VLN Cigarette

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VLNC (Very Low Nicotine Cigarettes) For those who are new to smoking, it is hoped that with the low nicotine content people won't become addicted to them and convert to habitual smoking. For people who already habitually smoke, it is hoped that the lower level of nicotine will help them break free from smoking or if they want/need more nicotine, convert to a safer alternative. The US FDA granted the first MRTP (Modified Risk Tobacco Product) to a VLNC on December 23, 2021.

  • Terms:
    • VLN = Very Low Nicotine
    • VLNC = Very Low Nicotine Cigarettes
    • CPD = Cigarettes Per Day
    • RNC = Reduced Nicotine Cigarette (non-brand hypernym used in some papers)



Studies

2023: E-Cigarette price impacts legal and black-market cigarette purchasing under a hypothetical reduced-nicotine cigarette standard.

  • The authors looked at various conditions in a hypothetical marketplace that included VLN cigarettes, illicit cigarettes and e-cigarettes at different prices.
  • Some rare informative work on a reduced nicotine rule looks at choices made by users facing a market in which a nicotine rule has been imposed. This is an experimental economic study and, therefore, more closely approximates the behavioural processes involved in responding to a regulation that requires users to make economic choices (i.e. pay money to buy something they want). More so than, say, randomised controlled trials, which have very poor external validity and tell us very little beyond their high level of non-compliance.
  • Results: Usual-brand cigarette purchasing was greater than illicit normal-nicotine content cigarettes and less than reduced-nicotine content cigarettes. In the cross-commodity purchasing tasks, illicit cigarettes and e-cigarettes both served as economic substitutes for reduced-nicotine content cigarettes; however, when e-cigarettes were available for $4/pod, they were purchased at greater levels than illicit cigarettes and resulted in greater reductions in reduced-nicotine content cigarettes purchasing than when available for $12/pod.
  • Implications: E-cigarettes available at low, but not high, prices were stronger substitutes for legal, reduced-nicotine content cigarettes than illegal, normal-nicotine content cigarettes in a hypothetical reduced-nicotine tobacco market. Our findings suggest the availability of relatively inexpensive e-cigarettes may reduce illicit cigarette purchasing and combusted cigarette use under a reduced-nicotine cigarette standard.
  • There's an interesting and revealing Twitter thread by senior author Matthew Johnson, Professor of Psychiatry and Behavioral Sciences at Johns Hopkins.  Here are the headlines, starting with the resistance to publishing sceptical research about tobacco control Big Idea:
    • Had a hell of a time publishing this due to zealotry in nicotine research field. Never received money from tobacco/e-cig companies but have long recognized e-cigs as a powerful public health benefit to replace smoking.
    • I've long recognized the potential catastrophe of banning full nicotine cigarettes. As if a hundred years of drug prohibition of other substances has worked and as if the world isn't finally moving away from those failed policies. The cigarette black market would EXPLODE.
    • We need to view nicotine/tobacco in the broader context of drug policy. We need to recognize that e-cigs are inherently different than the debacle of "light" cigarettes which likely harmed public health. E-cigs poised to be far less deadly than cigarettes, esp if well regulated.
  • Dolan SB, Bradley MK, Johnson MW. Nicotine Tob Res. 2023 May 17:ntad067. doi: 10.1093/ntr/ntad067. Online ahead of print. PMID: 37195268

2022: Educating the public on the health risks of very low nicotine content cigarettes: Results from a U.S.-based convenience sample

  • Messaging on mortality effects of VLNC cigarettes (i.e., cigarettes with 95% less nicotine are as deadly as current cigarettes) was associated with more accurate perceptions of the health risks of VLNC cigarettes than the control; however, misperceptions remained in one-third of participants.


2021: Switching to Progressively Reduced Nicotine Content Cigarettes in Smokers With Low Socioeconomic Status: A Double-Blind Randomized Clinical Trial

  • Differential dropout and noncompliance indicate some smokers had difficulty transitioning to cigarettes with reduced nicotine. These smokers will benefit from supplemental nicotine in medicinal or noncombustible tobacco products if a nicotine reduction standard is established. Other smokers successfully transitioned to very low nicotine content cigarettes exclusively and substantially reduced their exposure to nicotine.


2021: Reactions to reduced nicotine content cigarettes in a sample of young adult, low-frequency smokers

  • Reducing nicotine content will likely lower the abuse liability of cigarettes for most young, low-frequency smokers. Additional work is needed to determine if compensatory smoking may lead to increased toxicant exposure, and if a subset of individuals choosing lower nicotine cigarettes may continue to smoke regardless of nicotine content.


2021: Responses to Gradual and Immediate Reduction of Nicotine in Cigarettes in Young Versus Older Adult Smokers

  • These results indicate that an immediate reduction in nicotine would result in beneficial effects in both young and older adults. Young adults show less positive subjective effects of smoking following switching to VLNC cigarettes relative to older adults.


2021: Acute subjective sensory perceptions predict relative reinforcing effects of smoked nicotine

  • Consistent with assumed-but rarely tested-causes of smoking reinforcement, sensory perceptions from a cigarette predict its relative reinforcing efficacy.


2021: "I actually finally feel like the cigarettes aren't controlling me." - Interviews with participants smoking very low nicotine content cigarettes during a residential study

  • Several participants expected, prior to trying VLNC cigarettes, to compensate for the reduced nicotine levels by smoking more cigarettes but were surprised when they did not increase their smoking. A subset of participants reported experiencing minor withdrawal symptoms, such as irritability and fatigue. Several participants reported feeling less dependent after exclusively smoking VLNC cigarettes. Most participants said they would smoke VLNC cigarettes if they were the only cigarettes available to purchase. Some also said that smoking VLNC cigarettes could help people taper down or quit smoking.


2021 The Public Health Gains Had Cigarette Companies Chosen to Sell Very Low Nicotine Cigarettes

  • Here we report that cigarette manufacturers have had the ability to voluntarily implement such a standard for decades. We use a well-validated model to demonstrate that millions of smoking attributable deaths and life-years lost would have been averted if the industry had implemented such a standard.


2020: Changes in Cigarette Consumption With Reduced Nicotine Content Cigarettes Among Smokers With Psychiatric Conditions or Socioeconomic Disadvantage

  • These 3 randomized clinical trials including 775 participants with affective disorders, opioid use disorder, or socioeconomic disadvantage found that reducing nicotine content significantly decreased total cigarettes smoked daily and nicotine dependence severity.


2020 Commentary: Is Nicotine Reduction in Cigarettes Enough?

  • "Is this strong policy statement warranted by the findings in this study? We think not. The main finding—a modest within-trial reduction in cigarette consumption—does not support the objectives of the comprehensive plan for nicotine regulation at a national level. The ability of the VLNC intervention to promote smoking cessation was specifically tested at week 12 when participants were offered $100 to abstain from smoking for 24 hours, a modest goal given that most smokers who abstain for 24 hours relapse, and smokers do not get such offers in real life. The VLNC intervention did not result in smoking cessation. This raises serious questions about the conclusion that a VLNC cigarette policy alone would promote smoking cessation or reduce morbidity and mortality. The health benefits of VLNC cigarettes remain unclear. Reductions in the level of NNAL (4-[methylnitrosamino]-1-[3-pyridyl]-1-butanol), a biomarker for tobacco smoke carcinogens, were small, and 1 group (opioid users) experienced an increase in the level of NNAL."


2020 Abuse liability of cigarettes with very low nicotine content in pregnant cigarette smokers

  • Ten pregnant smokers in Burlington, VT and Baltimore, MD participated in 2017–2018.
  • Reducing the nicotine content of cigarettes may decrease their abuse liability in pregnant smokers without causing untoward craving/withdrawal or compensatory smoking. Studies of extended exposure to VLNCs in pregnant women are warranted.


2020: Differences in Acute Reinforcement Across Reduced Nicotine Content Cigarettes

  • 17 people completed the study.
  • Although replication with larger samples and longer access is needed, results indicate nicotine reduction to ≤2.3 mg/g in cigarettes would attenuate reinforcement. This choice procedure may efficiently inform future clinical trials to assess relative reinforcing effects of smoking reduced nicotine cigarettes.


2019: Misperceptions of Nicotine and Nicotine Reduction: The Importance of Public Education to Maximize the Benefits of a Nicotine Reduction Standard

  • Recent population-level data highlight that 49%–80% of US adults incorrectly believe that nicotine is responsible for most of the cancer caused by smoking
  • Nearly half (47%) of adult smokers believe that continued smoking of VLNC cigarettes is less likely to cause cancer than smoking their current cigarettes.This misperception is more common among smokers who are age 55+ (57%) and Black (57%).


2019: Effects of 6-Week Use of Very Low Nicotine Content Cigarettes in Smokers With Serious Mental Illness

  • "These results suggest that a reduced-nicotine standard for cigarettes would reduce smoking among smokers with SMI. However, the lack of effect on total nicotine exposure indicates VLNC noncompliance, suggesting that smokers with SMI may respond to a reduced-nicotine standard by substituting alternative forms of nicotine."
  • It can be assumed that even if reduced nicotine cigarettes are mandated, the black market will continue to supply nicotine containing tobacco, and cigarettes as long as there is demand.


2019: Abuse liability of cigarettes with very low nicotine content in pregnant cigarette smokers

  • Small trial - 10 participants
  • Reducing the nicotine content of cigarettes may decrease their abuse liability in pregnant smokers without causing untoward craving/withdrawal or compensatory smoking. Studies of extended exposure to VLNCs in pregnant women are warranted.


2018: Nondaily Smokers' Changes in Cigarette Consumption With Very Low-Nicotine-Content Cigarettes: A Randomized Double-blind Clinical Trial

  • Switching to VLNCCs caused substantial smoking reduction among ITS (non-daily intermittent smokers) but did not significantly increase abstinence. Response to a VLNCC intervention suggests that nicotine-seeking motivates ITS' smoking.


2018: Effect of Immediate vs Gradual Reduction in Nicotine Content of Cigarettes on Biomarkers of Smoke Exposure

  • In this study, compared with gradual nicotine reduction, immediate reduction was associated with lower toxicant exposure across time, smoking fewer CPD (cigarettes per day), greater reduction in dependence, and more cigarette-free days. However, the immediate reduction in nicotine caused greater withdrawal symptoms, greater use of nonstudy cigarettes, and higher drop-out rates.


2017: A review of the effects of very low nicotine content cigarettes on behavioral and cognitive performance

  • The results from this review suggest that smoking VLNC cigarettes may fail to reverse withdrawal-induced disruptions in performance following complete smoking abstinence or reduced nicotine exposure. Of the 19 studies reviewed herein, 15 reported significant differences in performance when smokers smoked VLNC versus NNC cigarettes. All results were in the direction of performance being worse when participants smoked VLNC relative to NNC cigarettes.
  • It is important to underscore the evidence suggesting that combined NRT and VLNC cigarettes restore disrupted performance when smoking VLNC cigarettes alone does not. Thus, if a reduced nicotine content policy was adopted, supplemental use of NRT and likely other non-combustible forms of nicotine (e.g., e-cigarettes) would be a viable option for protecting against the type of performance disruptions revealed in this review, although a larger number of studies directly examining this matter would be helpful.


2017: Estimating Demand and Cross-Price Elasticity for Very Low Nicotine Content (VLNC) Cigarettes Using a Simulated Demand Task

  • LNC cigarettes share the behavioral and sensory components of smoking while delivering negligible levels of nicotine. Although smokers rated VLNCs as less satisfying than regular cigarettes, smokers said they would increase their consumption of VLNCs as the price of regular cigarettes increased, if VLNCs were available at a lower price. This suggests that VLNCs are partially substitutable for regular cigarettes. VLNCs can be part of an effective tobacco control strategy, by reducing nicotine dependence and improving health and financial outcomes for smokers.


2017: Reduced nicotine content cigarette advertising: How false beliefs and subjective ratings affect smoking behavior

  • Smokers may misconstrue RNC cigarettes as less harmful than regular cigarettes. These beliefs, in conjunction with favorable subjective ratings, may increase product use.


2015: Biochemical Estimation of Noncompliance with Smoking of Very Low Nicotine Content Cigarettes

  • Biomarker analysis demonstrates a high degree of noncompliance with smoking VLNC cigarettes, indicating that smokers are supplementing these with conventional cigarettes.


2015: Randomized Trial of Reduced-Nicotine Standards for Cigarettes

  • In this 6-week study, reduced-nicotine cigarettes versus standard-nicotine cigarettes reduced nicotine exposure and dependence and the number of cigarettes smoked.


2015: Effect of Reducing the Nicotine Content of Cigarettes on Cigarette Smoking Behavior and Tobacco Smoke Toxicant Exposure: Two Year Follow Up

  • During the 12 months follow-up, cotinine levels in RNC smokers rose to baseline levels and to those of control smokers. Quit rates among RNC smokers were very low (7.5% vs 3 % in controls, N.S.).
  • Article: Low-Nicotine Cigarettes Fail to Sway Smokers
    • Study Finds Effectiveness of Cessation Aid Slips After 6 Months


2013: Reduced nicotine content cigarettes and nicotine patch

  • Combining very low nicotine content cigarettes with nicotine patch may improve the acute effects resulting from switching to either of these products alone.


2012: The combined effect of very low nicotine content cigarettes, used as an adjunct to usual Quitline care (nicotine replacement therapy and behavioural support), on smoking cessation: a randomized controlled trial

  • To determine the combined effect of very low nicotine content (VLNC) cigarettes and usual Quitline care [nicotine replacement therapy (NRT) and behavioural support] on smoking abstinence, in smokers motivated to quit.
  • VLNC cigarettes plus NRT (nicotine patch, gum and/or lozenge) significantly increased quit rates at all measured time points (3 & 6 weeks and 3 & 6 months) over use of NRT only
  • VLNC found to be slightly better than nicotine replacement alone


2010: Reduced nicotine content cigarettes: effects on toxicant exposure, dependence and cessation

  • "Unlike the 0.3 mg cigarettes, 0.05 mg cigarettes were not associated with compensatory smoking behaviors. Furthermore, the 0.05 mg cigarettes and nicotine lozenge were associated with reduced carcinogen exposure, nicotine dependence and product withdrawal scores. The 0.05 mg cigarette was associated with greater relief of withdrawal from usual brand cigarettes than the nicotine lozenge. The 0.05 mg cigarette led to a significantly higher rate of cessation than the 0.3 mg cigarette and a similar rate as nicotine lozenge."


2009: Toxicological Analysis of Low-Nicotine and Nicotine-Free Cigarettes

  • In summary, a toxicological analysis does not indicate that low-nicotine and nicotine-free Quest® cigarettes have less adverse toxicological effects in the laboratory than conventional cigarettes. This should draw the attention of the consumers and policy makers. A more comprehensive evaluation in smokers is expected for these new products.

Statements, Official Comments, Testimony

2018: ANPRM comment by Iowa AG, Tom Miller, and leading public health experts

  • However, we all agree that there is one important requirement common to each of the perspectives above: that is the availability of low-risk non-combustible alternative tobacco or nicotine products that are sufficiently satisfying alternatives to cigarettes that smokers who choose to continue to use nicotine would be willing to switch to them.


Discussion links BLOGs, Articles, Videos, etc

2022: Policy masterstroke or political quagmire?

2021: FDA spreads confusion about nicotine and smoking

2021: Reducing nicotine in smoked tobacco products: A pivotal feature of the proposals for achieving Smokefree Aotearoa 2025

2021: New Zealand’s plan to outlaw smoking for the next generation is misguided

2021: Desperate to Win the Smokefree Race, New Zealand Resorts to Prohibition

2021: A Mixed Record

2020 Modified Risk Tobacco Product Applications (MRPTAs) 22nd Century Group Inc.

2018: Video Low-Nicotine Cigarettes

2017: Feds should think twice before trying to reduce nicotine in cigarettes


Suggestions to add to this page

2021: Predicting Non-Adherence With Very Low Nicotine Content Cigarettes Among Adults With Serious Mental Illness Who Smoke

2020: Measuring Support for Requiring Reduced Nicotine Cigarettes: Issues with Questions, Answers, and Respondents

2019: Misperceptions of Nicotine and Nicotine Reduction: The Importance of Public Education to Maximize the Benefits of a Nicotine Reduction Standard

2019: Reducing Nicotine Without Misleading the Public: Descriptions of Cigarette Nicotine Level and Accuracy of Perceptions About Nicotine Content, Addictiveness, and Risk

2019: The Role of Compensation in Nicotine Reduction

* “The data from this study are important because they suggest that smokers do not engage in compensatory smoking by smoking each cigarette more intensely when switching to low-nicotine cigarettes,”

2018: Effects of reduced nicotine content cigarettes on individual withdrawal symptoms over time and during abstinence

2016: U.S. adults' addiction and harm beliefs about nicotine and low nicotine cigarettes

Studies on 22nd Century website