Competent or careless? Directions in European policy on low-risk nicotine products
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Presentation to ENDS conference, 20 April 2021. Discussion of (1) the threat posed by upcoming EU regulatory developments on tobacco/nicotine; (2) the importance of understanding the underlying public health model; (3) the danger of perverse unintended consequences; (4) the adolescent vaping narrative and what is wrong with it; (5) the proactive alternative - risk-proportionate regulation.
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Competent or careless? Directions in European policy on low-risk nicotine products
- 1. 1 Competent or careless? Directions in European policy on low-risk nicotine products Clive Bates Counterfactual Consulting 20 April 2021
- 2. Five messages 1. The threat 2
- 3. Europe’s beating cancer plan – February 2021 • Commission will continue to prioritise protecting young people from the harmful effects of tobacco and related products • Decisive action will be taken by reviewing the Tobacco Products Directive, the Tobacco Taxation Directive and • The legal framework on cross-border purchases of tobacco by private individuals. • This includes working in full transparency towards plain packaging and a full ban on flavours, using existing EU agencies to improve the assessment of ingredients, • Tackling tobacco advertising, promotion and sponsorship on the internet and social media. • Update Council Recommendation on SmokeFree Environments both extending its coverage to emerging products, such as e-cigarettes and heated tobacco products, and expanding smoke-free environments, including outdoor spaces. • In addition, the EU track and trace system will be extended to all tobacco products by 2024. 3
- 4. European legislative developments 4 Tobacco Excise Directive 2011/64/EU Tobacco Advertising Directive 2003/33/EC • Inclusion of more products • Minimum excise levels • Choice of tax base • Maximums and differentials? • No change in sight Tobacco Products Directive 2014/40/EC • Flavours and Ingredients • Nicotine • Medicalisation • No relaxation of bad regulation 4Q 2021 or 1Q 2022 Mid-2022 Not applicable
- 5. Tax posture – 5 elements 5 1. No tax justified 2. Zero minimum rate 3. Maximum 4. Tax base: mg nicotine? 5. Cigarette equivalence factor
- 6. Tobacco Products Directive 2014/40/EU Article 20 (1) Medical Medicines Directive 2001/83/EC Medical Devices Directive 93/42/EEC Consumer Tobacco Products Directive Article 20 ( 2-13) Pathways for ENDS in the Tobacco Products Directive 6
- 7. Five messages 1. The threat 2. The public health model 7
- 8. The public health mechanism 8
- 9. Smoking cessation vs consumer alternative 9
- 10. The public health mechanism is not “smoking cessation medication” Harm reduction = Reduced risk x Number who switch Product toxicity & other risks Proportion who succeed Who tries and how many Harm reduction equation (simplified) Appeal and user choice 10
- 11. The public health mechanism: consumer “value propositions” – the 7 Ps Value Price Promotion Place Product Positioning People Packaging 11 Adapted from: Bitner MJ, Booms BH (1981). Marketing Strategies and Organization Structure for Service Firms. Conference Proceedings: American Marketing Association, Chicago, IL,.
- 12. The public health mechanism: rival “value propositions” Tobacco control Smoking Price Promotion Place Product Positioning People Packaging Degrade the value Tobacco harm reduction Enhance the value to smokers 12
- 13. 2. The public health mechanism: rival “value propositions” Tobacco control Smoking Price Promotion Place Product Positioning People Packaging Degrade the value Tobacco control Degrade the value to everyone 13
- 14. Evidence for beneficial population effect ‘triangulates’ • Also, user testimony • And… it is what you would expect!! 14 Professor Robert West, UCL. Presentation at SRNT-Europe 2019
- 15. Five messages 1. The threat 2. The public health model 3. The unintended consequences 15
- 16. …if a risk-averse, precautionary approach makes e-cigarettes: • less easily accessible • less palatable or acceptable • more expensive • less consumer friendly • pharmacologically less effective • inhibits innovation … …then it causes harm by perpetuating smoking. Royal College of Physicians – unintended consequences 16 Royal College of Physicians. Nicotine without smoke: tobacco harm reduction London: RCP; 2016.
- 17. Taxing economic substitutes 17 … implementing differential taxes on nicotine-yielding products on the basis of degree of risk could substantially expedite the move away from cigarette smoking Chaloupka FJ, Sweanor D, Warner KE. Differential Taxes for Differential Risks — Toward Reduced Harm from Nicotine-Yielding Products. N Engl J Med 2015;373(7):594–597.
- 18. 18 High e-cigarette tax More smokers Pesko MF, Courtemanche CJ, Maclean JC. The effects of traditional cigarette and e-cigarette tax rates on adult tobacco product use. J Risk Uncertain 2020
- 19. 19
- 20. 20 Highlights • E-cigarette advertising on TV causes adult smokers to quit. • A ban on these ads would have reduced the number of smokers who quit by 3%. • A more relaxed regulatory environment might have increased the quit rate by 10%. Dave D, Dench D, Grossman M, Kenkel DS, Saffer H. Does e-cigarette advertising encourage adult smokers to quit? J Health Econ ];68:102227.
- 21. 21 Don’t be socially irresponsible Don’t target or feature children Don’t confuse e-cigarettes with tobacco products Don’t make health or safety claims Don’t make smoking cessation claims Don’t mislead about product ingredients Don’t mislead about where products may be use Set standards avoid bans
- 23. Perverse consequences: flavour bans Tobacco Fruit Dessert or pastry Choc, sweets Russell et al. vaping flavour preferences Russell C, et al. Changing patterns of first e-cigarette flavor used and current flavors used by 20,836 adult frequent e-cigarette users in the USA. Harm Reduct J. BioMed Central; 2018 23
- 24. CDC, Tobacco Product Use and Associated Factors Among Middle and High School Students — United States, 2019, Table 6 (simplified) Reasons for e-cigarette use among middle and high school students who reported using e-cigarettes and other tobacco products during the past 30 days Reason given for vaping Use e-cigarettes only Use e- cigarettes and other tobacco products I was curious about them 56.1% 38.4 % Friend or family member used them 23.9% 22.2% They are available in flavors, such as mint, candy, fruit, or chocolate 22.3% 26.6 % I can use them to do tricks 22.0% 29.0% They are less harmful than other forms of tobacco, such as cigarettes 17.2% 19.1% Adolescents are curious 24
- 25. Possible consequences – a flavour ban • The intended outcome - abstinence from nicotine and not adopting any other risk behaviour • Using tobacco flavoured vape products instead of other flavoured products • Accessing flavoured vapes via an illicit supply chain (a black market) • Relapsing back from vaping to smoking – both teenagers and adults • Not switching from smoking to vaping and continuing to smoke • Continuing to smoke or to start smoking as an adolescent because parents or adult role models smoke instead of vaping • Using other tobacco or nicotine products – hand-rolling tobacco, smokeless tobacco, heated tobacco, or new nicotine pouches • Buying from foreign suppliers in person or via the internet and importing for personal use • Buying from foreign suppliers to resell to others through informal networks • Making and mixing their own flavours at home or buying or selling home-mixed flavours • Using vapes that are made to look tobacco flavoured but have other flavours • Using flavour agents for food, drink or aromatherapy for adding to unflavoured nicotine liquids • Using flavours made for vaping but ostensibly marketed for another purpose • Switching to cannabinoid (THC or CBD) vapes • Initiating smoking instead of initiating vaping • Adopting another risk behaviour that may be worse 25
- 26. Five messages 1. The threat 2. The public health model 3. The unintended consequences 4. Concern about teenage vaping 26
- 27. UK experience 27 Low levels of regular youth vaping ASH / YouGov surveys 2013-2020
- 28. UK experience 28 Vaping concentrated in young smokers (black bars) ASH / YouGov survey 2020
- 29. Youth smoking has fallen rapidly 29 Rate of decline post-2010 is 4 times greater than 1975- 2010 3 times
- 30. Youth risk behaviors in context – United States 2017 0.0 5.0 10.0 15.0 20.0 25.0 30.0 35.0 E-cigarette Smoking any combusible tobacco Marijuana Alcohol Binge drinking Drink driver riding as passenger Carried a weapon Texting while driving Percentage of high school students Past 30 day prevalence – high school students NYTS and YRBS 2019 2018 2017 2020 Kann L, McManus T, Harris WA, et al. Youth Risk Behavior Surveillance — United States, 2017. MMWR Surveill Summ 2018;67(No. SS-8):1–114. * Refers to driver or passengers riding in vehicles where the driver had been drinking.
- 32. Five messages 1. The threat 2. The public health model 3. The unintended consequences 4. Concern about teenage vaping 5. Risk proportionate regulation 32
- 33. Risk-Proportionate Regulation Measure Cigarettes, hand-rolling tobacco and other combustibles Vaping, heated tobacco smokeless and oral nicotine Taxation Relatively high taxes Low or zero tax (sales tax only) Illicit trade Track and trace (FCTC protocol) Complaint-driven Advertising Prohibit other than within trade Control themes and placement Warnings Graphic warnings depicting disease Messages encouraging switching Public places Legally mandated controls Up to the discretion of the owner Plain packaging Yes No Ingredients Control reward-enhancing additives Blacklist material health hazards Flavours Prohibit Allow, subject to health hazards Flavour descriptors Not applicable if flavours banned Control appeal to youth/trademarks Age restrictions No sales to under-21s No sales to under-18s Internet sales Banned Permitted with age controls Product standards Control risks and reduce appeal Control risks 33
- 34. Five messages 1. The threat 2. The public health model 3. The unintended consequences 4. Concern about teenage vaping 5. Risk proportionate regulation 34
- 35. 35 Thank you Clive Bates Counterfactual Consulting @clive_bates clivedbates@gmail.com 20 April 2021
Editor's Notes
- Don’t worry if you aren’t mathematical… this is just codifying common sense…. The simple idea is that a the impact of reduced risk alternative to cigarettes is the risk reduction per user multiplied by the number of users who switch. Both terms are important. The first term is really determined by toxic exposure arising from continued nicotine use – a product characteristic. For e-cigs and snus this is 95-99% - at least 20-fold improvement… The second term is why we don’t want to be too prescriptive and end up dissuading people from take the 95-99% reduction and carrying on with the greatest danger. That’s why alarm bells should ring when there are plans to restrict reduced risk only to the ‘cleanest and safest’ - or there are plans to ban things that might make these products attractive – like flavourings – or to have regulators control ingredients – or attempt to remove all residual toxins (some of which might be important for flavour) The consumer and mechanisms of market competition should be the primary driver of what makes these products attractive – not regulators who may insist they are safe at the expense of making them less attractive [The equation could be elaborated to have a second term… those that use the reduced risk products who would otherwise have stopped completely. Not shown here because the residual risk is so low – the reduced risk products are not that much difference to quitting completely].