61.E-cigarettes are regulated under the UK Tobacco and Related Products Regulations 2016 (TRP Regulation), which implemented the EU’s Tobacco Products Directive. Because the regulations are connected with trade, it is largely a reserved matter and the Department of Health and Social Care transposed the regulations on behalf of Northern Ireland, Scotland and Wales. The EU Directive:
It leaves national governments to stipulate and control:
62.E-cigarettes and e-liquids are subject to a notification scheme, for which the Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority in the UK. This system is intended to ensure standards that:
63.The Department of Health and Social Care regarded the e-cigarette regulatory framework as “proportionate”. The EU and national regulations, they told us, have enabled them:
[…] to introduce measures to regulate e-cigarettes to reduce the risk of harm to children and protect against any risk of re-normalisation of tobacco use, provide assurance on relative safety for users, and provide legal certainty for businesses. This has enabled the UK to implement standards and consistency. There are a few exceptions in terms of UK domestic law and it is right for each UK country to decide on those matters. For example, in Scotland there are powers to introduce domestic legislation banning domestic advertising of e-cigarettes. This is a matter for the Scottish Parliament.
64.The Scottish Government has made provision, through the Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016, to restrict the advertising of vapour products through secondary legislation, though this is not yet in place. This would require retailers selling ‘nicotine vapour product’, or e-cigarettes, to register on a tobacco retailer register. It would also restrict domestic advertising and promotions and bans staff under the age of 18 from selling tobacco and ‘nicotine vapour products’. In 2015–16, the Welsh Government attempted to go further and introduce stricter controls on the use of e-cigarettes in public places and, like Scotland, introduce a national register for tobacco and nicotine retailers. Its Bill was defeated in the Welsh Assembly.
65.Many of our witnesses identified problems with the regulatory system in four main areas: the 20mg/ml maximum nicotine refill limit, a size restriction on the tank, a block on advertising e-cigarettes’ relative harm-reduction potential, and the notification scheme for e-cigarette ingredients, as we discuss below.
66.The Centre for Addictive Behaviours Research at London South Bank University told us that the 20 mg/ml nicotine limit for e-cigarette refills was not evidence-based and was actually counter-productive:
Vapers using higher nicotine e-liquid concentrations have been compelled to switch to lower nicotine concentrations since the introduction of the [EU Directive]. This upper limit is arbitrary and is not based on empirical evidence. In fact, it may increase harm if smokers cannot achieve the nicotine delivery they need to supress cravings for tobacco, which in turn may dis-incentivise switching to electronic cigarettes and expose high nicotine-dependent smokers, willing to switch to e-cigarettes, to greater risks of relapse.
Sarah Jakes from the New Nicotine Alliance similarly told us, in regard to the size of the tank size restriction, that:
There is no scientific basis at all for the 2 ml tank limit and 10 ml bottle limit. Speaking for consumers, they make things fiddlier and the bottles are easier to lose. It is generally inconvenient and there is no possible gain from it.
67.Under the current EU tobacco regulations, there are restrictions on how e-cigarettes and tobacco products can be advertised and where. The detailed rules are determined by the Committee on Advertising Practice for non-broadcast media and by the UK Code of Broadcast Advertising for broadcast media. The Advertising Standards Authority, who regulate and monitor advertisements, told us:
The [Department of Health and Social Care] took a minimal approach to implementing the advertising prohibitions in the [EU tobacco directive]. The legal prohibitions emanating from the Directive and the TRP Regulation apply only to ads which promote (directly or indirectly) certain types of products (those which are unlicensed and which contain nicotine) and only in some media channels. In general terms the prohibited media channels are those which have a cross-EU-border effect. The result is that a nicotine-containing e-cigarette may be lawfully advertised on an outdoor poster, in a leaflet and in the cinema. However, the same ad would be illegal on television and radio and in magazines and newspapers.
68.Health claims in advertising can only be made about a product which has a medical licence from the MHRA, but the Advertising Standards Authority is reviewing whether health claims should be allowed when promoting e-cigarettes. We were told that 27 representations made to the consultation had been in favour of allowing health claims for e-cigarette advertising, and six for the retention of the current legislation.
69.The UK Centre for Tobacco and Alcohol Studies argued that due to currently restrictive advertising rules, there is a lack of clear guidance on the relative harms of e-cigarettes and conventional cigarettes. This, they believed, contributes to a common misconception among smokers who have never used an e-cigarette that they are no less harmful. Fraser Cropper from the Independent British Vape Trade Association explained that e-cigarette manufacturers wanted to make claims only about the products’ relatively lower harm compared with conventional cigarettes:
To tie a hand behind our back and not allow us to be able to promote our products, to seize even more of those smokers out of the hands of the tobacco businesses, does not make sense. We are in a regulated space; we are protecting our consumers because of that. It should, therefore, also allow for confidence that we can continue to deliver those products and services in an ethical and responsible way.
Vaping does not make anybody better per se; it significantly reduces the risk of what a smoker is exposed to. It is a relative health claim. It is not a health claim in the singular sense that it makes somebody better.
70.One way of targeting information about the relative harm reduction of e-cigarettes at existing smokers, rather than more broadly, would be through ‘pack inserts’ placed in conventional cigarette cartons. Dr Moira Gilchrist from Philip Morris International told us that:
We are very interested in ensuring we have the opportunity to have targeted communications to smokers. We are not interested in broad communication opportunities; we are interested in attracting the right users—smokers who would otherwise continue to use cigarettes. Pack inserts in conventional cigarette packs are one example of that. Unfortunately, we cannot do that here in the United Kingdom, because of the laws that exist. We believe that that would be a tremendous opportunity to talk only to smokers, to tell them about the existence of new smoke-free products. That would be a very simple thing to do here in the United Kingdom that would allow marketing to exactly the right audience and not to the wrong audience.
71.Dr Tim Baxter from the Department of Health and Social Care told us that, in relation to ‘pack inserts’ in conventional cigarette packs, “there is not a single UK phone number for helping people to stop smoking, so that is an issue. We cannot use inserts. We do effectively use the pack to give various messages, with graphic health warnings.”
72.Whilst the MHRA includes all nicotine containing e-cigarette products in its notification scheme for obtaining product approval, non-nicotine containing products such as nicotine-free vaping liquids fall outside of the approval process. Dr Grant O’Connell from Fontem Ventures noted that there is a blacklist of ingredients which are not allowed, and took issue with the less rigorous approach of the notification process for products which do not contain nicotine:
The issue regarding whether some liquids already contain these chemicals is that in the absence of product standards, particularly around testing methods, you are comparing apples with pears. There is not one standard method. One lab will use method A and one will use method B, so you might not detect the chemical. We agree that strict enforcement of product standards is absolutely essential. We believe that that would form the basis of a bespoke regulatory framework for these products.
Dr Ian Jones from Japan Tobacco International wanted non-nicotine containing liquids to be tested in the same way as nicotine containing liquids:
Consumers are still inhaling the vapour from these liquids. We are also seeing—I believe, in the UK—what are called ‘short fills’, where consumers buy a small bottle of nicotine-containing liquid and add it to an unregulated bottle of zero-nicotine flavoured liquid. For me, as a scientist, that is a concern, because we do not know what is in that zero-nicotine flavoured liquid combination. Based on the principles of consumer protection, I think that zero-nicotine liquids should be regulated in the same way.
73.Dr Ian Hudson, Chief Executive of the MHRA, wrote to us:
The [MHRA] is aware of concern in the industry that products that do not contain nicotine when sold could potentially include harmful ingredients as they do not fall under scope TRP Regulation. MHRA is collaborating with the Department of Health and Public Health England, who are carrying out research into the safety of e-cigarette products. Together with the compliance work undertaken by Trading Standards and trade bodies, this research will provide clearer view of the risks of these products.
When subsequently he gave evidence to us, he elaborated:
We are doing a number of things. One of them is to work with the Chartered Trading Standards Institute in relation to the sampling of products, such that they can be tested, and to confirm that they comply with the regulations and notifications—and also to ensure that there are no banned substances in there. […] We cannot test directly, but we are working with trading standards to do a pilot of testing, to ensure compliance.
74.The regulatory system is also being applied to new products in two areas: ‘heat-not-burn’ products (Chapter 2) and ‘snus’. ‘Snus’, a Scandinavian non-combustible tobacco product inserted under the user’s lip, is currently illegal in the UK under the EU Tobacco Products Directive. The same directive does however make an exception for the product to be produced and sold in Sweden:
Given the general prohibition of the sale of tobacco for oral use in the Union, the responsibility for regulating the ingredients of tobacco for oral use, which requires in-depth knowledge of the specific characteristics of this product and of its patterns of consumption, should, in accordance with the principle of subsidiarity, remain with Sweden, where the sale of this product is permitted pursuant to Article 151 of the Act of Accession of Austria, Finland and Sweden.
Swedish Match, a company which develops, manufactures and sells tobacco alternatives including Snus, recently challenged the ban on the product in British courts, arguing that new scientific data had shown it to be less harmful than cigarettes. The Advocate General of the European Courts of Justice has judged that the ban outside Sweden remains valid, and the Court will make a ruling in the coming months.
75.Professor Peter Hajek of Queen Mary University told us that snus’ use in Scandinavia provided useful data on the health impact of nicotine from long-term users of nicotine replacement treatments:
It is not a huge sample, but it is very reassuring. We have a huge population of data from Sweden and Norway on people who use snus, which is a nicotine-containing tobacco product. There is no sign of an increase in cancer that is linked to nicotine. There are some pancreatic cancer concerns, but there are nitrosamines in those products; the concerns are not nicotine linked. Smoking-linked lung cancer is gone. The same applies to heart disease. […] I do not think we have any evidence of nicotine being that harmful.
76.We wrote to the then Health Secretary, Jeremy Hunt MP, about the UK Government’s position on the Swedish Match case at the European Court of Justice including its support for maintaining the ban on snus. In response, he set out the grounds of the Government’s continued support for the ban:
It is worth noting that there are strongly diverging views in terms of the evidence on the health risks of snus—with significant concerns in Norway and Sweden about the impact of the use of snus, particularly by young people and pregnant women. Where such controversy exists, our view is that a ban constitutes a proportionate response. However, the primary objective of the UK government was not to secure the continued prohibition of snus, but to seek to protect the principle of proportionality on which it is based.
When we subsequently asked the Health Minister, Steve Brine MP, whether he could see a case for an end to the ban on snus in the UK post-Brexit, he replied: “No—but I have an open mind”.
77.The University of Otago, New Zealand, has argued for a differentiated risk-proportionate regulatory framework for e-cigarettes, heat-not-burn products and conventional cigarettes “to ensure the least harmful products are the most affordable, accessible and appealing to smokers, while the most harmful smoked tobacco products are the least affordable, accessible and appealing to both smokers and young people at risk of starting to smoke”. Their framework would involve abolishing excise duty and taxation of e-cigarettes, except potentially for a level deemed to be required to deter young people from starting.
78.The Government’s Tobacco Control Plan states that, once the UK has left the EU, tobacco regulation will have to “reflect the new environment in which tobacco control will be delivered”. The current regulations will be reviewed and the legislation will be re-assessed, including the regulatory framework around e-cigarettes. ASH recommended a review of the various regulations post-Brexit. Health Minister Steve Brine MP told us:
On the question of post-Brexit and whether Brexit gives us more room for manoeuvre, unquestionably yes. That is a bit of “take back control” that I do not remember seeing on any buses, but it is a fact that we would have more room for manoeuvre.
79.Some of our witnesses nevertheless raised a concern about needing to ensure that vaping products were only advertised to adults, and preferably only to existing conventional cigarette smokers. Although currently the proportion of young people using e-cigarettes is very small (Chapter 3), the Association for Young People’s Health believed that e-cigarettes are marketed to young people, and were concerned that “young people, who are early adopters of all new technologies may be attracted to use e-cigarettes whether or not they already smoke”.
80.Currently, e-cigarettes are not subject to excise duty in the UK, unlike conventional cigarettes, heat-not-burn and other tobacco-containing products. Dr Lion Shahab from UCL believed that taxation could play an important part in encouraging smokers to switch from conventional smoking to less harmful alternatives including e-cigarettes.
81.Some aspects of the regulatory system for e-cigarettes appear to be holding back their use as a stop smoking measure. The limit on the strength of refills means that some users have to puff harder to get the nicotine they seek and may put some heavy smokers off persisting with e-cigarettes. The tank size restriction does not seem to be founded on any scientific rationale. A prohibition on making claims for the relative health benefits of switching to e-cigarettes from conventional cigarettes means that some who might switch are not getting that message. A ban on advertising ‘tobacco’ products, has prevented manufacturers putting ‘pack insert’ information about e-cigarettes in cigarette cartons. The Government, together with the ASA and the MHRA, should review all these regulatory anomalies and, to the extent that EU directives do not present barriers, publish a plan for addressing these in the next annual Tobacco Control Plan.
82.The level of taxation on smoking-related products should directly correspond to the health risks that they present, to encourage less harmful consumption. Applying that logic, e-cigarettes should remain the least-taxed and conventional cigarettes the most, with heat-not-burn products falling between the two.
83.The Government should conduct a review of regulations on e-cigarettes and novel tobacco products which are currently applied under EU legislation, to identify scope for change post-Brexit, including an evidence-based review of the case for discontinuing the ban on ‘snus’ oral tobacco. This should be part of a wider shift to a more risk-proportionate regulatory environment; where regulations, advertising rules and tax/duties reflect the evidence on the relative harms of the various e-cigarette and tobacco products available. While an evidence-based approach is important in its own right, it also may help bring forward the behaviours that we want as a society—less smoking, and greater use and acceptance of e-cigarettes and novel tobacco products if that serves to reduce smoking rates.
113 , BBC News, 22 May 2015
119 , the Advertising Standards Authority, September 2017
136 , The University of Otago, New Zealand, March 2018
137 , Department of Health, 2017
138 , Department of Health, 2017
139 Action on Smoking and Health (ECG0071)
Published: 17 August 2018