5. Regulation – how should governments handle reduced risk products?
- 5.1 Should e-cigarettes be banned?
- 5.2 Should e-cigarettes be regulated like cigarettes?
- 5.3 Should e-cigarettes be regulated as smoking cessation medicines with pharmaceutical regulation?
- 5.4 What is the right approach to regulating e-cigarettes?
- 5.5 What are the potential unintended consequences of vaping regulation?
- 5.6 Should different categories of vapour products like THC or nicotine salts be regulated in different ways?
- 5.7 Should regulators impose limits on the strength of nicotine in e-liquids?
- 5.8 Why does Juul use a high strength nicotine liquid in the US?
- 5.9 Should there be a special tax on e-cigarettes?
- 5.10 Does tobacco harm reduction undermine tobacco control?
5.1 Should e-cigarettes be banned?
No, absolutely not. This would prevent smokers (of any age) accessing much less risky alternatives to cigarettes, protect the cigarette trade from disruptive competition, and cause more disease and death. It would also put legitimate suppliers out of business, create a large black market and stimulate international internet trade. If nicotine is a legal drug, like alcohol or caffeine, then policymakers should be encouraging the least risky options to use it – not banning the safer alternatives to create a monopoly for the most dangerous nicotine products, cigarettes. Bans on e-cigarettes can be explicit prohibitions (as in India), implemented through poisons regulation (as in Australia), through classification as a medicine (Japan) or can be de facto prohibitions of essential elements of the product like bans on flavours (United States) or insurmountable evidential hurdles required for authorisation (United States).
There are multiple likely negative consequences arising from prohibition or de facto prohibition. These include:
- current vapers reverting to smoking
- current smokers not switching to vaping
- new users (adolescents) taking up smoking instead of vaping
- a boost for the cigarette trade as it benefits from reduced competition
- the development of widespread home DIY mixing
- the development of a black market in vaping products – with issues of quality and consumer rights and loss of regulatory supervision
- the enrichment of criminals and increase in crime
- the exposure of more people to criminal suppliers who also supply illicit drugs and other illegal commodities
- …and above all… the basic infringement of the liberty and autonomy or people to control their own risks, make their own pro-health decisions and to take their own initiatives to protect their own health at their own expense. On what basis does a government or public health activist intervene to stop that?
Policymakers and activists proposing prohibitions need to show that they have assessed the consequences listed above and concluded that the benefits outweigh these costs. Not a single state that has prohibited vaping has done this.
5.2 Should e-cigarettes be regulated like cigarettes?
No. Cigarettes are far more harmful than e-cigarettes and e-cigarettes can help people quit smoking. For these two reasons alone, the policy needs to take account of difference in risk and the potentially large benefits of e-cigarettes. The aim should be to use ‘risk proportionate’ regulation to encourage switching from cigarettes to e-cigarettes while controlling safety risks and preventing youth uptake of all tobacco and nicotine products. See 5.4 below.
5.3 Should e-cigarettes be regulated as smoking cessation medicines with pharmaceutical regulation?
No, do not do that. These products are not medicines. They work as consumer products – effective competitors to cigarettes rather than medicinal therapies for tobacco dependence. They are not medicines, the people using them do not see themselves as sick and many do not want to enter a healthcare setting. They are using these products as a lifestyle consumer choice and as a better alternative to cigarettes. The fundamental problem with medicine regulation is that ‘appeal’, which is the key to the success of vaping as a consumer rival to smoking, becomes ‘abuse liability’ in the regulatory framework for medicines.
5.4 What is the right approach to regulating e-cigarettes?
Regulation of tobacco and nicotine products should be “risk-proportionate” – with more stringent controls placed on the highest risk products. This means (in brief) a regulatory agenda as follows:
|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|
|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|
5.5 What are the potential unintended consequences of vaping regulation?
The danger is that excessive regulation will make vaping (or heated, smokeless or oral nicotine products) relatively less attractive to nicotine users compared to cigarettes. Poorly designed regulation has the potential to shift the calculations of users in favour of more harmful products. As the Royal College of Physicians said in its 2016 report, Nicotine without smoke: tobacco harm reduction:
However, if [a risk-averse, precautionary approach to e-cigarette regulation] also makes e-cigarettes less easily accessible, less palatable or acceptable, more expensive, less consumer friendly or pharmacologically less effective, or inhibits innovation and development of new and improved products, then it causes harm by perpetuating smoking. Getting this balance right is difficult. (Section 12.10 page 187)
But there is an important fact to consider when striking this balance, the possible unintended consequences (more smoking) are much more serious than almost all of the conceivable harms that the regulation of low-risk products is designed to prevent. This means that regulators and policymakers should be paying particularly vigilant attention to unintended consequences that would cause more smoking. The uncritical endorsement of outright prohibitions by WHO, suggests that at the highest levels this simple idea has not been grasped.
- Clive Bates, Plausible unintended consequences of excessive regulation of low-risk nicotine products. 2019 [link]
- Michael Pesko: E-cigarette Policy Evaluation Research, accessed 20 February 2020 (updated regularly) [link]. Mike Pesko’s group specialises in economically-based research, looking at behavioural responses to policy interventions.
5.6 Should different categories of vapour products like THC or nicotine salts be regulated in different ways?
Yes, if they present different types of risks. The underlying principle should be risk-proportionate regulation (see 10). One obvious candidate for better regulation is cannabinoid vapes, for example, THC oil vapes. The current model of THC regulation is ‘prohibition’, but this has just created a black market and that has created extremely serious supply chain risks (see 3 above). But more regulation is not always good. There are dangers that regulators become the enemies of innovation and protect incumbents (including cigarettes) and from innovative entrants. For example, the Juul product has been extremely successful with adults in providing a good nicotine delivery to rival a cigarette but in a compact and easy to use form. This has been achieved by the use of nicotine salts and relative strong e-liquids. It would be wrong to use regulation to stop this. Measures to protect youth should be focussed on youth, not on undermining the strong selling points of innovations aimed at adults.
5.7 Should regulators impose limits on the strength of nicotine in e-liquids?
No, definitely not. The danger of limiting nicotine is that it leaves cigarettes in place as the most rapid and effective way of delivering nicotine. Such limits will make e-cigarettes ineffective alternatives for heavier smokers or those struggling to convert from smoking to vaping. It also may be a block on current and future innovation (e.g. to make products safer, smaller, easier to use) and make them more dangerous by forcing users to consume more liquid for a given dose of nicotine. Limits should only be set for poison-safety reasons (for example 7.2% or approximately 72mg/ml is a poison threshold in the UK) and not to limit nicotine uptake as this would provide an advantage to cigarettes
5.8 Why does Juul use a high strength nicotine liquid in the US?
In the United States, Juul uses a 5% nicotine liquid (59mg/ml) in its pods. The maximum concentration allowed in the European Union is 20mg/ml (under 2% strength).
Some commentators have misunderstood the purpose of Juul’s higher strength e-liquid. It is not primarily there to deliver more nicotine to the body but to deliver whatever the user is seeking in a smaller volume of liquid. Juul is a compact and convenient device and therefore has a small battery and a small container for the liquid (0.7ml compared to a maximum EU tank size of 2ml – already low compared to products on the market elsewhere). The small battery means it has lower power and can only heat a smaller volume of liquid in response to user puffing. Also, partly for energy efficiency reasons, the Juul device also operates at a relatively low temperature, meaning that it is less likely that the product will overheat liquid and start to generate products of thermal decomposition, such as aldehydes.
Juul also uses nicotine salts form by adding benzoic acid. This means that more of the nicotine from a Juul and similar devices is in ‘protonated‘ or salt form (the nicotine molecule is bound to a hydrogen ion, which is a proton). This means less of the nicotine is in ‘freebase’ form and so it is less easily absorbed on its journey through the mouth and throat and more of it is eventually absorbed in the lungs, from where it is transported more rapidly to the brain. This improves the ‘pharmacokinetics’ (the speed and peak of the blood nicotine level in the brain, sometimes known as the ‘PK’) of nicotine delivery. This is essential for this product to compete with nicotine delivery – the PK profile – of cigarettes and it explains why Juul has been a very successful product with a very high rate of conversion from smoking to vaping. The success of teh Juul is based on its nicotine delivery, a range of pleasant flavours, combined in a small form factor with the ease of use of a cartridge-based system.
The strength of the nicotine in the liquid is not a reliable guide to how much the device delivers to the user. The only point at which regulators should become concerned is if the nicotine delivery and PK profile exceed that of cigarettes in actual users, and we should remember that the user controls nicotine exposure, not the device or liquid.
- Hajek P. et al. Nicotine delivery and users’ reactions to Juul compared with cigarettes and other e‐cigarette products, Addiction, January 2020 [link]
- Russell C et al. Factors associated with past 30-day abstinence from cigarette smoking in a non-probabilistic sample of 15,456 adult established current smokers in the United States who used JUUL vapor products for three months, Harm Reduction Journal, 2019 [link]
5.9 Should there be a special tax on e-cigarettes?
No. In any country with high rates of smoking, most vapers will be using e-cigarettes to cut down or quit smoking – they are doing this on their own initiative and at their own expense to improve their own health. Policymakers should be trying to make this as economically attractive as possible by using taxes to maintain a difference in the cost of vaping and smoking. At this stage, the priority is to reduce smoking as deeply and as rapidly as possible and a tax on e-cigarettes would slow down that progress, protect the cigarette trade, and increase the burdens of disease and premature death.
The danger is that raising taxes on e-cigarettes simply changes the choice of nicotine products, with only minor deterrent effects on overall uptake. For example, Cotti et al. used data from US 35,000 retailers and showed that every 10% increase in e-cigarette prices reduced e-cigarette sales by 26%, but also increased traditional cigarette sales by 11%, concluding that e-cigarettes and traditional cigarettes are economic substitutes. So those determined to impose taxes on e-cigarettes need to account for likely increases in cigarette consumption as a result.
- Pesko M, et al. The Effects of Traditional Cigarette and E-Cigarette Taxes on Adult Tobacco Product Use. Cambridge, MA; 2019 Jun. [link]
- Cotti CD, The Effects of E-Cigarette Taxes on E-Cigarette Prices and Tobacco Product Sales: Evidence from Retail Panel Data; NBER, January 2020 [link]
- New Nicotine Alliance: To tax or not to tax? Response to EU on taxing vaping and other reduced-risk products, 2016 [link]
- Chaloupka FJ, et al. Differential Taxes for Differential Risks–Toward Reduced Harm from Nicotine-Yielding Products. New England Journal of Medicine 2015. [link]
5.10 Does tobacco harm reduction undermine tobacco control?
No, this is an empty myth. In fact, tobacco harm reduction is supportive, not undermining, of conventional tobacco control. For example, if taxes are raised on cigarettes, smokers can respond by quitting, cutting down, paying more (regressive) tax, trading down to a cheaper brand or by accessing the black market. But if there are also low-risk products available to switch to, then this increases the options available to respond to a tax-induced price change. Because switching from smoking to vaping involves giving up less than going from smoking to abstinence, it is likely that this pathway will be relatively attractive to many users. The vaping route may also reduce the numbers making the pro-smoking responses to a cigarette tax increase (carry on smoking and pay the tax, cut down, trade down or go to the black market). The effect of adding switching as an option is to improve positive behavioural responsiveness to tobacco control measures and avoid some of the harms induced by such measures (e.g. regressive effects of tax). Similar arguments can be made for other pressures on users created by tobacco control policies.