An attempt to distill the current US situation into a nutshell:
1. The FDA is a regulatory-captured government agency and works for the pharmaceutical industry to protect its income. Where there is a clear conflict with public health imperatives and a straight decision is required to either benefit pharma or public health, the FDA always rules for pharma. They make the rules, and the rules are made to suit pharma. Pharma wins, at any cost.
2. In the UK, the pharmaceutical industry earns at least the same from smoking as the tobacco industry does (and possibly a whisker more). I don't know what the US figures show, but it needs to be appreciated that pharma earns the same amount as tobacco does from smoking in at least one country, so the same may be true elsewhere. Indeed, my projections for the UK are that pharma will soon be earning more from smoking than the tobacco industry.
The key to this is:
1. The immense value of the drug trade for treatments for sick and dying smokers.
2. The boost to all other drug sales across the board due to smoker sickness.
3. Pharmacotherapies for smoking cessation come in at a distant 3rd place.
I have guessed at the value of the smoker treatment market as $100bn globally, although this needs to be calculated more efficiently. This is for the main part of the income channel: chemotherapy drugs, COPD drugs, cardiac drugs, vascular drugs and the other related treatments and income channels. Secondly, there are additions to this from general drug sales increases due to smoking, plus OTC meds, OTC patent meds etc. This is one of pharma's main income sources and will be protected at all costs. Pharmacotherapies for smoking cessation such as NRTs and psychoactive drugs also come into the equation, but are strictly chump change in comparison (at around $3bn - $5bn globally).
So, this battle is about the vast gravy train that smoking creates; in at least one country, pharma earns as much as the tobacco industry as a result of smoking. Globally the figures are so vast that they exceed the GDP of small countries.
3. In Sweden, they reduced smoking prevalence by 45% and it is still going down (male smoking prevalence was 17% in 2003, 8% in 2012, and still falling). So perhaps in 3 years it will be 5%. Then 3%? Compare that with the ~20%+ figure for males in comparable countries. This was achieved simply by allowing free and unhindered access to Snus, plus the ability to give true information about the risks (virtually zero). Since Snus has no statistically-demonstrable elevation of risk for any disease, it follows that a reduction of smoking prevalence of 45% by a population-level switch to Snus might be followed by a reduction in smoking-related death and disease by 44% - 45%. This is proving true in practice, with the result that Sweden has the lowest smoking-related mortality of any developed country by a wide margin. It's called the Swedish Miracle for obvious reasons: no other country has the slightest chance of achieving such a drastic reduction in smoking-related morbidity and mortality.
4. Developments in Sweden have been a disaster for pharma, as many fewer are getting sick and dying, and sales of NRTs are poor. Pharma is absolutely desperate to stop the Swedish scenario spreading elsewhere. A reduction of about 45% in pharma's income is not something they are keen on.
5. We also know that ecigs are more popular with smokers than Snus - considerably more popular in fact. This is especially true of female smokers. Access to Snus reduced smoking by 45% in Sweden, leading to a smoking prevalence of 11% averaged across male/female (8% male, 15% female approx.) at Q4 2012. Male smoking was reduced by 55% in Sweden as only around 8% of Swedish men now smoke, which is another unique feature of the Swedish situation, since in all other countries (I believe), male smoking prevalence is higher.
Because e-cigarettes are measurably more popular (two reasons: the explosive uptake which has occurred and has been many times faster per year than Snus uptake; and the outselling of ecigs vs Snus in places where both are sold, such as some areas in the USA) it seems reasonable that e-cigarettes could reduce smoking prevalence by more than that achieved in Sweden - perhaps by as much as 60%, in a country where they are fully permitted and unrestricted.
Anecdotal reports from within the community suggest a 75% - 80% success rate, but this is unlikely to be replicated in the real world because the key to all processes of this nature is effective mentoring - and we know that the majority of ecig buyers won't get any. Nevertheless, we have to assume that ecigs will outperform Snus (eventually) because to say otherwise makes no sense. Like many, or even all, questions in this area, the main variable is just the timescale; what will happen is inevitable, though no one can really estimate the time points accurately due to the number of factors.
6. Also, the US smokeless tobacco situation needs to be factored in. There is a long tradition of oral tobacco use, now being expanded by new products such as orbs, strips, dissolvables and so on. In fact the US tradition is richer than other places and certainly when compared to Europe, where everything apart from cigarettes is commonly banned or unknown in many/most places. This affects the gradual move away from cigarettes to THR products, in the US, because there is already an appreciation that there are other options. Modern smokeless tobacco products are low-risk compared to the old days, and as the public become more educated in alternatives to smoking, the US has a wider variety of options that can be used compared with other countries. Perhaps this means that although we can expect an eventual shift of about 50 - 60% of smokers to e-cigarettes in the UK (after several decades - let's make that clear), the percentage will be even higher in the US, as a combination of options is available, not just ecigs, and the population have more awareness of the alternatives.
7. Pharma is desperate to find a solution to this. They are absolutely committed to preserving the status quo at all costs. There is sufficient reason to think they pay off government staff and assorted medics to do their dirty work for them: first a propaganda assault is needed, then some juicy lies that can be repeated ad infinitum; and then the bought & paid for government regulator can claim there is some justification for restricting access to ecigs. Remember that pharma eventually stands to lose a cool $60bn globally per year if ecigs are freely available everywhere (i.e. if an eventual global 60% switch to THR, Tobacco Harm Reduction, takes place); I haven't worked out how much they will lose in the US if a 50% switch to ecigs and Snus occurs but you can see that it will eventually be tens of billions of dollars.
They are sure to pass that pain on to their pals in the FDA. The gravy train needs to be protected, and it will be, at all cost.
8. The FDA thought it was on solid ground when it tried to ban ecigs back in 2010, but got a bloody nose in court. Lies and propaganda work well in the media but the courts tend to require some sort of evidence.
9. The FDA can't give up just because Plan A failed. They have to go back and try again. Plan B will be to gradually apply more and more of the tobacco legislation to e-cigarettes. If they fully succeed (which is unlikely) then effectively ecigs will be banned and will have to go to the black market to survive.
As stated, this is unlikely. However there is a very strong likelihood they will manage to get some sort of 'light touch' or 'sensible' regs in place to 'ensure the safety of consumers'. Such regulations, once the legal framework is in place to apply them, will get stricter and stricter every year, with the intention of strangling the life out of the e-cigarette market. This method is well-known and called stealth regulations or the backdoor approach.
10. It is likely to be some considerable time before any of this affects consumers. There will be an almighty row if/when the FDA start down this road, because there are now around 3 million e-cigarette users in the USA, in other words about 6% of the 47 million smokers have switched. These would basically be forced back to smoking (or to the black market), and there are probably too many vapers now to push through draconian regulations to benefit pharma and their pals. Nevertheless we have a fight on our hands, make no mistake.
11. The longer we can extend this process, the better. The more of us there are, the more it becomes a voting issue - and that makes them listen up. The politicians are happy to let the FDA get on with it and fill their boots, and some of them no doubt join the FDA senior management at the trough. But when votes come into the equation - then they wake up. We have 6% of smokers now but need a lot more. At some stage we'll reach 25% without a shadow of a doubt - the question is simply when, not if. Certainly by 2025, and maybe even by 2020. At that point we will have too much clout to ignore.
12. This is a long road with a lot of battles to be fought. I am in no doubt whatsoever that all these issues will have been resolved in 20 or 30 years' time, as you can only suppress the truth, or maintain a prohibition, for a finite length of time. The problem lies between now and then...
What is our campaigning goal?
So to answer your basic question: are we trying to influence the FDA? The answer is that they work for the opposition, so this is a lost cause. In any case you'd have to find some way of matching their price dollar for dollar plus a bit, which is unlikely.
The same goes for some of the political processes involved: there are such huge sums of money involved that it is extremely naive to think that everyone can be persuaded by the health issues; these are probably irrelevant when smoking generates income streams worth hundreds of billions of dollars, and vaping (and other Tobacco Harm Reduction, THR, solutions) will cut all of that by 25%, then 50%, then maybe even 60% in time.
I'm not sure why people can't see that this is the core issue.
Our job is instead is (1) to convince everyone else that ecigs are the way to go - i.e. that THR is the best solution we have - and especially those who have power channels that bypass the FDA; and (2) expand vaping so it can't be swept under the carpet.
The key issue will always be: how to make the saving of life due to public health advances in the smoking area more important than the power and influence of people earning tens of billions of dollars from smoking, who obviously need to preserve the status quo. If you know the answer to that question then let's hear it...
How to go about point #1 is the current debate, and it probably always will be - how to locate friends and work efficiently. As far as #2 goes it's a done deal, because once the genie is out of the bottle you can't put it back; at some point there will be 50% of the current smoking prevalence in the USA as half of smokers will inevitably switch to ecigs, US smokeless products and Snus. Part of our job is how to ensure that process goes as smoothly and quickly as possible, without involvement of a black market at some stage.
The sooner we reach 25% of smokers the better, so vape proud and pay it forward.
