January 26th, 2015

Keep calm it’s only poison

A quick update on the e-cigarette and e-liquid poison scare stories..

Much has been made of the rapid rise in calls to US Poison Centers (chart by Clive Bates from AAPPC data)

Commentators have piled in, highlighting the rapid percentage rise between years. Some examples…

Poison reports in context

Two factors are likely to explain these observations: (1) the rapid rise in e-cigarette and e-liquid use – a good thing as it displaces smoking; (2) the increased fear about these products arising from the negative publicity and fear-mongering in the press and by ‘public health organisations’. But such rises have to be put in context… in the United States there were 2.6 million calls in 2013, and 0.06 percent of those related to nicotine. See American Association of Poison Control Centers Annual Report 2013 Table A17 (chart by Clive Bates from AAPPC data – plots the data points from 2013, 2014 alongside the top calls to poison centres – data in the appendix below)

The point is that poisons and risks of exposure are ubiquitous in society, and are associated with products from which society benefits. We do not ban them or over-regulate them, we find proportionate approaches to managing the risks.

Peak Poison

Calls to poison centers may also be affected by publicity – and there was quite a media blitz in March and early April 2014, leading to ‘peak poison’.

Source for graph: American Association of Poison Control Centers Annual Report 2013 Figure 6 p.1063.

How poisonous?

As well as being proportionate about the scale of exposure, there is also the question of how dangerous nicotine liquids actually are. Dr Bernd Mayer showed that conventional estimates of the toxicity (the dose that would kill 50% of subjects) was based on poor experiments undertaken in the 19th Century and that these likely exaggerated the toxicity by 10-20 times.

Mayer B. How much nicotine kills a human? Tracing back the generally accepted lethal dose to dubious self-experiments in the nineteenth century. Arch Toxicol 2014; 88: 5–7. [link] [blog]

The trade association ECITA commissioned expert advice from consultants Bibra on how e-liquids should be classified under the European Classification, labelling and packaging of substances and mixtures (CLP) Regulation. The report is excellent: see ECITA’s summary: How Toxic is E-liquid…

European officials have been wrongly labelling e-liquid as extremely toxic. This is the view of ECITA, based on a report by toxicology consultants which has been verified by Professors Riccardo Polosa and Bernd Mayer, and Dr Jacques Le Houezec. The civil servants had been misclassifying e-liquid as either a CLP category 2 product, alongside strychnine, or a category 3 product, alongside formaldehyde. The new report demonstrates that the acute oral and dermal toxic hazards of the strongest consumer e-liquids only merit being classed as category 4 – along with washing-up liquid – while the vast majority of e-liquid (which has nicotine concentrations below 25mg/ml or 2.5%) does not require any type of formal hazard warning. ECITA will still mandate its members to provide clearly labelled e-liquid in child-proof containers.

Pragmatic approach – not a cause for panic

Instead of indulging in panic-stricken commentary or regulatory over-kill, there is a simple measure, which meets the requirement for a duty of care to consumers. Just ensure tamper proof containers are used, as set out in ISO 8317 – Child Resistant Packaging. Something the industry can easily do and increasingly does.

Of course, regulators could have mandated this by now if they were taking a pragmatic and proportionate approach to regulation under consumer protection legislation. Instead they are indulging in legally vulnerable and grandiose schemes like the FDA’s deeming regulation, EU Directive 2014/40/EU Article 20 or attempting to de facto outlaw these products by classifying them as medicines or poisons (Canada and Australia).

Appendix: calls to US poisons centers – data

E-cigs & liquids 2013 1,543 E-cigs and liquids 2014 3,957 Analgesics 298,633 Cosmetics 199,838 Cleaning substances 196,183 Sedatives 153,398 Antidepressants 109,110 Foreign bodies 103,737 Cardiovascular drugs 101,544 Antihistamines 99,176 Topical preps 89,287 Pesticides 85,033 Alcohols 70,258

Source (non-nicotine): 2013 Annual Report of the American Association of Poison Control Centers ’ National Poison Data System (Table 17A)

Source (nicotine): AAPPC E-Cigarette Devices and Liquid Nicotine