Electronic cigarettes and the EU

The EU is currently debating whether electronic cigarettes should be classified as medicinal products

– and EU member states like Italy are looking at the safety of e-cigarettes more closely.

Italy currently has a ban on those under 18 years old buying e-cigs, which will last until October 2013 to give researchers time to assess the nicotine levels in electronic cigarettes. Some governments like Italy are concerned that the nicotine levels in electronic cigarettes may frequently exceed the amount stated.

The choice of nicotine level available for electronic cigarettes has been one of the factors which have led many smokers to make the change to e-cigarettes in an attempt to quit using tobacco products.

The EU defines a medicinal product as “any substance … which may be used … either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis”. (Article 1 of EU Directive 2001/83/EC)

Electronic cigarettes were first marketed as a smoking cessation aid by the Chinese government, but in the UK and many other countries, e-cigarettes have slipped under the regulatory radar and are treated as consumer products.

The EU’s current consideration about whether to classify them as medicinal products has a further implication for ex-smokers who have switched to e-cigarettes, because one EU proposal involves limiting the levels of nicotine in e-cigs to just 4mg and might also ban flavoured nicotine liquids.
Electronic cigarettes could be classified as a tobacco product under the EU’s revised Tobacco Products Directive even though they are tobacco-free, with liquid nicotine delivered via an atomiser. The Tobacco Products Directive was issued in 2001 before the launch of electronic cigarettes and is currently being redrafted.

Under the Tobacco Products Directive, the EU defines tobacco products as “products for the purposes of smoking, sniffing, sucking or chewing, inasmuch as they are, even partly, made of tobacco, whether genetically modified or not”.

The main advantage to switching to electronic cigarettes for smokers is the fact that they are tobacco free, while delivering comparable levels of nicotine in a cigarette-style device using atomiser technology.

The EU classifies e-cigarettes as “nicotine inhalators”, but the current concern is regarding the variety of nicotine strengths available (from 0-11mg), which can be changed according to individual tastes by uploading a different liquid nicotine cartridge onto the e-cigarette.

The impact of electronic cigarettes has not gone unfelt by the tobacco industry – and there is some contention as to whether current reviews of e-cigarette regulation are more to do with a tobacco industry whose profits are being hit by the technology, or a genuine concern over the health and safety of e-cigarettes.

In the10 years since electronic cigarettes were first made available, however, there has been no recorded death from an individual using them, although some commentators may claim it is too early to predict the future impact on health.

However, what is known is that tobacco products kill 6 million people every year.

Electronic cigarettes began to boom in 2008, after various governments banned smoking in public places – including Scotland and later Northern Ireland, England and Wales and the Irish Republic.

Electronic cigarettes can currently be used freely in public places and are considered a consumer leisure item and are marketed as such by manufacturers.

One contradiction which may affect the current EU proposals regarding e-cigarettes is that a directive also states that for a product to be classed as “medical device”, it must have a medical purpose.

The EU will have to assess the evidence to decide whether e-cigarettes do serve a medical purpose in helping smokers quit or cut back on their tobacco use.

The EU may even classify the electronic part of an e-cigarette as the medical device – which delivers a medicinal product (eg the liquid nicotine). The charger might even be considered to be an accessory to the medical device and defined as such under the proposed review of the Tobacco Products Directive.

As a consumer item, the electronic cigarette would be governed by a different EU Directive – the General Product Safety Directive 2001/95/EC (GPSD). This does not cover food and medicinal products, but goods which are intended for use by consumers or which may reasonably be used by consumers.

Article 13 of the GPSD Directive may enable the EU to take action on the grounds of health and safety if it is thought e-cigarettes pose a health risk, allowing the EU “under specific circumstances to take temporary, urgent measures to restrict the marketing or use of products posing a serious risk to the health and safety of consumers”.

Such measures have already been seen in Italy with the temporary ban on those under the age of 18 buying e-cigarettes.

Whether vapers – the term given to those who use electronic cigarettes – should rush out and stock up on e-cigs and nicotine refills before the EU strikes is a matter of debate.

One UK public health expert, Professor Gerry Stimson, has written to MEPS sitting on the EU’s Environment, Public Health and Food Safety (ENVI) Committee about the proposed regulation of electronic cigarettes, warning against over-regulation which may drive smokers back to smoking tobacco.

“Since these products are consumer products, regulators do not have to ensure that the product is an effective smoking cessation aid,” said Prof Stimson in his letter to the ENVI Committee – and added:

“Unless the maker makes a claim for some beneficial effect, there is no need for a medicines regulator to become involved in determining efficacy.

“Many smokers have found brands that have worked for them and competition will sort out the reliable products from the rest.”

Until the advent of electronic cigarettes, generations of smokers had very little choice in how they quit tobacco – for the first time, e-cigarettes have offered even hardened smokers an alternative to tobacco which fulfils as closely as possible all the requirements of the smoking experience, without the harmful by-products of tobacco smoke and tar or the high cost of smoking tobacco.

The proposals for revising the Tobacco Products Directive will most likely be discussed by the EU Parliament in 2014 for introduction across the EU in 2015/16 if agreed.