scholarly journals Applying the Population Health Standard to the Regulation of Electronic Nicotine Delivery Systems

2020 ◽  
Author(s):  
Zachary Cahn ◽  
Jeffrey Drope ◽  
Clifford E Douglas ◽  
Rosemarie Henson ◽  
Carla J Berg ◽  
...  
Keyword(s):  
Population Health ◽  
Indirect Effects ◽  
Delivery Systems ◽  
Status Quo ◽  
The State ◽  
Electronic Nicotine Delivery Systems ◽  
Nicotine Delivery ◽  
The Status ◽  
The Impact ◽  
The U.S

Abstract Regulatory authorities have devoted increasing attention and resources to a range of issues surrounding the regulation of novel nicotine and tobacco products. This review highlights the inherent complexity of evaluating prospective policies that pertain to products that heat solutions containing nicotine but not tobacco leaf, sometimes referred to as electronic nicotine delivery systems (ENDS). The U.S. Food and Drug Administration (FDA) is compelled to incorporate a set of public health criteria in their decision-making, collectively referred to as the Population Health Standard. Adherence to this standard is necessary to estimate the impact of prospective ENDS policy decisions on net population harm associated with non-therapeutic nicotine products. For policies that are expected to decrease or increase ENDS use, application of the Population Health Standard requires a comprehensive assessment of the status quo impact of ENDS use on population health. Accordingly, this review first assesses the state of the evidence on the direct harms of ENDS and the indirect effects of ENDS use on smoking, particularly rates of initiation and cessation. After that, the example of flavor restrictions is used to demonstrate the further considerations that are involved in applying the Population Health Standard to a prospective ENDS policy. Implications This narrative review aims to inform regulatory considerations about ends through the prism of the population health standard. More specifically, this review: 1) describes and explains the importance of this approach; 2) provides guidance on evaluating the state of the evidence linking ends to the net population harm associated with non-therapeutic nicotine products; and 3) illustrates how this framework can inform policymaking using the example of flavor restrictions.

Updated Health and Cost Impacts of Electronic Nicotine Delivery Systems, Using Recent Estimates of Relative Harm for Vaping Compared to Smoking

2021 ◽  
Author(s):  
Jennifer A Summers ◽  
Driss Ait Ouakrim ◽  
Nick Wilson ◽  
Tony Blakely
Keyword(s):  
New Zealand ◽  
Cost Saving ◽  
Health System ◽  
Population Health ◽  
Delivery Systems ◽  
Electronic Nicotine Delivery Systems ◽  
Nicotine Delivery ◽  
Life Years ◽  
Per Capita ◽  
The Impact

Abstract Background Measuring population health and costs effects of liberalizing access to electronic nicotine delivery systems (ENDS) is an evolving field with high persisting uncertainty. A critical area of uncertainty for policy-makers are estimates of net harms from ENDS relative to cigarettes, therefore, we model these harms using updated estimates incorporating disease specificity. Methods We use updated estimates of relative harm of vaping vs smoking, based upon relevant biomarker studies to model the impact of liberalizing access to ENDS in New Zealand (NZ), relative to a ban (where ENDS are not legally available), in an existing proportional multi-state life-table model of 16 tobacco-related diseases. Results This modeling suggests that ENDS liberalization results in an expected gain of 195 000 quality-adjusted life-years (QALYs) over the remainder of the NZ population’s lifespan. There was wide uncertainty in QALYs gained (95% uncertainty interval [UI] = −8000 to 406 000) with a 3.2% probability of net health loss (based upon the number of simulation runs returning positive QALY gains). The average per capita health gain was 0.044 QALYs (equivalent to an extra 16 days of healthy life). Health system cost-savings were expected to be NZ$2.8 billion (US$2.1 billion in 2020 US$; 95%UI: −0.3 to 6.2 billion [2011 NZ$]), with an estimated 3% chance of a net increase in per capita cost. Conclusions This updated modeling around liberalizing ENDs in NZ, still suggests likely net health and cost-saving benefits—but of lesser magnitude than previous work and with a small possibility of net harm to population health. Implications This study found evidence using updated biomarker studies that ENDS liberalization could result in QALY gains across the New Zealand population lifespan that are also cost-saving to the health system. Governments should include the information from these types of modeling studies in their decision-making around potentially improving access to ENDS for existing smokers, while at the same further reducing access to tobacco.

Government intervention in the market for electronic nicotine delivery systems (ENDS). The known, the unknown and challenges

2020 ◽  
Vol 20 (3) ◽  
pp. 283-294
Author(s):  
Ayda A. Yurekli ◽  
Patricia Kovacevic ◽  
Emil Sunley ◽  
Karthik Ranganathan
Keyword(s):  
Simulation Analysis ◽  
Health Impact ◽  
Delivery Systems ◽  
Economic Research ◽  
Electronic Nicotine Delivery Systems ◽  
Content Type ◽  
The Public ◽  
Premature Deaths ◽  
Nicotine Delivery ◽  
The Impact

Purpose This paper aims to describe the various government measures that regulate the market for novel tobacco harm reduction products (THRPs), with an emphasis on e-cigarettes [electronic nicotine delivery systems (“ENDS”)], and evaluates the public health impact of excise taxes levied on these products. Design/methodology/approach The paper reviews the economic research on the impact ENDS. Using cited evidence, the paper compares the tax treatment of ENDS and cigarettes and provides a simulation of potential lives that can be saved under alternative tax treatment of ENDS. Findings ENDS are considerably less harmful than cigarettes. Imposing the same tax burden on them (per unit of “harm”) as on cigarettes leads to poorer health outcomes. Differential tax treatment of ENDS will encourage more cigarette smokers to switch to ENDS and could save millions of lives worldwide. Research limitations/implications Country experiences with regulatory measures on ENDS are limited to those with high THRP penetration. The paper’s simulation analysis used evidence from a limited number of studies. Rigorous economic analysis is needed to understand how ENDS could save lives and could prevent expected one billion premature deaths by the end of this century. Originality/value The paper uses research evidence in its analysis of the impact that the differential taxation of cigarettes and ENDS would have. It also provides a rough estimate of the number of lives that could be saved if more smokers who are trying to quit can make the switch to ENDS.

scholarly journals The impact of flavour, device type and warning messages on youth preferences for electronic nicotine delivery systems: evidence from an online discrete choice experiment

2017 ◽  
Vol 27 (e2) ◽  
pp. e152-e159 ◽  
Author(s):  
Ce Shang ◽  
Jidong Huang ◽  
Frank J Chaloupka ◽  
Sherry L Emery
Keyword(s):  
Discrete Choice Experiment ◽  
Discrete Choice ◽  
Choice Experiment ◽  
Delivery Systems ◽  
Electronic Nicotine Delivery Systems ◽  
Health Warning ◽  
Warning Messages ◽  
Nicotine Delivery ◽  
Device Type ◽  
The Impact

ObjectiveTo examine the impact of flavour, device type and health warning messages on youth preference for electronic nicotine delivery systems (ENDS), and to provide evidence and data to inform the Food and Drug Administration’s potential regulatory actions on ENDS.DesignAn online discrete choice experiment was conducted in September 2015. Each participant was given nine choice sets and asked to choose one out of two alternative ENDS products, with varying characteristics in three attributes (flavour, device type and warning message). The impact of the attributes on the probability of choosing ENDS was analysed using conditional and nested logit regressions, controlling for individual sociodemographic characteristics and current smoking status.Setting and participantsA general population sample of 515 participants (50 ever-users and 465 never-users of ENDS) aged 14–17 years were recruited to complete the experiment using an online panel.ResultsFruit/sweets/beverage flavours significantly increase the probability of choosing ENDS among youth (p<0.01 for never-users and <0.1 for ever-users) and flavour has the most pronounced impact among three attributes. Among never-users, menthol flavour also increases (p<0.05) the probability of choosing ENDS compared with tobacco flavour. Vaping devices that are modifiable, compared with cigarette-like e-cigarettes, increase (p<0.05) the probability of choosing ENDS among adolescent never-users. Warning messages reduce (p<0.01) the probability of choosing ENDS among never-users.Conclusions and relevanceRestricting fruit/sweets/beverage flavours in ENDS, regulating modifiable vaping devices and adopting strong health warning messages may reduce the uptake of ENDS among youth.

scholarly journals Impact of Nicotine Replacement and Electronic Nicotine Delivery Systems on Fetal Brain Development

2019 ◽  
Vol 16 (24) ◽  
pp. 5113 ◽  
Author(s):  
Sebastian Sailer ◽  
Giorgia Sebastiani ◽  
Vicente Andreu-Férnández ◽  
Oscar García-Algar
Keyword(s):  
Brain Development ◽  
Pregnant Women ◽  
Tobacco Smoking ◽  
Fetal Brain ◽  
Delivery Systems ◽  
Nicotine Replacement ◽  
Electronic Nicotine Delivery Systems ◽  
Nicotine Delivery ◽  
Fetal Brain Development ◽  
The Impact

Maternal tobacco smoking during pregnancy remains a major public health issue. The neurotoxic properties of nicotine are associated with fetal neurodevelopmental disorders and perinatal morbimortality. Recent research has demonstrated the effects of nicotine toxicity on genetic and epigenetic alterations. Smoking cessation strategies including nicotine replacement therapy (NRT) and electronic nicotine delivery systems (ENDS) show lack of clear evidence of effectiveness and safety in pregnant women. Limited trials using randomized controls concluded that the intermittent use formulation of NRT (gum, sprays, inhaler) in pregnant women is safe because the total dose of nicotine delivered to the fetus is less than continuous-use formulations (transdermal patch). Electronic nicotine delivery systems (ENDS) were hyped as a safer alternative during pregnancy. However, refill liquids of ENDS are suspected to be cytotoxic for the fetus. Animal studies revealed the impact of ENDS on neural stem cells, showing a similar risk of pre- and postnatal neurobiological and neurobehavioral disorders to that associated with the exposure to traditional tobacco smoking during early life. There is currently no clear evidence of impact on fetal brain development, but recent research suggests that the current guidelines should be reconsidered. The safety of NRT and ENDS is increasingly being called into question. In this review, we discuss the special features (pharmacodynamics, pharmacokinetics, and metabolism) of nicotine, NRT, and ENDS during pregnancy and postnatal environmental exposure. Further, we assess their impact on pre- and postnatal neurodevelopment.

scholarly journals Fluctuation between cigarette smoking and use of electronic nicotine delivery systems: Impact on clozapine concentrations and clinical effect

2021 ◽  
Vol 11 (6) ◽  
pp. 365-368
Author(s):  
Daniel J. Montville ◽  
Jaclyn M. Lindsey ◽  
Jonathan G. Leung
Keyword(s):  
Delivery System ◽  
Health Care Professionals ◽  
Psychiatric Symptoms ◽  
Delivery Systems ◽  
Serum Concentrations ◽  
Hydrocarbon Production ◽  
Electronic Nicotine Delivery Systems ◽  
Nicotine Delivery ◽  
Polycyclic Aromatic ◽  
The Impact

Abstract Unlike with smoking cigarettes, electronic nicotine delivery systems do not cause CYP450 1A2 induction as there is a lack of combustion and polycyclic aromatic hydrocarbon production. Changing to the use of an electronic nicotine delivery system from cigarettes can result in the deinduction of CYP450 1A2 and the increase of certain medication serum concentrations, including clozapine. A case is reported in which the switch from smoking to an electronic nicotine delivery system resulted in increased clozapine serum concentration and constipation, necessitating pharmacologic management. The patient ultimately transitioned back to cigarettes, which resulted in the emergence of psychiatric symptoms. An evaluation of longitudinal serum concentrations and clinical correlation is provided. It is important that patients and health care professionals have knowledge not only about the impact of smoking cigarettes on clozapine metabolism, but also the effects of switching to or from an electronic nicotine delivery system.

scholarly journals Flavors Enhance Nicotine Vapor Self-administration in Male Mice

2020 ◽  
Author(s):  
Skylar Y Cooper ◽  
Austin T Akers ◽  
Brandon J Henderson
Keyword(s):  
Mouse Model ◽  
Electronic Cigarettes ◽  
Fixed Ratio ◽  
Progressive Ratio ◽  
Delivery Systems ◽  
Male Mice ◽  
Self Administration ◽  
Electronic Nicotine Delivery Systems ◽  
Nicotine Delivery ◽  
The Impact

Abstract Introduction Although the use of combustible cigarettes has decreased in many urban regions of America, the use of electronic nicotine delivery systems (ENDS) has dramatically increased. ENDS, or electronic cigarettes (e-cigarettes), differ from combustible cigarettes given that there are no restrictions on flavorant additives in e-liquids. With 95% of ENDS users vaping flavored e-liquids, it is critical to understand how flavors alter vaping-related behaviors. We have previously shown that menthol and green apple flavors enhance nicotine reward-related behavior in a mouse model and in the present study have investigated how menthol and green apple flavors alter e-Vape self-administration behavior in male mice. Methods Adult C57/BL6J male mice were used in vapor-inhalation self-administration assays. Mice were assigned vaping e-liquids (6 mg/mL nicotine with or without menthol or green apple flavor) to escalate on a fixed-ratio 1 (FR1) schedule in daily 3-hour sessions to examine initiation-related behaviors. Following escalation, mice were transitioned to a FR3 and progressive ratio schedules in 3-hour sessions to examine reinforcement-related behaviors. Results Here we observed that male mice exhibited increased rates of self-administration escalation on a FR1 schedule when assigned to flavored e-liquids. Upon transition to FR3, mice continued to exhibit enhanced levels of reinforcement with flavored e-liquids. We also observed that mice self-administer zero-nicotine green apple flavored e-liquids. Conclusions These data provide additional evidence that ENDS flavors enhance vaping-related initiation and reinforcement-related behavior and promote the need to continue investigating the role ENDS flavors play in vaping-related behaviors. Implications There has been much discussion recently regarding the impact of flavors on vaping-related behavior. Our study here shows that flavors significantly enhance the acquisition and reinforcement of vaping-related behavior. This suggests that flavors in electronic nicotine delivery systems significantly increase the risk of addiction-related behaviors among users of vaping products.

scholarly journals Pilot Study of Electronic Nicotine Delivery Systems (ENDS) Cessation Methods

Pharmacy ◽  
2021 ◽  
Vol 9 (1) ◽  
pp. 21
Author(s):  
Michelle Sahr ◽  
Shelby Kelsh ◽  
Noah Blower ◽  
Minji Sohn
Keyword(s):  
Young Adults ◽  
Pilot Study ◽  
Replacement Therapy ◽  
Nicotine Replacement Therapy ◽  
Delivery Systems ◽  
Self Control ◽  
Behavioral Support ◽  
Electronic Nicotine Delivery Systems ◽  
Nicotine Delivery ◽  
The U.S

Currently, 7.6% of the U.S. young adults aged 18–24 years old use e-cigarettes. This study piloted three methods of Electronic Nicotine Delivery Systems (ENDS) cessation by measuring cessation rates, motivational techniques that contributed to cessation success, and participants’ changes after decreasing vape use. Participants were randomized into three study arms (nicotine replacement therapy (NRT) + behavioral support, vape-taper + behavioral support, self-guided) in a 1:1:1 ratio. All participants were invited to attend nine in-person or phone appointments over the 6-month study period. At 12 weeks, 3 of 7 (42.9%) participants in the NRT + behavioral support arm, 6 of 8 (75%) vape-taper + behavioral support arm, and 7 of 9 (77.8%) self-guided arm self-reported being vape-free and nicotine-free. At 6 months, 3 of 7 (42.9%) participants in the NRT + behavioral support arm, 6 of 8 (75%) vape-taper + behavioral support arm, and 4 of 9 (44.4%) self-guided arm self-reported being vape-free and nicotine-free. A challenge to quitting and remain quit is social pressures, but participants identified self-control and establishing new habits to be the best methods to overcome the desire to vape. Participants who received behavioral support and a vape-taper plan from pharmacists were more likely to be vape-free and nicotine-free at 6 months.

scholarly journals Perceptions and Use of Electronic Nicotine Delivery Systems Among Floridian Middle and High School Students: Secondary Analysis of Cross-sectional Survey Results

2020 ◽  
Vol 13 ◽  
pp. 1179173X2095340
Author(s):  
Anastasiya Ferrell ◽  
Linda Hadddad ◽  
Jennifer Harrison Elder ◽  
Cyndi Garvan ◽  
Christa L Cook ◽  
...  
Keyword(s):  
High School ◽  
High School Students ◽  
Secondary Analysis ◽  
Delivery Systems ◽  
The State ◽  
School Students ◽  
Cross Sectional ◽  
Electronic Nicotine Delivery Systems ◽  
Nicotine Delivery ◽  
Minimum Age

Introduction: Rapid increase in youth use of Electronic Nicotine Delivery Systems (ENDS) led the state and the federal governments to implement minimum-age policies to restrict minors’ access to vaping products. Limited success of the age restrictions fueled efforts to increase the distribution age of all tobacco products to 21 (ie, Tobacco 21 or T21 policies). With limited data on the T21 policies, the current study examines the prevalence of ENDS use and the perceptions about ENDS among youth in the pre- and post-policy-implementation periods for one of these bans in the state of Florida. Methods: This study conducted secondary analysis on the responses from the 2014 and 2015 Florida Youth Tobacco Survey, which collected cross-sectional data. Results: Compared to the data from spring of 2014, the minimum-age policy enacted on July 1, 2014 did not lead to a significant decrease in Florida’s high school and middle school students’ ever ENDS use (14.9% in 2014 vs 25.8% in 2015) and current ENDS use (7.5% in 2014 vs 12.4% in 2015). There was some ambiguity among students regarding the ENDS harm—more students in 2015 thought of ENDS as both equally (11.0% vs 7.7%) and less (32.4% vs 28%) harmful than cigarettes. There was a decrease in the proportion of students who were unsure about their answer to this question (51.5% vs 59.2%). Conclusions: Policy change alone may not be effective in shifting the trend of ENDS use among middle and high school students. Although students may know about some of the ENDS effects, many of them are still not aware about the harms. Interventions in school and in the community should be aiming to raise this awareness.

Sign in / Sign up

Export Citation Format

Share Document