Thank you for a well-balanced article about electronic cigarettes. Can I correct some minor errors?
"The licensing process usually includes scientific tests and trials and often results in health warning labels on packaging or bans on sales to minors. Simply applying for MHRA marketing authorisation can cost over £100,000, and the cost of large-scale clinical trials can run well into the millions."
The figure of £100k for licensing costs is the one that I produced as a result of meeting with the MHRA at the E-Cigarette Stakeholders consultation meeting last year. It has become recognised as the base cost of the simplest-possible MA application, as it is fairly realistic: £28,000 for the license; £60,000 for the cheapest possible research trial that would need to draw on plenty of previously published research of a similar nature in order to come in at this figure; and £12,000 for documentation and legal fees. As you can see, this is a bare-bones costing, so in some cases it would be double this or more. Your quote of several millions is correct, in cases where a new medicine with no previous published work is available to utilise. This would most likely not apply in the case of an e-cigarette or refill liquid as there is a wealth of previous research on the inhalation of the materials involved.
We think that it may be possible for an e-cigarette wholesaler/retailer to license a basic product for £100k or more likely £150k. However, since the absolute smallest e-cigarette business has around 5 different hardware models and 20 different types of refill liquid, exactly where does this leave the unlicensed products? Illegal no doubt - which is why 99% of the trade will shut down, and the largest black market ever seen will start up. Remember, it won't be illegal to buy them from abroad and have them mailed in. Anything you want is one click away on the internet.
"Tobacco industry research has demonstrated that fruit and sweet flavours increase the social acceptance of cigarettes, their excitement factor and curiosity,' says Dr Jonathan Winickoff, chair of the American Academy of Pediatrics Tobacco Consortium. 'E-cigarettes are being marketed as an entry-level product for children and young adults who are nicotine-naive. Once a youth has decided to try an e-cigarette, there's nothing that protects him from getting addicted to nicotine and later using regular cigarettes."
...is a quote from a front organisation funded by the pharmaceutical industry, and is utter twaddle. E-cigarettes are not marketed anywhere for children - why would they be? Since they cost from £35 / $50 to £100/ $150 and require a credit card for web purchase, and will be delivered with the retailer's logo and marketing message on the package, it seems unlikely that many children would be able to purchase them. Cigarettes are free from a pal, why go to those lengths?
The pharmaceutical industry is going to be the biggest loser as more smokers change to e-cigarettes. Nobody will need their expensive and virtually useless smoking cessation drugs if smoking is no longer harmful. Why quit if it's as harmless as drinking coffee? These cessation drugs (called NRTs) have a failure rate of at least 93% - some research says 98% - so guess which route people will choose if they can buy an e-cigarette instead, which at least 60% of smokers trying them have found easy to change to?
Because of this they are waging a war to get ecigs banned, and their money is being spread around judiciously. Find someone who says e-cigarettes are harmful, or sold to children, or need to be regulated as medicines, and you've found a home for the pharma money - it's as simple as that.
They have been used by millions of people worldwide for many years, and not a single incident of morbidity or mortality has been reported. Contrast that with the hundreds of deaths from smoking cessation drugs such as Chantix - still legal, still fully supported by the FDA and MHRA (I wonder why). In the court cases the FDA lost, and in the requirements for medical licensing that the MHRA had to complete, they were asked to provide some evidence that e-cigarettes are harmful, or could possibly be harmful. There is none, so they lost. All the ingredients are in approved OTC medicines or cake mixes
Ask yourself: what else could be used globally by millions of people for many years without a single report of harm (and you can be sure that the FDA and MHRA looked *very* hard indeed)? Not even coffee, I should think.
Two other pertinent facts:
1. Most e-cigarette users change to a different flavor from tobacco after a month or two. As the sense of taste repairs and renews, tobacco is less attractive than chocolate or caramel flavour. Why stay with burning plant flavour when you can have toffee or blueberry cheesecake? That doesn't make any sense. Some people make their own refill liquids*, and tobacco flavour doesn't come high on the list of popular recipes. Peppermint, coffee and vanilla from the local store's cake flavouring shelf are far more popular.
* Some people don't use nicotine any more, so it's easy to make a refill liquid from glycerine and cake mix flavours. That's all that's in there - maybe a bit of distilled water as well. Lethal stuff, huh?
2. The membership of the largest e-cigarette community site, www.e-cigarette-forum.com, seems to be predominantly over 40. There are a multitude of over-50s and over-60s. The age group least seen there is under 30. Under 20 doesn't appear to exist - and we know how kids love the internet and forums. E-cigarettes therefore seem to be used primarily by those who have realised their health is being compromised by tobacco.
So: banning something that is essentially harmless and will save millions and millions of lives doesn't make a lot of sense. The people who will feel the pain are in the pharma industry, and their paid agents. Next time you hear someone spreading lies about electronic cigarettes, keep that in mind. Ka-ching!