Category: Nicotine

FDA Submits Proposal to Limit Nicotine

The U.S. Food and Drug Administration has submitted a proposal to limit the amount of nicotine in tobacco products, reports CNN.
The FDA has been discussing limiting nicotine levels since 2018, and this week, the FDA submitted the proposal to the Office of Management and Budget (OMB). This move comes as the Biden administration enters into its last weeks and President-elect Donald Trump prepares to take office in January 2025.
“A proposed product standard to establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain combusted tobacco products, when finalized, would be among the most impactful population-level actions in the history of U.S. tobacco product regulation,” the FDA said in a statement.
“Once finalized, this rule could be a game-changer in our nation’s efforts to eliminate tobacco use,” said Harold Wimmer, president and CEO of the American Lung Association. “Making tobacco products nonaddictive would dramatically reduce the number of young people who become hooked when they are experimenting. To fully address the toll of tobacco on our nation’s health and across all communities, it is critical to reduce nicotine levels to nonaddictive levels in all commercial tobacco products, including e-cigarettes.”
“Certainly, there would be individuals who would benefit from substantially lower nicotine levels and find it easier to quit,” said Rose Marie Robertson, a cardiologist and chief science officer at the American Heart Association. “It’s really hard to quit. I’ve seen patients over many years who have gotten the wake-up call with a heart attack or a stroke and really want to improve their health and reduce their risk, but it’s just very, very hard to do.”
The submitted proposal does not mean that there will be any immediate changes. The OMB’s approval process can take months, and there must be a public comment period. It is likely that the tobacco industry will sue the government as well, as has been seen with other proposed regulations.
It is unclear what will happen with the proposal following the change in presidency. In Trump’s first term, the Trump administration signaled that it wanted to limit nicotine, but during this year’s election season, the tobacco industry donated heavily to Republicans, and Trump’s pick for chief of staff was previously a tobacco lobbyist.
December 13, 2024
Korea Seeks to Restrict Synthetic Nicotine

South Korea is working to restrict the use of synthetic nicotine e-cigarettes, reports The Korea Times.
Korea’s current law defines tobacco products as those made from the leaves of tobacco plants. Some companies saw this as an opportunity to sell products using synthetic nicotine created in a lab rather than from tobacco leaves.
Recently, BAT Rothmans Far East, launched its synthetic nicotine vape product, Nomad Sync 5000, which currently does not meet the definition of “tobacco-leaf products” and thus avoids multiple taxes and special charges.
In recent months, lawmakers have filed more than a dozen bills to amend the law.
The latest bill, proposed by lawmakers of the opposition Democratic Party of Korea on Nov. 26, aims to redefine what constitutes tobacco products, seeking to include vapes that use synthetic nicotine.
Another group of lawmakers are attempting to require sellers to put warnings on vape packaging just as cigarette sellers do, in addition to the expansion of the legal tobacco definition.
The Ministry of Health and Welfare has vowed to support such legislation efforts.
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November 28, 2024
Inaccurate Disclosures Nicotine Analogs: Study

Photo: ryanking999
Companies are inaccurately disclosing the ingredients in products containing nicotine analogs, according to researchers at Duke University and Yale University. Remarkably, in many instances, the levels measured were lower than those labeled on the packaging.
Nicotine analogs are currently not subject to the U.S. Food and Drug Administration’s marketing authorization process and have not been extensively studied for their health effects. One chemical, known as 6-methyl nicotine, has been shown in rodent experiments to be far more potent than nicotine in targeting the brain’s nicotine receptors.
The scientists analyzed a Spree Bar e-cigarette, which is listed as containing 5 percent 6-methyl nicotine. Study results showed the actual amount of the chemical was about 88 percent less than labeled. The e-cigarettes also included an artificial sweetener that is up to 13,000 times sweeter than table sugar, and an artificial coolant that mimics menthol’s effects.
A second brand of e-cigarettes, marketed as Nixotine, Nixodine, Nixamide and Nic-Safe, contained a nicotine analog called nicotinamide, also at levels lower than the labels indicated, and combined with undisclosed amounts of 6-methyl nicotine. This brand did not include sweeteners or coolants.
The researchers speculated that companies are using nicotine analogs to bypass health regulations covering vaping products.
“These products appear to be designed to circumvent the laws and regulations in place to protect people—especially children—from the harmful effects of smoking and tobacco use,” said senior author Sven Eric Jordt in a statement. “We do not know what these chemicals do when they are heated and inhaled. These are questions that should be answered before we allow products on the market.”
August 8, 2024
No Shortcuts

The effort to correct nicotine risk misperceptions will be a marathon rather than a sprint.
By Stefanie Rossel
“Nicotine contained in tobacco is highly addictive, and tobacco use is a major risk factor for cardiovascular and respiratory diseases, over 20 different types or subtypes of cancer and many other debilitating health conditions.” With phrases like this, the World Health Organization links the undisputed harms of burning and inhaling plant tissue with the ingredient smokers seek in a cigarette.
Regardless of its form of delivery, such statements suggest, nicotine is the devil incarnate. In spreading this message, it appears, the WHO has done a good job. In a 2021 study funded by the National Cancer Institute, 83.2 percent of surveyed U.S. physicians “strongly agreed” that nicotine directly contributes to the development of cardiovascular disease. Nearly 81 percent thought it contributes to chronic obstructive pulmonary disease (COPD), and 80.5 percent associated nicotine with cancer.
While recognizing that nicotine is responsible for the addictive nature of tobacco products, the study authors pointed out that the strongest evidence for direct causality for nicotine is for birth defects (neurodevelopment), with only limited evidence supporting causal links to cancer and cardiovascular disease and scarce data for COPD. The misperception that nicotine is responsible for smoking-related health risks, they observed, is not only common among the public but also among other healthcare professionals.
“Correcting misperceptions should be a priority given that in 2017, the FDA [U.S. Food and Drug Administration] proposed a nicotine-centered framework that includes reducing nicotine content in cigarettes to nonaddictive levels while encouraging safer forms of nicotine use for either harm reduction (e.g., smokeless tobacco) or cessation (pharmacologic NRT [nicotine-replacement therapy]),” the study concluded.
In product use, risk perceptions play a critical role; they can influence smokers’ decisions on whether to switch to products with lower risk profiles. The messaging is an essential part of changing misperceptions. Studies on nicotine corrective messaging have shown that it was effective in decreasing misperceptions of nicotine harm, but repeated exposure to such messaging was necessary to reduce false beliefs about nicotine and tobacco products.
With physicians and other healthcare professionals often being the first point of call for people seeking to quit smoking, it is obvious that their misperceptions should be corrected first so that they can educate their patients and accurately convey nicotine’s relative and absolute risks.
Carolyn Beaumont
Carolyn Beaumont, a general practitioner (GP) from Victoria, Australia, has taken on the challenging task of educating her colleagues. Since July 1, 2024, all nicotine vapes in Australia have been regulated as therapeutic goods, which means they are available only at pharmacies to help people quit smoking or manage nicotine dependence. Currently, all buyers of nicotine vapes require a prescription from a doctor or a nurse practitioner.
Starting Oct. 1, the rules will be somewhat relaxed. From that date, people 18 years or over will be able to purchase therapeutic vapes directly from a pharmacy without a prescription. People under 18 will still need a prescription to access vapes, where state and territory laws allow it, to ensure they get appropriate medical advice and supervision.
The concentration of nicotine in vapes sold in pharmacies without a prescription will be limited to 20 mg per milliliter; people who require vapes with a higher concentration of nicotine will still require a prescription.
The law requires pharmacists to consult customers of both prescription and nonprescription vapes before allowing them to make a purchase.
Following the announcement of the new rules, several major pharmacy chains in Australia stated that they will no longer stock vapes. Beaumont is not surprised: “They simply don’t have the time, product knowledge or resources to advise customers on appropriate products and use. It is greatly complicated because any pharmacist-only product must be an approved medical product, yet there are no approved vapes in Australia. They are listed but not approved. Fortunately, there are some online pharmacies who specialize in vapes, and these will continue to operate but likely will require a script to avoid the ‘nonapproved’ issue.”
“There is no official doctor education in Australia that adequately presents the fuller context of smoking, vaping and nicotine.”
Enjoyment Doesn’t Feature
Despite the hostile environment for nicotine, Beaumont says she has found that her colleagues are quite interested in the field of tobacco harm reduction (THR). “Yet, to communicate THR on a larger scale, typically via continuing medical education (CME) courses or webinars, is difficult. These generally require support from the Royal Australian College of General Practitioners (RACGP), and to date, there is no official doctor education in Australia that adequately presents the fuller context of smoking, vaping and nicotine,” she says.
“In medical school and as a trainee GP, we were taught of the many smoking-related health and social issues. But a more nuanced understanding of working with smokers wasn’t appreciated. We all knew the ‘three A’s’ approach—ask, advise, assist—the measure of nicotine dependence—time to first cigarette—and the first line NRTs. Yet it stopped there as though magically, smokers would be motivated to quit, and this would happen within six months. If not, repeat the process ad nauseum.”
According to Beaumont, doctors aren’t taught that some smokers like nicotine and simply want a less harmful alternative. “Enjoyment doesn’t feature in medical education,” she says. “Doctor support can truly help some people reduce their use. But it’s not enough for many heavy smokers, and they often become disengaged with the same messaging they keep hearing from doctors.”
Beaumont is encouraged, though, that Australia’s GP College recently revised its smoking cessation guidelines and increased the recommendation of vaping from “low” to “moderate.” “I hope this will have a reasonable impact on doctors’ willingness to prescribe, or at least be open to the conversation,” she says. “I also hope this signals a greater willingness by the RACGP to support vape-related CME that is broader in scope and includes input from ‘progressives’ such as myself.”
Beaumont first became aware of vaping as a cessation tool in 2020 when Australia was on the verge of making vapes prescription-only. “My approach was simply this: I listened to the needs of smokers and vapers,” she says. “It didn’t take long before I was convinced of [the] merits [of vaping], and also, I developed a deeper understanding of nicotine use and addiction. Compassion and health improvements were, and still are, the underlying reasons why I’ve remained involved in this field.”
Beaumont aims to help disadvantaged groups, which are among the most affected by smoking-related death and disease. “It is simply unjust that smokers are also affected by nicotine myths, and it is getting to the point where people think that smoking is better than vaping.”
“Like so many areas where science is contested, adherents of contrarian positions are rarely persuaded by more science or data.”
Open Dialogue Required
Derek Yach
While some believe that science will correct misperceptions of nicotine, others are skeptical, pointing, for example, to the WHO’s proposal to define aerosols as smoke. Derek Yach, a global health expert originally from South Africa who played a key role in crafting the WHO’s Framework Convention on Tobacco Control, says that while some topics require more research, these gaps should not delay WHO support for THR, noting that they have not prevented the U.S. Food and Drug Administration and other government agencies from authorizing a range of reduced-risk products.
“Like so many areas where science is contested, including vaccine benefits, climate change or even beliefs that the earth is flat, adherents of contrarian positions are rarely persuaded by more science or data,” says Yach. “Their views deeply reflect emotional, ideological and sometimes cultural views based on their life experiences. A mother whose child gets autism after a vaccine is easily convinced that vaccines are dangerous. A tobacco control advocate who experienced tobacco industry subversion of public policies keeps that view and doubts anything new coming from industry.”
Having worked on all sides of the issue and having spoken with a wide variety of stakeholders, Yach says that there is no shortcut to finding safe spaces to not only talk honestly about the science but also examine the reasons behind the mutual suspicion. “I saw this bear fruit in the declining years of apartheid when talks about talks led to a peaceful transition of power,” says Yach. “It is possible in that setting; it must be possible in our world.”
The Morven Dialogues, a series of meetings between U.S. public health officials and tobacco industry representatives first held in 2012, have been a modest example of what is needed, according to Yach.
“They recently reported on their March 2024 meeting, which brought together industry with some public health leaders in the U.S.,” says Yach. “Further, I see signs of hope in a recent article by authors from public health I have long respected. They argue for dialogue between scientists in the public sector and industry—as I have—and not for boycotts and bans.”
Without agreement on the basic scientific issues and progress on correcting disinformation, sound policies are unlikely. “A study of how change happens in public health shows that it always starts with physician acceptance of the evidence,” says Yach. “They apply that evidence to themselves, to their patients and through organized efforts to public policy. Recall that no country has ever seen a reduction in their smoking rate before it goes down in physicians. I suspect that is true regarding uptake of THR products. And that starts with doing more to have disagreeing groups talk.”
It’s going to be an uphill struggle, though: In mid-June, the WHO in a press release expressed “grave concern over the tobacco industry’s manipulative tactics aimed at influencing healthcare providers through continuing medical education programs and thereby advancing the interests of the tobacco industry.”
Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.

August 1, 2024
Nicotine 2040

Photo: Artinun
The market for tobacco and nicotine is transforming—how could it look by 2040?
By Clive Bates
“Prediction is very difficult, especially if it’s about the future,” said the great Danish physicist Niels Bohr. The future is a burial ground for expert reputations, but that should never be a reason to shy away from predictions. Much of what we do today will shape the world in 2040, and our view of how the world should be in 2040 should shape what we do today. So let us consider the evolution of the market for tobacco and nicotine products out to 2040. There’s a lot to think about, so buckle up!
First, three epochs. I see the evolution of the tobacco and nicotine policy as three overlapping epochs covering 1960 to 2040.
(1) The tobacco control epoch stretched from 1960 to 2010. It was triggered by reports from the U.K. Royal College of Physicians and U.S. Surgeon General. It involved an all-out struggle between public health and the tobacco industry over the multiple harms of cigarette smoking, culminating in the World Health Organization Framework Convention on Tobacco Control, agreed in 2003.
(2) The tobacco harm reduction (THR) epoch started around 2000 with the increasing recognition that smokeless tobacco, especially Swedish snus, was much safer than cigarettes and could displace smoking. That epoch took hold in 2010 with the rise of vaping, then heated tobacco, and now nicotine pouches. The THR controversy is focused on reducing the harms associated with smoking and exploiting (or resisting) a massive public health opportunity (or risk). However, this is an interim phase.
(3) The rethinking nicotine epoch is already underway and beginning to shape thinking about the future. We will need to confront the fundamental question: What is the place of nicotine in society? What does nicotine use mean if few people are smoking and there is not that much harm to reduce? This is already a live question; around half of American vapers aged 18–24 have not previously smoked, though some might have smoked had there been no vapes. We will undo the deep conflation between the relatively benign stimulant nicotine and the harms of smoke inhalation and place it alongside caffeine, alcohol and, increasingly, cannabinoids as legal recreational substances.

Second, the persistence of the demand for nicotine. Many tobacco control activists have hoped that the relative decline in cigarette smoking would also eventually lead to a nicotine-free society. However, they misjudged the underlying behavioral drivers. The decline in smoking was driven by the harm to health and welfare, reinforced by policy-induced pain, such as taxes, smoking restrictions or “denormalization” designed to create a deterrent to uptake and motivation to quit. However, without the underlying harms, the deterrents are greatly weakened, and there is no justification for a punitive, coercive and stigmatizing policy. We are left to answer the question: Why is there a demand for nicotine? The demand derives from a simple proposition: For some people, nicotine use makes them feel or function better. Looking out to 2040, we should see the demand for nicotine as robust and resilient. The demand for any particular way of taking it is much more fluid or, as economists say, “elastic.” In fact, without the harms of smoking and related deterrents, demand might increase. That may seem unnerving, but should we care if the harms are low or negligible? As a 1991 Lancet editorial put it: “There is no compelling objection to the recreational and even addictive use of nicotine provided it is not shown to be physically, psychologically or socially harmful to the user or to others.”
Third, technology and innovation. Can smoke-free nicotine products entirely replace smoking to meet all nicotine demand? Many smokers have tried the alternatives and chosen not to switch. There is more to smoking than nicotine self-administration, including the speed and peak of nicotine delivery, other psychoactive agents, sensory experiences such as “throat hit,” flavors and aromas, behavioral and ritual aspects, and perhaps deep brand loyalties that reach right into the individual’s identity. However, the pace of change in alternative technologies has been extremely rapid since the emergence of cigalike vapes at a noticeable scale about 15 years ago. Imagine the product landscape 15 years from now. That will include better versions of the product categories we have today: vapes, oral nicotine, heated tobacco and smokeless tobacco, but perhaps also sprays, inhalers and nasal products. Who knows? Competitive innovation meets consumer demand in novel and sometimes surprising ways. Many public health commentators, and perhaps tobacco industry die-hards, believe that these products will remain a niche alternative for only some smokers. Don’t count on it. Over time, that niche will expand through innovation until it dominates the market. That trend is inevitable and unstoppable.
Fourth, regulation and markets. The twin forces of consumer demand and innovation will squeeze the cigarette market into contraction and lower profitability. The greatest danger is that the rise of smoke-free alternatives will be treated as a threat, not an opportunity, and be met with prohibitions or excessive regulation and taxation. Although such regulation will aim to reduce nicotine use by constraining supply, its effect will be to switch from lawful commercial supply to illicit, criminal and informal supply. This effect is already visible in supposedly strong regulatory jurisdictions like Australia and the United States, where authorized products from approved suppliers meet less than 10 percent of the vape market. Jurisdictions such as Brazil and India have imposed prohibitions, but all that means is that the regulator is missing in action along with any consumer protection. Prohibitions trigger the nasty triad of more smoking, more illicit vapes and more risky workarounds. Whatever the regulation, there will be supply. Banned products do not simply disappear. Whether the supply is lawful or illegal will become the nicotine and tobacco policy conflict of the coming decade. The market will remain lawful if (and only if) the policies adopted for smoke-free alternatives are risk-proportionate, focus on consumer protection and meet the adult demand for low-risk nicotine.
“If you had a product that addicted 45 million people and killed none of them, I would take that deal. Then you’d have coffee!”
Fifth, young people and nicotine. By 2040, a more sophisticated discussion of youth nicotine use will emerge. If we accept that adult use of nicotine will persist indefinitely, then we should expect some young people to try it, and for some, it will make them feel or function better. To the extent that youth vaping displaces smoking, it provides net benefits to public health. No reasonable person, including me, wants young people to smoke, vape or use nicotine in any form. However, it is one thing to express an opinion on what is best for young people, but it is quite another to believe this can or should be achieved by various forms of prohibition imposed on adults. Four strategies will emerge to provide reasonable protections to young people. The first will be an imperative to keep the adult nicotine market lawfully supplied and thus inhibit the formation of large criminal supply networks that will also supply youth. The second will be age-secure retailing, drawing on technology and licensing. The third will be controls on marketing, including branding, packaging imagery and flavor descriptors. Finally, we need to be candid and not hysterical in communicating the risks of nicotine use. The global public health problem is not youth vaping but the millions of existing adults who have already been smoking for a decade or more.
Sixth, the tobacco control complex. The abstinence-only tobacco control field will face a bruising contest with reality. As the wide range of negative consequences of prohibitions are increasingly visible and articulated scientifically, major funders will become wary and back away. The research funding agencies will become more skeptical. The “realists” will grow in stature and begin to prevail over the “idealists” (see “Realists and Idealists,” Tobacco Reporter, June 2024). Pragmatism will drive out hubris, and grand regulatory schemes will fall into disrepute. The original goal of tobacco control has been to address the range of serious diseases and other harms caused by smoking. But that game is up. In comments to the New York Times almost 20 years ago, the then president of the Campaign for Tobacco-Free Kids, Matthew L. Myers, endorsed a world of nicotine use without significant harm: “The challenge to me is not to eliminate smoking but the death and disease from smoking,” Myers said. “That should be the end goal. If you had a product that addicted 45 million people and killed none of them, I would take that deal. Then you’d have coffee! I have to believe that if the marketplace incentives were such that over time, someone could devise a product that would give the same satisfaction as tobacco but didn’t kill them, people would flock to it.”
Then you’d have coffee! Yes, precisely. But there is no gigantic “coffee control” movement. There is no multimillion-dollar Campaign for Caffeine-Free Kids. As Myers’ statement unintentionally suggests, the tobacco control movement is profoundly threatened by nicotine use without significant harm. Without harm, it has no purpose.

Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).

August 1, 2024
Playing with Numbers

Photo: Hafiez Razali
How research methods distort nicotine effects and risks
By Cheryl K. Olson
“The paper seems like a joke.” That’s what Harvard researcher Miguel Hernan said recently to the journal Science about a report linking e-cigarettes and strokes.
The article was concocted by a dubious research group, founded to help young international medical school graduates get coveted authorship credits. Its analysis of U.S. government survey data claimed that respondents who vaped had a higher risk of stroke, at younger ages, than those who smoked. Its glaring flaws included inflating the number of survey takers by tens of thousands and failing to correct for the relative youth of vapers.
Despite this, the 2022 paper’s findings found their way into media headlines and anti-vaping advertising. The Science article credits Gal Cohen and Floe Foxon with sounding the alarm on this appalling study.
Subtler issues that affect research quality, and how research is perceived by the public, are harder to spot. Research methods may seem a dull or arcane topic. But a peek at how the research sausage is made reveals some simple yet surprising ways that the process can go wrong.
Sometimes old habits or unquestioned assumptions are to blame. Just as typewriters affect how we text on our mobiles, legacy cigarette research methods and mindsets influence how we study noncombustible nicotine products.
Hours of Vaping?
Everyone understands cigarettes. When it comes to totting up use, cigarettes are easy. They come in standard units. You light, puff and extinguish. Not so for products such as vapes. How, then, do researchers compare smoking with these new nicotine-delivery systems?
“There’s a lot of research showing that people who use e-cigarettes graze throughout the day,” says Arielle Selya, who conducts nicotine product research at Pinney Associates. “Unlike cigarettes, there’s no defined stopping and starting. They don’t have to finish a discrete unit; they just puff on and off.” Measuring this kind of variable, intermittent activity is a challenge.
This problem is not unique to vaping. Studying nicotine pouch use, I found unexpectedly wide variations in what people did and what they thought was normal. Some tossed a pouch in the trash after 10 minutes or 15 minutes. Others kept one in their mouth for a couple of hours. A few sometimes reused a pouch they’d started earlier or cheeked pouches of two different flavors at once.
As an example of what can go wrong, Selya pointed to a recent study of vaping and respiratory symptoms. To the authors’ credit, they tried to measure heaviness of e-cigarette use. The problem was the poor fit between their question and the behavior. They asked, “How many hours did you use electronic cigarettes per day?”
“I’m not a vaper, but that seems like such a strange question,” says Selya. “Like asking how many hours do you spend drinking water?”
Better approaches to measuring nicotine product use include writing down what you’re doing whenever a device pings you (ecological momentary assessment) or in a daily diary.
Twisted Terminology
Another holdover from cigarettes is the way tobacco is seen as the default flavor for all nicotine-containing products. “With e-cigarettes, you have to add a tobacco flavor,” notes Selya. “But researchers often say ‘flavored’ when they mean ‘non-tobacco flavored’–in some communications even the NYTS team does this–but tobacco itself is a flavor! This generates misunderstandings.”
Nicotine research terminology can defy common sense. Consider the concept of “abuse liability.” In everyday English, abuse implies harm. When the U.S. Food and Drug Administration assesses new drugs, stricter regulation may be required if there’s abuse potential, defined as “intentional, nontherapeutic use” to “achieve a desired psychological or physical effect.” An effect like euphoria, hallucinations or distorted thoughts or perceptions.
When it comes to reduced-harm nicotine products, abuse potential becomes, weirdly, a plus. A backhanded compliment. If you want to attract someone away from cigarettes, features like rapid nicotine absorption, relaxation and relief of withdrawal encourage that transition.
Abuse liability also illustrates another nicotine methodology vexation: there is no agreed-on way to measure it. One article looked at comments made by the FDA on manufacturers’ submissions for multiple types of nicotine products. Regulators considered a whole range of measures related to abuse liability, from product chemistry and pharmacokinetics to subjective factors. Of the latter, “liking” the product turned out to be the most reliable and sensitive abuse liability measure!
Misleading Measures
Again, cigarettes are simple and familiar. Novel nicotine products, by contrast, come in ever-evolving variations. U.S. government surveys, such as the Population Assessment of Tobacco and Health (PATH) and National Youth Tobacco Survey (NYTS), measure trends in who is using what products. The results are widely used and reported. However, for survey results to make sense, people must understand the questions.
Discrepancies in results suggest that research participants often misunderstand nicotine products and/or the terms being used to describe them. For example, answers about vaping brands and device types often don’t match. In the NYTS, just two-thirds of teens who said they “usually” used a pod/cartridge brand of e-cigarette (such as Juul, Logic or Vuse) also said they “most often” used a pod/cartridge device. Almost one in five adults in the PATH study had these kinds of mismatched answers about their vaping behavior.
Some questions have even larger errors. “The NYTS asks whether your e-cigarette product contains nicotine salts,” says Selya. “And overall, about 50 percent said they don’t know.”
This is also true for so-called “concept” flavors, she notes. “Not strawberry-banana, but something like cosmic fusion. When youth are asked about concept or ice flavors, they don’t know the characteristics of their product, or maybe don’t understand those words.”
NYTS first asked youth about tobacco-free nicotine pouches in 2021. That year, just 1.9 percent of teens reported ever using one. Checking the details, I found a flaw: The questionnaire defined nicotine pouches as “flavored.” However, over a third of teen ever-users said the pouch product they used was unflavored. (Perhaps they confused pouches and snus?)
A further example: the 2023 NYTS found that 1 percent of youth—an estimated 370,000—had ever used a heated-tobacco product. At the time, that product category was not sold in the United States.
As Ray Niaura of New York University told me, “That can’t be right. Literally, it’s impossible. So that means it’s measurement error.”
This suggests young survey takers were befuddled. “Kids aren’t going to know,” says Niaura. “‘Heated tobacco: Yeah. I smoked a cigarette. It’s heated. I light it on fire.’”
Yet the Centers for Disease Control and Prevention reported the result without comment or explanation.
If a product is only used by a small percentage of people, these sorts of errors could create unreal changes in year-to-year trends. The reporting of those potentially misleading trends affect the perceptions of academics, regulators and the public. “With that amount of uncertainty and some of the low numbers, it’s hard to figure out what’s the signal versus the noise,” notes Selya.
Questionable Choices
Another seemingly simple but complicated issue: Who counts as a current product user? Youth surveys typically ask “have you used e-cigarettes at all, even a puff, in the last 30 days?” Surveys aimed at adults commonly ask, “Do you currently use e-cigarettes some days, every day or not at all?”
If you assume capturing any youth e-cigarette use is important, then “even a puff” makes sense. But it also makes it difficult to separate teens who are briefly experimenting from teens at risk for problematic ongoing use.
In studies that look at how using nicotine products affect some aspect of health, researchers choose what outcomes to measure. Their choices can suggest biases or suspicious holes in what’s reported.
A recent study using PATH data tried to compare e-cigarette use and the age at which people developed asthma. “Why age of asthma onset rather than whether they developed asthma at all?” says Selya. “Often, I read a study and think, did you look at these other related outcomes? If so, why weren’t they published?” This issue of results that may exist but aren’t reported are known as the “file drawer problem.” Preregistering study plans would avoid this issue.
Researchers, Meet Users
Before I dove deeply into tobacco harm reduction, my research focused on the effects of violent video games on youth. Finding discrepancies between research reports and what teens told me, I realized that many of the field’s most-cited “experts” had never actually played or even observed the games they studied.
Similarly, many nicotine researchers seem to have never held or used the noncombusted products they study. This leads to findings that don’t reflect real-world situations. One example is an article by Sebastien Soulet and Roberto Sussman on metal contents of e-cigarette aerosols. They found that researchers were overheating tank vaping devices, generating aerosols that would be “likely repellent to human users.”
“I think there’s a big disconnect and abysmally low involvement of actual consumers, the people affected by policies,” says Selya. Partnering with people who actually know and use novel nicotine products would be a giant step toward improved research quality.

References
Foxon F. (2023). Discordant device/brand reporting among adolescents who used e-cigarettes in the National Youth Tobacco Survey. Nicotine and Tobacco Research. https://doi.org/10.1093/ntr/ntad228
Joelving F. (2024). Prescription for controversy. Science. https://www.science.org/content/article/questionable-firms-tempt-young-doctors-with-easy-publications
Selya A, Ruggieri M, Polosa R. (2024). Measures of youth e-cigarette use: strengths, weaknesses and recommendations. Frontiers in Public Health. https://doi.org/10.3389/fpubh.2024.1412406
Soulet S, Sussman RA. (2022). A critical review of recent literature on metal contents in e-cigarette aerosol. Toxics. https://www.mdpi.com/2305-6304/10/9/510
Vansickel A et al. (2022). Human abuse liability assessment of tobacco and nicotine products: approaches for meeting current regulatory recommendations. Nicotine and Tobacco Research. https://doi.org/10.1093/ntr/ntab183
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.

August 1, 2024
The Case for Nicotine

Image: Maridav
Many policymakers see nicotine as part of the problem; THR proponents see it as part of the solution. Understanding why such deeply opposing views are held also provides a view of the way ahead.
By Barnaby Page
Advocates of tobacco harm reduction (THR) and the industry making THR products are accustomed to fighting battles on multiple fronts—simultaneously contending with the threat of flavor bans, new taxes and misrepresentations of science, for example. But perhaps the most essential battle of all is the one against the demonization of nicotine; it’s possible to imagine vaping continuing to exist without nontobacco flavors, for example (even if it might be a less appealing kind of vaping), and it’s possible to imagine consumers continuing to buy THR products even if taxes hike their price, but it’s not really possible to imagine THR without nicotine.
This means that, while its opponents are not wrong to say that that nicotine is to an extent an initiator and certainly a perpetuator of smoking, it’s also a “friend” as much as an “enemy” in the quest to reduce smoking rates and smoking-related harm. Persuading others, including lawmakers, the medical profession and the public health establishment, to see it this way is a key and decidedly nontrivial task for the THR movement, one that could have profound effects on future policy and regulation concerning THR products and therefore their uptake.
Smoking and Addiction
Opposition to nicotine probably derives, at heart, from two somewhat different but related factors: cigarettes and addiction. First, it’s easy to forget—but essential to remember—that until around a decade ago, nicotine effectively meant cigarettes for most people in most countries. Sure, there were other delivery mechanisms (e-cigarettes were already starting to make their presence known; oral products of different kinds had traction in some places; a few people even smoked cigars or pipes), but the cigarette was dominant … and so for the average person, who in a specialist field like this also includes the average policymaker, nicotine was inextricably tied to smoking, which in turn was inextricably tied to combustible cigarettes.
As a result, it’s not surprising that many people find it difficult to separate the effects of nicotine from the effects of cigarette smoking in their head. (Even some people who ought to know better seem to find it tough.) Meanwhile, public health messaging had for decades reinforced the same point—Superman’s foe, the evil Nick O’Teen, is a classic example.
Plus, and this brings us to the second point, nicotine was not only that generally sinister thing, a “chemical,” but it was one you could become addicted to. Again, it’s understandable that people who weren’t specialists in addiction science wouldn’t realize that the concept itself was a much-debated thing, and people who had grown up in a War on Drugs era when “drug addicts” were seen as an undifferentiated group of miserable, ruined junkies naturally saw addiction itself—regardless of the addictive substance concerned—as a terrible condition.
Again, of course, there are those who ought to know better who use the concept to spread distrust; it amused me a few years ago when the then U.S. surgeon general, Jerome Adams, said that nicotine was “as addictive as heroin.” Leaving aside the whole issue of how you assess comparative addictiveness, the logical corollary here was that heroin is no more addictive than nicotine, but I doubt he would have wanted to spread that as a public health message.
THR advocates need to recognize that the perception is just as potent as the reality.
The Power of Perception
In any case, some definitions of addiction or dependency now stipulate that it must be harmful, and it’s highly questionable whether nicotine—once separated from cigarette smoking—falls into that category. So there’s even a case to be made that nicotine addiction doesn’t exist as a problem in the first place. But the bottom line is that it is widely perceived to be harmful and addictive.
And that is a huge obstacle for THR to overcome. Nicotine is absolutely central to the THR proposition. Indeed, it is founded on the distinction between nicotine and smoking, as famously expressed by Michael Russell when he observed that people smoke for the nicotine but die from the byproducts of smoking. It is the ability to make this distinction that leads to the concept of the continuum of risk—the idea that though different product categories (cigarettes, oral, vapor, heated tobacco, nicotine-replacement therapy [NRT] and so on) may all deliver nicotine, they do so with different risks, with some categories (for example, NRT, pouch and vape) at the bottom of the range while others (all of them involving combustion) are at the maximum.
This concept is hardly news to anyone involved in THR or indeed anyone in the tobacco industry. But it’s worth repeating that it may not only be an unfamiliar idea but an apparently contradictory one to people outside those worlds if they believe that risk is inherent to nicotine use. Before any progress can be made on improving policy and regulation, this is a misconception that needs to be corrected, and for the reasons that I’ve discussed, it can be quite a deep-seated one. Of course it’s illogical—it’s like concluding that because it is very dangerous to drive on icy roads at high speed, it must be equally dangerous to drive on any road at any speed—but being illogical doesn’t mean it’s not thoroughly believed in by many people.
The continuum of risk also means that where public health is concerned, logical regulation would focus on the delivery mechanisms (the icy road and the 90 mph) rather than the nicotine (the existence of cars). Except insofar as it may encourage use of more-risky delivery mechanisms, it doesn’t make sense for nicotine itself to be a prime concern. The on-off debate about very low-nicotine cigarettes (VLNCs) is a vivid illustration of this; there are surely questions to be asked about a policy that retains the dangerous thing (combustion) and concentrates on eliminating the far less dangerous thing (nicotine). To be fair, the research on how consumers might use VLNCs in real life is not yet conclusive, and it is possible they would have a deterrent effect beneficial to public health. But it’s difficult to escape the impression that the image of the evil Nick O’Teen is lurking in the background here as well.

A survey on U.S. vape stores published in 2023 by ECigIntelligence, one of a regular series, found that misconceptions about vaping—which often means misconceptions about nicotine—are a persistent problem.
What Regulation Might Look Like
Of course, we can’t realistically expect that lawmakers are going to leave nicotine entirely alone. So if we were going to regulate nicotine the substance—as opposed to characteristics of the delivery mechanisms, and nonproduct issues such as minimum purchase age, advertising and public usage—what areas could be looked at?
We could regulate nicotine content, which we could measure in two ways: either absolutely—the total amount in a cigarette stick or a vape pod, for example—or comparatively, by measuring concentration. The latter makes more sense for product categories where there is notable variation in product size (for example, e-liquid bottles).
We could also look at regulating the nicotine yield, which is the amount of nicotine actually emitted from the product and thus available for consumption by the user; although clearly dependent on the nicotine content level to some extent, this is a more meaningful number in terms of effects. (A hypothetical product with very high content yet very low yield would contain an awful lot of nicotine that might just as well not have existed—it would be irrelevant in any calculation of risk or health impact.)
We could also look at nicotine flux, the rate of nicotine emission—a crucial difference between combustible cigarettes and vapes, for example, and one that strongly affects the actual experience of use. And finally, just to be complete, of course we would want to regulate safety where nicotine is sold in very high concentrations such that accidental consumption of a relatively small amount could have seriously deleterious effects. The perception of risk here is, again, quite possibly exaggerated, but measures like childproofing do nothing to undermine the value of THR, they may prevent some accidents, and many countries have implemented them. This aspect, at least, is a no-brainer ….
But (apart from the childproof caps) does regulating nicotine itself actually solve any problems that aren’t addressed by, for instance, regulating underage purchase—especially if we don’t consider dependency in itself, among adults, to be a problem?
The THR movement will have to work relentlessly to keep the focus on risk profiles of delivery mechanisms, not on nicotine.
The Gateway Effect
The biggest contender for “problem to be solved” could, of course, be the so-called “gateway effect”—the idea that even when less risky forms of nicotine consumption are available, enjoyment of and/or dependency on them (take your pick) could lead the user toward more-risky forms.
A logical riposte would be that though doubtless there are individual cases of such a gateway being passed through (as there are individual cases of almost anything you care to imagine), there is no convincing evidence of it happening on a large scale—and in any case, other measures could deter it. If we want to prevent people progressing from vapes to combustibles, the THR argument would go, surely it’s sensible to make vapes more attractive and combustibles less (whether that’s through differential taxation, marketing restrictions, flavor restrictions or other measures). Going in the other direction—for example, reducing nicotine levels in THR products (which are often less effective than combustibles at delivering nicotine to the body anyway)—would likely just have the effect of making THR less attractive to existing smokers and discourage them from switching.
Nevertheless, the gateway effect is a widespread concern that ties in at an emotional level with the idea of nicotine as an irresistibly addictive substance leading users further and further into its grip. And once again, THR advocates need to recognize that, as is so often in this field, the perception is just as potent as the reality—often more so. Addressing that will be a long and tough task, but the agenda for THR should be clear.
The THR movement will have to work relentlessly to keep the focus on risk profiles of delivery mechanisms, not on nicotine itself. It will have to encourage policy based on proven risk, not on nicotine-specific characteristics such as concentration that in themselves don’t obviously connect to risk. It will have to put forward convincingly the idea that THR products need to be at least as attractive to the consumer as combustible products if their public health potential is to be realized—this means, in effect, undertaking the very difficult task of persuading policymakers that we should encourage nicotine consumption via THR.
And, to achieve all this, it will have to educate not just policymakers but also health professionals, the media and the public. This includes actively countering misinformation, but simply saying people are wrong is clearly not going to be persuasive in itself, and it’s those THR advocates who engage directly and deeply with the “nicotine skeptics” who will end up making the biggest difference.
For not only can nicotine be part of the solution rather than part of the problem, ignoring this is also a risk in itself. We shouldn’t lose the focus on reducing smoking by becoming distracted into reducing nicotine consumption.
Barnaby Page is the editorial director of Tamarind Intelligence, the publisher of ECigIntelligence, TobaccoIntelligence and CannIntelligence. As a journalist, he has been covering the worldwide reduced-risk nicotine sector since 2014, with a particular focus on public health and regulatory issues.In his current role, he manages Tamarind’s editorial and reporting teams, producing a wide range of nicotine-related content. He previously spent 30 years as a reporter and editor for newspapers, magazines and online services, specializing in technology and business. He is based near London, England.

August 1, 2024
Pouches Scrutinized

Photo: ir1ska
Scientists at Georgetown University’s Lombardi Comprehensive Cancer Center have synthesized evidence from 62 studies related to the use of oral nicotine pouches to better understand their potential impact on public health. The findings have been published in Nicotine and Tobacco Research.
Oral nicotine pouches are rapidly increasing in popularity. While they may present a less harmful nicotine alternative for cigarette users, there is considerable concern about them becoming a new form of nicotine dependence, especially in youth who don’t use tobacco or nicotine,” said the study’s corresponding author, Nargiz Travis, in a statement.
The investigator’s analysis was based on 45 academic and 17 industry-funded studies, mostly from the U.S. Sales of the products have been concentrated in Scandinavia and the U.S., mainly because of the established smokeless tobacco market in these regions.
In the U.S., the researchers found, based on nationally representative surveys, that through 2023, oral nicotine pouches were currently used by 1.5 percent of all youth while lifetime use by young people was under 2.5 percent.
In terms of awareness of the products, between 35 percent and 42 percent of U.S. adolescents and young adults have heard of oral nicotine pouches, and 9 percent to 21 percent of tobacco-naive (nontobacco users) youth surveyed were not opposed to trying them. U.S. adult usage estimates varied widely across surveys; in 2023, 0.8 percent to 3 percent of Americans currently used the products while 3 percent to 16 percent used them at some point in time. In view of rising nicotine pouch sales trends in 2024, their use in the U.S. population has likely increased.
Because oral nicotine pouches do not contain tobacco leaves, they are often marketed as tobacco-free, but we found that descriptor may confuse the understanding of the source of nicotine and may be associated with the perception that they are not as harmful as other tobacco products.
Nargiz Travis, project director for the Center for the Assessment of Tobacco Regulations at Georgetown Lombardi
The investigators’ findings suggest fewer harmful chemical compounds are present in the pouches and occur at lower levels than in cigarettes and smokeless tobacco, with the exception of formaldehyde. However, an analysis of 37 oral nicotine pouches of different brands, nicotine strengths and flavors yielded a wide range of total nicotine content from 0.89 mg to 6.73 mg per pouch.
“Because oral nicotine pouches do not contain tobacco leaves, they are often marketed as tobacco-free, but we found that descriptor may confuse the understanding of the source of nicotine and may be associated with the perception that they are not as harmful as other tobacco products,” says Travis.
“In the U.S., oral nicotine pouches are currently neither authorized by the FDA for marketing as a modified-risk product nor approved as a cessation product. It is important to know that nicotine is an addictive chemical with harmful health effects, regardless of whether it is synthetic, meaning tobacco-free, or derived from tobacco.
One of the studies included in the authors’ analysis was a U.S. survey of young adults 18 years to 34 years of age, many of whom used cigarettes and e-cigarettes. The survey found that among those who had tried nicotine pouches, curiosity about the product (28 percent), flavors (26 percent) and the ability to use in places where other tobacco products are prohibited (26 percent) were among the main reasons for trying the pouches. The availability of flavors (31 percent) was the main motive for use in another U.S. sample of adult current nicotine pouch users.
Leading brands of the products are currently owned by major tobacco companies. The authors note that a substantial investment in marketing by the companies suggests that oral nicotine pouches are becoming increasingly important to the tobacco industry.
“As more evidence on oral nicotine patches becomes available, and more importantly, more independent studies become published, it will be essential to conduct further analyses comparing the findings of industry versus non-industry sponsored research and critically assess the quality and risk of bias of such studies,” said Travis.
June 17, 2024
Investor Plans Nicotine Extraction in Zimbabwe

Photo: Tobacco Reporter archive
A Chinese investor plans to build a multi-billion dollar nicotine-extraction factory in Zimbabwe, reports The Herald. The plans are at an advanced stage, according to the country’s former ambassador to China, Christopher Mutsvangwa.
The facility will extract nicotine from tobacco stalks, leaves and flowers for the cigarette alternatives, such as e-cigarettes. Once established the factory is expected to also process tobacco from neighboring countries including Malawi, Mozambique and Zambia.
“There is going to be a very big industry to extract nicotine from the by-products after selecting the premium tobacco leaves,” Mutsvangwa told participants in meeting of the ruling Zanu PF’s party’s Mashonaland West provincial coordinating committee in Chinhoyi.
“The Chinese firms have an interest in setting up the factories here in Zimbabwe because of our production levels,” he said.
The investor’s board of directors reportedly met on May 31, 2024, to finalize the modalities of setting up the factory, which will likely be built in Karoi, in one of Zimbabwe’s largest tobacco producing districts.
Zimbabwe is also expected to be a major producer of cannabis seeds following plans to establish a US$400 million factory. “We now have capacity to produce cannabis seed in the country. After an initial investment of $30 million, the company now wants to set up a seed production factory,” said Mutsvangwa.
The investments in nicotine extraction and cannabis production will boost Zimbabwe’s attempts to extract more value from its tobacco industry, as detailed in the government’s Tobacco Value Chain Transformation Plan.
June 4, 2024
Nicotine Alternatives Under Scrutiny

Photo: Alexey Stiop
Nicotine alternatives, such as 6-methyl nicotine, may be more potent and addictive than nicotine itself, reports Reuters, citing U.S. Food and Drug Administration scientists and independent researchers.
Traditional nicotine found in many vapes and pouches is extracted from tobacco leaves; 6-methyl nicotine, in contrast, is made in a laboratory.
While chemically similar to nicotine, the synthetic substances are not subject to U.S. tobacco and vaping regulations, allowing manufacturers to sell vapes with nicotine analogues without seeking FDA authorization.
Tobacco and vape companies have criticized that the FDA product authorization process is costly and time-consuming. Only a handful of applications have been approved.
In response to questions from Reuters, the FDA said it was reviewing the available data on nicotine alternatives to inform potential actions.
Three academic researchers told the news agency that current studies of 6-methyl nicotine are too limited to draw definite conclusions on the health impact or to what degree it is addictive.
The limitations of existing research, the researchers said, included that some papers were industry funded while others focused on the short-term impact on animals or cells and were insufficient to understand 6-methyl nicotine’s effects on human bodies.
The FDA has yet to approve any flavored vape using traditional nicotine for sale in the United States, saying companies have not been able to show that the health benefits they offer to smokers outweigh the known risks to young people, who may be more attracted by the flavors.
The Spree Bar vaporizer, which uses a 6-methyl nicotine solution branded as “Metatine,” notes on its website that Metatine “may have a toxicity profile similar to nicotine.”
Sven Jordt, a professor at Duke University who has authored papers on products like Spree Bar, said 6-methyl nicotine could me more addictive and toxic than its traditional cousin.
“Do we want to have such a chemical as a recreational product, available to anyone?” he asked. “That’s really questionable.”
May 29, 2024