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)
You may also be interested in...
FDA-Endorsed Use Of Non-Animal Toothpaste Test Reaffirmed By Agency
FDA's willingness to accept an intra-oral remineralization test for fluoride toothpaste as a substitute for a required animal test is reaffirmed by the agency in a recent letter to petitioners on the issue.
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands