Drug-maker asks FDA to stop RJR test-market sales
The battle lines are being drawn over the marketplace potential of smokeless tobacco products.
The consumer health-care division of GlaxoSmithKline (GSK) — one of the world’s largest pharmaceutical companies — fired a salvo last week across the bow of R.J. Reynolds Tobacco Co.
GSK, which sells nicotine-replacement therapy products Nicorette and NicoDerm, is requesting that the Food and Drug Administration take Reynolds’ dissolvable tobacco products out of test markets.
“Smokeless tobacco products are currently being marketed without clear evidence of their safety,” GSK said in a statement.
Those same products — Camel Orbs, Camel Sticks and Camel Strips — are being reviewed by the FDA’s Tobacco Products Scientific Advisory Committee.
The FDA acknowledges that Reynolds is marketing the products to adult consumers, but has concerns that the marketing and shape of the dissolvable products may be appealing to children and adolescents.
GSK’s request strikes at the core of Reynolds’ attempt to create a reputation as an innovator of products that could be less harmful to consumers than cigarettes. Reynolds recently bought a company, Niconovum, which specializes in smoking-cessation products.
It also is likely to stoke further debate between two sets of anti-smoking groups.
One set says smokeless tobacco serves as gateway products for teenagers to cigarettes. The other set encourages the products as a way to reduce the risk of tobacco use compared with cigarettes.
GSK said it agrees with a recent American Heart Association statement that smokeless tobacco products should not be used as an alternative to cigarettes or for smoking cessation because of “potential negative health consequences.”
Reynolds said that the flavored, finely milled tobacco products give adults a discreet option in venues where smoking is banned out of concern for secondhand smoke exposure.
“The best course of action for adult tobacco consumers concerned about their health is to quit,” Reynolds spokesman David Howard said.
“Camel dissolvables are tobacco products and are marketed as such. No tobacco product has been shown to be safe and without risks. Adult tobacco consumers have a right to be fully and accurately informed about the risks of serious diseases related to tobacco use. This information should be based on sound science.”
Star Scientific, another producer of smokeless products containing nicotine, has applied to the FDA to market its Ariva and Stonewell lozenges as “modified risk” to consumers. It could take the FDA as long as a year to make a decision.
“Why shouldn’t tobacco users ... have an opportunity to know this and make an informed decision?” said Paul Perito, the president of Star Scientific. “That’s why we took the risk, that’s why we spent the money.”
Bill Godshall, the executive director of SmokeFree Pennsylvania, said he was not surprised by GSK’s request since in 2002 it petitioned the FDA to remove Ariva and Stonewall from shelves.
GSK said it “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 nicotine-reduction products.”
However, Dr. Elizabeth Whelan, the president of the American Council on Science and Health, said that “GSK is clearly trying to protect its own market for dissolvable tobacco.”
“They figure that if they went through the FDA hurdles to get their product on the market, why should tobacco companies be able to launch a similar product without FDA approval?
“From a business perspective this is understandable. But from a purely public-health point of view, if products like the orbs can help more smokers quit more effectively than other cessation products, then let them stay on the market.”
Matt Myers, the president of the Campaign for Tobacco-Free Kids, said that the FDA can use scientific standards to assess health impacts. “If there are tobacco products out there that can be marketed in such a way that can significantly reduce the risk of disease, I don’t know of anybody who opposes that,” Myers said.
Scott Ballin, the past chairman of the Coalition on Smoking or Health, said that tobacco, pharmaceutical and biotechnology companies “should be given the necessary incentives to develop science based, lower-risk products that, as the Institute of Medicine has stated, have a reasonable prospect of reducing the risk of tobacco related disease.
Oct 11, 2010