Details Created on Saturday, 15 March 2014 15:26

Is e-cigarette industry the biggest enemy of the e-cigarette today?

By Dr Farsalinos

It is very common to see vapers attacking everyone for improper regulation or for efforts to restrict e-cigarette use and development. Whether it is regulators, Big Pharma, Big Tobacco, journalists, scientists, some parts of the e-cigarette industry itself (for example, TVECA) etc. Maybe in some cases they are right, maybe in other cases they exaggerate. However, in my opinion this is not the real picture. The EU regulation is now a reality. Perhaps it could have been better; perhaps it was the best that could be achieved. The most important thing is to look forward by seeing the mistakes of the past, and prevent any future mistakes. But is the e-cigarette industry doing this?

Before the TPD there was in reality no organized e-cigarette industry. Despite the fact that it was inevitable for regulators to address the issue of e-cigarettes in the TPD (which we all knew would come up in December 2012), the industry was caught by surprise. They tried to organize themselves in a matter of few weeks to months. They hired PR companies and law firms. To some point they were successful, if we can consider success the fact that e-cigarette was not classified as medication or banned while ignoring the negative aspects of the regulation (e.g. nicotine limits).

In reality, the future is more important and crucial that the past. The TPD is just a vague approach to some requirements needed before releasing a product to the market. The true impact of the regulation comes from the negotiations that have started now, which will specify the tests, conditions and requirements needed. But what is the industry doing for this?

The industry should be extremely active in this process. They should have started this process YESTERDAY. Unlike legal issues, defining and implementing testing protocols is an extremely complicated process. Do they believe that they have the knowledge or the people who can do it? PR firms and lawyers are useless in this case. Will they define what test should be done in every liquid, what should be done in every atomiser, which protocol should be followed and why? In reality they know nothing about e-cigarette testing. Protocols for regulatory purposes should have specific standards. They should be feasible, realistic, accurate and reproducible. And right now we have no idea about anything.

For example, I am the only one who has done cytotoxic tests on e-liquid vapor. The studies have been published in peer-reviewed medical journals. However, in order to implement any protocol for regulatory purposes you have to assess a huge list of parameters: cell stability, accuracy of the results, reproducibility of the results (which by itself is a separate complicated protocol and not just doing some repetitions), consistency in results, and appropriateness of the protocol for the testing purpose. You should start by planning and programming the whole procedure, defining which tests and protocols could theoretically be used, and test each one of them with a pre-specified protocol to define which will be chosen. You should start by defining a standardized e-cigarette device that should be used as comparator for every test. After completing all tests, you should prepare a detailed report (and even a publication), with results and proper explanation of the procedure and the reasons for proposing the X protocol instead of the Y protocol. Who is going to do that? The lawyers? The PR people? The businessmen? Who is going to fund that? The vapers (as some from the e-cigarette industry have publicly suggested in the past)? Is anyone with knowledge and experience with e-cigarette research being involved in this process? None to my knowledge (we are a handful of scientists involved in research, so we know each other and speak almost every day). You may find a lot of laboratories willing to do the tests, but if they have no idea about the product itself they are just respected scientists who are unable (or even dangerous) to help in this field (I have many examples for this).

I am afraid it is already too late. All this process takes a long time and needs a lot of programming and funding. In reality, there is a huge risk that any inappropriate proposal and subsequent implementation will kill the e-cigarette. The lack of knowledge and testing and the lack of proposals based on evidence are more dangerous than the TPD regulation itself. It is the e-cigarette industry which is now the biggest enemy of the e-cigarette, by being inactive and by failing to act promptly, fast and methodologically.

I hope that this is not considered as an attack against the industry but as a free piece of advice. From a public health perspective, it is of outmost importance that proper and realistic testing should be implementing, ensuring the quality of the product without overly restricting it. Until now, the mentality and approach of the e-cigarette industry is completely wrong, and I am not sure there is enough time to change this. However, better be late than never.



