Sept. 30 comments from Chese-Pond's on the dentifrice tentative final monograph (TFM), published in June, support FDA proposal to require new drug approvals for products with more than 1,150 parts per million (ppm) fluoride. Firm says safety is not an issue with higher concentrations, but "the lack of non-proprietary efficacy data precludes the marketing of such a product under the monograph." Chese-Pond's Extra Strength Aim, approved via an NDA in August 1986, contains 1.2% sodium monofuorophospate at 1,500 ppm level.
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