Lack of regulation is a drag

Dithering regulators and a complete absence of conclusive clinical research has left e-cigarette brands guessing about how they should manufacture and sell their products, writes Dan Matthews

In July, armed anti-terrorist officers swooped on a bus as it passed through the M6 toll crossing near Lichfield in Staffordshire. A nervous passenger raised the alarm calling 999 when they saw “smoke” rising from an electrical device being carried by a fellow passenger on the bus.

A seven-hour ordeal ensued involving 16 fire crews, nearly 30 police-vehicle teams (plus ten unmarked vehicles), ambulances and sniffer-dog units. The Federation of Small Businesses estimated the toll closure could have cost the economy millions of pounds in manpower and lost productivity for commuters caught up in the madness.

But what the authorities feared was Al Qaeda’s next “big hit” was in fact something much more prosaic and inoffensive: a member of the public satisfying their nicotine cravings with a couple of cheeky pulls on an electronic cigarette.

This incident is the most dramatic in a long-line of misunderstandings about what e-cigarettes are and whether they have a place in the everyday world. Although e-cigarette vaping is permitted anywhere under UK law, including in public buildings and on public transport, people using e-cigs regularly find themselves turfed out of pubs, cabs and shops.

At the centre of the confusion is government and more specifically ministers’ seeming inability to make a decision on how nicotine vapour devices should be classified, despite the fact that they have been around for years. When it eventually arrives, this decision will impact on the whole industry in the way the products are constructed, marketed, sold and consumed.

Ask any of the government or non-governmental health organisations about their stance on electronic devices and their responses will be vague. This is because they take their cues from the Department of Health which is set to make a ruling on the matter in spring 2013.

The future of electronic cigarettes should be determined by long-term studies into their use and safety

When asked for a response, the National Institute for Health and Clinical Excellence (NICE) simply says: “Electronic cigarettes are not currently licensed, so we have made no recommendations about their use.”

The Medicines and Healthcare products Regulatory Agency (MHRA) has a more committed stance. “Our view is that products designed to help you beat the addiction to nicotine can fall within the definition of a medicinal product. We would regard any e-cigarette presented as an aid to quitting smoking as being a medicinal product.”

But then, unhelpfully as far as electronic cigarette manufacturers are concerned, the MHRA adds: “In the UK, it is illegal to sell e-cigarettes as a ‘quit smoking’ aid unless they are licensed as a medicine by the MHRA.” Which, of course, none of them are and this is why NICE is unable to take a stance.

Licences require a significant investment of time and money in clinical trials. These trials are underway and are ongoing, and they will most likely result in electronic cigarettes being classified as pharmaceutical products.

If, as expected, this happens it will turn the whole industry on its head. Left unchecked for ten years, the majority of brands have evolved into lifestyle consumer products for pleasurable consumption with a drink or in conversation, not to be taken in doses like pain killers.

As consumer products, they are covered by a thin layer of legislation dictating aspects of the online sales process, the disposal of electrical goods and the supply of chemicals to the public. As a pharmaceutical product, the rules become more numerous and harder to comply with.

“Electronic cigarettes still deliver nicotine, which is a highly addictive and toxic substance, and therefore cannot be considered a novelty,” according to the European Lung Foundation. “There is also a risk that young people will use these products for experimentation and initiation of tobacco use; studies into this are currently being performed.

“There are serious questions to be addressed as to whether the devices create or sustain addiction to nicotine and the behavioral aspects of smoking, and as such we would not advocate exchanging one smoking device for another.

“The future of electronic cigarettes should be determined by long-term studies into their use and safety.”

Faced with the prospect of having to adapt to the label of a pharmaceutical product, but also a potentially drawn-out wait for that to happen, many of the cannier brands are choosing to self-regulate with measures that reflect a more responsible stance on vaping.

One such example is Electric Zebra which, like other brands, claims to be a healthier alternative to traditional cigarettes by stripping out most of the toxins and cutting out harmful emissions of smoke that others endure second-hand.

Each cigarette is heavily stylised with zebra-print finish and at the tip an LED light that glows green each time you take a drag on the device. But Electric Zebra director Gerard Holmes says his products are only available to over-18s, unlike tobacco which can be purchased by 16 year olds in the UK, which mitigates the attractiveness to younger smokers.

He also claims that the extra design work is to help vapers show that they are not smoking a cigarette when they use the electronic cigarette in public. That might not have prevented the M6 snarl-up, but it could have averted confusion in other less headline-grabbing instances.

“The problem we’re seeking to overcome is the confusion that exists at the moment,” says Mr Holmes. “If a landlord sees someone using an electronic cigarette or if another customer complains that someone is ‘smoking’, then the easy next step is to say they are causing confusion and that they should stop.

“The whole point of the Zebra brand and communication is the distinctively different approach that Zebra has. Across a crowded room, you can see very clearly that this thing is not a cigarette. That approach has proved popular with the hospitality industry.”

The government is due to finalise its position on nicotine delivery products in a few months. This will likely be just one step in a long process that will result in the proper classification and regulation of electronic cigarettes. Until then, the industry will just have to keep on guessing.

STATEMENT

Official research projects?

According to the Medicines and Healthcare products Regulatory Agency (MHRA):

“The cross-government view is that proportionate, ‘right-touch’ medicines regulation is the most appropriate framework within which to regulate all nicotine containing products (NCPs) and this was the basis of the government’s consultation on the regulation of nicotine.

“The right from of regulation will support and stimulate innovation of the nicotine market, which will have a positive impact on delivering harm reduction. Further work to inform a final decision is ongoing and the government plans to finalise its position in spring 2013.

“Little is known in relation to quality, safety and efficacy of novel NCPs, such as electronic cigarettes, as these products are not currently regulated. There remain clear gaps in knowledge regarding these products, in particular around the contents of the cartridges, the properties of the vapour they generate and whether these products are safe or effective.

“Sound research evidence is required to determine the risk of the continuing availability of these products and to inform the decision on regulation of NCPs, such as electronic cigarettes. The MHRA is discussing the commissioning of two research projects to help fill the knowledge gap relating to the important questions of quality and safety of electronic cigarettes on the market.”