April 15th, 2013

E-cigarettes are unregulated, right?

wrongWhen the UK Medicines Regulator (MHRA) consulted in 2010 on whether e-cigarettes should be regulated as medicines, it gave three options: I summarise the first two and quote the third:
Option 1. Regulate as medicines and withdraw unlicensed products in 21 days
Option 2. Regulate as medicines and withdraw unlicensed products in a year (June 2011)
Option 3. “Do nothing and allow these unregulated products containing nicotine that have not been assessed for safety, quality and efficacy to remain on the market.” [emphasis mine]

See what they did there…? It’s either medicines regulation or ‘unregulated’. We call this framing bias – and they were rightly criticised for it.  But the idea persists that e-cigs are unregulated, and it is the reason why some people think they should be regulated as medicines.   In reality, there is very little in the European Union that is ‘unregulated’. Most products fall under general consumer protection legislation. Here is a selection of the key EU directives and regulations that already apply (or could be applied) to e-cigarettes and other non-medicinal nicotine containing products:

General safety
General Product Safety Directive 2001/95/EC
The RAPEX system – notification and alerts of dangerous products
Technical Standardisation under Regulation 1025/2012 and related legislation (an option not so far used, but could be used to set performance or design standards)

Packaging and labelling
Dangerous Substances Directive 67/548/EEC
Dangerous Preparations Directive 99/45/EC
Classification, Labelling and Packaging of Substances and Mixtures – the CLP Regulation 1272/2008 applies from 2015.

Chemical safety
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation (EC) 1907/2006

Electrical safety
Low Voltage Directive 2006/95/EC
Electro-Magnetic Compatibility Directive 2004/108/EC
Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU (where appropriate)
Waste Electrical and Electronic Equipment (WEEE) Directive 2012/19/EU
Batteries Directive 2006/66/EC

Weights and measures
Making-up by weight or by volume of certain prepackaged products – Directive 76/211/EEC
Nominal Quantities for Prepacked Products Directive 2007/45/EC

Commercial practice
Sale of consumer goods and associated guarantees 99/44/EC
Distance Selling Directive 97/7/EC
Directive on Electronic Commerce 2000/31/EC
Misleading and Comparative Advertising Directive 2006/114/EC
Unfair Commercial Practices Directive 2005/29/EC

Data protection
Protection of Personal Data – Directive 95/46/EC

(with thanks to ECITA)

What the consumer protection framework doesn’t do

  • Therapeutic claims. It does not validate a therapeutic (ie. health) claim, such as “relieves nicotine withdrawal symptoms” or “prevents cancer”. Asserting that using an e-cigarette is an alternative to smoking cigarettes is not therapeutic – see  my briefing: Are e-cigarettes medicines?. It’s a competitive claim about product utility that says nothing about benefits to health, or modification of physiology (the two reasons to class a product as a medicine).   In fact surveys show that smokers are often motivated to switch for other reasons (cost, odour nuisance, social etc) as for perceived benefits for long term health. Companies that wish to make therapeutic claims should be able to apply for a marketing authorisation under the Medicines Directive 2001/83/EC – but that should be an option, and it certainly has potential benefits for vendors willing to go through the process. Companies that wish to make competitive claims need to be able justify them as a fair marketing practice, as with any other claim for any other product. [note this para updated 16 April 2013]
  • Guarantee a certain nicotine hit. It does not require proof that an e-cigarette will deliver a certain quantity of nicotine to the body at a certain speed (ie. validate the so-called “pharmacokinetics”).  Some commentators believe it should be mandatory to class them as medicines so they can prove they are adequately potent alternative nicotine delivery devices to rival cigarettes. If vendors believe this to be important and wish to communicate that to the customer, they can simply make a factual evidence-based claim about the product – the consumer is protected by Unfair Commercial Practices Directive (2005/29/EC).  If such claims were to be regulated or standardised,  it  would be better to develop technical standards under consumer protection legislation using Directive 98/34/EC for this.
  • Second guess consumer preferences. It does not guarantee that people will like the products and switch over from smoking. We normally allow consumer preferences, trial and error, producer innovation, pricing, fair marketing practices, user feedback and third party commentary (ie market forces) to sort out which products consumers will choose, and so which ultimately succeed in the market. Unless their health is at risk or there are unfair practices, consumers do not need so much protection that they have their choices made for them by a regulator – and that is not a good principle for developing the single market.

What now?

  • We should ask:  if medicines regulation is the answer, what was the question? What problem or opportunity do we have and how will regulating as a medicine address it? Does that problem need to be solved by a regulator or by consumer preference? Is there an easier lighter touch way of doing it in consumer regulation?
  • The Commission could produce guidance on the application of existing EU consumer protection legislation as it applies to nicotine containing products.
  • Where specific standards may be justified – ie for contaminants in e-liquids – a standard can be set.
  • The Commission should be asked to conduct a detailed study of the evolving nicotine market and assess whether additional legislative measures are necessary – either with specific decisions and standards under consumer protection legislation, or with a purpose built regulatory framework of the type developed for cosmetics (another product that does not fall neatly into any other category).

35 comments to E-cigarettes are unregulated, right?

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  • Karin

    Hi Clive,

    The Library Briefing on electronic cigarettes states that The Netherlands consider electronic cigarettes as medicinal product (see page 7: “Annex: Regulation in EU Member States”).

    In the same briefing however, it is stated that the ‘s Gravenhage Court has ruled in March 2012 that e-cigarettes do not fall under medicinal products legislation. In fact, the court has ruled twice in this case, and electronic cigarettes are dealt with under consumer products legislation (de Warenwet).
    The same goes for Germany.

    Apparently, there was some confusion when the Libary Briefing was written and the Annex contains rather serious flaws…

    I would like to take action on getting Mr. Erbach (the author) to amend the briefing. Would you mind giving me your advice on the best way to go about this?

    Thanks in advance,
    Karin

  • […] on the 17 directives that already apply to e-cigarettes, and only go further if there is material evidence of a problem that cannot be addressed by the […]

  • […] are unregulated, far from it.  They are covered by at least 17 directives (I have set these out here).  This is not to say that the regulation is currently perfect – though there is little sign […]

  • Electric cigarettes make no sense, people smoke for the nicotine, these do no good except aggravate others. Use self control, smoke outside if one has to smoke at all.

  • Clive Bates

    These personal stories about e-cigarettes are very powerful – and for me they are quite moving. I know they are having an impact on MEPs and regulators too. You have to ask “what is the problem that all this new regulation is supposed to fix?”

  • Diane Harp

    My father died a horrible death of lung cancer and so did my uncle. I am 52 and was smoking up to 50 cigaretes a day. My lungs were so bad I expected to develop lung cancer at any moment. I messed around with a couple of E cigs and they did not work almost going to abandon it and Found the E-VIC. Incredible results. Just stopped cigarettes dead and have not touched one since I had it. Can ran up the stairs, the house is cleaner and I feel fitter. No craving for one even when I got a letter through the post today to say I have had an abnormal Mammogram and I have to go to the Hospital at 9am Monday.

    The Irony of it ……..

    • Keith Kelly

      Hi Diane, I just read your post on the ecig blog and I felt I had to ask how everything went at the hospital. Good I hope! My wife was diagnosed with breast cancer in December 2011 and we have gone through what seems like a lifetime of surgery and treatment, which seems to have worked.
      Good luck on your journey and stay positive!
      Keith

  • Ron Francis

    I have smoked for 52 years,I started with e-cigs in april 2012 I know only real cigarettes when on holiday which means approximately 200 a year.I haven’t totally given up but it is better than 152 gram of pipe tobacco each week.

  • Graham Spiers

    Hi I’m 58 have been smoking since I was 11 I have severe osteo arthritis in both hips nothing to do with smoking but I am on a large dose of morphine for the pain the side effects of this is you tend to fall asleep while just sitting any time of the day which is no good whilst holding a lit cigarette I have been vapeing now for the last five weeks started on a tornado and worked my way upto a vape pro so the most damage I can do now is break s toe so using an ecig has probably stopped me setting fire to myself

  • im a 64 year old senior citizen who has smoked since i was 18. because of this habit i encountered COPD. my asthama, was getting worse. i was given a home care giver because i could go 15 steps without huffing and puffing. my care giver sharon graham showed me her tornado t e cigarette. i even tried it. id made up my mind that i was finished with smoking with all the chemicals and not breathing. i went on line and bought my own e cig. its been over 3 1/2 years that i have never touched a regular cig. my doctor says that he has seen a really big change in my lungs and breathing. he told me if i hadnt have stopped the regular cig i would have most likely died. my mothe died at 54 with the same disease. if she had the e cig im sure she would still be alive today. thankyou totally wicked. im alive today because i feel i made the right choice. respectfully submitted: Cheryljean McDaniels

  • Sven-Eric BERARD

    well, ecig can help stop smoking cigarettes… playing sport can help to stop smoking too.
    sport isn’t medicine right? so ecig has nothing to do with medicine too.

  • Darren

    I am a committed believer in not just the benefits of e-cigs but also the fact that with all the variety of flavours,vaping is an absolute pleasure rather than the beast of an addiction requiring constant attention. Although as you have so clearly pointed out, there are a number of EU regulations and Directives that are capable of covering the many concerns over what is not just a new product but one into which we imbibe and fill our bodies. This is of course so vulnerable to unethical practices of which as the recent horse meat scandal so clearly demonstrated, there is unfortunately no shortage of companies willing and un-ambivalent when it comes to risking the well-being of the trusting consumer just to increase profit margins.
    In the United Kingdom the dual nature of our legal system does not officially make legitimate EU law until an Act of parliament creates and includes the law into our legal system. An example of this would be the Human Rights Convention which took decades to become part of the UK legal system in the form of the Human Rights Act in 1998. Do you have any thoughts on how this may affect British vapers especially the difficulties already faced making even the simplest and beneficial laws common to all the member states?

  • paul

    Clive and Katherine, many many thanks for all you are doing. I’ve written to my local MP, who has apparently visited E-lites recently, so hopefully he is “e-cig aware”. Over-regulation or banning of e-cigs makes about as much sense as regulation or banning of tea and coffee! (P&O and others, please note!) The bottom line is that governments are scared stiff of losing the enormous revenue from their punitive taxes on tobacco. Apparently, Utah is now proposing to tax e-cigs at similar rates – let’s hope they don’t get away with this. Any restrictive regulation or excessive taxation would simply create a black market peddling products of suspect quality – what a disaster that would be. Incidentally, my own story is that I changed to e-cigs literally overnight, after trying my first disposable, and will never go back to analogues.

  • james

    i started using one to attempt to quit smoking and after a week of smoking and using a e cig i quit for good and still have quit it some how turns smoking boring when you use a e cig and makes the taste of a cig turn disgusting so you just don’t want a cig any more i feel so much heather now than befor thanks

  • hetty

    But where do you draw the line .we have become such an intolerant race.Its ridiculous really.I don’t like the smell of some peoples fragrance but you know what I get over it.We have all got to live in this world together & its about give & take, respect,& personal differences & CHOICES.If I don’t like a programme on the tv I watch something else or switch it off but somebody else has the right to watch what they want reguardless of what I find distasteful or not as this is subjective.Yes I am tired of being dictated to & I’m not easily offended & believe in live & let live.I’m not going to go out into the world to purposely upset or offend anybody but if it does’nt physically hurt the person next to me why should my choice of enjoyment be compromised. :) x

  • Electronic Cigarettes are a great healthy alternative to a traditional tobacco smoker. Ecigs contain no tar or tobacco hence reduce lung damage and most people I know have used an electronic cigarette as a route to quit smoking all together. They could regulate ecigs in confined areas such as buses and trains as it may bother others.

  • The European Parliament Library has published a (in most parts) good “Library Briefing” concerning “Electronic cigarettes” :

    http://www.europarl.europa.eu/RegData/bibliotheque/briefing/2013/130494/LDM_BRI%282013%29130494_REV2_EN.pdf

    The MPs only have to read..

  • Jonathan Bagley

    If the EU Parliament is genuinely informing itself fully about ecigs and we end up continuing to enjoy them as a normal part of everyday life, without extra regulations and taxes, how will the EU justify to Sweden and the rest of the EU, its ban on snus export? Snus has been studied extensively and no reasonable person would consider it harmful. A significant proportion of Swedes would be smoking tobacco if it didn’t exist; and, as a bonus, snus has little aesthetic appeal and it doesn’t resemble smoking. They now want pre authorisation of novel products – as if ecigs took them by surprise and they can’t yet figure out a way to get rid of them.

    All this leads me to think a decision on ecigs will not be based on scientific evidence. If ecigs was unknown outside Sweden until recently, would the TPD ban their export? Surely it would?

  • Thank you for highlighting this crucial point, Clive. As far as a standard for eliquid manufacture is concerned, I can confirm that ECITA is working on this. We are sourcing some very specific testing to inform one particular aspect, and once this is completed, we hope to be ready to put our standard forward for accreditation as a British Standard (BS), a CEN (European Committee for Standardisation), and ISO.

    The current regulations – codifed and enforced by ECITA for its members over the past three years – are robust, appropriate and proportionate to the risks posed by electronic cigarette products. We are very pleased to see that the European Parliament is taking the approach it is, in seeking further clarification of these regulations, and informing itself fully before taking any significant decisions with regard to electronic cigarettes.

    Thanks again, Clive, for (once again!) tackling the real issues head on.

  • Vaper

    Smoking causes disease. But smoking is not a disease.

    A company that claims its electronic cigarette will help a person break their dependence on nicotine is indeed making a therapeutic claim.

    A company that claims their electronic cigarette will help you quit smoking, but not nicotine is not making a therapeutic claim.

    Electronic cigarette companies and vendors should be allowed to tell their customers the truth.

    Electronic cigarettes do help people quit smoking.

    • Clive Bates

      I think you are right: ‘quit smoking’ is at best ambiguous and unhelpful as an example here as usually associated with nicotine withdrawal – hence the therapeutic value. But clearly not necessarily. I’ve amended the post.

      • Paul K

        I am concerned that a lot of worried ecig users have written to or emailed their MEPs saying “I quit smoking using ecigs!” and those MEPs are now thinking “They help you quit smoking so are therefore a medicine! Hoorah!” when that was not the intention of the ecig users correspondence. It’s very sad that we have to be so careful with our words in case they are used against us in this way.

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