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In Brief: Toothpaste bioavailability testing

This article was originally published in The Tan Sheet

Executive Summary

Toothpaste bioavailability testing: Tom's of Maine may use its intra-oral remineralization testing in humans to demonstrate bioavailability of the fluoride ion in Tom's original fluoride toothpaste but may not use the data to show effectiveness of Tom's other fluoride-containing dentifrices with different abrasive concentrations and combinations, FDA tells the firm Aug. 22. Tom's, which does not test its products on animals, was hoping to use the testing as an alternative to the animal tests required in the OTC anticaries monograph. The letter finalizes a preliminary ruling presented in a September 1996 letter ("The Tan Sheet" Oct. 28, 1996, p. 12). Tom's is currently working on providing the intra-oral tests for its Natural Baking Soda and children's flavor toothpastes...





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