E-cigarettes have two possible lines of development: as a consumer product and as a medicine. Think coffee aka caffeine: a consumer drink in one form, but a medicine when the caffeine is used for medicinal purposes. E-cigs are exactly the same. Just as it is perfectly logical for people to drink coffee or take caffeine in a medicine, an e-cig (and nicotine) can function in the same way, as two different classes of product.
Intellicig would first obtain a pharmaceutical license in the UK, and that seems likely this year.
An e-cigarette licensed for pharmacotherapy would be advertised at first to doctors as a quit-smoking product, then perhaps be available OTC in pharmacies. It would be supplied, packaged and used in a different way to the (basically identical) consumer product: it would be an entirely separate product line, subject to increased quality controls, and the refills would be supplied as doses - not free-form cartos or bottles as for the consumer version. A carto would be presented as containing for example 20mg of nicotine (in total) as a dose, not 18mg/ml or even 1.8%. So the presentation is different although the product is essentially the same.
They would run for a while there, building up experience and data on the usage of this new product. Then the application process would start in the US. This costs a lot of beer coupons so it's probable they would license the product to a US pharmaceutical company that wants the product and could expedite the process. Intellicig have just borrowed $3m for UK licensing and promotion costs, so may not want to get into more debt until they have some cashflow.
The FDA will license any new medical device or therapy that appears to work and be acceptably safe, and does not clash with policy or the industry's agenda. The last item is the problematic one. The pharma industry is extremely resistant to e-cigarettes because of the very real threat to their income. On the other hand, some elements within pharma will be keen to capitalise on this new product line, especially if they don't sell any of the big money-spinners such as chemotherapy drugs. These will take a big hit eventually as e-cigs become more widely used. So perhaps in the end we will see a contest between elements within the pharma industry over this.
I would expect resistance to be strong at first, then later on as reality kicks in, and millions of consumers switch to e-cigs, pharma will realise that it's better to be inside the tent. The progressive elements within pharma who need new product lines, and those who don't depend on smokers getting sick for a major slice of their income, will win out in the end, although it is impossible to put a timescale on that kind of thing.
When pharma has decided to go for it, it's as good as done. The FDA does what their paymasters tell it to.
It is inevitable that e-cigarettes will develop into two separate product lines: consumer and pharma. There is no logical reason why there should be any difference from the way coffee / caffeine is treated. In practice there are a huge number of obstacles to that, not least the fact that the arrival of e-cigarettes is going to have major financial repercussions in every corner of life. Some cities and States depend on tobacco money for their survival - smokers pay for everything, with the vast contributions of tax and funding from the MSA. That will all be under threat one day, as a 50% cut is foreseeable.
