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GlaxoSmithKline pushes FDA to withdraw dissolvable tobacco from market

October 13, 2010
by Press Release
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Durham, NC — GlaxoSmithKline (GSK) Consumer Healthcare, a leader in helping smokers quit and the marketer of nicotine replacement therapy (NRT) products, including Nicorette and NicoDerm CQ, supports the findings of the American Heart Association (AHA) policy statement regarding smokeless tobacco products.1 GSK Consumer Healthcare agrees that these products should not be used as an alternative to cigarettes or for smoking cessation due to the potential negative health consequences and their impact on smoking behavior.

The AHA statement is important because the U.S. Food and Drug Administration (FDA) has just finished accepting comments from the public on how FDA should regulate certain smokeless tobacco products. GSK Consumer Healthcare submitted a comment to the FDA on the potential public health impact of oral dissolvable tobacco products. In our submission, GSK Consumer Healthcare called for oral dissolvable tobacco products to be withdrawn from the market until their sponsors can demonstrate to FDA that their marketing is appropriate for the protection of public health.

The AHA policy statement, notes that smokeless tobacco products are not safe alternatives to smoking and are associated with heart attack, stroke and certain cancers.1 Also, due to the marketing of these products, smokeless tobacco products may also initiate further tobacco use and perpetuate smoking.1

Tobacco use, including smokeless tobacco, is the largest cause of preventable death and disease in the world.2 More than 400,000 Americans die every year from tobacco-related disease.2 The only proven way to reduce these health consequences is to stop using tobacco completely. Smokeless tobacco products are currently being marketed without clear evidence of their safety.

NRT products alternatively have helped millions of people around the world quit smoking and, as a result, have significantly reduced their exposure to the risks of cancer and other smoking-related diseases.3 GlaxoSmithKline Consumer Healthcare believes that before considering a potential role for oral dissolvable tobacco products in reducing the adverse health effects of smoking, there are significant opportunities to enhance the impact of existing smoking cessation aids, including expanding access to and use of NRT products. While the FDA is the final authority on the labeling of NRT products sold in the U.S., GSK Consumer Healthcare is committed to continuing to work with medical and clinical experts, and the FDA, to ensure that consumers have the best possible chance to quit smoking.

Quitting smoking is the single most important step smokers can take to improve their health—and it’s also one of the most difficult. By developing innovative new products and support systems to improve the quit experience, and helping to make the products as accessible as possible, GSK Consumer Healthcare works to inspire and enable every smoker to quit for good.

1. Piano, et al. Impact of Smokeless Tobacco Products on Cardiovascular Disease: Implications for Policy, Prevention, and Treatment. A Policy Statement From the American Heart Association. Circulation published online Sep 13, 2010. Available at
2. Centers for Disease Control and Prevention. Targeting Tobacco Use: The Nation’s Leading Cause of Preventable Death. Available at
3. GSK data on file.