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Upcoming ruling on smokeless tobacco will offer window to government's view

November 25, 2015
by Gary A. Enos, Editor
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As the advocacy community awaits final action from the Food and Drug Administration (FDA) on how electronic cigarettes may be regulated, another nicotine-related topic that has received less national attention could surface soon and will say much about the federal government's perspective on health risks associated with nicotine-containing products.

The Swedish company Swedish Match in 2014 asked the FDA to consider labeling changes for its smokeless tobacco “snus” products that are available in the U.S. Among the changes would be removal of a product warning about mouth cancer risk, as well as replacement of language stating that smokeless tobacco products are not a safe alternative to cigarettes with a statement that they pose a substantially lower risk than cigarettes.

An FDA advisory panel in April recommended against the labeling changes, although most panelists at a public hearing appeared to agree that snus is less harmful than cigarettes for smokers who switch to the smokeless product. Snus is widely popular among men in Sweden, a country with substantially lower rates of lung cancer than other industrialized nations.

The FDA is expected to act soon on the snus proposal, which constitutes an unprecedented “modified risk tobacco product” application. While the FDA is not required to follow the recommendations of its advisory board, it would come as a surprise to many if it changed course and approved the labeling changes. If it did so, it would reverse a stance of numerous federal agencies that have long warned of dangers associated with smokeless tobacco—a stance that one leading researcher says is based on spreading misinformation.

“The agenda is to paint all smokeless tobacco products as high risk for mouth cancer,” says Brad Rodu, professor of medicine at the University of Louisville, who has published research stating that the most widely used smokeless tobacco products do not significantly increase mouth cancer risk. In a broader sense, “The federal government's position, illustrated by the National Cancer Institute's tobacco control program, is that the U.S. will be a tobacco-free society,” says Rodu.

With more alcohol and drug treatment programs seeking to address patients' concurrent tobacco use, the question of whether a tobacco harm reduction approach that Rodu espouses could be helpful becomes compelling. It is why the addiction treatment community is keenly interested in what the FDA ultimately will do about e-cigarettes, although Rodu again sees efforts to paint these newer delivery systems as equally dangerous to smoked tobacco.

“It is exactly the same playbook,” he says of the government's statements on e-cigarettes.

Research on smokeless tobacco

Rodu, a dentist and oral pathologist, chairs the Tobacco Harm Reduction Research effort at the University of Louisville's medical school; his research has been supported by makers of smokeless tobacco products, including Swedish Match. He says his decision to pursue industry support stemmed from past battles with federal authorities, during which he says he was accused of unethical practices. He says the overriding message he heard at that point was, “Don't bother to apply to the [National Institutes of Health] for money to research tobacco harm reduction.”

In 2006, Harm Reduction Journal published Rodu's review of research evidence around a variety of smokeless tobacco products. The article offers several recommendations from scientists under the auspices of the American Council on Science and Health, an association that numerous public advocacy groups and media outlets have criticized for being controlled by industry interests.

One of the review's recommendations at the time stated that the federally mandated warning “This product is not a safe alternative to cigarettes” should be replaced with “Smokeless tobacco has risks, but cigarette smoking is far more dangerous. Quitting tobacco entirely is ideal, but switching from cigarettes to smokeless tobacco can reduce greatly the health risks to smokers and those around them.”

What is not in dispute is that all tobacco products contain the highly addictive nicotine, and smokeless tobacco products include this warning. Where the disagreement lies is in whether nicotine-containing products such as smokeless tobacco (and now e-cigarettes) constitute a safer alternative to smoked tobacco for those unable to quit. Rodu's 2006 review of smokeless tobacco research stated that studies have not found a significant increased risk of oral cancer in users of moist snuff (such as snus) or loose-leaf chewing tobacco, while there is a higher risk of mouth cancer from powdered dry snuff (a product not widely used in the U.S.).

These findings have formed the basis for Swedish Match seeking the label changes from the FDA for snus products, including removal of the mouth cancer warning as well as a warning about gum disease and tooth loss. In addition, it wants labeling to state that its products carry a substantially lower risk than cigarettes.

The FDA's advisory panel in the spring said Swedish Match did not offer sufficient evidence that the Swedish experience with snus could be replicated in the U.S. Exactly half of the panel members did say that there was enough evidence of no significant risk of mouth cancer from snus. The FDA's final decision will help indicate whether it believes that different tobacco products come with different degrees of risk.