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*"There are at least three advantages to nicotine flux as a regulatory target. First, rate of drug delivery is a key aspect of the extent to which a drug will be abused, and nicotine flux describes the rate at which an ECIG delivers nicotine to the user. If the goal of regulation is to decrease the likelihood that ECIGs will be abused by a population (i.e., non-smoking youth), decreasing ECIG nicotine flux may be an effective way to achieve this goal. Second, a given ECIG’s nicotine flux is a result of all aspects of that ECIG’s characteristics (e.g., construction, wattage, liquid nicotine content) so regulators need not try to focus simultaneously on myriad targets that can evolve over time. Rather, they focus on a product performance target – a range of nicotine emission rates – and manufacturers can choose whatever device/liquid characteristics that they can prove fall within that target performance range safely. Note that the flux target need not be a single value, but rather a range of allowable nicotine flux conditions (i.e., a nicotine emission rate no less than X and no greater than Y), thus allowing for a range of closed system products. Third, a mathematical model can be used to predict the nicotine flux of any ECIG. Thus, regulators have at their disposal a tool that allows them to examine efficiently an array of products to determine if those products meet or fall outside of a specified nicotine flux range. Overall, a performance standard like nicotine flux has clear advantages over multiple product standards. However, as with restricting flavor availability and limiting nicotine content, flux regulation, whatever its advantages, fails in an open-system context where users are able to modify devices and liquids easily." | *"There are at least three advantages to nicotine flux as a regulatory target. First, rate of drug delivery is a key aspect of the extent to which a drug will be abused, and nicotine flux describes the rate at which an ECIG delivers nicotine to the user. If the goal of regulation is to decrease the likelihood that ECIGs will be abused by a population (i.e., non-smoking youth), decreasing ECIG nicotine flux may be an effective way to achieve this goal. Second, a given ECIG’s nicotine flux is a result of all aspects of that ECIG’s characteristics (e.g., construction, wattage, liquid nicotine content) so regulators need not try to focus simultaneously on myriad targets that can evolve over time. Rather, they focus on a product performance target – a range of nicotine emission rates – and manufacturers can choose whatever device/liquid characteristics that they can prove fall within that target performance range safely. Note that the flux target need not be a single value, but rather a range of allowable nicotine flux conditions (i.e., a nicotine emission rate no less than X and no greater than Y), thus allowing for a range of closed system products. Third, a mathematical model can be used to predict the nicotine flux of any ECIG. Thus, regulators have at their disposal a tool that allows them to examine efficiently an array of products to determine if those products meet or fall outside of a specified nicotine flux range. Overall, a performance standard like nicotine flux has clear advantages over multiple product standards. However, as with restricting flavor availability and limiting nicotine content, flux regulation, whatever its advantages, fails in an open-system context where users are able to modify devices and liquids easily." | ||
*Citation: Eissenberg T, Soule E, Shihadeh A; CSTP Nicotine Flux Work Group. 'Open-System' electronic cigarettes cannot be regulated effectively. Tob Control. 2021 Mar;30(2):234-235. doi: 10.1136/tobaccocontrol-2019-055499. Epub 2020 Mar 17. PMID: 32184338; PMCID: PMC7848783. | *Citation: Eissenberg T, Soule E, Shihadeh A; CSTP Nicotine Flux Work Group. 'Open-System' electronic cigarettes cannot be regulated effectively. Tob Control. 2021 Mar;30(2):234-235. doi: 10.1136/tobaccocontrol-2019-055499. Epub 2020 Mar 17. PMID: 32184338; PMCID: PMC7848783. | ||
==2020: [https://www.otru.org/wp-content/uploads/2020/07/researchnews_ecig_dependence.pdf E-Cigarette Dependence: Policies for Product Regulation: Theory, Evidence and Regulatory Policy]== | |||
*"The utility of these individually considered features is limited because no one feature alone determines the rate at which nicotine is emitted (i.e., the flux). For instance, a high-voltage/low nicotine concentration combination may provide the same or greater flux as a low-voltage/high nicotine concentration combination. The flux, as a result, determines the effect of a given nicotine dose, ranging from no effect to acute toxicity. If the e-cigarette nicotine flux is low, users likely will abandon the device. If the flux is high (e.g., exceeds levels characteristic of combustible cigarettes), users may accept the device despite the fact that it carries with it the potential for toxic side effects." | |||
*Citation: Research News, The Ontario Tobacco Research Unit, March 2020. | |||
==2019: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6814574/ What is the nicotine delivery profile of electronic cigarettes?]== | ==2019: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6814574/ What is the nicotine delivery profile of electronic cigarettes?]== | ||
*"A potential first step in effective regulation may involve regulating the rate at which nicotine is emitted from an e-cigarette (i.e., nicotine “flux”; [98,99]). Using nicotine flux as a regulatory target, all of the factors that influence it (e.g., device power, liquid nicotine concentration, user behavior) can be accounted for, and conditions that produce a flux that is too low (i.e., ineffective nicotine delivery) or too high (e.g., exceeding the flux of a combustible cigarette) can be made unavailable to consumers. Whether or not nicotine flux is the correct regulatory target, the current state of affairs, in which uninformed consumers use products that may or may not deliver nicotine and a variety of other toxicants, is incompatible with an empirically-based regulatory approach that prioritizes public health." | *"A potential first step in effective regulation may involve regulating the rate at which nicotine is emitted from an e-cigarette (i.e., nicotine “flux”; [98,99]). Using nicotine flux as a regulatory target, all of the factors that influence it (e.g., device power, liquid nicotine concentration, user behavior) can be accounted for, and conditions that produce a flux that is too low (i.e., ineffective nicotine delivery) or too high (e.g., exceeding the flux of a combustible cigarette) can be made unavailable to consumers. Whether or not nicotine flux is the correct regulatory target, the current state of affairs, in which uninformed consumers use products that may or may not deliver nicotine and a variety of other toxicants, is incompatible with an empirically-based regulatory approach that prioritizes public health." | ||
*Citation: Voos N, Goniewicz ML, Eissenberg T. What is the nicotine delivery profile of electronic cigarettes? Expert Opin Drug Deliv. 2019 Nov;16(11):1193-1203. doi: 10.1080/17425247.2019.1665647. Epub 2019 Sep 13. PMID: 31495244; PMCID: PMC6814574. | *Citation: Voos N, Goniewicz ML, Eissenberg T. What is the nicotine delivery profile of electronic cigarettes? Expert Opin Drug Deliv. 2019 Nov;16(11):1193-1203. doi: 10.1080/17425247.2019.1665647. Epub 2019 Sep 13. PMID: 31495244; PMCID: PMC6814574. | ||
==2019: [https://repositorio.udd.cl/server/api/core/bitstreams/59c237c0-2d39-4275-a093-180806468be8/content 3. Clinical pharmacology of nicotine in electronic nicotine delivery systems]== | |||
*To address the first concern, there is growing interest in measuring nicotine “flux”, the rate at which nicotine is emitted from ENDS (56, 57). Nicotine flux can be measured (usually reported in µg/s) and can be compared among ENDS and with cigarettes. Those ENDS that mimic the flux of a cigarette may be more likely to substitute well for a cigarette than ENDS that do not. | |||
*Armando Peruga, Centre of Epidemiology and Health Policies, School of Medicine, Clínica Alemana, University of Desarrollo, Chile and Thomas Eissenberg, Center for the Study of Tobacco Products, Department of Psychology, Virginia Commonwealth University, USA | |||
*Citation: WHO Study Group on [http://Tobacco%20Product%20Regulation Tobacco Product Regulation]. Report on the scientific basis of tobacco product regulation: seventh report of a WHO study group. Geneva: World Health Organization; 2019 (WHO Technical Report Series, No. 1015). Licence: CC BY-NC-SA 3.0 IGO. | |||
==2017: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5502764/ Transport phenomena governing nicotine emissions from electronic cigarettes: model formulation and experimental investigation]== | ==2017: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5502764/ Transport phenomena governing nicotine emissions from electronic cigarettes: model formulation and experimental investigation]== | ||
*"Performance standards are commonly written in consumer product regulations in the USA and elsewhere, and with the appropriate scientific basis, can be developed for ECIGs. To the extent that proposed performance standards will involve nicotine emissions, models like the one described can be used to predict nicotine emissions of any existing or future ECIG product, without recourse to costly testing in an analytical laboratory. These models can also be used to test the effects of proposed regulation on factors that influence nicotine flux." | *"Performance standards are commonly written in consumer product regulations in the USA and elsewhere, and with the appropriate scientific basis, can be developed for ECIGs. To the extent that proposed performance standards will involve nicotine emissions, models like the one described can be used to predict nicotine emissions of any existing or future ECIG product, without recourse to costly testing in an analytical laboratory. These models can also be used to test the effects of proposed regulation on factors that influence nicotine flux." | ||
*Citation: Talih S, Balhas Z, Salman R, El-Hage R, Karaoghlanian N, El-Hellani A, Baassiri M, Jaroudi E, Eissenberg T, Saliba N, Shihadeh A. Transport phenomena governing nicotine emissions from electronic cigarettes: model formulation and experimental investigation. Aerosol Sci Technol. 2017;51(1):1-11. doi: 10.1080/02786826.2016.1257853. Epub 2016 Nov 8. PMID: 28706340; PMCID: PMC5502764. | *Citation: Talih S, Balhas Z, Salman R, El-Hage R, Karaoghlanian N, El-Hellani A, Baassiri M, Jaroudi E, Eissenberg T, Saliba N, Shihadeh A. Transport phenomena governing nicotine emissions from electronic cigarettes: model formulation and experimental investigation. Aerosol Sci Technol. 2017;51(1):1-11. doi: 10.1080/02786826.2016.1257853. Epub 2016 Nov 8. PMID: 28706340; PMCID: PMC5502764. | ||
==2015: [https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-015-0355-y Electronic cigarettes and nicotine dependence: evolving products, evolving problems]== | |||
*"ECIG use well may be a method for achieving significant decreases in the disability, disease, and death associated with combustible tobacco use worldwide. Achieving these decreases may require ECIGs that approach the nicotine delivery profile of a tobacco cigarette, but likely do not require ECIGs that exceed that profile. In addition, these decreases in cigarette-caused morbidity and mortality must not be accompanied by an increase in compulsive nicotine use among those who do not currently use the drug." | |||
*Cobb, C.O., Hendricks, P.S. & Eissenberg, T. Electronic cigarettes and nicotine dependence: evolving products, evolving problems. BMC Med 13, 119 (2015). https://doi.org/10.1186/s12916-015-0355-y | |||
==2015: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4837999/ Electronic Cigarette Effectiveness and Abuse Liability: Predicting and Regulating Nicotine Flux]== | ==2015: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4837999/ Electronic Cigarette Effectiveness and Abuse Liability: Predicting and Regulating Nicotine Flux]== | ||
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===Response: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4838002/ Nicotine Flux: A Potentially Important Tool For Regulating Electronic Cigarettes]=== | ===Response: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4838002/ Nicotine Flux: A Potentially Important Tool For Regulating Electronic Cigarettes]=== | ||
*Citation: Eissenberg T, Shihadeh A. Nicotine flux: a potentially important tool for regulating electronic cigarettes. Nicotine Tob Res. 2015 Feb;17(2):165-7. doi: 10.1093/ntr/ntu208. Epub 2014 Oct 19. PMID: 25332456; PMCID: PMC4838002. | *Citation: Eissenberg T, Shihadeh A. Nicotine flux: a potentially important tool for regulating electronic cigarettes. Nicotine Tob Res. 2015 Feb;17(2):165-7. doi: 10.1093/ntr/ntu208. Epub 2014 Oct 19. PMID: 25332456; PMCID: PMC4838002. | ||
==2015: Article: [https://whyy.org/articles/as-fda-readies-plan-on-e-cigarettes-experts-and-vapers-debate-best-approach/ As FDA readies plan on e-cigarettes, experts and vapers debate best approach]== | |||
*"Eissenberg’s team talked about perhaps regulating “nicotine flux” – the amount of the drug that comes out of the mouth-end of a vaping pen. He says there must be enough nicotine produced so the experience is satisfying to smokers — and helps them quit tobacco cigarettes. “There’s a sweet spot,” he said. “We don’t want a level that’s so high that adolescents or non-smokers will pick up electronic cigarettes and start using them.” | |||
=Waiting on results= | =Waiting on results= | ||
==2023-2024: [https://ctv.veeva.com/study/effects-of-electronic-cigarette-flavors-on-abuse-liability-in-smokers-p3-taste Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)]== | |||
==2023: [https://www.researchprotocols.org/2023/1/e38732/ The Vaping and Patterns of e-Cigarette Use Research Study: Protocol for a Web-Based Cohort Study]== | ==2023: [https://www.researchprotocols.org/2023/1/e38732/ The Vaping and Patterns of e-Cigarette Use Research Study: Protocol for a Web-Based Cohort Study]== | ||
*[https://www.researchprotocols.org/2023/1/e38732/PDF PDF] | |||
*[https://cstp.vcu.edu/projects-and-cores/analytical-laboratory-toxicity-testing/ Analytical Laboratory: Toxicity Testing] | *[https://cstp.vcu.edu/projects-and-cores/analytical-laboratory-toxicity-testing/ Analytical Laboratory: Toxicity Testing] | ||
==2022-2025: [https://classic.clinicaltrials.gov/ct2/show/NCT05430334 Assess the Influence of Nicotine Flux and Nicotine Form on Subjective Effects Related to Dependency]== | ==2022-2025: [https://classic.clinicaltrials.gov/ct2/show/NCT05430334 Assess the Influence of Nicotine Flux and Nicotine Form on Subjective Effects Related to Dependency]== | ||
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