted that a similar approach has been used by the agency with topical OTCs such as hydrocortisone. The method also is used in Europe, ADA said. NDMA and CTFA submitted a joint response to FDA in August 1991 objecting to the idea of identifying fluoride levels in toothpaste packaging. The associations asserted that "there should be no requirement for stating the precise quantity of fluoride on dentifrice products" because: (1) "this would not be actionable by consumers in view of the lack of scientifically credible evidence for any contribution of dentifrice use to enamel fluorosis; and (2) such labeling might unjustifiably raise concerns by consumers about use of fluoride-containing dentifrices, thereby leading to their decreased use and a resultant increase in the incidence of dental caries." FDA said it has "considered this concern about decreased use and is not presently aware of any data or information that providing this specific additional information in the labeling of dentifrice products would lead to a decreased use of these products." The notice asks for comments or data on "this issue." The agency indicated that it is considering other methods of measuring fluoride levels in toothpastes, including parts per million (ppm) and milligrams per inch (mg/in). FDA observed that fluoride concentrations are measured in ppm in drinking water and mg/in in oral vitamin/mineral products and oral fluoride tablets. In addition, FDA pointed out that consumers are already familiar with the use of mg in food labeling. However, the ADA suggested that the varying tube orifice sizes used for toothpaste brands would result in consumer confusion if mg/in were used as the measurement of fluoride content. FDA acknowledged that using percent weight of fluoride per unit volume, as recommended by the ADA, "has merit." However, the agency said it "believes that use of the terms ppm and/or mg might provide a more uniform approach to labeling of different types of products that contain fluoride."

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