As promised, here is Section 2, providing a “Chronology of significant political and legal events”.
- Chronology of significant events:
January 2010: Judge Leon rules that ecigs cannot be classified as ‘drug delivery devices’ (i.e. medicinal products) in the United States District Court for the District of Columbia, and admonishes the FDA:
“Unfortunately, its [the FDA’s] tenacious drive to maximize its regulatory power has resulted in its advocacy of an interpretation of the relevant law that I find, at first blush, to be unreasonable and unacceptable.”[ii]
February 2010: MHRA issues public consultation, stating their ‘preferred option’ is to remove all electronic cigarette products from sale within 21 days following the end of the consultation period.
March 2010: Simon Christou and Katherine Devlin begin developing their idea for the formation of an Industry Trade Association.
4th June 2010: Stakeholder meeting with >30 representatives from the UK electronic cigarette industry in attendance.
9th June 2010: Regulatory Policy Committee publishes its opinion on the MHRA’s consultation, and roundly condemns it:
“It is not clear from the consultation letter or IA what specific policy problem MHRA is trying to address through the proposed new regulations. MHRA claims that the licensing of all NCPs is needed “in order to ensure there is no risk to public health from these products” (paragraph 18 of consultation letter). However, the evidence provided in the IA and consultation letter is not sufficient to conclude that there are serious risks to public safety and health to warrant regulatory intervention. In fact, the consultation letter itself acknowledges that the risk to the public health from NCPs is “unknown”.”[iii]
21st June 2010: MHRA focus group ‘infiltrated’ by Katherine Devlin. Entire session recorded, thus providing evidence of misdirection of the group, leading to inaccurate outcomes. (For more information, see our blog.[iv])
September 2010: ECITA Ltd incorporated.
24th September 2010: EU Public Consultation on proposed revisions to the Tobacco Products Directive published.
28th September 2010: ECITA has meeting with MHRA, to discuss the ISE regulatory framework, and the issues surrounding the legal definition of a medicinal product.
13th October 2010: ECITA publishes its petition to Members of the European Commission ‘Freedom of Choice for Smokers’.[v] The petition achieved 1,000 signatures in its first week. (By the time it was presented to the Commission, it had nearly 17,000, and has now exceeded that.)
7th December 2010: US Appeals Court for the District of Columbia upholds Judge Leon’s January ruling against the FDA.[vi]
16th December 2010: ECITA submits response to EU Public Consultation on the Tobacco Products Directive.[vii]
9th March 2011: MHRA announces the results of its public consultation, and is forced to admit that it must currently ‘do nothing’ – its third option, and the one which it described as: “Do nothing and allow these unregulated products containing nicotine that have not been assessed for safety, quality and efficacy to remain on the market.”[viii] The MHRA told ECITA that they would be “undertaking more research over the next 18 months.”
April 2011: ECITA meets with Trading Standards, to discuss the final draft of the ISE book. We were told that the current political will – set against the climate of inevitable cuts, the vast majority of which are hitting the public sector hardest – is very likely to support our desire to provide self-regulation for the ecig industry. Trading Standards told us that this is precisely what this government wants to see, in terms of providing a robust, appropriate regulatory framework, based on the relevant legal statutes. Trading Standards later described the ISE as “a Code any industry would be proud to have.”
May 2011: ECITA produces the ISE guidebook, and provides copies to its members as well as to Trading Standards Officers and other relevant government regulators. The ISE auditing programme is launched and ECITA members begin to be audited biannually. Significant amounts of regular product testing begin.
June 2011: ECITA meets with UK National Measurement Office. They told us about some of the problems they had been finding, and explained that electronic cigarettes are very high on their agenda at the moment. The NMO are examining ecigs with regard to batteries and RoHS as they do not consider that they are medicinal products and therefore do not qualify for exemption from these regulations.
In products they had tested recently from an online vendor (not an ECITA member), the NMO found unacceptably high levels of lead in the solder used to connect the battery to the switching circuitry. Unfortunately, despite the best intentions of the vendor in question, the NMO told us they had “recently removed from the marketplace in excess of £10k stock value”. The vendor in question was also required to pay for the disposal costs of these items.
Since this meeting, ECITA has continued to work co-operatively with the NMO, and has benefitted from some useful advice and input to the ISE programme from this government agency. NMO enforcement agents recently informed one of our members that “ECITA will be able to tell you how the law should be interpreted” with regard to capacity labelling. This advice has been provided to the members, and will be included in the revision to the ISE in due course.
July 2011: European Commission publishes its Report on the Public Consultation on the possible revision of the Tobacco Products Directive.
August 2011: ECITA reincorporated to include our European partners as ECITA (EU) Ltd.
September 2011: Behavioural Changes Insights Team (“Nudge” Unit) publishes its Annual Report, with its advice to government, which suggests:
“exploring new products for people addicted to nicotine – products that deliver nicotine quickly in a fine vapour instead of as harmful smoke could prove an effective substitute for ‘conventional smoking’. It will be important to get the regulatory framework for these products right, to encourage new products, which smokers can use as safer nicotine alternatives, to be made available in the UK.3 A tenet of behaviour change is that it is much easier to substitute a similar behaviour than to extinguish an entrenched habit (an example was the rapid switch from leaded to unleaded fuel). If more alternative and safe nicotine products can be developed which are attractive enough to substitute people away from traditional cigarettes, they could have the potential to save tens of thousands of lives a year
3 Treating smoking-related diseases costs the NHS £2.7 billion each year in England. Only 21% of adults now smoke, compared with nearly half of all adults in the 1960s. A review by the Medicines and Healthcare products Regulatory Agency concludes that ‘nicotine, while addictive, is actually a very safe drug’. BIT is working with DH on how to encourage smokers to substitute to safer but nonetheless appealing sources of nicotine, noting that products that produce a fine vapour appear to reproduce the pleasant ‘hit’ without the harms associated with smoking.”[ix]
7th March 2012: ECITA representative attends meeting (along with Tobacco Industry stakeholders) with the European Commission, to discuss the revisions to the Tobacco Products Directive. (Report published 9th March on the ECITA blog.[x])
13th March 2012: The Hague fines the Dutch government for attempting to classify ecigs as medicinal products.[xi]
14th March 2012: ECITA submits letter to European Commission, having been invited to make an extra submission following the meeting.[xii]
26th March 2012: In one of the German Bundesländer, North Rhine Westphalia, the Ministerium für Gesundheit, Emanzipation, Pflege und Alter (Ministry of Health, Empowerment, Care and Age) also loses its case to have electronic cigarettes classified as medicinal products, in court.[xiii]
April 2012: ECITA has further meeting with MHRA (at their request), who acknowledges its awareness that “it has become very litigious”. MHRA confirms its intention to continue to pursue a medicinal classification for ecigs as ‘medicinal by function’. This is, of course, an untenable position, as case precedent confirms in the EU.
5th June 2012: In Germany, in the Higher Administrative Court of Saxony-Anhalt, the City of Magdeburg loses its case to have electronic cigarettes classed as a medicine, and is ordered to pay costs.[xiv]
June 2012: ECITA representatives invited to attend further meeting at the European Commission, to discuss the ISE programme in more detail. This followed ECITA requests for a meeting to acknowledge that the Electronic Cigarette Industry is entirely separate from both the Pharmaceutical Industry and the Tobacco Industry.
Smoking Everywhere (Plaintiff) and Sottera Inc., d.b.a. NJOY (Intervenor-Plaintiff) versus U.S. Food and Drug Administration et al. (Defendants), , in the United States District Court for the District of Columbia, Civil Case No. 09-771
[ii] Smoking Everywhere (Plaintiff) and Sottera Inc., d.b.a. NJOY (Intervenor-Plaintiff) versus U.S. Food and Drug Administration et al. (Defendants), in the United States District Court for the District of Columbia, Civil Case No. 09-771, Memorandum Opinion
[iii] Regulatory Policy Committee, Opinion on MHRA Consultation on regulation of nicotine containing products, 9th June 2010
Devlin, K., ECITA blog, Analysis of Regulatory Policy Committee Opinion of June 2010, 14th March 2011
[iv] Devlin, K., ECITA blog, Analysis: MHRA’s Research Company’s Report of Qualitative Research Findings, 10th March 2011
[v] Devlin, K., Freedom of Choice for Smokers, Sponsored by ECITA Ltd and the EU Vaping Community, 13th October 2010, Petition Online
[vi] Sottera Inc., d.b.a. NJOY (Appellee) versus Food & Drug Administration et al. (Appellants), , in the United States Court of Appeals for the District of Columbia Circuit, Case No. 10-5032
[vii] Devlin, K., ECITA blog, ECITA submits response to EU Public Consultation on the Tobacco Products Directive, 16th December 2010
[viii] MHRA, Consultation Letter MLX364, The Regulation of Nicotine Containing Products, 1st February 2010
[ix] Cabinet Office, Behavioural Insights Team, Annual Update 2010-11, September 2011
[x] Devlin, K., ECITA blog, ECITA at the European Commission, 9th March 2012
[xi] United Tobacco Vapor Group Inc. versus the State of the Netherlands (the Ministry of Health, Welfare and Sport and the Ministry of Finance), in the Netherlands Court of the Hague, , Case number 414117
Rechtspraak.nl – LJN: BV8613.
[xii] Devlin, K., ECITA blog, Extra submission to EU Public Consultation, 14th March 2012
[xiii] na.presseportal, [i]E-Zigarette SNOKE® ist Genussmittel, kein Arzneimittel/ecoreal GmbH & CO KG feiert Erfolg vor dem Oberverwaltungsgericht, 26th March 2012
E-Zigarette SNOKE® ist Genussmittel, kein Arzneimittel | ecoreal GmbH & Co. KG | Presseportal.de
[xiv] Wahrheit über ezigaretten.de, [i]Court ruling from Saxony-Anhalt, Case no. 3M129/12, 5th June 2012
… and if anyone made it all the way down to HERE, past all the boring references – you definitely deserve a vape!
And, of course, if you can stand any more, Section 3 gives lots of lovely details about the regulatory framework.