Author: Taco Tuinstra

Juul Accuses NJOY of Patent Infringement

Photo: TheaDesign
Juul Labs has asked the U.S. International Trade Commission (ITC) to block sales and imports of the NJOY Ace vapor device, claiming that the product infringes several Juul patents. It has also filed a complaint against NJOY with the U.S. District Court for the District of Arizona.
“Our technology, designed internally and in the U.S. and protected by our robust patent portfolio, has been the most effective product development to transition adult smokers from combustible cigarettes—switching over 2 million adult smokers in this country. Innovation is critical in this space to advance tobacco harm reduction,” said Juul Labs Chief Legal Officer Tyler Mace in a statement.
“When others infringe on our technology, we have no choice but to protect our intellectual-property rights.”
This ITC complaint follows three prior successful actions from Juul Labs at the Commission, which all resulted in barring the importation and sale of infringing products, according to Juul Labs.
“Just like we have in three prior successful ITC actions that vindicated our company’s IP rights, we intend to reach the same result here,” said Mace.
Juul Labs complain also targets Altria Group, which agreed to acquire the NJOY in March after exchanging its minority investment in Juul for a heated tobacco product intellectual property license.
The NJOY Ace device received marketing authorization from the Food and Drug Administration in April 2022.

July 3, 2023
Firms Start Posting Warning Statements

Photo: Krakenimages.com
Altria Group, R.J. Reynolds Tobacco Co. and ITG Brands have started posting warning signs about cigarette smoking in more than 200,000 stores across the United States, reports CNN. The move represents one of the final steps in a lawsuit the Justice Department filed against the tobacco industry in 1999.
The signs include court-specified statements such as “Smoking kills, on average, 1,200 Americans. Every day.” They must be posted until June 30, 2025, in “highly visible places” in English and also Spanish in regions with significant numbers of Spanish speakers.
The postings come after years of dispute following U.S. District Court Judge Gladys Kessler’s judgment in 2006, when the tobacco companies were first ordered to make the corrective statements. The landmark judgment found the industry defendants guilty of lying about the dangers of cigarettes and secondhand smoke.
The defendants lied “about the devastating health effects of smoking and environmental tobacco smoke, they suppressed research, they destroyed documents, they manipulated the use of nicotine so as to increase and perpetuate addiction, they distorted the truth about low tar and light cigarettes so as to discourage smokers from quitting, and they abused the legal system in order to achieve their goal—to make money with little, if any, regard for individual illness and suffering, soaring health costs, or the integrity of the legal system,” Kessler said in her final opinion.
R.J. Reynolds said these corrective statement signs appear on its website and had previously appeared in newspapers, television, radio and on pack inserts. “The tobacco industry has evolved considerably since this lawsuit was filed nearly 25 years ago, back in 1999,” a company spokesperson said. “Today, Reynolds American Inc. and its operating companies have a clear purpose to build ‘A Better Tomorrow’ by reducing the health impact of our business.”
July 3, 2023
ITGA Calls Attention to Growers’ Viability

Photo: ITGA
During a recent tour of Africa’s leading tobacco growing country’s José Javier Aranda, the president of the International Tobacco Growers Association (ITGA), stressed the importance of sustainability and grower viability.
“Sustainability starts by securing viability to growers; without it, the very pillar of the sector is at risk,” he said.
A fifth-generation tobacco grower in Salta, Argentina, Aranda shared examples to improve social and environmental conditions in tobacco growing that had been successfully implemented in his home country. He cited the contributions of Argentina’s Special Tobacco Fund, which has allowed local growers to remain viable and reinvest in social, economic and environmental initiatives.
As part of his tour, Aranda attended TAMA Farmers’ Trust annual general meeting in Lilongwe, Malawi, which was opened by Malawi’s minister of agriculture, Dalitso Kawale. During the gathering, Aranda stressed the need for governments and grower bodies to work against the demonization of the sector.
Another key point of discussion was the conference of the parties to the World Health Organization’s Framework Convention on Tobacco Control, which will take place in Panama in November (COP10). The ITGA has been campaigning to counter the claims raised by WHO about tobacco farming and about the economic viability of alternatives crops.
“WHO FCTC operates against its own rules of procedure and under Article 5.3 is deliberately excluding the tobacco farmers’ voice and other tobacco sector key players from the discussion,” said Aranda. “This is the main reason why Article 17 (economically viable alternatives to tobacco growing) has not seen any evolution.
“Article 17 has not provided any results in the search of viable alternative crops in the great majority of tobacco growing countries. Growers are already planting complementary crops whenever the conditions are provided. We urge the WHO FCTC to apply a pragmatic approach towards this issue. ITGA and its member associations are ready to cooperate.”
In Harare, Zimbabwe, the ITGA attended the Zimbabwe Tobacco Association’s annual general meeting and conducted its 2023 Africa regional meeting, officially opened by Minister of Agriculture Anxious J. Masuka. Representatives of four leading tobacco-growing countries attended these meetings: Malawi, Tanzania, Zambia and Zimbabwe, while the public session was joined by key partners and stakeholders in the sector.
During the ITGA Africa regional meeting closed session, growers’ representatives presented reports highlighting the key dynamics in their respective markets. Tobacco growers in Malawi have strengthened their efforts in producing a compliant crop, for example, while in Zimbabwe, the current sustainability focus is on curing fuels, agricultural labor practices and traceability.
Earlier in June, ITGA CEO Mercedes Vázquez participated in several events in Tanzania, hosted by Tobacco Cooperative Joint Enterprise. Among other parties, she met Tanzania’s minister of agriculture, Hussein M. Bashe and the Tanzania Tobacco Board.
July 3, 2023
From Plantations to Nicotine ’Plants’

Photo: Taco Tuinstra
Synthetic nicotine could help promote global food security.
By Sudhanshu Patwardhan
The tobacco industry is undergoing rapid transformation. Companies are increasingly offering safer nicotine alternatives to current consumers of risky forms of tobacco. Is it time for them to reassess their supply chains to procure nicotine from nonagricultural sources and in the process free up land for growing crops that can feed the world’s 8 billion people? A study of the economics of tobacco cultivation and nicotine consumption may give us practical answers.
Millions of hectares of rich, fertile land are used for growing tobacco to meet the nicotine needs of over 1.1 billion tobacco users globally. Except for Swedish-style snus and tobacco used in novel heated-tobacco products, most of the tobacco grown eventually harms public health due to the toxicants arising out of its curing and manufacturing (e.g., tobacco-specific nitrosamines, added chemicals in smokeless tobacco products) and use (e.g., harmful smoke components). On May 31, the World Health Organization marks World No Tobacco Day (WNTD) with an interesting theme: “We need food, not tobacco.”
Last year, for the first time ever, two U.N. bodies—the WHO and the U.N. Environment Programme)—published a list of the environmental harms from tobacco-related farming, manufacturing, supply chain and consumption. Tobacco-related harms to the environment start from the seed and go well beyond the cigarette and bidi smoke. The WHO notes that globally, an additional 200,000 hectares of land is cleared annually for growing tobacco and curing tobacco leaves that are used in making smoked and smokeless tobacco products. Rich and diverse natural habitats, including pristine rainforests, are being lost to meet the global tobacco demand. It is estimated that 3.7 liters of water are used to make one cigarette. Worldwide, trillions of cigarettes are sold and burned annually. The environmental pollution is not limited to the emitted smoke and the ash but also the cigarette butt litter that refuses to decompose for years. In South Asian countries, spitting smokeless tobacco imposes an additional burden on health and leaves unsightly marks in buildings and roads. Even the pharmaceutical grade nicotine used in medically licensed nicotine-replacement products and e-liquids for vaping products is obtained predominantly from tobacco plants.
Any slogan that simply calls for more food instead of tobacco oversimplifies the economics of tobacco.
This year’s WNTD theme intends to put a spotlight on the arable land locked in tobacco plantations that could instead provide food security to the world’s 8 billion people. Indeed, hunger and lack of nutritious food kill millions of people worldwide every year. Feeding the ever-growing world population without denuding forest land remains a big challenge for reasons ranging from environment and climate change to biodiversity. Therefore, in a world with finite arable land, repurposing tobacco farms for growing food are an obvious target for policymakers, environmentalists and economists.
Sadly, the WNTD theme creates a false dichotomy, unnecessarily pitting tobacco farmers against a hungry world. Alas, one cannot simply switch tobacco farms and farmers to grow alternative food crops with a snap of a finger. Global demand for tobacco continues relatively unabated, thus keeping suppliers invested in a profitable crop. It is also important to remember that tobacco is an unusually hardy plant. Not all food crops can withstand conditions that the tobacco plant can endure. Unlike edible vegetables and fruits, the produce from tobacco plantations is a leaf that is included as a raw material for further processing into a product, thus not subjecting the farmers to the whims and shameful wastage due to strict size and shape requirements of western supermarket buyers. The tobacco leaf markets are utility focused and well supported through longstanding relationships among stakeholders across a sophisticated global supply chain and have lifted millions out of poverty. Any slogan that simply calls for more food instead of tobacco oversimplifies the economics of tobacco.
The health harms from risky forms of smoked and smokeless tobacco products such as cigarettes, cigars, bidis, hookah, gutkha, khaini, mishri, zarda, etc. are already well known. That knowledge has not made these products or their use obsolete—even today, over a billion people around the world consume these risky products, and more than half of them die prematurely as a result. Nicotine is addictive but is not the cause of tobacco-related cancers, cardiovascular disease and lung disease.
Many doctors harbor misperceptions about nicotine, wrongly believing that nicotine in the tobacco products causes cancer.
The invention of nicotine-replacement therapy (NRT) products over three decades ago, in the form of nicotine gums, skin patches, lozenges and mouth sprays, was crucial in realizing nicotine’s role as a medicine in helping quit tobacco and finding these products a place on the WHO’s model essential medicines list. NRT enables smokers and smokeless tobacco users to better manage their cravings and withdrawal symptoms. Still, quitting tobacco and preventing relapse remains a big challenge globally for a variety of interlinked reasons: (i) Pharmaceutical investment and innovation in improved tobacco cessation tools and products has been lacking in recent years, (ii) universal access to affordable and appealing nicotine-replacement products remains poor, and (iii) healthcare professionals around the world are not adequately trained on how to advise their patients to use nicotine-replacement products.
In fact, many of the doctors themselves harbor misperceptions about nicotine, wrongly believing that nicotine in the tobacco products causes cancer. This limits doctors’ ability to confidently support their patients’ tobacco de-addiction journey using nicotine-replacement principles. The obvious question then is: How do we ensure that current users of tobacco get all the help they can from their healthcare advisers and governments to make quitting tools accessible, affordable, appealing and available? If done at a global level, quitting success will further inspire confidence among consumers, healthcare practitioners and policymakers to accelerate the decline of the demand for tobacco.
The WHO Framework Convention on Tobacco Control (FCTC) is often elegantly simplified as a treaty for demand reduction, supply reduction and harm reduction strategies. The largest demand arises from the billion-plus cohort of current users of risky tobacco products—and that’s where affordable cessation support and safer nicotine alternatives offer the highest likelihood of practical harm reduction. So, for the agricultural transformation much needed to free up arable land, a global reduction in demand for tobacco will be a key economic driver over time for farmers to actively seek other viable alternatives. It would then be crucial to provide government support and subsidy over a phased reduction in tobacco farming.
The FCTC dedicates two entire articles in the original treaty text to alternative livelihoods for those in the supply chain and addressing environmental impact—Articles 17 and 18. Particularly in implementing those two articles, little progress has been made in the past 20 years since the treaty came into force. That is because even lesser success has been achieved on a ground-level implementation of the FCTC’s Article 14 that calls for tobacco dependence treatment provision at a national level.
In recent years, many advances in chemistry and chemical engineering have resulted in new processes and patents issued for synthesizing nicotine from nontobacco raw materials. If the correct isomer of nicotine—the S-isomer—can be manufactured at scale using these processes, that can be revolutionary and indeed game changing. Using such synthetically manufactured nicotine, nicotine-replacement products that are innovative, suitably regulated and where necessary medically licensed can thus be introduced globally for tobacco cessation at low cost and in product formats appealing to current adult smokers and smokeless tobacco users. Agricultural transformation and enhanced food security will naturally follow this purely on economics principles.
Sudhanshu Patwardhan is a British-Indian, U.K.-licensed medical doctor who is passionate about helping people quit risky forms of tobacco. For the past two decades, he has lived and worked in three continents, doing senior roles in research, strategy and policy in the pharmaceutical and tobacco industries.

In his early years in tobacco harm reduction, his team of clinical researchers and lab scientists set the foundations for the assessment of reduced-risk products, now accepted by regulators and the industry as the definitive approach for duty of care and regulatory compliance. At Nicoventures, a wholly owned subsidiary of British American Tobacco, he was instrumental in enabling the first e-cigarette company acquisition by a global tobacco business. In his policy role there, Patwardhan shaped the creation of a global key opinion leader network in consumer advocacy and public health champions. .

With the British Standards Institution, Patwardhan led the creation of the world’s first vaping products’ standards for safety and quality in 2015 and the BSI Online Age Checking specifications in collaboration with the Westminster-based Digital Policy Alliance in 2018. .

In 2018, he co-founded the Centre for Health Research and Education that now has a team of over 40 medical and public health experts globally working in cancer prevention. Patwardhan splits time between the U.K. and South Asia on tobacco harm reduction projects that address the needs of the most disadvantaged tobacco users.

July 1, 2023
Doctor’s Orders
Photo: Minerva Studio
Medical licensing of e-cigarettes and nicotine pouches should be an urgent priority.
By Derek Yach
The alarm about the risks of products to health is usually first sounded by physicians. That was certainly the case with tobacco and health. The 1962 Royal College of Physicians (RCP) Report on Smoking as well as the 1964 Surgeon General’s (SG) Report on the same topic were led by physicians and drew upon the best epidemiological evidence available. The reports’ statement that “smoking kills” led to rapid changes in physicians’ smoking behavior well before regulators took up the challenge. The world had to wait eight years before the World Health Organization passed its first modest resolution on smoking. Only then did modest public health policies emerge.
Internationally, the evidence is clear: No country experiences a serious decline in their smoking rates before it declines among physicians. And it takes about a decade before the population benefits start appearing. Globally, smoking rates among men approach 40 percent to 50 percent in countries as diverse as China, Bulgaria, Jordan and Bangladesh—or 50 years behind where the U.K. is today. Smoking rates among the physicians in these countries are about the same. There are few examples of physician-led reports like those of the RCP or SG from middle-income or lower middle-income countries. In such settings, we cannot expect to see substantial progress in ending smoking if we stick with the status quo.
Physician Leadership Is Crucial for the Introduction of Innovative Interventions
Innovations in healthcare are usually led by physicians armed with solid epidemiological and clinical data showing the benefits of new interventions for patients and the population. Physician leadership gives credibility to new products. The opposite is also true. Products that are not endorsed or approved by physicians rarely achieve population benefits and may face stiff regulatory approval.
Sluggish Progress on Improving Cessation Outcomes
For decades, physicians have followed a “medicalization” path to cessation, so it is not surprising that they have neglected tobacco harm reduction (THR) options. The basic advice given by physicians has changed little. Quit cold turkey, counseling, nicotine-replacement therapies (NRTs) and a few other pharmaceutical and behavioral services remain the mainstay of cessation. None have success rates that exceed 15 percent over the year, and most are associated with repeated relapses. The World Health Organization’s own reports to the World Health Assembly this year pointed to slow progress in addressing cessation. Numerous reports, such as those issued by the Foundation for a Smoke-Free World, have pointed to the failure of the pharmaceutical industry to bring better cessation tools to the market despite advances in behavioral and neuroscience that have led to new therapies for a range of diseases.
It is long overdue that physicians have access to far more efficacious and effective ways of ending smoking. We now have a full range of feasible options that have been authorized by the U.S. Food and Drug Administration as “appropriate for the protection of public health”: heated-tobacco products, e-cigarettes, snus and most recently nicotine pouches. E-cigarettes and nicotine pouches are well placed to form the basis of a new approach to cessation and harm reduction.
How Do We Engage Physicians in Scaling up Access to These Lifesaving Products?
Recent experience shows that physicians have been resistant to these products for several reasons. They fear these are a new tactic by the tobacco industry to keep the next generation addicted. They seek data on long-term benefits. They are bamboozled daily by well-funded nonprofits and WHO messages about the dangers of these products for kids, and the impact of them on cancer or heart disease. The fact that none of this is based on science has not stopped the opposition.
Could Medically Licensed Products Break Through and Reach Physicians?
I strongly believe that they could.
At a recent Keller and Heckman meeting, Ian Fearon, chief scientific officer at McKinney Scientific Advisors, described the “halo” effect of having medically licensed e-cigarettes on the market. To get medically licensed requires proof of quality, safety and efficacy. Once achieved, this could legitimize the category and open the doors to widespread physician acceptance of the products. The same could happen with nicotine pouches.
This could start to erode distrust of these products by physicians as they use them and advise their patients to use them. The predictable positive outcomes would accelerate adoptions and use.
Recall that almost 50 percent of male doctors in many low-income and middle-income countries and countries across the Middle East smoke. Helping them to switch first deserves concerted effort. And having a new medically licensed e-cigarette or nicotine pouch could well trigger the desired cascading impacts on their patients and then among the general population.
The process to obtain a medical license has been well outlined by the FDA’s Center for Drug Evaluation and Research (CDER) and the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA). Neil Benowitz et al. (see below) and Fearon have stressed that CDER requirements are particularly onerous. The MHRA process is more “encouraging.” According to them, a major benefit of the MHRA is that studies required can be conducted in any country whereas only U.S. studies are accepted by the CDER.
A unique authoring partnership between people who usually disagree about the value of THR concluded that the CDER should “reach out to companies that may be interested in developing smoking cessation products” and indicated that that could include medically approved vapes. Authors included Benowitz and Ken Warner, known supporters of THR, and Matt Myers and Joanne Cohen, who until now have opposed THR.
They commented that “the deadliest form of nicotine delivery has been subject to limited oversight whereas products marketed to help people quit face far more regulatory barriers.” The fact that agreement can be reached on the value of THR in the context of medically licensed products should be taken as a signal to how broader acceptance might happen.
Mitch Zeller, previous head of the FDA’s Center for Tobacco Products, jumped into this field recently and urged action on medical licensing when he announced that he had joined a company aiming to bring a medically licensable vape to market.
Why Has Industry Not Led the Way?
There can be little doubt that the pharmaceutical industry and leaders in the tobacco industry have long had the scientific knowledge and technical capabilities to develop medically licensed equivalents to e-cigarettes and nicotine pouches. So why has there been no progress? Are short-term commercial interests taking precedent over health needs? I suspect this is a major factor delaying progress by large companies. But thankfully, smaller entrepreneurial companies are pursuing medical licenses at considerable cost to them.
In addition to commercial interests, industry leaders and analysts have mentioned three other issues as hampering to progress:
Concern that the WHO and anti-harm reduction activists would mount campaigns against them.
Tobacco companies fear that a medically licensed product would reach a small part of the market—people with early symptoms of disease or those deeply concerned about their health. That might turn off other smokers seeking to use safer products for recreation and pleasure. They do not want to be stigmatized as being “patients.”
Any innovation or improvement to a medically licensed reduced-risk product needs costly, lengthy and comprehensive re-appraisals by the regulating body with no guarantee of consumer acceptance. For industries specializing in fast-moving consumer goods, this can be a deterrent.
What Is the Size of the Market?
Companies need to look at data on the burden of disease and at data they have showing that an extremely high percentage of e-cigarette users switched from combustibles for health reasons. Global burden of disease data shows that 8 million people die annually from tobacco use. That figure hides the fact that hundreds of millions of tobacco users have early symptoms or signs of cancers, heart and lung disease or tuberculosis. It hides the fact that over 50 percent of people with serious mental illness smoke, that about 60 percent to 70 percent of people with early chronic obstructive pulmonary disease, tuberculosis and schizophrenia smoke at the point they are diagnosed. And that figure does not change much during their treatment, suggesting physicians’ failure to help their patients end smoking.
It is not surprising that a recent Bloomberg analysis suggests that the size of the nicotine-replacement market could reach $100 billion by 2028. That should stimulate companies to invest in medically licensed options that consumers demand and enjoy in unprecedent numbers.
How Would These Products Be Marketed?
Marketing strategies would need to distinguish between products that are medically approved versus others. There are many precedents for designing marketing plans to reach two different audiences using the same basic product. The most recent being how Ozempic addresses the needs of people with diabetes while Wegovy (both made by Novo Nordisk) addresses obesity. Two brands, one set of active ingredients. In an analogous way, initially NRTs were prescription-only in most countries but were changed to “over the counter” use to improve access to “essential medicine,” and NRTs are noted as such in the WHO Model List of Essential Medicines.
I could see this developing a comparable way for e-cigarettes and nicotine pouches.
Conclusion
There is a massive untapped need to get more efficacious cessation products on the market. Medically licensed e-cigarettes and nicotine pouches could well be the key to gaining widespread and critically needed physician support for the categories. That could unblock deep opposition to THR as it has happened with so many innovations that benefit health.
A global health expert and anti-smoking advocate for more than 30 years, Derek Yach is the owner of Global Health Strategies. Previously, Yach was the director of the Foundation for a Smoke-Free World and a World Health Organization cabinet director and executive director for noncommunicable diseases and mental health. He was deeply involved with the development of the Framework Convention on Tobacco Control.
July 1, 2023
Why Don’t They Just Stop?

Photo: Wosunan
Utopian visions and unintended consequences
By Cheryl K. Olson
“The decline in smoking prevalence has slowed to a trickle.” That’s how Kenneth Warner of the University of Michigan’s School of Public Health phrased it in a 2013 editorial on the tobacco endgame. With progress stalled, tobacco control advocates searched for dramatic measures to kick-start it. A Google Scholar search for “tobacco endgame” brings up over 7,000 results for the past decade.
One popular idea is to simply declare game over. A 2018 editorial in Tobacco Control pointed to clever ads placed in U.K. newspapers by Philip Morris International saying, “We’re trying to give up cigarettes.” Rephrasing that slogan as “Stop me before I kill again,” the editorial stated, “There is no reason why a plan to phase out cigarette sales cannot be developed and pursued now.”
The disruptions and isolation of the Covid-19 pandemic brought fresh calls in major medical and public health journals to stop marketing smokes. “In this context, now is an opportune time to move toward removing cigarettes from general retail sale,” said a BMJ editorial.
If the tobacco industry is sincere about reducing harm, why don’t they just stop selling cigarettes? “That’s a very common talking point. It’s a nice utopian vision,” says Dave Dobbins, an independent consultant currently working with Altria and former chief operating officer of the Legacy Foundation/Truth Initiative.
What would actually happen if Big Tobacco shut down cigarette sales tomorrow? And more realistically, what actions might speed the day when the last Marlboro or Salem is packaged and trucked? Experts in public health, economics and law enforcement have some thoughts.
‘In the Hands of Criminals’
Dave Dobbins
Cigarette sales could stop, but the desire to buy them wouldn’t. “All industries are a product of supply and demand,” says Dobbins. “And eliminating supply does not eliminate demand.” He pictured equipment idled by Big Tobacco being bought up and put to use by less-scrupulous entities.
“If the tobacco companies stopped selling cigarettes, you would find an explosion in the black market and the counterfeit market,” says Richard Marianos, retired assistant director at the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives and faculty member at Georgetown University. “They would be smuggled into the United States and supplant that demand that has been voided by the tobacco companies.”
Halting sales of cigarettes would have unintended consequences. Currently, tobacco companies are regulated and taxed, and their products are distributed in legal commerce.
“By taking them out of commerce, you put the market in the hands of criminals who will sell on the street and create additional crime,” says Marianos.
We see an analogous situation unfolding with the regulation of vaping. After the U.S. Food and Drug Administration prioritized enforcement against mint and fruit-flavored prefilled cartridges in January 2020, youth sales of disposable flavored brands soared. On June 22, the FDA announced a “nationwide retailer inspection blitz” that led to warning letters cracking down on the disposable brands Elf Bar and Esco Bars.
“There’s vaping out there that is designed for a tobacco harm reduction strategy, which is good, to get people off combustibles,” Marianos says. “But these disposable vapes with flavors like bubblegum and gummy bear, marketed to kids, made by unregulated factories in China, need to be put away.”
Marianos also points to an additional public health risk from counterfeit or contraband overseas products: “A lot of them are made in facilities that contain rat feces and dirty machines.”
A report in the June 23 issue of the CDC’s Morbidity and Mortality Weekly Report noted an increase in e-cigarette associated cases reported to U.S. poison centers. Sixty percent involved Elf Bar, and more than 90 percent of those were among children younger than five.
Prohibition Lessons
“It’s just not clear that there are methods that are both plausible and coercive enough to enforce a prohibition if people really want drugs,” says Dobbins. “The drug wars in every other field have been an utter failure. I don’t think there’s a lot of hope that there’d be a different result if you declared a drug war on nicotine.”
The U.S. experience with alcohol Prohibition in the early 20th century is enlightening. Entertaining examples of law evasion can be found on the website for the Ken Burns public television documentary about this failed experiment. Grape juice concentrate was sold with sly warnings not to leave it sitting too long, lest it ferment into wine. Home distilling equipment could be bought at hardware stores, and instructions on making booze could be found at the library. In short, “The law that was meant to stop Americans from drinking was instead turning many of them into experts on how to make it.” And the problem of alcohol abuse, far from being solved by Prohibition, was made worse.
“It’s hard for me to imagine the kind of coercive measures a state would have to employ to curtail supply, much less demand,” Dobbins says. “In countries that essentially eliminated marketing and imposed plain labeling or graphic depictions of the death and disease that can occur from cigarette use, those efforts have only very mildly curtailed demand.”
During the Covid-19 pandemic, South Africa enacted a temporary ban for the public good. Research showed that people who smoked were at higher risk for severe illness; this could buckle the healthcare system. Unfortunately, the usual happened: Less than 10 percent of smokers quit. The existing black market ramped up production. Prices increased over 240 percent. When the ban ended, the illicit sellers had a larger share than before. (For other examples, see “Prohibitionists at Work” on Clive Bates’s The Counterfactual website.)
Harm Maintenance?
In 2013, Warner noted the lack of consensus on what the “end of the endgame” might look like for tobacco control. The end of smoking? Of all forms of tobacco use? A nicotine-free population? Or “a more modest tobacco harm minimization objective”?
In that 2018 Tobacco Control editorial, Ruth Malone wrote, “So we should all be clear about one thing: ‘Giving up cigarettes’ for PMI does not mean the company wants people to quit using its addiction sticks. It means they want to get people hooked on a different type of addiction stick.”
Harm minimization looked like a profit-maintenance ploy to skeptics in public health. They felt burned by “light” cigarettes and saw poor adoption of the available nicotine replacement options. As John P. Pierce wrote in Nicotine & Tobacco Research in 2002, “Without more research on whether these products can be substituted effectively for smoking, endorsing harm reduction as a goal could lead to another 25 years of harm maintenance.”
How different things look 21 years later! Novel nicotine alternatives abound. We have data that many people who smoke, including those from vulnerable groups, are indeed willing to substitute these products. Anti-smoking eminences such as Warner now advocate for “nicotine e-cigarettes as a tool for smoking cessation.”
For public health people, it’s hard to let go of the desire to punish Big Tobacco for real and serious past harms. But we can’t wish away the accumulating data. Evidence suggests that helping multinational cigarette makers transform into diversified sellers of noncombustible nicotine products will save more lives with fewer unintended effects. Ditto for helping people who can’t or don’t want to quit smoking switch to satisfying lower risk options.
‘Novelty Items’
Michael Pesko
Michael Pesko, an associate professor at Georgia State University who studies nicotine policy, gave me the economist perspective. “How do we intervene in a marketplace determined by supply and demand to reduce purchases of combustible tobacco products? No intervention will fully stamp out combustibles, but it may be possible to reduce their use to novelty items,” he says.
He recommends a combination of education and risk-based regulation. “Raising public health awareness about the dangers of combustibles and the harm reduction benefits of reduced-risk tobacco products such as e-cigarettes is a way to reduce demand for combustible tobacco products,” he says. “Heavy regulation of combustibles, such as taxing them, can be used to reduce supply.”
A new article by eight prominent academics and lawyers titled Do Tobacco Companies Have an Incentive to Promote “Harm Reduction” Products? says, yes, they do—provided there is competition from noncigarette companies and appropriate government regulation.
The authors mention multiple ways that tobacco control researchers can add sunshine to speed this transition. This ranges from analyzing the effects of government regulations on competition and the market position of noncombustibles versus cigarettes to monitoring and exposing smoking promoting or alternative discouraging activities by tobacco companies.
Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Advisors. She spent 15 years on the faculty of Harvard Medical School.

July 1, 2023
Best Practices
Photo: doidam10
How to approach environmental assessments for the best chance of success
By Adam Bonin and Antony Jones
An Environmental Assessment (EA) is an analysis prepared in accordance with the U.S. National Environmental Policy Act (NEPA) to determine if a product’s approval would significantly affect the environment. It applies to all federal actions in the U.S., including regulations, policies, projects, licensing and permission granting. The assessments give insights into potential risks associated with a product’s manufacture, use and disposal and help manufacturers develop effective mitigation strategies to reduce or avoid possible environmental consequences.
EAs therefore help regulatory agencies identify potential adverse environmental impacts from the manufacture, use and disposal of electronic nicotine-delivery systems and oral nicotine products. They are a small yet important part of premarket tobacco product applications (PMTAs) and modified-risk tobacco product submissions. The U.S. Food and Drug Administration requires manufacturers to submit EAs for each individual tobacco product, or stock-keeping unit, within a PMTA.
An inadequate or absent EA will result in either a “refuse-to-accept” or a “refuse-to-file” order from the FDA. In 2021, the FDA rejected 4.5 million vaping applications on the grounds that they “lacked an adequate environmental assessment.” With companies spending millions on PMTA submissions, they cannot afford to miss out on approval due to such a small part of the process. So, what does a good EA look like?
What to Include in an Environmental Assessment
In general, an EA includes an executive summary, applicant details, description of the proposed action and purpose and need of the proposed action. Further EA sections include the identification of alternatives, including the proposed action and no action alternative, potential environmental impacts of the alternatives (affected environment [or existing conditions] and environmental impacts), cumulative impacts and mitigation measures. An EA is appropriate for submission if it is determined that the impacts of the proposal will not be significant or the FDA concludes a finding of no significant impact. Mitigation measures may be recommended if impacts are anticipated, to reduce them below the significance threshold.
The initial stage of the EA process is building a well-defined project description, covering the purpose and need for the regulatory decision (marketing granted order) that triggers the requirement for an EA under the NEPA. The applicant will also need to include details of product components, product formulation (where applicable) and predicted sales projections for the first and fifth years. It is particularly important to include the mass of individual metals in product hardware components (e.g., devices, pods) to assess potential impacts at the end of life.
A good EA includes a thorough screening and comprehensive modeling of product components (e.g., e-liquid ingredients), with all conclusions and results backed up with hard data. The evaluation of the potential release of materials to the environment should be quantitively assessed, with the resulting potential concentrations in the environment explicitly stated and compared with relevant ecotoxicity standards to determine the possible impact.
Throughout, it is important to appropriately manage confidential information. EAs include both confidential and nonconfidential appendices, and it is important that these are prepared correctly. For example, if there is proprietary information in the e-liquid formulation, this would be best listed in the confidential appendices, as would sales and marketing projections. It can be difficult to know which information is appropriate for inclusion in the confidential apprentices, and working with an experienced team offers the best chance of success.
Determining the Possible Impacts
E-liquids typically consist of a mixture of ingredients, including propylene glycol, vegetable glycerin and nicotine. The formulation can be screened using a predictive tool to determine which ingredients are of most ecotoxicological concern and should be carried forward into the analysis. The selected ingredients can be assessed for estimated acute and chronic aquatic toxicity for aquatic organisms, including plants, fish and invertebrates, and then be assessed in subsequent fate and transport modeling.
The EA should analyze the plausible scenarios for the impact of the identified substances being released into the environment, including quantitative release modeling. For example, this could include the possible impact of the material being released into surface water or soils at quantities considered reasonable based on predicted sales data.
The project supply chain should also be documented, including details of manufacturing and shipping to retail entities. The environmental and social resources around U.S. manufacturing facilities require characterization to provide an understanding of the affected environment (existing or baseline conditions). The potential impacts of projects can then be evaluated based on changes to the baseline conditions—for example, if chemical mixtures or raw ingredients are accidentally released into surface water or chemicals are released down the drain during manufacturing.
It is important that the EA is realistic. In our experience, the inclusion of conservative analyses appears to be the soundest approach. It may be tempting to conduct modeling for a wide variety of release scenarios, but if they are deemed unlikely by the FDA, you may receive a deficiency for evaluating unreasonable scenarios.
Tips and Tricks
Start early. Considering the EA process early in the application can improve efficiencies, particularly for characterizing natural resources around U.S.-based facilities and engaging with manufacturers and other vendors to understand product supply chains.
Use a robust standard operating procedure. In an EA, it is vital that every section includes explicit information that satisfactorily evaluates the product against FDA requirements.
Choose an experienced team. Many businesses do not have employees with sufficient NEPA experience; in this case, we recommend working with a consultancy. NEPA-specific jargon and other regulatory nuances can be challenging for new practitioners.
Stay up to date. Attending FDA and NEPA meetings can be a great way to stay up to date with any changes in the guidance. In addition, manufacturers can engage directly with an FDA project manager if they receive deficiency comments.
Adam Bonin is a senior consultant at Broughton with over 22 years of scientific consulting experience. He earned a Bachelor of Science degree in environmental management from the University of Rhode Island and a doctorate in environmental microbiology from Portland State University. Bonin also completed a postdoctoral appointment in microbial ecology at Oregon Health and Science University.

Antony Jones is a managing consultant at Broughton with more than 22 years of experience in risk assessment with a focus on characterizing and reducing risks across the pharmaceutical, biotechnology, food, nicotine and environmental industries. He earned a Bachelor of Science degree in biology from the University of York and a doctorate in molecular biology and microbiology from Newcastle University. Jones also completed a postdoctoral appointment at King’s College London.

Broughton is a global scientific consultancy-based Contract Research Organization serving industries in pharmaceuticals, next-generation nicotine-delivery products and cannabinoids. Its team has developed a robust and proven approach for preparing defensible NEPA-compliant EAs for the FDA PMTA. For more information, visit www.broughton-group.com/us-pmta-and-mrtp-nepa-environmental-assessments-ea.
July 1, 2023
Minister Expresses Support for Tobacco at ITGA Meeting

Photo: Taco Tuinstra
Zimbabwe’s minister of agriculture, Anxious Masuka, opened the International Tobacco Growers Association’s (ITGA) 2023 Africa regional meeting June-28-29 expressing strong support for the tobacco sector
Growers’ representatives from four of the leading tobacco producing markets in Africa—Malawi, Tanzania, Zambia, and Zimbabwe—gathered in Harare to debate the challenges and opportunities facing their sector. Participants requested the support of their governments in the face of multiple threats affecting tobacco production, which brings considerable socioeconomic benefits to the region. Among other topics, they discussed growers’ sustainability efforts and the situation of in their respective markets.
Highlighting the central role of tobacco growing in Zimbabwe’s economy, Masuka provided details about the country’s Tobacco Value Chain Transformation Plan, which is supposed to increase value addition of the crop and improve local earnings (also see “The Man Behind the Plan,” Tobacco Reporter, May 2023). Masuka aims at record volumes, record earnings and record average prices for tobacco growers. He stated that the actions of the World Health Organization Framework Convention on Tobacco Control (FCTC) are “ill-informed and ill-timed.” “Tobacco in Zimbabwe is an important crop and we are not making any apologies about it,” said Masuka.
Ryan Swales, the president of Zimbabwe Tobacco Association (ZTA), highlighted the important opportunity presented by the meeting in debating the regional and national issues, given the specific challenges attached to the market, predominantly in sustainability.

Governments need to look at farmers as their main strategic partners and support their efforts.
Jose J. Aranda, president, ITGA
ITGA’s President Jose J. Aranda called on governments to support growers in their sustainable tobacco production efforts as the livelihoods of millions of people around the world depend on it. Tobacco growing, he said, brings valuable contributions to local economies in the form of labor, income, and further opportunities for growth. Aranda also emphasized that tobacco growers operate within a legal framework. “Governments need to look at farmers as their main strategic partners and support their efforts.”
During the Open Session, participants were able to follow presentations about the current developments in the global leaf market, with focus on African production and pricing, the outlook of the regulatory environment and possible implications for growers, along with a detailed analysis of the ITGA 2023 Market Survey, which highlights the economic, social and environmental challenges for growers in all leading tobacco growing areas. Finally, there were two comprehensive debate sessions with key stakeholders in the four represented markets discussing sustainable tobacco productions and the efforts made to overcome the pressing challenges of the region—cost of production, deforestation, climate change, poverty and lack of opportunities for the youth.
The ITGA also highlighted its World Understanding Tobacco Farming Day campaign. Aranda urged the sector to work together against the demonization of tobacco growing. ITGA is raising awareness about the realities of tobacco farming to stop the unfounded claims by the WHO FCTC in their World No Tobacco Day.
June 29, 2023
Tobacco Production Up in Tanzania

Photo: Taco Tuinstra
Tanzania produced 125 million kg in 2023, up from 60 million kg in 2022, reports the Xinhua News Agency
Addressing the fifth general meeting of the Tobacco Cooperative Joint Enterprise in the Morogoro region, Stanley Mnozya, the director general of the Tanzania Tobacco Board, said his organization has taken measures to increase the production of the crop to 231 million kg in 2024.
The increase is in line with the objectives of Tanzania’s ruling party, Chama Cha Mapinduzi, which wants the country to produce 250 million kg of tobacco by 2025.
Mnozya attributed this year’s increase in tobacco production to the emergence of new buyers on the markets. There are now 11 companies purchasing tobacco in Tanzania.
TCJE Chair Ntezilyo John said Tanzania tobacco cultivation is facing a number of challenges, including delayed payments and a lack of subsidized fertilizers.
June 29, 2023
Tobacco Outranks Electric Vehicles on ESG

Photo: uflypro
Tobacco companies perform better in environmental, social and governance (ESG) rankings than manufacturers of electric vehicles, reports The Washington Free Beacon.
Earlier this month, S&P Global raised eyebrows when it gave Tesla, the world’s largest manufacturer of electric cars, a lower ESG score than Philip Morris International.
Tesla earned just 37 points on the 100-point scale compared with PMI’s 84.
It’s not the first time that tobacco companies have outranked companies with greener reputations. Sustainalytics, a widely used ESG ratings tool, gives Tesla a worse score than Altria Group. And the London Stock Exchange gives BAT an ESG score of 94—the third highest of any company on the exchange’s top share index—while Tesla earns a middling 65.
The strong ESG performance of tobacco companies is due in part to their emphasis on inclusion and social justice. Altria, for example, has gone out of its way to emphasize the diversity of its corporate board and the breadth of its social justice initiatives. Tesla, by contrast, has resisted that bandwagon, going so far as to fire its top LGBT diversity officer last year.
Imperial Brands touts its trainings on “microaggressions” and a board that is 40 percent women. PMI and BAT promote their scores on Bloomberg’s Gender Equality Index.
Critics contend that tobacco companies’ ESG scores mask the negative impact of their activities, which they say include pollution from filters and nondegradable e-cigarettes along with the soil erosion and deforestation associated with tobacco growing.
June 15, 2023