GlaxoSmithKline said the FDA should take the products off the market until companies can demonstrate that selling them is appropriate for the protection of public health. "These [image-nocss] 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," it said in a news release.
An FDA scientific panel is tasked with evaluating how the use of dissolvable tobacco products may impact public health, including the health of children. GlaxoSmithKline's comments were submitted as part of an FDA request for public input.
The FDA sent letters in February to R.J. Reynolds Tobacco Co., maker of Camel cigarettes, and the Star Scientific Inc. voicing concern over the smokeless products, which are made from finely milled tobacco.
In June 2010, Winston-Salem, N.C.-based Reynolds American Inc. issued statement regarding Camel dissolvable tobacco products:
"Camel dissolvables are tobacco products, NOT mints or candy. These are tobacco products. Finely milled tobacco is the predominant ingredient. They are sold on the same store shelves as other tobacco products, behind the sales counter, requiring a clerk's assistance to access them. They carry the same health warnings as other smokeless tobacco products. They are taxed at the same rate as other smokeless tobacco products. Their sale is age-restricted, requiring proof of age before purchase. The packaging is child-resistant. The front label on all Camel dissolvables' packaging clearly identifies the contents as "dissolvable tobacco." Those who keep referring to these tobacco products as "candy" or "mints" are irresponsibly perpetuating false and misleading information. If a minor hears these products referred to as "candy," they may be more likely to try to get them. A better approach is to make sure everyone knows these are tobacco products, and like all tobacco products they carry risks and should only be used by adult tobacco consumers who have made the informed decision to use tobacco products." It added, "Camel dissolvables are marketed to adult tobacco users, not to children."
Click hereto read R.J. Reynolds' full statement.
Richmond, Va.-based Star Scientific Inc. has made itself the test case for whether the FDA will allow certain tobacco productsparticularly the company's tobacco lozenges that dissolve in the user's mouthto be marketed as less harmful than cigarettes, said AP.
The application to market the product as safer also highlights a philosophical debate over how best to control tobacco. One camp says there's no safe way to use tobacco and pushes for people to quit above all else. Others embrace the idea that lower-risk alternatives like smokeless tobacco or electronic cigarettes can improve public health, if they mean fewer people smoke, said the news agency.
How the FDA handles the products is being closely watched by both the public health community and bigger tobacco companies.
So far only Star Scientific has applied for approval to market what the agency calls "modified-risk" products. The company said the small, flavored tablets that dissolve in the user's mouth contain "below detectable levels" of certain cancer-causing chemicals found in tobacco and its smoke. It wants to sell them to smokers as "a useful alternativewith greatly reduced toxin levels."
"Why shouldn't tobacco users...have an opportunity to know this and make an informed decision? That's why we took the risk, that's why we spent the money," Paul Perito, president of Star Scientific, said in an interview with AP.
The company has sold varieties of the dissolvable tobacco under the Ariva and Stonewall brands since 2001.
The tablets contain tobacco's most addictive component, nicotine. Star Scientific said its method of tobacco cultivation and preparation creates tobacco leaves with low levels of some carcinogens.
While the FDA's Center for Tobacco Products has not yet ironed out its guidelines for approval of such products, draft guidelines suggest it could take nearly a year to review an application.
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