Prevention mouthrinse safety to be re-reviewed by FDA plaque subcommittee.
This article was originally published in The Rose Sheet
Executive Summary
PREVENTION MOUTHRINSE SAFETY RE-REVIEW called for by FDA's Dental Plaque Subcommittee following a motion to table any recommendation regarding the safety and efficacy of the product at the group's meeting in Gaithersburg, Md. May 27. The subcommittee decided to re-review the safety of Prevention Mouthrinse after realizing it had not received results from a six-month clinical trial prior to its initial analysis, subcommittee member Max Listgarten, DDS, University of Pennsylvania, explained. Based on the study results available at the time, Listgarten concluded the data for the oral mouthwash were sufficient to substantiate safety designating the ingredient combination Category I (safe and/or effective) but insufficient to establish efficacy classifying it as a Category III (data insufficient to permit classification) combination.