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European Commission report on the “potential risks to public health” of refillable e-cigs.

20, May, 2016

By Tom Pruen

As someone who has been involved in the regulation of e-cigs for a considerable period of time, this report is everything I was expecting it to be.

Awful.

It is framed in an unhelpful way, and raises hypothetical concerns that have little basis in reality.

“The  report  does  not  aim  to make  comparisons  between  refillable  and  other  types  of  e-cigarettes,  and  does  not  consider  the potential  public  health  impact  of  e-cigarettes  in  general  (such  as  initiation,  cessation,  dual  use  and long-term health effects).”

Or, to put in simple terms, this report examines refillables in an entirely negative light, considering only potential risks, ignores potential benefits, and does not make any meaningful comparisons that might put the identified risks in any meaningful context.

The potential risks identified were:

“ (1) poisoning from ingesting e-liquids containing nicotine (especially for young children), (2) skin reactions related to dermal contact with e-liquids containing nicotine and other skin irritants, (3) risks associated with home blending and (4) risks due to using untested combinations of e-liquid and device or hardware customisation.”

Each of these is then ‘analyzed’ ‘in depth’ in a separate section.

Here are the highlights (or lowlights, depending on your viewpoint):

Poisoning by ingestion

“Refillable e-cigarettes and refill containers are, in most cases, open systems that allow direct access to nicotine-containing liquids.”

“A highly  addictive  drug,  nicotine  is  also  acutely  toxic  (lethal)  by  all  routes of  exposure  in  high  enough doses.”

“the European Chemical Agency’s Committee for Risk Assessment  (RAC)  considered  that  5mg  per  kg  bodyweight  was  a  justified  estimate  for  the  acute toxicity of nicotine through oral exposure….. This Acute Toxicity Estimate (ATE) value is in the same order as outlined by Mayer (2014) who estimated the lower limit causing fatal outcomes as 0.5-1 g…. This translates to 390-780mg of nicotine for a 60 kg adult and 65-130mg for a 10 kg child.”

Quite how 500-1000 translates to 390-780 is left as an exercise for the reader.

“There have been media reports of lethal poisonings of young children in the US and Israel from e-liquids”

There have, although only one of these tragedies has actually been confirmed. Two poisonings, no matter how tragic, across the entire global population, with millions of users of electronic cigarettes, would actually seem to be a good indication of low risk (more on this shortly).

“The  PRECISE  study  commissioned  for  DG  Health  and  Food  Safety  analysed  277  cases  of nicotine poisoning reported to poison centres in eight EU Member States… Of the cases studied, 71.3% related to unintentional poisoning.”

This means about 200 accidental exposures (of which about nearly 60% were by adults) in an unspecified period, but probably in total.

“23.7% of cases required hospitalisation and 6.8% had a moderate or major effect”

So moderate to major toxicity was found in around 14 people, and no deaths occurred. Compare this with the effects of something like paracetamol, which accounted for 433 consultant referrals in a single year[i], and resulted in 200 deaths[ii], in the UK alone.

Or perhaps we should look at toys, which despite being intended for use by children resulted in 250,000 hospital visits and 11 deaths in the US in a single year[iii]. (I was unable to find comparable UK or EU statistics).

Compared to this, do the numbers for e-cigarettes actually seem like an issue worthy of great scaremongering? Not really.

It should be noted, however, that this research was clearly extremely poor and does not represent the real number of exposures. Data from the UK was not included, despite being available. The UK data, for a country with one of the more prevalent uses of electronic cigarettes is 241 exposures (year 2014-2015), of which 206 were accidental. 230 of these cases had no, or minor signs of toxicity, 7 had moderate and only one was severe[iv]. Quite why they ignored this easily available data, I do not know. Since this data was published, but long before the publication of this report, one death did occur in the UK, as the result of a tragically successful suicide attempt.

However, even assuming that these numbers are reflected across the rest of the EU, this suggests that these are not particularly dangerous products.

Yes, child-proof containers should be used, and labelling should ensure people are aware of the risks, but this is already the case, and the evidence suggests that this is working well enough. We do not hear of the “risks to public health” associated with paracetamol. Indeed, arguably, none of these risks are large enough to have any measurable effect on public health, unlike the risks of smoking.

So what does the Commission propose to do to mitigate these terrible risks to public health?

Child-resistant caps (which no-one would argue with), warning labels (likewise), and support for the elements of article 20 that

“ensure that e-liquid containers do not contain excessive levels of nicotine (which could be lethal to children and adults)”.

Clearly while the first two of these are sensible, and widely supported, and would help to minimize the number of exposures, the third would seem to involve reducing a risk from effectively zero (there have been no accidental deaths from e-liquid poisoning in the EU), to something lower. It seems somewhat implausible that reducing the size and strength of nicotine will reduce the number of accidental deaths to below zero (unless this is somehow to occur by resurrecting people), and of course the counterbalancing risk of people relapsing to, or remaining smoking, is conveniently ignored.

Skin reactions

“Refillable  e-cigarettes  require  users  to  refill  the  device  directly  with e-liquid,  usually  using  a  small bottle  or  refill  container.  There  is  a  risk  when  opening  or  refilling  that  e-liquid  from  refillable  e-cigarettes  is  spilled  and  comes  into  contact  with  the  skin.”

“at the concentrations allowed by the TPD, the amount of e-liquid needed to produce an acutely toxic effect through dermal exposure in humans is 35ml for a small child and 210ml for a 60kg adult. This is larger than the maximum size of a refill container allowed under the TPD.”

It is also larger than any amount that can realistically be expected to remain in contact with the skin. If you pour 200ml (or even 10ml) of liquid on yourself, the vast majority of it will simply run off.

“In their analysis of poison centre data, the PRECISE study also found that 10% of reported cases were related to dermal exposure.”

This is much higher than the UK data, where it was around 5%, but as before this is a vanishingly small number of exposures, resulting in little or no toxicity, and no deaths have ever been reported for fatal poisonings through skin contact with e-liquid.

So how to mitigate these risks?

“In order to mitigate the risk of dermal contact… should  be  child-resistant  and  protected  against  leakage  (Article  20(3)(g))…. designed in a way that ensures refilling without leakage as…in Article  20(3)(g),  and  specified  further  by  Commission  Implementing  Decision (EU) 2016/586…should  also  be  sold  with  appropriate instructions…  (Article 20(4)(a)(i) and (iv))”

So the answer to the non-existent death toll caused by e-liquids before the TPD was introduced is the TPD. How unspeakably convenient.

Home blending

“home  blending  requires  that  users  purchase  high-concentration  nicotine…. here  are  risks  to  users  and  others  if  high  concentrations  of  nicotine  liquid  are  stored  at home  and  handled  inappropriately….. a  risk  that  consumers  do  not  dilute  the  solution correctly  resulting  in  much  higher  nicotine  concentrations  than  intended  in  the  final  e-liquids”

Well, let’s see, how many deaths have there been through people handling nicotine, or inhaling it through their ecigs in the terrible ‘wild west’ years before the introduction of the TPD?

Oh yes. None.

“there is a risk that home blending may also allow users to circumvent the limits set for  e-cigarettes  in  the  TPD”

To describe this as a risk would imply some likelihood that it won’t happen. This is not a risk, it is a certainty (and frankly, if it keeps users vaping instead of smoking, and they observe some simple safety precautions, it’s hard to say anything other than ‘best of luck to them’).

“One concern is that refillable e-cigarettes will allow users to continue to use untested or unsafe flavours. Users could also potentially mix flavours with unknown effects”

This is a risk (although probably not a massive one), and one that could have been mitigated by regulating all vaping products the same, regardless of nicotine content. The Commission didn’t even attempt to do this, so it seems foolish to complain now.

“The health risks of second-hand exposure of vapour from such self-mixed e-liquids are also unknown”

Ok, so the risk of a second hand exposure to an unknown mix is unknown. That’s tautological, and not very helpful. Here’s a better way of thinking about this – whatever the first hand risks are, will they be significant after the (at least) thousandfold dilution inherent in second hand exposure?

Unlikely.

“An additional concern is that refillable e-cigarettes may be used with illegal substances”.

Well, it is a concern, but also one that applies to cigarettes, teaspoons, and kitchen foil. The problem here isn’t the availability of the ecigs, it’s the availability of the illegal substances (which of course proves the durability of the black market – the war on drugs has many losers, but not even a single winner).

Clearly, the risk mitigation for this is going to be drivel of an even higher order:

“Member States should ensure that manufacturers and importers respect the limits on nicotine concentration set by the TPD.”

Well, given that the risks of nicotine appear not to need much mitigating, should they? Or would they actually help the health of their populations more by ignoring the Directive?

“high-concentration liquid or powdered nicotine “

Sorry, what? Powdered nicotine? Nicotine is a liquid with a melting point of -79 centigrade. Powdered nicotine is possible, I suppose, but I’ve never seen any. This might refer to Nicotine Bitartrate (which is used in many of the pharmaceutical preparations of nicotine), but it’s not widely available to consumers, and never has been.

“Authorities should also ensure that oils or liquids with THC or other illicit substances..”

Member states should ensure that illegal products are not sold. Thank you Captain Commissioner Obvious.

Use of e-liquids with untested devices and hardware customisation

“Refillable e-cigarettes allow users to mix and match e-liquid and devices and to customise their devices by purchasing components separately and 'building’ their own device”

Yes, yes they do. So?

“There is a risk therefore that the combination of device and e-liquid chosen by users will not have been adequately tested, in particular as regards the safety of the emissions produced. Hardware customisation may further mean that users boost e-cigarettes with powerful batteries, increasing the amount of toxic emissions”

Well, yes, that’s a theoretical risk but...

“although it should be noted that vapour heated to a very high temperature may not be palatable to users.”

Yes, exactly. We could at this point consider the emissions profile of the product people are replacing (and avoiding) with vaping, but clearly the Commission didn't, so let's just move on.

“There is also a risk to users if untested or inappropriate components are used, such as leaching of metals into the e-liquid or battery explosions”

Well, there’s absolutely nothing in the TPD that has any effect at all on the safety of batteries, so there seems little point in the statement that:

“According to Article 20(2)(e) to (g) of the TPD, manufacturers and importers must include a description of the components used, the production process and a declaration that they bear full  responsibility for the safety and quality of the products they place on the market.”

especially since they already have exactly this responsibility under the General Products Safety Directive.

And these risks are mitigated by….

“Member States should ensure when enforcing the TPD that manufacturers and importers of e-cigarettes do not sell untested components and that all notified components have undergone appropriate tests to ensure they are safe”.

Yes, but as already stated, there are no safety tests for hardware in the TPD.

“Member States should also ensure that when measures are taken on dangerous products posing a risk to the health and safety of consumers they are notified through the Rapid Alert System for dangerous non-food products”

The RAPEX system you say? This one? The one that has been used for a number of years to notify products identified as dangerous under the GPSD? The one that is already used for dangerously non-compliant e-cig products?

I’m sure that using the existing system will mitigate risks. Exactly as it already does.

Fortunately, we are near the end of this drivel.

Conclusions

“The use of refillable electronic e-cigarettes, and the potential exposure to e-liquids containing nicotine in high concentrations, may pose risks to public health”

No. No, they really don’t. The existing market has successfully transitioned a significant number of people away from smoking, providing a massive benefit to public health. The risks identified are too small to offer anything of sufficient scale to be a risk to public health, although there is the potential for isolated tragedies. Better enforcement and risk communication could, and should, be used to reduce these.

“the measures relating to refillable e-cigarettes provided for in the TPD and secondary legislation, combined with national regulation, provide an adequate and proportionate framework”.

Well, the existing regulations did a good job, and many of them will continue to do so. The TPD, on the other hand, risks massively reducing the uptake of vaping by smokers, and being a public health catastrophe.

Perhaps a risk assessment of this might be more usefully undertaken?

 

[i] http://www.npis.org/NPISAnnualReport2014-15.pdf

[ii] http://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarria...

[iii] http://www.cpsc.gov//Global/Research-and-Statistics/Injury-Statistics/To...

[iv] http://www.npis.org/NPISAnnualReport2014-15.pdf

Comments

Wow just read this article and all I can say is what a load of tosh please just leave us vape to do as we please I really cannot explain how much vaping has saved my life

So, this report has basically been commissioned to justify the contents of the TPD AFTER the fact... Also, it would seem the only product that answers all of their 'helpful' criticisms is a cigalike with cartridges? Off to build a Callahan shrine and pray a lot to it... ;)

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