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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?]== | ||
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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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