Smoking: E-cigarettes

Viscount Astor Excerpts

Tuesday 17th December 2013 Grand Committee

Asked by

[Viscount Astor]

To ask Her Majesty’s Government what is their policy on regulation of the sale, advertising and promotion of e-cigarettes.

[Viscount Astor (Con)]

My Lords, electronic cigarettes are tubes that simulate the effect of smoking. Some e-cigarettes contain nicotine, but importantly they do not contain tobacco. Inside an e-cigarette is a small computer chip, a lithium battery, a heating element and a cartridge filled with water containing dissolved pharmaceutical-grade nicotine. You take a puff and the heater fires up the element to around 150 degrees centigrade, which heats the liquid in the cartridge so that it can evaporate. You inhale and that gives a so-called nicotine hit. You then exhale what looks like smoke but is in fact water vapour. E-cigarettes are regarded by some as a new and dangerous nicotine habit, but by others as a successful way to quit smoking. The truth is perhaps somewhere in the middle, but it is clear that e-cigarettes are here to stay. The market is expected to grow from £1 billion this year to £10 billion over the next five years. It is unregulated at the point of sale in this country, as it is in most countries worldwide.

There has been a recent attempt by the European Commission, which introduced a draft directive, backed by this Government, to regulate electronic cigarettes as medicines, but the proposal was thrown out by the European Parliament. A majority in the European Parliament supported using a mixture of tobacco regulation, controls on promotion and the reporting of adverse reactions. I understand that negotiations are continuing right up to today, and I hope that the Minister will be able to give us notice of any progress.

The Government have encouraged e-cigarette producers voluntarily to seek a licence for their products so that they can meet standards of safety and quality and be sold on prescription. Can the Minister say how many of the companies that produce and sell e-cigarettes have signed up to the voluntary code, and how many are estimated not to have signed up? Perhaps he could also confirm what the cost of validation might be for producers complying with a medical directive. I understand that it would be more than £250,000. This would put most of the smaller suppliers out of business and hand the industry over to the large tobacco companies, thus perhaps stifling competition.

As one drives into London on the M4, one can see three new vast advertising hoardings promoting e-cigarettes. Do the Government approve of this kind of advertising, which would not be allowed for normal cigarettes? There is a difficult issue here because most e-cigarettes are made up with 5% nicotine, but some, probably 10% of the market, have no nicotine in them at all. They are, for example, cherry or bubblegum flavoured. Some look like cigarettes and some like pencils, while others look like a pipe end without a pipe. If they wanted to regulate, how would the Government regulate an e-cigarette that contains no nicotine? Indeed, is it an e-cigarette, is it a toy or is it something else?

At the moment, e-cigarettes can be sold to children. Does the Minister believe that there should be an age limit, or will we see school playgrounds full of puffing children—or perhaps I should say even more full of children puffing? If so, would it be illegal for them to puff an e-cigarette that does not contain any nicotine? After all, what comes out of an e-cigarette is just harmless vapour, not smoke. Most e-cigarettes are made in China, with the nicotine and other flavours mainly being manufactured there. Is there any form of inspection regime for the importation of this nicotine additive?

There is evidence from America that e-smoking is on the increase, but not necessarily that e-cigarettes are a gateway to smoking, although it is estimated that the US has around 2.5 million users. We do know that nicotine is an addictive drug, and this new invention could set some on the path to nicotine addiction, but that is nicotine in very small amounts, which is hardly harmful in comparison with the danger of and damage caused by smoking. E-cigarettes could save the lives of millions of smokers by weaning them off normal cigarettes. They are a welcome aid to smokers trying to quit; for example, those who have failed with nicotine chewing gum or the patches. The value of the health gains associated with a single successful quit attempt is very substantial, and the Government’s own Department of Health estimates it at more than £70,000.

This is the dilemma facing health experts, policymakers and regulators—and, indeed, the Minister. There is very little research on the effects of e-cigarettes. While they are definitely less harmful than normal cigarettes, they contain carcinogens and toxic chemicals, albeit in very small quantities. E-cigarettes have been described as,

“the triumph of wishful thinking over data”,

and,

“an opportunity to improve public health”.

Closer to home, ASH—Action on Smoking and Health—supports the use of licensed nicotine products as an aid to cutting down or quitting smoking, and as a substitute for smoking. They satisfy the desire to smoke, help cut down on cigarettes and, of course, eradicate the smell of stale smoke and the effect of passive smoking on anybody nearby. Most diseases associated with smoking are caused by inhaling smoke, which contains thousands of toxic chemicals. As I have said, by contrast, nicotine is relatively safe.

My final question to my noble friend the Minister is: do we have to wait until the European Commission and European Parliament finally agree—if they ever do—or can the Government introduce sensible regulations on the advertising, promotion and sale of e-cigarettes? If the Government overregulate the sale of e-cigarettes and restrict their use, they will increase the costs to health in this country and miss an opportunity to cut down on smoking.

--- Later in debate ---

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)]

My Lords, I thank my noble friend Lord Astor for securing this important and highly topical debate.

As we have heard, e-cigarettes are nicotine-containing devices that work by atomising a nicotine solution which is then breathed in as a vapour by the user. E-cigarettes claim to deliver nicotine to the user without the toxins and carcinogens found in tobacco smoke. They do not involve any combustion and do not produce smoke. E-cigarettes are a very recent innovation. They are available in various shapes and sizes, as we have heard, and many are designed to both look and feel like conventional cigarettes. Some even incorporate a light at the end of the device that glows when the product is being used, to replicate a cigarette. Today, they are marketed as a cheaper and healthier alternative to smoking tobacco. However, e-cigarette manufacturers have avoided directly suggesting that their products are smoking cessation aids, as making such claims would subject their products to regulation as medicines.

I turn to whether e-cigarettes are safe to use. When we compare the use of e-cigarettes to smoking of tobacco, the Department of Health is confidently able to say that e-cigarettes are likely to be much safer to use. That does not mean that e-cigarettes are safe to use; it probably says more about how enormously unsafe it is to smoke tobacco. Nevertheless, the safety of e-cigarettes is yet to be fully established. Given how novel these products are, we need to see much more evidence about their safety, especially regarding the use of e-cigarettes over a long period.

At present, e-cigarettes are sold without any product-specific controls relating to quality and safety in use, or specific provisions on advertising and promotion. There are general product safety provisions that apply to these products, but they are not designed for these sorts of product and are not fit for this purpose. We also must keep in mind that nicotine itself is not only highly addictive but can be highly toxic. Electronic cigarettes are not risk-free. Known and reported health risks include acute effects on lung function, possible pneumonia and other risks related to poor product quality.

My noble friend Lord Astor made reference to Action on Smoking and Health. ASH says that there is significant variation in device effectiveness, nicotine delivery and cartridge nicotine content, both between and sometimes within product brands. ASH cites research that suggests the presence of toxins, released in low concentrations, from the vaporisation process involving certain e-cigarette cartridges. It cites other research that concluded that e-cigarettes have a low toxicity profile, are well tolerated and are associated only with mild adverse effects.

As we have heard during this debate, the e-cigarette market is growing rapidly. More than 300 companies are estimated to be importing or supplying e-cigarettes in the United Kingdom. The e-cigarette market in the UK is estimated to be worth in excess of £100 million, and we know that across the world the tobacco industry is becoming increasingly involved. There is little doubt that awareness of e-cigarettes has increased quickly through advertising and promotion of these products. It has been said that e-cigarettes are being promoted in similar ways to how cigarettes were promoted before we introduced a comprehensive ban on tobacco advertising in this country. I am sure that I am not alone in noticing the vast amount of promotion for e-cigarettes in my local convenience store, or the representatives of e-cigarette companies in shopping malls or outside train stations promoting their products.

The University College London smoking toolkit study is a national study of smoking and smoking cessation in England. The most recent data from the survey suggest that electronic cigarette use by tobacco smokers has increased from around 2% in 2011 to around 14% in August 2013. If this trend were reflected across the UK, it would translate to around 1.4 million smokers who have used electronic cigarettes. There is little evidence to suggest that non-smokers are becoming attracted to using e-cigarettes.

My noble friend Lord Borwick asked about the behaviour of children and young people. ASH commissioned research into the use of e-cigarettes by young people and found that, in Great Britain in 2013, 95% of 11 to 14 year-olds and 90% of 16 to 18 year-olds have never used e-cigarettes. Among young people, e-cigarette use appears to be confined to those who have already tried smoking. Nevertheless, we remain concerned that e-cigarettes could quickly become popular with young people, particularly if they continue to be vigorously advertised and promoted. We are also very aware of concerns expressed that e-cigarettes could act as gateway products for young people into smoking, and will continue to watch the evidence closely.

The Government recognised in the tobacco control plan for England that smokers are harmed by the tar and toxins in tobacco smoke, not necessarily by the nicotine to which they are addicted. There is no way of avoiding these deadly toxins if you inhale smoke from burning tobacco.

Earlier this year, the National Institute for Health and Care Excellence published public health guidance on harm-reduction approaches to smoking. The noble Lord, Lord Hunt, asked about this. NICE recommends the use of licensed medicines only. The guidance suggests that while the best way to reduce smoking illness and death is to encourage smokers to quit completely, there are other ways of reducing the harm from smoking, even though this may involve the continued use of nicotine. If someone does not want to, is not ready to or is unable to stop smoking in one step, the guidance suggests that licensed nicotine replacement therapies could be of use.

My noble friend Lord Borwick asked about the possibility of sponsoring research in this area. We already know quite a lot about the safety profile of nicotine and its use in cutting down and quitting. The evidence we have is that these products are used mainly to cut down and quit.

My noble friend Lord Ridley called for clearer evidence of effectiveness. The problem is that there is not good evidence of effectiveness. These products are not magic bullets, in other words, but even at this stage we feel that we want to exploit the potential that we see in them. He referred to aubergines as potential medicines. I think he would agree with me that people do not eat aubergines in the expectation that that will help them to quit smoking. Clearly, whatever remedy we encourage has to be effective in its ability to cut down and quit the habit of smoking.

There is potentially a place for e-cigarettes within a harm-reduction approach to public health, but only if they meet the requirements set out in the public health guidance; that is, if they are licensed medicines. I would expect that the NHS and health professionals would also only recommend the use of e-cigarettes that are licensed as medicines. My noble friend Lord Astor asked whether we envisaged e-cigarettes being sold on prescription. We want effective products to be widely available, not just on prescription but in general sale outlets such as supermarkets and corner shops.

The noble Lord, Lord Hunt, asked how much it would cost an e-cigarette manufacturer to get a medicines licence. The impact assessment that we published estimated that the annualised cost to a single UK e-cigarette importer for complying with medicines regulation ranged from £87,000 to £266,000.

I am particularly grateful to my noble friend Lord Astor for securing this debate because it provides me with the opportunity to explain to your Lordships the action that is under way to regulate e-cigarettes. As the Chief Medical Officer for England has said, since more and more people are using e-cigarettes, it is only right that these products are properly regulated to be safe and work effectively.

A European tobacco products directive was proposed late last year and is now in its final stages of negotiation in Brussels. I can tell noble Lords that no deal has yet been reached in the discussions but the Government hope that agreement might be reached shortly. I reassure your Lordships that the United Kingdom has been active during these negotiations, as we believe that the proposed tobacco products directive will benefit public health and help to reduce the number of young people who take up smoking in the UK.

From the outset, it was envisaged that e-cigarettes would be regulated within the proposed directive. Protecting and promoting public health has always been our starting point, and we want safe and effective nicotine-containing products that can help smokers cut down and quit. The Government took the view that proportionate medicines regulation was the best way to deliver that objective.

[Viscount Astor]

Does my noble friend consider that e-cigarettes that contain no nicotine at all but contain other flavours will or should come under the tobacco directive?

[Earl Howe]

My Lords, that is probably the hardest question that my noble friend has asked me during this debate. My answer is that we certainly need to give careful consideration to that issue, which is about products that have the appearance of e-cigarettes but contain no nicotine. We would need to look at how common those products are or are becoming. Frankly, that work has yet to be done, but I am grateful to him for raising the issue.

I was speaking about our approach to the regulation of e-cigarettes, saying that we felt that proportionate medicines regulation was the best way forward. Nevertheless, we must consider carefully the views that have been forthcoming, including from the European Parliament, that there are alternative approaches to the regulation of e-cigarettes. Moving forward, the Government will want to be satisfied that the directive can deliver the right checks and balances on e-cigarettes. It is important to underscore the fact that there is a wide consensus across the European Commission, the European Parliament and European member states that additional regulatory safeguards are needed for this relatively new category of product. We are listening carefully to the genuine debate about how best to take this forward in the directive.

There is also emerging consensus that the advertising of e-cigarettes needs to be controlled. Options for doing so as part of the proposed European directive are under negotiation. In addition, the Committee of Advertising Practice, which writes and maintains the UK advertising codes that are then administered by the Advertising Standards Authority, announced in October that it intends to develop new rules to give clarity to advertisers and to ensure that e-cigarettes are promoted responsibly. It is considering running a public consultation on this issue early in the new year.

The Government’s priority during negotiations is to secure a directive that will reduce as far as possible how attractive e-cigarettes are to young people and closely to monitor the development of this market. When the directive has been settled, we will undertake an analysis to consider whether further action could be taken on a domestic basis, in particular to protect young people from e-cigarettes that contain nicotine. We also need to give further consideration to my noble friend’s question about non-nicotine-containing products, as I mentioned.

Regardless of how e-cigarettes are regulated within the proposed directive, we will still encourage the manufacturers of these products voluntarily to seek medicines licences for their e-cigarettes, so that they can be made available to support smokers to quit in the same way as other forms of nicotine replacement therapy, such as gum and patches. These e-cigarettes could be recommended for use in reducing harm, in accordance with the recently published public health guidelines.