ENDS Toxicity / Carcinogenic: Difference between revisions
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*Acknowledgement: The Tobacco Advisory Group acknowledges the help of the UK Centre for Tobacco and Alcohol Studies (www.ukctas.net), which is funded by the UK Clinical Research Collaboration, in writing this report; and thanks Natalie Wilder, Claire Daley, Jane Sugarman and James Partridge in the Royal College of Physicians Publications Department for their work in producing the report. | *Acknowledgement: The Tobacco Advisory Group acknowledges the help of the UK Centre for Tobacco and Alcohol Studies (www.ukctas.net), which is funded by the UK Clinical Research Collaboration, in writing this report; and thanks Natalie Wilder, Claire Daley, Jane Sugarman and James Partridge in the Royal College of Physicians Publications Department for their work in producing the report. | ||
===2016 | ===2016 [https://www.sciencedirect.com/science/article/pii/S0273230016302938?via%3Dihub A randomised, parallel group study to evaluate the safety profile of an electronic vapour (vapor) product over 12 weeks]=== | ||
*In this study, we have demonstrated that no clinically relevant, product-related safety findings were observed for smokers of Combustible Cigarettes (CCs) switching to an [[Abbreviations|Electronic Vapor Product (EVP)]] for 12 weeks under real-life settings. [[Abbreviations|AEs]] reported by subjects switching to the EVP occurred primarily within the first week after switching, and only 1.3% of all AEs reported were considered to be almost definitely related to the product. Up to a third of all reported AEs in the EVP group were related to nicotine withdrawal symptoms, which were observed to decrease after the first two weeks from product switch. EVP use was associated with significant decreases in exposure to nicotine and other chemicals such as benzene and acrolein, typically found in CC smoke. Changes were also observed in the level of WBC, haemoglobin, RBC and LDL cholesterol, which although minor, were consistent with those observed after smoking cessation. The data presented in this study shows the potential that EVPs may offer to smokers looking for an alternative to CCs. | *In this study, we have demonstrated that no clinically relevant, product-related safety findings were observed for smokers of Combustible Cigarettes (CCs) switching to an [[Abbreviations|Electronic Vapor Product (EVP)]] for 12 weeks under real-life settings. [[Abbreviations|AEs]] reported by subjects switching to the EVP occurred primarily within the first week after switching, and only 1.3% of all AEs reported were considered to be almost definitely related to the product. Up to a third of all reported AEs in the EVP group were related to nicotine withdrawal symptoms, which were observed to decrease after the first two weeks from product switch. EVP use was associated with significant decreases in exposure to nicotine and other chemicals such as benzene and acrolein, typically found in CC smoke. Changes were also observed in the level of WBC, haemoglobin, RBC and LDL cholesterol, which although minor, were consistent with those observed after smoking cessation. The data presented in this study shows the potential that EVPs may offer to smokers looking for an alternative to CCs. | ||
*[https://sci-hub.se/10.1016/j.yrtph.2016.10.003 PDF Version] | *[https://sci-hub.se/10.1016/j.yrtph.2016.10.003 PDF Version] | ||
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*Acknowledgement: This work was funded and supported by Fontem Ventures B.V. Imperial Brands plc is the parent company of Fontem Ventures B.V., the manufacturer of the EVP prototype used in this study. | *Acknowledgement: This work was funded and supported by Fontem Ventures B.V. Imperial Brands plc is the parent company of Fontem Ventures B.V., the manufacturer of the EVP prototype used in this study. | ||
2016: Exposure to Nicotine and Selected Toxicants in Cigarette Smokers Who Switched to | ===2016 [https://academic.oup.com/ntr/article-abstract/19/2/160/2631650?redirectedFrom=fulltext Exposure to Nicotine and Selected Toxicants in Cigarette Smokers Who Switched to Electronic Cigarettes: A Longitudinal Within-Subjects Observational Study]=== | ||
Electronic Cigarettes: A Longitudinal Within-Subjects Observational Study | *After switching from tobacco to e-cigarettes, nicotine exposure remains unchanged, while exposure to selected carcinogens and toxicants is substantially reduced. | ||
*[https://sci-hub.se/10.1093/ntr/ntw160 PDF Version] | |||
*Citation: Maciej L. Goniewicz, PharmD, PhD, Michal Gawron, PharmD, Danielle M. Smith, MPH, Margaret Peng, BSc, Peyton Jacob, III, PhD, Neal L. Benowitz, MD, Exposure to Nicotine and Selected Toxicants in Cigarette Smokers Who Switched to Electronic Cigarettes: A Longitudinal Within-Subjects Observational Study, Nicotine & Tobacco Research, Volume 19, Issue 2, 1 February 2017, Pages 160–167, doi: 10.1093/ntr/ntw160 | |||
*Acknowledgement: This work was supported by the Ministry of Science and Higher Education of Poland (grant number N N404 025638). Instrumentation and analytical chemistry at UCSF was supported by the National Institutes of Health, P30 DA012393 and S10 RR026437. | |||
2016: Tobacco Consumption and Toxicant Exposure of Cigarette Smokers Using Electronic | ===2016 [https://academic.oup.com/ntr/article-abstract/20/2/206/2730216?redirectedFrom=fulltext Tobacco Consumption and Toxicant Exposure of Cigarette Smokers Using Electronic Cigarettes]=== | ||
Cigarettes | *Smokers using [[Abbreviations|EC]]s over 4 weeks maintained cotinine levels and experienced significant reductions in carbon monoxide, [[Abbreviations|NNAL]], and two out of eight measured [[Abbreviations|VOC]] metabolites. Those who switched exclusively to ECs for at least half of the study period significantly reduced two additional VOCs. | ||
Smokers using | *[https://sci-hub.se/10.1093/ntr/ntw333 PDF Version] | ||
*Citation: Pulvers, K., Emami, A. S., Nollen, N. L., Romero, D. R., Strong, D. R., Benowitz, N. L., & Ahluwalia, J. S. (2016). Tobacco Consumption and Toxicant Exposure of Cigarette Smokers Using Electronic Cigarettes. Nicotine & Tobacco Research, ntw333. doi:10.1093/ntr/ntw333 | |||
*Acknowledgement: This study was funded by the University of Minnesota (JA), P30 DA012393 (NB), P50 CA180890 (NB), and California State University San Marcos (KP). | |||
2016: Reductions in biomarkers of exposure, impacts on smoking urge and assessment of product use and tolerability in adult smokers following partial or complete substitution of cigarettes with electronic cigarettes | ===2016 [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4940751/ Reductions in biomarkers of exposure, impacts on smoking urge and assessment of product use and tolerability in adult smokers following partial or complete substitution of cigarettes with electronic cigarettes]=== | ||
Subjects switching to e-cigarettes had significantly lower levels (29 %–95 %) of urinary | *Subjects switching to e-cigarettes had significantly lower levels (29 %–95 %) of urinary [[Abbreviations|BoE]]s after 5 days. Nicotine equivalents declined by 25 %–40 %. | ||
Dual users who substituted half of their self-reported daily cigarette consumption with e-cigarettes experienced 7 %–38 % reductions, but had increases (1 %–20 %) in nicotine equivalents. | *Dual users who substituted half of their self-reported daily cigarette consumption with e-cigarettes experienced 7 %–38 % reductions, but had increases (1 %–20 %) in nicotine equivalents. | ||
Blood nicotine biomarker levels were lower in the cessation (75 %–96 %) and e-cigarette use groups (11 %–83 %); dual users had no significant reductions. | *Blood nicotine biomarker levels were lower in the cessation (75 %–96 %) and e-cigarette use groups (11 %–83 %); dual users had no significant reductions. | ||
All groups experienced significant decreases in exhaled CO (27 %–89 %). Exhaled NO increases (46 %–63 %) were observed in the cessation and e-cigarette use groups; dual users had minimal changes. | *All groups experienced significant decreases in exhaled CO (27 %–89 %). Exhaled NO increases (46 %–63 %) were observed in the cessation and e-cigarette use groups; dual users had minimal changes. | ||
By Day 5, all groups had greater reductions in smoking urge compared to cessation. However, reductions were larger in the dual use group. | *By Day 5, all groups had greater reductions in smoking urge compared to cessation. However, reductions were larger in the dual use group. | ||
No serious adverse events were observed. | *No serious adverse events were observed. | ||
*[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4940751/pdf/12889_2016_Article_3236.pdf PDF Version] | |||
*Citation: D'Ruiz CD, Graff DW, Robinson E. Reductions in biomarkers of exposure, impacts on smoking urge and assessment of product use and tolerability in adult smokers following partial or complete substitution of cigarettes with electronic cigarettes. BMC Public Health. 2016 Jul 11;16:543. doi: 10.1186/s12889-016-3236-1. PMID: 27401980; PMCID: PMC4940751. | |||
*Acknowledgement: This study was funded by Fontem Ventures B.V., a fully owned subsidiary of Imperial Brands plc, and the manufacturer of the e-cigarette products used in this study. | |||
2016: The mutagenic assessment of an electronic-cigarette and reference cigarette smoke using the Ames assay in strains TA98 and TA100 | ===2016 [https://www.sciencedirect.com/science/article/pii/S1383571816301711?via%3Dihub The mutagenic assessment of an electronic-cigarette and reference cigarette smoke using the Ames assay in strains TA98 and TA100]=== | ||
In the presence and absence of metabolic activation, e-cigarette ACM and aerosol were deemed non-mutagenic in tester strains TA98 and TA100, under the test conditions described previously, despite clear positive control responses. Conversely, 3R4F cigarette smoke TPM and freshly generated whole smoke were clearly positive. | *In the presence and absence of metabolic activation, e-cigarette [[Abbreviations|ACM]] and aerosol were deemed non-mutagenic in tester strains TA98 and TA100, under the test conditions described previously, despite clear positive control responses. Conversely, 3R4F cigarette smoke TPM and freshly generated whole smoke were clearly positive. | ||
In the case of freshly generated cigarette smoke, a positive response in both strains was observed within 24 min, whereas e-cigarette aerosols remained negative up to 3 h. | *In the case of freshly generated cigarette smoke, a positive response in both strains was observed within 24 min, whereas e-cigarette aerosols remained negative up to 3 h. | ||
*[https://sci-hub.se/10.1016/j.mrgentox.2016.10.005 PDF Version] | |||
*Citation: Thorne, D., Crooks, I., Hollings, M., Seymour, A., Meredith, C., & Gaca, M. (2016). The mutagenic assessment of an electronic-cigarette and reference cigarette smoke using the Ames assay in strains TA98 and TA100. Mutation Research/Genetic Toxicology and Environmental Mutagenesis, 812, 29–38. doi:10.1016/j.mrgentox.2016.10.005 | |||
*Acknowledgement: The authors are employees of British American Tobacco or Covance Laboratories Ltd. Covance Laboratories Ltd., Harrogate, UK, | |||
conducted all experimental work and were funded by BritishAmerican Tobacco. Nicoventures Ltd., UK, is a wholly-owned subsidiary | |||
of British American Tobacco. | |||
2016: Electronic cigarette aerosol induces significantly less cytotoxicity than tobacco smoke | |||
Under the conditions tested, Vype ePen e-cigarette aerosol was significantly less cytotoxic than reference 3R4F cigarette smoke. | ===2016 [https://www.tandfonline.com/doi/full/10.1080/15376516.2016.1217112?src=recsys Electronic cigarette aerosol induces significantly less cytotoxicity than tobacco smoke]=== | ||
*Under the conditions tested, Vype ePen e-cigarette aerosol was significantly less cytotoxic than reference 3R4F cigarette smoke. | |||
*[https://sci-hub.se/10.1080/15376516.2016.1217112 PDF Version] | |||
*Citation: Azzopardi, D., Patel, K., Jaunky, T., Santopietro, S., Camacho, O. M., McAughey, J., & Gaça, M. (2016). Electronic cigarette aerosol induces significantly less cytotoxicity than tobacco smoke. Toxicology Mechanisms and Methods, 26(6), 477–491. doi:10.1080/15376516.2016.1217112 | |||
*Acknowledgement: This study was funded by BAT. The authors are employees of British American Tobacco (BAT). Nicoventures Ltd., UK, is a wholly-owned subsidiary of British American Tobacco. | |||
===2015 [https://www.sciencedirect.com/science/article/pii/S0887233315001228?via%3Dihub Development of an in vitro cytotoxicity model for aerosol exposure using 3D reconstructed human airway tissue; application for assessment of e-cigarette aerosol]=== | |||
*Despite being tested with a more intense puffing regime, e-cigarette aerosol showed no acute cytotoxicity in this study when compared with traditional 3R4F reference cigarette smoke. | |||
*Under the study conditions cigarette smoke demonstrated a dose-dependent response that resulted in near-complete cell death after a 6 h exposure period. In contrast, e-cigarette aerosol showed no decrease in tissue viability following a 6 h exposure, despite appropriate positive control responses. Furthermore, cytotoxicity appears to be unaffected by different e-cigarette formulations as tested in this study. | |||
*[https://sci-hub.se/10.1016/j.tiv.2015.05.018 PDF Version] | |||
*Citation: Neilson, L., Mankus, C., Thorne, D., Jackson, G., DeBay, J., & Meredith, C. (2015). Development of an in vitro cytotoxicity model for aerosol exposure using 3D reconstructed human airway tissue; application for assessment of e-cigarette aerosol. Toxicology in Vitro, 29(7), 1952–1962. doi:10.1016/j.tiv.2015.05.018 | |||
*Acknowledgement: Louise Neilson, David Thorne and Clive Meredith are employees of British American Tobacco. Courtney Mankus, Jason DeBay and George Jackson are employees of MatTek Corporation, USA. All work conducted was funded by British American Tobacco. | |||
===2014 [https://www.sciencedirect.com/science/article/pii/S0273230014002505?fbclid=IwAR0ivUs1bNfN2HGxl240LRHiCSB-EJ7xIhR4WNEQxZUgEKHGlAQ_RvNkHBU Comparison of select analytes in aerosol from e-cigarettes with smoke from conventional cigarettes and with ambient air]=== | |||
*No significant contribution of tested HPHC classes was found for the e-cigarettes. | |||
*[https://sci-hub.se/10.1016/j.yrtph.2014.10.010 PDF Version] | |||
*Citation: Tayyarah, R., & Long, G. A. (2014). Comparison of select analytes in aerosol from e-cigarettes with smoke from conventional cigarettes and with ambient air. Regulatory Toxicology and Pharmacology, 70(3), 704–710. doi:10.1016/j.yrtph.2014.10.010 | |||
*Acknowledgements: The company for which the study authors work and the companies that manufacture the e-cigarettes tested for this study are owned by the same parent company (Lorillard Tobacco Company) | |||
===2014 [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110871/ Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: a systematic review]=== | |||
*Existing evidence indicates that E-cigarette (EC) use is by far a less harmful alternative to smoking. There is no tobacco and no combustion involved in EC use; therefore, regular vapers may avoid several harmful toxic chemicals that are typically present in the smoke of tobacco cigarettes. Indeed, some toxic chemicals are released in the EC vapor as well, but their levels are substantially lower compared with tobacco smoke, and in some cases (such as nitrosamines) are comparable with the amounts found in pharmaceutical nicotine products. Surveys, clinical, chemistry and toxicology data have often been mispresented or misinterpreted by health authorities and tobacco regulators, in such a way that the potential for harmful consequences of EC use has been largely exaggerated. It is obvious that some residual risk associated with EC use may be present, but this is probably trivial compared with the devastating consequences of smoking. Moreover, ECs are recommended to smokers or former smokers only, as a substitute for conventional cigarettes or to prevent smoking relapse; thus, any risk should be estimated relative to the risk of continuing or relapsing back to smoking and the low efficacy of currently approved medications for smoking cessation should be taken into consideration…. | |||
*[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110871/pdf/10.1177_2042098614524430.pdf PDF Version] | |||
*Citation: Farsalinos KE, Polosa R. Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: a systematic review. Ther Adv Drug Saf. 2014 Apr;5(2):67-86. doi: 10.1177/2042098614524430. PMID: 25083263; PMCID: PMC4110871. | |||
*Acknowledegement: Riccardo Polosa is a Professor of Medicine and is supported by the University of Catania, Italy. He has received lecture fees and research funding from GlaxoSmithKline and Pfizer, manufacturers of stop smoking medications. He has also served as a consultant for Pfizer and Arbi Group Srl (Milano, Italy), the distributor of Categoria™ e-Cigarettes. His research on electronic cigarettes is currently supported by LIAF (Lega Italiana AntiFumo). | |||
*Acknowledgement: Konstantinos Farsalinos is a researcher at Onassis Cardiac Surgery Center. He has never been funded by the pharmaceutical or the tobacco industry. For some of his studies, the institution has received financial compensation from electronic cigarette companies for the studies’ cost. His salary is currently being paid by a scholarship grant from the Hellenic Society of Cardiology. | |||
===2014 [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4154473/ Levels of selected carcinogens and toxicants in vapor from electronic cigarettes]=== | |||
*The levels of potentially toxic compounds in e-cigarette vapor is from 9 to 450-fold lower than those in the smoke from conventional cigarettes, and in many cases comparable to the trace amounts present in pharmaceutical preparation (Note: Reference product was a medicinal nicotine inhaler.). Our findings support the idea that substituting tobacco cigarettes with electronic cigarettes may substantially reduce exposure to tobacco-specific toxicants. | |||
*[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4154473/pdf/nihms-624084.pdf PDF Version] | |||
*Citation: Goniewicz ML, Knysak J, Gawron M, Kosmider L, Sobczak A, Kurek J, Prokopowicz A, Jablonska-Czapla M, Rosik-Dulewska C, Havel C, Jacob P 3rd, Benowitz N. Levels of selected carcinogens and toxicants in vapour from electronic cigarettes. Tob Control. 2014 Mar;23(2):133-9. doi: 10.1136/tobaccocontrol-2012-050859. Epub 2013 Mar 6. PMID: 23467656; PMCID: PMC4154473. | |||
*Acknowledgement: This study was conducted while the first author was at Medical University of Silesia, Poland and was supported by | |||
the Ministry of Science and Higher Education of Poland under grant number N N404 025638. Analysis of nitrosamines at the University of California, | |||
San Francisco was supported by grants P30 DA012393 and S10 RR026437 from the National Institutes of Health. | |||
===2014 [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4481723/ Evaluation of Toxicant and Carcinogen Metabolites in the Urine of E-Cigarette Users Versus Cigarette Smokers]=== | |||
*With respect to the compounds analyzed here, e-cigarettes have a more favorable toxicity profile than tobacco cigarettes. | |||
*[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4481723/pdf/ntu218.pdf PDF Version] | |||
*Citation: Hecht SS, Carmella SG, Kotandeniya D, Pillsbury ME, Chen M, Ransom BW, Vogel RI, Thompson E, Murphy SE, Hatsukami DK. Evaluation of toxicant and carcinogen metabolites in the urine of e-cigarette users versus cigarette smokers. Nicotine Tob Res. 2015 Jun;17(6):704-9. doi: 10.1093/ntr/ntu218. Epub 2014 Oct 21. PMID: 25335945; PMCID: PMC4481723. | |||
*Acknowledgement: This work was supported by the National Cancer Institute at the National Institutes of Health (R01 CA081301, U19 CA157345, and CA77598). | |||
===2013 Cytotoxicity evaluation of electronic cigarette (EC) vapor extract on cultured mammalian fibroblasts (ClearStream-LIFE): comparison with tobacco cigarette smoke (CS) extract | |||
*This study indicates that EC vapor is significantly less cytotoxic compared to tobacco CS. | |||
==ENDS (without comparison to other products)== | ==ENDS (without comparison to other products)== | ||