VLN Cigarette
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
- 'In the overall population, 4.1% reported that low-nicotine cigarettes were much more addictive than typical cigarettes, 67.5% said they were equally addictive, while 28.4% reported they were slightly/much less addictive."
- "Harm and chemical information can be prioritised to ensure VLNCs are not misperceived as less harmful than regular cigarettes. Messages about increased quitting efficacy and reduced addictiveness associated with VLNCs may backfire if presented to those who do not smoke."
- "Nearly two-thirds of participants who were assigned to the VLNC condition and who attained seven-day abstinence from combusted tobacco at the end of the intervention used e-cigarettes."
- 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
- 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.
- "Reducing nicotine content in cigarettes to very low levels reduces some toxicant exposures and cigarette addiction and increases smoking cessation in smokers with mood and/or anxiety disorders, without worsening mental health."
- "Results offer preliminary insight into potential barriers to adherence in SMI populations. Adherence might be enhanced by supplementing VLNC cigarettes with alternative sources of non-combusted nicotine, paired with educational campaigns to encourage quitting or switching to less harmful products. Future studies should replicate these analyses in a larger sample of individuals with SMI who smoke."
- 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.
- 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.
- Consistent with assumed-but rarely tested-causes of smoking reinforcement, sensory perceptions from a cigarette predict its relative reinforcing efficacy.
- 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.
- 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.
- 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."
- 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.
- 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.
- "Findings from our study revealed that consistent significant differences between the RNC and the UNC treatment groups started to occur at visit 6 with 1.4 mg nicotine/cigarette. The most consistent differences occurred at visits 8 and 9 when the RNC group was smoking VLNC cigarettes (0.2 mg nicotine/cigarette). The study indicates that even with reduced nicotine, cigarettes still provide some pleasurable and reinforcing effects. Subjects using RNC stated they were less likely to purchase RNC cigarettes, which would facilitate the goal of a nicotine reduction policy, but also points to the need to reduce access to black market high nicotine cigarettes. Understanding the impact of nicotine reduction on subjective effects through cigarette evaluation and liking scales would provide valuable information and possible direction to the FDA on implementing a nicotine reduction policy for cigarettes."
- "Survey design, including question type and the response order, resulted in a substantial difference in participant responses. Better and multiple questions may be needed before drawing conclusions about mandatory reduced nicotine cigarettes support, especially among smokers."
- 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%).
- "Stating that 95% of nicotine would be removed more accurately conveyed the nicotine content and addictiveness of VLNC cigarettes. However, descriptions that better conveyed nicotine content and addictiveness misled people about cancer risk."
- "The available research on switching from NNCs to VLNCs shows minimal evidence of compensatory smoking such that smokers do not smoke more cigarettes per day and are not exposed to higher levels of tobacco combustion toxicants. Furthermore, mathematical estimations based on the nicotine availability in VLNCs compared with NNC cigarettes with consideration of potential increases in bioavailability that could occur with intensive smoking suggest that substantial compensation would be impossible. It is much more likely that smokers who are unable to tolerate the extent of proposed nicotine reduction would switch to other sources of nicotine, rather than try to compensate by smoking more VLNC cigarettes more intensively."
- Many smokers had the misperception that smoking VLNC cigarettes is less likely to cause cancer, and some stated that they would be less likely to quit. A VLNC standard may be more effective if accompanied by a communication campaign that emphasizes the continued dangers of smoking VLNC cigarettes due to the many toxic chemicals in smoke.
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."
- "Additional dose–response relationships have been detected on the number of cigarettes smoked per day when low and high nicotine Spectrum cigarettes are available. For example, after 7 days of smoking Spectrum cigarettes, individuals given the low-nicotine content cigarettes significantly reduced the number of experimental cigarettes smoked compared to those given the high-nicotine content research cigarettes."
- 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.
- 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.
- "Thus, a reduced-nicotine standard for cigarettes produced a relatively mild and temporary increase in withdrawal among non-treatment seeking smokers."
- About three quarters of people either were unsure of the relationship between nicotine and cancer or incorrectly believed that nicotine causes cancer. Incorrectly believing that nicotine causes cancer could discourage smokers from switching to safer nicotine-containing alternatives, and could lead nonsmokers to experiment with low nicotine tobacco products, believing that cancer risk would be reduced. Findings underscore the need to educate the public on the health effects of nicotine and LNCs...
- Subjects rated the "very low" nicotine cigarette as less harmful to their health overall compared to the "average" nicotine cigarette; this effect held true for specific smoking-related diseases.
- 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.
- 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.
- Smokers may misconstrue RNC cigarettes as less harmful than regular cigarettes. These beliefs, in conjunction with favorable subjective ratings, may increase product use.
- "Incorrectly believing that nicotine causes cancer could discourage smokers from switching to safer nicotine-containing alternatives, and could lead nonsmokers to experiment with low nicotine tobacco products, believing that cancer risk would be reduced. Findings underscore the need to educate the public on the health effects of nicotine and LNCs, and can help public health practitioners determine which subgroups should be prioritized in targeted educational efforts."
- Biomarker analysis demonstrates a high degree of noncompliance with smoking VLNC cigarettes, indicating that smokers are supplementing these with conventional cigarettes.
- In this 6-week study, reduced-nicotine cigarettes versus standard-nicotine cigarettes reduced nicotine exposure and dependence and the number of cigarettes smoked.
- 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
- Combining very low nicotine content cigarettes with nicotine patch may improve the acute effects resulting from switching to either of these products alone.
- 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
- "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."
- 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.
Letters to the FDA CTP in Support or Opposition
Statements, Official Comments, Testimony
- 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: Can We Smoke Out Cancer?
2021: A Mixed Record
2018: Video Low-Nicotine Cigarettes
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