Category: Law

Who cares about a few thousand dead? Defending EU limits on the strength of nicotine e-liquids

graveyard
Not that many dead – what’s all the fuss about…?

Updated 16 May 2016

Apparently, there are still people in public health trying to defend the EU Tobacco Products Directive as it applies to vaping! It’s a ludicrous measure, that protects the cigarette trade, has costs and risks that vastly outweigh the non-existent benefits. ASH (London) appears relaxed about the nicotine strength limit: New EU rules on nicotine strength not a problem for most vapers it declares this morning (16 May 2016).

ASH claims that because ‘only’ nine percent of current vapers use liquids over the limit set by the EU Tobacco Products Directive, concerns raised in Parliament (Lords debate, Prime Minister’s Questions) are unjustified:

Concerns raised in Parliament [4] 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).

Or maybe Parliament is right and ASH is wrong…? How might one respond to this defence of the indefensible?  Continue reading “Who cares about a few thousand dead? Defending EU limits on the strength of nicotine e-liquids”

Regulators and the compliance fallacy – buying 99% nicotine e-liquid from China

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99% nicotine e-liquid bought from China

How easy will it be to sidestep European Union and U.S. FDA regulation? To find out, I bought some high strength e-liquid from the internet. The problem is that bad regulation doesn’t attract compliance, it attracts non-compliance. Continue reading “Regulators and the compliance fallacy – buying 99% nicotine e-liquid from China”

Bluffer’s guide to FDA regulation of tobacco and nicotine products

FDA puzzle

Updated 27 August 2016

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.

Continue reading “Bluffer’s guide to FDA regulation of tobacco and nicotine products”

Mayo Clinic progresses from blatantly wrong to deeply misleading

william-blake-truth

Some trusted health institutions seem unable to cope with the reality of a huge variation in risk between different tobacco products – notably combustible versus non-combustible. If you were paying attention, you may have noticed a subtle change in the Mayo Clinic’s approach to smokeless tobacco last week. Continue reading “Mayo Clinic progresses from blatantly wrong to deeply misleading”

Vaping bans – asking the wrong question

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Following the dumping of the Wales Public Health Bill and its attempt to ban vaping in public places, the Daily Telegraph covered the story (Plans to ban e-cigarettes in public places defeated) and included an online poll – see above. But I think they ask the wrong questions. These were the questions asked: Continue reading “Vaping bans – asking the wrong question”

Brexit: utopia, dystopia or PONCE?

UK-EUtrade
UK trade with EU (ONS data): interdependency will create massive pressure to preserve the status quo

Updated 29 May 2016

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?

Continue reading “Brexit: utopia, dystopia or PONCE?”

Annual quiz on e-cigarettes and harm reduction – 2016

quizFun with a purpose – twelve thought experiments in the form of a quiz designed to interrogate your views on e-cigarettes and harm reduction. Continue reading “Annual quiz on e-cigarettes and harm reduction – 2016”

What was unethical about snoopers measuring particulates at a vape convention?

ethics

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.

So I gathered my thoughts and responded: Continue reading “What was unethical about snoopers measuring particulates at a vape convention?”

Totally Wicked case: Advocate General’s flawed reasoning would protect the cigarette trade

CJEU
Looking for justice? Keep walking.

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:

Continue reading “Totally Wicked case: Advocate General’s flawed reasoning would protect the cigarette trade”

Public health snoopers detect vapour aerosol at vape conference and fake a particulates scare

snooping

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.

Let us examine its scientific and policy claims.   Continue reading “Public health snoopers detect vapour aerosol at vape conference and fake a particulates scare”