While the MHRA decision to reclassify and regulate (via the EU, provided, of course, that the EU is willing to go along with the idea) electronic cigarettes as medicines is far from good news, the documents they provided as part of their study provide a wealth of good news. Good news from a fairly unimpeachable source, the UK’s medicines regulator.
“As the major constituents of electronic cigarette vapour, propylene glycol and glycerine, are water soluble the potential for these compounds to be involved [in] lipoid pneumonia is not clear at present. The MHRA is not aware of any other cases of lipoid pneumonia associated with propylene glycol or glycerine products.”
Similarly, the WHO suggested a terrible risk of poor, uninformed users accidently killing themselves by overusing their e-cig.
Anyone with even the vaguest hint of knowledge about e-cigs recognised that as rubbish, but so did the MHRA:
“Given the low toxicity of nicotine at the doses observed and the fact that long before any dangerous nicotine concentrations could be reached, an over-enthusiastic user would be warned by nausea, there is little concern that e-cigarettes can harm their users by delivering toxic nicotine levels.”
They also have a rather less strident and panicky view than many about the potential of electronic cigarettes to be a gateway into smoking:
“There is little evidence of non-smokers taking up electronic cigarettes.”
“The available evidence from the UK, Europe and the USA suggest that only very low proportions of adults who have never reported smoking have tried electronic cigarettes.”
“What little use that was reported was confined almost entirely to children who currently smoke or used to smoke.”
The MHRA is clearly not overwhelmed by the argument that electronic cigarettes renormalize smoking, either:
“The denormalisation of smoking behaviour, if electronic cigarettes become commonly used indoors, is as likely to occur whether electronic cigarettes remain regulated under the current legislation or under medicines regulation.”
What the MHRA documents DON’T do is make a case for interfering in the electronic cigarette market at all.
As I quoted in a previous blog:
“However, as yet there is an absence of scientific evidence that shows long term harm to health is occurring in reality because of product safety.”
“While contaminants in ENDS have been identified, and the long term health effects of inhaling ENDS vapour are unknown, so far there is an absence of evidence that shows that these problems create significant harm to health.”
“Safety concerns have been reported. Given the extent of use, however, and despite the lack of a formal reporting mechanism (such as the yellow card scheme), these do not of themselves suggest a major public health concern.”
So the final bit of good news is that the MHRA has demonstrated that there is no need for further regulation, identifying as they have that there is a total “absence of scientific evidence that shows long-term harm to health”. Clearly, it would be completely disproportionate, therefore, to increase the regulatory burden on our thriving young industry. Evidence, it would seem, that even a regulator with an extreme preconceived bias, cannot justify reclassification as a medicine.
It appears that the MHRA can’t ‘level the playing field’ for the tobacco industry after all….