Concerns raised in Parliament  about the EU rules are not borne out by the ASH Smokefree GB Adult Survey. Only 9% of vapers report using e-liquid containing 19mg/ml or more of nicotine (the limit set by the EU Tobacco Products Directive is 20mg/ml).
If you aren’t American, or even if you are, the regulation of tobacco, nicotine, and vape products in the United States can seem bewildering but somehow important. So if you want to be on it, here’s my bluffer’s guide to the United States Food and Drug Administration (FDA) and its approach to tobacco and nicotine products.
Okay, here are some thoughts on ‘Brexit’ (British exit from the European Union), which is the subject of a UK referendum to be held on 23 June 2016. I’ve added a discussion on implications for vaping and the TPD.
My view… there is a lot to dislike about the EU: it can be unaccountable, incompetent, over-reaching, arrogant, lawless, captured and dishonest. The more you have to do with it, as we saw recently with the EU Tobacco Products Directive, the more appalling it looks. We witnessed the unedifying spectacle of the amateurish drafting of incompetent but irreversible legislation that will affect millions with no apparent concern for science or evidence while blatantly disregarding even the modest procedural requirements of the EU treaties to consult, prepare impact assessments and minimise burdens. Is anyone accountable? If everyone is, no-one is.
So why am I in favour of the UK remaining in the EU?
I recently posted on Public health snoopers detect vapour aerosol at vape conference and fake a particulates scare. I mentioned that I thought the subterfuge involved was unethical and contemptuous, but didn’t really explain why. My main point in that post was to focus on why this was bad science and why there was no basis to justify a policy recommendation to ban vaping wherever smoking is banned. Also, I mostly had a hostile instinctive reaction about it, rather than a fully worked through perspective worth sharing.
I’ve now had an opportunity to reflect on it more carefully. This is partly because I was contacted by a senior figure at the university (someone I respect) pointing out that the study been assessed against a flowchart encoding USDHHS definitions and regulations, and that they had concluded there was no human subjects aspect of this study. Without a human subject dimension, there is no requirement to seek an approval from an Institutional Review Board (IRB), a committee that governs the ethical acceptability of research.
Update: predictably on 4 May 2016, the judgement was announced and Totally Wicked’s case rejected in full. See judgement in case C‑477/14. No appeal is possible. The basic problem is that the law depends on the science, bad science makes bad law, and the Commission and members states drew on bad science to defend this completely counterproductive law. The court did add any value or interrogate the science. The court has defended the status quo and the cigarette trade and shaped the e-cigarette market for the convenience of the tobacco companies. My full account of the case and its history is here. End of update.
On 23rd December, the Totally Wicked case against the EU tobacco products directive treatment of e-cigarettes suffered a setback at the European Court. The Advocate General, Dr Julianne Kokott issued her opinion on the case – this was hostile to the case and deeply disappointing. It confirmed my fear that good legal judgements could only be made with a sound grasp of the science, ethical issues and commerce of the products facing disproportionate regulation. I think that was lacking in Dr Kokott’s opinion. I don’t think a line-by-line critique is worthwhile, but I do want to draw out what I consider are major flaws in her reasoning. This post covers:
In an apparently clandestine operation, undercover public health snoopers ventured into a vape conference carrying concealed air-quality monitoring equipment. They detected … wait for it … e-liquid aerosol in the air. This secretive operation is reported (where else?) the journal Tobacco Control.