Swedish Match AB should not be allowed to alter the warning label on its snus smokeless tobacco products to claim they are less harmful than cigarettes, an advisory panel to the U.S. Food and Drug Administration concluded on Friday.
The Stockholm-based company is seeking FDA approval to remove warnings about mouth cancer, gum disease and tooth loss from its snus products and to state that they present a "substantially" lower risk than cigarettes.
It was the first time the committee had been asked by the FDA to consider allowing a tobacco product to carry a reduced harm claim. The FDA is not obliged to follow the recommendations of its advisory panels but typically does so.
Advocates of a risk-based regulatory approach to tobacco products were disappointed.
"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 is a moist tobacco product placed underneath the upper lip that does not involve spitting or chewing. It has been used for decades in Sweden and is now the country's most popular tobacco product. Swedish smoking rates have plummeted, as have the primary tobacco-related diseases: lung cancer, chronic obstructive pulmonary disease and heart disease.
Most panelists agreed that snus appears less harmful than cigarettes when used by smokers who switch.
Kurt Ribisl, a panel member and professor at the University of North Carolina Gillings School of Global Public Health, said for people using tobacco products, "we need to find a way to nudge them to the less toxic products."
Still, committee members said Swedish Match did not provide enough evidence to show Sweden's experience could be replicated in the United States, or that the company had properly tested its proposed warning to ensure consumers would understand or be able to interpret it.
They also said the company had not provided enough information to rule out an association between snus and tooth loss or gum disease, although four of eight panelists found enough evidence to rule out a meaningful link to mouth cancer.
Tobacco control advocates welcomed the vote, saying the company's proposal did not reflect the full range of associated risks, including a potential increased risk of pancreatic cancer and risks to pregnant women.
Matthew Myers, president of the Campaign for Tobacco-Free Kids, said "a properly prepared application could well have received a different result." He said he would like to have seen the company separate its request for a warning label change from its request to make a modified risk claim.
Dr. Lars Erik Rutqvist, senior vice president of Scientific Affairs at Swedish Match, said some of the panel's concerns about the lack of specificity in the proposed message to consumers were "reasonable." But on balance, he said, he would not have done anything differently.
Myers said the company's application will provide a roadmap for others. "My hope is that everybody will learn from it," he said.