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  • Pondering Prohibition

    Pondering Prohibition

    Photos: Chris Frenzi

    The pitfalls of banning tobacco and nicotine

    TR Staff Report

    Mention prohibition and most people will think of the United States’ ill-fated attempt to eradicate the health and social problems associated with alcohol consumption by banning the manufacture, transportation and sale of intoxicating beverages in the 1920s. Rather than achieving the desired effects, the experiment fueled a wave of illegal manufacturing and smuggling while spawning some of America’s most notorious crime syndicates. In 1933, the federal government acknowledged defeat and repealed the law.

    Given prohibition’s poor track record, it’s tempting to conclude that the measure has been consigned to the dustbin of history. Surely, modern policymakers would steer clear of such a crude and ineffective tool? But as became clear during a panel discussion at the recent Global Tobacco and Nicotine Forum (GTNF), prohibition has been making a bit of comeback lately, even if its contemporary proponents are careful to avoid the term. As moderator Flora Okereke of BAT pointed out, 15 years ago, the concept existed only at the fringes of tobacco control. “Today it is mainstream,” she said. “At some point in the not-too-distant future, tobacco and even nicotine could be outlawed.”

    Okereke’s panel included experts with a variety of professional backgrounds: Christopher Snowdon, head of lifestyle economics at the Institute of Economic Affairs; Abrie du Plessis, trade law consultant; Kgosi Letlape, president of the Health Professions Council of South Africa and president of the Association of Medical Councils of Africa; Simon Clark, director of the smokers’ rights group Forest; and Riccardo Polosa, full professor of internal medicine at the University of Catania and director of the Center of Excellence for the Acceleration of Harm Reduction.

    During a skillfully guided, hour-long debate at the Hay-Adams hotel in Washington, D.C., they examined the drivers and consequences of the new prohibition movement and offered suggestions on how tobacco regulation might more sustainably evolve to embrace harm reduction instead of prohibition.

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    Snowdon started by noting that, despite the negative U.S. experience with alcohol, prohibition has always been the natural conclusion of the anti-smoking campaign. “Prohibition somewhere is probably more imminent than some people think,” he said, pointing to New Zealand’s recently announced policy of gradually raising the age at which consumers can buy tobacco until it covers the entire population and the United States’ plan to require tobacco companies to reduce the nicotine in their products to a level at which nobody would want to smoke. “Both are variations of prohibition,” said Snowdon, but neither country is calling it that, instead using euphemisms such as “tobacco-free generation” and “endgame.”

    The panelists identified several reasons for prohibition’s revival, including pressure from advocacy groups, continued hostility to the tobacco industry and health ministers eager for approval from their colleagues and the World Health Organization.

    Other unfortunate examples of recent tobacco prohibitions include that in Bhutan (recently lifted in the wake of thriving illicit trade and concerns about cigarette smugglers spreading Covid), the ban implemented by the Islamic State terrorist group when it controlled swaths of Iraq and Syria, and the quickly reversed South African prohibition temporarily instituted during the Covid-19 lockdown.

    Clark observed that the threat of prohibition has never gone away. The temperance lobby from the start of the 20th century, he said, has simply reappeared under the guise of public health and devised a new strategy—creeping prohibition. As examples, Clark cited public smoking bans, which in some jurisdictions have expanded to include outdoor areas and even social housing, preventing people from smoking in their own homes. Britain’s ban on menthol cigarettes, he observed, has outlawed a product category that accounted for 20 percent of the domestic market.

    Meanwhile, England, Scotland, Wales and Ireland have all set dates by which they want their countries to be “smoke-free,” by which they mean less than 5 percent of adults smoking. According to Clark, those targets can be achieved only by further and excessive regulation. He was particularly disturbed by Philip Morris’ call on the U.K. government to ban the sale of cigarettes by 2030—a step that could very well backfire, according to Clark. “The day will surely come when alternative nicotine products, including e-cigarettes, will also be targeted for prohibition—as indeed they already are in some parts of the world,” he said.

    In recent years, prohibition has also been deployed under the guise of Covid prevention. Snowdon pointed out that, in 2020, one in five people lived in a country where you could not buy tobacco or e-cigarettes—mainly as a result of India’s temporary sales ban. But the most striking recent illustration of the risks associated with prohibition comes from South Africa.

    After the World Health Organization declared Covid-19 a public health emergency in March 2020, South Africa quickly banned sales of alcohol, tobacco and e-cigarettes to help slow the spread of the virus. According to du Plessis, the minister in charge acted rationally based on the information available at the time. She feared that smokers sharing cigarettes would accelerate transfer of the disease and that smoking would exacerbate the symptoms of Covid, resulting in an overload of hospitals. Unfortunately, when evidence for her assumptions failed to emerge and the cigarette market moved underground, she failed to adjust her strategy.

    The University of Cape Town Research Unit on the Economics of Excisable Products found that within a short period after the start of the ban, 100 percent of South African tobacco users were able to find tobacco in the illicit market, albeit at heavily inflated prices. This meant that none of the outcomes the minister sought were possible anymore; the measure could not serve as a break on Covid transmissions because, unlike the treasury, the virus does not distinguish between licit and illicit cigarettes.

    The tobacco industry challenged the ban and the case went all the way to the Supreme Court, which ruled the measure was unconstitutional. Because the illicit market had completely replaced the licit market, the ban had no impact, the judges noted, so denying legal operators the right to sell tobacco was senseless.

    South Africa lifted its tobacco ban on Aug. 17, 2020, but its negative impact endures. To maintain their market share, illicit traders started selling their products below the minimum collectable tax level after prohibition ended. Today, one in four cigarettes in South Africa are sold below the excise and VAT level combined while the share of the illicit market remains higher than that of the licit market.

    Despite such experiences, one GTNF panelist saw a role for prohibition under certain conditions. Polosa said he would favor a ban on traditional cigarettes providing there are alternatives in the form of combustion-free products. In a market still dominated by combustibles, however, he said such a move would be ill advised.

    Clark said that tobacco harm reduction is best achieved by extending consumer choice and allowing companies to produce and market reduced-risk products (RRPs). “The onus is not only on government to adopt light-touch regulation policy on vaping and smokeless products; the industry can also help by developing better RRPs that appeal more to smokers,” he said, adding that many smokers don’t want to switch because they don’t like the currently available RRPs as much as they like smoking. “So instead of calling for a ban on cigarettes as Philip Morris has done in the U.K., the industry should fight prohibition and focus on improving e-cigarettes and other RRPs,” Clark said.

    Letlape stressed that the key to tobacco harm reduction is education, empowerment and appropriate regulation based on science and evidence. “Prohibition should be prohibited,” he said, noting that the main party harmed by smoking is the smoker himself. Part of the challenge, according to Letlape, is that the “tobacco wars” of the past century have not been dealt with. Health advocates battered by that conflict hold on to a grudge and pass it on to new generations based on lack of information, he observed. “How do we break the chain? By saying, ‘we don’t have to reconcile—we don’t have to love each other—but we must sit around the table and talk about these issues.’ Anywhere you want to reduce harm, you got to get all parties around the table.”

    Asked what role prohibition might play during next year’s Conference of the Parties to the Framework Convention for Tobacco Control (FCTC), du Plessis reminded his audience that, while currently dormant, the concept of prohibition is present in the FCTC preparatory documents. When the FCTC was negotiated, the smoking rate was so high that the parties considered a ban inappropriate. Yet if prevalence is reduced to a certain level, the FCTC may very well again look at the feasibility of prohibition. Pursuing an endgame, however, requires getting the illicit market under control, according to du Plessis, because the FCTC measures were designed for a controlled environment. “You can’t do tobacco control unless you control tobacco,” he said.

    Okereke then invited the panelists to speculate on which countries would attempt to ban tobacco next. Snowdon expected it to be a place with an authoritarian leader—“any of the countries with names ending in ‘stan,’” he ventured—or perhaps North Korea “if President Kim Jong-un gives up smoking and becomes a classic ex-smoker.” Other candidates were countries with histories of temperance movements and already low smoking rates: the Scandinavian nations, Australia and New Zealand, along with, remarkably, the country with arguably the most traumatic prohibition experience, the United States, if it moves forward with its nicotine-reduction plan.

    In a post-panel interview, Okereke identified three lessons from the history of prohibition: First, she said, policymaking must be context specific. “There is no one-size-fits-all approach to tobacco control policies,” she said. “What is right in the Pacific will not necessarily be right in South Africa or Singapore or Malaysia. And if the preconditions are wrong for a policy—such as high levels of illicit trade—there can be serious and irreversible consequences for society.”

    Second, policymaking must be evidence-based and science-based. “Policy experimentation is prone to failure, can violate international law and can create unintended consequences that can create costs for society that vastly outweigh the benefits of a proposed policy,” said Okereke, adding that policies should be based on what has worked historically, subject to impact and cost-benefit analysis, and must take into account science about the behaviors of people and the relative risks of products. “Believe it or not, these first two points hew very closely to what the WHO itself has said about extreme tobacco control policies,” said Okereke. “They must be context specific, and they must be based on evidence.”

    Finally, Okereke noted, the world has a better chance of changing through choice. “We should strive for promotion and not prohibition,” she said. “We will more quickly and effectively move consumers away from more harmful forms of tobacco by providing appealing, affordable and well-regulated access to reduced-harm products versus pouring our energy and resources into prohibition and at the same time criminalizing a whole segment of society that uses nicotine and tobacco.”

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  • On a Mission

    On a Mission

    Photo: ANDS

    ANDS has set out to promote a smoke-free lifestyle in the Middle East and North Africa region.

    By Stefanie Rossel

    At first glance, the Middle East and North Africa (MENA) region holds massive potential for the sale of reduced-risk products (RRPs). Of the 547 million inhabitants, 140 million—mostly men—smoke. Smoking prevalence is generally high, with Jordan leading the area with a record smoking rate of 65.3 percent among males, and it is still increasing. But the promise comes with many hurdles. Of the 22 markets in the region, 14 have banned electronic nicotine-delivery systems (ENDS), and of those markets where ENDS are legal, several have implemented prohibitively high taxes on these products.

    Despite the often adverse business environment in the region, Fadi Maayta has ventured into the ENDS market. In 2020, he co-founded Alternative Nicotine Delivery Solutions (ANDS), which he heads as president. Headquartered in Dubai, the company sells and distributes vaping products and heated-tobacco products (HTPs) across the Middle East and Africa, including in the United Arab Emirates (UAE), Saudi Arabia, Kuwait, Jordan, Egypt and Bahrain.

    Maayta, who at the recent Global Tobacco and Nicotine Forum described MENA as a forgotten region in terms of tobacco harm reduction (THR), says his company’s mission is to provide adult smokers with high-end, verified and tested alternative nicotine-delivery solutions promoting a cigarette-free region. He believes there are two main reasons why THR in the MENA region is making only slow process: misinformation and isolated policymaking, which stands in stark contrast to the approach taken in the United Kingdom, the United States and several European countries. “These countries have made huge steps toward reducing smoking incidences through switching smokers and encouraging nicotine alternative solutions while the Middle Eastern countries are still treating e-cigarettes as combustible cigarettes,” says Maayta.

    According to him, disproportionate taxation of ENDS is a symptom of this wrongheaded approach. In January 2022, Bahrain, Saudi Arabia and the UAE implemented 100 percent custom duties on e-cigarettes, from 5 percent before 2022, making e-cigarettes far more expensive than the illicit products that evade all taxes, Maayta points out.

    “In Jordan, the government applies 200 percent excise tax on e-cigarettes, which makes their prices relatively higher than combustible cigarettes,” says Maayta. “The price of a disposable device of 500 puffs is five times higher than the price of a pack of cigarettes. This kind of fiscal treatment will cause two effects: unprecedented numbers of illicit trade in e-cigarettes and a relapse of [former] smokers to smoking combustible cigarettes.” Meanwhile, state budgets and legitimate companies are deprived of revenues.

    Fadi Maayta (Photo: Chris Frenzi Photography)

    Differentiation Needed

    To accelerate the transition toward safer alternatives in the region, governments need an unambiguous strategy of communicating the benefits and risks, according to Maayta. “First, we need to be clear [that] these products are not risk-free, and they are addictive,” he says. “We don’t recommend the use of these products by minors or nonsmokers. On the other hand, these products represent a better chance for smokers who cannot quit smoking conventional cigarettes. Countries need to define differential fiscal and regulatory frameworks that will encourage smokers to switch to these products, having the right information backed by science while explaining to smokers and users the advantages to switch to these alternatives and explaining that they are not 100 percent risk-free. These products should be taxed and regulated differently from combustible cigarettes, and more open and controlled communications should be allowed with users while at the same time protecting minors and nonsmokers.”

    Despite the challenges operating in the Middle East and North Africa, he is confident about the future of ENDS there. “I can see that this category will be growing further in the region,” says Maayta. “My only concern is that Middle Eastern countries will be missing out on a lot of chances to reduce smoking incidences and save the lives of millions of smokers by being resistant to recognizing the role of ENDS in making smokers switch from combustible cigarettes. We therefore advise government and regulatory authorities to think differently about this category, allowing further development in research and development and allowing further communication with adult smokers.”

    The experience of Egypt is encouraging for the future of RRPs. In December 2021, the region’s most populous country, where 42.3 percent of men and 0.4 percent of women smoke, lifted a ban on e-liquids and cartridges and subjected them to regulation. Vaping products and e-liquids must be compliant with Egyptian standards and are subject to VAT and/or excise tax. Egypt also recently legalized HTPs.

    ANDS has not yet launched its products in Egypt, as authorities took time to develop and validate the product registration process. “But this has been expected because these products are new to the Egyptian market, and usually, new products take time to be normalized in such markets,” says Maayta. ANDS has big plans for Egypt, which represents a big addressable RRP market given the country’s high adult smoking rate.

    Comprehensive Product Range

    Setting up a corporation with mass operations amid a pandemic was challenging, according to Maayta. but with its experience and determination, the team was able to achieve the desired expansion and commercial success.

    Prior to creating ANDS, Maayta worked in various senior positions with Juul and Philip Morris International throughout the region. “Through the past three years, we have learned a lot, faced many challenges, succeeded in some and failed in some—but overall, I’m proud of what the company has achieved so far and how the team of professionals have made this happen,” he says. “But more importantly than the commercial success is that we are playing a big role in changing the mindset of our audience regarding the ENDS category.”

    ANDS currently has more than 10 brands representing different categories of ENDS, including disposables, closed systems, open system liquids, zero-nicotine disposables and HTPs. “Within the vape category, we have different volume sizes, number of puffs and a wide range of flavors,” he says. “Our plan is to have a total-category solution that ranges from vapes and HTPs to smokeless products, like nicotine pouches and patches, to cover different needs of smokers and users. Our plan is in line with the concept of population harm reduction, which aims at having products with the potential [for] risk reduction while being accepted by the population of smokers.”

    In addition to distributing products made by other manufacturers, ANDS has registered three HTP and vapor brands under its name: Slix, Zing and Seek. “We have plans for far more advanced technologies that we will reveal in 2023,” says Maayta. “We are also planning to have smokeless products like patches and pouches in our portfolio for the next year, as these products are getting more attention by health authorities and harm reduction advocates.”

    To prevent underage use, ANDS has developed and implemented the “Sentinel Program,” which monitors sales channels to make sure that the company’s products’ packaging and marketing practices are not appealing to minors and nonsmokers.

    Sustainability also plays an important role at ANDS. “We are making sure that our products have a route to be disposed of properly, and some of the materials used in them are being recycled as well,” says Maayta.

  • Science-based Regulation?

    Science-based Regulation?

    Photo: Li Ding

    Politics and data in tobacco harm reduction

    By Cheryl K. Olson

    In the last couple of years, I’ve written several articles for Tobacco Reporter on how the U.S. Food and Drug Administration thinks about science. Trying to get a novel nicotine product authorized by the Center for Tobacco Products (CTP)? Tell a story about why your particular vape, pouch or gum, is appropriate for the protection of public health, illustrated by data.

    That’s how the system is supposed to work. FDA staff make decisions based on what the science says about the relative health risks and benefits of a novel nicotine product. The CTP’s website states: “Our ability to enact science-based regulation has the true potential to reduce the death and disease toll from tobacco products.”

    But evidence suggests that stronger forces have shoved science out of the driver’s seat. Recently released memos from the CTP’s Office of Science show that subjective factors drove the decision to deny a marketing authorization for a flavored vaping product. JTI’s Logic brand was teed up as the first menthol-flavored electronic nicotine-delivery system (ENDS) likely to complete the premarket tobacco product application review process. After CTP leadership changed last summer, the emphasis shifted from how menthol vapes might help adults quit smoking, to the purported risks that any flavored ENDS product (including menthol) posed to youth. Prominent politicians have openly pressured the CTP to eliminate flavored vaping products. 

    In 2019, a CTP toxicologist filed a complaint that the organization had changed its review process from a “fully quantitative review to a more qualitative one,” according to a report on the Government Executive website. CTP researchers were found to have been retaliated against for raising concerns and disagreeing with interpretations of science.

    Disagreements about research findings ought to be dispassionate and evidence based. But in tobacco harm reduction, debates about “the science” are often mere veneers over deeper disputes. Trying to make sense of divergent perspectives on e-cigarettes, researchers from the University of Toronto and the University of Cambridge recently interviewed 21 experts on tobacco and harm reduction. They concluded, “The majority of meanings attached to tobacco harm reduction were rooted in values, ideology, politics and opinions rather than straightforward disagreements about the scientific evidence.”

    Some industry commenters found the Reagan-Udall Foundation’s much-anticipated operational evaluation of the CTP to be a damp firecracker. Their report does correctly note that “some issues before CTP are fundamental policy questions that must be informed by science but are not, themselves, scientific issues. Rather, they are policy issues with profound societal impacts.”

    Before we can talk about the science, we need to acknowledge the values-laden differences in meaning that make logical, civil discourse about nicotine products so difficult. It would take a book to cover it all, but here are a few of the stumbling blocks.

    The Legacy of “Light”

    In 2009, Mitch Zeller (future director of the CTP), Dorothy Hatsukami and colleagues laid out a vision and blueprint to guide tobacco control efforts. It focused on harm reduction, defined as “strategies that would reduce morbidity and mortality … from continued use of tobacco or other nicotine-containing products.” It noted the now-famous continuum of risk—with smoking far more hazardous than noncombustible nicotine sources—and cautiously acknowledged a role for “potential reduced exposure products,” between cigarettes and nicotine-replacement therapies.

    But the article also made clear that all novel reduced-harm products are burdened with the legacy of past industry deception: “The major concern held by some public health experts is that these new products may be nothing more than a more scientifically sophisticated version of the ‘light’ cigarette.” As tested by smoking machines, such products appeared lower risk; as used by humans, they were not. In the authors’ view, naive public health officials were duped by industry into promoting light cigarettes to health-conscious smokers.

    Fear of repeating the experience of “light” cigarettes, where claimed reduced exposure to toxins did not lead to reduced disease or death, shaped the Tobacco Control Act of 2009. A well-intended effort to prevent future deceptive advertising now blocks another stated goal of Zeller and colleagues: to “educate the public accurately on the precise risks of different [nicotine] products.”

    Unclear Definitions

    Before moving full-time into harm reduction, I studied the potential effects of violent video game content on youth. I learned how important shared, clear definitions are to research. In that case, the biggest problem was defining “aggression.” To some researchers in the field, arguing or play-fighting were equivalent to attacks with intent to harm. A study about time spent virtually running amok has very different implications if the consequences are teasing versus criminal assault.

    Nicotine research has similar problems with definitions, often also involving youth. For example, anti-tobacco organizations, such as the Campaign for Tobacco-Free Kids, have long worried that “kid-friendly flavors” might attract teens to experiment with vaping.

    What constitutes a “kid-friendly flavor”? As Clive Bates has pointed out, as of 2017, this label was attached to candy store or ice cream shop ENDS flavors, or silly ones like “Unicorn Puke.” Removing them from the market would still leave many options for adults who smoked. But today, by definition, all ENDS flavors—other than “tobacco,” and including menthol—attract kids. This is a classic case of moving the goalposts to achieve a win. (The use of “kids” to represent adolescents is a separate debate.)

    Unquestioned Assumptions

    In a recent interview, author Malcolm Gladwell defined bad science as “science committed by people who think they know the answer before they start.”

    Assumptions about vaping’s harm to youth have an increasingly tenuous relationship to science. Objections used to be automatically couched, as in this 2020 article, as a concern that these new nicotine users “may become addicted to vaping, which may lead to smoking.”

    Has the availability of vaping coincided with a youth smoking increase? Look at the newly released results from Monitoring the Future, an ongoing national study of U.S. youth substance use. Among 12th grade students, who are typically aged 17–18, any reported nicotine use other than vaping showed a “quite dramatic” decrease, from 21 percent in 2017 to 8 percent in 2022. (Vaping and marijuana use have also dropped, and stayed down.)

    By contrast, past-year alcohol use by 12th graders is up, at 52 percent. Documented youth appeal of “alcopop” flavors receives little attention. Interestingly, a Google Scholar search for recent papers on “flavored alcohol youth” brings up more articles on e-cigarette flavors than on alcohol products.

    Data suggesting that the gateway from vaping to smoking may be imaginary does not make it less real in the minds of believers. The Campaign for Tobacco Free Kids’ website still describes a vaping epidemic and “serious health risks to the health of young people.” Their list of risks consists of the possibility that nicotine “can harm … parts of the brain responsible for attention, memory and learning,” the risk of nicotine addiction and the increased risk of smoking or “future addiction to other drugs.”

    On one hand, we see declining nicotine use and limited real-world evidence of specific health harms to youth. On the other, we see hundreds of thousands of dead adult smokers every year. It’s hard to understand how U.S. regulators consistently weight the former more heavily than the latter. The Reagan-Udall report singled out this balance (on page 15) as one that “scientific analysis alone will not resolve.”

    A Shared Goal

    Finally, we come to the ultimate policy controversy that research can inform but not solve: Is the goal to end all nicotine use (and addiction)? Or, is the goal to reduce tobacco-linked death and disease? Whether the latter goal is your endgame, or just step one of two, all sides ought to be able to work toward it together.

    Dismissing data that doesn’t fit a desired narrative has consequences for public health. As eight respected U.K. experts wrote in response to repudiations of tobacco harm reduction: “The pursuit of arguments that vaping cannot help people to quit smoking, in the face of clear evidence that it does, risks undermining public trust in science.” 

    It’s time to rethink our assumptions and take a fresh look at patterns of evidence. One pattern we observe, exemplified by Karl Fagerstrom’s new country-by-country analysis, is that more use of reduced-risk noncombustible tobacco is linked to less smoking. Let’s start a discussion about how to rapidly put attractive, lower risk nicotine products in the hands of people who smoke.

  • Cohiba Trademark Canceled in U.S.

    Cohiba Trademark Canceled in U.S.

    Image: Tobacco Reporter archive

    After more than 25 years of court battles, General Cigar Co.’s trademark for Cohiba cigars was canceled by the United States Trademark Trial and Appeal Board (TTAB).

    Scandinavian Tobacco Group, General’s parent company, and Empresa Cubana del Tabaco (Cubatabaco) have fought over the U.S. rights to the Cohiba trademark since 1997. In a ruling earlier this month, the TTAB sided in favor of the Cuban cigar conglomerate in its claim on the name, saying that General Cigar Co.’s registrations on the Cohiba trademark are to be canceled due to a violation of an international agreement that dates back to 1929.

    In the U.S., the Cohiba brand is made by General Cigar Co. and is known for a Cohiba logo with a red dot that fills the O in the word. In the rest of the world, the Cohibas found on store shelves come from Cuba and are known for a gold and black color scheme as well as the profile image of a Taino Indian, writes Patrick Lagreid from Halfwheel.

    While the TTAB’s ruling indicated that General’s registrations on the Cohiba marks are to be canceled “in due course,” it does not mean that the General-made Cohibas have to immediately be pulled from store shelves. First, the TTAB did not award the Cohiba mark to Cubatabaco; second, General Cigar Co. has vowed to appeal, saying that it will continue to manufacture and sell Cohiba cigars during that process.

    Cohiba is a particularly unique case due to both its prominence on the global stage and its creation by the state-run tobacco company after the Cuban Revolution, whereas other brands with Cuban roots that General Cigar Co. owns, such as Partagas, Hoyo de Monterrey and La Gloria Cubana, were assumed by the Cuban government in 1959.

    Similarly, General’s largest competitor in the cigar industry, Altadis USA, owns several brands with pre-Revolution roots, including Montecristo, Romeo y Julieta and H. Upmann. Prior to Imperial Brands selling its premium cigar business in April 2020, Altadis USA was owned by Imperial, which also owned a 50 percent stake in Habanos S.A., a joint venture with the Cuban tobacco monopoly for the sales and marketing of Cuban cigars. Imperial also owned stakes in distributors of Habanos S.A. products around the world and stakes in companies that make and distribute Cuban machine-made cigars.

    The U.S. Court of Appeals for the Federal Circuit in 2015 ruled in favor of Cubatabaco. After the Supreme Court’s denial to hear the case, it went to the TTAB.

  • Registration Open for Menthol Ban Seminar

    Registration Open for Menthol Ban Seminar

    Interested parties can now register for the Jan. 12 U.S. Food and Drug Administration seminar covering the ban of menthol flavors in tobacco products. “The Scientific Basis of Proposed Tobacco Product Standards to Prohibit Menthol as a Characterizing Flavor in Cigarettes and Flavors in Cigars” is the first FDA tobacco-related seminar of the year.

    The presentation will provide an overview of the scientific evidence that informed the development of these proposed rules, with an explanation of the external peer review process the FDA utilized for review of the highly influential scientific assessments for these proposed rules.

    Bridget Ambrose, director of the Division of Population Health Science in the Office of Science at the FDA’s Center for Tobacco Products, will be the speaker. Ambrose has over 20 years of experience in tobacco control and regulatory science, with specialized experience in longitudinal analyses of tobacco use.

  • Vape Industry Experts Predict a Better 2023

    Vape Industry Experts Predict a Better 2023

    With Republicans in control of the U.S. House, some experts expect the vape industry to thrive.

    By Timothy S. Donahue

    The next two years should be better than the past two years. That was the overall outlook from vapor industry experts speaking during the Vapor Technology Association’s (VTA) 2022 Post-Election Round-Up webinar in late November. Tony Abboud, executive director of the VTA, told attendees that his organization has been working diligently with two Washington, D.C.-based firms, West Front Strategies, a lobbying group, and FORA Partners, a public affairs agency, to promote the interests of the vaping industry as Republicans take over the U.S. House of Representatives in 2023. “We have a very specific agenda, some of which we’ve discussed (as an overview of what) we are pursuing,” he said. “We’ve done an enormous amount of groundwork.”

    Shimmy Stein

    Shimmy Stein, a partner with West Front Strategies, said the change in leadership at the House could have a positive impact on the vaping industry until at least the next election cycle. “Anytime you can take over the gavels, take over the control of the messaging, take over control of the chairmanships and the legislation, that is an important piece of governing,” he explained. “And so, while it was not to the extent or to the size which Republicans were hoping for in terms of the majority in the House of Representatives, it’s still pretty significant and will change the manner in which Washington will function.”

    Over the next two years, the vaping industry should feel “a little more comfortable, a little more secure” going into a divided Congress (the U.S. Senate leadership did not change), according to Craig Kalkut, a partner with West Front Strategies. However, the vaping industry has always faced threats from both Democrats and Republicans due to their concerns over teen vaping. “We still need to work with both parties. We still could face issues and threats of overregulation and poorly conceived legislation. But the bottom line is that we will have a more comfortable environment with Republicans controlling one house of Congress,” said Kalkut.  

    Craig Kalkut

    Reconciliation, a way for Congress to enact legislation on taxes, spending and the debt limit with only a majority vote, is no longer a threat to the vapor industry, according to Kalkut. He said that’s just not something that can happen in a divided Congress. “What that means, ultimately, is that anything that passes will need to have bipartisan support,” said Kalkut. “And because of that, [legislation] will likely be more limited, more moderate, and hopefully, if there’s any legislation passed in our area, that will be something that allows us to thrive, which addresses the concerns that linger over teen vaping but does not overregulate and drive people away from vaping.”

    Kalkut also confirmed that gridlock is a concern in a divided Congress; however, gridlock could also provide incentives for both parties to compromise. “They’re both seen as in charge, so they both sometimes want to get something done. And that will bring people to the table and often over issues that are not central to either party’s ideology,” he said. “It’s hard to come to a compromise on taxes, or it’s hard to come to a compromise on healthcare … but something like vaping, perhaps there will be opportunity for common sense provisions to prevail in an area where Democrats and Republicans can come together.”

    Max Hamel

    Max Hamel, founding partner of FORA, said when Congress is split, the White House typically relies heavily on its executive privilege. There is no known administration agenda on vaping, so a vaping-related rule is unlikely. With Republicans in control of the House, they also head committees. The House oversight committee and its subcommittees could present opportunity for the vaping industry, according to Hamel.

    “We do have new personalities on both the majority and the minority side, so they’ll probably have some growing pains,” he said. “The big question is, how does this new authority, especially in the House, get wielded[?] … whether it’s one seat or 40 seats, the authority with the majority is the same, and it is substantial from [an] investigation and oversight standpoint; [that’s] probably not necessarily true from a legislative standpoint … the oversight subcommittee, we do have the opportunity to surface some things, but it’s really an opportunity for us now to not be on defense and [to] put forth an agenda and some messaging that really focuses on the things that are advantageous to us.”

    Additionally, with Juul losing its stranglehold on the vaping market, Hamel said the vaping landscape is changing. Juul became the focus to save youth from vaping, and today, Juul isn’t the focus. The market is made up of a more diverse group of companies with different technologies dedicated to harm reduction. Hamel said this is the message that should be projected. “I think our priority will be focusing on the messages that really emphasize the harm reduction aspects,” he said.

    Kalkut then added that the vaping industry has an opportunity now to change the conversation, particularly with Democrats but also Republican critics and skeptics of vaping through the ever-expanding body of science that shows the relative safety and incredible potential for harm reduction that next-generation tobacco products have. “That has become more and more clear as time has gone on over the last couple of years,” he said. “I think once we show that, once we demonstrate our commitment as an association in the industry to addressing teen vaping, we have a real chance of changing the narrative.”

    Ashley Davis

    Ashley Davis, a founding partner at West Front Strategies, told attendees that, looking back on industry challenges, there has been success. However, her concerns going into the last Congress (2020–2022) were that she didn’t really know in what direction or how forcefully Biden would lean on the vapor industry. She says the industry “dodged a bullet.” The industry could have suffered more than it did those first two years in a Biden administration. She also said the issue of youth use will remain at the forefront of any discussion concerning electronic nicotine-delivery system products.

    “We do have to still deal with the youth issue. And I think we all realize that any negative press that comes up is around the youth issue … Everyone loves a microphone. It’s a member of Congress. If there’s an issue to discuss, that’s what they’re going to discuss,” explained Davis. “[We are] trying to make sure that any bad legislation is not passed—it’s much more unlikely in this Congress than it was before.”

    Taking a question from the audience, Abboud closed the session speculating on the impact of the Reagan-Udall Foundation’s external review of the U.S. Food and Drug Administration’s Center for Tobacco Products, the results of which are expected in mid-December.

    Abboud said that numerous comments from staffers of the FDA for the Reagan-Udall assessment suggest the regulatory agency is in a state of disarray and is being influenced by outside forces not scientific research. He said he hopes the foundation will advise the FDA that premarket tobacco product application (PMTA) decisions should be free from any external pressures, especially political pressure.

    “[The review should recommend to the FDA that PMTA] decisions must be made based upon the science that is submitted as well as making sure that the agency does, in fact, review all of the science that has been submitted as part of any applications as well as [reviewing] all of the applications that have [been] submitted,” said Abboud. “Because that was another big failing of the current process where applications have been rejected [without a full review].”

  • Drone Used to Smuggle Smokes Into Prison

    Drone Used to Smuggle Smokes Into Prison

    Credit: Adragan

    Three men were arrested in Malaysia for attempting to smuggle tobacco products using a drone into the Machang Prison, according to the New Straits Times.

    The trio aged between 35 and 39 were arrested after the Machang district criminal investigation division received a report involving a drone being flown above a compound near the prison at Jalan Kuing Indah, Kampung Pangkal Meleret, at 1:05 a.m.

    Kelantan Police Chief Datuk Muhamad Zaki Harun said the prison, which is equipped with tracking device technology, detected the drone near the premises.

    The police deployed a team to the location before the three men sped off in a Honda CRV. “A chase ensued between the police and the three men before they were arrested near the main Kuala Krai-Kota Baru road in Kampung Bukit Belah,” Zaki said in a statement, according to media reports.

    Zaki said police also found an RC123 drone remote control device, 13 packets of tobacco and 41 small compressed packages believed to contain tobacco.

  • Cabbacis Patents Low-Nicotine Pods in Canada

    Cabbacis Patents Low-Nicotine Pods in Canada

    A U.S. federally licensed tobacco product manufacturer focused on harm reduction products announced today that the Canadian Intellectual Property Office (CIPO) has issued patents for its pods comprising blends of very low-nicotine tobacco and hemp for use with electronic nicotine-delivery systems (ENDS).

    Canadian Patent No. 3,151,047 was issued to Cabbacis and includes 27 claims which will expire on September 10, 2040. Earlier in 2022, CIPO also issued Patent No. 3,107,796 to Cabbacis for cigarettes comprising blends of very-low-nicotine tobacco and hemp.

    “I am pleased that both types of our products are now patented in Canada, which is one of our early target countries for commercialization,” said Joseph Pandolfino, founder and president of Cabbacis.

    Credit: Feng Yu

    Primary applications of the company’s very low-nicotine cigarettes and vaping pods in development comprising blends of very low-nicotine tobacco and hemp are to assist smokers of conventional cigarettes to smoke less, transition to less harmful tobacco or nicotine products or quit nicotine use altogether, according to a press release.

    Cabbacis’ patent portfolio includes 25 issued patents and various pending patent applications across the United States, Europe, China, Japan, South Korea, Canada, Australia, New Zealand, Mexico, Brazil and other countries. The company holds six U.S. patents.

  • Experts Call for Simplified Tobacco Tax

    Experts Call for Simplified Tobacco Tax

    Credit: Talulla

    Tobacco taxation experts have recommended the government of Vietnam simplify the country’s excise tax structure on tobacco, reports EIN News. The move would facilitate tax administration, reduce opportunities for tax avoidance and evasion, increase the government’s revenues and have a greater impact on reducing tobacco use.

    The recommendation comes after the Vietnam government approved a tax reform strategy for up to 2030, which sets the process for switching from an ad valorem tax system to a hybrid tax system for tobacco and other products subject to excise tax.

    A number of experts suggest that a hybrid tax system that includes ad valorem and specific taxes is the most simple and effective system. In a recent report titled “Study on the Special Consumption Tax System,” PwC Vietnam called it “The right direction in line with the general trend in the world.”

    According to the report, the government has lost revenues due to tobacco smuggling, especially in 2016–2017.

    The total tax loss due to smuggled tobacco consumption has reached nearly 9 percent of tobacco tax collection, and tax collection of tobacco remained unchanged in the 2006–2020 period without factoring in inflation, the report said.

    Based on the analysis of the current excise tax policy, the objectives of the government and tax policies in comparable countries, it outlined a number of options for SCT reform along with roadmaps for the short-term and the long-term.

    The first option is transitioning into a hybrid tax system then gradually increasing the specific component and decreasing the ad valorem component at an appropriate time in future, considering to move to a single-tier specific tax system when being suitable.

    The second option is transitioning into a multi-tier specific tax system and then gradually narrow down the number of tiers to become a one-tier specific system.

    Both options have both advantages and disadvantages, but PwC Vietnam believes that the first is more reasonable for Vietnam. According to the Asia Illegal Tobacco Index, in 2017, more than 24.3 billion illegal cigarettes were consumed in Vietnam, or 23.4 percent of total tobacco consumption.

  • England’s Ports Seeing Boost in Fake Vapes

    England’s Ports Seeing Boost in Fake Vapes

    The number of potentially unsafe disposable vapes being seized at English Channel ports has risen “dramatically,” according to trading standards.

    More than 300,000 of the counterfeit products had been seized during December, Kent Trading Standards said, according to the BBC.

    “A lot of our work has been focused on retail outlets, but this is now higher up the supply chain,” James Whiddett, spokesperson for KTS, said. “We’re stopping these devices, which may have about 10 times the legal limit of nicotine in them.”

    He said the current legal limit on the tank on disposable vapes is 2 mL, which is the equivalent of 600 puffs.

    “The products which we’re seeing coming into the country at the moment have 3,500 puffs on them and some have 7,000 puffs, so they are illegal and cannot be supplied to anyone,” he said.

    Whiddett said the demand for disposable vapes had risen dramatically over the last nine months.

    “The flavors, the fact that people don’t have to put their own liquids in, means it’s convenient and easy,” he said. “We’re not sure where these illegal vapes were going, and our investigations are ongoing.”

    Gillian Golden, CEO of the Independent British Vape Trade Association, said noncompliant vape products are also associated with noncompliant sales, “often to underage consumers.”

    She said the association would continue to assist trading standards over noncompliant vaping products.