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FDA on anticaries testing

This article was originally published in The Rose Sheet

Executive Summary

Agency affirms use of human intra-oral test as a substitute for the animal test required in the OTC anticaries monograph in a response to "numerous" letters it has received on the subject. In a letter posted on FDA's Web site, CDER Office of Drug Evaluation V Director Robert DeLap, MD, says while there is disagreement in the dental research community about the test, the agency "believes that the criticisms of the intra-oral test are not sufficient to conclude that the use of this test as an alternative to the animal caries reduction test is unacceptable." The agency "will continue to accept petitions to allow these substitute tests and will review them on a product-specific basis," DeLap notes. FDA has allowed Tom's of Maine, which markets its products as not tested on animals, to use the intra-oral method, and denied a citizen petition from dental experts opposing the test (1"The Rose Sheet" Oct. 4, 1999, p. 9)

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