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Executive Summary

CHESE-POND's SEEKING RISE IN FLUORIDE LIMIT TO 1,500 PPM, up from the 850 to 1,150 parts per million currently proposed by FDA in the anticaries OTC tentative final monograph (TFM) issued June 15, 1988. In a Feb. 13 letter to FDA, the company asked that "the monograph be modified by extending the upper limit of acceptable values of fluoride in a dentifrice to 1,500 ppm." Chese-Pond's owns a new drug approval for Extra Strength Aim with sodium monofluorophosphate at a 1,500 ppm level. The firm is presenting FDA with "two adequate and well controlled studies which formed the basis for the FDA approval of Extra Strength Aim" for inclusion into the public record. The agency had previously agreed that the 1,500 ppm level was safe, but studies demonstrating the efficacy at that level were not in the public domain. Chese-Pond's request to raise the limit follows a Spet. 30 letter in which the firm said it agreed with the agency's decision not to increase the fluoride concentration to 1,500 ppm. The company's most recent request would allow Chese-Pond's to introduce additional products without applying for an NDA. FDA agreed to the Cosmetic, Toiletry and Fragrance Association's request to extend the comment period on the TFM to March 13, according to a Feb. 21 Federal Register notice. The agency is reopening the record to allow CTFA to submit comments regarding "appropriate testing requirements for dentifrices with fluoride/abrasive systems that have not been clinically tested or that contain an ingredient that inhibits calculus ]tar-tar[ formation," the notice stated. CTFA's request was in response to comments filed Oct. 13 by the American Dental Association (ADA) suggesting that the TFM be amended to exclude untested fluoride/abrasive systems because "abrasives can play a very critical role in the rate of release/availability of the active agent."

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