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DENTIFRICE FLUORIDE LIMIT OF 1,500 PPM BEING CONSIDERED BY FDA

This article was originally published in The Tan Sheet

Executive Summary

DENTIFRICE FLUORIDE LIMIT OF 1,500 PPM BEING CONSIDERED BY FDA for inclusion in the final monograph for OTC anticaries drug products, the agency told Chese-Pond's in a Sept. 2 letter. "After reviewing the data and additional information submitted by Chesebrough-Pond's in support of general recognition of the safety and effectiveness of its extra-strength fluoride dentifrice (1,500 ppm), we are considering including this type of dentifrice product in the monograph," the letter from OTC Monograph Review Staff Director William Gilbertson says. The OTC anticaries final monograph is due out in "four to six months," Gilbertson pointed out. He indicated that the monograph is almost ready to leave the OTC division to begin the clearance process in the agency's upper ranks. Chese-Pond's requested that the monograph be reopened to include the higher fluoride content in a Feb. 13, 1989 letter to FDA. The company also submitted two clinical studies demonstrating the safety and efficacy of such a formula. The data had been used by Chese-Pond's to gain NDA approval in 1986 for its Extra Strength Aim with 1,500 ppm sodium monofluorophosphate. The tentative final monograph on OTC anticaries drug products proposed a total fluorine range of 850 to 1,150 ppm. While the agency noted in the TFM that it had previously agreed that the 1,500 ppm level was safe, studies demonstrating efficacy at that level were not in the public domain since they had been submitted under the Chese-Pond's NDA. Colgate-Palmolive has requested that the TFM be amended to allow fluoride concentrations up to 1,650 ppm. In the letter, FDA asked Chese-Pond's to "be the provider of the U.S. Pharmacopeial 1,500 ppm fluoride dentifrice reference standard formulation if such a formulation were included in the final monograph." If the agency includes the fluoride concentration level in the final monograph, a USP reference standard "would need to be established for distribution by the USP Convention," the letter notes. FDA also is "considering" including a sodium fluoride/sodium bicarbonate powdered dentifrice formula in the final monograph, Gilbertson told Church & Dwight in a separate Sept. 2 letter. "After reviewing the data and additional information submitted by Church & Dwight in support of general recognition of the safety and effectiveness of its powdered fluoride dentifrice, we are considering including this type of dentifrice product in the final monograph," Gilbertson said. He asked the company to be the provider to the USP of the dentifrice reference standard for such a formula. Church & Dwight has marketed its Arm & Hammer Dental Care sodium fluoride/sodium bicarbonate tooth powder nationally since 1989. "As the responsible supplier of the reference standard, Church & Dwight Company would be expected to provide [USP] with stability profile data and a recommended storage temperature for the established reference standard," the agency said. Stability profile data would include information on theoretical total fluorine, available fluoride ion, pH, and specific gravity. Such data would be made available to other manufacturers from USP upon request, based on an agreement reached between FDA and industry representatives at a May 20 meeting ("The Tan Sheet" May 24, In Brief). The Cosmetic, Toiletry and Fragrance Association is preparing a submission to FDA regarding industry's agreement on appropriate labeling for dentifrice reference standards. Although the document is still being developed, the labeling elements currently include: fluoride dentifrice reference standard identification; active- abrasive system identification; a new reference standard storage temperature of 20 degrees F (-6 degrees C to -7 degrees C); the manufacturers lot number and a net content statement. Procter & Gamble reviewed the progress of the labeling standards in an Aug. 30 letter to the agency. FDA also has asked CTFA to supply information on an existing dentifrice reference standard that is expected to be either changed or discontinued. In a Sept. 9 letter to the association, Gilbertson noted that CTFA had indicated at the May 20 meeting that "inactive ingredients in two of the currently available USP dentifrice reference standards are no longer available and thus, the manufacturers will not be able to prepare another batch as initially formulated." Gilbertson said that the agency is aware of only one reference standard, sodium fluoride/calcium pyrophosphate, that will no longer be available, adding: "In order to complete the final monograph for OTC anticaries drug products, we need to know the other dentifrice reference standard that also will no longer be available. As you know, only those dentifrice products that have established USP dentifrice reference standards will be included in the final monograph." Gilbertson also said that "our office needs to know specifically whether there are plans to modify and replace the standards (and how this will be done) or to permanently discontinue their availability."
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