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Nicowater OTC Homeopathic Remedy Classification Illegal – GSK

This article was originally published in The Tan Sheet

Executive Summary

QT5's Nicowater nicotine beverage cannot legally be marketed as an over-the-counter homeopathic product because it contains "too great a concentration of nicotine," GSK asserts in a March 21 1citizen petition filed by Washington, D.C. law firm Ropes & Gray

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GSK on NicoWater

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)...

NicoWater washes westward

"Homeopathic nicotinum (nicotine) product designed to relieve the symptoms of tobacco cravings" will be sold throughout entire Rite Aid chain, Westlake Village, Calif.-based QT 5 announces Nov. 3. Chain is "first major retailer to bring our product to the entire West Coast market as well as many mid-western markets not previously served," firm says. NicoWater has been in distribution in northeast at Eckerd, Rite Aid and other stores since May. Product is marketed as homeopathic drug since objections from FDA quashed launch as dietary supplement (1"The Tan Sheet" March 17, 2003, In Brief). Nicorette gum marketer GlaxoSmithKline filed a citizen petition in March asserting water's potency falls outside legal potency for OTC homeopathics (2"The Tan Sheet" April 7, 2003, p. 7)...

FDA Tobacco Regulation Resurfaces As Senate HELP Considers Bill

The definition of FDA-regulated tobacco products in legislation under consideration by the Senate Health, Education, Labor & Pensions Committee excludes "conventional foods.

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