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How e-cigarettes should be regulated



Jean-François ETTER, PhD
Associate Professor
Faculty of Medicine
University of Geneva, Switzerland
Jean-Francois.Etter@unige.ch



E-cigarette Summit, London



November 12, 2013
Disclosure


Tobacco industry:
- never received any funding
- no conflict of interest



Pharmaceutical industry
- no funding in past 7 years
- no conflict of interest



E-cigarette industry
- plane tickets + hotel (London + China)
Outline



How should e-cigarettes be regulated
- regulation today (USA, UK, EU)
- future regulation
… as tobacco products ?
… as medications ?
… as consumer products ?
… as a specific category ?
Summary of evidence
1.

E-cigarettes are used by current and former smokers, as a cheaper and
safer alternative to tobacco

2.

Most users report that e-cigs help them quit or reduce smoking

3.

Regular or daily use in non-smokers has not been documented so far

4.

E-cigs are less addictive and less toxic than cigarettes

Sources:
1)
Cho.
J Adol Health.
2011
Choi.
Am J Public Health.
2013
Corey
MMWR
2013
Dockrell
Nic Tob Res
2013
Douptcheva
J Epidemio Comm H
2013
Goniewicz.
Pediatrics.
2012
King.
Nicotine Tob Res.
2013
McMillen.
J Environ Public H
2012
Pearson
Am J Public Health
2012
Regan
Tob Control
2011
Sutfin
Drug Alc Depend
2013
2)
Etter (2010), BMC Public Health, 10, 231.
Siegel (2011), American Journal of Preventive Medicine, 40, 472-5.
Etter (2011), Addiction, 106, 2017-28.
Foulds (2011) International Journal of Clinical Practice, 65, 1037-42.
Goniewicz (2013), Drug and Alcohol Review, 32, 133-140.
Dawkins. (2013) Addiction.
Kralikova (2013), Chest.
Farsalinos (2013), Int J Environ Res and Public Health, 10, 2500-14.
3) Douptcheva et al. J Epidemiol Comm Health. 2013; Zhu et al. PLOS One. Oct 2013; ASH-UK. 2013
4) On addictiveness of e-cigs: Foulds Int J Clin Pract 2011, Goniewicz Drug Alc Rev 2013, Dawkins Addiction 2013, Farsalinos IJERPH 2013
Regulation: aims



Aims:
- decrease the number of cases of disease and death
(which are mainly caused by smoked tobacco)
- protect the freedom of citizens



Should cover not just e-cigs but also ‘next generation’ products
Regulation


E-cigs are mostly regulated as consumer products or tobacco,
seldom regulated as medicines



EU + FDA regulation will be extraordinarily influential + important
Once written, these laws will be very hard to change



In each country, regulation will differ because it will depend on specific :
- stage of the tobacco epidemic
- history of tobacco regulation
- political process, weight of lobbies
- stage of development of the e-cig market
Regulation: USA


Currently :
- FDA cannot regulate e-cigs as drugs : court decision Sottera 2010
- FDA regulates all non-medicinal nicotine as tobacco : FSPTCA 2009
- E-cigs are currently largely unregulated at federal level
- State and local regulations (bans in public places, sales to <18 yr)



FDA «deeming regulation» proposal due November 2013, forecast :
- ban sales + advertising to minors
- limit advertising
- ban most flavors ?
- ban Internet sales ?
- require approbation for new products ?
Regulation: UK


Medicines and Healthcare products Regulatory Agency (MHRA)



MHRA public consultation, published in 2011



MHRA announced (2013) that the UK Government will regulate e-cigs
as medicines



Rationale: to improve product safety, quality and efficacy



There is no such thing as “light touch” regulation



By asking MHRA (rather than any other agency) to propose e-cig
regulation, one could expect this outcome



Impact of EU directive on UK decision ?
Regulation: European Union (EU)


Tobacco Products Directive: article 18



EU Parliament (October 8)
- prohibits sales to minors
- restrictions on advertising and sponsorship
- rejects proposal to regulate e-cigs as medicines



Vote on medicines regulation was close (article 18, amendment 170):
- for: 386
- against: 283
- required to pass: 335



Trialogue
- the Council and Commission are in favor of the medicines regulation
- many member States want tighter regulation than EU Parliament
Regulation



Intensive lobbying of FDA + EU Parliament + national governments



Unprecedented lobbying by vapers, e-cig industry



In general, governments + parliaments are excessively responsive to
special interests, rather than to the general interest



As a result, almost any regulation will favor those who are best at
lobbying (Big Tobacco, Big Pharma) and detrimental to those less
present (Chinese inventors + manufacturers)



Even before they have been drafted, financial analysts have said that
future regulations may be favorable to Big Tobacco
- best expertise in regulatory environment
- treasure trove
- lists of customers, mandatory shelf space in shops
Nicotine : only in smoked tobacco or
in medications


Currently, nicotine is available either in :
- smoked tobacco (smokeless banned in many countries)
- medications (patch, gum, etc.)



For public health, this approach is largely a failure



The most deadly product is cheap + available everywhere



Nicotine replacement therapy
- not very appealing
- not very effective in the long term (increases smoking cessation
rates by a few percentage points only)



The success of e-cigs challenges this approach



The regulation of nicotine needs to be rethinked, but how ?
Regulation as a tobacco product


Aim:
- to offer consumers the same level of protection as for tobacco products



Bans in public places



Restrictions on advertisements, marketing



Sale restrictions to minors



Content, additives
Problems with tobacco regulation


E-cigs do not contain tobacco
(even though nicotine is extracted from tobacco)



Current measures used to control tobacco are excessive,
disproportionate if applied to e-cigarettes



Bans in public places
- would require stronger evidence that passive vaping is toxic and
- that vaping in public encourages smoking



Advertising bans
- would require stronger evidence that e-cigs are toxic
- no evidence that non-smokers become regular users
- consumers have a right to be informed by advertisements



Sale restrictions to minors who smoke
- minors can buy nicotine gums, patches
- e-cigs may protect both minors and adults against smoking
Regulation as a medicine



Aim:
to give consumers the same level of protection as for medicines
- efficacy
- safety, toxicity
- quality requirements
- stability of the product
- protect young non-smokers, «gateway» (advertising, age limits)
Problems with medicines regulation
(in most, but perhaps not all countries)


No therapeutic claim: e-cigs are not medicines



Medicines regulation has been and will be challenged in court



Inequality with tobacco (makes e-cigs less competitive)



Costs associated with obtaining drug approval



Prices will increase



Administrative barriers (application = 10,000 pages)



Only large companies will survive (Big Tobacco + Big Pharma if they
step in)



Many products, manufacturers and retailers will disappear, in particular
Chinese ones
Potential problems with medicines
regulation (2)


Will kill innovation
e.g. nicotine gum + patch ‘frozen’ in same stage as when they were
first approved, in the 1970s + 1980s



If flavors are banned, e-cigs will attract fewer smokers



Maximum levels of nicotine in liquids: arbitrary, not evidence-based



Excessive restrictions on marketing, advertisement



Bans of unlicensed products
- incompatible with quality control
- banned products cannot be taxed
- enforcement will be costly and ineffective



Internet sales will continue



Black market
Potential problems with medicines
regulation (3)


Contrary to constitutional free market principles : unnecessarily
excludes a competitor



Lack of popular support: not viable in democracy



Unduly protects Big Pharma, which has not been innovative in NRT



Fewer e-cig users = more smokers, more healthcare costs

2 main consequences of tobacco or medicines regulations :


Fewer users, fewer smokers will quit, more will die



Gives the entire e-cig market to Big Tobacco ?
Regulation as a consumer product


Aims:
offer consumer the same protection as for many other consumer
products, including food, cosmetics, chemicals, electrical devices, etc.



Several EU Directives + national laws already apply to e-cigs :
- safety
- RAPEX system (alerts)
- chemical safety (hazardous substances: RoHS Directive)
- electrical safety
- packaging, labeling
- weights and measures
- commercial practice (advertising, Internet)
- data protection



Source: C. Bates, G. Stimson. Costs and burdens of medicines regulation for e-cigarettes.
September 2013
Is regulation as a consumer product
sufficient?


First, apply and enforce existing laws and EU Directives



If necessary, create a specific category or specific norms for recreational
nicotine products (i.e. e-cigs + ‘next generation’ products):
- manufacturing process, components, e-liquid content
- advertisement
- sales to minors



This does not require regulation of e-cigs as medicines or tobacco



Create a tax on e-cigs, earmarked for
- research
- education of the public, Drs, journalists, policy makers, legislators
Conclusions (1)



E-cigs = major innovation that has the potential to save many lives



Regulation : balance public health impact vs. risks



Relative risk is relevant, compared with cigarettes, not absolute risk,
e-cigs don’t need to be 100% safe, only 99% or 99.9% safer than cigarettes



Regulation as medicines or tobacco : disproportionate



Prohibition of unlicensed products: not feasible, nor desirable



Main danger for public health = excessive regulation, not e-cigs
Conclusions (2)



Current laws cannot survive, which allow nicotine only
in tobacco (deadly when smoked) and in medications (gum, patch)



Laws need to change, to accommodate this very popular product and
also ‘next generation’ products



One of the most important public health debates in recent decades:

To redefine the place of nicotine in society and in the law,
and make room for recreational nicotine products

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How E-Cigarettes Should Be Regulated as Consumer Products

  • 1. How e-cigarettes should be regulated  Jean-François ETTER, PhD Associate Professor Faculty of Medicine University of Geneva, Switzerland Jean-Francois.Etter@unige.ch  E-cigarette Summit, London  November 12, 2013
  • 2. Disclosure  Tobacco industry: - never received any funding - no conflict of interest  Pharmaceutical industry - no funding in past 7 years - no conflict of interest  E-cigarette industry - plane tickets + hotel (London + China)
  • 3. Outline  How should e-cigarettes be regulated - regulation today (USA, UK, EU) - future regulation … as tobacco products ? … as medications ? … as consumer products ? … as a specific category ?
  • 4. Summary of evidence 1. E-cigarettes are used by current and former smokers, as a cheaper and safer alternative to tobacco 2. Most users report that e-cigs help them quit or reduce smoking 3. Regular or daily use in non-smokers has not been documented so far 4. E-cigs are less addictive and less toxic than cigarettes Sources: 1) Cho. J Adol Health. 2011 Choi. Am J Public Health. 2013 Corey MMWR 2013 Dockrell Nic Tob Res 2013 Douptcheva J Epidemio Comm H 2013 Goniewicz. Pediatrics. 2012 King. Nicotine Tob Res. 2013 McMillen. J Environ Public H 2012 Pearson Am J Public Health 2012 Regan Tob Control 2011 Sutfin Drug Alc Depend 2013 2) Etter (2010), BMC Public Health, 10, 231. Siegel (2011), American Journal of Preventive Medicine, 40, 472-5. Etter (2011), Addiction, 106, 2017-28. Foulds (2011) International Journal of Clinical Practice, 65, 1037-42. Goniewicz (2013), Drug and Alcohol Review, 32, 133-140. Dawkins. (2013) Addiction. Kralikova (2013), Chest. Farsalinos (2013), Int J Environ Res and Public Health, 10, 2500-14. 3) Douptcheva et al. J Epidemiol Comm Health. 2013; Zhu et al. PLOS One. Oct 2013; ASH-UK. 2013 4) On addictiveness of e-cigs: Foulds Int J Clin Pract 2011, Goniewicz Drug Alc Rev 2013, Dawkins Addiction 2013, Farsalinos IJERPH 2013
  • 5. Regulation: aims  Aims: - decrease the number of cases of disease and death (which are mainly caused by smoked tobacco) - protect the freedom of citizens  Should cover not just e-cigs but also ‘next generation’ products
  • 6. Regulation  E-cigs are mostly regulated as consumer products or tobacco, seldom regulated as medicines  EU + FDA regulation will be extraordinarily influential + important Once written, these laws will be very hard to change  In each country, regulation will differ because it will depend on specific : - stage of the tobacco epidemic - history of tobacco regulation - political process, weight of lobbies - stage of development of the e-cig market
  • 7. Regulation: USA  Currently : - FDA cannot regulate e-cigs as drugs : court decision Sottera 2010 - FDA regulates all non-medicinal nicotine as tobacco : FSPTCA 2009 - E-cigs are currently largely unregulated at federal level - State and local regulations (bans in public places, sales to <18 yr)  FDA «deeming regulation» proposal due November 2013, forecast : - ban sales + advertising to minors - limit advertising - ban most flavors ? - ban Internet sales ? - require approbation for new products ?
  • 8. Regulation: UK  Medicines and Healthcare products Regulatory Agency (MHRA)  MHRA public consultation, published in 2011  MHRA announced (2013) that the UK Government will regulate e-cigs as medicines  Rationale: to improve product safety, quality and efficacy  There is no such thing as “light touch” regulation  By asking MHRA (rather than any other agency) to propose e-cig regulation, one could expect this outcome  Impact of EU directive on UK decision ?
  • 9. Regulation: European Union (EU)  Tobacco Products Directive: article 18  EU Parliament (October 8) - prohibits sales to minors - restrictions on advertising and sponsorship - rejects proposal to regulate e-cigs as medicines  Vote on medicines regulation was close (article 18, amendment 170): - for: 386 - against: 283 - required to pass: 335  Trialogue - the Council and Commission are in favor of the medicines regulation - many member States want tighter regulation than EU Parliament
  • 10. Regulation  Intensive lobbying of FDA + EU Parliament + national governments  Unprecedented lobbying by vapers, e-cig industry  In general, governments + parliaments are excessively responsive to special interests, rather than to the general interest  As a result, almost any regulation will favor those who are best at lobbying (Big Tobacco, Big Pharma) and detrimental to those less present (Chinese inventors + manufacturers)  Even before they have been drafted, financial analysts have said that future regulations may be favorable to Big Tobacco - best expertise in regulatory environment - treasure trove - lists of customers, mandatory shelf space in shops
  • 11. Nicotine : only in smoked tobacco or in medications  Currently, nicotine is available either in : - smoked tobacco (smokeless banned in many countries) - medications (patch, gum, etc.)  For public health, this approach is largely a failure  The most deadly product is cheap + available everywhere  Nicotine replacement therapy - not very appealing - not very effective in the long term (increases smoking cessation rates by a few percentage points only)  The success of e-cigs challenges this approach  The regulation of nicotine needs to be rethinked, but how ?
  • 12. Regulation as a tobacco product  Aim: - to offer consumers the same level of protection as for tobacco products  Bans in public places  Restrictions on advertisements, marketing  Sale restrictions to minors  Content, additives
  • 13. Problems with tobacco regulation  E-cigs do not contain tobacco (even though nicotine is extracted from tobacco)  Current measures used to control tobacco are excessive, disproportionate if applied to e-cigarettes  Bans in public places - would require stronger evidence that passive vaping is toxic and - that vaping in public encourages smoking  Advertising bans - would require stronger evidence that e-cigs are toxic - no evidence that non-smokers become regular users - consumers have a right to be informed by advertisements  Sale restrictions to minors who smoke - minors can buy nicotine gums, patches - e-cigs may protect both minors and adults against smoking
  • 14. Regulation as a medicine  Aim: to give consumers the same level of protection as for medicines - efficacy - safety, toxicity - quality requirements - stability of the product - protect young non-smokers, «gateway» (advertising, age limits)
  • 15. Problems with medicines regulation (in most, but perhaps not all countries)  No therapeutic claim: e-cigs are not medicines  Medicines regulation has been and will be challenged in court  Inequality with tobacco (makes e-cigs less competitive)  Costs associated with obtaining drug approval  Prices will increase  Administrative barriers (application = 10,000 pages)  Only large companies will survive (Big Tobacco + Big Pharma if they step in)  Many products, manufacturers and retailers will disappear, in particular Chinese ones
  • 16. Potential problems with medicines regulation (2)  Will kill innovation e.g. nicotine gum + patch ‘frozen’ in same stage as when they were first approved, in the 1970s + 1980s  If flavors are banned, e-cigs will attract fewer smokers  Maximum levels of nicotine in liquids: arbitrary, not evidence-based  Excessive restrictions on marketing, advertisement  Bans of unlicensed products - incompatible with quality control - banned products cannot be taxed - enforcement will be costly and ineffective  Internet sales will continue  Black market
  • 17. Potential problems with medicines regulation (3)  Contrary to constitutional free market principles : unnecessarily excludes a competitor  Lack of popular support: not viable in democracy  Unduly protects Big Pharma, which has not been innovative in NRT  Fewer e-cig users = more smokers, more healthcare costs 2 main consequences of tobacco or medicines regulations :  Fewer users, fewer smokers will quit, more will die  Gives the entire e-cig market to Big Tobacco ?
  • 18. Regulation as a consumer product  Aims: offer consumer the same protection as for many other consumer products, including food, cosmetics, chemicals, electrical devices, etc.  Several EU Directives + national laws already apply to e-cigs : - safety - RAPEX system (alerts) - chemical safety (hazardous substances: RoHS Directive) - electrical safety - packaging, labeling - weights and measures - commercial practice (advertising, Internet) - data protection  Source: C. Bates, G. Stimson. Costs and burdens of medicines regulation for e-cigarettes. September 2013
  • 19. Is regulation as a consumer product sufficient?  First, apply and enforce existing laws and EU Directives  If necessary, create a specific category or specific norms for recreational nicotine products (i.e. e-cigs + ‘next generation’ products): - manufacturing process, components, e-liquid content - advertisement - sales to minors  This does not require regulation of e-cigs as medicines or tobacco  Create a tax on e-cigs, earmarked for - research - education of the public, Drs, journalists, policy makers, legislators
  • 20. Conclusions (1)  E-cigs = major innovation that has the potential to save many lives  Regulation : balance public health impact vs. risks  Relative risk is relevant, compared with cigarettes, not absolute risk, e-cigs don’t need to be 100% safe, only 99% or 99.9% safer than cigarettes  Regulation as medicines or tobacco : disproportionate  Prohibition of unlicensed products: not feasible, nor desirable  Main danger for public health = excessive regulation, not e-cigs
  • 21. Conclusions (2)  Current laws cannot survive, which allow nicotine only in tobacco (deadly when smoked) and in medications (gum, patch)  Laws need to change, to accommodate this very popular product and also ‘next generation’ products  One of the most important public health debates in recent decades: To redefine the place of nicotine in society and in the law, and make room for recreational nicotine products