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E-Cigarette Regulation - The Lancet

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Prof. Polosa is a pulmonologist with specialisms in airway provocation, immunology, smoking cessation and e-cigarette research. Among pulmonologists, he may be uniquely qualified to examine e-cigarette pulmonary issues. With his colleague P Caponnetto, also experienced in ecig research, he has published an opinion on e-cigarette regulation in The Lancet.

Regulation of e-cigarettes: the users' perspective
Riccardo Polosa, Pasquale Caponnetto
www.thelancet.com/journals/lanres/article/PIIS2213-2600(13)70175-9/fulltext

Overview

The opinion piece is balanced though favourable to e-cigarettes. It advocates what might be termed an uprated form of consumer regulation as opposed to medical regulation. In particular, it mentions (probably for the first time) the possibility of utilising the dietary supplement regulation system, as this provides a format for sensible consumer product regulation that is neither too onerous nor too lax.

There have been alternative approaches advocated by others, such as proper enforcement of existing consumer product regulations (in the EU), or cosmetic regulations to be used as a basis for a new system for leisure nicotine-containing products. Both of these have advantages although there seems to be no current system in existence that could be universally applicable and workable. The multitude of issues include:

  • In the EU, consumer products are so strictly regulated that there is no room for any contamination, packaging or labelling issues - these areas are stringently regulated. The products must comply with 17 statutes.
  • A 'federal' alert system for EU consumer product inspectors, the RAPEX system, adds to the protection layer.
  • In the UK, due to the combination of EU-standard consumer product regulation plus local inspectors in every area closely examining e-cigarette products (both in stores and online vendor premises), the products may be uniquely safe.
  • In addition, it is very easy indeed to show that consumer products in the UK are far safer than pharmaceutical products (for any comparative factor used: the relative mortality rates, the ease of removal from the market, the penalties imposed on transgressors - for example).
  • However, in the USA, there seems to be a lack of local inspectors visiting every store and online vendor to examine products and marketing, and to take away products for inspection, testing and analysis (as is normal practice in the UK). Therefore, whatever regulations are in force, there seems no practical way to enforce them down to micro-local level; no doubt this is due to the huge scale of the mechanisms required, together with the high cost.

Consumer protection

The protections advocated by Polosa et al are not just sensible but inevitable: it is impossible that a situation will endure where products designed for high-frequency long-term inhalation by millions of people are not widely subject to specific controls. Naturally, we are talking about new products here and not cigarettes, which by a combination of 'grandfathering', political expediency, and the huge revenues smoking generates are protected from any realistic control (since the implementation of even basic modern safety standards would mean cigarettes would have to be removed from the market). Thus, a new product that essentially substitutes for cigarettes will become subject to controls that should be applied to cigarettes but are not.

In the medium term we will see increasing pressure to regulate e-cigarettes, and in the long term such regulation is inevitable, despite the fact the product they compete with is uniquely dangerous. In the modern consumer product environment, each product is measured on its own merits and not what it competes against; thus, e-cigarettes will probably have to demonstrate very low levels of risk elevation in order to survive.

There are other factors of course, the most important of which is quite simple: it is impossible, in practice, to ban anything. Therefore, economic considerations must be a core factor in regulatory policy. The black market will simply replace any volume lost to regulatory pressures.

Realism

Polosa correctly points out that regulatory pressure is mainly driven by the threat of lost revenues rather than any real risks. This point is obvious even from the short period of eight years' product usage we have data for: other products with real and concrete risks, introduced at the same time, have a terrible record for mortality and harm; ecigs have an almost perfect record despite millions of user-years to date.

Perspective

At last an expert in tobacco control and e-cigarettes has pointed out that the users' perspective is the most important. There is a continual background hum in these sorts of debate about 'stakeholders'; and although it should be fairly obvious that the millions of people who will live or die by the regulatory decisions made are the main (and only important) stakeholders, this self-evident fact seems lost on those making policy, since the consumers are always deliberately excluded from any decision-making.

In fact, decisions in this area are always, universally, and exclusively, made for financial and not health reasons. Polosa illuminates this nicely, although in the reserved tone used by medical professionals of his stature. The rest of us would probably not be quite so polite about it. At least he has gone so far as to point out that this is not really a medical issue, it is a consumer and financial one - and this probably counts as heresy in the medical world, since medics as a group appear to think everything that remotely affects health is a medical issue and needs stringent regulation or the sky will fall.

 

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