July 26th, 2013

Because you’re worth it – are there ideas from cosmetics regulation useful for e-cigarettes?

cosmetics-skin-Care
I have been pretty scathing in a number of posts about how wrong it would be to regulate e-cigarettes as medicines (see, for example: The case for regulating e-cigarettes as medicines; 10 reasons not to regulate e-cigarettes as medicines; Medicines regulation for e-cigarettes – when caution can kill – and pointed out it is probably illegal, not least because they are not medicines. I’ve also stressed the significant body of legislation that already applies to e-cigarettes, and suggested how the tobacco products directive can be amended to take better advantage of this.
Can any more be done…? Well perhaps we can learn from the approach taken to regulating cosmetics in the European Union.

Why look at cosmetics regulation?

Similarities between cosmetics and e-cigarettes. This is a useful area to explore for e-cigarettes, not because e-cigarettes can be classed as cosmetics (they obviously are not cosmetics), but because they have some interesting characteristics in common.  If they have similar characteristics, perhaps they would be regulated in a similar way.
  • Both are fast moving consumer goods;
  • Both are marketed as lifestyle products;
  • Both are capable of making claims (eg. of eternal youth) that need justification;
  • Both have potential human health and safety risks;
  • Both are in contact with to the human body;
  • Both industries have many vendors, different business models and long supply chains;
  • Both markets rely on rapid innovation, short product cycles, and ‘creative destruction’;
  • Both are functional and have to work properly (eg. makeup must not run, change colour etc);
  • Both sets of consumers expect products to be the same each time they buy;
  • Both have diverse ranges – colours and textures for cosmetics, flavours for e-cigs;
  • The cosmetic market is huge, the e-cig market will become huge;
  • Neither are foods or medicines (or tobacco products) and neither fit into regulatory frameworks designed for other products
An evolving purpose-built regulatory framework since 1976. So given these similarities, what can we learn from how cosmetics are regulated? In the case of cosmetics, legislators have taken the trouble to create a bespoke regime that is fit for purpose (ie. it has been designed to regulate cosmetics, not something else). With e-cigarettes legislators are trying to cut corners by hammering e-cigarettes into the most convenient and risk averse regulatory framework to hand, namely the medicines directive – an approach that is poor from a regulatory perspective and almost certainly unlawful.  Since the 1970s there has been an evolving system of regulation for cosmetics at EU level.  Until this month, cosmetics had been regulated by a 1976 cosmetics directive (76/786/EEC) – this was amended in 1982, 1983, 1988, 1989, 1993 and 2003 and finally replaced in 2013. It also had nine related directives. This is important: they didn’t get there in one go.  A new purpose built regulatory regime can be seen as a destination or direction – not something achieved at the outset. 
The current regulation. Cosmetics are now covered by a purpose-built EU regulation:  Regulation (EC) No 1223/2009 on cosmetic products. This was agreed in 2009 and entered into force on 11 July 2013 (note, a good long lead time). It also draws on evolving standards – for example ISO 22716 was introduced in 2007 to provide a Good Manufacturing Practice standard appropriate for cosmetics, and this is different to that used for pharmaceuticals.  It shows that the EU is capable of developing a purpose built regulatory regime if it chooses to. Given the conceptual similarities above, it turns out that cosmetics regulation has many of the features we would might eventually expect in an e-cigarette regime. It shouldn’t be blindly replicated either – this regulation has been a long time in the making and operates in a mature market. But it has several potentially useful features:
  • It respects the internal market. Manufacturers and distributors are required to comply with the regulation, but do not need pre-market authorisation.
  • It establishes a ‘responsible person’ in each manufacturer or distributor operating in the EU – and places obligations on them
  • It requires each product to have a safety assessment to a common format and for a product file to be kept
  • It requires proper labelling and product descriptions
  • It has lists of prohibited and permitted substances
  • It sets out what must happen if problems arise with products
In other words, it establishes the regulatory platform for a highly competitive innovative market.
See European Commission legislative overview for more detail and below for an outline of the articles in the regulation.

What does this tell us for the Tobacco Products Directive?

It means that the full challenge of e-cigarettes does not have to be addressed finally, once and for all in the TPD. We can take time (as with cosmetics) to get it right – there is no health emergency, consumer crisis or rioting among users that demands an draconian regulatory response.  Existing provisions (like the RAPEX system) are picking up faulty or dangerous products and there is scope to apply the existing consumer protection legislation more effectively. At this point we should concentrate on avoiding damaging and costly errors, imposing inappropriate regulation, creating needless legal vulnerabilities.  Here’s what to do:
  1. Reject medicines regulation for e-cigarettes – it is a ‘quick fix’ and not appropriate for these products [see here and here] – and allow this only where a therapeutic claim within the meaning of the medicines directive is made.
  2. Use the directive to require member states to more robustly apply and enforce the body of safety and consumer protection regulations that already exists [see here] and require the member states to report on compliance and enforcement activity and bring in this quickly (ie without the long lead in time needed for very disruptive regulation)
  3. Establish a new evidence based regulatory development process aimed at creating bespoke fit for purpose regulation of e-cigarettes and, potentially, other low risk alternatives to smoking.  This requires scientific advice,  a technical review, options development and appraisal, legal underpinning, consultation with users and producers etc.
A new regulatory regime does not have to be concluded now – progress can and should  be made, bad choices rejected, and a good direction set.  Achieve that modest ambition, and MEPs, ministers and officials can be proud of taking a proportionate, non-discriminatory, lawful, evidence-based, ethically sound approach to tobacco harm reduction. But that does require a change of direction in the final months of this year.

Appendix: Structure of the cosmetics regulation

The articles of  regulation EC 1223/2099 cover the following:
  1. Scope and objective (internal market with high level of health protection)
  2. Definitions
  3. Safety (a broad responsibility to be ‘safe’)
  4. Responsible person (designation of a responsible person for each product)
  5. Obligation of responsible person (to ensure compliance with the regulation and general duties)
  6. Responsibilities of distributors (general duties and responsibilities – eg. regarding labelling and product shelf life)
  7. Identification within the supply chain (traceability in the distribution chain)
  8. Good manufacturing practice (requirement to meet a quality standard for manufacturing – in practice ISO22716)
  9. Free movement (asserts basic right of free movement in the single market subject to compliance with the regulation)
  10. Safety assessment (an assessment to be made to a standard set out in Annex I)
  11. Product information file (a dossier on the product, safety profile etc)
  12. Sampling and analysis
  13. Notification (important – this requires notification of the Commission, not an authorisation process)
  14. Restrictions on substances listed in Annexes (refers to annexes II-VI)
  15. Substances classified as CMR materials ( restrictions on carcinogenic, mutagenic, reprotoxic substances)
  16. Nanomaterials
  17. Traces of prohibited substances ( a de minimus clause for unintended traces of harmful substances)
  18. Animal testing
  19. Labelling (ingredients, shelf life etc)
  20. Product claims (duty to be truthful)
  21. Access to information by the public (right to know what is in the product and any known safety risks)
  22. In market control and surveillance (duty of memeber states to monitor compliance)
  23. Communication of undesirable effects (responsibility to notify authorities etc)
  24. Information on substances (how to act when in doubt about safety)
  25. Non-compliance by responsible persons 
  26. Non-compliance by distributors 
  27. Safeguard clause (powers for competent authority to intervene)
  28. Good administrative practice (application on 25-27)
  29. … to 40 co-operation, administrative and final provisions etc
Annex I     Cosmetic product safety report
Annex II    List of substances prohibited
Annex III  List of substances restricted
Annex IV  List of colorants permitted
Annex V    List of preservatives permitted
Annex VI   List of UV filters permitted
Competent authority.  The ‘competent authority‘ for cosmetics in the UK is the Department for Business Innovation and Science and the Laboratory of the Government Chemist.

 

32 comments to Because you’re worth it – are there ideas from cosmetics regulation useful for e-cigarettes?

  • You actually make it seem so easy with your presentation but I
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  • […] Allows for good policy-making. It avoids creation of poorly designed legislation. What seems like a good trade-off in the negotiating room may create harmful and unintended consequences in the real world. That is why policy-making is usually ‘deliberative’ (ie. involves those affected) and allows negotiation to concentrate on detail rather than major design features.  This would enable the Commission to propose measures that would provide: ‘specific safety and quality requirements’ to supplement existing consumer protection legislation; a safety regime including responsible persons and a product safety file; a proportionate disclosure and notification regime; establish accountability and responsibility arrangements; impose advertising controls as necessary (with properly shared competence with member states).  I have discussed the type of regulation that might emerge by comparison with cosmetics regulation. […]

  • Bill Godshall

    Clive, a very thought provoking analysis.

    Regarding ASD’s endorsement/advocacy to regulate e-cigarette products as tobacco products, I suggest reading my presentation at the Food Drug and Law Institute conference in April on the absurd ramifications of an FDA “deeming” regulation (that the agency has stated its intent to impose on e-cigarettes) at:
    http://www.e-cigarette-forum.com/forum/legislation-news/409895-godshall-presentation-fda-deeming-regulation-food-drug-law-institute-conference-dc.html

    In sum, the proposed EU TPD, the announced UK MHRA medicines regulation, and the FDA’s potentially forthcoming “deeming” regulation would ALL threaten consumer and public health, protect cigarette markets, ban >95% of (perhaps all) e-cigarette products, eliminate >95% of (perhaps all) e-cigarette manufacturers (from legal markets), and would significantly increase the price of e-cig products that are allowed to remain on the legal market.

    So far, Nicolites, NJOY and (I believe) BAT have endorsed UK MHRA e-cigarette regulation (for their own selfish financial interests of increasing their market share and eliminating many/most competitors) even though NJOY and BAT have just began selling e-cigs in the UK).

    Similarly, NJOY and Altria have publicly endorsed FDA regulation of e-cig in the US (even though Altria hasn’t sold its first e-cig yet).

    Several weeks ago, I had a correspondence with NJOY CEO Craig Weiss about UK MHRA e-cigarette regulation at:
    http://www.e-cigarette-forum.com/forum/legislation-news/443800-njoy-ceo-craig-weiss-correspondence-smokefree-pennsylvanias-bill-godshall-uk-mhra-e-cigarette-regulation.html#post10121719

    While I strongly support reasonable and responsible public health and safety regulations, I consider banning sales to minors as the only reasonable and regulation for e-cigs. All other proposed e-cigarette laws/regulations are nothing more than extremist solutions for nonexistent problems. And the only reason sales bans to minors are reasonable is because FDA officials and other e-cig prohibitionists have (since 2009) falsely accused e-cig companies of target marketing the products to youth.

    Bill Godshall
    Executive Director
    Smokefree Pennsylvania
    1926 Monongahela Avenue
    Pittsburgh, PA 15218
    412-351-5880
    [email protected]

  • Jonathan Bagley

    In many parts of the USA it is still possible to smoke indoors, and tobacco taxes are low. Perhaps that’s why those of us in the UK are generally more opposed to associating ecigs with tobacco. The Anti Tobacco and Public Health Industries have made it clear that, given the chance, they would ban non residential indoor ecig use and the Government is itching to tax ecigs. Associating them in the Public’s eye with tobacco will make taxes and indoor bans more likely to come about.

  • Tom Pruen

    I’d see tobacco classification as more of a deferred suicide than a sensible way forward (at least in the EU, the US market is different, although possibly not different enough).
    We have already seen that the EU policy makers want to remove flavourings from tobacco products (they even attempted to ban flavourings in Snus, despite already having banned the sale of Snus outside Sweden!) – and since ecigs are entirely dependant on flavourings, even for ‘tobacco’ flavours (a nicotine/glycol solution is broadly flavourless, about the only way around that would be to use deliberately low purity nicotine to give flavour as well, making the product in all likelihood less safe) this would pretty much destroy the product (and generate an uncontrolled after-market for flavours – at least the currently marketed ecig flavourings are designed to be free from things that are known to be bad if inhaled – most off the shelf food flavourings aren’t).
    Then there’s emission testing which is also going to be expensive if you have a lot of products – not something that is going to help innovation in the market.
    There is also the EUs strange aversion to discussing or considering relative risk for tobacco products, as exemplified by the scientifically inexplicable ban on Snus.

    (This leaves aside the huge variation (despite the EU) in national regulation. For example, here in the UK, tobacco products cannot be advertised, including a ban on displaying them at the point of sale. There is also a ban (for tax reasons) on cross border imports.)

    I’d also be very wary about starting down the slippery slope of tobacco taxation, not only for the inevitable huge price rises this would directly cause, but also the huge added overhead for the vast amounts of paperwork it would result in. There is a reason (Ok, actually, there are many)that SMEs struggle in the tobacco market. Compliance costs have a tendency to not scale down very well( or indeed at all).

    Taking a long term view, I think that while tobacco classification would possibly yield short term benefits, most of these would prove illusory and the long term results would be pretty much the same as medicine regulations – no flavours, increased costs to consumers, reduced availability, and all the current players crushed out of the market by costs.

    And if you look at it from that perspective, it’s a dead loss (unless you are a big tobacco company of course)

  • Chris Price makes some excellent points — but I do think one omission is the acknowledgement that consumer products don’t tend to be inhalation products. Quite the opposite — alcohol inhalation and caffeine inhalation have gotten some pretty nasty regulatory reactions.

    Here you’ve got nicotine and potential longterm use of pg/glycerin neither of which is GRAS or e-numbered for inhalation…

    So I just don’t see the consumer product route as working — and that’s why I think the best protection for this category is tobacco regulation. Of course, I have to acknowledge that the tobacco regulators have made a mess out of SNUS (and our MRTP category in the uS) to date, so I can appreciate the lack of trust for the tobacco approach.

    I just see tobacco as the least bad route as between what (I see) as a non-viable consumer product path and a challenging medical route (I think drug approval would strip out all the appealing features though the thought cannot be lost on us that drug approval would remove tobacco taxation as a possiblity).

    Chris, Clive thank you (and the others) for you thoughtful posts and replies.

    • Chris Price

      Consumer products for inhalation are rare, they tend to involve inhalation (sometimes extensively) as a secondary feature or consequence – aroma therapy oils, disco/theatre fog, building aircon treatment.

      GRAS / Acceptably Safe licences for inhalation are a feature of pharmaceutical licensing, not consumer product law. PG, glycerin and nicotine all have multiple licenses for medical inhalation in every Western country. For example PG is used as the excipient for the nebulised drugs used by lung transplant patients and in asthma inhalers (although is being replaced by glycerin for that duty. See Dow Optim.) It has 70 years’ safe use for inhalation and has been used for that purpose since the 1940s. Glycerin is being used more now as it doesn’t have the same throat-drying issue for 1 in 10 patients that PG has.

      PG and glycerin also have multiple uses in inhaled consumer products such as disco fog and treating the water cooling plant in large building aircon. The addition of PG to building aircon cooling water is why you don’t get Legionnaire’s Disease, and it means that people in large buildings must inhale PG at very low concentrations. In the UK employment laws are strict, and impossible to pervert (unlike some other areas of regulation) because too many people would have to be paid off and a fix could not be kept quiet. PG is perfectly acceptable for long-term high-volume inhalation by employees and has passed numerous investigations for that purpose. As glycerin is also used we know that no issue has been found for long term inhalation by staff in entertainment venues.

      I don’t regard cigarettes as a consumer product, by the way – they are the most dangerous drug commonly available and are only still around due to the grandfathering issue and the huge amount of money they make for so many people, all of whom have far more power than the rest of us. If the smoking economy was not so vast, and so well able to protect itself, cigarettes would be long gone. They are a special case: a state-sponsored drug that breaks every consumer law in existence but that cannot be removed (up till now). Ecigs will do the job that nothing else could, and when the smoking money machine is too small to protect itself any longer, it will be gone.

  • Roger Hall

    An interesting article as well as the many comments. Forgive me my ignorance, but if the primary stated reason for the need for medical regulation as stated by the EU TFD proposals are safety issues plus effectiveness, reliability and not to appeal to children, than logically the stellar growth of e-cigs is already proving their effectiveness and reliability. Also as far as I’m aware there are no documented public health concerns regarding safety. No one has died or suffered permanent injury in the past 4/5 years by using e-cigs so with millions of current users one can conclude that the existing product regulation is actually working to provide safe e-cigs.

    Medical regulation is well proven to be no absolute guarantee of public safety as even the Pharmaceutical owned Chantix NRT product has killed people and been the cause of multiple law suits resulting in financial damages/settlements paid out by Pfizer of hundreds of millions of dollars. There are many other well documented medically regulated products such as Mediator and Vioxx that have suffered similar public health issues. E-cigs already have a proven safety, reliability and effectiveness record and “what if” scenarios is no reason for regulation.

    • godek

      You would be 100% right if the regulators who now try to get their hands on the e-zigs were actually concerned about what they claim. Hence that “what if” stuff and the “if it’s not proven to be 100% safe we cannot allow it”. This goes against many principles of lawmaking and such but it is not contested.

      Chris is right, it’s about the money. It really angers me that both the state and BigPharma seem to really think that they have the right to access my wallet indefinitely because I started smoking years ago.

      Noone but the smokers and their relatives or close friends profit from e-zigs staying available or Snus unbanned.

  • godek

    We live in 2013.

    There is really not much additional regulation needed.

    If a device is not working as expected, the word is spread easily and fast via forums, blogs ans social media.

    If a vendor, say of liquid base fucks up, it does not take long for the community to notice and inform about it.

    So perhaps, no additional regulatory framework (what a word) would be best.

    HTH
    godek

    • Chris Price

      Godek, there is no issue other than that the two trillion dollar annual value smoking economy is under threat. That is what the problem is. It is pointless trying to ‘fix’ the symptoms (e-cigarette regulations) when that isn’t the problem – it’s like putting a sticking plaster over a chainsaw wound. A complete waste of time.

      The problem is that governments and industries will lose huge sums of money as e-cigarettes gradually replace smoking. There just isn’t any issue other than that.

  • In a debate on this issue on Carl Phillips’ site AntiTHRlies, he has made the useful point that any new form of regulatory process or committee will probably be captured by the same hate group who control tobacco, Snus, and now ecigs at EU level.

    This is an interesting point; these products all seem to be regulated by their opponents instead of independent public health figures or those who approve of them. How can you stop that happening with any new process or body?

    • Els

      It will give more time. More time is needed for more scientific reearch. The results will stop them. It happened inFrance where e-cig opponent Prof. Dautzenberg has done a turn and is now in favour of e-cigs. Unfortunately he still has some ‘politically correct reservations’ but the U-turn he made is evidence that time for the industry as it is now is crucial.

  • Just thinking out loud, but I’ve been pondering a solution to this mess. It’s to inform, but the written word doesn’t seem to be working, why? I think it’s because most people are audio/visual learners. Politicians are no different, send them a report, it may get read but won’t be understood, but how them to we pop that filter bubble. It’s been said time and again but the real power of persuasion happens in the real life, person to person discussion.

    We need to get the message out to a larger segment of users, those that do not visit the forums, the evidence is clear that we need to do a better job.

    With an estimated 1.3 million ecig users in the UK and we can only muster at most 20,000 signatures on a petition. we can do better than this.

  • Clive, sorry don’t quite catch your meaning here, are you saying asking MPs/MEPs to exclude ecig medicinalisation from TPD and start again with consumer regulation may not work?

    “Not sure *that* will work, unless we reach a crisis and they have to do *it* to get the directive through.”

    Grateful for clarification.

    • Clive Bates

      Ah sorry… what I meant was that it wouldn’t work to take e-cigs out of the directive completely – just delete article 18. The choice is between medicines regulation or more robust use of consumer legislation (eg. by getting something like the Industry Standard of Excellence mainstreamed). The idea of raising the cosmetics legislation is to strengthen the case for the latter by showing that this could be the first step in developing purpose built regulation for e-cigs that would evolve over time.

      If there is deadlock on e-cigs they just might drop article 18 completely, but I think that’s very unlikely.

  • So… we encourage MEPs to leave eCigs outside the TPD and create a directive specifically designed for this our industry, taking the successful regulation of cosmetics as a template?

    If I have understood correctly, that would be a huge leap forward. The current proposals are a disaster waiting to happen.

    With a regulatory pay to play fee in the millions, only a multinational tobacco or pharma companies will be able to particpate and the MHRA regs will simply drive the market offshore. All we will be able to buy in the UK is a limited range of fractionally safer but much less satisfying products.

    We are told every day by customers they will return to smoking rather than use an expensive and ineffective ‘medicinalised’ ecig. Or buy them from HK based suppliers, as many already do.

    Nicotine is not medicine. As you say, it be regulated under consumer not medicines legislation. Seems obvious… doesn’t it?

    • Clive Bates

      Not sure that will work, unless we reach a crisis and they have to do it to get the directive through. I think the consumer regulation with a follow-up has a better chance of getting through. When people don’t agree they often place the substantive decision in the future and require more work to be done before the decision is made. In this case more work really does need to be done – there has been minimal consultation on the impact of regulating e-cigarettes as a medicines, and next to nothing done on alternative regulatory approaches to medicines regulation.

  • There is no sensible basis to place a e-cigarette — which contains an active ingredient heretofore only allowed in drugs and tobacco products — in the cosmetic category. This is the type of self-serving clap trap that only gets the industry laughed at by regulators.

    Here are two tobacco products: if these companies can operate in tobacco frameworks — why can’t others?

    http://www.ploom.com

    http://www.globalvaporcorp.com

    • Clive Bates

      There are quite a few things with active ingredients that are not drugs or tobacco – alcohol and caffeine to name two. And tobacco regulation does next to nothing to regulate the active ingredient, nicotine. There is no real need to either it is taken in uncontrolled burning tobacco form by the vast majority of its user.

      I thought I had taken enough trouble to say that I wasn’t suggesting that e-cigarettes be regulated as cosmetics.

      not because e-cigarettes can be classed as cosmetics (they obviously are not cosmetics)

      What I am saying is: (1) that the European Union crafts legislation that is designed specifically for the product being regulated, and they ought to do that with this class of products: (2) that some (not all) of the characteristics of cosmetics have parallels with e-cigarettes (consumer, lifestyle, fast paced, innovation etc) – and therefore we might find useful parallels or even a useful sense of proportion in the approach taken to cosmetics.

      As for classifying them as tobacco products – actually it’s not a totally bad idea. If they were classed as ‘novel tobacco products’ and came under Article 17 of the proposed directive they could be placed on the market with just a notification regime. The contrast between article 17 and 18 is one of the most ridiculous features of the directive.

      But…. there are downsides with classifying them as tobacco products. Firstly they aren’t in any meaningful sense of the word, tobacco products – and that have no real resemblance to real cigarettes. Second, there is a risk that restrictive legislation that applies to tobacco being applied (advertising bans, taxation, smoking bans etc – though these are not the subject of this directive). Third, that ingredients restrictions like bans on characterising flavours etc would damage the viability of the products. But the main reason is that there isn’t a snowball’s chance in hell of the European institutions agreeing to it as far as I can see. It’s only being done by the FDA because they tried and failed to regulate them as drugs.

      So my proposal is to rely on consumer protection legislation now, and move towards something that is purpose built and designed for recreational nicotine products, incorporating some of the approaches used in cosmetics: safety assessment, responsible person, product information file, labelling regime, schedules of permitted or prohibited ingredients – but importantly the right to sell the product if it meets the regulatory requirements if a review shows that sort of regulation is needed.

      As for self-serving – I’m not representing the industry. I’ll leave it to others to decide what is and isn’t claptrap!

      • I apologize if my post was a bit flippant in tone — your post certainly wasn’t clap trap.

        I just don’t see cosmetics as being much a of precedent as they (i) don’t have systemic effects on the body and (ii) are typically topical as opposed to inhaled.

        Incidentally, I don’t know about Europe, but we actually do regulate caffeine as a drug here in the States above a certain threshold. I believe the leading brands are Nodoze (Novartis) and Vivarin (Meda). I am not sure in Europe how you treat them.

        Even if you were to used the current cosmetic regime as a framework, you’d still have to address the tough issues — like, for example, nicotine content.

        The Sottera njoy contains FORTY FIVE mg of nicotine per unit. The highest approved drug inhalator has just EIGHT only four of which are delivered from the device (and far less than that absorbed)…… Does that not strike you as strange — it certainly does to me.

        What I meant by clap trap was that many in the industry have staked out very aggressive positions and then scream murder when regulators get upset.

        To me — tobacco products regulation makes the most sense (point of sale protections, marketing restrictions) with a real modified risk path to allow the industry to demonstrate relative safety first, and then make appropriate modified risk label claims to consumers….. Of course, our FDA could really strengthen my argument by doing a better job with our MRTP pathway here in the States, which to date has been impossible to clear.

    • Gordon Beard

      The two examples that you cite are the very reasons that people are opposed to regulation in the form the EU are proposing .

      I want to be able to customise the whole experience ie battery size , nicotine strength and flavour . I have no desire to use the products that were shown in the two links BUT find it rather disturbing that the proposed regulation will leave the market to examples such as this . Regulation in some form or other is probably inevitable but whatever is chosen should not have been influenced by large outside commercial interests (pharma+tobacco) or by ideological zealots . Maybe that is a pipe dream in the modern world , the route that Clive advocates seems to offer the prospect of a genuine “right touch legislation” not something hastily cobbled together to fit existing regulations that will have totally unintended consequences.

      • If you are referring to my post — I did not mean that those products should have a monopoly (!) — more I cited them for the proposition that they represent a viable direction for further product development/commercialization within a tobacco framework.

    • [email protected]:

      http://www.asd.com appears to be the website of the American Schools Directory. Are you representing asd.com?

      Regarding your post, there is not much product information available on http://www.globalvaporcorp.com, but the other website seems to be selling herbal vaporizers which vaporize actual tobacco or other leaf based ingredients.

      The eCigs we are talking about contain propylene glycol and extracted nicotine. Quite different products to the ones you are promoting, neither of which I personally would be comfortable using.

      • Clive Bates

        I should make clear I’m very happy to have anonymous or proxy comments on this web site – especially if from knowledgeable people with interesting arguments, and would welcome more views from government or industry insiders.

      • Charles, I just used a-s-d because they are the closest on the qwerty keyboard; I don’t represent any schools. I do work in the tobacco industry; I don’t sell e-cigarettes.

        JTI’s ploom smokes (or vapes) pretty closes to a conventional e-cigarette. I strongly suspect the toxicant profile of these products looks a lot like Accord, or, for that matter, the nicotine based product you like so much.

        I realize there is not a lot of public data on Ploom, but go back and look at the tox studies of Accord — you get a very similar hoffmann analyte profile to the e-cog.

        My point is, you seem to react viscerally against these tobacco based products but they are closer in taste and toxicology to the nicotine e-cig than you may realize.

        With further product development, there is no reason that tobacco products cannot fill a lot of the space currently occupied by nicotine-based e-cig, while remaining all the while in a tobacco framework.

    • Clive Bates

      [email protected] at 7.56pm 26 July

      Once again, I am NOT proposing applying cosmetics regulation. I just said there are useful lessons there – the type of control applied, the degree of restriction of commercial freedom etc given there are some parallels. The idea would be to get regulation that is designed with the characteristics of the e-cigarette product, not medicines, cosmetics or anything else that e-cigs aren’t.

      Caffeine products are not regulated – at least up to very high doses as far as I know and caffeine drinks like Red Bull or Monster are widely available in Europe as recreational consumer products. The nicotine part of e-cigs is no more a medicine than the nicotine part of tobacco products. Tobacco product regulation does nothing to control the effect on the body. Actually there is little is can do – whatever the content of the product, users control their own dose by taking more or fewer, deeper or shallower puffs, with feedback between the reward system and the intake. That’s why no-one overdoses on nicotine taken in this way (it is possible to overdose with multiple patches if you leave them on, as there is do feedback control with absorption through the skin.

    • Chris Price

      Hi ASD.

      I could not reply to your post below as there is no reply button on it, so I’m replying here – sorry.

      You said: “The Sottera NJoy contains FORTY FIVE mg of nicotine per unit. The highest approved drug inhalator has just EIGHT only four of which are delivered from the device (and far less than that absorbed)…… Does that not strike you as strange — it certainly does to me.”

      This is a technical issue and probably a little too complex to explain here, but I’ll try.
      – The nicotine strength of the refill liquid is irrelevant because all that is of interest is what is in the vapour. For example a tobacco cigarette may contain 15mg of nicotine, but only 0.8mg is transferred to the smoke. What is in the tobacco is not relevant. It is incorrect to assume that all the nicotine in the solid phase material is transferred into the gas phase – it isn’t. There has not been sufficient research on the nicotine content of vapour thus far but a working hypothesis is that about 50% is transferred from the refill liquid to the vapour (as there have been numerous ad hoc tests by professional chemists on the ECF Forum and their tests average 50% transfer using cryogenic condensers, 5kV electrostatic discharge, etc.). See the ECF Library for more data.

      – There have been multiple clinical trials (~4) that demonstrated that a person using a mini e-cigarettes with an average strength refill received zero or very little nicotine transfer to the blood plasma. (You can find the references on the ECF forum – Eissenberg 1, Bullen et al, and so forth.) Intellicig also ran such a trial as part of their pharmaceutical license application (unpublished) and got the same result: mini ecigs (the beginner models that resemble a cigarette) don’t work very well. As a result, since they *had* to show nic transfer to the blood plasma, they introduced a super-strong refill just for use in minis (they are an effective placebo as they feel like a cig and may elevate blood plasma nic levels to 1 or 2ng/ml or so). Smoking replacement needs a device that can elevate blood plasma nic levels to 8ng/ml or more.

      So NJOY perhaps trialled this issue as well and came to the same conclusion: these tiny, obsolete models need rocket fuel in order to work.

      Keep in mind that: the amount of nicotine in the refill is irrelevant as it doesn’t all transfer to the vapour; the amount in the vapour is not really relevant either; the only important factor is what a typical new user’s blood plasma nic level is. This must be sufficient to allow them to avoid smoking.

      There is no OD issue for experienced users, who will receive far more more nicotine than a beginner as the user technique is totally different from smoking and needs to be learnt. As Prof Hajek says, when specifically addressing the issue of multi-device and multi-therapy concurrent usage: “…we now know these things are safe…..There is a built-in safety valve…..You just experience nausea and you stop…..and no health damage can come about. So these things are safe.”

      Hope this has explained the issues. If you require more technical data please contact me though http://www.ecigarette-politics.com

      • Chris,

        I am pretty familiar with the clinical data, and I don’t disagree with you a lot of your observations (of course, a cigarette does not contain 15 mg of nicotine by any measurement, but I understand the point you are making — focus on actual delivery as opposed to composition strength).

        I also don’t disagree with your point about self-regulation by the user (though I wish folks with put child resistent features in these re-fill bottles just to be sage).

        But, I stand by my point on some level that it does seem off kilter that a private company just privately (and without any publicly available data) devices to dial up nicotine levels on its own to a substantial multiple of the highest approved drug product. To me, that’s a big “ask” vis a vis regulators.

        I feel like frequently those opposed to e-cig regulation adopt a kind of libertarian view which, while appealing to many, is not a winning argument in the modern regulatory state.

        I could take a lot of drugs with reasonably broad therapeutic indices that could be safely used for recreational purposes (I know my diazepam example is purposefully incendiary, but why not allow recreational use since people will just sort of all asleep and chill out before they approach levels associated with morbidity)?

        Don’t misunderstand me — I’d personally like to live in this new libertarian state (which probably should not be in the EU btw), but I think in the state(s) we live in, tobacco regulation makes the most sense.

      • Chris Price

        ASD (in reply to your post of 28th @12:30)- the nicotine content of the tobacco in a cigarette varies between 13mg and 23mg, and the average is 18mg (there are numerous references for this). This figure is falling in the EU as the nicotine strength of cigarettes has gradually decreased over time due to various factors.
        The nicotine content of the smoke from a cigarette varies between 0.6mg and 1.2mg, and the average is 0.8mg (now) – there are numerous references for this. This figure is, again, falling in the EU. (The transfer process is inefficient and only about 5% of the nicotine in a cigarette is transferred to the smoke.)
        The average smoker appears to measure at around 15ng/ml to 25ng/ml in the EU (again, falling). In the past this measurement was much higher, with 30 – 50ng seen and even 60ng reported.
        Experienced vapers using their own hardware and refills, unrestricted by artificial requirements, appear to measure around 8ng to 15ng (anecdotal reports from ECF members).
        My opinion is that, in general, it appears that vapers are perfectly satisfied with a blood plasma nic level of around 40% lower than the smoking equivalent.

        The average nicotine content of a cigarette’s smoke globally is probably around 1mg. The safest cigarette is obviously the one with the highest nicotine content, as you will smoke less: the smoke causes the harm, not the nicotine. Cigarette manufacturers appear not to have resisted the downward pressure on nicotine content because if people smoke more then it benefits them. It is simply another ludicrous regulatory artifice that harms public health rather than helps it.

        Regarding the use of a 45mg strength for an ecig refill: I keep trying to reinforce the point that the nicotine content of the refill is not relevant – only the end result is (the blood plasma nic level). Numeric comparisons with anything else are not valid (and cannot be made in the first place since we lack some of the critical data needed, such as the average nicotine content of ecig vapour; for example Laugesen reported that vapour nic content is 10% of that in smoke: 10mcg vs 103mg per measured unit, but we know this can be increased easily now.)

        It is also worth making the point that consumer products, in the UK (a situation with which I am familiar) are many times safer than pharmaceutical products. Specifically, e-cigarettes are demonstrably many thousands of times safer than varenicline. It is absolutely impossible that a situation could exist in the UK where a consumer product approached one-thousandth of the risk of Chantix.

        It is not necessary, in the UK, to question the motives or practices of consumer product vendors. Their motives may of course be suspect, as we might expect from any commercial actor. But the crucial factor is the harm they cause; for example if Intellicig’s products caused one-ten-thousandth of the harm that Chantix does the directors would be in jail and the company would no longer exist. For that reason alone, we know that the supply of high-strength refills with their mini ecigs poses no risk.

        I well appreciate that this has nothing whatsoever to do with the situation in the USA.

  • Dodderer

    As an additional irony, Ms Willmott has just piloted the revised clinical trials proposal through ENVI – the problem with the previous directive?

    “There is broad agreement among all stakeholders that the current legislation on clinical trials urgently needs to be revised. There has been a severe decline in the number of clinical trials carried out in Europe over the last few years, which is due, at least in part, to some of the measures in the Clinical Trials Directive. Between 2007-2011, the number of trials carried out in the EU dropped by 25%, with many trials moving to emerging markets. Not only does this have dire economic consequences, but it hinders the advance of medicine to the detriment of patients.”

    See Willmott’s draft report

    You couldn’t make it up!

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