Fire where there’s no smoke? Virginia company test case for FDA’s review of lower-risk tobacco

By Michael Felberbaum, AP
Tuesday, September 28, 2010

Firm makes itself test case for lower-risk tobacco

RICHMOND, Va. — Tobacco maker Star Scientific Inc. 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’s 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,” Paul Perito, president of Star Scientific, said in an interview with The Associated Press.

The company, formerly known as Star Tobacco and Pharmaceuticals, 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.

Tobacco companies want to market more smokeless tobacco and other cigarette alternatives to make up for falling cigarette sales. Some have introduced snus — small pouches like tea bags that users stick between the cheek and gum — and dissolving tobacco — finely milled tobacco shaped into orbs, sticks and strips. But they can’t explicitly market them as less risky than cigarettes.

But 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.

Meanwhile, GlaxoSmithKline, which makes nicotine replacement therapy products like Nicorette gum and NicoDerm patch, has urged the FDA to take dissolvable tobacco off the market until companies can demonstrate that selling them is appropriate for the protection of public health.

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

Max Levin, a 29-year-old 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,” said Levin, who has tried snus a few times. “When I do decide to quit, it’s not like I’m going to quit cigarettes and switch over to another tobacco product.”

The powerful combination of addiction and the rituals of smoking are difficult to overcome, said Richard Brown, a Brown University professor whose research focuses on smoking behavior and nicotine addiction

“It’s a poor substitute. They know it won’t do the same thing,” he said.

But tobacco company research shows that many smokers transition to smokeless products in about a year and a half once they begin to notice the benefits of going smoke-free, said David Sweanor, a Canadian law professor and tobacco expert who consults with companies and others on industry issues.

“People can change what they do when they have sufficient motivation,” Sweanor said.

Several studies say that pushing alternatives such as smokeless products with lower levels of carcinogens could reduce the number of smokers by between 1 and 3 percent over five years.

Matthew Myers, president of the Campaign for Tobacco-Free Kids, said the FDA can now keep tobacco companies accountable for health claims and marketing, but also 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.

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