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Ends in Europe Research and Legislation

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Constantine Vardavas

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Ends in Europe Research and Legislation

  1. 1. ENDS IN EUROPE RESEARCH AND LEGISLATION CONSTANTINE VARDAVAS MD, RN, MPH, PhD, FCCP
  2. 2. DECLARATION  No conflicts of interest to declare.  All positions are personal.  Funding has been provided through  European Commission’s 3rd Health programme (2014-2020)  European Commission’s Horizon2020 Research and Innovation Programme. All information on this slides is in public domain. The content/interpretation of these slides are my own and may not necessarily reflect the views of the European Commission. This research has received funding from the European Union’s Horizon2020 research and innovation programme under grant agreement No 681109
  3. 3. E-CIGARETTES IN 2018
  4. 4. NICOTINE PRODUCT EVOLUTION
  5. 5. PRODUCT EVOLUTION
  6. 6. DIFFERENT “VIRUS” – DIFFERENT EPIDEMIOLOGY Nicotine containing products have evolved over the past few years into different subcategories • modes of transition • risk-benefit, • epidemiology, • high risk groups • “infectivity” (addictive potential) • social contagion Just as different viruses effect different target organs, cells due to a number of factors: susceptibility, proximity, Different tobacco types effect different “cells” and “organs” within a society.
  7. 7. “CLASSICAL” STAGES OF THE TOBACCO EPIDEMIC
  8. 8. EVOLUTION OF THE GLOBAL TOBACCO EPIDEMIC Type 1 Oral tobacco and Cigarettes Type 2 Dual use Type 3 Modified Risk Tobacco Products Vardavas & Agaku in “The Tobacco Epidemic-2nd edition” 2015 Karger. Editor(s): Loddenkemper R, Kreuter M
  9. 9. THE EU AND THE TOBACCO EPIDEMIC 28 EU MS, 508 million people Premature deaths in the EU per year 700,000 Current burden to public health care: 25 billion per year Productivity losses: 8 billion per year.
  10. 10. TOBACCO PRODUCTS DIRECTIVE The Tobacco Products Directive provides a mandate for stronger regulation of the manufacture, marketing and sales of tobacco products, ingredients, additives, disclosure to the public, oral tobacco and e-cigarettes. “… will improve the functioning of the internal market for tobacco and related products, while ensuring a high level of health protection for European citizens” Article 20 “The Member States shall ensure that electronic cigarettes and refill containers are only placed on the market if they comply with this Directive and with all other relevant Union legislation.” Commission Implementing Decision (EU) 2016/586 of 14 April 2016 on technical standards for the refill mechanism of electronic cigarettes The Council of the European Union. Revision of the tobacco products directive. Updated 2014. http://ec.europa.eu/health/tobacco/products/revision/ (accessed 14 Feb 2014).
  11. 11. EPIDEMIOLOGY
  12. 12. E-CIGARETTE USE IN EUROPE 84% 9% 4% 2% 1% You have never tried or uded them You have never tried them once or more You used to use them, but no longer do so You currently use e-cigarettes or similar electronic devices (e.g. e- shisha, e-pipe) Don’t know Nov.-Dec. 2014 – Mar. 2017 Base: All respondents, N= 27,901
  13. 13. REASONS FOR EXPERIMENTING (2017) 0 3 2 6 11 12 15 25 31 61 0 20 40 60 80 Don't know None (spontaneous) Other (spontanteous) They were cool or attractive Your friends used e-cigarettes You liked the flavours of e-cigarettes So you could vape in places where tobacco smoking is not allowed They were cheaper than tobacco You believed that vaping was less harmful than using tobacco To stop or reduce your tobacco consumption Base: Respondents who currently use or used e-cigarettes, N= 1,565
  14. 14. TRENDS OF E-CIGARETTE USE IN THE EU 2012-2017 1% 2% 3% 5% 7% 9% 0% 1% 2% 3% 4% 5% 6% 7% 8% 9% 10% 2012 2014 2017 Yes, you use or used it regurarly Yes, you tried it once or twice
  15. 15. This project has received funding from the European Union’s Horizon2020 research and innovation programme under grant agreement No 681109
  16. 16. This project has received funding from the European Union’s Horizon2020 research and innovation programme under grant agreement No 681109
  17. 17. This project has received funding from the European Union’s Horizon2020 research and innovation programme under grant agreement No 681109
  18. 18. TWO-YEAR TRENDS AND PREDICTORS OF E-CIGARETTE USE IN 27 EUROPEAN UNION MEMBER STATES.  Data from the 2012 (n=26 751) and 2014 (n=26 792) waves of the adult Special Eurobarometer for Tobacco survey.  The prevalence of ever use of e-cigarettes increased from 7.2% in 2012 to 11.6% in 2014 (adjusted OR (aOR)=1.91).  The perception that e-cigarettes are harmful increased from 27.1% in 2012 to 51.6% in 2014 (aOR=2.99), but there were major differences in prevalence and trends between member states.  18-24 year olds: OR 5.75 (5.11 to 6.47) This project has received funding from the European Union’s Horizon2020 research and innovation programme under grant agreement No 681109 Tob Control. 2017 Jan;26(1):98-104
  19. 19. States with and without laws prohibiting smoking and use of electronic nicotine delivery systems (ENDS) in indoor areas of private worksites, restaurants, and bars - United States, March 2016 No Comprehensive Smoke-Free Law or Prohibition on Indoor ENDS Use Prohibits Indoor Smoking and Indoor ENDS Use Prohibits Indoor Smoking Only D.C
  20. 20. FACTORS ASSOCIATED WITH SUPPORT FOR BANNING E-CIGARETTE USE IN PUBLIC PLACES IN EUROPE There is limited data on public support for banning e-cigarettes in public places  Support for indoor e-cigarette bans was lower among those who had ever used them  Believing e-cigarettes to be harmful was linked to increased support for such bans  Support for such bans was higher among never smokers than former/current smokers This project has received funding from the European Union’s Horizon2020 research and innovation programme under grant agreement No 681109
  21. 21. DESIGN AND MARKETING FEATURES INFLUENCING CHOICE OF E-CIGARETTES IN THE EU. 1. Taste (39.4%), price (39.2%) and amount of nicotine (27.3%) were the most commonly cited reasons for choosing their brand of e-cigarettes. 2. Health concerns were not commonly cited as a reason to use e-cigarettes. 3. Those aged 15–24 were more likely to cite  external packaging [aPR = 2.06, 95% CI 1.00–4.23)]  design features (aPR = 1.99, 1.20–3.29) as important. 4. Younger people were more likely to cite external packaging and design features of e-cigarettes as reasons to use them. This project has received funding from the European Union’s Horizon2020 research and innovation programme under grant agreement No 681109
  22. 22. Requirements of labelling and packaging in accordance with TPD
  23. 23. SAFETY AND QUALITY REQUIREMENTS FOR E-CIGARETTES The Directive sets a maximum nicotine concentration and volume for cartridges, tanks and nicotine liquid containers. E-cigarettes should be child-resistant and tamper evident and have a mechanism that allows refilling without spillage to protect consumers. E-cigarette ingredients must be of high purity and e-cigarettes should deliver the same amount of nicotine when puffed at the same strength and duration. Manufacturers and importers must notify all products they place on the EU market through a standardised electronic format.
  24. 24. PACKAGING AND LABELLING FOR E-CIGARETTES 1 Health warnings for e- cigarettes advising consumers that they contain nicotine and should not be used by non-smokers are mandatory. 2 Packaging must also include a list of ingredients contained in the product, information on the product's nicotine content 3 leaflet with instructions for use 4 Information on adverse effects. • risk groups, • Addictiveness • toxicity. 5 Promotional elements are not allowed on e-cigarette packaging. Cross-border advertising and promotion of e- cigarettes is prohibited.
  25. 25. PRODUCTS Evaluation of the top 5 best selling companies in 9 MS Evaluation of all products Purchase of random sample of products from each company (n=122) Pre vs. Post TPD study design Cohort and repeated cross sectional design
  26. 26. 85,2% 72,2% 86,1% 81,8% 87,6% 94,2% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Hazard sign Hazard info Tactile Pre Post Hazard information on the vials This project has received funding from the European Union’s Horizon2020 research and innovation programme under grant agreement No 681109
  27. 27. Warning labels evaluation on vials, external packing and leaflet of e- liquids 50,8% 50,8% 27,9% 11,5% 69,3% 75,9% 37,2% 27,7% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Hazard sign Hazard info Hazard text Tactile Pre Post p=0,03 p<0.001 p=0,001 Hazard information on the packaging This project has received funding from the European Union’s Horizon2020 research and innovation programme under grant agreement No 681109
  28. 28. Vial regulation and Child Safety- cigarettes p=0,05 p=0,022 p=0,002 p<0.001 85,2% 95,9% 93,3% 59,0% 95,6% 100,0% 100,0% 86,1% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Refill volume ≤10ml in vials Nicotine ≤20mg/ml Child proof Tamper proof Pre Post This project has received funding from the European Union’s Horizon2020 research and innovation programme under grant agreement No 681109
  29. 29. Technical design/safety features among e-cigarettes p=0,01 Refill mechanism requirements This project has received funding from the European Union’s Horizon2020 research and innovation programme under grant agreement No 681109
  30. 30. Leaflet, ingredients, health warning and sales 27,9% 58,4% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Inclusion of a leaflet Pre Post p<0.001 This project has received funding from the European Union’s Horizon2020 research and innovation programme under grant agreement No 681109 20(4)a: Member States shall ensure that unit packets of electronic cigarettes and refill containers include a leaflet with information on:
  31. 31. Leaflet 27,9% 37,4% 9,8% 27,9% 27,9% 25,4% 23,0% 27,9% 59,1% 46,0% 45,3% 56,9% 59,1% 54,7% 56,9% 56,9% 0% 10% 20% 30% 40% 50% 60% 70% Instructions Use and storage Instructions Not for young people Instructions Not for non- smokers Contraindications Warnings for specific risk group Possible adverse effects Addictiveness and toxicity Contact details of the manufacturer or importer p<0.001 p<0.001 p<0.001 p<0.001p<0.001 p<0.001 p<0.001
  32. 32. Warning Labels 33,6% 89,1% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Health warnings Pre Post p<0.001 This project has received funding from the European Union’s Horizon2020 research and innovation programme under grant agreement No 681109
  33. 33. “EXCEPT FOR NICOTINE, ONLY INGREDIENTS ARE USED IN THE NICOTINE-CONTAINING LIQUID THAT DO NOT POSE A RISK TO HUMAN HEALTH IN HEATED OR UNHEATED FORM” TPD Article 20(3)e,
  34. 34. POTENTIAL RESPIRATORY IRRITANTS This project has received funding from the European Union’s Horizon2020 research and innovation programme under grant agreement No 681109 Substance % positive Mean values (%, w/w) Maximum (%, w/w) Menthol 42.9% 0.116 0.4991 Ethyl maltol 37.5% 0.439 7.0960 Linalool 29.8% 0.044 0.2630 Methyl cyclopentanolone 26.3% 0.253 2.5067 Beta damascone 22.7% 0.006 0.0742 Ethyl vanillin 16.5% 0.108 0.9135 b-ionone 9.7% 0.002 0.0076 Ethyl hexanoate 9.1% 0.01 0.0554 a-ionone 8.7% 0.003 0.0120 Acetyl pyrazine 8.2% 0.036 0.1067 2,5 dimethylpyrazine 4.2% 0.005 0.0197 Alpha damascone 2.6 % 0.001 0.0078 3,4 dimethoxy benzaldehyde 1.9% 0.006 0.0359 Limonene 1.2% <0.0001 0.0001
  35. 35. INHALATION TOXICOLOGY  Qualitative analysis, 171 different compounds were detected.  Discrepancies in measured versus reported nicotine concentration were identified.  Forty-one (85.4%) of the most commonly detected compounds were registered with Warning GHS codes, eleven with Danger GHS codes and nine with both codes.  Of the total number of the detected compounds, 293 were attributable to fruits flavor, followed by tobacco flavor (204), non-alcoholic drinks (n=64), desserts–sweets (n=50), menthol – mint (n=42) and alcohol (n=39).  Menthol which is classified as a strong irritant to skin and eye, was the most frequently detected compound.  No samples tested positive for PAHs or nitrosamines.
  36. 36. OFFERING HELP TO QUIT TOBACCO USE
  37. 37. EUROBAROMETER 2017 1 4 1 5 10 11 75 0 20 40 60 80 Don't know Other (spontanteous) Oral tobacco (snus), chewing tobacco or nasal tobacco (snuff) Medical support or stop smoking services (such as a quitline) Electronic cigarettes or any similar device Nicotine replacement medications or other medications You stopped or you tried to stop without assistance Base: Respondents who used o smoke or have tried to stop, N= 9,430
  38. 38. IMPACT ON CESSATION – CONSUMPTION IN THE EU 2 5 59 13 7 14 1 6 52 17 10 14 0 20 40 60 80 Don't know No, actually increased tobacco consumption No, did not reduce tobacco consumption Yes, reduced tobacco consumption but you did not stop Yes, stopped smoking for a while but then started again Yes, stopped smoking completely Nov.-Dec. 2014 Mar. 2017 Base: Respondents who used smoke or used to smoke and have at least tried e-cigarettes, N= 3,612
  39. 39. CHANGE IN USE OF CESSATION AIDS
  40. 40. Lost opportunity for clinicians
  41. 41. Evidence based Tobacco Control Needs Data
  42. 42. Reporting requirements for e-cigarettes Manufacturers and importers must notify all products they place on the EU market through a standardised electronic format.
  43. 43. REPORTING REQUIREMENTS TOWARDS REGULATORS (ART 20.2) IT tool designed to ensure  uniform application of the reporting and notification obligations,  harmonise the submission of data,  facilitate comparison and  reduce administrative burden
  44. 44. REPORTING REQUIREMENTS  Divided into domains which correspond to different categories of information that is to be reported/notified.  Key variables – specific structure  Structuring of a reporting format as a tool to collect data that can be useful to regulators and increase the utility of the collected data  Adaptation from epidemiological research (outcomes, numeric responses etc)
  45. 45. 1. Submissions in production 50 Period Sept '16 Oct '16 Dec '16 March '17 Oct '17 Feb'18 July 2018 N° of industries submitting in production 41 127 522 787 1247 1362 1573 Tobacco products 378 2436 21612 23246 30366 34640 37939 E-cigarette products 1562 3888 73613 114033 159374 169975 185 635 Total number of products 1940 6324 95225 119787 189740 204615 223 574 Total number of submissions treated by the system 6653 29808 308198 499497 700791 1 142 322 1 366 262
  46. 46. 378 2436 21612 23246 30366 34640 37939 1562 3888 73613 114033 159374 169975 185635 0 20000 40000 60000 80000 100000 120000 140000 160000 180000 200000 Sept '16 Oct '16 Dec '16 March '17 Oct '17 Feb'18 July 2018 Tobacco products E-cigarette products
  47. 47. 499,497 submissions through the EU-CEG 171 variables (average 1-2 responses) 1 366 262 submissions 171 variables Per Year across 28 countries
  48. 48. THEORETICAL EXTRAPOLATION submissions through the E-CEG 171 variables (average 1-2 responses) 233,630,261 data entries / year + detailed pdfs on market data, toxicity, etc.
  49. 49. Joint Action on Tobacco Control The JATC is a collaborative action between the European Commission and the EU Member States built on evidence based tobacco control policies with the overarching aim to be implemented at a national, regional and European level in order to improve Public Health protection in the EU.
  50. 50. Next Steps forward
  51. 51. EVALUATING – MONITORING THE TOBACCO PRODUCTS DIRECTIVE 5 year follow up Monitoring Data Collection Re- evaluation Alteration of the legislation
  52. 52. THANK YOU

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