Safety of dissolvable tobacco products disputed

By Shari Roan, Los Angeles Times

July 21, 2011 12 AM PT

Tobacco company rep David Howard waxes enthusiastic when he talks about a new product his employer, R.J. Reynolds Tobacco Co., has developed: a pellet of finely cured tobacco, binders and flavoring that dissolves in the mouth in 10 minutes.

Under test market in two U.S. cities — Denver and Charlotte, N.C. — Camel Orbs will join two dissolvable tobacco lozenges already on the market if it graduates to broader distribution. And Howard is optimistic it will.

“These products provide smokers with an option to enjoy the pleasure of nicotine without bothering others,” Howard said. “No secondhand smoke. No spitting. No cigarette butt.”

Dissolvable tobacco consists of small pieces of compressed, finely ground tobacco powder, binders and flavorings that are shaped into pellets, sticks or strips. When placed in the mouth, they dissolve within minutes, providing a nicotine hit.

The tobacco industry says that the products contain far fewer cancer-causing chemicals such as tobacco-specific nitrosamines and are a “harm reduction” strategy that, like electronic cigarettes, might help people turn to less risky tobacco habits or eventually quit smoking.

But public health officials and anti-smoking advocates fear that the products will help initiate a new generation of smokers. The flavoring and packaging appeal to children, they argue, and teenagers will gravitate toward a product they can easily hide.

On Thursday, the Food and Drug Administration will take up the issue with an advisory committee hearing on the effect of dissolvable tobacco products on public health.

“Tobacco companies are always one step ahead of the sheriff,” said Sen. Sherrod Brown (D-Ohio), one of several senators who asked the FDA to review the products. “They have found ways to evade the rules and regulations and public health warnings.”

The first dissolvable tobacco product, a lozenge called Ariva, debuted in 2001. But in the last year the number of products on sale or in test marketing has jumped and major tobacco companies have entered the arena. Reynolds is market-testing two other products, Camel Strips and Camel Sticks, in addition to Camel Orbs. Philip Morris is test marketing a dissolvable tobacco stick.

At the same time, use of smokeless tobacco — snuff, chew, electronic cigarettes and, increasingly, dissolvable tobacco — is growing at a rate of about 7% per year, according to a 2010 report by Research and Markets, an international market research and data company.

In some states, use of smokeless tobacco products among men is almost as high as the national prevalence of cigarette smoking among adults, which stands at 20.8%, according to the Centers for Disease Control and Prevention. Across the U.S., 7% of U.S. adult males use smokeless tobacco, the CDC said.

Use among children is growing too. According to a 2010 survey by Monitoring the Future, an annual nationwide study funded by the National Institute on Drug Abuse, 8.5% of 12th-graders said they had used a smokeless tobacco product in the last 30 days compared with 6.7% in 2003.

“Because it has a mild taste, we’re concerned dissolvable tobacco will be a starter product for kids,” said Matthew Myers, president of the Washington-based anti-smoking group Campaign for Tobacco-Free Kids. “Traditionally, girls have not used smokeless tobacco products. But this product does not have a substantial smell or require spitting. There is a real concern that this product will appeal to adolescent girls, particularly those concerned about weight.”

Public health officials also have expressed concern about the effect on teeth and gums of holding the product in the mouth for 10 to 20 minutes and the effect on the stomach from swallowing the tobacco chemicals.

Few studies have been done specifically on the potential health risks of dissolvable tobacco.

One study, published in March in the Journal of Agricultural and Food Chemistry, tested four dissolvable tobacco products, three of which were being test-marketed, and found they contained mostly nicotine and a variety of flavorings, sweeteners and binders.

Some products contained coumarin, which has been banned as a flavoring agent in foods because of its link to liver damage, said study author John V. Goodpaster, an assistant professor in the forensic and investigative sciences program at Indiana University-Purdue University Indianapolis.

Studies on other smokeless tobacco products show they are considerably less risky than smoking cigarettes and cigars, which raises the risk of lung and a variety of other cancers, respiratory illness and heart disease. However, smokeless products still increase the risk of oral, pancreatic and esophageal cancer as well as heart disease. They can cause gum disease and can be unsafe for a fetus, health experts say.

The lowered risks of dissolvable products should be seen as a positive development, said Brad Rodu, a professor of medicine and chairman of tobacco harm reduction research at the University of Louisville in Kentucky.

“One cannot call any tobacco product absolutely safe,” said Rodu, who said he received funds from tobacco companies to do his research but had no personal ties to any company. “But the health risks of using smokeless tobacco products over the long term are so low that they are barely measurable by modern epidemiological evidence.”

Rodu added that smoking-cessation aids such as nicotine gum and the medication Chantix have limited success and that people who can’t quit should be urged to try safer products.

“We have 45 million smokers in the United States,” he said. “If we had almost any other activity in society that was this dangerous, we would welcome products that were safer.”

Sara Troy Machir, vice president of communications and investor relations at Star Scientific Inc., maker of Ariva and another dissolvable tobacco product called Stonewall, said the Glen Allen, Va.-based company is developing two new products, Ariva BDL and Stonewall BDL, with lower levels of tobacco-specific nitrosamines (BDL stands for “below detection limits”).

Machir said the company was founded with the mission of reducing harms associated with tobacco use and that “we have absolutely no interest in recruiting another generation of tobacco users.”

Star Scientific applied to the FDA last year for approval to market its two new products as “modified risk tobacco products.” To the chagrin of anti-smoking advocates, the FDA announced in March that the products were not subject to regulation under the 2009 Family Smoking Prevention and Tobacco Control Act, which gives the agency the authority to regulate tobacco products.

Twelve senators, including Brown, Jeff Merkley (D-Ore.) and Barbara A. Mikulski (D-Md.), have asked the FDA to reverse its decision.

In April, the FDA announced it was developing a strategy to regulate additional categories of tobacco products and that it would review information on dissolvable tobacco from published studies, manufacturers’ research and the advisory committee meeting this week. The agency is expected to eventually close any loopholes that might prevent dissolvable tobacco products from escaping its jurisdiction.

“It’s very clear dissolvable products are here to stay, and I believe the FDA will have to deal with them,” Rodu said.

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