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In Brief: Tom's of Maine

This article was originally published in The Tan Sheet

Executive Summary

Tom's of Maine: Petitions FDA on Sept. 11 to stay the Oct. 7 effective date of the animal caries testing requirement in the anticaries monograph with regard to its Tom's Natural fluoride toothpastes until the agency comes to a decision on whether the firm can substitute a non-animal test for the required animal test. Tom's products highlight the lack of animal testing. Under the anticaries monograph, FDA can accept alternative testing methods if they are shown to provide equivalent accuracy to the specified animal test. In August, Tom's argued in a letter to the agency that its proposed test provides "ample" evidence to prove fluoride bioavailability ("The Tan Sheet" Sept. 23, p. 18)...

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