Farsalinos: e-cigs need a fresh legal approach

bear in the woods - George Pankewytch 900x540Two of vaping’s most eminent scientific advocates have called for bespoke regulatory regimes that follow neither the tobacco nor the pharmaceutical model, but they acknowledge that formulating appropriate rules can be a “very challenging process”.

Konstantinos Farsalinos and Jacques Le Houezec write in the journal Risk Management and Healthcare Policy that “e-cigs are not tobacco products and are not used as medications. For this reason, a specific regulatory scheme is needed.”

They are opposed to medical regulation partly because the high cost of compliance would stifle innovation and make it difficult for smaller firms to produce e-cigs; and to tobacco-style regulation because “it makes no more sense to argue that nicotine-containing e-cigs are tobacco products than to argue that biodiesel is a vegetable product because it is derived from plants”.

However, they favour the model imposed by the European Union’s Tobacco Products Directive (EU TPD) over that proposed by the U.S. Food and Drug Agency (FDA), saying that “although there are many unnecessary and unexplained restrictions…the regulation proposed by the EU is more moderate, feasible, and financially sustainable compared to the U.S. FDA proposal”.

Farsalinos and Le Houezec support warning labels, some restrictions on ingredients based on modified food industry standards, and toxicology testing. They say that “advertising and marketing should not be banned, but appropriately regulated in order to encourage use by the intended population while avoiding use by never-smokers”, observing that “there is no reason for never-smokers to be exposed to any (even minimal) risk by initiating e-cig use”.


Overdosing on precaution


Their paper, “Regulation in the face of uncertainty: the evidence on electronic nicotine delivery systems (e-cigarettes)”, explores common objections to e-cigarettes in the policy debate, and blames excessive reliance on the precautionary principle for over-stringent regulation.

“Even for those supporting the value and applicability of the precautionary principle in public health, it is difficult to currently justify the level of criticism for e-cigs and the need for restrictions up to the point of complete ban on e-cig products…the application of this principle justifies taking precautionary measures before ‘full scientific certainty’ has been achieved, but there must be at least some evidence of risk or harm,” they write.

Instead, they say, regulation “should be regarded as setting proper rules that will ensure good quality products, removal of avoidable risks, and targeting the intended population (smokers), while avoiding initiation and long-term use by never-smokers. This is a very challenging process.

“It must take into account the following: how e-cigs are used in realistic settings, what are the potential benefits and risks from encouraging use, how will regulation comply with innovation and future development, and how to make the regulations financially sustainable to maintain a competitive advantage for e-cigs against tobacco cigarettes.”

Farsalinos is a cardiologist at the Onassis Cardiac Surgery Center, while Le Houezec works in the UK’s Centre for Tobacco and Alcohol Studies at the University of Nottingham.

What This Means: Finding these two writers in support of relaxed e-cigarette regulation is, of course, no surprise: it recalls well-known phenomena concerning Popes and bears.

But while criticism of actual or mooted regulatory measures by vaping’s proponents is commonplace, solid proposals on the principles that law-makers instead should follow – in the recognition that zero regulation is not a realistic option – are often much less forthcoming.

So this well-reasoned article is a welcome addition to the conversation, and a useful resource for those who would contribute to it.

– Barnaby Page ECigIntelligence staff

Photo: George Pankewytch

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