FDA on triclosan
This article was originally published in The Rose Sheet
Executive Summary
Agency solicits safety and efficacy data on .3% triclosan as an antigingivitis ingredient in dental pastes and oral rinses in a notice slated to be published in the Federal Register July 6. FDA will review data to determine if ingredients can be generally recognized as safe and effective under the OTC oral health care drug products monograph. Comments will be accepted up to 90 days following publication of the notice. Triclosan review responds to a time and extent application filed by Ciba Specialty Chemicals last November. In the TEA, Ciba stated that 3.5 bil. units of dental paste containing triclosan have been used in 13 selected countries over the past six years (1"The Rose Sheet" Dec. 8, 2003, p. 5). Triclosan currently is marketed in the U.S. as an oral care ingredient through an NDA filed by Colgate-Palmolive...