Are the Skies Opening for E-Cigarettes?

Source from:  Tobacco Asia  03/17/2014

Two recent regulatory decisions in Europe, and the US and even bigger rulings to come in the next few months, mean 2014 could be a defining year for the e-cigarette industry. And as the political and social climates take shape, the big tobacco companies have been very active, rapidly increasing their stake in the nascent sector.

In December, New York City passed a bill that bans e-cigarette in restaurants, bars and clubs, bringing their use into line with the same restrictions placed on smokers of regular cigarettes. History has shown that where New York leads on this type of legislation, the rest of the country follows. After the city's ban on regular cigarettes in places of work was enacted in 2003, the practice soon became common across the US.

In a possibly more influential move, the Food & Drug Administration (FDA) has proposed a new rule it says will allow it to regulate "additional categories of tobacco products". The proposal wasn't due to be published for public comment until early in 2014, but it is widely thought to be aimed at bringing e-cigarettes under similar controls to those that govern the sale and advertising of tobacco. The FDA currently only regulates devices marketed as drugs or other health aids, and e-cigarettes can be freely advertised, whether or not they deliver a dose of nicotine.

In the last weeks of 2013, the EU passed its first legislation on e-cigarettes. This is due to be formally approved by EU ministers and the full parliament this year. Amid what one European MP described as "unprecedented lobbying", and despite strong opposition, the commission ruled that the majority of e-cigarettes – those with nicotine content below 20mg/ml – will be sold as consumer products. This avoids the devices being defined as medical products, which are subject to much stricter regulations.

Lobbyists have been working long and hard for e-cigarettes to be classified outside the medical sector. Ray Story is CEO of the Tobacco Vapor Electronic Cigarette Association (TVECA), one the prime lobbying organisations working with EU and US legislators. Ray will give his views in depth when he appears at the joint Bali exhibition ProToBex Asia and Inter Tabac Asia, in February, which is co-organised by October Multimedia, the publishers of this magazine.

Speaking to Tobacco Asia before the EU vote, he said, "We stand by our conviction that e-cigarettes are not a drug delivery device, should be sold as an alternative to conventional tobacco products and should be taxed as a tobacco product, even though there is no history of harm."

The EU also put through a resolution to allow refillable e-cigarettes, which appears at first glance to be a victory for the industry. But there is an important proviso. If three or more member states initiate future bans on refillable e-cigarettes on health grounds, the European commission could extend those bans to include the whole of the 28 member trading bloc.

Many people voiced warnings about the new rulings, saying there will now be a fight to show that it would not be justifiable to ban refillable cartridges on health and safety grounds.

Martin Callanan, who is the leader of the UK's Conservative party 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 Pros and Cons

And so the arguments continue. It seems obvious to the pro lobby that e-cigarettes are less dangerous to health than conventional cigarettes, for both smokers and those affected by passive smoke. Vapers – people who use e-cigarettes – don't inhale any smoke at all and no smoke is left in the atmosphere to affect people in public places. What's more, the easy availability of e-cigarettes helps smokers to quit. They may well still be addicted to nicotine and remain vapers of e-cigarettes, but most experts agree that nicotine itself is harmful only in extreme doses. However, in the absence of reliable testing, the health benefits can't be proved.

The anti lobby also argues that that allowing e-cigarettes in public places makes smoking normally acceptable again and encourages people to go back to conventional cigarettes. Or e-cigarettes might act as a gateway for a new generation of non-smokers to move on to conventional cigarettes. Again, there is no reliable research, and these are mere conjectures.

As Amy L. Fairchild and James Colgrove, respectively professor and associate professor of sociomedical sciences at the Mailman School of Public Health at Columbia, wrote in the New York Times recently, "If e-cigarettes can reduce, even slightly, the blight of six million tobacco-related deaths a year, trying to force them out of sight is counterproductive."

Another decision at the end of 2013, in a local commercial court in Toulouse, France ruled that e-cigarettes could only be sold by registered tobacconists, and ordered an e-cigarette shop to stop selling or advertising the devices. Some commentators see this as an indication of what could happen on a wider scale when the EU publishes revisions to its Tobacco Products Directive (TPD) in 2014.
One argument is that e-cigarettes becoming more intensely controlled under existing tobacco legislation will benefit the big tobacco companies more than e-cigarette companies, because they have the resources in finance, distribution and customer base to deal with the increased demands.

The Market is on a roll

One thing is certain – e-cigarettes are booming worldwide. Euromonitor International recently published estimates of an e-cigarette industry already worth $2.5 billion globally. According to some predictions that will rise to $10 billion by 2017, and Bloomberg Industries thinks that sales will outgrow traditional cigarettes by 2047.

In such a ripe climate it's no surprise to see the largest tobacco companies making their move. Lorillard, already the first big player in the frame with over half the US market, increased its share of global sales to 49% with the purchase of the UK premium brand SKYCIG in 2013. BAT (British American Tobacco) introduced its e-cigarette Vype onto UK shelves, also last year, and Philip Morris International has announced plans to enter the market in the months ahead, calling it: "the single greatest opportunity for us".

The current tangle of varying rules across the world on how e-cigarettes are classified, on advertising standards, and where they can be sold and consumed harms everyone. Closer regulation is inevitable, which will have benefits for people's health as well as for business environments and government coffers through taxation. And it can't come quickly enough for players in either the e-cigarette or tobacco industries.

Talking to CNBC following the Toulouse ruling, a British American Tobacco spokesman welcomed regulation, "to ensure consumer safety and product quality, as well as the appropriate level of innovation, marketing and distribution freedoms required to enable this important category to grow."

Ray Story said, "Global harmonization is required so the product can flow freely from Asia into all the other markets. The more commerce that exists, the fewer misunderstandings there are [...] if we have the ability to influence the process in the US and EU, the rest of the world will follow in the interests of commerce."

Testing, Testing ...

Over 200 companies currently manufacture e-cigarettes, which vary widely in quality and type. Without regulation, there will be few safety standards in place to monitor those products, which risks harming the good name and prospects of responsible e-cigarette makers. There is great demand for proven universal testing methods.

The medical journal Addiction recently published findings by Professor Jean Francois Etter, of the University of Geneva's medicine faculty, after analyzing ten of the world's most popular brands of e-liquids. In results that emphasize the need for regulation and reliable testing methods, Etter found that only ten would be acceptable as medicinal products, "while the other half contained up to five times the maximum amount of impurities specified for nicotine medications".

The study concluded, however, that if this latter group is compared with tobacco, not with nicotine medications, the presence of impurities in e-liquids is less relevant. "Even if e-liquids contained the level of impurities found in this study, 'vaping' (using e-cigarettes) would still be much less dangerous than smoking."

E-cigarettes were also a high priority at two scientific conventions – the Tobacco Science Research Conference (TSRC) and CORESTA Smoke Science/Product Technology meeting – held late last year.

Essentra Scientific Services gave presentations about new research at both, as Mike Taylor, Director of Scientific Development at the company explains. "At the TSRC conference, in Williamsburg, Virginia, we presented findings on research that specifically examined the comparative yields of a number of potentially harmful minor constituents found in the vapor of a commercially available e-cigarette against those found in the mainstream smoke of a conventional cigarette. During testing, all smoking was carried out under the Canadian Intense regime, with a standard puff profile using a linear smoking machine."

The results revealed that, other than minor alkaloids, all compounds tested were below the Limit of Detection (LOD), with the exception of formaldehyde which was marginally above.

The research shows that testing methods have been further refined, Taylor said, adding: "It also found that it is possible to adapt existing analytical methods used for the testing of conventional cigarettes to quantify levels of TSNAs, carbonyls, VOCs, phenols and minor alkaloids in e-cigarette vapor."

At the CORESTA congress in Seville, Spain, Essentra presented a research paper on the effect of puff profile and volume on the yields of particulate matter, nicotine and TSNAs in e-cigarettes. They again concluded that some aspects of tests on tobacco cigarettes can be adopted.

"For instance," Taylor explains, "the research found that methods for measuring the yields of potentially harmful compounds such as TSNAs can be modified for use with e-cigarettes. It was also successfully determined that using a standard Cambridge Filter smoke trap was an acceptable method for the trapping of nicotine in e-cigarette vapor."

Another recent study, conducted in New Zealand and published in The Lancet, was the first to address whether e-cigarettes work as an established quit-smoking aid. It reported that in the trials they were about as effective as nicotine patches, but, crucially, e-cigarette users who hadn't stopped smoking by the end of the study reported they were smoking fewer cigarettes. This is a positive result, as smoking-related illnesses are associated with the number of cigarettes smoked along with number of years smoking.

Getting Sociable

In other developments that show the rapid spread of the industry, e-cigarette producer Blackout Cigs has started accepting payment with the online virtual currency Bitcoin; and a new e-cigarette from France called Smokio connects to your smartphone through Bluetooth. Vapers can then use it to download an app that can track data about their usage and alter some functions of the e-cigarette. Among other things it can measure blood oxygenation, how much you're vaping, and estimate how much money you've saved compared to smoking traditional cigarettes.

In the UK, Gamucci last year launched what it termed "the world's first electronic cigarette airport vaping zone" at Heathrow Airport. A survey by the travel search site Skyscanner subsequently found that 57% of people, including half of all non-smokers, would be OK with the prospect of vaping lounges expanding to other airports.

There is sure to be turbulence ahead, and these might not yet be the open skies that the industry demands, but whichever way you slice it e-cigarettes are on the up, and rapidly gaining speed. Enditem