McNeil Nicotrol "labeling" comparative claims targeted in warning letter.
This article was originally published in The Tan Sheet
Executive Summary
NICOTROL "ALL PATCHES ARE EQUALLY EFFECTIVE" CLAIM "MISLEADING" without supporting comparative trials, FDA tells McNeil Consumer Products in a Dec. 11 warning letter. FDA notified McNeil that two trade promotions containing several statements comparing the Nicotrol smoking cessation patch to SmithKline Beecham's Nicoderm CQ are deceiving and "cause `Nicotrol' to be misbranded." The brochures have since been recalled, McNeil reports.