(and interesting lack of funding bias in scientific research…)
By Tom Pruen
A study, recently accepted for publication in the journal Addiction, examined the levels of nicotine in ecig cartridges, and the delivery of nicotine in the vapour from them. It also touched on a recent literature search into the toxicity of nicotine, which is widely quoted as an LD50 of around 60mg, despite several documented cases of survival after ingested doses of up to 1500mg. There is increasing reason to believe that a more reasonable estimate needs to be derived.
The results, while quite possibly surprising to many outside of the e-cig industry, are much what we in ECITA would have predicted. One particular facet of the results came as quite a surprise to the researchers:
“The fact that the variation of nicotine content of the cartridges has little bearing on nicotine in vapour is the most striking finding of this study.”1
That the ability of a given device to deliver nicotine is dependent on its design, as well as the contents of the cartomiser, is not surprising; in fact it would be more surprising if the design did not affect the delivery. It does serve to show how little most of the researchers know about these products. Another example of this can be found in the suggestion that a specific regulation is required for child proof containers when, in fact, this is already explicitly required as part of the chemical labelling directives.
It may well be that they have been misled by the lack of obvious child proofing on disposable and cartomiser products they were examining. However, ECITA members are required to test both disposables and cartomisers for child resistance (by a recognised consumer product safety expert), and if the products themselves are not inherently child resistant, they need to be packaged in child resistant containers. It is not clear if others in the industry follow this example, but as child resistance is an existing legal requirement, we would anticipate this being the case. (The vast majority of modern cartomisers are inherently child-resistant.)
There is a general tendency in the vaping community (and indeed elsewhere) to assume that the source of funding for research predetermines the outcome of the research. While this can be clearly seen in some cases, it is fairly spectacularly refuted in this instance. Since this research was funded by the MHRA, it would be easy to assume that its predetermined outcome would be a recommendation for the MHRA to regulate ecigs as medicines – but this is far from the case.
The study did find that there was some variation in both the content and delivery from ecigarettes, but the conclusion they drew from it was:
“The medicinal products accuracy for nebulisers require 9 out
of 10 samples to lie between 75% and 125% of the average value (all must lie between 65% and 135%). The consistency of nicotine content in EC cartridges we tested is not perfect, but it is well within this range and seems overall acceptable”.
Because of the variation in the delivery from different devices, even with similar levels of nicotine in the cartridges, they also concluded:
“Our finding that the nicotine content of eliquid has little if any relationship to nicotine content in vapour (let alone nicotine intake by users) suggests that a pharmaceutical level of accuracy of labelling of the nicotine content in EC cartridges is also unlikely to be informative for the user”
“Consumers need to find models that suit their needs”
Despite a maximum variation of 31% within the same product, they concluded:
“Given the large variation in how nicotine is delivered to vapour and how EC are used, the consistency seems adequate.”
I am not entirely convinced of this – I think that the electronic cigarette industry can, and should, do better than this – but I do agree that this doesn’t require additional regulation (and particularly medicinal regulation), but rather reflects a need for vendors to insist on better quality control procedures from their suppliers. The ECITA standard requires a maximum deviation from stated level of 9% of the declared amount, rounded to the nearest 0.1% (i.e. a 2.4% liquid must fall between 2.2 and 2.6%) and we believe this is a level of accuracy that is both desirable and achievable. If one of our member’s products falls outside this margin, we require the product to be either relabelled or removed from sale , and that the member undertake corrective action within their supply chain.
The researchers’ conclusions that:
“The consumer protection regulations need to be implemented strictly to ensure that EC are safe, fit for purpose and ‘as described’”
“a regulation of EC over and above such consumer protection safeguards seems unnecessary”
are conclusions I can only agree with: what is needed is not a regulatory sledgehammer to solve a non-existent problem and create a perfect product; what is needed is better enforcement of the existing regulations to ensure that products are good enough. In parallel with this there is a real and urgent need for government agencies to stop describing these products as unregulated, and start insisting on the current regulatory regime being firmly enforced.