Broader Implications of the Snus Decision

WASHINGTON D.C. -- One of the more surprising omissions from last months’ NATO Show was the fact that U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) director Mitch Zeller neglected to weigh in on the recent decision by a TPSAC (Tobacco Products Scientific Advisory Committee) panel to reject Swedish Match AB’s application to market their snus moist smokeless tobacco products as less harmful than cigarettes. 

 

It was the farthest any tobacco manufacturer has gotten in the modified risk tobacco product (MRTP) application process and many within the industry believed would set the standard for modified risk across the board.

 

“The tobacco industry is really looking very closely at how the FDA reviews and ultimately decides on this modified risk application to determine how they proceed,” David Bishop, managing partner of Barrington, Ill.-based sales and marketing firm Balvor LLC, told Tobacco E-News. “Swedish Match has put a considerable amount of time, effort and resources into this process that would support claims that (snus) lowers the harm to the user and the general population. If they can’t get a modified risk application approved, the thinking is, who can.”

 

Though the CTP has not officially rejected Swedish Match’s MRTP application—Zeller was quick to point out that committees like TPSAC “serve an advisory function: they are not the decision makers”—speculation has already begun on whether any product will ever garner modified risk status.

 

It’s important to note that, unlike electronic cigarettes, snus has years upon years of usage research to support its claims.

 

“Smokeless tobacco provides nicotine and is vastly safer than smoking,” Dr. Brad Rodu, a professor of medicine at the University of Louisville, said during his appearance at the NATO Show. “There’s evidence from Sweden and the U.S. that (smokeless) works and modern products are socially acceptable.”

 

According to Rodu, if snus was used as frequently across the entire European Union as it is in Sweden, there’s be 274,000 fewer smoking-related deaths per year. 

 

Not surprising, Rodu took the TPSAC news as the final nail in the coffin of the MRTP debate, describing it as “a punch in the gut.”

 

“If they can’t make that case for snus, there will never be any product that will be seen as a modified-risk tobacco product by that legislation,” he said. “It will be impossible.”

 

Jim Dillard, senior vice president of regulatory affairs for the Richmond, Va.-based Altria, said he certainly understands the skepticism surrounding modified risk in the wake of the Swedish Match decision—but added he’s ultimately an optimist on the subject.

 

“I believe with greater clarity and collaboration, working with the FDA to develop the science that’s necessary to support these applications, we will see MRTP applications approved by the FDA,” said Dillard at the NATO Show. 

 

There will, however, be multiple hurdles to the process for both the tobacco industry and the FDA. Specifically, Dillard cited the need for tobacco companies to develop truly modified-risk products that are embraced by adult tobacco consumers, the need for tobacco companies to provide the scientific proof necessary for MRTP approval and, perhaps most importantly, the need for the FDA to provide better clarity on what scientific evidence is needed to garner modified-risk status.

 

“There needs to be a process constructed by the FDA that is reasonable, clear and attainable,” he said.

 

Bishop was quick to point out that the CTP isn’t the only center within the FDA that could potentially allow tobacco products to establish themselves as less harmful than cigarettes: the Center for Drug Evaluation and Research is responsible for classifying and regulating smoking cessation devices.

 

“It’s speculative, but if we can’t get harm reduction because basically the CTP is saying ‘there’s no such thing as a tobacco product that can reduce harm,’ the only alternative for tobacco manufacturers is to go to another department of the FDA to get classification as a different product,” he said. "While it may not relate directly to snus, it could apply to products like electronic nicotine devices or products that are still under development."

 

It’s interesting to note that Zeller himself seemingly brought up this concept at the NATO Show, discussing the need for multiple FDA centers to define which nicotine-derived products should be regulated as tobacco and which should be regulated as therapeutic.