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GlaxoSmithKline Consumer Healthcare Launches Suit To Stop Misleading Marketing Of Unproven Herbal Smoking Cessation Therapy


10/19/2005 5:12:40 PM

PITTSBURGH, Feb. 8 /PRNewswire/ -- GlaxoSmithKline (GSK) Consumer Healthcare filed suit today in Federal district court to seek an injunction against Nicodrops, Inc., the maker of Nicodrops, for false claims relating to the safety and efficacy of its so-called smoking cessation system. There is no proof that any herbal ingredient in Nicodrops, or the Nicodrops product itself, is a safe or effective therapy for smoking cessation, yet the company is making safety and efficacy claims.(1) Nicodrops and any other products making health claims as a drug should be subject to the same, rigorous FDA review process as GSK Consumer Healthcare's nicotine replacement therapies, which are proven to help smokers quit.

GSK Consumer Healthcare has a long history in developing innovative smoking cessation products, and currently sells the broadest range of non- prescription FDA-approved methods, including NicoDerm CQ(R) patch, Nicorette(R) gum, and Commit(R) lozenge. "Quitting smoking is one of the most important steps smokers can take to improve their health, but it's very hard to do," said George Quesnelle, President, GSK Consumer Healthcare, North America. "GlaxoSmithKline Consumer Healthcare is in this business to help people quit smoking, and we've invested decades of work and considerable financial resources to ensure that our products are safe and are proven to work. Smoking is the number one preventable cause of disease and death in this country. When people are misled into using snake oil instead of products that are proven to work, they waste a critical opportunity to quit smoking and potentially save their own lives."

The complaint addresses specific and false information about GSK Consumer Healthcare's products published by Nicodrops, and seeks immediate retraction. "Unproven products making unsubstantiated claims of superiority over FDA- approved smoking cessation therapies puts smokers at risk," said Quesnelle. "We simply want Nicodrops to stop making false claims about their products and ours, and to withdraw their products from the marketplace until they can market them truthfully."

To date, GSK Consumer Healthcare's stop-smoking products have helped more than 2 million Americans stop smoking by providing lower, safe doses of nicotine to ease withdrawal from cigarettes. GSK Consumer Healthcare's nicotine replacement therapy (NRT) products are clinically proven to help smokers safely manage the symptoms of nicotine dependence and withdrawal so they can quit successfully.(2) NRT helps smokers quit without exposing them to the more than 4,000 chemicals and at least 69 known or suspected carcinogens found in tobacco smoke.(3) Smokers can choose which medicinal nicotine product to use based upon their preferences and individual smoking habits, including how much they smoke. Further, smokers can choose a GSK Consumer Healthcare medication confident in the knowledge that these products have been tested in over 100 controlled clinical trials involving over 35,000 participants and found to be safe and effective in helping smokers quit.(4)

About GlaxoSmithKline Consumer Healthcare

GlaxoSmithKline Consumer Healthcare is one of the world's largest over- the-counter healthcare products companies. Its more than 30 well-known brands include the leading smoking cessation products, Nicorette and NicoDerm and Commit, as well as many medicine cabinet staples, Abreva(R), Aquafresh(R), Sensodyne(R) and Tums(R). GSK Consumer Healthcare continues to develop innovative products to help all smokers find their best support system and achieve their goal of being cigarette free.

About GlaxoSmithKline

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and consumer healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

(1) Public Health Service Guidelines, 2000. Fiore MC, Bailey WC, Cohen SJ, et al. "Treating Tobacco Use and Dependence." Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. June 2000. (2) Public Health Service Guidelines, 2000. Fiore MC, Bailey WC, Cohen SJ, et al. "Treating Tobacco Use and Dependence." Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. June 2000. (3) http://ntp.niehs.nih.gov/ntp/roc/toc11.html , Report on Carcinogens, Eleventh Edition; U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program. (4) http://www.cochrane.org/cochrane/revabstr/ab000146.htm

GlaxoSmithKline Consumer Healthcare

CONTACT: Malesia Dunn of GlaxoSmithKline Consumer Healthcare,+1-412-200-3544, or malesia.a.dunn@gsk.com


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