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GSK on NicoWater

This article was originally published in The Tan Sheet

Executive Summary

Nicorette and Nicoderm marketer "urges FDA to advise QT5 that it must immediately cease distribution and marketing" of its nicotine-containing beverage NicoWater as an OTC homeopathic product in recent comments. Claims in radio advertising and labeling that NicoWater "relieves the symptoms of tobacco cravings" render the product an unapproved new drug, the letter states. GSK also laments that FDA's failure to take action against the product has allowed QT5 to arrange for NicoWater to be sold through Rite Aid and Eckerd stores, and made it easier for consumers to purchase the product over the Internet. The comments follow a citizen petition objecting to the sale of NicoWater as an OTC homeopathic product, filed by the NRT marketer in March (1"The Tan Sheet" April 7, 2003, p. 7)...

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