Guest post by Dr Riccardo Polosa.
I was positively surprised when Members of European Parliament voted against the pharmaceutical regulation of e-cigs proposed by the European Commission, during the first reading of Tobacco Products Directive (TPD), on 8th October 2013. It seemed as if they finally figured out the risks of over-regulating a product designed to reduce the health damage caused by tobacco smoking. Or so I thought.
Hurriedly, behind closed doors, and with restricted consultation, the EU legislators managed to introduced substantial modifications in the revised TPD, producing a profoundly mutated document that takes a completely different approach for e-cigs. The newly approved document is riddled with many arbitrary and disproportionate measures. And it could have been much worse thanks to the determination of a handful of brave MEPs who have fought hard to limit the damage.
In essence, this new document makes e-cigs much less attractive for those tobacco smokers contemplating to switch to a much reduced risk product. In particular, introduces the arbitrary limit of 20 mg/ml on the max strength of nicotine allowed in e-liquids, advertising bans as stringent as those currently in place for conventional cigarettes, plus several (yet, poorly defined) lab testing, reporting and compliance requirements.
Unfortunately, no consideration was given to setting up useful agreed purity standards for e-liquids or operating standards for devices. A simple regulatory framework that ensures consumer protection and product quality and that may work for these products already exists.
For example, e-liquids may be marketed as dietary supplements or cosmetics, whereas marketing and safety of e-cigarettes’ electronics, batteries, and spare parts are already regulated by the existing directives about electronic products design.
The minor or implausible health concerns that have constituted the main obsessive focus of EU legislators in the e-cig debate may sound like stupid excuses, when in fact they are not stupid at all. To tell the truth, they are clever excuses. So clever that they succeeded in their purpose of dictating rules in line with the precautionary principle. Hence, the fact that the new document makes e-cigs much less appealing for new smokers is deliberate…
Lets face the truth, decisions in the area of tobacco products are always and exclusively made for financial and not health reasons. After weeks and weeks of fierce debate with the EU “legislators” I came to the conclusion that this has very little to do with a medical issue or science, it is a political and financial one. I briefly addressed this point in the concluding paragraph of my opinion letter
in the Lancet:
Similar conclusion can be drawn from the current situation in Italy.
From 1st January 2014 e-cigs will be regulated as tobacco products. Measures will include: excise taxes, lengthy bureaucratic process to obtain marketing permission from the national tobacco authority, vaping bans in public places, and advertising bans. No scientific debate was allowed, no input from vapers and their families was taken into consideration, the political agenda being “destroy e-cigs as soon as possible”. These draconian measures are already driving the prosperous and active national e-cig industry outside Italian borders, thousands of vape shops are closing, and current vapers will either have to turn into black market to stay off tobacco smoking or return to their own tobacco brand. Italy is well known for its lengthy legislative processes. For the e-cigs this was completed in less than 6 months ! A word to the wise is enough….
Clearly, the rapidly expanding popularity of e-cigs represents a threat to the interests of many, including national governments – because of the fat revenues generated by tobacco excise taxes. Only if these obstacles can be overcome, a truly sensible and rational regulation of e-cigs will be agreed upon, and millions of lives saved.