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Executive Summary

DENTIFRICE MFP/NaF COMBO IN THREE-TO-ONE RATIO should be included in the OTC Anticaries Final Monograph as the optimal ratio for a combination of the ingredients, Intradal Nederland B.V. maintained in comments to FDA. The comments were submitted by Intradal counsel Robert Pinco (D.C. firm Finley, Kumble, Wagner) on April 7. The firm maintained that "the effectiveness of widely available dentifrices is materially enhanced by the effect of the unintended mixture of NaF [sodium fluoride] and MFP [sodium monofluorophosphate]." The company said that such available dentifrices "are unintentional combination products, and for that reason, they are not combined in the optimal ratio (75% fluoride from NaF and 25% fluoride from MFP)." Intradal stated that "the effectiveness of widely available dentifrices is materially enhanced by the effect of the unintended mixture of NaF and MFP." The firm maintained that the effect of the combo "increases with age because MFP is continuously converted to NaF (as much as about 50% of the original MFP can be lost)." In addition, Intradal said, "although the amount of free fluoride in an aging, MFP dentifrice stays the same, or actually decreases, the bioavailability of the fluoride increases because the combination of NaF and MFP is more effective than either alone." FDA's OTC Anticaries Tentative Final Monograph, published in September, includes sodium fluoride 0.2% rinse and sodium monofluorophosphate dentifrice 0.76% among nine Category I anticaries ingredients ("The Pink Sheet" Oct. 7, T&G-8). The agency also recognized the additive effects of fluoride products, stating that labeling of OTC anticaries drug products could note that the combined use of fluoride rinses and gels with a fluoride toothpaste "can aid in reducing the incidence of dental cavities." Intradal said "it is necessary for the FDA to include recent information in the OTC monograph so that dentifrice mfrs. can officially control the ratio of these two fluoride agents [NaF and MFP] in their formulations to assure that consumers will gain the optimal advantage." Intradal asserted that "the administrative record must be amended because a mixture of MFP that is now known to contain more than 50% NaF can no longer be regarded as if hydrolyzed fluoride were a minor constituent. Indeed, the hydrolyzed fluoride is the major species in the oral environment that is in contact with the tooth surface." Intradal submitted results of a three-year clinical study of its combination fluoride dentifrice, Prodent, in which 560 ten-year-old children completed two years of study and 543 completed three years. Intradal said the study was "designed to confirm the enhanced caries preventive effect of a toothpaste containing an MFP/NaF combination 1,420 ppm with a comparable control toothpaste containing only sodium MFP." The firm reported that "the advantage of the combination fluoride compared to the control was highly significant for all test periods and lesion types" (enamel caries; enamel/dentin caries; and dentin caries). In addition, Intradal stated that the "caries reversal effect of Prodent was quite dramatic when compared to the MFP control." Intradal noted that the largest tube of Prodent, 75 ml, contains about 110 mg of fluoride, which is less than half of the maximum fluoride concentration of 260 mg approved by FDA.

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