Published on 9th March 2012
As promised, here is my report from the meeting I attended on Wed 7th March at the European Commission. I had been invited to attend, to represent the Electronic Cigarette Industry, in my role as Operations Manager for ECITA. The meeting was being held in the context of the public consultation on proposed revisions to the Tobacco Products Directive, and this was one of several meetings being held with stakeholders and NGOs.
There were 9 representatives from the Tobacco Industry (‘Big Death’), one representative of Big Death’s more enlightened subsidiary, the European Smokeless Tobacco Council, one representative from the Electronic Cigarette Industry (me), and 6 or 7 representatives from the Commission itself, including Commissioner John Dalli and Deputy Director of DG Sanco, Martin Seychell.
The choice of Commissioner Dalli as Health Commissioner for the European Union has attracted negative attention from the pro-freedom-of-choice camp (see here), but during his introduction to the meeting, Commissioner Dalli described Martin Seychell as the person “co-ordinating the efforts of the TPD Revision’. It seems that Dr Seychell will be the one who will be assessing the levels of evidence, and is likely to be the one recommending certain courses of action, and suggesting that others be left out of the proposed revisions.
Dr Seychell told us that the 2001 Directive on Tobacco Products needs updating in some aspects. Science and technology have moved on, and there have been new product advances. He mentioned the WHO Framework Convention on Tobacco Control (FCTC). “Young people are the biggest issue for Tobacco Control, and the idea is to reduce attractiveness.”
“To this end,” he continued, “there are three areas currently under review:
- Packaging, labelling and ingredients (for tobacco products)
- Scope – which products should be included as ‘tobacco products’
- Accessibility (to tobacco products).”
Concerning point (2) above, Dr Seychell said that the Commission is looking to see if there are reasons to expand the scope to include new products.
Not surprisingly, from the position that they are in, all the representatives from Big Tobacco made their case by way of pleading not to be restricted too much, or hit too hard by changes. Several of them mentioned the problems caused to their business partners by the growing contraband ‘industry’; they referred to business rights enshrined in the Lisbon treaty; and there was much discussion of “distortions to the internal market”.
In a quite astonishing display of utterly disingenuous irony, one of them suggested: “Plain packaging just helps contraband and undermines public health goals.” Really? Or is it offensive to Big Tobacco because it undermines their sales in the global marketplace?
Whilst we actually agree entirely with the lack of evidence concerning plain packaging, and accept that this would inevitably make it easier for smugglers to counterfeit tobacco products, it strikes me as virtually impossible for Big Tobacco to have any role in offering anything of any value to ‘public health goals’, since they are trying – by any means possible – to protect the sales of tobacco cigarettes which, by their own admission, kill people.
Anyone who has read our petition, or read this blog before, will know that I am a great believer in freedom of choice, including the freedom to choose to smoke. As adult citizens, I believe it is our inalienable right to make decisions for ourselves.
But it really sticks in my craw to hear Big Death beating the ‘public health goals’ drum.
The representative from Philip Morris said that they couldn’t see any need to change the labelling on tobacco products because the warnings are already prominent. He suggested that this would be “economically damaging”, and that packaging and labelling are not predictors of youth smoking.
He also suggested that restricting flavours would have a severe impact on everyone in the industry – from tobacco growers all the way through to retailers; an ingredients ban would eliminate an entire category of blended cigarettes; a menthol ban had not been part of the consultation process so far, and such a ban will “distort the internal market.”
(Anybody’s heart bleeding yet?)
The representative for the Tobacco Growers said that his sector had been negatively affected by agricultural policy already, and “thousands of jobs are at risk in poorer Member States”. He said that flavour restrictions are viewed as a “further attack”’.
Dr Seychell directed the meeting towards considerations of the scope of the Directive. He said that a number of products are not currently covered by the Directive:
- Oral tobacco, including snus, which were banned in most Member States in 1992. Dr Seychell said that it is difficult to justify lifting the ban;
- Several new products which are completely unregulated, e.g. electronic cigarettes. He said that there is potential for abuse with products like these because they are addictive and can be toxic;
- Herbal cigarettes. Dr Seychell said that while these products didn’t necessarily contain tobacco, and often advertise with claims of ‘no tobacco’, there is still combustion. He posed the question: “Is it proportionate to regulate when it’s a very small market?”
Dr Seychell suggested that I might like to respond at this point. However, I suggested that perhaps the representative from the European Smokeless Tobacco Council might like to go first, so that we could follow on in the order he had just given us.
She said that she would be giving a statement to the Commission, rather than a series of statistics and data. She said that we all have friends and family who smoke. She mentioned her father, and said, “I have told him about snus, but he believes you and continues to smoke.” (Harsh, but ultimately fair.)
She presented the case, citing the success of snus in Sweden, and contended that by promoting NRT while keeping snus banned, the Commission was “picking winners and losers”. She went on to talk about consumer choice, saying, “There’s pressure with the ‘quit or die’ approach. The current legislation violates consumers’ rights.” She described this as “difficult to justify”.
She concluded by saying that scientific, fair and honest regulation was essential to offer informed choice for consumers.
Dr Seychell offered me the floor at this point. First of all, I expressed our support for the ‘smokeless’ representative’s position, particularly with regard to freedom of choice for consumers, and the vital importance of accurate and truthful information, so that consumers are in a position to make informed choices. I mentioned our petition, and the many thousands of signatures it has already had, but said that I realise that this is perhaps not of great enough significance in the grand scheme of things for the Commission. Nevertheless, I asked the Commission to consider it as part of our submission, and to read the comments, where consumers (and former smokers) spoke directly about this issue of freedom of choice.
I said, somewhat apologetically, that I have to take issue with what Dr Seychell said about electronic cigarettes’ being ‘unregulated’. I agreed that they are not regulated as medicines, but said that this does not mean they are not regulated.
Dr Seychell said that he agreed that if a medicinal claim is made, then it becomes a medicinal product, but if no claim is made then it is not. I explained that we understand how difficult it has been for policy-makers to know how to approach the regulation of electronic cigarettes. I said:
“On the one hand, it seems like it might be a medicinal product, but EU law does not support this, so that’s not a solution [Dr Seychell nodded in agreement]; on the other hand, it sort of looks like smoking, so maybe it’s a tobacco product. But this doesn’t fit either, because electronic cigarettes contain no tobacco, and although nicotine is extracted from tobacco, if that means that all nicotine products are tobacco products then NRT would have to be a tobacco product… but they are medicines. So we understand that it is difficult.”
(Obviously, I was unable to take notes of what I said, but I have done my best to try to remember and write it out for you all!)
I went on to explain our work in going through all of the relevant EU legislation, and how we had found all the statutes, and put them together into the Industry Standard of Excellence (ISE), which we use to audit ECITA members. I told the Commission how we have had considerable support from ‘on-the-ground’ regulators in the UK, such as Trading Standards, and that our programme includes working with the local enforcement officers in whichever Member State. I explained that this programme of internal regulation is funded by the industry, so does not cost anything from the funds of Member States, and reiterated that we welcome oversight from government agencies in those Member States.
Dr Seychell asked if we were UK only, or covered the whole EU, and I confirmed that we have partners in other Member States, and are ECITA (EU) Ltd, covering the whole area.
I explained our eliquid testing protocols, CHIP labelling, etc., and pointed out that this was the most comfortable regulatory fit for these products, since they are not medicines or tobacco products. “Electronic cigarettes do not need a new set of regulations,” I continued. “There is already a set of EU regulatory laws which fit, and which we are applying.”
I told the Commission that we would like to see central ratification from them for our programme, so that Member States can be informed that this is how electronic cigarettes should be regulated, as set down in the law. I said that we needed them to confirm that electronic cigarette vendors should be monitored and have their products tested to comply with the existing legislation.
I suggested that our testing protocols were sufficiently rigorous, together with our auditing of all the other EU legal requirements, to provide a strong level of consumer protection and public health and safety. I continued that incorrect classification as a tobacco product would mean restrictions on the trade of these products, and would mean that electronic cigarettes would no longer be able to offer the significant public health benefits they could.
Commissioner Dalli appeared to shake his head at this point, but Dr Seychell was nodding slightly. (Talk about conflicting viewpoints!)
I urged the Commission not to “get this wrong” because the consequences would be devastating for the many hundreds of thousands of EU vapers who have made the switch, and would be made to go back to smoking, or get unregulated and unsafe products from the black market.
I emphasised the fact that these products are ‘fun’, and ‘recreational’, and that they sit perfectly neatly within the General Product Safety Regulations (and others), and that with our auditing programme, there was an entirely sufficient level of protection for public health and safety.
I concluded by thanking the Commission for giving us the opportunity to make our representations.
(It was only on the drive home from Heathrow, after flying back to London, that I realised – with some horror – that I had gone into this meeting with no notes! Ultimately, however, I think this may have helped, since it was in obvious contrast to the Tobacco camp, some of whom read their submissions verbatim.)
The representative from the European Cigar Manufacturers Association was up next, and presented his group’s case. He asked for cigars to be treated separately from tobacco cigarettes. He said that packaging and labelling changes were not required because the existing TPD covers this sufficiently. He suggested that the ingredients disclosure regulations are also already sufficient.
The European Smoking Tobacco Association’s representative spoke about ‘roll-your-own’, and said that these were mostly small and medium-sized companies, often family businesses. He said there were enormous varieties of packaging types. He said it was difficult to cope with the legislation if you’re a smaller business.
(Anyone at all?)
The Philip Morris representative requested permission to speak again, and said:
“Non-tobacco products containing nicotine are substantially different. Philip Morris wants the European Commission to produce reduced-risk products regulations as a separate set.”
(This was his offer of ‘support’ for our cause, which he had hinted at before the meeting, in the foyer.)
I asked Dr Seychell if I could respond, was given the ‘nod’, and said:
“While we appreciate the… spirit of… co-operation…offered by Mr Morris… sorry, Philip Morris, although we agree that this might be appropriate for smokeless tobacco products, this would not be the right approach for electronic cigarettes, since these are already sufficiently covered under EU regulatory law.”
Dr Seychell addressed me directly, and said that the levels of nicotine are a concern for the Commission, because of the risk of dual use, i.e. vapers using electronic cigarettes together with patches, for example. He said they wanted to ensure no risk of overdose.
He continued (without giving me the opportunity to respond to that point) and discussed display at point of sale, and then mentioned that cross-border trade may undermine Member State efforts. He clarified that when he said “cross-border trade” he was referring to internet sales, which he described as “almost impossible to police”.
He handed straight over to the representative of the European Tobacco Wholesalers Association, who started talking about vending machines, and said that the industry supports reasonable and proportionate regulation. He pointed out that age restrictions are in place, and huge investment has gone into these restrictions. He mentioned the German age restriction technology for vending machines.
He said there was no potential for harmonisation on this, and suggested that a ban on vending machines would not be proportionate in Germany where the age restrictions are better. He continued by saying that as long as a channel of distribution is there, it can be regulated. The same is not true for smugglers.
I asked if I could interject, and was given permission by Dr Seychell. I said, “This is why we need central ratification for our programme. It is really important that the Commission does not get this wrong, because there is a genuine risk of an unregulatable black market. Many millions of smokers have already switched to vaping around the world, and they will continue to source products through the illegal black market if electronic cigarettes are classified incorrectly and regulated out of existence.” (Commissioner Dalli appeared to visibly ‘flinch’ when I said this.)
I thanked the Commission for allowing me to speak, then Dr Seychell passed it to the Chairman of the European Confederation of Tobacco Retailers. Although the meeting was being held in English, Mr Risso presented his case in Italian, reading from a script. He had an interpreter who translated after fairly large sections. He thanked the Commission for allowing him to present his case in this way.
He said that plain packaging would have a direct effect on retailers. If brands disappear, consumers would go to cheaper cigarettes, and there would be losses for tax revenues, paving the way for contraband.
“Retailers are capable of being responsible,” he said. “So are consumers. All the necessary information is accessible to consumers; licensing works, so a product display ban would be excessive and discriminatory.”
He suggested that decisions about retail regulation should be made by individual Member States, and not at the EC level. He suggested that shop closures would not lead to young people being discouraged to start smoking.
He said that it would take too long for retailers to find products for customers from under the counter. He suggested that this would pose a security risk for smaller retailers, who need to be able to keep an eye on their store to prevent theft.
(Still no-one? )
He concluded by thanking the Commission for listening, and for allowing him to speak in Italian and use his interpreter.
Dr Seychell responded by saying that the illicit trade of tobacco products is being considered by the Commission as part of the Impact Assessment. He said that they are “looking to improve traceability of products.”
He finished by thanking everyone for their submissions, and said that we would be allowed to make further submissions to the consultation process, either today or within one week, so that they can be taken into account while the Commission is looking at the Impact Assessment.
Commissioner Dalli said, “Our objective really is the health. We have to focus on this. If you have any reports of evidence on snus, etc., please submit these.”
The EU Regulatory Affairs Manager for BAT asked if he could speak, and posed a question: “We are in darkness about what you’re looking at specifically. Are there preferences?”
He continued: “Are there calls for bans on specific product types? What should we be responding to?”
Dr Seychell replied that all options are still available, since the Impact Assessment is the preceding stage before identifying concrete options. They are looking at benefits and costs, and need evidence to feed these.
He said they are looking at 3 broad areas, but if stakeholders point out specific things which have been missed, the Commission can weigh the evidence and decide which options to include.
The meeting closed.
Afterwards, I went forward to speak with Dr Seychell. I explained that I didn’t want to leave the petition letter with him now, because I had only been able to print a very small font copy while I was in Athens. (Suffice to say, this was not a holiday, but a trip to carry out ECITA audits on our Greek members. The trip resulted in our travelling through 4 countries in one day: on Wednesday, we woke in Greece, flew to Belgium, flew to London, then drove home to Wales! Fortunately, I have mastered the art of knitting spare hours! )
I thanked him for the opportunity to make further submissions, and suggested that I would email the petition in full, since this would save on printing.
This means that we have a few more days to gain even more signatures! If you haven’t already, please do go to http://www.petitiono…m/petition.html and add your name to the 16,146 people who have already signed. It’s still not too late!
He agreed that this would be perfect, and assured me that it would all be fully taken into consideration. I said that we would send through other supporting documents too, and he seemed very receptive to this.
Planning already to make my escape, since I had a plane to catch, I began to move towards the door, but one of the ladies from the Commission approached me. We had shaken hands before the meeting when we first came in, but I did not know who she was.
She asked me to take her card, and suggested I contact her. I took the card, and it transpired that she is a Legal Officer for Health measures from the Health and Consumer Protection Directorate-General.
Now I do not know whether it was Dr Seychell who suggested that she should approach me, or whether she decided for herself, but it seems a particularly fortuitous approach. On the flight back to London, and in the car on the way home, Tom and I wracked our brains to try to figure out how this could be a bad thing, and couldn’t think of one. No, on the contrary, this appears to be a very good thing indeed!
Since her focus is on ‘Health Measures’, and she is a legal officer for the Commission, it seems that either she, or both she and Dr Seychell (and possibly others), have accepted our position that electronic cigarettes are not tobacco products. We know they are not medicinal products, so maybe now we can talk further with this Legal Officer about how public health and safety can be best protected and promoted by leaving electronic cigarettes where they currently sit in regulatory law.
Only time will tell, but we shall certainly be approaching this lady in the coming weeks to try to arrange a meeting to discuss the details of our programme and how they are applied. Maybe we can finally achieve the holy grail: central ratification – at the EU level – for classification of electronic cigarettes as recreational consumer products.