Prevention mouthrinse safety will be re-reviewed by FDA advisory group.
This article was originally published in The Tan Sheet
Executive Summary
PREVENTION MOUTHRINSE SAFETY RE-REVIEW will come from FDA's Dental Plaque Subcommittee following a motion to table the review of the oral mouthrinse at the group's meeting in Gaithersburg, Md. May 27. The subcommittee had not received six-month clinical trial results prior to its premeeting analysis, subcommittee member Max Listgarten, DDS, University of Pennsylvania, said. Based on information available at the time, however, Listgarten concluded the data for Prevention Labs' Prevention mouthrinse were sufficient to substantiate safety for the ingredient combination (Category I), but insufficient to establish efficacy (Category III).
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