FDA on anticaries testing
This article was originally published in The Tan Sheet
Executive Summary
Agency affirms use of the human intra-oral test as a substitute for the animal test required in the OTC anticaries monograph in a response to the "numerous" letters it has received on the subject. The letter from CDER Office of Drug Evaluation V Director Robert DeLap, MD/PhD, says the agency believes "the criticisms of the intra-oral test" aired by the dental research community "are not sufficient to conclude that the use of this test as an alternative to the animal caries reduction test is unacceptable." FDA "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 alternative method, and denied a citizen petition from dental experts opposing the test (1"The Tan Sheet" Oct. 4, 1999, p. 23)