Just when smokers thought it was okay to inhale again, a debate over the safety of electronic cigarettes is threatening to cut off their nicotine.
Smokeless and odorless e cigarettes are catching on, touted in the U.S. and Europe as less harmful than real ones because they don t contain tar, arsenic and other cancer causing toxins. Yet a U.K. government decision this week to treat the steel tubes as a medicine and a plan by France to ban them from public venues raises questions about what health risks the devices carry.
E cigarettes, on the market in the U.S. and Europe since 2006, are battery powered devices that deliver vaporised nicotine and light up when puffed. Faulty e cigarettes have been known to explode, causing second degree face burns, U.K. health regulators said earlier this week. And because e cigarettes give a dose of nicotine to users, there s growing concern that the device can become addictive.
Current controls look at battery safety, electrical safety, but they don t focus on what s in the product and how it s delivered, said Jeremy Mean, a risk management official at the U.K. s drug regulator.
That s a warning shot for the small yet fast growing e cigarette market. The sector will approach $2 billion in sales by the end of 2013, and may exceed $10 billion by 2017, according to Bonnie Herzog, an analyst at Wells Fargo & Co. in New York. Demand for the smokeless devices may surpass that of traditional cigarettes in the next decade, Herzog said.
As manufacturers and tobacco companies step up their e cigarette advertising in the U.S. and as the device gains popularity on both sides of the Atlantic, the biggest concern among British and French health officials is so far unproven that e cigarettes could lead users to graduate to the real thing.
European Template
E cigarettes must become an aid to quit smoking, not a tool to enlarge the number of smokers, said Jean Louis Touraine, a Socialist lawmaker, doctor and expert on health care policy. They are becoming a fad, and many young people are being attracted to them.
In the U.S., the Food and Drug Administration intends to propose a regulation that would expand its authority over e cigarettes, though no time table has been set, according to Jenny Haliski, a spokeswoman for the agency. Regulators in Europe are moving more quickly. And the U.K. decision will probably serve as a template for a European Union ruling, said Erik Bloomquist, an analyst at Berenberg Bank.
In the U.K., the devices will be licensed as medicines by 2016 and overseen by the Medicines and Healthcare Products Regulatory Agency, which will require manufacturers to present data on the quality of their products, on how they deliver nicotine to the body and on how they compare with other nicotine replacement products, the agency said June 12.
Reduced Cravings
E cigarettes have been shown to reduce cravings and withdrawal symptoms, leading some people to cut down on smoking. And existing research has found no connection to heart disease.
Still, the devices use ingredients that can irritate the airways and cause allergic reactions, the German Cancer Research Center noted earlier this year. A study by scientists at the University of Athens found that they trigger an increase in airway resistance that lasts 10 minutes, making it harder for participants to breathe.
French Healthcare Minister Marisol Touraine said May 31 she plans to ask the country s highest administrative court to look at the legality of banning the devices in public places. Touraine cites the potential long term health impact, nicotine content and possible introduction to smoking as reasons to regulate devices that strikingly resemble cigarettes.
Some public health experts say the urge to take the safe route with e cigarettes risks is causing more harm than good.
Hand Grenades
We should be doing everything to encourage smokers to shift to new nicotine products, said Gerry Stimson, an emeritus professor of health behavior at Imperial College in London. The desire to make them safer is leading to over regulation and it will in effect turn them into a medicine and make them harder to obtain than cigarettes. It s a shame.
Many former smokers agree. This is effectively condemning people to going back to smoking cigarettes, says Dave Dorn of Sunderland, in northeast England, who adopted the smokeless tubes four years ago. Dorn, who produces an Internet broadcast program on e cigarettes called Vapour Trails that features ads for the devices, says none of those currently for sale will meet the U.K. s new regulations.
Poor Comparison
Adrian Everett, chief executive officer of closely held Zandera, says e cigarettes should be viewed as a tobacco alternative, not a smoking cessation tool. He objects to drawing parallels with the real thing.
To compare electronic cigarettes to tobacco cigarettes is like comparing playing football with juggling live hand grenades, he said in a telephone interview.
Amid evidence that more customers are adopting the product including Hollywood celebrities such as Charlie Sheen and Lindsay Lohan tobacco companies are also investing to counter declining sales of traditional cigarettes.
Lorillard Inc. (LO) based in Greensboro, North Carolina, last year acquired Blu Ecigs for $135 million. Altria Group Inc. (MO) of Richmond, Virginia, has said it plans to introduce an e cigarette later this year.
The U.K. decision may give tobacco companies and larger e cigarette companies the upper hand by mandating a costly level of product scrutiny, according to Berenberg s Bloomquist.
It s clearly a benefit for tobacco companies, he said. It will put in place requirements that they meet certain regulatory standards and they are the ones that will be able to do that.
Vapoteur Tips
In France, the product has struck a chord with people from Paris cafes to the old Mediterranean harbor of Marseille, where converts can be found sharing stories, drinks and tips on new e cigarette products and flavors.
More than 1 million people in France are now regular users, compared with 500,000 at the end of last year, according to a government commissioned report published last month. The country has more than 150 dedicated shops, according to the report, a number expected to double by year end. And users have coined a new verb to describe their smokeless puffing, the French vapoter.
Amaury Delamaire, a 20 year old student at the Sorbonne in Paris, says freedom to indulge in public places is a reason he switched.
There is no way I ll stop, Delamaire said as he popped into the AlterSmoke store in the Latin Quarter, one of the dozens of dedicated shops that have sprouted on Paris streets, for a refill. I ll just have to be more discreet.
Others aren t so sure.
Why switch to electronic if you can t use them in places where regular cigarettes are forbidden, said Marilyn Kaye, an American writer living in Paris. Regulators want to deny the right of people to enjoy themselves in a way that does not harm others. It s ridiculous.
To contact the reporter on this story Albertina Torsoli in Paris at atorsoli Makiko Kitamura in London at mkitamura1
To contact the editor responsible for this story Phil Serafino at pserafino
Have eu plans to regulate e-cigarettes as medicinal products gone up in smoke? – lexology
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The European Parliament rejected Commission proposals under the Tobacco Products Directive (“TPD”) to regulate e cigarettes as medicinal products in October 2013, but what does this mean in practice for the regulation of e cigarettes across the 28 EU Member States?
At present e cigarettes are regulated in a variety of ways across the various Member States across nine members states (including the UK) there are no specific rules relating to e cigarettes only existing consumer product safety legislation currently applies. In another eleven Member States (including Germany and the Netherlands), e cigarettes are considered medicinal products which subjects the products to stricter regulation. At the extreme, currently e cigarettes are prohibited in Greece unless specifically approved by the Health Ministry.
Under the original Commission proposal for the TPD, rules applying to e cigarettes would have been harmonized and e cigarettes would have been treated as medicinal products resulting in stricter regulation and a more costly approval process across the entire EU. Approvals for medicinal products cost on average f200,000 to secure. Regulating e cigarettes as medicinal products would also have limited sales points to pharmacies. The European Parliament rejected this proposal on in October 2013 and has now reached a compromise with the Council which will see the majority of e cigarettes regulated as consumer products.
While this should help to clarify the current regulatory uncertainty, the debate is far from over.
Although the full text of the compromise is not yet publicly available it is understood that the compromise sets mandatory safety and quality requirements, for example on nicotine content, ingredients and devices, as well as refill mechanisms. The new rules also make health warnings and information leaflets obligatory and introduce notification requirements for manufacturers and importers of e cigarettes, stricter rules on advertising and monitoring on market developments.
In relation to refillable e cigarettes the compromise contains a safeguard clause which could result in refillable e cigarettes being banned in the EU in the future.
The new rules are due to enter into force in 2016 (subject to adoption of the TPD in the course of 2014) and as such it is important that all manufacturers, exporters and importers of these products familiarize themselves with these new rules and begin considering securing any approvals that are necessary to ensure a smooth transition and continued access to the EU market.