FDA Advisers Split on Claim That Snus is Lower-Risk

Alicia Ault

April 10, 2015

SILVER SPRING, MD — A US Food and Drug Administration (FDA) advisory committee could not reach consensus over whether a smokeless tobacco product poses less risk for harm than cigarettes and appeared skeptical that existing data were sufficient to support the claim.

The Tobacco Products Scientific Advisory Committee was asked by the FDA to weigh the scientific evidence submitted by Swedish Match, maker of snus. Snus is a powdered form of tobacco that comes in a pouch that the user places between the cheek and gum.

Swedish Match was seeking to have the 10 types of snus it sells in the United States designated as modified-risk tobacco products, which would mean removing warnings that it could cause gum disease and tooth loss or mouth cancer. The warning that smokeless tobacco is addictive would remain. The company also proposed replacing the warning that "This product is not a safe alternative to cigarettes" with the statement, "No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes."

When asked whether the evidence supported that alternative warning, four members of the Committee agreed, while four disagreed.

Panelist Gary A. Giovino, PhD, Professor and Chair department of community health and health behavior, State University of New York at Buffalo, agreed that "the health risks are a lot lower than the risks posed by cigarettes," especially for respiratory diseases. But, he added that he has concerns about snus' effects on pregnancy and the impact of nicotine on the brain.

Thomas E. Eissenberg, PhD, codirector of the Center for the Study of Tobacco Products, at Virginia Commonwealth University, Richmond, said that the evidence was insufficient. And he said that the company seemed to be focusing too narrowly on smoking-related diseases. "We are demanded to look at the wider range of health risks, and not just those attributable to cigarettes," said Dr Eissenberg.

The committee was asked whether the proposed warning would adequately communicate the potential risks. All eight panel members said it would not, in part because it glossed over some risks.

"I don't think this is a warning, it's an advisory," said Thomas E. Novotny, MD, MPH, professor in the division of epidemiology and biostatistics at San Diego State University in California. He said there should be specific warnings about specific risks — such as ones for pre-eclampsia and preterm birth.

"I think it's really incumbent on the company to be clear," agreed panel member Warren K. Bickel, PhD, director of the Addiction Recovery Research Center, Virginia Polytechnic Institute and State University, Roanoke, Virginia.

The panel also said that Swedish Match had not adequately tested whether consumers would understand the proposed warning.

The FDA asked whether the company's data from Swedish snus users provided relevant information on whether current American tobacco users would switch to snus, or if nonusers would initiate use if Swedish Match was able to claim reduced harm.

A majority of the committee said that the Swedish experience was not sufficient, in part because of sociocultural differences.

First to Be Evaluated for Modified Risk

This is the first time that the FDA has accepted a manufacturer's application seeking a modified-risk designation. Seven other applications were rejected or withdrawn.

In the law giving the FDA authority to regulate tobacco, "Congress set high standards for modified risk tobacco products," said Mitchell Zeller, JD, director of the FDA's Center for Tobacco Products, in his opening remarks.

Manufacturers have to demonstrate that the products will significantly reduce risks to individual users and benefit the population as a whole. The agency has to consider whether individual tobacco users might switch to the modified-risk product or become dual users, and the likelihood that nonusers would be tempted to start because of the product's perceived lower risk.

The FDA's decision on modified risk "is all about the product's promotion and presentation to the consumer," Zeller said.

Swedish Match said that snus presents less harm, citing what it calls "The Swedish Experience." Tobacco-related cancers have fallen in Sweden, while there is growing use of snus. In 2011, 18% of adult Swedish men used snus daily, compared with 10% who smoke. Three percent of women used snus, compared with 3% who smoke.

Snus is less popular in the United States. According to the company, its General Swedish snus brand accounts for 11% of American convenience store snus sales. The 60-million cans it sells annually in the US are dwarfed by the billion cans of smokeless tobacco sold, said a company spokeswoman.

Assessment of Risks

Swedish Match submitted close to 150,000 pages of documents supporting its application for a modified-risk designation.

There were 12 studies looking at gingivitis and tooth loss. Eleven were cross-sectional, which limited the ability to assess temporality, said FDA scientist Hannah R. Day, PhD. None looked at tooth loss as an outcome, and six were in adolescents or adults aged less than 25 years, making it difficult to assess gingivitis, she said.

The committee was also not convinced. "I'm not seeing evidence that would suggest these products are different" from other smokeless tobacco products, said Scott Tomar, DMD, MPH, DrPH, a nonvoting panel member from the University of Florida College of Dentistry, Gainesville.

He suggested that the warning on gum disease and tooth loss should not be removed for snus.

The company provided six studies looking at oral cancer risk. FDA scientist Cindy Chang, PhD, MPH, said that while there did not appear to be a strong consistent association, two studies observed positive associations. The agency "can't rule out the possibility of an association," she told the panel.

The committee, however, was split. Three voted there was sufficient evidence to say there was no risk, and three said there was not enough evidence to decide, while two abstained.

The FDA concluded that, when compared with smoking, snus is not likely to be associated with lung cancer, chronic obstructive pulmonary disease, or chronic respiratory disease. But it said that Swedish Match did not provide adequate data to support a lack of association with other diseases, including esophageal, stomach, and pancreatic cancers, coronary vascular disease, stroke, and all-cause mortality.

Company Not Deterred

In addition to concerns raised by the FDA and the panelists, several public speakers said that snus should not be granted the modified-risk designation.

Dennis Henigan, director of legal and policy analysis for the Campaign for Tobacco-Free Kids, said that "the application submitted by Swedish Match is seriously flawed." In particular, he said that the company had failed to show that users would not use both cigarettes and snus, or that young people would not initiate use.

Several tobacco companies also spoke and suggested that the warnings should be removed for all smokeless tobacco products. Reynolds American, Inc. petitioned the FDA in 2011 and again in 2013 to have the warnings removed.

But the FDA's Zeller said that the modified-risk order would only apply to the Swedish Match products.

After the meeting, Swedish Match Senior Vice President for Scientific Affairs Lars-Erik Rutqvist, MD, PhD, told Medscape Medical News that the company was pleased with many of the panel's comments. "I was happy that they seemed to accept that, yes, we have a product that has considerably lower risks," Dr Rutqvist said.

He said it was also clear that the committee was concerned about risk communication. "I'm sure there will be a discussion on this issue" with the FDA, Dr Rutqvist said.

The FDA said that it will make a decision by June 5. But Dr Rutqvist said the agency, which is required to respond to the company's application within 365 days of submission, has some wiggle room.

Swedish Match's application was not considered complete until August 25, 2014, so a decision could come as late as August this year, he said.


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