ECF Policy - Classification of E-Cigarettes

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rolygate

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    The ECF viewpoint on ecigarette classification and legislation


    What is an e-cigarette?
    An e-cigarette is a consumer leisure product that supplies nicotine, as an alternative to smoking a cigarette. It supplies a cool mist vapor that contains on average less than 10 constituents (and sometimes as few as four), as against the 5,300-plus identified in the latest research on cigarette smoke.

    An ecigarette is also commonly used with zero nicotine content, as a cigarette-type pacifier and displacement activity facilitator. When used in this way, by approximately 7% of users according to polls, it is of course neither a nicotine supply device nor a tobacco product.


    Legislation and the e-cigarette
    As they are a fairly new phenomenon, involve the use of a potentially addictive substance, are in a no-mans'-land where tax is concerned, possibly conflict with current legislation that forbids the introduction of new tobacco products, are the subject of complaints from various vested-interest groups, and are generally an unknown quantity, governments are unsure as to what action to take regarding ecigarettes.

    As always, the safe route is to ban it, or place it in a category of maximum control and minimum free variation. Therefore some countries have enacted bans, and some are considering placing ecigarettes in the medicinal category.

    In most cases the loudest voices have been those of various pressure groups funded by the pharmaceutical and tobacco industries, who are dedicated to eliminating ecigarettes in order to protect their incomes. The consumer has not been heard - or their voice has been drowned by the huge sums of money at the disposal of the pharmaceutical and tobacco industries.

    Consumers clearly want to be left alone to enjoy their nicotine, alcohol and caffeine products as they see fit. Doctors have expressed the opinion that ecigarettes are probably 1,000 times safer than tobacco cigarettes - but again, their voices have not been heard.


    What ECF supports
    ECF supports the classification and taxation of the e-cigarette as (in the following order):

    1. A consumer product of the same type as tobacco or alcohol
    2. An alternative nicotine product of the consumer variety
    3. A Harm Reduction product
    4. A tobacco product

    ECF does not support, and will actively assist campaigns against, the classification of all e-cigarettes as a pharmaceutical or medical device of any kind, or as a medicine. Neither cigarettes nor alcohol are licensed medicines and there is no reason to classify e-cigarettes as a medicine since they are clearly not and clearly a consumer product; and, according to the majority of doctors who have expressed an opinion, clearly safer than tobacco cigarettes.

    If a distributor with large resources wishes to clinically trial and license a specific product as a medical device, then in the opinion of ECF, it is their right to do so. There is no reason why the manufacture, testing and licensing of a specific product as a medical device should affect any other product. Indeed, it is impossible for products that have not been through this process to be classified as medicines. ECF will support the marketing of consumer products and medical products as they are different and both have a legitimate use.


    Harm Reduction
    'Harm Reduction' has two distict meanings: (1) it specifically means a consumer choice process; and (2) it is a blanket term for all forms of consumer choice or alternatively medical treatment using less-harmful products. In fact, correctly applied, Harm Reduction is mainly a consumer choice process that involves such products as low-alcohol beer, decaf coffee, and ecigarettes - ie general consumer products that are seen as beneficial when compared to other products.

    The medical variant is specifically referred to as Harm Management. This process involves the use of licensed medicines or devices. Therefore when correctly used and applied, 'Harm Reduction' is a consumer-led process and 'Harm Management' is a medical-oversight process.

    The main thrust of modern medical treatment for the treatment of addiction to potentially harmful substances is by Harm Management. This involves alternatives to quitting, to either reduce the potential for harm, or to provide a way to reduce dependency.

    The older method of treatment, which centered around the premise that the best solution was to make the patient quit, has been discredited due to the poor success rate.

    E-cigarettes are the most promising Harm Reduction system in existence for anything. They are a consumer choice that is seen as a better alternative to tobacco.

    E-cigarettes are not a Harm Management mechanism because they are not medicines and are not sold as medicines. They are not licensed pharmaceuticals and would not qualify as such, since (a) they do not claim to be, and (b), they do not contain any medicines (substances that are exclusively available only as licensed substances when used for human consumption). The ingredients in ecigarette refills are commonly found in foodstuffs or other types of products consumed but not licensed. Ecigarettes are not designed, manufactured, or sold to treat any disease or condition, they are an alternative nicotine or alternative vapor supplying consumer product.


    Classification of e-cigarettes as a medicine

    It is clear to everyone, except some government bodies keen to increase their territories, that use of an ecigarette is analogous to drinking a cup of coffee. Despite this, the move to classify ecigarettes as a licensed pharmaceutical is prevalent in some countries. There are many reasons for this but the weight of funds provided by the pharmaceutical and tobacco industries has to be the key factor - after all, no one complains if a new brand of whisky is brought on to the market.


    Why do they want to call ecigarettes a medicine?
    Quite simple - to kill them off.

    The pressure to classify e-cigarettes as a medicine is driven by the pharmaceutical and tobacco industries, since such a classification would result in the disappearance of 99.9% of e-cigarette businesses, together with a price rise of many hundreds of percent, and a reduction in choice of 99.99% or more. This would protect the sales of the pharmaceuticals used to try and quit smoking (again and again - because the success rate is so low*) and tobacco cigarette sales.
    * The success rate for NRTs (ie for those who manage to quit smoking tobacco for a period exceeding one year when using licensed medical products) is said to be a maximum possible figure of around 7%, although some reports indicate a figure as low as 1.6%, little more than the placebo success rate of 0.75%. This very poor performance is not widely reported.

    We think that government revenue departments are unlikely to assist the classification of ecigarettes as a medicine, when correctly apprised of the facts, since such a classification would immediately destroy the legitimate market and reduce it to 1% of its current size or less, and cause virtually the entire market to become an underground-supplied market, with all the negatives that implies. Since ecigarettes will gradually replace cigarettes on a larger and larger scale - with or without the assistance of governments - it would appear sensible to legitimize them and tax them. Since the unit cost is commonly between $40 and $100, and refills are commonly around $15, tax revenue even at standard sales tax levels will run to millions. Classification as a medicine would reduce the tax revenue by 95%.

    The consumer has every right to choose their method of caffeine, nicotine or alcohol consumption, and just as they are able to choose between thousands of alcoholic drinks and hundreds of cigarette brands of varying sizes and strengths, they also have the right to choose alternative nicotine products of different types, especially when several doctors' groups have commented that safety is likely to improve dramatically.

    Any attempt to restrict consumers' choice is a direct attack on their rights, and will force smokers to return to tobacco cigarettes and a one-in-three chance of early death. This is clearly an attack on their human rights, and sentencing hundreds of thousands of people to death is hardly justifiable. There is no alternative for the majority since NRTs clearly do not work, by any reasonable measurement of efficacy.


    E-cigarette classification as a medicine: the likely result

    It is ECF's opinion that if classified as a medicine, the following will occur:

    • 99.9% of current retailers and wholesalers will be forced to cease legitimate trading.
    • An initial period of reduced supply will ensue.
    • No manufacturers will cease operation as ecigarettes are a global consumer product. Manufacturers are supported by their individual governments as the revenues and jobs are desirable, and no effective pressures can be exerted by countries that do not wish to import the products since the products are a legitimate consumer product and have no known negatives.
    • Global supply is fluid. There is an overabundance of product. Supply will remain at the current level externally, and will eventually re-penetrate the individual market area.
    • An underground supply system will be established.
    • The black market will grow to proportions so vast that it is impossible to control - certainly to ten times the size of the illegal drug market, if not larger.
    • Consumer demand will rise due to media publicity. Usage will grow since the item becomes a fashion trend, is publicized by the media, has no known negatives, is desired by a sizeable portion of the population, and becomes a symbol of resistance to government interference.
    • Young smokers will obtain the product as it becomes a fashion item of increased desirability. Older adults obtain the product because they feel they have a right to use it and see government interference as an increasing issue in their lives. Seniors obtain the product because they see themselves as being better placed to determine their own needs than government. Everyone sees the obvious benefits and resents government intrusion.
    • Harsher and harsher penalties have to be introduced. People refuse to pay fines and are jailed. Large numbers of people are criminalized by association with the product.
    • Human rights cases are brought against the government since they are in effect condemning people to death by forcing them to return to smoking tobacco.
    • Government spends millions, if not billions, on preventing the use of something with no known negatives that could easily be permitted and taxed.
    • The entire process helps to create a powerful fashion trend that is unstoppable by any government, even though huge sums are expended to try to do so.
    • Pressure by consumer groups, public opinion and the medical establishment grows. Eventually, use grows to such a scale, and pressure from voters, other groups, and factions within the government increases to such a level, that government is forced to do a U-turn and legitimize the product.
    • The end result is a defeat for government, the waste of vast sums of money, a massive increase in disrespect for the law and contempt for government, a victory for consumers and common sense, a clear improvement in public health, an increase in the power and income of criminals, and the loss of legitimate tax revenue.
    Above all, the result is certain - it's happened before. The difference this time will be one of scale: to try and prevent such a genuinely desirable consumer product will be tantamount to standing in front of a tsunami; and all simply to protect the income of a few pharmaceutical companies.


    Implications of Prohibition

    The classification of ecigarettes as a medicine is effectively a ban.

    Prohibition does not work, and when applied to a large-scale consumer product, cannot possibly succeed - as has been seen before. When added to the fact that ecigarettes have the potential to be the largest and fastest-growing consumer trend of all time, the banning route (as medical classification most certainly is) seems somewhat ill-advised.

    The only people who would benefit in any way are criminals, pharmaceutical companies and certain government employees. Pharma is desperate to stop ecigarettes, and their funding currently seems to be having fair success.

    Since the manufacture of ecigarettes is a large-scale industry, introducing unrealistic controls cannot be successful since a vacuum is created and supply is more than sufficient to fill that vacuum. As an example, there are dozens of large manufacturers who would not be curtailed in any way by their regional governments (in fact the opposite of course). The annual turnover of just one of these manufacturers in 2008 was $36m - thirty-six million dollars.

    Manufacture is a large-scale operation, is supported by their respective governments and will never be restricted due to the welcome revenue earnings - and is likely to grow rapidly.


    Why even consider a ban?

    From the practical perspective: prohibition does not work when the product has high demand, there are unlimited supplies, consumption has no known negatives and is supported by public opinion. It has not worked for consumer products of large physical size when compared to an ecigarette; and if applied to something of such small size is even less likely to work.

    From the medical perspective: respected and independent doctors, doctors' associations, and health groups have stated that ecigarettes appear to be 99% safer than tobacco cigarettes, or 1,000 times safer according to one authority. The doctor considered the leading expert has stated, "It is impossible for ecigarettes to cause lung cancer".

    From the cost perspective: it is difficult to understand the attitude of government departments in some countries at present, assuming they are fully apprised of the facts. Huge sums of money will be expended in the fight to prevent ecigarette sales - to no avail - and large amounts of tax lost. It must simply be the effect of the funds the pharmaceutical industry can apply to protect its income. Such expenditure can only be a rearguard action in any case since in the long term any ban (ie pharmaceutical classification) will be overturned.

    Nothing ever demonstrated the divorce of government departments from reality so well - except the previous instances of the same loss of sanity. It's happened before, in the US and UK, and it seems that government has forgotten.


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