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McNeil Nicotrol Inhaler

This article was originally published in The Tan Sheet

Executive Summary

Direct-to-consumer TV, print and Web site advertising for the Rx smoking cessation product is "false or misleading," FDA's Division of Drug Marketing, Advertising & Communications says in a March 19 letter to the company. The TV ad is "lacking in fair balance" because the risk information is not presented loudly enough and is obscured by the concurrent visual presentation, FDA says. The ad also "depicts the person casually inhaling on the unit," the agency states, whereas "using the inhaler requires a concerted effort to draw nicotine from the unit, and depicting it as easy to inhale is false or misleading." The print and Web ad instructions also are misleading, FDA says. By telling the consumer to "[s]imply hold the inhaler between your fingers and draw on it" the ad implies "one simply draws on the inhaler as one would a cigarette to obtain nicotine from the product," the agency notes. McNeil is to respond to the letter by April 3. The Nicotrol Inhaler is sold over-the- counter in Europe and is a switch candidate in the U.S.; FDA approved it for Rx sales in May 1997 ("The Tan Sheet" May 12, 1997, p. 10)...

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