Nicotine Levels In Cigarettes Research Articles

Using the Past to Understand the Future of U.S. and Global Smoking Disparities: A Birth Cohort Perspective

Using the Past to Understand the Future of U.S. and Global Smoking Disparities: A Birth Cohort Perspective

FDA to reduce nicotine levels in cigarettes

FDA to reduce nicotine levels in cigarettes

New Zealand Smokers' Perceptions of Tobacco Endgame Measures: A Qualitative Analysis.

New Zealand's equity-focused endgame goal (Smokefree 2025) aims to reduce smoking prevalence to minimal levels (ie, <5%) in all population groups by 2025. Inadequate progress has stimulated discussion of innovative measures to reduce prevalence; because few studies have explored how marginalized groups perceive these measures, we addressed this knowledge gap. In November and December 2020, we conducted 20 in-depth interviews with people who smoked daily, were aged between 21 and 53, earned less than the median income (NZD33 900), and had marginal or inadequate income sufficiency. We explored participants' smoking history and used an elicitation exercise to probe their views on smokefree policies, including potential endgame measures. We used qualitative descriptive analysis and reflexive thematic analysis to interpret the data. Participants favored increasing personal support to quit and reducing nicotine levels in cigarettes, but generally opposed tobacco excise tax increases and paying people to quit. While many privileged their right to "choose," some recognized that stronger policies could restore the loss of agency addiction caused. Participants felt smoking's powerful addictiveness remained poorly understood, and called for smoking to be recognized and treated as an addiction. Several participants supported intensifying existing measures or introducing new measures. However, their use of tobacco industry rhetoric to frame smoking as a choice they had made could inadvertently reinforce the stigma they experienced. Reframing cigarettes as an addictive product engineered by a deceptive industry, may make it easier for participants to access the expanded support and compassion they sought. Policy measures, such as reducing the nicotine level in cigarettes, could support endgame goals; however, greater public understanding of addiction is needed to reduce stigma, support self-efficacy, and foster smoking cessation. Industry denormalization campaigns could challenge views of smoking as a personal choice, decrease self-blame among people who smoke, and present endgame goals as likely to enhance agency.

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

As the FDA works to determine whether a nicotine reduction policy would benefit public health, one key question is whether to mandate an immediate or gradual reduction in nicotine levels in cigarettes. The aim of this study was to determine whether the effects of gradual versus immediate nicotine reduction on cigarettes per day (CPD), total nicotine equivalents, and subjective responses differed in younger adults versus older adults. Using data from a recent randomized trial conducted in the United States (N = 1250) that switched smokers over a 20-week period to very low nicotine content (VLNC) cigarettes either immediately, gradually (via monthly reductions in nicotine content), or not at all (control condition, normal nicotine content research cigarette), we analyzed the moderating effect of age (age 18-24 or 25+). For both age groups, CPD in the immediate condition was significantly lower relative to gradual condition (estimated mean difference of 6.3 CPD in young adults, 5.2 CPD in older adults; p's < .05). Younger and older adults in the immediate and gradual reduction conditions had lower total nicotine equivalents at Week 20 (all p's < .05) than those in the control condition; age group did not moderate this effect. Positive subjective responses to cigarettes were lower among young adults relative to older adults in the immediate condition. 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. As researchers work to understand how a potential reduced-nicotine product standard for cigarettes may affect public health, one question is whether nicotine should be reduced immediately or gradually. This study demonstrates that both young and older adults who were switched immediately to the lowest content of nicotine smoked fewer CPD and had lower nicotine intake than those in the gradual condition. Furthermore, young adults appear to show lower positive subjective effects following switching to VLNC cigarettes relative to older adults. This is consistent with previous work demonstrating that young people appear to show lower abuse liability for VLNC cigarettes.

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

The Food and Drug Administration issued an advanced notice of proposed rulemaking for setting a product standard for nicotine levels in cigarettes, with an emphasis on minimally or non-addicting very low nicotine content (VLNC). A 33 week, two-arm, double-blind randomized trial conducted in Hershey, Pennsylvania, USA and Washington, DC, USA included adult daily cigarette smokers (≥5 cigarettes per day) with less than a college degree, and who had no plans to quit within the next six months. Participants were randomized to either reduced nicotine content (RNC) study cigarettes tapered every three weeks to a final VLNC (0.2 mg/cigarette) for six weeks or to usual nicotine content (UNC) study cigarettes (11.6 mg/cigarette). Outcomes included acceptability of study cigarettes measured by attrition (primary outcome), compliance, reduction in cigarette dependence and tobacco biomarkers, and post-intervention cessation. The RNC (n = 122) versus UNC (n = 123) group had higher attrition (adjusted Hazard Ratio 3.4; 95% confidence interval [CI] 1.99 to 5.81). At the end of the intervention, cotinine levels were 50% lower in the RNC group (mean group difference -137 ng/mL; 95% CI -172, -102). The RNC group smoked fewer CPD (-4.1; 95% CI -6.44, -1.75) and had lower carbon monoxide levels (-4.0 ppm; 95% CI -7.7, -0.4). Forty seven percent (29/62) of the RNC group were biochemically-confirmed compliant with smoking VLNC cigarettes (mean cotinine = 8.9 ng/ml). At three month follow-up, only compliant VLNC smokers quit with an assisted quit attempt (N = 6/22, 27%). This study supports a VLNC standard in cigarettes. 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.

Effects of Reduced-Nicotine Cigarettes Across Regulatory Environments in the Experimental Tobacco Marketplace: A Randomized Trial.

Cigarette smoking remains the leading preventable cause of death in the United States. Recent efforts have explored the potential health and policy benefits of reducing nicotine, an addictive component, in combustible cigarettes. To date, an experimental, prospective analysis directly comparing the effects of varying regulatory environments on purchases of multiple products has yet to be conducted. The present study compared real purchasing of conventional cigarettes, reduced-nicotine cigarettes, and a variety of other nicotine and tobacco products across a range of regulatory environments. Participants were assigned to one of five groups, each associated with a different nicotine level (mg of nicotine to g of tobacco) in SPECTRUM investigational cigarettes (15.8, 5.2, 2.4, 1.3, and 0.4 mg/g). Across sessions, participants made real purchases for nicotine/tobacco products in an Experimental Tobacco Marketplace. Each session corresponded with a distinct regulatory environment wherein different nicotine/tobacco products were available for purchase. Our results suggest that the primary drivers of cigarette and nicotine purchasing are regulatory environment and the presence/absence of alternative nicotine and tobacco products. Perhaps surprisingly, nicotine level does not appear to be such a driver of purchasing behavior under these experimental conditions. Investigational cigarette purchasing is lowest when other preferred combustible products are available and highest when investigational cigarettes are the only combustible product available for purchase. If a reduced-nicotine policy is implemented, great care should be taken in determining and making available less-harmful nicotine/tobacco products as the availability of preferred combustible products may result in undesirable levels of purchasing. This is the first experimental study investigating different potential regulatory effects related to a reduced-nicotine policy by examining purchasing across a range of nicotine/tobacco products. Our results suggest the presence of affordable, highly preferred combustible products is likely to maintain tobacco purchasing at undesirable levels. To promote switching to less-harmful products, affordable alternate nicotine and tobacco products should be readily available. Finally, our results suggest that the availability of noncigarette products, not cigarette nicotine level, will most likely affect purchasing of reduced-nicotine cigarettes.

Kicking the habit is hard: A hybrid choice model investigation into the role of addiction in smoking behavior.

Use of choice models is growing rapidly in tobacco research. These models are being used to answer key policy questions. However, certain aspects of smokers' choice behavior are not well understood. One such feature is addiction. Here, we address this issue by modeling data from a choice experiment on the US smokers. We model addiction using a latent variable. We use this latent variable to understand the relationship between choices and addiction, giving attention to nicotine levels. We find that more addicted smokers have stronger preferences for cigarettes and are unwilling to switch to e-cigarettes. Addicted smokers value nicotine in tobacco products to a much greater extent than those that are less addicted. Lastly, we forecast short-term responses to lowering nicotine levels in cigarettes. The results suggest that current nicotine-focused policies could be effective at encouraging addicted smokers to less harmful products and lead to substantial public health gains.

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

Objective: In this study, we assessed the effect of question type and answer options on support for lowering nicotine levels in cigarettes to make them less addictive. Methods: We surveyed 540 US adults using Prime Panels. Participants randomly received: (1) one of 2 Likert-type questions and (2) a forced-choice question on a range of policy options, with responses in one of 2 orders. Generalized linear models examined policy support using a latent outcome variable. Results: Overall, 53% of smokers and 77%-81% of former/never smokers supported the policy. With Likert questions, support was higher when ‘support’ options were presented first; with the forced-choice question, there were no answer order effects. Few smokers (21%) supported the policy consistently, compared to 47% of former and 52% of never smokers. In the multivariate latent model, current smokers (b = -0.13, 95% CI: -0.24, -0.02) and former smokers (b = -0.48, 95% CI: -0.58, -0.38) were significantly less likely to support the low nicotine policy compared to never smokers. Conclusions: 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.

Nicotine Reduction in Cigarettes: Literature Review and Gap Analysis.

BackgroundThe US Food and Drug Administration (FDA) is considering reducing nicotine levels in cigarettes to “minimally or non-addictive levels.” However, important research gaps remain, and the FDA must determine when the available research is sufficient to support moving forward.MethodsThe authors conducted a systematic review of research articles in PubMed relating to nicotine reduction. Building on a review of risk assessment best practices, the authors also developed a risk assessment framework for tobacco regulation and used it to guide a gap analysis of nicotine reduction research.ResultsThe final sample consisted of 78 articles. The majority examined either nicotine dependence on very low nicotine cigarettes (VLNCs) or markers of potential health effects of using VLNCs. One-third of the identified articles reported results from four large randomized controlled trials (RCTs). While these studies report promising results and suggest that a nicotine reduction rule would be a powerful tool to reduce cigarette smoking, our gap analysis suggests that there is a need for studies that better reflect the use and availability of a wide range of tobacco/nicotine products and the potential for dual- or multi-product use.ConclusionThe current body of research on nicotine reduction is weighted towards RCTs, which is appropriate for a policy that has not yet been implemented anywhere in the world. The FDA must consider a wide range of factors that may impact a product standard’s public health impact, including those difficult to assess in RCTs, such as a nicotine reduction rule’s impact on smoking initiation and relapse.ImplicationsThis systematic review presents a gap analysis based on a risk assessment framework to help identify remaining research priorities to inform FDA’s potential product standard to reduce nicotine levels in cigarettes. Quickly addressing those gaps would support the FDA’s effort to develop a nicotine reduction product standard that will be effective and withstand legal challenges.

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

SignificanceThe public incorrectly believes very low nicotine content (VLNC) cigarettes are less carcinogenic than current cigarettes, a belief associated with lower motivation to quit under a VLNC standard. We examined how different descriptions of the nicotine level in VLNC cigarettes affect the accuracy of the public’s perceptions about nicotine content, addictiveness, and cancer risk.MethodsParticipants were a national convenience sample of 1353 US adults (22% smokers). In an online experiment, we randomized participants to a VLNC description using (1) concise language; (2) a percentage; (3) an interpretation; (4) a percentage and interpretation; (5) a percentage and a pictograph; or (6) a percentage, interpretation, and pictograph; or to a control description using (7) FDA's “minimally or nonaddictive” phrasing. We assessed accuracy of perceived nicotine content, addictiveness, and cancer risk compared to current cigarettes.ResultsCompared to control, the percentage description resulted in more accurate perceptions about nicotine content (76% vs. 49% accuracy) and addictiveness (44% vs. 34%), but less accurate perceptions about cancer risk (56% vs. 68%; all ps < .05). Adding interpretation or pictographs to the percentage description did not increase accuracy. The concise language description reduced accuracy of perceived nicotine content and addictiveness but increased accuracy of cancer risk (all ps < .05).ConclusionsStating 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.ImplicationsImplementation of a VLNC standard should include plans for a communication campaign that conveys that VLNC cigarettes will be less addictive but equally toxic to smoke. Stating the percent reduction in nicotine is likely to more clearly communicate reduced addictiveness but may also exacerbate risk misperceptions. VLNC communication requires further study to ensure the public accurately understands a VLNC standard.

U.S. Adults’ Attitudes Toward Lowering Nicotine Levels in Cigarettes

This study assessed U.S. adults' attitudes toward lowering the nicotine levels in cigarettes to make them less addictive. Data from the 2018 SummerStyles, a web-based panel survey of U.S. adults aged ≥18 years (n=4,037) fielded in June-July, were analyzed in 2018. Respondents were asked: Do you favor or oppose requiring cigarette makers to lower the nicotine levels in cigarettes so that they are less addictive? Responses were strongly favor, somewhat favor, somewhat oppose, and strongly oppose. Sociodemographic correlates of favorability (strongly favor or somewhat favor) were assessed using multivariable Poisson regression. Eighty-one percent of adults in 2018 strongly or somewhat favored requiring cigarette makers to lower the nicotine levels in cigarettes to make them less addictive, including 80.6% of current cigarette smokers, 84.3% of former smokers, and 81.3% of never smokers. Favorability was 71.5% among current noncigarette tobacco product users and 81.9% among nonusers. Following adjustment, slight variations in favorability existed by sex, age, race/ethnicity, and other tobacco product use. Most adults favor requiring cigarette makers to lower the nicotine levels in cigarettes, including 8 in 10 current cigarette smokers. These findings can help inform the U.S. Food and Drug Administration's recent proposal to pursue a nicotine reduction standard for cigarettes.

The Debate About Nicotine Regulation: Commentary on Zeller.

Fifty-five years ago, Addison Yeaman, the General Counsel of Brown and Williamson, famously wrote, “Moreover, nicotine is addictive. We are, then, in the business of selling nicotine, an addictive drug effective in the release of stress mechanisms.” Until now, tobacco-related deaths and nicotine have been inextricably linked. Today, for the first time there is a serious debate about whether it is possible to separate nicotine from the products that kill. US Food and Drug Administration Commissioner Scott Gottlieb deserves enormous credit for his bold proposal to reduce nicotine levels in cigarettes. This proposal has great potential for accelerating declines in smoking and has transformed the debate about alternative nicotine products into a serious discussion about how best to regulate nicotine to protect public health. The debate is intense and has been divisive precisely because so much is at stake; the answers depend on scientific evidence that is difficult to develop and easy to dispute; these answers depend upon a series of variables that dramatically impact the eventual outcome and go well beyond a scientific analysis of any single product; and e-cigarettes are not a single “product,” but rather a highly variable group of products with potentially significant differences among them.

Anticipating Industry Arguments: The US Food and Drug Administration's Authority to Reduce Nicotine Levels in Cigarettes.

The US Food and Drug Administration has announced that it is considering lowering nicotine levels in cigarettes to "minimally addictive or nonaddictive levels." This could be a transformative public health measure, but the tobacco industry is likely to challenge such an action in court. This article reviews some of the key legal arguments that industry is likely to advance and considers possible responses. As we demonstrate, there are strong arguments that the US Food and Drug Administration has the authority to implement a policy to reduce nicotine in cigarettes to nonaddictive levels.

Potential Public Health Effects of Reducing Nicotine Levels in Cigarettes in the United States

Using a simulation model, the FDA has estimated that lowering the nicotine content in cigarettes to a minimally addictive level could substantially reduce tobacco-related mortality.

Age Moderates Smokers' Subjective Response to Very-Low Nicotine Content Cigarettes: Evidence from a Randomized Controlled Trial.

Reducing the level of nicotine in cigarettes is a regulatory strategy that has the potential to greatly improve public health. If nicotine levels are reduced in all commercially available cigarettes, current smokers might find it easier to quit and young people might be less likely to become dependent. However, it is not yet known whether age moderates subjective or behavioral responses to low-nicotine cigarettes. Recently, a large, multisite randomized clinical trial was conducted to compare the effects of cigarettes differing in nicotine content (either usual-brand or research cigarettes containing 15.8, 5.2, 2.4, 1.3, or 0.4 mg nicotine/g tobacco) across 6 weeks of exposure. In this secondary analysis, we tested whether age moderated smokers' subjective (measures of psychological reward, smoking satisfaction) and behavioral (cigarettes smoked per day, smoking topography, and nicotine exposure) responses to cigarettes varying in nicotine content after 2 and 6 weeks of use, while controlling for baseline dependence and demographic factors. Results indicated that younger adults (age 18-24) who smoked cigarettes with 2.4-0.4 mg/g nicotine reported significantly less smoking satisfaction and psychological reward, and smoked fewer cigarettes per day, than older adults (25+ years) after 2 weeks of use. No differences in topography were observed at either time point. After 6 weeks of use, differences had diminished on all measures. The reduced positive effects of reduced-nicotine content cigarettes in young adults suggests that this regulatory policy may reduce smoking reinforcement in this vulnerable population. As the FDA considers reducing the level of nicotine in cigarettes to make them less addictive, understanding the potential impact of this policy on young people is of crucial importance. We found that young adults had significantly lower positive subjective effects to very-low nicotine content (VLNC) cigarettes and smoked fewer VLNC cigarettes than older adults after 2 weeks of use, indicating that this policy may reduce smoking reinforcement more quickly in young adults. These data add to the growing body of evidence on the potential for this policy to positively affect public health.

Potential Mandated Lowering of Nicotine Levels in Cigarettes: A Plant Perspective.

The Food and Drug Administration has announced the potential for mandated lowering of nicotine levels in combustible cigarettes. The World Health Organization has recommended a lowering of cigarette filler nicotine levels to below 0.4 mg/g. To devise appropriate nicotine control strategies, regulators must consider technical feasibility, timelines for compliance, and potential impediments to implementation. Outlined here is previously unsummarized information on genetic approaches that might be used to reduce nicotine levels in cured tobacco leaves. For the benefit of regulators, altered alkaloid or toxicant profiles that might result by implementation of some of these methodologies are discussed. Also mentioned are potential licensing or regulatory impediments to use of some of the technologies per se. Implications: An understanding of technical feasibility of plant-based nicotine reduction technologies, along with the potential for corresponding alterations in alkaloid or toxicant profiles, is needed by regulators to develop effective nicotine control strategies with minimal impediments or undesirable consequences.

Attitudes towards Potential New Tobacco Control Regulations among U.S. Adults.

Favorable attitudes towards tobacco control policies can facilitate their implementation and success. We examined attitudes toward four potential U.S. Federal tobacco regulations (banning menthol from cigarettes, reducing nicotine levels in cigarettes, banning candy and fruit flavored electronic cigarettes, and banning candy and fruit flavored little cigars and cigarillos) and associations with individual and state variables. A nationally representative phone survey of 4337 adults assessed attitudes toward potential policies. Weighted logistic regression was used to assess relationships between attitudes and demographic factors, smoking behavior, beliefs about the government (knowledge, trust, and credibility), exposure to tobacco control campaigns, and state variables from the US Centers for Disease Control and Prevention (CDC) State Tobacco Activities Tracking and Evaluation (STATE) System. Most respondents supported three out of four policies. Respondents that were female, non-white, Latino, living below the poverty line, had less than high school education, were of older age, did not smoke, had higher trust in government, and were exposed to national tobacco control campaigns had higher odds of expressing favorable attitudes toward potential new tobacco regulations than did their counterparts. No state-level effects were found. While differences in attitudes were observed by individual demographic characteristics, behaviors, and beliefs, a majority of participants supported most of the potential new tobacco regulations surveyed.

FDA considers lowering nicotine levels in cigarettes

FDA considers lowering nicotine levels in cigarettes

FDA to propose cut in nicotine levels in cigarettes

FDA to propose cut in nicotine levels in cigarettes

Cigarette prohibition and the need for more prior testing of the WHO TobReg's global nicotine-reduction strategy

One can expect that the WHO Framework Convention on Tobacco Control (FCTC) Conference of the Parties may well be influenced by the recent WHO TobReg ‘Advisory Note’1 that supports, albeit...