Swedish Match must not be allowed to Alter Warning Label on its Snus Smokeless Tobacco Products: FDA

An advisory panel to the US Food and Drug Administration said that Swedish Match must not be permitted to change the warning label on its snus smokeless tobacco products to claim they are less harmful compared to cigarettes.

The Stockholm-based company is looking for the FDA approval in order to remove warnings about mouth cancer, gum disease and tooth loss from its snus products and also to state that they offer a ‘substantially’ lower risk as compared to cigarettes.

For the first time, the FDA has asked the committee to consider enabling a tobacco product to carry a reduced harm claim. The FDA is not forced to follow the suggestions of its advisory panels but usually does so. Advocates of a risk-based regulatory approach to tobacco products are disappointed with the FDA’s suggestion.

“The committee appears to have set an absolute standard of safety that ignores decades of evidence showing that snus is vastly safer than cigarettes”, said Dr. Brad Rodu, a professor of medicine at the University of Louisville.

Snus has been used for decades in Sweden and presently is the most popular tobacco product of the country. Swedish smoking rates have dropped because of the primary diseases related to tobacco use, like lung cancer, chronic obstructive pulmonary disease and heart disease.

The majority panelists agreed that snus seems to be less harmful compared to cigarettes when used by smokers who switch. According to Kurt Ribisl, a panel member and professor at the University of North Carolina Gillings School of Global Public Health, for people who make use of tobacco products, there is a need to find a way to nudge them to the less toxic products.

According to committee members, Swedish Match has not provided sufficient proof to show Sweden's experience might be replicated in the US. The company has also not provided evidence that it had correctly tested its proposed warning to make sure consumers would understand or be able to interpret it.