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.

 


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Comments   

 
+1 #45 R.C. 2014-03-20 12:46
For the rest of the industry...is it so difficult to understand what they have to do??? Why?...BT is showing them all along how to "protect" their products...they only have to copy that successful schedule.
Which is, take your big money, hire TOMORROW a team of scientists/experts for 2,3,4,5th...generati on e-cigarettes, like the team of Dr.F. here, and take a strong stand during the upcoming measurements- negotiations with the commission!!!
What do they think???...CORESTA and/or TVECA will do that for their products?...and for free??? :lol:
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+1 #44 R.C. 2014-03-20 12:28
One big happy BT-family. And of course BT doesnt sleep at all...2nd generation and up mods are already, including patents, on the market or at least in their drawers. So, its not difficult to guess who will do also the "measurements fixing" and for whom.
The rest of the e-cig-industry....wh at are they doing???...still sleeping?
...end...
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+1 #43 R.C. 2014-03-20 12:26
Quoting vaporama:
BT will not just sit there and sleep on their current cigalikes, they are working on egos and mods, or even the next generation.
Now who can, today do what Dr; Farsalinos suggests? SCIENTISTS ! I have seen that a scientific organisation, CORESTA, has started work on this (they presented at the e-cig europe conference inLondon and again in Wiesbaden this week). Yes, CORESTA was created by BT long ago. Today, e-cig companies are joining this working group whose purpose is to define science-based measurement .........

Yes, CORESTAs excellent work we could already admire...they were the final supervisor on the trilog result before it went back to the EUP-plenary. Of course CORESTA needs to be paid for their good work by their clients, and on their web page you can see exactly who they are.
..continues...
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+1 #42 vaporama 2014-03-20 08:54
BT will not just sit there and sleep on their current cigalikes, they are working on egos and mods, or even the next generation.
Now who can, today do what Dr; Farsalinos suggests? SCIENTISTS ! I have seen that a scientific organisation, CORESTA, has started work on this (they presented at the e-cig europe conference inLondon and again in Wiesbaden this week). Yes, CORESTA was created by BT long ago. Today, e-cig companies are joining this working group whose purpose is to define science-based measurement methods, reproducibility and everything in the proper way with a large number of accreditated laboratories to base the statistics. The issue is not to promote the products, but the standardised measurement of the compounds in liquids and vapour..
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0 #41 R.C. 2014-03-19 17:19
Right, Alan Depauw
The industry-except BTindustry- has to stand up NOW !!!
What are they still waiting for? United as association -what I really doubt that would ever happen- or every single one, however. Who will set things straight for this part of the industry?...BT, again??? ....for crying out loud!
Is it that what they want?...I really havent seen such unfit industry, in all aspects, my whole life!
Exactly this sloppy and unprofessional attitude has brought us in the TPD, and the todays situation in the first place! And the consumer, their clients, should now pay the bill? I really dont think so!
What are they expecting??? We, the consumer, are obliged to fight for their products on the market?
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+5 #40 Alan Depauw 2014-03-18 08:24
Large chunks of the industry are being acquired by Big Tobacco. They know all about the mass production of standardised goods and have long experience of adapting them to stringent standards imposed by legislation. Hence they are most interested in promoting cigalike products and we can expect to see them acquire greater market share with the development of other ecig products being inhibited by the same legislation.

Therefore trade associations representing all types of ecigs may themselves be restrained by the presence amongst their members of BT subsidiaries. They certainly read this blog and perhaps they could comment: are they able to organise a concerted effort to fund in-depth research to condition norms that otherwise will be imposed by other influences such as BT, Big Pharma or ill-informed bureaucrats; or are they unable to react because of internal dissent?
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0 #39 Mick Wright 2014-03-18 06:45
Real simple just apply the same requirements that are required by the food industry. Since its now regulated NOT as a medication but as a tobacco product then nobody in the EU can object.

But Vaping businesses can indeed object if the requirements for testing are similar in cost, scope or precision to those required by pharmaceutical products. The product being now mentioned as a tobacco product is (thanks to the EU) well outside the scope to apply pharmaceutical and medical product grade testing.

In fact all vaping businesses should be able to carry out these tests themselves... in house.

In fact its pretty likely that the same testing applied to tobacco should suffice... hey its their directive, we'll agree to all the strict tests that are applied to tobacco to guarantee its safety for consumption in the general population. In other words NONE!
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+1 #38 Irish Lass 2014-03-18 03:30
(contd) ........So far, the comments here indicate people who are apparently unsure about the point of Dr F's advice; and people who seem unsure about whether or not there is any point in the industry getting involved at all, because they think it will not achieve anything. Well - if the industry doesn't get involved then it definitely won't achieve anything and Dr F's dire predictions may well come true, which would be a nightmare for the industry and its customers. So, if these comments are typical of the kind of thinking going on in the EU e-cig companies, then I feel decidedly worried!
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0 #37 Irish Lass 2014-03-18 03:26
It seems to me that the e-cig industry associations in Europe need to get organised NOW and each appoint someone to represent them, as a starting point. These representatives should then get together (e-conference?) to discuss whether they are going to try to get involved in the TPD definitions process or whether they are just going to leave this to the bureaucrats, and therefore leave the field clear for Big T and Big P to influence what is decided.

Assuming that the industry reps agree to TRY to get involved then they need to agree on a strategy for doing so, including how they will raise the necessary funds. That MUST be the first step - otherwise they will get nowhere at all.
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+2 #36 Dr Farsalinos 2014-03-17 23:25
Bill, this is according to the EU TPD regulation that has already been voted.
In reality, they require toxicological testing of the ingredients (!), which implies that each of them should be tested properly. It is rare that toxicologic analysis is required (unless under pharma regulation), but this is what the TPD states/
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