Under Review

Tobacco companies look to provide smoking alternatives as the FDA takes up the issue of dissolvables

Big changes have come to the tobacco industry since President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act on June 22, 2009. The Tobacco Control Act, as it is known, gives the Food and Drug Administration (FDA) the authority to regulate the manufacture, distribution and marketing of tobacco products to protect public health.

In the intervening two-plus years, several new rules and regulations governing the industry have come down the pike — many of which have taken aim at the cigarette segment. First, cigarette makers were prohibited from using certain terms such as “light,” “mild” or “low” in their labeling or advertising. So as a result, for example, Philip Morris USA's popular Marlboro Lights became Marlboro Gold.

Next up was the release of the FDA's Tobacco Products Scientific Advisory Committee's (TPSAC) Menthol Report that found the “removal of menthol cigarettes from the marketplace would benefit public health in the United States.” The finding is nonbinding and is currently under review by the FDA.

Three months later, in June of this year, the federal agency issued its final nine graphic health warnings that will be required to appear on every cigarette pack and ad by September 2012. The FDA explained that the graphic warnings — which include pictures of diseased lungs and rotted teeth — were necessary to make sure every American is aware of the dangers of smoking. “With these warnings, every person who picks up a pack of cigarettes will know exactly what risks they are taking,” Health and Human Services Secretary Kathleen Sebelius said in a White House briefing at the time.

But just because the headlines seem to be directed at cigarettes does not mean other tobacco products have escaped the attention of the FDA. Next up: dissolvable tobacco's turn in the spotlight.

At its late July sessions, TPSAC began its review of the nature and impact of the use of dissolvable tobacco products on the public's health — the first step in the committee's required report to the Secretary of Health and Human Services on the issue. The committee members are charged with taking several points into consideration for its final report, such as the risks and benefits to the population as a whole, including users and nonusers of tobacco products; the increased or decreased likelihood that existing users of tobacco products will stop using such products; and the increased or decreased likelihood that those who do not use tobacco products will start using such products.

Currently, there is no statutory definition of dissolvable tobacco products, David Ashley, director of the FDA's Center for Tobacco Products, explained at the July 21 meeting. However, he added, the center believes many dissolvable products on the market now would fall under the smokeless category. He expects TPSAC to hold three or four meetings to review dissolvable tobacco and the final report is due March 23, 2012.

As TPSAC embarks on its review, two major tobacco companies will be paying close attention.

R.J. Reynolds threw its hat into companies will paying close attention. Reynolds threw its hat into the dissolvable tobacco ring two years ago with the launch of Camel Sticks, Camel Strips and Camel Orbs. Initial testing of the products kicked off in Columbus, Ohio; Indianapolis; and Portland, Ore. The Richmond, Va.-based company started the second round of testing in Denver and Charlotte, N.C., earlier this year.

R.J. Reynolds entered the field at the request of adult tobacco consumers who said they were interested in tobacco products they could use in a variety of settings without affecting others. With smoking bans even reaching public parks and beaches, the move toward dissolvable may prove to be a smart one.

“As the tobacco industry is transforming, R.J. Reynolds is a leader in that transformation, and innovative products such as Camel Dissolvables are a perfect example,” said Richard Smith, a company spokesman. “We believe our dissolvable tobacco products are a good business proposition.”

Since hitting the initial lead markets in 2009, Camel Dissolvables have trended positively among adult consumers, he added. “We were very pleased with the feedback we received from adult tobacco consumers and retailers in those markets,” Smith said. “Incorporating those learnings and by [gaining] additional feedback and new perspectives on these products, we made Camel Dissolvables available in two new lead markets, Charlotte, N.C., and Denver, in March 2011.”

And while the company is happy with the sales of its Camel Sticks, Camel Strips and Camel Orbs, R.J. Reynolds is turning its focus to educating retailers and adult tobacco users about the products.

Currently, Camel Dissolvables are considered smokeless tobacco products and subject to regulation as such by the FDA, Smith explained, adding that, for example, the packaging features the appropriate warning labels for smokeless tobacco products. They are also taxed at the same rate as other smokeless tobacco products.

For the current review of dissolvable, R.J. Reynolds has submitted a presentation to the FDA providing information on Camel Dissolvables' background, development and marketing in two separate submissions in September 2010 and June 2011. “We believe government regulations should enhance the information available to adult tobacco consumers to enable them to make informed choices,” Smith said. “We believe this information should be based on sound science, and we look forward to full exploration of the subject with the Center for Tobacco Products.”

R.J. Reynolds also looks forward to working with the FDA and TPSAC, and building an open dialogue. “We believe in these products, and also in providing what adult tobacco consumers want — the opportunity to enjoy tobacco on their own terms,” he said. “These products offer a convenient alternative for adult tobacco consumers with no secondhand smoke, no spitting and no cigarette butt litter. There's a real opportunity here for a product that meets both adult tobacco consumer and societal expectations. Plus, the use of the Camel brand aligns well with its history of innovation.”

Star Scientific also has a vested interest in the FDA review. The company propelled dissolvable tobacco products onto the U.S. market with Ariva, the first low-TSNA (tobacco-specific nitrosamine) dissolvable tobacco product, in 2001. In the past 10 years, the Glen Allen, Va.-based company voluntarily got out of the cigarette business (in 2007) and concentrated all of its efforts on dissolvable. It has since added Stonewall, Ariva BDL and Stonewall BDL to its stable of products.

In its submission to the FDA in July, Star Scientific stated that “dissolvable tobacco technology has a great potential for reducing tobacco-related harm for the poor, the uneducated and those in the areas of the United States with cultural ties to smokeless tobacco” who will continue to use tobacco with no plans to quit. “Advances in cultivation, harvesting and curing of tobacco, and new manufacturing processes allow for the manufacture and sale of smokeless tobacco products, which have greatly reduced risk to the user relative to current smokes or smokeless tobacco products,” Paul L. Perito, chairman, president and COO, wrote in the submission.

Like R.J. Reynolds, Star Scientific is looking forward to working with the FDA during the review process. “Star Scientific strongly believes there should be and must be appropriate controls on dissolvable tobacco technology to avoid the development and sale of ‘gateway’ products, leading to tobacco addiction for the younger adult,” he added. “Star Scientific has implemented such controls in the case of its own products, and therefore knows they are both possible and effective.”