Tag: gtnf 2020

Open Mic

The challenges facing the tobacco and vapor market
During the final session of the Global Tobacco & Nicotine Forum (GTNF), the future of this industry was put on center stage. The panel of experts suggested that regulation, taxation and confronting misinformation are going to be the major challenges that the tobacco and vapor industries will battle over the next 12 months.
In the U.S., the premarket tobacco product application (PMTA) process is going to be a major legal and regulatory focus, according to Stacy Ehrlich, partner at Kleinfeld Kaplan & Becker LLP. She said that while companies need to file PMTAs or standard equivalency (SE) reports, it is unknown how the U.S. Food and Drug Administration (FDA) will review these new products and enforce its rules.
“How wide will the FDA enforcement be over these products? Another regulatory key issue over the coming 12 months will be flavors in vapor and cigar products at all levels of government,” she said. “Flavors may increase initiation in youth … but they may also help move adults to lower risk products.”
So far, the only action toward flavors by the FDA has been to remove all flavors except tobacco flavors for closed pod systems. The absence of federal rulemaking has motivated some local and state entities to enact their own flavor bans. “What are unintended consequences of flavor ban?” Ehrlich asked. “A push towards the black market—push people back to smoking? What are the long-term impacts on public health? These are significant regulatory issues to watch in the coming year.”
The fight against misinformation will also be a major issue. David O’Reilly, director of scientific research for British American Tobacco, told attendees that the industry is still suffering from the effects of the e-cigarette or vaping product use-associated lung injury (EVALI) that began in mid-2019. That crisis was later found to be caused by vitamin E acetate in black market THC products and not any nicotine-based vapor products.
“What the pandemic might do, and the jury is still out on this, but it has brought science and evidence into everyone’s lives,” said O’Reilly. “There is an opportunity for this industry to use that science to promote harm reduction and bring this information to consumers and make them more savvy, and maybe they will look at the different products and brands [and move to a less-harmful product].”
Another effect on the industry caused by the pandemic may be on packaging. Omar Rahmanadi, CEO of BMJ, said that before the pandemic, there was a pressure through social media and from political groups to lessen the use of single-use plastics. The pandemic, however, has caused a major increase in the use of such plastics because of the massive need for gloves and masks. When the pandemic ends, there could be a major pushback toward removing single-use plastics from the market completely, Rahmanadi speculated. “It’s only a matter of time before the vapor and tobacco industries are pressured to use less single-use plastics,” he said.
Sally Satel, resident scholar at the American Enterprise Institute and psychiatry lecturer at Yale University, said that for any innovation or regulation to be implemented properly, the industry needs “a massive public reckoning of the truth” about the advantages of switching to vaping from combustible cigarettes. For example, there has been a move toward negative science and studies in recent months, she says. The World Health Organization (WHO) endorsed a vaping study centered on heart disease that was later retracted. The study, which appeared in the Journal of the American Heart Association (JAHA), was written by Dharma Bhatta and Stanton Glantz of the University of California, San Francisco, and concluded that “Someday and everyday e‐cigarette use are associated with increased risk of having had a myocardial infarction, adjusted for combustible cigarette smoking.”
Another study from Rutgers University found that 80 percent of doctors wrongly believe nicotine causes cancer. It also took the Centers for Disease Control months to clarify that EVALI was caused by black market THC vapor products. “This paints a fairly grim picture of what we are up against,” said Satel. “And all of this while allowing cigarette sales to go undisturbed while putting barriers on devices that are a great benefit to public health.”
Whatever the challenges facing the tobacco and vapor industries, answers are out there, according to David Sweanor, adjunct professor of law at the University of Ottawa. He said several countries have lessened restrictions on next-generation tobacco products in recent years, and that has had a ripple effect in the tobacco industry. Cigarette sales have slumped.
“We have seen what happens in other countries when we see a slight lessening of restrictions on these [next-generation] products like we have seen in Japan … Norway, Iceland, Sweden. These aren’t places that are actively trying to see how rapidly ending smoking is happening; it was just the effect of lessening restrictions,” explains Sweanor.
“What would happen if any jurisdiction in the world wanted to see how rapidly they could get rid of cigarettes? … Good policy is contagious. It would be very hard to resist if we saw something like that happen on a major scale to end smoking. Any country that gets that right—backs new technology—could save hundreds of millions of lives and possibly even create a new technology sector for its economy.”
October 24, 2020
Eliana Golberstein

Eliana Golberstein
Eliana Golberstein, a scientist at Myriad Pharmaceuticals and chief of standards at the Vaping Trade Association of New Zealand, shared her views on vaping from a pharmaceutical perspective. Harm reduction, she said, is about the world we live in—not the world in which we want to live. And while it is impossible to eliminate risk, it is perfectly possible to reduce risk. Golberstein used the analogy of driving, an inherently risky activity. “But we don’t stop people from driving,” she said. “We implement seatbelts, build infrastructure and provide education to minimize the risk while respecting people’s freedoms.”
Similarly, smokers can reduce the risk of nicotine consumption by switching to e-cigarettes, which satisfy their cravings without the disease-causing products of combustion. E-cigarettes, she said, present a fraction of the risk of combustible products, and the small risks they do present can be mitigated by product design. “Every time we learn about substances that can be of concern—especially those that come from flavors—we can use rational design to remove them or reduce exposure,” said Golberstein.
She stressed that toxicity is about relativity. Half a century before Professor Michael Russel made his famous observation that people smoke for nicotine but die from tar, Swiss Alchemist Paracelsus noted that all substances, in sufficient amounts, are poisonous. “All things are poison, and nothing is without poison. Solely the dose determines that a thing is not a poison,” Paracelsus said.
For vapor product designers, this means keeping the levels of potentially harmful compounds below the highest concentration at which no adverse effect is found.
Vapers can further mitigate their risk by following best vaping practices. That starts with product selection, by buying devices manufactured by reputable manufacturers. Poor airflow, below-standard coils and unsafe settings in unregulated mods can enable the generation of undesirable compounds through excessive heat. Inexperienced vapers would do best by sticking with regulated closed pod systems or simple ready-to-use kits, according to Golberstein.
October 23, 2020
Jonathan Foulds

Jonathan Foulds
Nicotine is addictive. Most people who have smoked 60 cigarettes are going to be daily smokers. According to Jonathan Foulds, professor of public health sciences and psychiatry and co-director of Penn State Center for Research on Tobacco and Health, the average middle-aged smoker has made about 20 serious attempts to quit. After deciding to try to quit, the average smoker has a 95 percent chance of still smoking a year later. Even with counselling and using a U.S. Food and Drug Administration (FDA)-approved cessation medicine, there is still an 80 percent chance they will be smoking again in a year.
Speaking during the Global Tobacco & Nicotine Forum (GTNF), Foulds said that people smoke for the psychological effects of nicotine, but they suffer the health effects created by inhaling combustible tobacco. To lessen the harms of nicotine consumption, regulators should focus on ways to get cigarette smokers to switch to less-risky forms of nicotine intake.
“If it were not for the nicotine in tobacco smoke, people would be little more inclined to smoke than they are to blow bubbles,” he said. “Blowing bubbles is fun, but no one wants to do it 20 times a day for the rest of their life. It’s the nicotine that’s key to [people smoking].”
Despite the addictiveness of nicotine, cigarette consumption in the United States has been falling consistently over the past 20 years. Cigarette consumption has fallen more than 50 percent since 1997. That is equal to approximately 200 billion fewer cigarettes being sold per year since 1997, and there are now many more people in the U.S. Foulds said there is also evidence that the decline has been accelerating over the past few years [alongside the growing popularity of vapor products].
Meanwhile, youth smoking rates have declined dramatically. In the 1970s, an average of 30 percent of high school seniors smoked cigarettes. In 1995, that number dropped to 25 percent. Today, less than 2 percent of high school seniors smoke cigarettes.
“The massive cigarette sales that the industry has been used to—clearly, that is coming to an end. I mean, the end is in sight from the cigarette industry,” Foulds told the GTNF audience. “What I’m trying to get across here to many of you—who are from the industry—is that we may be coming to a tipping point where it would be much better, rather than to just fight [regulators], it may actually be a wiser strategy to accept that this is happening sooner or later in terms of cigarettes and get ahead of it and embrace it.”
For cigarette manufacturers to survive, Foulds said they must promote less-risky forms of nicotine intake. Lower nicotine cigarettes are one example of how manufacturers can help push people to other products, such as e-cigarettes. He was unconcerned about consumers compensating for lower amounts of nicotine by smoking more cigarettes. “There’s now a bunch of studies—almost a dozen studies and they’re fairly consistent—showing that compensatory smoking really isn’t a thing that happens with these kinds of cigarettes,” he said. “The smokers learn pretty quickly that they can puff as much as they like, and they’re not going to get any satisfying amount of nicotine out of them.”
Another concern is that if only lower nicotine cigarettes are available, this would push smokers to the black market for higher nicotine cigarettes. Foulds says several studies have shown that that is not true. Smokers would be more likely to move to products such as e-cigarettes and heat-not-burn systems to get the nicotine they crave.
E-cigarettes are not without health risks, according to Foulds. “They are likely to be far less harmful than combustible tobacco cigarettes,” he clarified. “E-cigarettes contain fewer numbers and lower levels of toxicant substances than conventional cigarettes. There’s been more and more evidence that e-cigarettes deliver far, far lower levels of harmful toxicants than cigarettes. It’s become very, very consistent … e-cigarettes can help people quit.”
If regulators allow high-nicotine, reduced-harm products, like e-cigarettes, to remain in the market, Foulds says that it is highly likely that many current smokers will reduce their smoking, quit or switch to reduced toxic-exposure products, resulting in a substantial improvement in overall public health. “It is time for major cigarette manufacturers to support nicotine reduction in combustibles as perhaps their best chance of still being in business in 2030,” he said.
October 23, 2020
Marewa Glover

Marewa Glover
Constraining the Overton Window
Marewa Glover, director of the Centre of Research Excellence on Indigenous Sovereignty and Smoking in New Zealand, drew analogies between the Covid-19 response and tobacco control. Smokers are a minority, and most people don’t care how they are treated, she said.
Now, however, with similar strategies being employed to achieve compliance with governments’ Covid elimination policies, many are balking at being subjected to similar disrespect for their autonomy. “The authoritarian restrictions on what they can do and the dirty looks when not wearing a mask where it is being advised […] If you have experienced any of that, now you know what it is like to be a smoker in New Zealand or a vaper in Sweden where the public have been incited by government to police and punish people who disobey the rules,” Glover said.
As in the formulation of antismoking policies, authorities have been cherry-picking their counsel in the fight against the coronavirus, according to Glover. “Many public health experts have advised against lockdowns because of psychological and economic losses,” she said. “But their voices have been ignored—a familiar pattern from tobacco control.”
Glover warned that Covid has been exploited by power-hungry governments to blast open the Overton Window—the range of policies acceptable to society. “A public health argument now starting to be voiced is that if government and the public were willing to do what they had to do to eliminate Covid, then they should allow public health to employ similarly excessive strategies to end smoking and all nicotine products,” she said.
Glover further noted that New Zealand rammed through its new vaping regulation during the first lockdown. “We had to prepare and submit concerns during lockdown,” she noted. “Those who wanted to present to the Health Select Committee overseeing the proposed legislation had to do it via Facebook live—a prohibitive process for many.”
While New Zealand came out of the “quit-or-die-versus-harm-reduction brawl” better than Australia or India, according to Glover, she described the legislation as a “highway to prohibition.” Unlike tobacco, which can still be sold in corner stores, vapor products may be sold only in specialized shops, which require a license, she said. “The Ministry of Health can change the rules or increase the fees at any time, allowing it to strangle the vapor industry out of existence.” New Zealand, she cautioned, is not a model to be followed.
October 23, 2020
The Fight Against Illicit Trade

Where next?
Illicit cigarette trade causes an annual worldwide revenue loss that is estimated at $40 billion to $50 billion, which means that about 600 billion cigarettes, or 10 percent of global consumption, comprises illegal product.
The European Union (EU) is one of the major targets, with illicit cigarette consumption in 2019 amounting to 38.9 billion cigarettes, or 7.9 percent of all cigarettes smoked in the region. With €7.8 billion to €10.5 billion per year, the profit of illicit cigarette trade is comparable to that of the cocaine or heroin markets, making it a “crime enabler” and financer of organized crime and terrorism.
Over the past years, the nature of illicit cigarette trade has changed: The countries of origin are increasingly located in the Middle East. Today, the fakes are primarily cheap whites manufactured closer to their destination markets, with the number of illicit factories in the middle of Europe having risen significantly.
In response to this trend, Europol has adapted its structure. The EU law enforcement agency now works closely with liaison bureaus in all EU member states, according to Simone Pierre di Meo, senior specialist, head of office and project manager of Analysis Project Smoke at the European Financial and Economic Crime Centre for Europol.
As the cash flow generated by illicit trade activities is huge, Europol has come to focus on tracking the money. In June, the agency launched a European economic and financial crime center that is aimed at strengthening the cooperation between EU member states to promote the consistent use of financial investigations to combat illicit crime.
In the fight against contraband cigarettes, getting the support from the public is essential. The nongovernmental organization (NGO) Crime Stoppers International supports law enforcement efforts to prevent and solve crime by mobilizing citizens to anonymously share information about suspected illegal activity. According to CEO Shane Britten, the organization will, over the next 12 months, focus on raising governments’ awareness of the links between illicit trade syndicates and groups involved in criminal activities, such as human trafficking, wildlife smuggling or terrorism.
Attempts to curb smoking through disproportionate tax increases has provided fertile ground for illicit trade. Malaysia provides a cautionary tale: As of August 2020, 65 percent of the country’s tobacco market was illegal, according to Cormac O’Rourke, general manager of Japan Tobacco International (JTI) Malaysia.
Before a significant tax hike in 2015, contraband cigarettes accounted for around 35 percent of the market; since then, the country has become the country with the world’s least affordable legal cigarettes. A sophisticated system of illegal syndicates, which have been able to infiltrate state agencies, has made it difficult to tackle the problem. Illicit cigarette trade costs the Malaysian government approximately $1 billion in lost tax revenues annually. The country has a coastline of almost 4,700 kilometers. Most illegal cigarettes are brought into Malaysia on container ships from countries such as Indonesia, China and Vietnam.
Declared as nontaxable transshipment goods destined for a third country, they are not examined by customs. Instead of being shipped to their destinations, however, the smokes are smuggled into Malaysia. The practice is called transshipment. To address the long-standing issue, Royal Malaysian Customs in January 2020 established a multi-agency task force, which has paved the way for a public-private sector partnership.
The Covid-19 pandemic is likely to further aggravate the global cigarette contraband situation. A report commissioned by JTI, which was conducted across 50 countries where tobacco smugglers currently have a strong presence, found that the global public health crisis and financial downturn has contributed to a “perfect storm” where organized criminal groups will further exploit public demand for cheap goods and capitalize on dwindling buying power in the impending global recession, particularly in countries with high tax regimes.
As Ian Monteith, JTI’s global anti-illicit trade operations director, pointed out, criminal gangs were biding their time in readiness for an anticipated boom in illegal tobacco sales. They then quickly exploited the inconsistent approach to travel and lockdown rules and found alternative routes from production to distribution, and they used the limited supply in legal cigarettes brought about by changed law enforcement priorities and border restrictions.

October 1, 2020
Roberto Sussman

Vapor products didn’t begin to take hold in Latin America until 2009. They took the region by surprise. Everyone, including regulators and tobacco industry controllers, were “caught with their pants down,” according to Roberto Sussman, senior researcher and lecturer at the National University of Mexico and founder and director of Pro-Vapeo.
“The reaction was pure panic,” he says. “Tobacco controllers immediately wanted to prohibit the devices. The WHO [World Health Organization] was also afraid of them. In Mexico, tobacco controllers and a lot of physicians pressed a regulatory agency called COFEPRIS to ban them outright.”
In 2012, Mexican officials banned the marketing of e-cigarettes. However, Mexico’s tobacco laws were designed to ban candy cigarettes not regulate a market disruptor, according to Sussman. In 2015, the Supreme Court in Mexico ruled that the ban on marketing was unconstitutional. Now, Mexico, along with many other Latin American countries, has what is referred to by Sussman as “a tolerated nonregulation,” where regulators, tobacco control entities and other public bodies have become the “visceral opposition and [purveyors of] nasty misinformation campaigns.” The regulators started to take the same approach as the WHO, explains Sussman.
“These are nongovernmental organizations (NGOs) sponsored by Bloomberg Philanthropies and associated charities like the Campaign for Tobacco-Free Kids, acting in synergy with small but influential groups of health professionals clustered in the tobacco control sections of government public health institutions. But at the same time, despite all this, the usage of the devices became socially accepted,” he explains. “It was tolerated even in many indoor spaces. Vaping started to boom. In Mexico, we estimate that we have 1.5 million vapers.”
Speaking during the 2020 Global Tobacco & Nicotine Forum (GTNF), Sussman told attendees that Mexico also has its own small, self-regulating vapor industry that produces e-liquids. Like many other countries, Latin America gets its hardware from China. While rules are fluid from country to country, Sussman says vaping was still helping people quit combustible cigarettes. This meant vaping itself was not a big concern for the most authorities.
In the last five years, the vapor industry in Latin America has changed, says Sussman. E-cigarettes are illegal in Brazil, Mexico, Argentina and Uruguay. These are the countries with the strictest rules against vaping. Vapor products are legal [with heavy restrictions] in Costa Rica, Guatemala, Columbia, Paraguay, Ecuador, Chile and Panama. Regulators, however, still did not see regulation as a priority in any of these countries. “The products were in a sort of nonregulation gray area,” Sussman says. “Regulators had better things to do and a lot of other things going on.”
Then, two events further changed the course of the vapor industry, especially in the region’s largest market, Mexico. First, says Sussman, the Mexican people elected Andres Manuel Lopez Obrador, and his MORENA party is now in control of both houses of congress. Mexico had not seen this degree of centralization of political powers since 1997.
“One of the most powerful officials in the government of Lopez Obrador is Dr. Hugo Lopez-Gatell. He’s an epidemiologist, and he has strong links with the Pan American Health Organization and with Bloomberg Philanthropies. He’s also the health minister. And at the same time, together with this appointment was a massive increase of lobbing activity by Bloomberg Philanthropies in the whole region,” says Sussman. “This [is] how Bloomberg works in our countries. First, they set up NGOs that they use as lobbying machines. This lobbying is done through the WHO or the Pan American Health Organization. Now, health ministries and government, they get grants from Bloomberg, but they will never say [that].”
Second, the U.S. Centers for Disease Control and Prevention (CDC) announced they had reason to believe a dangerous, newly identified lung disease was linked to vaping. The acronym EVALI (e-cigarette or vaping product use-associated lung injury) was born.
“The use of EVALI to spread fear [of] nicotine vaping in Mexico and in Latin America was particularly crude, dishonest and more intense than in other places. Up to this day, all officials of the health ministry in Mexico are still blam[ing] nicotine vaping,” says Sussman. “And when you try to engage them, they say, ‘No, no, no. That’s it. Full stop. End of discussion.’ That’s it.” EVALI has since been found to be caused by illegal THC vape pens not nicotine-based e-cigarettes. Sussman says no one has told Latin America.
The misinformation surrounding e-cigarettes and their role in EVALI persist. Earlier this year, Mexico’s president signed legislature prohibiting the importation, manufacture and distribution of all noncombustible tobacco products, including heat-not-burn products. “Their justification was that we need to protect Mexican youth from EVALI. Given the proximity of the U.S., this epidemic can come to Mexico any time,” says Sussman. “Pure fear-mongering, and they’ve refused all debate.”
Sussman says the true objective of prohibition is to prevent the tobacco industry from introducing noncombustible tobacco products. Regulators and anti-vaping groups also want to destroy the existing distribution network of vape shops and the emerging local e-cigarette industry. “Like all regulations surrounding vaping products, this is failing because vaping still operates in Latin America and in Mexico not exactly through black markets, but through the informal sector,” explains Sussman. “And it is very widespread. Nevertheless, the WHO will praise the Mexican government for implementing this ban.”
Then came the Covid-19 pandemic. Now these same groups have begun to blame the spread of Covid-19 on vapor products, even though there is no record of any vaper being hospitalized or progressing to severe stages of the disease or death. Even combustible smokers are underrepresented, according to several studies.
Now, according to Sussman, more regulations and more enforcement are on the horizon. This time, The Union, a global scientific organization that says it is working to improve “health for people in low-[income] and middle-income countries” (LMICs) is stepping into the fray. Sussman says the group plan for vapor regulations is a “pernicious technocratic fantasy that is completely detached from the realities of smokers and health institutions” in Latin American countries. The Union’s plan is simple: total prohibition.
The Union justifies outright prohibition with arguments allegedly based on the need to comply with the tobacco control policy advice of the WHO’s Framework Convention for Tobacco Control (FCTC), an international treaty on tobacco regulation sponsored by the WHO, which has been signed by more than 180 countries, including most LMICs. At first glance, these arguments might look reasonable, but a closer look reveals that they are real recipes for disaster, says Sussman.
October 1, 2020
Oral Tobacco

New oral tobacco products have the power to dethrone cigarettes as the leader in nicotine delivery.
Think of combustible cigarettes as dinosaurs. Regulators want them to become extinct. Next-generation oral tobacco products are like the furry little animals scurrying about under the feet of the dinosaurs. These small creatures have the potential to take over when the dinosaurs are gone.
This analogy was presented to attendees of the recent Global Tobacco & Nicotine Forum (GTNF) by health behavior consultant Cheryl Olson while moderating the panel “Oral Tobacco Products — The Road Less Travelled … Until Now?” Olsen said that oral tobacco products are growing in market share and are less-risky alternatives to combustible cigarettes. However, getting consumers to make the switch to any less-risky product is difficult, especially an oral product that doesn’t mimic any of the properties of a combustible cigarette.
Karl Fagerstrom, clinical psychologist at the Smokers Information Center in Sweden, said that a cigarette and an oral product are very different objects, and it can be difficult for smokers to switch from a cigarette to a pouch-style product that is designed to be held between the upper lip and gum. Smokers become addicted to the mouth feel and other properties of the cigarette, not just the nicotine. “The reason for this difficulty is that an individual’s dependence to a drug or whatever is tied to a product. Our brains are not craving an invisible substance but the object that contains the substance,” he explained. “In many circumstances, the individual may not even be aware of the dependence to the substance.”
George Adams, cardiologist for Rex Healthcare at the University of North Carolina Chapel Hill, said that the behavior that goes into the thought process of people who smoke is more personalized than what most people would think. He explained that there are different reasons that people smoke and use these different types of nicotine-delivery systems. He said that a major difficulty in getting smokers to switch are the misconceptions surrounding nicotine in general.
“There’s multiple different products. There are multiple technologies out there. Going from smokeless tobacco products to vaping, gums, pouches, tablets. I mean there’s a whole host of them rather than just the combustible cigarettes that we commonly know,” he said. “As a practicing physician, the thing is that we are not educated on these types of different products. When we think about beneficial effects of choosing products, to help our people who smoke, that causes detrimental effects.”
Doctors are untrusting of the tobacco community, according to Adams. This has led to a disconnect between the science conducted by tobacco companies and health professionals. “I think it’s a detriment to the patients not to have a collaborative effort between the two entities to figure out the best solutions [to help people quit smoking]. We [doctors] are ignorant. We don’t have enough education in terms of the products that are out there and the benefit that they could possibly offer [to our patients],” said Adams. “We know that nicotine is a stimulant; how it affects at the cellular level. And there’s a large group of us—or physicians—that believe that all nicotine products are the same.”
Fagerstrom said that the misconceptions surrounding nicotine are a detriment to public health. He said that many physicians and consumers wrongly believe that nicotine “causes cancer … is causing cardiovascular disease. He believes these misconceptions are the main reason next-generation tobacco products like oral have such difficulties gaining mainstream acceptance.
Adams agreed that many doctors wrongly believe nicotine causes cancer. This makes it difficult for them to recommend any product that contains nicotine, even if a product is 95 percent less harmful than traditional cigarettes. He said the mistrust between the tobacco and health communities runs deep, and doctors do not understand all the different types of nicotine-delivery systems. “It’s a lack of education,” he said.
Mohamadi Sarkar, scientific and regulatory strategist at Altria, said that oral tobacco products have been shown to be safer than combustible cigarettes. He said the vision of oral products is grounded in the foundation of the continuum of risk, which has not only started to gain acceptance in public health but has also been embraced by the U.S. Food and Drug Administration (FDA). “Combustible products are in the extreme end, and noncombustible products, including inhaler and oral products, are on the other end of the spectrum.”
Sarkar showed attendees the results of a study he conducted on harmful and potentially harmful constituents (HPHCs) in oral products compared to traditional cigarettes. “The levels of many of the HPHCs are either not detectable or below levels of quantification. Harmful carcinogens and [other chemicals] are not even detectable,” he explained. “It’s not surprising that these products will completely either eliminate or substantially reduce the exposure to HPHCs, and if this is sustained on a long enough time period, we expect that they would also see a reduction in smoking-related diseases.”
Olsen said she conducted two primarily web-based surveys for another oral tobacco product. She said that her studies found that 43 percent of the never-smokers perceived a high or very high risk of getting a serious illness from using [the oral product] versus 18 percent of smokers not planning to quit,” she said. “And similarly, half of the smokers not planning to quit saw low or no risk versus a quarter of the never-smokers.”
Adams said the solution is education. The FDA needs to allow for better communication about the levels of risk in different types of tobacco products. Nicotine is dangerous and addictive, but if you [are] going to use nicotine, consumers should be able to choose the safest delivery method. “That is a testament to the lack of education that we have across the spectrum. You can’t just group everything together,” he said. “There may be a benefit with certain patient populations to get them off combustible cigarettes … but if you have a closed mind and your shutters are up, you’re never going to have the opportunity to help those patients because you don’t believe in them. It’s a lack of education.”
October 1, 2020
Innovations on the Horizon

In their comparatively short time in the market, electronic nicotine-delivery systems (ENDS) have revolutionized the consumption of nicotine. While the next big thing in the category remains anyone’s guess, the continuous developing pipeline of these products shouldn’t be underestimated. In the early days, a lot of innovation was inspired by consumers; these days, new developments mostly come from the leading ENDS manufacturers.
Regulations across the world have so far been rather friendly toward innovations, creating an open atmosphere for the industry to innovate, noted panelist Ming Deng, a professor at Yunnan University. In the U.S., the world’s largest market for e-cigarettes, which is often pointing the way for policymaking in other countries, all innovations are now regulated under the Food and Drug Administration’s (FDA) premarket tobacco product application (PMTA) guidance.
Critics say the long-winded, costly PMTA approval process was inherently designed to stifle innovation. Jon Glauser, co-founder and chief strategy officer at Demand Vape, believed the market would adjust but that it would take time for U.S. consumers to get new products.
Eve Wang, vice president of Shenzhen Smoore Technology Co., expected future innovation in the U.S. to focus more on demand of the existing consumer following FDA approval requirements. She was confident that U.S. consumers would still have choices for devices and e-liquids as companies could plan innovation rather than rushing into something.
James Xu, CEO of Avail Vapor, said that with FDA approval as a barrier, small players would disappear, but bigger players would invest more. Furthermore, they were able to collect data in, for example, Asian markets in order to access the U.S. market. Development of new products, he stated, now was a more meaningful, thought-through process.
While the time PMTA orders take to be processed (they can take up to two years) represents a major hurdle for innovations to be marketed, the guidance has led to significant investments in ENDS manufacturers’ in-house lab facilities, enabling them to better evaluate their products. Due to FDA regulation, the amount of scientific data and studies on ENDS has increased significantly, which panelists hoped would contribute to the public’s understanding and differentiation between ENDS and combustible cigarettes.
For the switch from cigarettes to ENDS, flavor bans or partial bans in the U.S. were counterproductive, according to the panelists. A large variety of flavors offering former smokers more choice is pivotal to the category as only a small percentage of first-time switchers is interested in tobacco flavors. Besides, studies have shown that smokers who start using ENDS without tobacco flavors are more likely to stay away from combustible cigarettes. The benefit of flavor bans, however, was that they forced e-liquid manufacturers to work on their tobacco flavor liquids, Deng said. If that happened, he predicted a switch time 10 times as high as the current one.
As far as ENDS sales in 2019 and 2020 are concerned, Glauser spoke of a perfect storm: Last year’s EVALI crisis, followed by partial flavor bans, PMTA regulation and the Covid-19 pandemic, have had quite an impact on the U.S. vapor industry. Jonathan Ng, global head of external affairs for Relx Technology, criticized the misinformation spread during the EVALI crisis, saying that more consumer education was needed and required to be allowed. For the better information of the public, Deng suggested publications on ENDS in leading magazines such as Nature whereas Glauser saw the responsibility of consumer education with the industry.
October 1, 2020
Population Modeling

Population modeling has a major influence on the regulatory framework of tobacco products.
Population modeling is a key component in meeting regulatory requirements for traditional tobacco and next-generation tobacco products, such as oral and electronic nicotine-delivery system products. Population modeling is a complex process that requires vigorous fundamental procedures for safeguarding clean data, proper computing platforms, suitable resources and effective communication.
Saul Shiffman, senior scientific advisor of behavioral science, study design and analysis at Pinney Associates, said population health is at the center of the U.S. Food and Drug Administration’s (FDA) framework for regulating tobacco products.
“We want to understand what the impact is of the entire population. And that includes people who perhaps are intended to use the product, such as the adult smokers, and people who are not intended to use the products, so those former smokers or perhaps youth,” said Shiffman. “So, there’s a balance of benefits and harms, and the purpose of modeling is to integrate all of those to look at the net effect.”
Although there are many ways that researchers can implement population models, the basic principles are simple, according to Schiffman. The model defines the transitions or flows between the stages of tobacco use (going from being a never smoker to a smoker and going from being a smoker to being an abuser of cigarettes). “We start with a model that’s referred to as the base case—that is, what does the world look like now before a policy change or product introduction?” he explains. “And then, we contrast that to [a] counterfactual case, which is basically what do we expect to happen once this policy change or product introduction is implemented?”
Everyone models. They just do it very informally, said Shiffman. “If you [or] someone has ever thought to themselves, ‘How much does the harm that a new product might do to youth compare to the benefit to adult smokers?’ you’re doing modeling,” he said. “You’re just doing it nonquantitatively, intuitively. [What experts] have done is to do it very systematically and quantitatively.”
Ray Niaura, professor of social and behavioral science for the College of Global Public Health at New York University, said that conventional statistical analyses of data gathered is all about the past. It’s analyzing what happened, and by definition, the results are the results—it’s over and done with. However, population modeling is very different.
“It’s very hard to look at what happened in the past and project that into the future without a formal toolbox and framework to do that, and that’s what modeling represents,” he said. “It’s really the tools that allow us to go from the past to the future, the multiple futures. Any other statistical analysis just does not permit it. So, that’s why population modeling is a great set of tools.”
Population models are based on complex algorithms, according to Ryan Black, senior director of psychometrics, analytics and methods at Juul Labs. However, at its core, it’s quite straightforward.
“It really is. It’s posing the question whether or not—in the tobacco regulatory research—more people are going to move down the continuum of harm versus move up, and it does a fair assessment, taking into account both beneficial pathways—that is, cigarette smokers switching exclusively to noncombustible products as well as initiation, as well as relapse,” he said. “But a model is only [as] good as its inputs.”
Benjamin Apelberg, director of the Division of Population Health Science at the Center for Tobacco Products in the Office of Science at the FDA, said that Black touched on one of the more challenging questions faced by tobacco companies: trying to understand how new products, novel products, are going to behave once they’re on the market.
“Ultimately, it tends to be a kind of triangulation of different types of information that can be informative in a premarket setting. Sometimes we see actual use studies, so over a short period of time trying to understand how consumers respond to a product. We’ve seen experimental studies, consumer perception studies trying to understand at least the marketing and the positioning of a product.”
Schiffman said that while modeling is a powerful tool, it isn’t perfect. He said an example of the fallacies can be seen in most surveys pertaining to youth use. “I’m thinking here not about publications, but what’s in the press often neglects the fact that when they’re talking about use, they’re talking about any use in the past 30 days,” he said. “Someone who had a puff on a friend’s cigarette at a party is counted as a user, and that obviously leads to confusion because that has no health impact, and yet it’s what we count as use.”
According to David Levy, professor of oncology at Georgetown University, models become useful in not what they tell researchers but in that they suggest what is important. “We live in a world that can be simplified … what models can do is get us started thinking about what factors are important,” he said. “They ultimately tell us what pathways are important.”
October 1, 2020
Communication

The modified-risk tobacco product (MRTP) authorization comes with challenges. The brand needs to communicate its message to adult smokers without allowing youth to misconstrue the risks of using nicotine products. That is the conundrum faced by the two companies who currently have MRTP authorizations from the U.S. Food and Drug Administration (FDA).
During the Global Tobacco & Nicotine Forum (GTNF) held in September, Robyn Gougelet, director of health policy and regulatory strategy at Pinney Associates, moderated a panel representing 100 percent of the companies that have earned an MRTP designation: Swedish Match and Philip Morris International (PMI). Currently, three other products are under MRTP review by the FDA: 22nd Century’s low-nicotine cigarettes, Camel brand snus and Copenhagen snuff.
The panelists agreed that the MRTP authorization is complicated for consumers to understand. Consumers may think a product is safe or “FDA approved,” and this is not true. So, manufacturers are challenged to find a way to explain what the MRTP order means without confusing the consumer. The message must also be conveyed in a way that does not entice youth to try the products. The panelists said that none of the organizations they represent have perfected the process of communicating the MRTP’s complicated messaging. However, “helping people to understand how this process works is imperative,” said Gougelet.
Clifford E. Douglas, director of the Tobacco Research Network and an adjunct professor in the Department of Health Management and Policy at the University of Michigan School of Public Health, said that tobacco companies have to navigate a difficult path in collecting youth data. Douglas said he could not offer any advice on how tobacco companies should proceed, and he was “unclear on [any] best approach” to collect the youth data. “In the end, there has to be careful attention given to what is happening with youth use of products and the dynamics of youth use,” he said. “It also has to be done in real time … the data on youth use, it moves month-to-month.”
In a note on its website, the FDA states that to receive an MRTP order, a company must establish that submitted modified-risk data for a product is supported by scientific evidence, which 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.” Gougelet says that companies struggle with helping consumers understand the claims being made as well as the potential risks.
Tryggve Ljung, vice president of scientific affairs at Swedish Match, which received an MRTP authorization for its General brand snus products last year, says that while he understands why the Swedish Match claim reads like it does—it’s very evidence based—he fails to grasp how the message can be effective from a communications viewpoint.
In June of 2014, Swedish Match filed an MRTP application for its General snus brand. It was the first such application to ever be accepted for review by the FDA. In mid-December 2016, the FDA 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.
Then, on Oct. 22, 2019, the FDA announced for the first time that it had authorized the marketing of products through its MRTP pathway. The authorization order allowed Swedish Match to market these specific products with the claim, “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.”
The FDA stated that it had made this authorization after reviewing scientific evidence submitted by the company that supports the claim. To help prevent youth access and exposure, the agency also placed stringent advertising and promotion restrictions on the products, including a requirement to restrict advertising to adults.
“It has helped to transform the company and the market,” Ljung told attendees. “It was a learning experience for both us and the FDA … it’s changing the industry.”
There are two types of MRTP orders the FDA may issue: a “risk modification” order or an “exposure modification” order. PMI’s IQOS tobacco-heating system was the second product to receive an MRTP and the first tobacco product to receive “exposure modification” orders, which permits the marketing of a product as containing a reduced level of or presenting a reduced exposure to a substance or as being free of a substance when the issuance of the order is expected to benefit the health of the population.
Moira Gilchrist, vice president of strategic and scientific communications at PMI, says the important aspect of the MRTP order is that it allows for exposure reduction communication, information PMI believes can help guide consumer choices toward less risky products.
“The IQOS authorization was a validation for what we set out upon as a viable path … IQOS has the potential to not only benefit health across the United States but also around the world,” explained Gilchrist. “The decision was an important milestone for our industry overall. Now we have a really clear example of evidence-based decision making that was done in an inclusive and transparent way and really clearly recognizes a continuum of risk.”
Gougelet said that the MRTP review is one of the most transparent regulatory processes. A company’s MRTP application is available for the public to review. The application also goes before the FDA’s Tobacco Products Scientific Advisory Committee, a panel created to provide advice, information and recommendations to the FDA commissioner on matters related to the regulation of tobacco products. “It is important for everyone to remember it didn’t end with a ‘yes’ decision. There is continual oversight,” she explains. “In order to remain on the market, we have to be able to show that the product is appropriate for public health through its entire life cycle.”
The MRTP authorization requires the company to conduct post-market surveillance and studies to determine whether the MRTP orders continue to be appropriate, including assessing the potential for increased use among youth. Ljung said that Swedish Match has been carrying out its post-market study, but “it’s too early to say” what the data shows about consumer understanding of the MRTP authorization. Gilchrist said that PMI has submitted its plans for post-market surveillance to the FDA. She added that even though the company has not seen any data to support an uptick in youth use in other countries where IQOS is available, “we still think about it every minute of every day.”
Gilchrist added that people in public health were caught by surprise by the FDA’s decision to approve an MRTP application, especially the Swedish Match decision (because it was the first). She said she can understand why public health groups are cynical about large tobacco companies, but there is a general misunderstanding about how these products can help adult smokers and the guardrails the FDA put in place to prevent youth use and to stay abreast of developments to prevent it from happening. “Why this visceral reaction to hard work by scientists to figure out if a product is a benefit to public health?” she asked.
Douglas suspects U.S. tobacco control organizations view any FDA campaign placing e-cigarettes or heated-tobacco products in competition with combustible cigarettes as support for tobacco companies. “If the industry favors it, it immediately becomes suspect,” he says. “There are strong feelings about distrust on both sides.”
Another worry for both regulators and tobacco companies is that the “public in general, not to mention the medical community, suffers from a significant misunderstanding” of nicotine, according to Douglas. This is supported by a recent study from Rutgers University, published in the Journal of General Internal Medicine, that concluded that most specialists from fields that treat lifelong smokers believe that nicotine contributes to cancer, heart disease and chronic obstructive pulmonary disease.
“As long as people are under the misconception [of] the effects that nicotine has physically and pharmacologically and the role it plays in different products … it is going to, to put it bluntly, is going to screw up this whole process,” he said.

October 1, 2020