Category: Nicotine

  • ‘FDA Downplays PMTA Acceptance Numbers’

    ‘FDA Downplays PMTA Acceptance Numbers’

    Amanda Wheeler (Photo: AVM)

    The U.S. Food and Drug Administration is understating the number of nontobacco nicotine (NTN)-related premarket tobacco product applications (PMTAs) it has accepted for review in order to avoid criticism from tobacco control groups that seek prohibition of all vaping products, reports Vaping360, citing American Vapor Manufacturers Association (AVM) President Amanda Wheeler.

    On Sept. 8, the FDA announced it has accepted over 350 PMTAs (out of nearly 1 million applications) for NTN products. Wheeler insists that AVM member companies alone have received acceptance letters for 4,700 PMTA submissions.

    “Once again, the FDA and its Center for Tobacco Products are misleading the public and press on crucial data and methods in its approval process for vaping products,” Wheeler said in a statement. “The figures stated in its press release today on synthetic nicotine applications are demonstrably inconsistent with FDA letters to our own members indicating many thousands more applications successfully filed than FDA now claims.”

    An acceptance letter indicates that the application has met the basic requirements to move forward in the review process. It does not authorize the applicant to market the product.

    The AVM also says the FDA altered required PMTA forms close to the submission deadline to disqualify already-submitted applications. According to Wheeler, the application forms were “abruptly altered” without public notice, “apparently as a means to disqualify wide swaths of already-filed applications.”

    In March, U.S. President Joe Biden signed legislation authorizing the FDA to regulate synthetic nicotine products. Manufacturers had until May 14 to submit PMTAs and were given two additional months to continue selling products with pending PMTAs. When the grace period ended July 13, all synthetic nicotine-based products became subject to FDA enforcement.

  • FDA Reports Progress With NTN Applications

    FDA Reports Progress With NTN Applications

    Photo: Postmodern Studio

    The U.S. Food and Drug Administration has sent more than 44 warning letters to manufacturers and over 300 warning letters to retailers for violations relating to nontobacco nicotine (NTN) products since President Joe Biden signed legislation authorizing the agency to regulate tobacco products containing nicotine from any source. Additionally, the FDA has issued new warning letters to 102 retailers for illegally selling NTN products to underage purchasers.

    In an update, the agency detailed what it described as “significant progress” in processing and reviewing premarket tobacco product applications for synthetic nicotine products.

    On March 15, 2022, a new federal law gave the FDA the authority to regulate tobacco products containing nicotine from any source. This law took effect April 14, 2022, and after July 13, 2022, any new NTN product that has not received premarket authorization from the FDA cannot be legally marketed.

    The FDA says it received nearly 1 million NTN applications from more than 200 companies. To date, all applications submitted by May 14 have been processed, and more than 85 percent have been reviewed to determine if they meet the minimum requirements to be accepted for further review, according to the agency. In total, the FDA has issued refuse to accept (RTA) letters for more than 800,000 NTN products in applications that do not meet the criteria for acceptance.

    In total, the FDA has accepted over 350 applications for NTN products, with the vast majority being for e-cigarette or e-liquid products. The agency stresses that acceptance is not a determination about the products’ authorization status. “Accepted applications will enter further review, which ensures certain criteria are met for applications to proceed with further review,” the FDA wrote in its update.

    More information about the FDA’s premarket review progress and compliance and enforcement actions is available at the agency’s NTN product webpage.

  • 22nd Century Launches VLN in Colorado

    22nd Century Launches VLN in Colorado

    Photo: 22nd Century Group

    Encouraged by the strong results of its pilot program in Chicago, 22nd Century Group will launch its VLN low-nicotine cigarette in Colorado and expand sales of the brand in Illinois.

    In  addition to its existing partnerships with cigarette retailers Circle K and Smoker Friendly, 22nd Century will announce two distribution partners as part of its launch in Colorado.

    To date, the company has already completed state attorney general registrations for VLN in 44 U.S. states and the District of Columbia.

    “We are excited to expand our VLN launch to Colorado with both current and new partners. The overwhelmingly positive feedback from consumers during our Chicago pilot has demonstrated impressive demand and rapid market entry for VLN as the first and only tobacco cigarette that actually helps adult smokers smoke less,” said John J. Miller, president of 22nd Century’s tobacco business, in a statement

    “Extrapolating our strong pilot market results to a national scale with additional points of sale and geographic coverage gives us confidence we can disrupt and rapidly take significant share in the more than $80 billion U.S. market and $800 billion global tobacco market to create substantial value for our stakeholders.”

    In December 2021, the U.S. Food and Drug Administration authorized 22nd Century to market its VLN King and VLN Menthol King cigarettes as modified-risk tobacco products, making them the first combustible products to receive such a designation.  

  • Nicotine And The Weirdness Of Harm

    Nicotine And The Weirdness Of Harm

    Photo: artefacti

    The availability of nicotine with minimal harm justifies a complete rethink of our approach to this legal recreational drug.

    By Clive Bates

    Whisper it quietly, but people use nicotine for a reason. Nicotine has psychoactive effects that provide functional benefits and pleasurable sensations to its users. Neal Benowitz, a global authority on nicotine, writing in the U.S. Annual Review of Pharmacology and Toxicology in 2009, summarized the effects: “In humans, nicotine from tobacco induces stimulation and pleasure and reduces stress and anxiety. Smokers come to use nicotine to modulate their level of arousal and for mood control in daily life. Smoking may improve concentration, reaction time and performance of certain tasks.”

    Writing in the journal Nicotine & Tobacco Research in 2018, the neuroscientist Paul Newhouse described the cognitive benefits of nicotine: “Cognitive improvement is one of the best-established therapeutic effects of nicotinic stimulation. Nicotine improves performance on attentionally and cognitively demanding vigilance tasks and response inhibition performance, suggesting that nicotine may act to optimize attention/response mechanisms as well as enhancing working memory in humans.”

    With such characteristics, one is tempted to ask why nicotine has so few users. It turns out this is a serious question with some interesting implications. The answer is that nicotine use is strongly associated with the harms of smoking and an addiction so powerful that former U.S. Surgeon General C. Everett Koop compared it to heroin or cocaine. The iron grip of nicotine addiction keeps people smoking even though they are well aware of the lethal consequences.

    Nicotine seems to provide valuable benefits for people whose lives are difficult and stressful, those prone to anxiety or distraction or those who just enjoy the strange mixture of its stimulating and calming effects. Perhaps that could mean most of us? At one point, it did. In the decades before the health implications of smoking were widely understood, smoking prevalence was very high. In the United Kingdom in 1948–1952, smoking prevalence was about 80 percent for men and 40 percent for women. That compares to a combined total of around 14 percent today. But the overwhelming driver of this decline has been intense concern about harm to health and the introduction of policies to reduce these harms by making smoking less appealing, more expensive and more difficult to do. But maybe our concerted public health efforts to reduce disease and death caused by smoking deterred people who would otherwise have benefited from or enjoyed the mood-regulating and cognitive benefits of nicotine had it been available in safer forms.

    So, here is the interesting question. What if nicotine use is no longer all that harmful? What if the real problem was always the inhalation of toxic smoke while trying to consume nicotine for its benefits? As early as 1991, the leading medical journal The Lancet reflected on how the nicotine landscape might look after the year 2000: “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.”

    In my view, we have reached the position where smoke-free nicotine products, such as e-cigarettes, heated tobacco, smokeless tobacco or nicotine pouches, can provide nicotine at acceptably low risk. By acceptably low risk, I don’t mean perfect safety, but within society’s normal risk appetites for consumption and other recreational activities. If continuing innovation in the design of the products ultimately leads to smoking cigarettes becoming obsolete, then the vast burden of smoking-related disease will decline and fade away.

    So why is there so much opposition to low-risk nicotine products? Why do so much effort and money go into trying to demonstrate that these products are harmful? I call this the weirdness of harm, and it takes several forms.

    First, perhaps good science shows these products are very harmful and should be treated no differently than cigarettes? We can rule out this explanation quite easily. The toxicants found in users’ blood, saliva and urine are far fewer, and the levels are far lower than in smokers. Credible data show a range of benefits in switching from smoking to smoke-free products, and there is little convincing evidence to suggest material risks at present. We might be concerned about currently unknown long-term effects, but these are more likely to be trivial than severe and may be tackled if and when they emerge, which they haven’t so far. Yet the ferocity of the backlash against safer products goes far beyond doubts about safety or concern for the welfare of consumers. It looks more like a reaction to a threat.

    Second, much safer products pose an existential threat to a powerful interest group. As a profession, tobacco control exists only because of a need to control severe harm to health. A significant part of the professional tobacco control field could ultimately be rendered irrelevant and unemployed by safer forms of nicotine. The whole edifice of careers, grants, university departments, journals, conferences, advocacy campaigns and the personal prestige of anti-tobacco warriors has harm as its foundation. Otherwise, it becomes the equivalent of “coffee control,” which barely exists. That creates strong, perverse incentives to find (or fabricate) harms to sustain the profession. That conflict of interest is large and pervasive, yet it is paradoxically invisible and never acknowledged or discussed. But for many, it means good news is unwelcome, and bad news is good news. Take, for example, the muted reactions to the recent sharp decline in U.S. teen smoking compared to the apparent enthusiasm that has greeted the long list of (unfounded) scares about nicotine vaping, such as e-cigarette or vaping use-associated lung injury, popcorn lung and seizures.

    Third, without harm, the case for a nicotine-free society falls apart. Harm is the primary reason for abstinence from nicotine. Gallus and colleagues found that about 80 percent of smokers quit because they currently experience harm, expect harm in the future, have taken a doctor’s advice about harm or worry about harming others. Only 2.8 percent mentioned “loss of pleasure or desire to smoke.” But if the products are no longer harmful, where does that leave those who feel we should aspire to be a “nicotine-free society”? That goal likely arises from a mixture of motives: a loathing of the tobacco industry and a sense that “harm reduction” is an unfair escape from its inevitable destruction, an instinctive disgust about the drug choices of others or just the stoical sentiment that if people can be abstemious, they should be. Harm has always been the trump card of the proponents of a nicotine-free society, but their case is greatly diminished if it rests mainly on moral instincts.

    Fourth, it is possible that nicotine use will increase without the deterrent effect of harm. This arises from a basic but unsettling economic argument. The underlying demand for nicotine was once very high but has been suppressed by harm to the user and related policies. The harms of smoking are part of the overall nonmonetary costs (health, stigma, welfare) of using nicotine to the individual. Low-risk products and proportionate regulation will reduce or eliminate these costs. All other things being equal, lower costs mean that nicotine use should increase. Many will be uncomfortable with the prospect of nicotine use rising after years of sustained decline. But we should recall that the effort to reduce nicotine use was driven by the harms of smoking not by opposition to the effects of nicotine as a drug. If we successfully address the public health goal, these smoking-related deterrence effects will no longer apply.

    Fifth, harm is integral to the definition of addiction. The casual and sloppy use of the word addiction is pervasive in public health. It is always worth asking what is meant by “addiction.” In the formal Addiction Ontology, serious harm is integral to the definition of addiction: “A mental disposition toward repeated episodes of abnormally high levels of motivation to engage in a behavior, acquired as a result of engaging in the behavior, where the behavior results in risk or occurrence of serious net harm” (emphasis added).

    The inclusion of serious net harm in the definition of addiction is intended “to limit the class to things that merit a treatment and public health response.” A similar reference to harm is also included in other definitions, such as those of the U.S. National Institute on Drug Abuse and the American Psychiatric Association. So, it could be argued that without the associated harm from exposure to smoke, nicotine would no longer be classified as addictive and would simply join the short but growing list of psychoactive chemicals people enjoy and society accepts, like caffeine, alcohol and increasingly, cannabinoids. C. Everett Koop’s 1988 comparison of nicotine to heroin was a powerfully provocative statement, but in the context of safer nicotine products and the U.S. opioid epidemic, the comparison is not convincing.

    The emerging range of smoke-free consumer tobacco and nicotine products means much more than tobacco harm reduction or an elegant way to help smokers quit. The availability of nicotine with minimal harm justifies a complete rethink of our approach to this legal recreational drug.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • First Warning Letters for Synthetic Nicotine

    First Warning Letters for Synthetic Nicotine

    Photo: 103tnn

    The U.S. Food and Drug Administration on July 13 sent its first warning letters to manufacturers for unlawfully marketing non-tobacco nicotine e-liquid products without the required authorization.

    In March, President Joe Biden signed into law a spending bill that gives the FDA authority over synthetic nicotine. The provision took effect in April and gave manufacturers until May 14, 2022, to submit marketing applications to the FDA.

    Products did not receive marketing authorization by July 13, 2022, are considered illegal and must be removed from the market.

    The recipients of the FDA’s first warnings letters, AZ Swagg Sauce and Electric Smoke Vapor House, have listed a combined total of approximately 10,000 products with FDA. Neither company submitted a premarket application for its non-tobacco nicotine products by the deadline, according to the FDA.

    In addition, the FDA issued 107 warning letters to retailers in the last two weeks for illegally selling non-tobacco nicotine products, including certain e-cigarette or e-liquid products, to underage purchasers.

    “FDA has been fully committed to actively implementing this critical new law regulating non-tobacco nicotine products since its passage, and the warning letters announced today are just the beginning of our compliance and enforcement actions” said Brian King, director of the FDA’s Center for Tobacco Products, in a statement.  “In the coming weeks, we will continue to investigate companies that may be marketing, selling, or distributing non-tobacco nicotine products illegally and will pursue action, as appropriate.”

    The FDA says it is currently processing applications for approximately 1 million non-tobacco nicotine products submitted by more than 200 manufacturers by the May 14, 2022, deadline.

    “FDA is working diligently to process the substantial number of applications submitted and, as always, will make marketing decisions based on the best available science and will pursue compliance and enforcement actions when warranted,” said King. “We remain fully committed to taking whatever steps are necessary to protect the public health and to provide timely updates on our ongoing progress regulating non-tobacco nicotine products.”

     

  • Smoore to Research Nicotine Addiction

    Smoore to Research Nicotine Addiction

    Photo: Smoore

    Smoore, the world’s largest vapor product manufacturer, today announced it has launched the first real-time monitoring research project on nicotine addiction.

    In partnership with the Shenzhen Institute of Advanced Technology, Smoore’s new research project aims to explore how best to minimize the nicotine strength in vaping products and ultimately to bring it to below the levels that cause addiction.

    The research will look at the secretion and metabolism of dopamine in animal brains, and will use this data to simulate the human brain when ingesting nicotine. As part of the project, the Shenzhen Neher Neural Plasticity Laboratory will conduct controlled trials by exposing subjects to the aerosol environments created by the atomization of Smoore’s Feelm vaping device and the aerosol environment created by combustible tobacco.

    In addition providing a better understanding of nicotine absorption through different organs, the research will aid Smoore in improving the design of vape devices, including through changes to heating elements and atomizers, to enhance the vaping experience through increased efficiency of delivery.

    “The atomization process between an e-cigarette and a combustible cigarette is very different, hence the physical and chemical properties derived from atomization and tobacco combustion also varies distinctively,” said Xiong Yuming, deputy dean of Smoore Shenzhen Fundamental Research Institute, in a statement.

    “Focusing on the underlying mechanism of atomization and tobacco combustion, our research aims to explore nicotine delivery and absorption, so as to reduce the health impacts of these products.”

    Supported by Southwest University in Chongqing, the researchers expected to release a stage report in the second half of 2022.

  • EPA Ruling Threatens FDA’s Tobacco Plans

    EPA Ruling Threatens FDA’s Tobacco Plans

    Photo: renaschild

    The U.S. Supreme Court’s recent decision to block the Environmental Protection Agency from curbing power-plant emissions also threatens the Food and Drug Administration’s attempts to limit nicotine and ban menthol in cigarettes, according to an article published by Bloomberg Law.

    In their ruling, the Supreme Court judges endorsed a legal approach that requires agencies to obtain Congressional approval to address issues of major financial or political importance in novel ways. The court’s conservative members have lamented the power agencies have to create and enforce their own rules.

    According to Lindsay Wiley, a professor at UCLA School of Law, the decision will be considered in any situation where an administrative agency is trying to solve a problem using authority given to it by Congress in more general terms.

    In the case of tobacco, the FDA will face greater pressure to prove it is authorized by Congress to propose its draft ban on menthol in cigarettes and cigars and other major rule changes, according to Marc Scheineson, a former FDA commissioner.

    While the Tobacco Control Act gives the FDA the authority to adopt product standards—including on the content of cigarettes—through notice and comment rulemaking, legal experts believe the June 30 court ruling will embolden tobacco manufacturers to challenge the menthol ban and other policies once they are finalized.

    “It definitely provides a roadmap that the industry will follow trying to attack the menthol regulation with everything they can come up with,” said Joelle Lester, director of commercial tobacco control programs at the Mitchell Hamline School of Law’s Public Health Law Center.

  • Pathways To Acceptance

    Pathways To Acceptance

    Photo: Artinun

    Scientists, regulators and industry must work together to help change perceptions of nicotine.

    By Phil Saunders

    A recent story in Tobacco Reporter highlighted that more than 60 percent of U.S. doctors are confused about the tobacco harm reduction risk continuum. Many incorrectly believe that all nicotine products are equally harmful, making them unlikely to recommend e-cigarettes to people trying to quit smoking.

    Elsewhere, the picture isn’t that different. For example, a survey released earlier this year showed that in England, one of the most pro-vaping countries in the world, only 40 percent of local authorities actively offer e-cigarettes as part of stop-smoking services. This might seem more positive, but it still leaves the remaining 60 percent unconvinced.

    There are some positive developments in Australia, which recently scrapped its earlier plans to ban e-cigarette imports. Hollie Hughes, chair of a committee established to examine vaping, recently stated that she believes vaping to be “an incredibly powerful cessation tool” that is part of the discussion on reducing smoking rates in the country. But there are still many countries with extremely high smoking rates where e-cigarettes are completely illegal, including India, Mexico, Brazil and Singapore.

    There is obviously still a long way to go to get a unified acceptance of the role reduced-risk nicotine products can play in tobacco harm reduction.

    Perception is Key

     Fundamentally, the issue is that nicotine is perceived as the bad guy. That is why 60 percent of doctors in the U.S. don’t understand e-cigarettes. For years, the popular discourse has equated tobacco and nicotine as completely interchangeable in terms of smokers’ health and the damage it does to society. Widespread misperceptions around nicotine remain the industry’s biggest challenge and are the No. 1 issue that public health bodies and regulators will need to address to change the status quo.

    Recently, U.K. Secretary of State for Health and Social Care Sajid Javid announced that anyone born after 2008 in the U.K. will not be allowed to purchase tobacco products and that the minimum age will raise every year. A similar approach is also being considered in Denmark. But Javid is not considering including e-cigarettes in this approach, which may be an acknowledgment that he at least doesn’t see nicotine as the biggest issue impacting smokers’ health.

    What is obvious is that the scientific community, regulators and the wider electronic nicotine-delivery system (ENDS) industry must work together to help change perceptions about nicotine and educate people about the difference between tobacco and nicotine.

    A Supportive Regulatory Environment

    Taking England as an example of an environment supportive of vaping, the Tobacco and Related Products regulatory framework for e-cigarettes as consumer products is a light touch compared with the premarket tobacco product application (PMTA) in the U.S. As a result, the U.K. offers one of the world’s fastest consumer routes to market for new vape products and has a thriving vape retail sector and a falling adult smoker rate.

    The U.K.’s Medicines and Healthcare products Regulatory Agency is now also actively encouraging the use of e-cigarettes to support smoking cessation. The Department of Health and Social Care 2017 Tobacco Control Plan states that the scientific evidence is clear that e-cigarettes are less harmful to health than smoking cigarettes. The U.K. has now set a target to be “smoke-free” by 2030 with vaping and next-generation alternatives seen as a key enabler in reaching that goal. A review commissioned by the government recommends that the National Health Service increases efforts to encourage smokers, particularly pregnant women, to switch to vaping and e-cigarettes.

    Scientific Substantiation

    Undoubtedly, we need to be led by science. Regulatory submissions, conference presentations, scientific posters and papers must continue to add to the body of evidence demonstrating the role of noncombustible next-generation nicotine-delivery products in tobacco harm reduction.

    “Real world” evidence and behavioral studies are also invaluable, particularly to convince regulators and medical professionals of smokers’ switching habits and that these products don’t encourage “on-ramping” of nonsmokers, particularly youth. Peer groups and professional bodies also have their role to play in supporting this aim to be driven by science rather than opinion and media headlines.

    In the U.S., the huge amount of data now available due to the rigor of the PMTA process is also invaluable. Companies have spent millions of dollars on scientific studies to demonstrate to the Food and Drug Administration that their products are appropriate for the protection of the public health.

    However, there is still the issue of a lack of independent scientific research into vaping as most universities shun research into tobacco-related products. The FDA’s first PMTA marketing orders for consumer vape products in the U.S. are the closest the ENDS industry has to independently verified in-depth scientific evidence that vape products can be evaluated as less harmful than smoking cigarettes.

    Industry Opportunities

    The next step in product acceptance is to see companies start to further develop consumer products for a medicinal regulatory pathway. Acceptance as a medicinal device to help smokers quit would further legitimize vaping as reduced harm. Achieving this could also lead the way for nicotine strengths to be prescribed at higher dosage levels to support smokers to give up more effectively through a medically monitored offramping process.

    Looking to the Future

    There are still significant global differences in the acceptance and understanding of the role of e-cigarettes in supporting tobacco harm reduction. The confusion between the different roles tobacco and nicotine play in causing smoking-related diseases, however, remains a common limitation.

    Robust regulatory frameworks for both consumer and medical ENDS will help build legitimacy for the sector with both regulators and consumers. In this way, regulation is an important tool to help build confidence in the sector.

    Whichever market is chosen for a product, an in-depth understanding of that country’s regulatory frameworks and ongoing investment in gathering scientific evidence is essential. The start of manufacturers looking to gain regulatory approval for their ENDS as medical devices will be an important next step in the industry’s journey to acceptance.

    Phil Saunders is the strategic partnership manager at Broughton.
  • Analyst: Nicotine Rule Could Take a Decade

    Analyst: Nicotine Rule Could Take a Decade

    Photo: Leo Lintang

    It could take up to a decade to resolve whether the Food and Drug Administration could require traditional cigarettes to contain minimal nicotine levels, reports The Winston-Salem Journal, citing Barclays analyst Jain Gaurav.

    On June 21, the FDA formally announced its proposal to reduce nicotine content in traditional cigarettes to minimal and potentially non-addictive levels.

    The FDA proposal is expected to draw legal challenges from tobacco manufacturers that could take several years to address.

    “We think it will take a decade or longer for the FDA to introduce nicotine caps due to the long nine-step process at the FDA, the inevitable litigation, and then the one-year time given to retailers to get rid of excess inventory,” Barclays analyst Jain Gaurav said in an investor note.

    “The FDA will need to take into consideration inputs from scientific, legal, law enforcement, public health, industry and budgetary stakeholders, and respond to all the comments in an iterative process before it can publish a final rule.”

    Some analysts also question whether the FDA has the authority to purposefully decrease demand for a legal product, in this instance by reducing nicotine levels to 5 percent of what most popular traditional cigarettes contain.

    In June 2019, Morgan Stanley analysts issued an “industry risk navigator” report that predicted a significant decline in revenue—up to 50 percent by 2034—for tobacco companies if the FDA succeeds in establishing significantly lower nicotine levels.

    With the lower nicotine levels, the tobacco industry could lose up to $165 billion in combined profits over the next 15 years even if manufacturers gain revenue from innovation nicotine products, such as electronic cigarettes, heat-not-burn traditional cigarettes and oral nicotine products.

    The analysts project BAT taking up to a 13 percent decline to its $88 billion market capitalization, partially limited because just 40 percent of BAT’s profits come from the U.S. Altria could experience up to a 20 percent decline of its $92 billion market capitalization.

    The only apparent manufacturing benefactor of the FDA proposal is 22nd Century Group, which specialized in nicotine-reduction and has said it is ready to license its technology to others.

    Those are the only combustible cigarettes that the FDA had authorized in the modified-risk tobacco product process. In December 2021, the FDA authorized 22nd Century to market its low-nicotine VLN King and VLN Menthol King cigarettes as modified risk tobacco products. They are currently the only cigarettes with such an authorization on the U.S. market.

  • Policy Masterstroke or Political Quagmire?

    Policy Masterstroke or Political Quagmire?

    Image: Zerbor

    Rules to reduce nicotine in cigarettes are back on the agenda.

    By Clive Bates

    On June 21, the United States Federal government announced its intention to develop a rule requiring deeply reduced nicotine levels in cigarettes on sale in the United States. This idea has been in circulation since first proposed in 1994 and was given a new lease of life in the FDA comprehensive plan in 2017. In late 2021, New Zealand adopted this policy and has committed to introducing legislation this year. The zombie policy is back, and it walks among us. Despite the warped logic of taking out the relatively benign nicotine and leaving the very harmful tar, despite the obvious practical problems of mounting a de facto cigarette prohibition at this scale, and despite the weird ethics of encouraging people to switch from one smoking product to another smoking product, this idea just will not die. How should we consider this proposal from a tobacco market transformation perspective?

    First, let us consider how this would work in practice. Regulators would introduce a rule requiring that cigarettes must have a very low nicotine level in the tobacco, say 0.4 mg per gram of tobacco compared to typically 16mg per gram—a 40-fold reduction. The level would be so low that nicotine could not play a meaningful role in the smoking experience, and “compensation” to obtain a satisfactory nicotine dose by puffing harder would not be possible. For unexplained reasons, regulators and researchers think that people would continue to buy and use these products, but smoke less and not become addicted to them. That forms the basis of the public health rationale for such a rule. But this is absurd.

    Second, the science is weak. Given that the main reason people smoke is to experience the effects of the stimulant nicotine, using low-nicotine cigarettes is among the least likely of all the possible responses to such a rule. After trying such products once, few smokers be willing to hand over hard-earned cash at the corner store for cigarettes with no noticeable nicotine. Yet nearly all the science to support rulemaking assumes that smokers will use these products and then finds out what happens if they do. But trials are not markets. In a trial, the subjects are volunteers and agree to participate. They are paid or incentivised to stick with the trial protocol and are usually provided with free cigarettes. This is nothing like real life.

    Third, what matters in real life is how users and suppliers respond to the disruption. A low-nicotine rule would eliminate the lawful supply of nicotine cigarettes. But it does not make them disappear from the market. It changes who supplies them, how, and at what price, creating incentives to develop a black market. The established producers would not remain passive either. They will find other lawful ways to sell nicotine-bearing smokes, for example, by selling cigars or hand-rolling tobacco or promoting workarounds such as personal cigarette-making machines. Consumers who use nicotine cigarettes will not automatically become abstinent or lose their interest in nicotine just because the FDA introduces a rule. Maybe they switch to black market cigarettes, cigars, or vaping. Nothing remains constant. A new rule disrupts the market, but it does not mean smokers will automatically do what regulators hope they will. The question is, what would they do, and can this be influenced?

    Fourth, regulators must shape the behavioural and market response to the rule. Merely implementing a low nicotine rule does not determine its public health impact. The pattern of behavioural responses to the rule will determine the overall effect. “Good pathways” like switching from smoking to vaping will compete with “bad pathways” like switching to black market products. Confidence in good behavioural responses to a rule should be a precondition for its introduction. Suppose we hope a reduced nicotine rule would prompt a migration of smokers to smoke-free alternatives. Three conditions would need to be met to incentivise migration from smoking to vaping. (1) the smoke-free products must be affordable, attracting zero or minimal tax. (2) the products would need to appeal to smokers by offering a diverse selection of flavours, good nicotine delivery, and a range of devices to suit all needs. (3) consumers must be aware of the benefits of switching, notably the dramatically reduced health risk compared to smoking. Sadly, there is no sign that the U.S. tobacco control community is working towards these meeting these preconditions, though there is a little more policy coherence in New Zealand.

    Fifth, there is a paradox at the heart of this proposal. A reduced nicotine rule needs good pathways to the low-risk options discussed above to make it viable. But when those preconditions are met, a low nicotine rule loses most of its purpose. Meeting the preconditions for a rule is a more useful policy than the rule itself. When those conditions are met, everyone who wants to quit smoking by switching can make an informed choice and just do it. What is the case for coercing the smoking holdouts? Surely, the state’s role should be to get in their corner with help and encouragement, not a big regulatory stick. And what if some people are fully aware of the risks, fully understand their options to switch to high-quality, low-risk alternatives, but still don’t want to switch? Should they be made to? And anyway, would anyone in public health want smokers to switch to a low-nicotine cigarette when they could be encouraged to vape? Imagine if a manufacturer brought out a vaping or heated tobacco product with the same nicotine delivery and toxicity profile as a low-nicotine cigarette? No one would take such a product seriously, let alone propose it as a public health intervention.

    Sixth, but what about youth? One of the big ideas that underpin this proposal is that non-addictive cigarettes would stop teenagers from falling into the trap of addiction and lifelong smoking and harm. This is now a much weaker argument than in 1994 when the reduced nicotine cigarette idea was conceived. In 1994, 12th grade past-30-day smoking prevalence was 31 percent. In 2021, it was down to 4 percent, according to the University of Michigan Monitoring the Future survey. The current trend in youth smoking is sharply downwards from a low base. Teenage vaping is likely doing the job that reduced nicotine cigarettes were once supposed to do – eliminate teen smoking. The other argument is that no evidence exists that this de facto cigarette prohibition would work. Consider the case of youth marijuana use. The Monitoring the Future survey shows that 12th grade past-30-day prevalence has been steady at an average of around 21 percent since 1994. But throughout most of this period, marijuana has been completely prohibited. The point is that banning something does not make it disappear or mean that teenagers cannot access it. It is more likely to mean they participate in illicit supply.

    Seventh, the politics will be very fraught. Though the legal base for such a rule would be Section 907 of the Tobacco Control Act, it would be a mistake to believe this could be done as a narrow technocratic rule-making exercise. Such a measure would impact a wide range of stakeholders far beyond the FDA’s routine contacts. U.S. cigarette sales are about $80 billion annually, and every part of that supply chain, from farmers to convenience store retailers, would be affected. There would be a substantial hit on the cigarette tax and master settlement receipts to State budgets. Law enforcement would be drawn in, with the potential for some of the adverse impacts we have seen in the War on Drugs. Then there is the question of identity politics. Surely, tobacco control activists have noticed that even sensible public health responses to the Covid-19 pandemic became weaponised into polarising identity politics. How would the Federal government intervening in the personal behaviour of 34 million American smokers play out in the febrile and divisive political climate that has developed in the U.S. since 2016? Which political leader will take a hard look at this measure and conclude, “yes, that is just what I need to win the next election”?

    In my view, measures like a low-nicotine rule are fantasy “policy masterstrokes”, in which a massive problem is solved with the swish of the regulator’s pen. I doubt this measure will ever work in real life. It will be mired in a practical, legal and political quagmire until it is no longer relevant. In the meantime, it is a distraction from the more useful, feasible and respectful regulatory business of setting up risk-proportionate regulation, fair taxation, and honest risk communication about smoke-free nicotine products. Migration of the market for consumer nicotine from smoking to smoke-free is the practical and viable way to make cigarettes obsolete and end the epidemic of smoking-related disease. A policy that relies on the consent of users rather than prohibition and coercion is far more likely to succeed.

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