Refillable electronic cigarettes face eu ban

The European Union has struck a deal which could curb the booming market in electronic cigarettes and lead to an EU wide ban on a popular version of the nicotine device.

In hard fought negotiations between the 28 governments of the EU and the European parliament, both sides agreed on Tuesday that refillable e cigarettes could be banned across Europe if three countries decided on prohibition.

The parliament, under intense lobbying from the tobacco industry, took a more liberal line than the European commission, which proposed that e cigarettes be legislated for in the same way as pharmaceuticals. That was rejected in the compromise, but individual countries were left free to regulate e cigarettes as medicines.

Governments also took a more restrictive position on the issue and could still try to reverse some of the agreed elements. Ambassadors from the 28 countries will meet on Wednesday to decide whether to accept the compromise or return to negotiations.

The issue of e cigarettes quickly became the most contentious aspect of new EU rules on the packaging and sales of tobacco products, although the electronic devices contain no tobacco.

Public health warnings and graphic images of the damage done by smoking are to cover two thirds of cigarette packaging, and cigarette flavourings are to be proscribed, if gradually phased out.

Martin Callanan, leader of the Conservatives in the European parliament, said «This is a perverse decision that risks sending more people back to real, more harmful, cigarettes. Refillable e cigarettes would almost certainly be banned, and only the weakest products will be generally available. As many smokers begin on stronger e cigs and gradually reduce their dosage, making stronger e cigs harder to come across will encourage smokers to stay on tobacco.»

The key question centred on the impact of e cigarettes and whether they encouraged people to start smoking or whether they weaned nicotine addicts off tobacco.

«It’s inhaled. It’s direct inhalation of nicotine into the lungs. That creates an addiction very fast,» said a senior diplomat involved in the negotiations. «It encourages a switch to real cigarettes.»

The European e cigarettes market is currently estimated at 2bn ( 1.7bn), but it is growing fast, with approximately seven million users.

In the UK some 1.3 million of an estimated current 10 million smokers have switched to the electronic devices. Celebrity endorsements and social media are attracting young people to use e cigarettes in large numbers, according to a recent report commissioned by Cancer Research UK.

But public health experts are sharply divided about the devices some argue that they could substantially cut deaths from tobacco currently 100,000 annually in the UK while others warn they will only glamorise smoking, especially among the young.

One study of 657 smokers, published in the Lancet last month, found that e cigarettes worked as well as nicotine patches in helping people stop smoking within six months.

France, which has an estimated 1.5 million e cigarette users, is currently pondering a ban, but a mayor in Normandy has already introduced a local ban.

The EU agreement allows e cigarettes with a nicotine content below 20mg/ml to be regulated for general sale, rather than treating them as medicinal products. Governments had demanded a 3mg/ml limit.

The deal, however, lets individual governments regulate the cigarettes as medicinal products if they choose.

Refillable cartridges became the biggest sticking point, with the parliament threatening to veto the legislation if replacement sales were banned. On refillable e cigarettes, the compromise allows cartridges of 1ml of liquid containing up to 20mg of nicotine. But governments will be able to ban refillable e cigarettes and if three countries do so, then the commission is empowered to impose a blanket prohibition across the EU.

«This will lead to another ridiculous ban from the EU on the majority of e cigarettes which are better for the health of smokers and for British manufacturers of e cigarettes,» said Nigel Farage, the UK Independence party leader and MEP. «The EU should not be putting restrictions on a safer alternative to smoking.»

Carly Schlyter, a Green MEP and public health spokesman, said «Member states will be free to decide whether they want to subject them to authorisation as medicines or apply new rules that should ensure the quality and safety of these products. Either way should ensure that e cigarettes can be used safely to help smokers stop smoking, and not act as a gateway for non smokers.»

Rebecca Taylor, a Lib Dem MEP, said the possible ban on refillable cartridges could push consumers back to tobacco.

«This the exact opposite of what the tobacco directive is supposed to achieve. The fight is now on to show that it would not be justifiable to ban refillable cartridges on health and safety grounds.»

This article was amended on 19 December 2013 to change the word «will» to «could» in the subheading.

Who

What are electronic cigarettes (e cigarettes)?

E cigarettes or ENDS (electronic nicotine delivery systems) are devices whose function is to vaporize and deliver to the lungs of the user a chemical mixture typically composed of nicotine, propylene glycol and other chemicals, although some products claim to contain no nicotine. A number of ENDS are offered in flavours that can be particularly attractive to adolescents. Electronic cigarettes (e cigs) are the most common prototype of ENDS.

Each device contains an electronic vaporization system, rechargeable batteries, electronic controls and cartridges of the liquid that is vaporized. The manufacturers report that the cartridges typically contain between 6 and 24 mg of nicotine, but sometimes can contain more than 100 mg. In the form of tobacco products, nicotine is an addictive chemical that in excessive amounts can be lethal (0.5 1.0 mg per kg of weight of the person).

Most ENDS are shaped to look like their conventional (tobacco) counterparts (e.g. cigarettes, cigars, cigarillos, pipes, hookahs or shishas). They are also sometimes made to look like everyday items such as pens and USB memory sticks, for people who wish to use the product without other people noticing.

Are electronic cigarettes (ENDS) safe?

The safety of ENDS has not been scientifically demonstrated.

The potential risks they pose for the health of users remain undetermined. Furthermore, scientific testing indicates that the products vary widely in the amount of nicotine and other chemicals they deliver and there is no way for consumers to find out what is actually delivered by the product they have purchased.

Most ENDS contain large concentrations of propylene glycol, which is a known irritant when inhaled. The testing of some of these products also suggests the presence of other toxic chemicals, aside from nicotine. In addition, use of these products when they contain nicotine can pose a risk for nicotine poisoning (i.e. if a child of 30 Kilos of weight swallows the contents of a nicotine cartridge of 24 mg this could cause acute nicotine poisoning that most likely would cause its death) and a risk for addiction to nonsmokers of tobacco products. Nicotine, either inhaled, ingested or in direct contact with the skin, can be particularly hazardous to the health and safety of certain segments of the population, such as children, young people, pregnant women, nursing mothers, people with heart conditions and the elderly. ENDS and their nicotine cartridges and refill accessories must be kept out of the reach of young children at all times in view of the risk of choking or nicotine poisoning.

As ENDS do not generate the smoke that is associated with the combustion of tobacco, their use is commonly believed by consumers to be safer than smoking tobacco. This illusive safety of ENDS can be enticing to consumers however, the chemicals used in electronic cigarettes have not been fully disclosed, and there are no adequate data on their emissions.

Is use of electronic cigarettes (ENDS) an effective method for quitting tobacco smoking?

The efficacy of ENDS for helping people to quit smoking has not been scientifically demonstrated.

ENDS are often touted as tobacco replacements, smoking alternatives or smoking cessation aids. But we know that for smoking cessation products to be most effectively and safely used, they need to be used according to instructions developed for each product through scientific testing. There are no scientifically proven instructions for using ENDS as replacements or to quit smoking. The implied health benefits associated with these claims are unsubstantiated or may be based on inaccurate or misleading information. When ENDS are used as cessations aids, they are intended to deliver nicotine directly to the lungs. None of the approved, regulated cessation aids, such as nicotine patches and chewing gum, delivers nicotine to the lungs. Therefore, the biological mechanism by which smoking cessation might be achieved by delivery of nicotine to the lungs and its effects are unknown. Delivery to the lung might be dangerous. Therefore, independently of the effects of nicotine, it is of global importance to study lung delivery scientifically.

The dose of delivered nicotine is also unknown. It is suspected that the delivered dose varies notably by product, which contain nicotine in various quantities and concentrations.

Conclusion

Until such time as a given ENDS is deemed safe and effective and of acceptable quality by a competent national regulatory body, consumers should be strongly advised not to use any of these products, including electronic cigarettes.