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Tobacco lozenge to test FDA's 'safer than smoking' guidelines

Smokeless products such as Ariva lozenges from Star Scientific and Marlboro Snus are touted as being healthier than smoking.

Associated Press

Smokeless products such as Ariva lozenges from Star Scientific and Marlboro Snus are touted as being healthier than smoking.

RICHMOND, Va. — Tobaccomaker Star Scientific hopes there's fire where there's no smoke.

The small Virginia company has made itself the test case for a big issue: whether the Food and Drug Administration will allow certain tobacco products — particularly the company's tobacco lozenges that dissolve in the user's mouth — to be marketed as less harmful than cigarettes.

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.

How the FDA handles the products is being closely watched by both the public health community and bigger tobacco companies, which are looking for new products to sell as they face declining cigarette demand due to tax increases, health concerns, smoking bans and social stigma.

A law enacted last year gives the FDA authority to evaluate tobacco products for their health risks and lets the agency approve ones that could be marketed as safer than what is currently for sale.

So far only Star Scientific has applied for approval to market what the agency calls "modified-risk" products. The company says 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 alternative — with 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," said Paul Perito, president of Star Scientific.

The company has sold varieties of the dissolvable tobacco under the Ariva and Stonewall brands since 2001. Its sales have grown about 47 percent since 2007, but it still remains a tiny player in the industry.

The tablets contain tobacco's most addictive component, nicotine. Star Scientific says 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.

A report from the Royal College of Physicians, a U.K. medical group, titled Harm Reduction in Nicotine Addiction — along with other scientific studies — suggests that when compared with cigarettes, some smokeless tobacco products are about 90 percent less harmful.

The question remains whether smokers, which total about 46 million in the United States, are really willing to switch, even if it means saving their lives.

Max Levin, 29, a longtime cigarette smoker from St. Louis, is skeptical.

"For me, the lighting of the cigarette is too convenient, and I wouldn't care to trade it just because I could do (smokeless tobacco) anywhere," Levin said. "When I do decide to quit, it's not like I'm going to quit cigarettes and switch over to another tobacco product."

Tobacco lozenge to test FDA's 'safer than smoking' guidelines 09/29/10 [Last modified: Wednesday, September 29, 2010 9:23pm]

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