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The European Tobacco Products Directive and the future of e-cigarettes in the UK

By Jasmine Khouja @Jasmine_Khouja

E-cigarettes have become a popular product among smokers and ex-smokers, and Action on Smoking and Health (ASH) estimates that there are 2.6 million current users of e-cigarettes in the UK. As an alternative to tobacco smoking, research commissioned by Public Health England estimates that e-cigarettes are likely to be roughly 95% less harmful. The evidence supporting these popular and effective quitting aids suggests that e-cigarettes could be a powerful tool for harm reduction amongst current smokers but there is still uncertainty over the safety of e-cigarettes. Limited research concerning the effects of long-term use and the current lack of strict regulation of the products has fuelled this uncertainty but new regulations have been introduced into the pre-existing European Tobacco Products Directive (TPD) to rectify this. The updated TPD will come into force on 20th May 2016 with a transitional period allowed by the TPD. UK e-cigarettes and refill containers which are not in compliance with the TPD will be allowed to be released for sale on the UK market until 20th November 2016, but from 20th May 2017 all products sold to consumers will need to be fully compliant with the TPD. The alternative to following the regulations set by the TPD will be for e-cigarettes to gain a medical licence from the Medicines and Healthcare products Regulatory Agency (MHRA) and be regulated as licenced medicinal products to be sold in the UK.

jaz blog

As I am about to commence a PhD investigating the reasons for e-cigarette use, I am interested in what the implications of the directive will be in the UK; will it encourage smokers to switch to e-cigarettes, consequently reducing harm to themselves and others, or will it result in a reduction of available products and cause an increase in relapses to smoking?

I have read the directive and listed some of the key changes that will happen and added my own thoughts on what may happen as a result.

  1. CHANGE: New e-cigarette products must be notified to the MHRA six months before their release to the public. E-cigarette companies will be charged £150 to notify MHRA of a new product and £80 for a modification to an existing product, and will then be charged £60 annually thereafter. POSSIBLE OUTCOMES: The MHRA should have more control over the products on the market and be able to prevent unsafe products entering the market but it may take longer for new products to become available to buy. Additionally, some existing products will be unavailable from 20th May 2017 if they do not to comply with the regulations by 20th November 2016.
  1. CHANGE: Under the TPD, e-liquids will only be allowed where the nicotine concentration does not exceed 20 mg of nicotine per ml of liquid. E-liquids containing more than 20 mg of nicotine per ml of liquid will have to gain a medical licence authorised by the MHRA. POSSIBLE OUTCOMES: People may reduce their doses of nicotine and reduce their addiction if their preferred dosage is no longer available. Fewer high dosage products may be available as gaining a medical licence is an expensive process (estimated between £87,000 and £266,000 annually over ten years for a single device). When current products with high dosages such as 36 mg of nicotine per ml of liquid become unavailable, people may use lower dosages such as 20 mg of nicotine per ml of liquid as a substitute and inhale twice as much vapour to get the same nicotine hit. Nicotine is not the only constituent of vapour though; there are low concentrations of other toxicants, so inhaling more vapour means inhaling more toxicants. Alternatively, current higher dosage users may relapse to tobacco smoking if they feel the lower dosages do not effectively deliver the nicotine hit they need.
  1. CHANGE: Products regulated under the TPD must provide information to the MHRA on the safety and contents of e-cigarette products (including ingredients, toxicants and emissions). Health warnings, instructions for use, information on addictiveness and toxicity must also appear on the packaging and accompanying information leaflet. POSSIBLE OUTCOMES: This should allow e-cigarette users to make informed choices. The notification fees mentioned above will include the storage of this information but the companies may have to bear extra costs in testing their products for the amount of toxicants and emissions produced. These tests will have to comply with the standards set in the TPD and by the MHRA which may prove too costly for smaller e-cigarette companies, forcing them to withdraw products from the market. This could leave the market open to the tobacco industry who generally have greater financial resources available to them. The tobacco industry have to also sustain the tobacco market; a consequence of this may be the deliberate placement of ineffective e-cigarette products on the market to encourage current smokers continue to smoke tobacco and ex-smokers using e-cigarettes relapse.
  1. CHANGE: E-cigarette products will be child-safe, will not break or leak during the refill process, and containers will not exceed 10 ml (refill cartridges will not exceed 2 ml). POSSIBLE OUTCOMES: This should prevent accidents involving children consuming dangerous levels of nicotine. Most changes will be made to newer devices, which require e-liquid refills. If these modifications aren’t made by 20th November 2016 the products will be removed from the market by 20th May 2017.
  1. CHANGE: Under the TPD, cross-border advertising will be banned, which includes in newspapers, radio and TV, but not on billboards and posters. Products will not be allowed to make smoking cessation or health claims. Advertising of products with a medicinal license will be allowed under “over the counter” medicine rules. POSSIBLE OUTCOMES: This should minimise the amount of e-cigarette advertising seen by those who should not use e-cigarettes such as children and non-smokers. However, only e-cigarette companies who can afford a medical licence will be able to advertise on TV and this could mislead people into thinking that these products are more effective than other products.

A possible outcome for many of these changes is the loss of products from the market because of non-compliance with the regulations. Although increased reassurance that e-cigarettes on the market meet certain quality standards may encourage new users, the removal of any e-cigarette product from the market will provide an opportunity for e-cigarette users to relapse to smoking; without their favourite brand or flavour, it may be easier for them to resume smoking again than to find a replacement that suits their needs and taste. This in turn could lead to increased levels of smoking, and therefore harms to both individuals and society as a whole. Additionally, high nicotine dosage e-cigarette users may be encouraged to inhale more vapour and therefore unnecessary amounts of other constituents. However, recent preliminary research findings from ASH UK suggest there are few high dosage users meaning that this should not affect many.

The withdrawal of products is likely to be determined by the cost of making products compliant. Tobacco companies generally have greater financial resources than e-cigarette companies, with the top companies making billions in profit each year, meaning they can afford to make the necessary changes to meet the new regulations. The few e-cigarette companies that are owned by tobacco companies mainly produce ‘cigalikes’ which are the least effective design of e-cigarettes and there is a higher chance of relapsing to smoking when using them compared to later-generation devices. Given that the tobacco-owned e-cigarette companies will probably have greater resources available to them, they could end up with a monopoly on the e-cigarette industry. In fact, this may already be happening; the first medically licensed e-cigarette is a ‘cigalike’ owned by British American Tobacco. This means British American Tobacco could own the only TV-advertised e-cigarette (until another company gains a licence). Consequently, smokers looking to try e-cigarettes may choose less effective devices because they are more widely advertised.

These changes may reassure the general public that the devices will be safe but may lead to many ex-smokers relapsing because they are forced to use e-cigarettes and e-liquids that do not meet their needs, all the while lining the pockets of the tobacco industry by allowing them a monopoly on higher nicotine dosage products. Of course, the possible outcomes stated here are speculative; research will need to be undertaken to evaluate the ongoing impact of the new guidelines.

Links

  1. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/489981/TPD_Cons_Gov_Response.pdf).
  2. http://www.telegraph.co.uk/news/health/news/12079130/E-cigarettes-win-first-approval-as-a-medicine-opening-way-for-prescription-by-the-NHS.html
  3. https://www.gov.uk/government/consultations/regulatory-fees-for-e-cigarettes
  4. http://ash.org.uk/files/documents/ASH_1011.pdf
  5. https://nicotinepolicy.net/documents/reports/Impacts%20of%20medicines%20regulation%20-%2020-09-2013.pdf

Photo Credits

http://ecigarettereviewed.com/ – Lindsay Fox

“Doubt is our product…”

Cigarette smoking is addictive. Cigarette smoking causes lung cancer. Today these statements are uncontroversial, but it’s easy to forget that this was not the case until relatively recently. The first studies reporting a link between smoking and lung cancer appeared in the 1950’s (although scientists in Germany had reported a link earlier), while the addictiveness of tobacco, and the isolation of nicotine as the principal addictive constituent, was not established until some time later. Part of the reason for this is simply that scientific progress is generally slow, and scientists themselves are typically not the kind of people to get ahead of themselves.

However, another factor is that at every stage the tobacco industry has resisted the scientific evidence that has indicated the harms associated with the use of its products. One way in which it has done this is by suggesting that there is uncertainty around the core evidence base used to support tobacco control efforts. A 1969 Brown and Williamson document outlines this strategy: “Doubt is our product, since it is the best means of competing with the ‘body of fact’ [linking smoking with disease] that exists in the mind of the general public”.

This approach seeks to “neutralize the influence of academic scientists”, and has since been adopted more widely by other lobby groups. The energy industry has used a similar approach in response to consensus among climate scientists on the role of human activity in climate change. But what’s the problem? There are always a number of ways to interpret data, scientists will hold different theoretical positions despite being in possession of the same basic facts, people are entitled to their opinion… That’s fine, but the tobacco industry goes beyond this and actively misrepresents the facts. Why do I care? Because recently our research was misrepresented in this way…

There is ongoing debate around whether to introduce standardised packaging for tobacco products. Public health researchers mostly favour it, while the tobacco industry is opposed to it. No particular surprises there, but there’s a need for more research to inform the debate. We have done some research here in Bristol suggesting that standardised packs increase the prominence of health warnings in non-smokers and light smokers. Interestingly, we didn’t see this in regular smokers. This research contributed to the recent European Commission Tobacco Products Directive and the UK government consultation on standardised packaging. British American Tobacco (BAT) submitted a response to this consultation, which cited our research and said:

“The researchers concluded that daily smokers exhibited more eye movements towards health warnings when the pack was branded than when it was plain, but the opposite was true for non-smokers and non-daily smokers”.

We didn’t find that, and we didn’t say that. This isn’t a matter of interpretation or opinion – this is simple misrepresentation. What we actually concluded was:

“…among non-smokers and weekly … smokers, plain packaging increases visual attention towards health warning information and away from brand information. This effect is not observed among daily (i.e. established) cigarette smokers”.

In other words, standardised packaging increases the prominence of health warnings in non-smokers and light smokers, but don’t seem to have any effect in daily smokers. This is an important difference compared to how BAT represents this research. In their response to the consultation, BAT argues that “plain packaging may actually reduce smokers’ attention to warnings”. Of course it’s possible that there could be negative unintended consequences to standardised packaging, but there is no evidence in our study for this.

Why does this matter? Maybe it doesn’t – people get misrepresented all the time. But scientists produce data and ideas, the latter ideally based on the former, and so to misrepresent their conclusions is fundamentally distorting. Unfortunately this sort of thing happens all the time, including in media coverage of scientists’ work. This often makes scientists less willing to engage in important debates where they could make a valuable contribution. If this happens, then those with clear vested interests will succeed in removing valuable evidence from these debates. More importantly, this example illustrates why it’s vital that scientists do engage with the public and the media. Only by doing so can scientists make sure that their research is accurately represented, and that attempts to misrepresent their research are challenged.

As the health effects of smoking became apparent, successive governments acted to reduce the prevalence of smoking in the population. In the United Kingdom these efforts have been pretty successful – the overall prevalence of smoking is currently around 20%, down from a peak of over 50% in the 1950’s. This is due to restrictions on tobacco advertising, increases in taxation on tobacco products, and other tobacco control measures, as well as public health campaigns to increase awareness of the health consequences of tobacco use and greater availability of services to help people stop smoking. We want these policies to be evidence-based, and we don’t want this evidence to be knowingly distorted. Scientists have an important part to play in this.

Posted by Marcus Munafo @MarcusMunafo