Glaxo urges dissolvable tobacco removal
This article was originally published in The Tan Sheet
Executive Summary
The maker of nicotine replacement therapies including Nicorette gum and NicoDerm CQ patches urges FDA to order dissolvable tobacco products from the market until manufacturers prove they benefit public health. In a Sept. 17 comment on FDA's request for information on smokeless tobacco, Caroline Tillett, GlaxoSmithKline's head of smoking control research and development, notes the products are "marketed not as substitutes but to be used in addition to cigarettes." The letter says the American Heart Association rejects smokeless tobacco as a smoking-cessation treatment (1"The Tan Sheet" Sept. 20, 2010, In Brief). Strips and lozenges of smokeless tobacco are spitless, unlike earlier formulations, which manufacturers promote as an advantage. GSK says the products could attract consumers to begin tobacco use or promote smokers' use of both products. Although switching from cigarettes to smokeless tobacco may pose a health benefit, "there are not sufficient data to warrant recommending switching to a smokeless tobacco product as a means of reducing the risks associated with" smoking, the firm says. An FDA workshop Oct. 26-27 will study changing NRT labeling beyond the current 12-week indication, which GSK previously asked FDA to consider (2"The Tan Sheet" Sept. 6, 2010)