Dissolvable tobacco harmless finds FDA panel but promises detailed review

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An advisory panel to the Food and Drugs Administration (FDA) said Thursday that people who exclusively use dissolvable tobacco products have a greatly reduced risk of cancer and respiratory illness compared with those who regularly smoke cigarettes.

Some anti-smoking advocates, who have steadfastly supported smokeless tobacco products as the better alternative to cigarettes, hailed the acknowledgement by the Tobacco Products Scientific Advisory Committee as important for public health as the landmark 1964 Surgeon General's report on cigarette smoking. However some experts are cautious. They say more research is needed to determine whether dissolvable products can have an overall positive societal influence compared with cigarettes.

This is the latest FDA toward the goal of determining whether smokeless tobacco products can be marketed as less harmful, or reduced risk, compared with cigarettes. Tobacco manufacturers, particularly R.J. Reynolds Tobacco Co., are putting more emphasis on smokeless tobacco sales as consumer demand for cigarettes declines. Reynolds said Thursday in a statement, “Adult tobacco consumers have a right to be fully and accurately informed about the risks of serious diseases, the significant differences in the comparative risks of different tobacco and nicotine-based products, and the benefits of quitting.”

The committee's findings reported that dissolvable tobacco products “were neither well liked nor being widely used by themselves for smoking cessation.” Part of that lack of acceptance, the committee acknowledged, may come from “people having a perception of the risks of dissolvable tobacco products that is exaggerated.” Some anti-tobacco groups claim the risks are the same as smoking a cigarette.

Reynolds has said the flavored, finely milled tobacco products give adults a discreet option in venues where smoking is banned out of concern for secondhand smoke exposure. Reynolds' dissolvable products include Camel Sticks (stick of pulverized tobacco, with flavoring, similar in shape to a toothpick), Camel Strips (tobacco film strips that dissolve in the mouth) and Camel Orbs (similar in shape to Tic Tacs).

The committee said dissolvable products could provide a societal benefit in reducing disease from tobacco use by decreasing the number of smokers through either cessation or preventing the first use of cigarettes. It however cautioned that increased use of dissolvable products also could lead to more smokers by serving as a bridge to cigarettes and/or reducing societal concern about the potential health risks of tobacco products in general.

As a result, the committee said it could not provide a definitive recommendation “since experience is limited and observational evidence on how dissolvable tobacco products might affect use of tobacco products is lacking.”

The committee cited how the dissolvable products sold by Star Scientific Inc. have limited market penetration after 10 years. The company markets Ariva and Stonewall tobacco lozenges in wintergreen, coffee and tobacco flavors. Because of the limited scope of dissolvable products to date, the committee said that “the context set by all aspects of industry marketing and regulation will be critical in determining the impact of dissolvable tobacco products.”

Bill Godshall, executive director of SmokeFree Pennsylvania, said the FDA should respond to the committee's report by “proposing a regulation to remove the misleading and inaccurate warnings now required on dissolvables and other smokeless tobacco products and advertisements.” “There is no evidence that dissolvables cause mouth cancer, gum disease or tooth loss, and…they are far less hazardous alternatives to cigarettes,” he said.

John Spangler, a professor of family and community medicine at Wake Forest School of Medicine, said that although dissolvable tobacco products appear safer than cigarette smoking, “they are not devoid of cancer-causing chemicals.” “There are just lower levels of these chemicals,” Spangler said. “We do not know the public health impact of calling any tobacco product safer,” particularly with teens considering using tobacco products and smokers considering quitting cigarettes, he said.

The FDA said it plans to review the findings to decide any future actions, but there’s no timeline for it to act. The agency has previously raised concerns that dissolvable tobacco products contain a lot of nicotine and could be particularly appealing to kids and young adults. Tobacco use claimed six million lives in 2012, according to the latest edition of Tobacco Atlas, a joint project of the American Cancer Society and World Lung Foundation.

Dr. Ananya Mandal

Written by

Dr. Ananya Mandal

Dr. Ananya Mandal is a doctor by profession, lecturer by vocation and a medical writer by passion. She specialized in Clinical Pharmacology after her bachelor's (MBBS). For her, health communication is not just writing complicated reviews for professionals but making medical knowledge understandable and available to the general public as well.

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