Stockholm-based Swedish Match AB, a leading manufacturer of moist, smokeless tobacco products called “snus,” applied to the U.S Food and Drug Administration to change the warning labels on 10 of its snus products. Currently, the FDA classifies all tobacco products, including smokeless tobacco, as causing cancer. Swedish Match, citing toxicological and social studies conducted in Sweden, claims it has the science to prove its products are far less harmful to human health and should have labels on its products that better reflect its products’ effects. Swedish Match wants the FDA to approve a label that states, "No tobacco product is safe but this product presents substantially lower risks to health than cigarettes."
“The risk of a man dying from a tobacco-related disease is less in Sweden than in any other European country, despite the fact that total tobacco consumption is comparable to that of other countries in Europe,” Swedish Match said in its initial application, filed in June 2014. “Researchers refer to this paradox as “the Swedish Experience,” a phenomenon which is most likely explained by the unique form of tobacco use among Swedish men, which largely takes the form of Swedish snus.”

Applying for updated product safety labels
Tobacco companies, electronic cigarette makers and anti-smoking groups are all closely watching the application, which is the first of its kind filed under the Tobacco Control Act of 2009, which gave the FDA authority to regulate tobacco products. Dr. Jonathan Foulds, a professor at the College of Medicine at Pennsylvania State University and an expert in tobacco effects, said he believes the application could change the landscape of product labels.
“It is clear, based on the science, that Swedish snus presents a much lower risk to human health than smoking,” he said. “I think the FDA would be very smart to approve the application, although I know the FDA tends to be cautious and come down on the side of any health risk being too much.”
For those of you who are new to it and us — we have covered this aspect of Scandinavian lifestyle at length — snus is a moist tobacco product that comes in two forms: loose and portioned. The portioned product comes in small pouches which users place under the upper lip. Each dose is pre-measured and pre-packaged for use. Loose snus is similar to American smokeless tobacco products such as Copenhagen or Skoal in that the user takes as much tobacco as he or she wants. Swedish snus, however, differs from American smokeless tobacco products as snus is essentially pasteurized in the manufacturing process.
“Although the use of Swedish snus may have some negative health effects, research results have shown that health risks are substantially lower with the use of snus compared with smoking. In light of the medical consensus that Swedish snus is approximately 90-95 percent less harmful than smoking, it would be contrary to both sound science and sound regulatory policy to treat snus and cigarettes as equally harmful,” Swedish Match said in its application.

Accurately communicating the risk
Advocates on either side of the tobacco debate agree. Dr. Brad Rodu, of the School of Medicine at the University of Louisville, is an outspoken advocate of using Swedish snus as a smoking cessation aid. While the Swedish Match application compares its products to cigarettes in terms of health risk, Foulds points out that Swedish Match adroitly avoided entering the smoke cessation debate in its application.
“The only thing Swedish Match tries to prove is that snus is less harmful than smoking. They don’t discuss smoking cessation for a reason,” he said. “That is a very controversial topic and clearly Swedish Match did not want to get into that. Its only focus is to have the labels changed on its products, and I agree with their argument.”
Swedish Match, which has its U.S. headquarters in Richmond, Virginia, filed its Modified Risk Tobacco Product application under a section of the Tobacco Control Act that allows the FDA to declare a tobacco product less harmful than another. Since becoming the regulatory agency overseeing tobacco products, the FDA has followed a mantra that all tobacco products are equally bad. The advent of snus, which is becoming more widely available in the United States, and more recently, of electronic cigarettes, has forced the FDA to re-examine its no-tolerance policy of all tobacco products.
“Harm reduction doesn’t allow us to enjoy risk-free lives,” Rodu said. “It does give us valuable information to manage the risks of the activities that make life enjoyable.”
Proponents of the Swedish Match application say changing warning labels only makes sense. One proponent, identified as Dr. MA, who commented on the Swedish Match application at www.regulations.gov, called the FDA practice of lumping all tobacco products into one harmful group unethical and possibly even illegal.
“Instead of falsely claiming that all tobacco products are as hazardous as cigarettes, FDA must distinguish between these vastly different types of tobacco products and users,” Dr. MA wrote. “Public health benefits every time a cigarette smoker substitutes a smoke-free tobacco product for a cigarette, and FDA needs to acknowledge this important fact. Thus, FDA also should correct or clarify ALL of the many inaccurate and misleading information about the health risks of different tobacco products, including those not explicitly covered in this MRTP application.”
Clive Bates, a health researcher based in Great Britain, writing on behalf of 17 British health professionals, said approval of the warning label change made sense: “The proposed changes to warnings on these snus products are justified by the low risk profile of these products.” Bates added, “The existing warnings do not adequately convey the relative risk of snus compared to smoking,” which “may have harmful consequences, such as causing people to choose smoking rather than snus use based on misunderstanding of relative risk. There is an ethical imperative to communicate risk as accurately as possible for all products.”
The organization of Consumer Advocates for Smoke-free Alternatives Association belittled the FDA in particular, as well as other government health entities for not moving sooner to differentiate between tobacco products. “It would benefit the public, who FDA and the rest of our government are charged with operating on behalf of, particularly by improving the public’s overall health,” said Carl V. Phillips, PhD, the group’s chief scientific researcher. “It would reduce a persistent problem of the government grossly misrepresenting risks to the public about this category of products. We can see no apparent downside for consumers or society as a whole in FDA granting SM’s application. The only apparent downsides are for two special interest groups: those who wish to keep consumers smoking because they have a financial interest in cigarette sales, or those who are pursuing tobacco prohibition and know that those goals will be unattainable if consumers have accurate information about low-risk products.”

Regulating American standards with Swedish data
Although Swedish Match provided scientific evidence from studies in Sweden showing the correlation between reduced cancer rates in snus users as opposed to smokers, an FDA advisory committee in April 2015 voted to deny the application and sent its findings to the FDA. The main sticking point among the committee appeared to be whether the data gathered in Sweden was also applicable in the United States.
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." Committee members said Swedish Match did not adequately test 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.
The apparent lack of evidence was a facet on which the American Dental Association seized its comments on the application. Dr. Maxine Feinberg, DDS, president of the ADA, and Dr. Kathleen T. O’Loughlin, DMD, said the FDA should delay making any decision until it has assembled its own research on the long-term effects of snus and other smoke-free tobacco products.
“Unfortunately, there is a scarcity of published research on — and certainly no scientific consensus about — the immediate and long-term effects of these new products on oral health. The lack of published literature makes it virtually impossible to justify claims that these products are somehow less harmful to the oral cavity than combustible tobacco products, or without other adverse effects,” the ADA said. “Preventing oral cancer and other tobacco-related diseases has been a longstanding priority for the ADA. We strongly support developing the published research on the latest generation of tobacco products and the immediate and long-term effects of those products on oral health.”
The panel decision disappointed many risk modification advocates, such as Rodu, who said, “The committee appears to have set an absolute standard of safety that ignores decades of evidence showing that snus is vastly safer than cigarettes.”
The decision, however, cheered those who oppose the application. “The text changes to the warning label requested by Swedish Match would be only on the alleged reduced-risk products, meaning the primary audience receiving the proposed reduce-risk text would be those already using the product (who would likely respond to the message by being less likely to try to quit or reduce consumption) and the claim would not be effectively delivered directly to smokers (those who would be the most likely to benefit from switching to the reduced-risk product),” said Stanton A. Glantz, PhD, of the Center for Tobacco Control Research and Education at the University of California San Francisco.
“Moreover, if the warning label text change were featured in Swedish Match ads, it would be seen by youth, those at risk of relapse, and all the other sub-populations that would not benefit from seeing it.”
Glantz argued Swedish Match should market any new warning label with a reduced risk statement directly at a pre-identified, specifically targeted audience of snus users only, ensuring “any reduced-risk claim that obtains an MRTP order should be permitted to be delivered only to the users of the higher-risk tobacco products (the only persons who could possibly benefit from using the reduced-risk product) and be required to be delivered in such a way as to minimize any exposure to the reduced risk claim among youth or adult non-tobacco-using populations (who might be prompted to start using) or even among current users of the reduced-risk.”

Potential impact on other efforts
The Swedish Match application covers its snus brand General in the U.S. Not surprisingly, those products are the top sellers for Swedish Match and the 10 products most commercially available in the United States. Nine of the products are portioned, while the tenth is General Snus loose. The application could have wide-ranging impacts on product labeling of tobacco products in particular as well as for non-tobacco products. The rapid growth of electronic cigarettes, which contain nicotine but only emit water vapor when lit, has put added pressure on the FDA to re-examine its policy of condemning all tobacco products as equally harmful. Lorillard Tobacco Company, which manufactures e-cigarettes under the trade name Blu e-Cigs, said acknowledgement of a modified risk between various tobacco products was critical for new products that have less risk and could help smokers quit.
“Lorillard believes it is critical for FDA to recognize — and publicly state — that the data needed to support an MRTPA will vary according to the unique characteristics and circumstances of the product at issue. In particular, FDA should make clear that the Swedish Match MRTPA is not a benchmark or standard against which all future MRTPAs will be assessed and should not mandate the same amount or type of data that Swedish Match provided,” the company said in a statement. “The data available for Swedish snus are unique due to the long history of marketing in Sweden and other markets. Thanks to this history, Swedish Match was able to amass a significant amount of epidemiology data. Although the data available is commendable and should support approval of an MRTPA for Swedish snus, FDA should not require the same amount of data for novel products that do not share the same history of use and market penetration.”
The possibility that a modified warning label on snus products could lead to modified labels on other products may be reason enough for the FDA to deny the application, argued Heidi Hanson, a citizen advocate for banning all tobacco products. “Those who work in the tobacco industry are not in the same league as the retail industry,” said Hanson. “They are not businessmen out to make a buck, or any other euphemism created to justify their existence or products. What they make and sell, when used as intended by the manufacturer, directly kills almost half a million Americans a year. Their relentless and targeted marketing paints a bull’s-eye on youth, communities of color, LGBT and the poor, including those with chronic mental illness and who are chemically dependent. These are predatory and criminal practices by executives of multi-national corporations.”
Other advocates, however, believe the Swedish Match application can and will have a major impact in how the FDA treats tobacco products other than cigarettes. Olivia A. Wackowski and Cristine D. Delnevo, professors at the Rutgers School of Public Health, Center for Tobacco Studies at Rutgers University in New Brunswick, NJ, said in a statement that how the FDA treats a product such as snus would inevitably impact how it treats other less-harmful products such as electronic cigarettes.
The two researchers put various warning labels before panels of smokers and non-smokers and asked them to evaluate the labels’ impact, if any. According to the researchers, slight changes in language produced widely different results. They also put the proposed Swedish Match warning label in front of the focus groups.
According to Wackowski and Delnevo, they asked their participants to comment on two versions of a modified risk message as a potential warning for e-cigarettes: the proposed Swedish Match label (“No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes”), and an alternative version the researchers developed which may warn about potential risks more actively (“This product may be harmful to health, but is substantially less harmful than cigarettes”). The researchers found modified risk labels “conveyed that e-cigarettes are not necessarily safe, but are safer than regular cigarettes.”
According to Matthew Myers, president of the Campaign for Tobacco-Free Kids, "A properly prepared application could well have received a different result." He would have liked to see the company separate its request for a warning label change from its request to make a modified risk claim. Myers said the application would provide a roadmap for others. "My hope is that everybody will learn from it.”
Foulds, who is also an advocate of replacement therapy for smokers —namely using Swedish snus to help smokers quit — believes the FDA, despite the opposition of the advisory panel, has almost no choice but to approve the Swedish Match application.
“I think it would be very short-sighted of the FDA to not acknowledge what science can prove,” Foulds said. “This application absolutely has merit and the FDA should approve it.”
As of April 2016, the FDA has not officially said anything. They may decide to reopen the case to public commentary or they could deliberate for any amount of time.
In the end, smoking or using smokeless tobacco is a matter of personal choice. Rodu, Foulds and others believe the public has a right to know all the data about using those products, not just the data that one side or the other in the tobacco debate wants made available. Let’s hope all the effects of smokeless and smoked tobacco emerge — and that all individuals will then be in a position to decide for themselves.