Pharma-friendly EU clampdown threatens suppliers with ban-hammer.
Analysis of the review by Public Health England on vaping made front-page news, shaming much of the professional health clerisy and the mainstream media, both of whom have campaigned to discourage use of the nicotine delivery tech.
But the newspapers splashed with something Public Health England didn’t recommend – e-cigs on prescription – while ignoring Public Health’s clear warnings about threats to vaping.
The dossier by Public Health England – a UK government body – wrapped up four studies, and concluded that vaping is a powerfully effective tool for smokers to cut down or quit altogether. It also demolished the tabloid myth that e-cigarettes are a “gateway” for non-smokers to start consuming nicotine: vapers are former smokers, or smokers who wish to stop smoking.
Latest estimates suggest that there are more than two and a half million vapers in the UK, and a third have stopped smoking, making it the most effective cessation product ever invented. (If British smokers switched to e-cigarettes, 5 million premature deaths would be avoided, according to one prof.) Recognising this, Public Health recommended sweeping changes to the UK’s tobacco reduction strategy, of which e-cigarettes are not yet a part.
But it also warned of threats that could strangle e-cigarette adoption, threats of which most of the UK vapers seem unaware. Missing from the yesterday’s headlines were Public Health’s misgivings about the future. E-cigarette use has hit a plateau in the UK (perhaps as a result of tabloid misinformation) and further adoption of the technology could be thwarted by regulation.
The United Nations (via its WHO arm) wants to ban e-cigarettes globally. In the UK, the immediate threat is from the EU, whose regulatory response is only slightly less potty.
E-cigarettes today are a consumer product, not a highly regulated medical product. But thanks to the efforts of a Labour MEP, that will soon change. The EU has revised the Tobacco Products Directive (TPD (2014/40/EU), or “TPD2”, which must come into force by May 2016.
TPD2 bans liquids being sold in bottles larger than 10ml, and any liquid stronger than 20mg/ml of nicotine (smokers looking to quit often start with 24mg/ml) and restricts the size of tanks. Manufacturers will also have onerous testing, reporting and monitoring obligations. Advertising the products will be prohibited. If that’s not bad enough, the real Devil’s in the detail: a manufacturer or supplier will need to inform the regulator of every new product six months in advance, while every change also needs six months’ notice.
A Blackburn-based company – Totally Wicked – is challenging the legality of TPD2 in the European Court. TPD2 prohibits all cross-border trade in vaping products, which rather runs counter to one of the EU’s “four pillars”: the free movement of goods.
TPD2’s legality is iffy for a number of other reasons too – see the PDF of the judicial referral to the ECJ, where the case is concisely summarized in par 62:
The EU legislature appears to have proceeded under an implicit assumption that [e-cigarettes] pose an equivalent risk to public health and should therefore be regulated. The assumption is significantly flawed.
The government has launched an 11th hour consultation on how to implement TPD2 – there’s an excellent summary with links here. (If you want to respond, hurry up, as it closes on September 3).
As Public Health notes, in its understated way: “The TPD certainly raises the barrier for bringing EC products to market or continuing to market existing products, and will undoubtedly constrain the EC market.”
The impact on British vapers is likely to be significant, because the choice of regulator of e-cigs in the UK is most likely to be the MHRA, which is part-funded by the pharmaceutical industry. (The taxpayer pays for the regulation of equipment, while pharma pays fees for the regulation of medicine.) The drugs industries’ own inferior NRT products (such as gum and patches, or varencline-based drugs such as Champix) have been comparatively ineffective in reducing smoking. What’s the betting that the MHRA’s interpretation of the directive becomes extremely demanding – demanding enough, say, to drive suppliers out of business?
We can already guess what regulation might look like, for the UK has had an opt-in regulatory regime for vaping suppliers for some time. This scheme permits a supplier to qualify their wares as medical product. In five years only one e-cigarette product – from tobacco giant BAT – has gained approval. As Public Health notes, the cost of bringing your manufacturing up to meet this standard costs millions. A startup selling juice or a new atomiser can’t hope to find such funding.
With cross border trade prohibited, e-cigarettes would rapidly become a black market product, leading the surreal situation of police and customs agencies being required to “bust” traffic in the most effective smoking cessation technology the UK has ever seen. As if they haven’t already got anything better to do. ®
E-cigarettes are already restricted in Wales, and banned at the BBC. But what on Earth compels people to do this?
Perhaps there’s indignation and envy among the health professionals that a successful technology became widely adopted without their involvement, making them look redundant? Perhaps they simply can’t stand people enjoying nicotine?
“Moral indignation towards pleasure-giving ‘vices’ may well be a motivation for some of those working in the tobacco control industry,” suggests Chris Snowden. What makes nicotine vaporisers effective – and the gums and patches ineffective – is that one is pleasurable, and the other is not.