Sting Free AB has received SEK27 million ($3.1 million) through an ownership dispersion. Investors include Curt Enzell, inventor of the snus pouch and former head of research at Tobaksbolaget (Swedish Match).
Sting Free has developed a product that prevents the familiar stinging sensation on the gum from snus and nicotine pouch consumption, widening the pool of potential consumers for snus and pouches (also see “Patching the Pouch,” Tobacco Reporter, July 2017).
The technology is applicable to both snus and tobacco-free nicotine pouches and has already been successfully produced in prototype series with industrial and unmodified snus packaging machines. Swedish Match has signed a nonexclusive license agreement for the new technology and several other Nordic and foreign producers are expected to do the same soon.
“The capital injection from the ownership dispersion enables the company to requisition national patents in about 40 countries, including all countries in Europe, as well as a capital base for coming industrial production,” said Sting Free CEO and founder Bengt Wiberg in a statement.
“We are very happy that so many prominent people and companies have chosen to invest in Sting Free AB.”
Sting Free’s innovation can make it easier for many to switch to snus, as the burning sensation often constitutes an obstacle for smokers to convert to snus.
“Sting Free AB’s innovation can make it easier for many to switch to snus, as the burning sensation often constitutes an obstacle for smokers to convert to snus,” says Enzell.
In a market survey with 660 male and female Swedish snus users, Sting Free found that 40 percent of the respondents dislike the stinging of snus. Only 11 percent of women and 17 percent of men enjoy the sensation. In empirical tests with adult nicotine users who had never tried snus or nicotine pouches before, nine out of 10 thought the burning sensation was unpleasant while an equally high proportion considered the identical contents in a Sting Free technology pouch to be enjoyable.
Former EU health commissioner John Dalli lost his final appeal before the bloc’s high court in a nearly decade-old bribery scandal, reports the Courthouse News Service.
On Feb. 25, the European Court of Justice upheld a lower court ruling that dismissed the Maltese politician’s claim for €1 million ($1.2 million) in damages stemming from his resignation following accusations of fraud in 2012.
In 2012, the EU anti-fraud office found that Silvio Zammit, an associate of Dalli, attempted to facilitate a €60 million bribe from a Swedish smokeless tobacco company in exchange for lifting an EU-wide ban on the product (the ban doesn’t apply in Sweden on cultural grounds). The snus company rejected the offer as improper and reported it to the European Commission.
Denying knowledge of the bribe, Dalli claimed that he was illegally forced from his post. In 2015, a lower EU court found that Dalli resigned voluntarily, a decision that was upheld in a 2016 appeal. A second lawsuit, in which Dalli demanded financial compensation for what he alleged was his wrongful termination, was rebuffed by the lower court in 2017.
This year’s Snus Con will take place virtually Oct. 19-24.
The event will feature pre-recorded interviews with an option for participants to interact.
Each video will be broadcast at a specific time via YouTube’s Premier feature. When the interviews go live, there will be a chat box available so visitors can watch along and chat with peers.
This year’s interviewees include Nihar Dholakia, director of next-generation products at Dholakia Tobacco; Bengt Wiberg of Wiberg Solutions and snus maker Conny Anderson.
Estimated at $1.1 billion in 2020, the global market for snus is projected to reach $1.7 billion by 2027, according to a new report. This represents a compound annual growth rate (CAGR) of 6.2 percent over the period.
“Original,” one of the segments analyzed in the report, is projected to grow at a 6.4 percent CAGR to $715.6 million by the end of the analysis period. After an early analysis of the business implications of the Covid-19 pandemic and the related economic crisis, the “fruit” segment is estimated to grow at 7.2 percent CAGR for the next seven-year period. This segment currently accounts for a 19.2 percent share of the global snus market.
The snus market in the U. S. is estimated at $317.2 million in 2020. The country currently accounts for 28.9 percent of global snus sales. China’s snus market is forecast to reach an estimated market size of $309.5 million by 2027.
Other noteworthy snus markets are Japan and Canada, forecast to grow at 3.4 percent and 5.6 percent respectively from 2020 to 2027. Germany is forecast to grow at approximately 4 percent CAGR while the rest of the European market (as defined in the study) will reach $309.5 million by 2027.
Europe’s top court on June 18 sent back to a lower court a dispute over immunity in a political scandal involving Swedish smokeless tobacco and millions of dollars in bribes, reports Court House News Service.
The European Court of Justice (EJC) found that a lower court erred in its decision to side with the former head of the European Union’s anti-fraud office, Giovanni Kessler, whose immunity from prosecution had been rescinded by the European Commission following allegations of illegal wiretapping.
The case dates from 2012, when Maltese politician John Dalli either resigned from or was forced out of his post as the European commissioner for health and consumer policy following allegations of bribery.
An investigation by the EU anti-fraud office OLAF found that an associate of Dalli, Silvio Zammit had demanded €60 million ($67 million) from Swedish Match to lift a ban on snus, which is legal in Sweden but outlawed in other EU member states.
Dalli denied he had any knowledge of the bribe. He brought several complaints about his resignation controversy to the court in 2015, which he all lost.
During the OLAF probe, investigators allegedly listened in to a conversation with a witness in the investigation. The information wasn’t used in the investigation, but the actions would be a violation of Belgian wiretapping laws.
The case now returns to the General Court for another decision.
By reducing snus’ notorious sting, a Swedish inventor wants to make it easier for smokers to go smokeless.
By Taco Tuinstra
Bengt Wiberg was devastated. He had just been diagnosed with a third-degree lesion, and the dentist blamed snus. The only way to restore oral health, his dentist insisted, was to quit smokeless tobacco.
“It was the worst day of my life,” says Wiberg.
A snus aficionado and former smoker, Wiberg did not want to stop snusing—and he certainly did not want to revert to smoking. The pain was so intense, however, that he could not even stand to hold snus in his mouth. So, back in his office, Wiberg started pondering his predicament.
The cause of his oral discomfort was clear: Snus has a high pH level, which assists nicotine uptake and delivery time but can also irritate the gum and oral mucus membrane. If the snus is pressed against the same spot of the mouth for a prolonged period—like snusers tend to do—it can cause a lesion. The affected area becomes extremely sensitive, and the spicy juices released by snus can sting like salt in a wound.
That analogy gave Wiberg an idea. “What do you do when you cut your hand?” he asks. “You put on a Band-Aid to keep out the dirt and sweat.” So, he took one from his employer’s first-aid kit, patched one side of a snus pouch and cut away the excess material. He then stuck the pouch in his mouth with the patched side facing his gums. “The pain disappeared immediately,” he says.
Remarkably, the flavor and nicotine absorption were unaffected by his improvised patch. Because nicotine is water soluble and absorbed by all the mouth’s mucous membranes, the snusing experience was as satisfying as before—but without the discomfort.
Wiberg continued snusing, experimenting with different patch materials, such as surgical tapes. After a year, he returned to his dentist, who was astonished to find no evidence of gum or mucosa irritation. Despite Wiberg’s ongoing snus use, the lesion had disappeared, and the color of his gums had changed from swollen red to healthy pink. “My oral health was excellent,” beams Wiberg.
Bengt Wiberg (left) and his dentist, following a satisfactory checkup
Getting started
Convinced that other snusers might benefit from his experience, Wiberg composed a long message to Swedish Match, the world’s largest snus manufacturer. He described his solution in detail, along with the market potential, but just as he was about to click “send,” he stopped himself.
Instead of giving away his idea, he contacted Start-Up Stockholm, a Swedish government-financed nonprofit consultancy for entrepreneurs in the startup and early growth stages of their ventures. Start-Up Stockholm helped secure a sek20,000 ($2,300) government grant to get started. “I am probably the only person in Swedish history to receive government money for a tobacco-related invention,” Wiberg says with a grin.
After due diligence revealed that nobody had claimed credit for a similar technology, Wiberg filed for patent protection in Sweden and, later, in the United States and at the European Patent Office. Sweden granted the patent in early 2017, and Wiberg is confident that the other jurisdictions will follow suit. “My country is quite fussy when it comes to recognizing patent applications,” he notes.
In the meantime, Wiberg kept perfecting his solution. After trying many different patch materials, Wiberg settled on an impermeable, soft and ultrathin (0.025–0.035 mm) membrane that has been approved by Sweden’s national food agency. Harmless and unnoticeable for the snus user, the material also complies with all applicable EU regulations.
In June 2016, Aftonbladet, a leading Swedish newspaper, published a big story about Wiberg’s invention. With 600,000 unique impressions, it became the paper’s most read article that day. In December 2016, the Venture Cup recognized the innovation, labeled “Sting Free Snus,” as one of the best business ideas in Sweden that year.
Harm reduction
While the patch can help prevent oral discomfort for existing snusers, Wiberg believes its real value lies in removing a hurdle to the adoption of snus by cigarette smokers. Snus has already proved to be an effective stop-smoking aid, delivering the enjoyment of nicotine without the disease-causing byproducts of combustion (snus is estimated to be up to 99 percent less unhealthy than smoking). A study by L.M. Ramstrom and J. Foulds revealed that more than 70 percent of snus users in Sweden were former cigarette smokers who had quit smoking permanently.
Wiberg suspects that snus could help even more people quit smoking if it wasn’t for the product’s characteristic sting, which he compares to the “pins and needles” sensation a person may feel after his foot has fallen asleep. This sting is experienced not only by users with compromised mucus membranes but also by the typical, healthy user (the “injured” users just experience it worse). In a consumer survey conducted by Wiberg, four out of 10 respondents said they found the sting unpleasant. A minority considered the sting an attractive feature in the way that some diners enjoy the “pain” associated with spicy foods, while others were indifferent. By dulling the snus sting, Wiberg’s solution could therefore contribute to public health.
The inventor is now working on the commercialization of his creation. Swedish Match has signed up for a nonexclusive licensing agreement for the rights to utilize Sting Free Snus technology for its products. That leaves Wiberg the options to start his own manufacturing operations, contract more licensees or sell the patent to a third party.
According to Wiberg, Sting Free Snus is an attractive business proposition. Incorporating his membrane, he says, adds little to the cost of production, but snus companies would be able to charge a premium for the sting-free varieties of their brands. Tobacco retailers stand to benefit, too. Even if increased snus sales would come at the expense of cigarette sales, they would still gain because retail profit margins (in Sweden, anyway) are almost 100 percent higher for snus than those of cigarettes.
The patch also creates opportunities for new, innovative products. A separate patent covers a two-in-one pouch, with two flavors separated by an impermeable membrane. Depending on his preferences, the user can flip the pouch with his tongue so that the desired flavor faces the lip (snus users taste their snus by striking their tongue over the front-facing side of snus pouch). Wiberg compares it to the popular crushable filter capsules that allow smokers to flavor their cigarette smoke. But whereas the crushable-capsule concept is irreversible—once crushed, there is no way of returning to the original flavor—the two-in-one snus pouch allows the user to keep switching flavors indefinitely. “For example, you can enjoy whiskey flavor and then quickly switch to strong mint before kissing your wife,” he says.
For the time being, the snus market is limited primarily to Scandinavia ($1 billion in annual sales) and the United States. Snus is banned in all EU member states except Sweden, but that may be about to change. The European Court of Justice is set to review a challenge brought by Swedish Match and others, and experts are cautiously optimistic that it will throw out the ban. If that happens, it could make snus available to more than 100 million smokers.
China, too, has approved snus. According to Wiberg, the China National Tobacco Corp. recently launched two flavors: “Black Tea” and “Deep Frozen.” China, of course, is the largest cigarette market in the world. If only a fraction of the country’s 350 million smokers converted to snus, the gains for public health—and snus sellers—would already be immense. And they would be even greater if Chinese smokers would have access to a non-stinging snus variety.
Snus lovers around the world have responded enthusiastically to Wiberg’s invention, describing it as a milestone. Retailers in Sweden report frequent inquiries about the product, which has not even been launched yet. But perhaps the biggest endorsement came from Curt Enzell, a professor of organic chemistry, a retired Swedish Match R&D director and the father of the snus pouch.
Tired of washing from his fingers the brown stains associated with loose snus, Enzell in 1967 placed his snus into an empty tea bag and thus inspired the creation of an entirely new product category. Portioned snus is still regarded as the most significant breakthrough in snus, as it has made the product more user-friendly and increased its consumer base. After evaluating Wiberg’s product, Enzell declared Sting Free Snus the greatest innovation relating to the snus portion since his pouch.
Taco Tuinstra is Tobacco Reporter’s editorial director.Based in Raleigh, North Carolina, USA, he coordinates the work of staff writers and contributors.On his watch, Tobacco Reporter has won several awards for editorial excellence.Since joining the magazine in 1997, Taco has visited more than 75 countries to meet industry representatives in their markets and to report tobacco news firsthand.
Manufacturers, aficionados and researchers talk snus in St. Louis.
By Taco Tuinstra
Snus enthusiasts gathered on May 27–28 in St. Louis, Missouri, USA, for the first Snus Con, a conference featuring experts from Sweden and the United States. Organized by Chad Jones of the popular snus blog www.snubie.com, the event tackled topics such as tobacco harm reduction, regulation and science. It also highlighted a remarkable innovation—Sting Free Snus—and featured several tasting panels.
Snus represents only a small share of global tobacco sales, but the product has a dedicated following, which became clear during the St. Louis meeting. Attendees passionately discussed their beloved smokeless tobacco, sharing news, tips and experiences. Illustrating the attachment some snusers feel to their product, one prospective participant was detained by U.S. immigration authorities after refusing to surrender a snus can containing Cuban tobacco.
The main snus markets are Sweden, with about $1 billion in annual sales, and the United States, with annual sale of approximately $800 million. The product is also gaining popularity in Norway. Due to a misguided risk assessment, snus is illegal in all EU member states bar Sweden—although that may change soon. The European Court of Justice is set to hear a legal challenge to the ban, and industry representatives are cautiously optimistic it will rule in snus’s favor.
Without the disease-causing byproducts of combustion, smokeless tobacco is considerably less harmful to health than are cigarettes. Unlike smoking, it presents no significant risk for emphysema, heart disease and stroke.
Brad Rodu
Brad Rodu, professor at the department of medicine of the James Graham Brown Cancer Center at the University of Louisville in Louisville, Kentucky, USA, kicked off the conference by detailing “the Swedish experience.” Sweden has the lowest rates of lung cancer and other smoking-related diseases in Europe, which Rodu attributes to tobacco consumers using snus instead of cigarettes. The country has the highest rate of male smokeless tobacco use and the lowest rate of male smoking in Europe. “If men in other EU member states smoked at the rate of Swedish men, almost 274,000 lives per year would be saved,” said Rodu.
Regrettably, this enviable state of affairs doesn’t extend to Swedish women, who are less likely to obtain nicotine through snus than are their male counterparts. According to Rodu, Swedish women are more likely to smoke. But while snus is still considered a male habit, women under 30 appear less hesitant to pop a pouch underneath their upper lip. If the trend holds, quipped Rodu, “it would be the first time in history that women adopted a healthier behavior from their husbands.”
Joe Ackerman
Joe Ackerman, director of marketing at Swedish Match North America, spoke about his employer’s vision: “a world without cigarettes.” He described a continuum of risk, with cigarettes residing at the very top and smokeless products near the bottom. “We operate at the safer part of the continuum,” he said. Ackerman marveled at the sheer variety of nicotine products, which had come about in response to concerns about the health effects of smoking.
The cigarette remains the ultimate nicotine-delivery device, he noted. “Without the health concerns about smoking, the other categories would not exist.” Ackerman went on to describe one of Swedish Match’s latest offerings, Zyn, which is currently being marketed in the western United States. A smoke-free and spit-free nicotine pouch, Zyn contains nicotine salt derived from tomatoes and tobacco leaves, along with food-grade ingredients, such as pH balancers and sweeteners. Careful to avoid health claims, Swedish Match markets Zyn as a “clean” product.
Swedish Match’s commitment to responsibility became evident also from the fact that Zyn’s child-safety lid—a first in the industry, according to the company—is sufficiently secure to deter even some adults. “I can kill a bear with my hands, but I am unable to open your can,” a burly audience member complained to Ackerman.
Jonas Yden
Jonas Yden, global director of Skruf Snus, told the story of his company’s meteoric rise. Created only in 2003, Skruf has managed to carve out a respectable niche in a business dominated by centenarians. In its first year of operations, the company packed 400,000 cans of snus; this year, it expects to manufacture 94 million.
While such rapid growth is exciting, it also presents challenges. “We are building the rocket ship while flying it,” said Yden. With machines running 24/7, it is difficult to test new innovations. Yden attributed Skruf’s success to its startup culture, which includes “the freedom to screw up,” and the fact that the company offers to snus users “something other than tradition.” Impressed by the company’s performance, Imperial Tobacco (now Imperial Brands) took a minority stake in Skruf in 2005 and purchased the remaining shares in 2008. As Scruf continues to grow and becomes more corporate, Yden said it must take care to retain its entrepreneurial spirit.
Larry Waters
Larry Waters of SnusCentral introduced himself in the way a heavy drinker might present himself at an alcoholics support group meeting. “Hello, I am Larry, and I am a nicotine addict,” he said to an amused audience. A former smoker, Waters credits snus with the fact that he’s alive today. He started snusing with R.J. Reynold’s Camel Snus—a product that was simultaneously scoffed (for its taste) and lauded (for introducing Americans to the category) throughout the St. Louis conference—and quickly “upgraded” to Swedish snus.
Within one week, Waters transitioned from using cigarettes and snus side by side to using only snus—and like a true convert he couldn’t stop telling people about his experience. He started blogging, reviewing products, sharing tips and commenting on industry developments. “I wanted to create a site where Americans could find everything about Swedish snus—a one-stop shop,” said Waters. In 2009, he visited Sweden at the invitation of snus manufacturers, who recognized the potential of the U.S. market. Unable to contain his excitement at being in the “Walhalla of snus,” Waters kissed the tarmac upon arrival.
Lars Rutqvist
A particularly interesting contribution to the St. Louis conference came from Lars Rutqvist, senior vice president for scientific affairs at Swedish Match, who also managed to quit smoking with snus. Prior to joining Swedish Match, Rutqvist led the oncology department of the Karolinska Institutet in Stockholm. Among other projects, he researched the risk factors for head, neck and mouth cancers.
Rutqvist’s studies quickly confirmed the roles of smoking and drinking but not the link with snus use. Because his findings went entirely against conventional wisdom in the 1990s, the department was reluctant to accept them. “In medical school we were taught that snus is a major risk factor for cancer,” said Rutqvist. But even after rechecking the basic data, he got the same results: Snus was not a contributor to any of the researched diseases. As it turned out, many of the prior studies supposedly linking snus to cancer related to powdered snuff instead.
When Sweden joined the EU, it received an exemption on cultural grounds from the bloc’s snus ban but was required to start printing cancer warnings on cans. Confronted with the new science, the EU in 2001 allowed Sweden to replace the warning with a more generic one. Rutqvist is hopeful that the EU will soon take the next step: lifting the snus ban. While the European Court of Justice rejected an earlier legal challenge, many things have changed since 2004, according to Rutqvist. Not only is the science more conclusive today; the European Commission has, under pressure from consumers, also been forced to accept e-cigarettes in its new Tobacco Products Directive. What’s more, leaving the snus ban in place would be discriminatory now that a regulatory route for novel products has been introduced.
Rutqvist was also optimistic about Swedish Match’s modified-risk tobacco products (MRTP) application in the U.S.—to the extent that he felt comfortable to bet a bottle of whiskey on its approval in 2018. In its MRTP application, Swedish Match asked the U.S. Food and Drug Administration (FDA) for permission to modify snus health warnings to more accurately reflect the current science. Even though the agency denied Swedish Match’s initial petition, it left the door open by allowing the company to submit an amended application.
Rutqvist noted that the level of scientific expertise at the FDA’s Center for Tobacco Products is much higher than that among its EU counterpart, which he said is staffed primarily by career administrators.
During Snus Con, speakers repeatedly stressed the importance of consumers, who are able to interact with authorities in ways that snus manufacturers cannot. Inspired by the World Health Organization’s Framework Convention on Tobacco Control, many lawmakers keep tobacco companies at arm’s length, preventing meaningful discussions and often resulting in ill-informed legislation.
Alex Clark, executive director of the Consumer Advocates for Smoke-free Alternatives Association (CASAA), which is best known for its work on behalf of vapers, stressed his organization’s support of snus users in the U.S. “People know us as ‘the vaping people,’” he said, “but CASAA talks about all alternatives to smoking.”
Rutqvist, too, spoke approvingly of consumer involvement. “I once naively thought that science could solve all problems—but politics trump science,” he said. Fortunately, Rutqvist added, politicians in many countries are beholden to consumers, who are also potential voters. The EU exception for snus in Sweden and the European Commission’s capitulation on e-cigarettes can both be attributed to consumer pressures, according to Rutqvist. “So, consumers trump politics,” he said. “That’s why conferences such as Snus Con are so important.”
The next Snus Con will be held in the summer of 2018. The date and location will be announced at www.facebook.com/snuscon.
R.J. Reynolds Tobacco Co. (RJRT) has submitted Modified Risk Tobacco Product (MRTP) applications to the U.S. Food and Drug Administration (FDA) covering six styles of Camel Snus, its premium pouched, smokeless tobacco product introduced in 2006 and marketed nationwide in the U.S.
To support the applications, R.J. Reynolds has provided the FDA more than 450,000 pages of documentation. As the submission guidelines advise, the documentation covers results and discussion from an extensive suite of scientific studies, including:
Chemistry, pre-clinical and clinical toxicology, as well as epidemiology
Consumer perception and understanding studies of the proposed MRTP
Likelihoods of use studies based on the proposed MRTP claims
Population-level modeling under a scenario in which the MRTP claims are authorized for dissemination to adult smokers
R.J. Reynolds now awaits FDA’s review of the applications to determine whether they are accepted for substantive review.
The company says it looks forward to working with the agency as the process moves forward.
In response to a study linking snus to diabetes, Swedish Match issued the following statement:
“Today, a scientific study was published that has gotten media attention. The study, Smokeless tobacco (snus) is associated with an increased risk of type 2 diabetes: results from five pooled cohorts, says that snus consumption [increases the risk] for diabetes (type 2).
The study says that among those who consumed fewer than five cans of snus per week there was no increased risk, but among those who consumed five-six cans per week there was an increased risk of 40 percent, a risk that increased to 70 percent with a consumption level of seven cans or more per week.
“The collective scientific documentation regarding snus and diabetes shows that there are six recently published studies that [don’t] show an increased risk, but in this one study, there is an increased risk for those using more than five cans of snus each week.
“The latter study is based on material from the county of Västerbotten, and it is unclear why that particular study [differs] from all the rest in its conclusions. It is possible that the difference exists because [the study] hasn’t [adjusted] for other known factors, such as food consumption, lifestyle habits and obesity.
‘When six studies say one thing and there comes a seventh saying something different, I think that you should be cautious in drawing any conclusions,’ says, Lars-Erik Rutqvist, head of scientific affairs, Swedish Match.”
‘The only study that shows a correlation is from Västerbotten and it only represents one cohort (group of people), and I would leave open for the possibility that there may be other explanations to diabetes than consumption of snus. This study does not change [my] or Swedish Match’s current assessment of the collected scientific research which has been done on this subject.’”
Even as it suffers setbacks, Swedish Match’s MRTP application offers a path for other tobacco companies to follow.
By Timothy S. Donahue
Developing less risky alternatives to cigarettes is all the rage nowadays. Nearly every tobacco company has an alternative tobacco product that aims to be safer than smoking. However, only one company can be first in gaining approval from the U.S. Food and Drug Administration (FDA) to make the claim publicly.
Despite recent setbacks, Swedish Match (SM) remains far ahead of the pack. In June 2014, the firm filed a modified-risk tobacco product (MRTP) application for its General snus brand. It was the first such application to ever be accepted for review by the FDA. Snus is a moist tobacco product placed under the upper lip that does not involve spitting or chewing. In mid-December 2016, the FDA finally responded to the 135,000-page document. The regulatory agency decided to defer any decisions on whether to allow the company to claim the products cause less harm than cigarettes or whether to allow removal of a warning that the products may cause mouth cancer.
In another first, the FDA stated that it believed the SM application “could be amended to support issuance of modified risk orders.” However, it also informed the company that it would not be able to remove a warning that the products may cause gum disease and tooth loss. SM intends to meet with the FDA (a 45-day response deadline places a possible meeting in mid-February, although no date could be confirmed as of this writing), according to Jim Solyst, vice president for federal regulatory affairs for SM. The FDA requires SM fully address all remaining concerns within two years.
“What we will do is certainly have a conversation with the FDA, but the exact nature of those discussions have yet to be determined. We are more than willing to keep this process going, to respond to the letters we’ve received and the document they put out,” said Solyst. “We would need some additional information, some clarification as to what would be the path forward. Yes, we will have discussions. We believe it’s in all parties’ best interests that we keep this dialogue going.”
One challenge facing SM is that the FDA’s “conversations” with tobacco companies are not necessarily of the type that most people associate with that word. They are more like a dialogue through documents. When a tobacco company meets with the FDA’s Center for Tobacco Products (CTP), it’s a listening session where a company presents, the FDA listens, and at some point later the FDA makes a decision that is often unclear and more often without explanation. “The burden has always been on us, the applicant, to propose something,” says Solyst. “Then they comment on it.”
Risk reduction quantified
Jim Solyst
The actions on the MRTP applications have no impact on SM’s premarket tobacco product application (PMTA) authorizations issued for eight of its General snus products in November 2015. SM was the first—and, so far, only—tobacco company to receive product approvals under the PMTA process. In its PMTA, SM proposed that General snus should be considered to be protective of the public health, and the FDA agreed. In its response, the agency determined that the General snus products are protective of the public health and contain significantly lower levels of harmful constituents compared with over 97 percent of the smokeless products on the U.S. market.
“They even went further than we did,” says Solyst. “They quantified the risk reduction.” The MRTP response, however, was different. “The FDA stated that ‘No, this is not quite what we need. We’re not willing to remove the warning labels, and we want you to do your consumer perception in a different way.’ Going forward, part of our conversation with them would be, well, ‘Which way is that?’ Yes, it’s been a difficult process. They aren’t very clear on their expectations.”
Understanding the industry interest and complexity of its decision, the FDA did attempt to explain its scientific review process and what was considered in the actions taken against SM in its MRTP application. In a note on its website, the FDA states that to pursue an MRTP order, a company, among other things, is required to establish that submitted modified-risk data for a product is supported by scientific evidence that shows “the product (as actually used by consumers) can significantly reduce the harm and risk of tobacco-related disease to individual tobacco users, as well as benefit the health of the population.”
In its MRTP applications, SM proposed to remove two warning statements required of smokeless tobacco products by the FDA: one stating that the product can cause gum disease and tooth loss, and the other stating the product can cause mouth cancer. In reviewing these requests, the FDA determined that “removing the warning statement about gum disease and tooth loss would imply that using these snus products cannot cause gum disease and tooth loss, as compared to other smokeless tobacco products,” according to its statement. Similarly, the FDA determined that removing the warning statement about mouth cancer would imply that using these snus products cannot cause mouth cancer. “Based on the available scientific evidence, we determined that the applicant’s proposal to remove this warning should be denied,” wrote the FDA. “There is sufficient evidence that the use of these products increases the risk of mouth cancer in users compared to nonusers.”
However, the FDA did state that evidence provided by SM may support other claims, such as a claim about the “reduced risk of mouth cancer provided on the product labeling, in advertising, or otherwise outside of a health warning. That claim would need to be carefully worded and adequately tested with consumers to ensure satisfaction of the MRTP requirements, including consumer comprehension.”
The FDA’s use of the word “imply,” however, is confusing. Is the agency attempting to determine how the general public may or may not interpret a statement without doing any reasonable research? Is the research of the wording a responsibility of the applicant? Solyst says he’s not sure. It’s hard to guess as to the FDA’s intent. “We believe that what they’re basically saying is that because there are the existing warning labels, they’re not going to remove them. They don’t address this specifically, but if you look back at the 2015 decision, the inference would be that had there not been a warning label at all, that’d be a different story,” says Solyst. “Because there is already a warning label, they’re not inclined to remove it no matter how much evidence we present.”
Public interpretation
Further muddying the waters, SM also asked to revise a third warning statement to say that General snus products present “substantially lower risks to health than cigarettes.” This seemed fair considering the FDA’s PMTA response that General snus products were 97 percent safer than similar products. Even the FDA’s review of the submitted scientific evidence for the MRTP concluded that “General snus products, as used by consumers in Sweden and Norway, may pose substantially lower health risks to individual smokers who switch completely to these products for some health outcomes, such as lung cancer or chronic obstructive pulmonary disease.”
Conversely, the FDA again claims that there is insufficient scientific evidence to support the claim, as would be implied by a generalized statement about health risks as compared to smoking. “However, as with the evidence related to mouth cancer, the evidence on relative health risks provided by Swedish Match may support a different explicit claim, such as one outside of a health warning providing information concerning the differences in specific health risks, if the claim is carefully constructed, and adequately tested,” wrote the FDA.
Why the FDA is trying to speculate at public interpretation is anyone’s guess. The agency may be losing sight of the bigger picture by being so vague and secretive. “We think that telling smokers that these products are 97 percent safer than similar products is the key message; this message is getting lost,” says Solyst, adding that maybe the FDA wants SM to take more of a relative risk approach. “Should our claims be that this product is significantly less risky than other products? That very well could be what they’re saying. The main message is, to us, that they’re not going to remove the current labels, but that doesn’t mean they wouldn’t consider other marketing claims. They seem to want us to continue this process. They gave us options, and one of those options was to present different claims. That’s why we need more information from them. What exactly do they mean by that; what evidence would be necessary to go that route?”
Spread the word
Looking back at its PMTA approval, Solyst says another frustration with the FDA is that the CTP didn’t really attempt to get the word out to the industry surrounding the significance of the first PMTA issued. The CTP decision was of global, and possibly even historical, significance. It was the first time any public health regulatory agency had made such a decision (allowing a new, safer tobacco product on the market). “We would have liked to have seen the FDA make more of it. Maybe they will, in the future, but that has been the frustration, which is: We agree with the decision; we just wish it was better known among tobacco users,” Solyst says. “We understand that this is an ongoing process, and we’re not discouraged. We think we have a harm reduction product that has already received one very positive decision from the FDA [in the PMTA], and we expect to continue this process and secure the first MRTP.”
While continuing and completing the MRTP is important to SM and its vision of a “world without cigarettes,” Solyst says the story is much bigger. As a leader in tobacco harm reduction and the only company to successfully navigate the PMTA course, SM has an obligation to the industry to establish the process of navigating the MRTP minefield. “We’re the only company who’s gotten this far. We feel we have to try to understand what exactly it is that they want. We’re not just acting as a company or as a product, but as a leader in the industry,” he says. “We feel this obligation to demonstrate how this [MRTP] can be done, and that it should be able to be done in an efficient manner. We felt the same way about the PMTA process. Now that we’re the only one with a PMTA, and we think we will do future PMTAs, we have that obligation to set a standard and continue the fight.”
This year’s 
