Pharmaceutical giant GlaxoSmithKline, maker of the Nicorette nicotine lozenges, urged the FDA on Monday to treat dissolvable smokeless tobacco products made by tobacco companies the same way as pharmaceutical-made smoking cessation products — by keeping them off the market until they “demonstrate to [the] FDA that their marketing is appropriate for the protection of public health.” But tobacco companies, such as Reynolds American, Inc., maker of the tobacco lozenge Camel Orbs, argue that they do not market these products as quit-smoking devices, but rather “provide an option for adult tobacco consumers who have made an informed choice to use tobacco.”
“GSK is clearly trying to protect its own market for dissolvable tobacco, its Nicorette Lozenges product, with this attempt to get the FDA to bar competition from tobacco companies marketing similar nicotine-delivery products,” comments ACSH’s Dr. Elizabeth Whelan. “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.”
ACSH’s Dr. Gilbert Ross adds, “It’s unfortunate that in this day and age we have to agree with the tobacco company’s position and disagree with the pharmaceutical company, which is biased towards eliminating competition for their product. GSK hasn’t a legal leg to stand on in this instance, since no tobacco company can truthfully tell smokers that their dissolvable product is safer than smoking and more effective as a cessation aid than the currently approved NRT products — the new FDA tobacco law prevents that, so RJR and Star Scientific are in fact not in violation and their products should not be barred.”
For more insight into the prospect of FDA regulation of smokeless tobacco products, check out harm reduction advocates Karl Erik Lund, Lars Ramström, Joel Nitzkin and Brad Rodu’s comments in a recent Journal of the National Cancer Institute article.
