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:
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").
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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
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