During his appearance at the 2015 NATO Show, Mitch Zeller talked a big game on the prospect of potentially reduced-harm options such as electronic cigarettes and snus.
“Future regulations should take into consideration a product’s place on the continuum of risk,” Zeller, director of the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP), said during his NATO Show panel.
However, one of the more glaring omissions from his presentation was any commentary on the Tobacco Products Scientific Advisory Committee (TPSAC) ruling April 11, 2015, against Swedish Match AB’s application to market its General Snus brand as less harmful than cigarettes.
This is the furthest any tobacco manufacturer has gotten in the modified-risk tobacco product (MRTP) application process.
Given the mountains of data Swedish Match brought forth to support its claim that snus is less harmful than cigarettes, the TPSAC ruling against it came as a devastating blow for harm-reduction advocates such as Brad Rodu, a professor of medicine at the University of Louisville who has spent his career studying the effects of smokeless tobacco. “Smokeless tobacco has risks so low that they can’t be measured with any precision,” says Rodu. “This opportunity is being squandered. It’s very frustrating.”
Many within the industry believe Stockholm-based Swedish Match could set the standard for modified-risk applications. If the FDA follows TPSAC’s recommendation and denies the company’s MRTP application, the decision could have very negative implications for newer (and therefore less studied) reduced-harm products.
“The tobacco industry is looking very closely at how the FDA reviews and ultimately decides on this modified-risk application,” says David Bishop, managing partner of Barrington, Ill.-based sales and marketing firm Balvor LLC. “Swedish Match has put a considerable amount of time, eff ort 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?”
'The Swedish Experience'
What makes the case for snus as a modified-risk product a unique one is what’s described as “The Swedish Experience.” Snus has been popular in Sweden for decades, providing researchers with an abundance of data on its effects. Not only have smoking rates plummeted, but so have the rates of smoking-related diseases including lung cancer, chronic obstructive pulmonary disease and heart disease. (See chart on next page.)
“If everyone in the EU smoked like they do in Sweden (i.e., using snus instead), there’d be 274,000 fewer smoking-related deaths (per year),” Rodu says. “That’s an amazing record.”
It’s so amazing that Swedish Match applied in June 2014 to have its Swedish brand General Snus classified as a modified-risk tobacco product. The company also applied to remove the required warning labels about mouth cancer, gum disease and tooth loss. When the application was accepted for CTP review last August, it marked the first time in the center’s history that it had accepted a MRTP application for review. But the battle was far from over.
As mandated by Congress, the CTP had to allow a period for public comments on the application and take the application before a TPSAC review panel.
For the TPSAC review, Zeller said the CTP requested the panel consider topics including the association of snus use with tooth loss and gum disease, the association of snus use and cancer (compared to cigarettes) and the relevance of Sweden’s history with snus.
On the first day of the TPSAC review in April, Swedish Match was given two hours to present its case. Jim Solyst, Swedish Match’s vice president of federal regulatory affairs, tells CSP the company needed the full two hours. “I was disappointed that, on the first day, the committee did not seem to understand the unique features of General Snus, that there is an abundance of human health evidence,” he says.
While there was a consensus that snus appears less harmful than cigarettes, committee members said there was not enough data to prove Sweden’s experience was applicable here. The eight-person panel also voted unanimously against removing the tooth-loss and gum-disease warnings and was split on removing the oral-cancer warning.
The ruling was considered by many to mark the death of Swedish Match’s MRTP application. Solyst admits the experience was “challenging,” but he says it’s far from the end of the line.
“If the decision had been made, we wouldn’t still be hearing from CTP,” he says, pointing out that he has had multiple calls with the CTP since the TPSAC meeting. “We’re continuing on with the process.”
Indeed, the closest thing Zeller came to commenting on related to the TPSAC decision at NATO echoes Solyst’s optimism.
“Federal committees like TPSAC serve an advisory function,” he said. “They are not the decision makers.”
All, Some or None
It’s a valid point. Months after the TPSAC recommendation against Swedish Match, the CTP still has not made its official ruling (as of press time).
In terms of what the CTP might do with this application, and MRTP in general, there are three potential outcomes: The center could accept all (or some) of Swedish Match’s requests, it could reject this application altogether, or the center could reject the application—for now.
Which option is most likely? It depends on whom you ask.
“It’s certainly not unusual for an FDA center to not take the advice of an advisory committee,” says Solyst. “There are many precedents.” As such, he’s optimistic the CTP will ultimately approve some, if not all, of the requests in the MRTP application.
“One option would be that CTP gives us the MRTP order, but not give us all of the warning-label changes,” he says. “That’s still a very positive development.”
Others anticipate a less cheery outcome.
“I’m disappointed, although the FDA has not ruled yet,” says Lou Maiellano, a former tobacco buyer for Sunoco and president of TAZ Marketing & Consulting Group, Sevierville, Tenn. “Most likely they will follow the TPSAC guidance.”
Given the wealth of information available in support of snus, a denial of Swedish Match’s MRTP application would not bode well for other products hoping to tackle modified risk.
“I am devastated,” Rodu says of the TPSAC recommendation. “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.”
Many people, however, believe the likeliest scenario falls somewhere in between: that the center will initially reject Swedish Match’s application but ultimately will grant MRTP status if Swedish Match (or another snus manufacturer) appeals or reapplies.
Matthew Myers, president of the Campaign for Tobacco-Free Kids, told Reuters “a properly prepared application could well have received a different result.” Specifically, Myers said he would have been more supportive if Swedish Match had applied only for modified-risk classification, not changing the product’s warning labels.
Also, making MRTP approval a long and difficult process for snus would send a clear message to other companies hoping to do the same that the bar is being set incredibly high.
And while Solyst says Swedish Match “is not currently in the mindset” to file an updated application, Maiellano says other manufacturers might jump at the opportunity.
“I don’t think modified risk is going away,” he says. “There will be companies that look to see how to do this and get the blessing. There’s at least a footprint now.”
CONTINUED: What Will It Take?
What Will It Take?
Even if the current MRTP application is rejected by the CTP, the fact that the TPSAC meeting gave the industry some clarity on what it might take to garner modified-risk approval is one of many positives to come out of the process.
“I would not say it was all doom and gloom,” Solyst says of the TPSAC meeting. “It was a good communication opportunity. I think TPSAC did have a better understanding of our product at the end of the two days than at the beginning, [and] I’d say Swedish Match and CTP have learned quite a bit.”
Another major benefit for Swedish Match: positive attention for its efforts. “At the end of the TPSAC meeting, Mitch Zeller referred to us as ‘trailblazers,’ ” Solyst says.
The attention has been good not only for Swedish Match, but also for other snus manufacturers and retailers. As with e-cigarettes, many consumers are recognizing snus as an alternative to cigarettes, even without the FDA’s official seal of approval.
“Will modified risk make a difference to consumers … or is it already?” Maiellano says. “Look at the continued growth of moist smokeless tobacco. People are using these products as a way to wean off cigarettes.”
And yet, retailers and manufacturers alike agree that an official modified risk would go a long way with consumers.
“I compare it to the ‘fat-free’ label,” says Andrea Myers, president of Seymour, Ind.-based c-store operator Kocolene Marketing LLC. “If people have the option of eating something that might not have 100% the same taste but is fat-free, most people choose the fat-free option. I think if people can get their nicotine in a way that has reduced harm, most of them will at least try it.”
The value of an official modified-risk label is why the Swedish Match application will likely have huge implications for the tobacco industry, despite the fact that snus represents only 4.4% of c-store dollar and unit sales in 2014, according to Nielsen.
“Even though it’s an apples-to-oranges comparison to e-cigarettes, it is still a fair comparison,” says Bishop of Balvor. “If the FDA doesn’t grant a modified risk for this product, what’s the likelihood that they’re going to grant a modified risk for any tobacco product?”
Other companies considering the MRTP application process will have to consider the massive dollars and man-hours it will take to come close to gathering the information Swedish Match included in its application. Solyst readily admits the company benefited greatly from the publicly available studies Swedish and Norwegian researchers had already conducted on General Snus.
“We could not have been this far along were it not for all this,” he says. “Swedish Match did not have to go out and spend millions of dollars conducting, for example, human health studies.”
If a product with so much epidemiology on its side cannot qualify as modified risk, it may be an impossible mission for any “normal” tobacco product to achieve. That’s why the tobacco industry continues to collectively hold its breath in anticipation of the CTP’s ruling.
“This is a very huge, watershed moment as to what direction the industry goes forward with,” says Bishop.
Mr. Zeller, we eagerly await your decision.
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