NJOY CEO Craig Weiss correspondence with Smokefree Pennsylvania's Bill Godshall on UK MHRA e-cigarette regulation
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Thread: NJOY CEO Craig Weiss correspondence with Smokefree Pennsylvania's Bill Godshall on UK MHRA e-cigarette regulation

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    Default NJOY CEO Craig Weiss correspondence with Smokefree Pennsylvania's Bill Godshall on UK MHRA e-cigarette regulation

    Following are relevant excerpts of an e-mail exchange I had with NJOY President and CEO Craig Weiss in response to an article at
    E-cigarette brands back MHRA plans for medical regulation
    stating that NJOY has endorsed the UK MHRA's proposed regulation of e-cigarettes as medicines.

    -------------------------------------------------------

    My e-mail to Craig:

    Hi Craig,

    There are more than 1,000 different e-cigarette products on the market, and the overwhelming majority (perhaps all) of those products would be banned under the vague "medicines" regulatory policy announced by the UK MHRA.

    Although NJOY and several other e-cigarette companies may have millions (or tens of millions) of dollars to submit each application to MHRA (for each e-cig product) in the hopes of gaining approval, the vast majority of e-cigarette manufacturers and importers don't have those resources, and will either disappear or go underground.

    Philip Morris deployed a somewhat similar regulatory strategy (to protect its Marlboro cigarette empire from competitors, and from far less hazardous smokeless tobacco products) a decade ago when it endorsed FDA regulation of tobacco products, negotiated the FSPTCA with CTFK, and aggressively lobbied Congress for its enactment.

    While I understand NJOY's desire to increase sales and gain market share, the vast majority of vapers do NOT use NJOY products, and many former NJOY consumers have switched to other vapor products they find superior and/or at lower cost.

    There's no evidence that NJOY products are safer or are more effective alternatives for smokers than are other e-cigarette products on the market. Consumers now determine winners and losers in the e-cigarette market, but MHRA would determine all the winners and losers under its policy announcement.

    Even if MHRA approves some e-cigarette applications, the cost of those products would increase (perhaps beyond what many/most smokers and vapers can afford). And of course, there's no assurance that MHRA will ever approve any e-cigarette as a medicine.

    Just as FDA's unlawful 2009-2011 import ban on e-cigarettes created a black market that grew by 500%, MHRA's announced policy is likely to create a similar black market for totally unregulated e-cigarettes, which could pose threats to consumers.

    If MHRA officials truly desire to keep e-cigarettes legally accessible for vapers and smokers, the agency would never have advocated enactment of the proposed EU Tobacco Products Directive, which would ban the sale of e-cigarettes in ALL other EU countries. Threatening the lives of tens of millions of smokers throughout Europe is public health malpractice, not public health advocacy.

    As one who collaborated with Clive Bates more than a decade ago (when he was director at ASH UK) advocating sound policies that reduced smoking and cigarette consumption in the UK, I totally agree with Clive's recent analyses and policy proposals for e-cigarette regulation in the UK and the EU.

    Please reconsider your support for MHRA's announced policy, and please read Bates' most recent posts at http://www.clivebates.com and those by ECITA at ECITA Blog

    We were pleased to support and assist with NJOY's legal challenge to FDA's import ban from 2009-2011, and we'll be pleased to do so if/when the FDA bans the products again (as the agency has repeatedly stated its intent to do via the "deeming regulation").

    Sincerely,

    Bill Godshall
    Executive Director
    Smokefree Pennsylvania
    1926 Monongahela Avenue
    Pittsburgh, PA 15218
    412-351-5880
    smokefree@compuserve.com

    -------------------------------------------------------

    Craig's reply e-mail to me:

    Bill,
    Having litigated the regulatory issues against the FDA over an extended period and at an enormous financial cost, NJOY fully understands and appreciates the litigation pathway, and that it is sometimes warranted. However, NJOY believes that the FDA circa 2009 is not the MHRA circa 2013. We sincerely believe that the MHRA, which has been at the forefront of harm reduction, "gets" electronic cigarettes. We believe that they see these products as part of the "cure" and not part of the "disease" and want to see them on the market — provided that there is an assurance that there is appropriate quality control and that folks are getting what they think they are getting when they buy an electronic cigarette, in terms of nicotine content, etc. They also want to ensure that the products are stable and consistent. Finally, they want to see that the products are delivering an efficacious amount of nicotine, as compared to NRT products or tobacco cigarettes.

    The pathway outlined by the MHRA does not rise to the level of FDA drug jurisdiction — and, among other things, will not require clinical trials to demonstrate efficacy. This is critical — lengthy, large-scale clinical trials are typically what accounts for the years-long process and multi-million price tag associated with drug approvals. In effect, the MHRA has created an achievable hurdle that any responsible company should be able to clear. As well, Action on Smoking and Health, Britain's leading anti-smoking NGO, similarly gets these products and has written several excellent monographs on electronic cigarettes. They have been an extraordinarily powerful and persuasive advocate for electronic cigarettes in the UK. At the same time, they have been clear that they too favor a sensible regulatory regime that will ensure appropriate quality, consistency, stability, etc. At the end of the day, this approach has enormous potential to really give existing tobacco smokers — who have been subject to all manner of misinformation about electronic cigarettes — a powerful comfort level with this technology, and a motivation to try these products.

    We hear the voices of Clive Bates and others who have argued against any medicinal regulation of electronic cigarettes, and we are sympathetic. Clive is a pioneer in this field and a brilliant thinker on harm reduction, and we will always consider his point of view with respect to any regulatory issue that comes up. However, we do take the MHRA at its word that it is trying to do something sensible here, and we believe we (and others in the market) can and should work with them. We have tried to be clear that our support is specific to the MHRA and its specific policy recommendation. We do not support medicinal regulation across the board, absent a comfort level that a particular agency understands the technology and is looking to support rather than suppress it, through a light-touch type of regulatory regime.

    With respect to your comment that there is no evidence that NJOY's products are safer than other electronic cigarette products on the market, we can only say that we have rigorously tested our products and continue to do so, and believe we can satisfy the standard articulated by the MHRA. We cannot speak for other companies and do not know whether they have similarly approached the testing/quality issue. Certainly, for the good of the industry generally, we encourage all electronic cigarette companies to take to heart the basic — and achievable — message sent by the MHRA. Doing so is not a multi-million, much less multi-ten-million, dollar undertaking.

    We take strong issue that we are in any way trying to limit competition from any of the smaller players on the market. We created the legal framework for the electronic cigarette industry in the U.S., for the benefit of all and with no financial contribution from anyone. We believe that a rising tide lifts all boats, and want to see a robust industry in the UK as well. Again, we believe the requirements the MHRA (and ASH) are focused on are achievable by any responsible actor, and we certainly don't believe that a total absence of regulation is in anyone's interests. As for those who try to lump us in with Big Tobacco — please be assured that NJOY is not in any way part of Big Tobacco — and remains fiercely and proudly independent. Our mission, of course, is to obsolete cigarettes, a statement that no tobacco company can make.

    Very truly yours,





    Craig Weiss | President & CEOO: 480.397.2300 | C: 480.201.8221

    NJOY Electronic Cigarettes
    15211 North Kierland Blvd., Suite 200
    Scottsdale, AZ 85254




    Last edited by Bill Godshall; 07-17-2013 at 04:27 PM.

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    Craig Weiss wrote:
    Finally, they want to see that the products are delivering an efficacious amount of nicotine, as compared to NRT products or tobacco cigarettes.
    Somehow I don't like this part of Craig's response (and some other parts).

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    To address a couple of Craig Weiss's points:

    1. "...we certainly don't believe that a total absence of regulation is in anyone's interests."

    If this comment is applicable to the UK, and it seems to be since the main topic is the MHRA, then Mr Weiss should be informed that the UK may be the only country in the word where e-cigarettes are already comprehensively and effectively regulated. As far as I am aware (and I invite correction) it is the only country which has a full set of statutes (17 in total) that must be complied with by vaping products, plus (and most importantly) sufficient inspectors in every local area to ensure that all consumer products are safe. The inspectors visit premises, inspect them, inspect marketing, take away stock, and inspect, test and analyse the products. If non-compliant products are found they must be removed from sale and the vendor risks prosecution.

    In addition we also have the federal-level RAPEX system of the EU, in which inspectors from one country can advise those in others of products with potential problems. This reveals that only 9 notices have been issued for vaping products, and all concerned minor issues; in contrast with other types of consumer products such as electrical goods, toys and cars, which have all received thousands of notices, some with serious implications (such as faulty car brakes, dangerous mains electrical goods, and poisonous toys). This alone shows the relative safety level of vaping products.

    To add to these three protection systems we should add a fourth: the community safety network. This is a powerful community safety weapon that ensures we all know very soon about any possible safety issues, and vendors take action as a result.

    It is inconceivable that (a) any dangerous product could remain on the market given this 4-layer protection system (although there can always be a first); or that (b) any product could ever approach one-thousandth of the proven level of danger of some pharmaceutical products. Indeed, pharmaceutical licensing appears to be a mechanism that ensures products that kill hundreds of people cannot be removed from the market. Consumer products and in particular e-cigarettes are clearly demonstrated to be thousands of times safer (in the UK).

    I cannot speak for other countries and Mr Weiss may be correct that in some (or many) places there is no effective regulatory or consumer protection system. I would be grateful if Mr Weiss did not confuse the UK with such other places: we already have sufficient regulation and, what is more, it is proven effective. More regulation would be counter-productive and indeed would remove choice and therefore cost lives.

    2. "We sincerely believe that the MHRA, which has been at the forefront of harm reduction, "gets" electronic cigarettes. We believe that they see these products as part of the "cure" and not part of the "disease" and want to see them on the market — provided that there is an assurance that there is appropriate quality control and that folks are getting what they think they are getting when they buy an electronic cigarette, in terms of nicotine content, etc. They also want to ensure that the products are stable and consistent. Finally, they want to see that the products are delivering an efficacious amount of nicotine, as compared to NRT products or tobacco cigarettes."

    If this is what Mr Weiss actually believes then perhaps he needs a reality check. The MHRA will do absolutely everything it can to remove e-cigarettes from the market, including delaying medical licensing as long as possible. This agency is probably the UK's best example of a regulatory-captured agency and appears to execute the pharmaceutical industry's wishes to the letter. They certainly "get" e-cigarettes: they get that pharmaceutical industry income in every area related to smoking, and several that aren't, is likely to take a 50% hit as a result of the likely 50%+ switch from tobacco cigarettes to PVs; their job appears to be to delay this for as long as possible.

    As to the statement that 'the MHRA has been at the forefront of harm reduction', I cannot answer that for disbelief. They have been at the forefront of harm reduction like American Legacy and Tobacco Free Kids has been. The term 'forefront' in this case presumably means standing in front of it fighting its advance aggressively.

    The rest of the statement about what the MHRA wants to see is piffle, hogwash and tripe - and that is being kind.

    The MHRA is about the best example I can think of for a government agency whose conduct would lead to a very great number of preventable deaths if their policies were fully implemented. Most people would probably agree that this is not the usual goal of an agency involved with public health. In the UK currently we refer to this type of health service policy as the 'Stafford Care Pathway'. The MHRA appear to be the leaders in the field since my interpretation of Prof Britton's figures indicates that if MHRA policies are fully implemented we are looking at 2.5 million preventable deaths in the UK.

    I believe that the MHRA should get the Care Quality Commission award for excellence because no one else has shown any promise of implementing the Stafford Care Pathway quite as effectively as the MHRA.


    ------------
    explanations for non-UK residents

    The CQC were supposed to be in charge of hospital care but when it was reported that some hospitals had appalling standards of care and unacceptable patient death stats, tried to bury the report.
    The Liverpool Care Pathway is a protocol designed to allow doctors to manage end of life care for terminal patients but was abused at hospitals such as Stafford, who used it as an excuse for poor care that led to a significant number of deaths among patients who probably weren't terminal when they went into hospital.
    The UK Dept of Health has lately had a difficult job explaining some issues. I am a huge supporter of the NHS - but this does not include their bungling, hugely incompetent and obviously corrupt masters at the DoH and one or two of its integral agencies.
    Last edited by rolygate; 07-17-2013 at 08:18 PM.
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    All I can say as of now, NJOY is making their own bed, they better be prepared to lay in it. This does concern me though for the pending US regulations. How far is NJOY willing to bend? We will see!
    EDIT: Additionally, I dont believe for a minute that NJOY has not or will not sacrifice some of their dollars to be one of the few left in the game!
    Last edited by 2coils; 07-17-2013 at 09:16 PM. Reason: additional comment
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    I feel that certain brands are playing "chicken" over this. They believe that by supporting the MHRA will help them long-term and annihilate most of the competition along the way. They might be right.
    There's little we can do, but I've now heard from 3 different sources that e-cigs "will not require clinical trials to demonstrate efficacy".
    So, if true these "judas" companies are already safe in the knowledge they can afford whatever it takes and will clear all hurdles without risking their horses legs.
    BUT, and this is the weird bit; if companies believe that there are bad products on the market, there are better methods to root these out. It doesn't require the big stick of a "medicine" label, it requires light-touch consumer regulation. This would leave most of the also-rans in the equation....which is why they are secretly banking on getting full approval and waving "bye-bye" to competitors in one double whammy.

    it's quite evil, but it's business.....

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    A pharmaceutical product, in the UK, does not need to work in order to get a license.

    I was told this repeatedly by Jeremy Mean and Julia Rayne of the MHRA at a meeting where there were dozens of witnesses and for which I have a set of minutes taken independently, that detail their repetition of the fact that a product does not need to work, does not need to be shown to work, and will not be checked by the MHRA as working. No requirement or evidence for or checking of efficacy will be needed. What the product must do, on the other hand, is be shown to deliver the drug (or other mechanism for functionality) that it is supposed to, and this must be demonstrated.

    Thus, an e-cigarette will not need to be shown as efficacious for any purpose such as smoking cessation or smoking replacement; but it must be shown to deliver nicotine if that is what its desired efficacy is based on. This is the reason why in the UK a 45mg nicotine strength is used in mini ecigs, because nic strengths below this are not effective at raising blood plasma nicotine levels in e-cigarette naive subjects [1]. Multiple published clinical trials demonstrate this. In contrast, Intellicig's unpublished trial, for the purpose of achieving a pharmaceutical license, I am given to believe demonstrates that a 45mg strength refill will elevate plasma nic levels above a point considered as the minimum for demonstrated efficacy of the delivery system (which may be 10ng/ml), even for users unfamiliar with the product and its optimum usage protocols.


    [1] This means beginners (a medicine or medical device must work for people who have never seen it before and have no training in its use).

    This is a reasonable requirement because when you get your prescription you don't get a training course. Mini ecigs with regular strength refills simply don't work, in terms of any useful alkaloid delivery; they are what may be called an uprated placebo, like the half-strength NRTs used as placebo in manufacturer's trials. Where ecigs are concerned, a good placebo may work as much as 10% of the time; but a good working product ought to aim at a 60% success rate as anything lower indicates issues with the product or mentoring.
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    Rolygate wrote:

    A pharmaceutical product, in the UK, does not need to work in order to get a license.
    Same in the US, as both UK MHRA and US FDA approved nicotine gums, patches and lozenges have a 95% failure rate as smoking cessation aids and for what they are actually approved for (treating the disorder of "tobacco dependence").
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    What NJOY may not be aware of is that the MHRA's Jeremy Mean is on record, publicly, as stating that "nothing currently on the market would qualify for an MA". That, naturally, includes all of NJOY's products. Or should I say includes them OUT of gaining marketing authorisation - like every other e-cig, PV or whatever you want to call it on the market today. Also, in the Impact Assessment, it is explicitly stated that, while the MHRA at the moment anticipates that clinical trials MAY not be required, there is every possibility that they WILL be required, and that the economic impact of that runs into "many hundreds of thousands of pounds". And that is PER PRODUCT.
    Again, the one UK e-cig company currently undergoing the MA process has reportedly spent over 2,000,000 and is still no nearer gaining the required paperwork - they have submitted as medicinal by presentation.
    Is NJOY aware of these facts?
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    Follow the NJoy's Corp Attorney's ulterior motive , which leads to the money trail for there share holders and top Exec's !
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    The MHRA stated that any clinical trial reports or similar documentation already in existence could be used by a new applicant for what is essentially the same product. This was, again, repeated multiple times. It appears to imply that if Intellicig provide clinical studies to support their application, and if the application is approved, then NJoy could use those studies instead of running the same trials again.

    A study that showed the Intellicig product delivered sufficient nicotine could not be used for the NJoy product; but any other materials of a non product specific nature probably could be used. For example, any study that showed nicotine is acceptably safe, or that showed subjects regard e-cigarette products to be as acceptable or more acceptable than current NRTs, and so forth. Any generic material, or material specific to ecigs but not product-specific, could be used. Someone else's product-specific material might be used for generic purposes.

    It is probably the case that licensing costs will be reduced for subsequent applicants because of this factor. The first successful applicant probably won't be overly pleased about this, but they will have the first-to-market advantage.

    With regard to Jeremy Mean's clear statement that nothing currently on the market would succeed in gaining an MA, no doubt he has to make this point for multiple reasons. If current products could be licensed, then many/most ecigs are acceptable as pharmaceutical products, are acceptably safe, and there is no need to prevent them being sold. Of course, a licensed product is simply a badge-engineered version of the regular product: no one has invented anything new, or something that works better, otherwise it would clean up the market in the consumer product area. Instead, the opposite is the case: new consumer products are significantly better than prospective licensed products. A licensed product by definition is one that was popular three years ago; that's about like a rotary pulse-dial bakelite phone with the plaited cord, compared to an iPhone. Things move a long way in three years in this game. Licensed products will be obsolete in consumer terms (and probably ridiculously expensive for an obsolete, inefficient product in today's terms).
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