8. Lack of Justifiable Reason
Related Links:
ECigarette Direct Response to MHRA Proposal to Regulate Electronic Cigarettes as Medicines
8.1 No justifiable reason has been given for the the MHRA's actions. To date, and despite over 800,000 kits being sold in the US, there has been no case of a user dying after use of an electronic cigarette. As we demonstrate in point 9.2 the evidence quoted in favour of the MHRA's position is not credible.
We believe that commercial interests are affecting this issue, including those of the tobacco industry, the government with its potential loss of lucrative cigarette-generated revenue and the pharmaceutical industry which itself largely funds the MHRA, and which earns very large sums through NHS-funded supply of nicotine cessation therapy products.
It is observed that the MHRA is ignoring the legal requirement of presentation and qualification or proof of purpose in order to close the commercial nicotine market. They have no evidence to show risk or a need to do this, and are breaking even their own mandate.
Nicotine itself does not cause tobacco-related disease or death (as is indeed acknowledged both in the MHRA's own consultation document and in the Royal College of Physicians' advice). It carries about the same health risk as another widely used addictive drug: caffeine. 9
NJOY and Gower Enterprises Limited believe that smokers should be truthfully informed about comparable health risks and have unhindered access to less hazardous, smoke-free alternatives.
A recent study showed that switching to alternative non-medicinal nicotine products reduces health risks nearly as much as quitting totally, which emphasises that the product must remain freely and easily accessible to all. 10
8.2 MHRA Evidence
The MHRA based its call for the electronic cigarette to be regulated as a medicine on an FDA press release which stated that the electronic cigarette contains toxic chemicals.
- The FDA manipulated the findings of its researchers, pointing out the existence of nitrosamines in the e-cigarette liquid whilst failing to point out that levels were similar to those found in existing approved nicotine cessation aids. 11
- The existence of one percent of diethlyne glycol in one sample of one brand (Smoking Everywhere) should not be reason to punish all brands of electronic cigarette. In particular, the same analysis of the NJOY electronic cigarette found that the ingredients of the electronic cigarette contained no diethlyne glycol at all. 12
- The FDA's position did not stand up in court, with Judge Leon pointing out that:
"While the FDA's interest in protecting public health and safety is, in the abstract, paramount to plaintiffs' purely economic interests, given the particular facts and circumstances of this case, I am not convinced that the threat to the public interest in general or to third parties in particular is as great as FDA suggests. Together, both Smoking Everywhere and NJOY have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone. Nor has FDA cited any evidence that electronic cigarettes are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available to the public." 13
Scientists have criticised the FDA's interpretation of their own study. Professor Carl Phillips argues that the FDA's announcements represented propaganda, not science 14, while Professor Michael Siegel has pointed out that banning the electronic cigarette based upon the findings of the FDA would also mean banning peanut butter. 15
ECigaretteDirect would also like to highlight that a press release issued by LACORS stating that electronic cigarettes contained up to 20% of nicotine was incorrect. The statement was based upon an elementary mathematical mistake which lead to the quantity of nicotine being exaggerated by a factor of 10. For example, one cartridge was labelled at 18mg/ml, and could have been assumed by a non-mathematician to contain 18% nicotine. However, 18mg/ml would represent a nicotine concentration level of 1.8%, not 18%. 16 The lower quantity is far more in line with tests carried out by Health New Zealand, the FDA and others.
8.3. Legal Advice
The MHRA tells us that they have received legal advice that nicotine should be regulated as a medicine because it affects the metabolism of the body. (We note that cigarettes, alcohol and caffeine also affect the metabolism of the body and yet are not required to be regulated as medicines.) However, the MHRA has refused to disclose any more details regarding this advice, despite a freedom of information request. It is our view that the overwhelming public interest in a decision which could return tens of thousands of e-cigarette users to tobacco cigarettes clearly outweighs the legal professional privilege the MHRA is trying to claim as its excuse not to disclose the information.
8.4 Extension of Power
The MHRA told us in a recorded (with permission) telephone call that one reason they want to regulate the electronic cigarettes as medicines is that this is the only way that electronic cigarettes can be regulated. We do not believe this is a valid reason for regulation. We dispute that Trading Standards' officers unable to regulate these consumer products. Electronic cigarettes are already regulated perfectly adequately by Trading Standards with cooperation from our industry. We note that in Judge Leon's judgement against the FDA he also accused the FDA of attempting to extend its regulatory power, stating:
"This case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices under the FDCA." 17
8.5 Conflict of Interest
A 2004 parliamentary select committee found that the MHRA had an "unhealthy" relationship with the pharmaceutical industry, was financed by the industry it regulated and was often staffed by that industry. 18 The electronic cigarette competes with the nicotine cessation products produced by the pharmaceutical industry, which often promotes them by funding studies designed to exaggerate claims of the success rate of nicotine cessations aids. 19 The electronic cigarette is regarded as a threat by the nicotine cessation industry, as shown by an industry report which stated: "E-Cigarettes Will Revolutionise the Face of Tobacco Smoking and Could Pose a Threat to the Smoking Cessation Market." 20
9 Tobacco Myths http://www.oasas.state.ny.us/admed/documents/TobaccoMyths.pdf
10 Phillips, C
Debunking the claim that abstinence is usually healthier for smokers than switching to a low-risk alternative, and other observations about anti-tobacco-harm-reduction arguments
http://harmreductionjournal.com/content/6/1/29
11 Siegel, M http://tobaccoanalysis.blogspot.com/2009/07/tobacco-specific-carcinogens-found-in.html
12 NJOY Tests http://www.ecigarettedirect.co.uk/research/NJOY-analyze-report.pdf
13 Judge Leon Memorandum p.30/31 http://www.ecigarettedirect.co.uk/research/judge-leon-report.pdf
14 Phillips, C http://www.ecigarettedirect.co.uk/carl
15 Siegel, M http://tobaccoanalysis.blogspot.com/2009/08/action-on-smoking-and-health-warns.html
16 Katherine Devlin: LACORS maths blunder threatens hundreds of thousands of UK lives (LACORS incorrect nicotine statement)
17 Judge Leon Memorandum p.30/31 http://www.ecigarettedirect.co.uk/research/judge-leon-report.pdf
18 House of Commons Select Committee The Influence of the Pharmaceutical Industry http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf
19 House of Commons Select Committee The Influence of the Pharmaceutical Industry http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf
20 (Webpage removed since we highlighted this on our website, but the table of contents have been published here: http://velvetgloveironfist.blogspot.com/2010/02/talking-e-cigarettes-and-rest.html.)
E Cigarette Direct is the UK based online retailer of the NJOY electronic cigarette. E Cigarette Direct has a strong interest in promoting research into the electronic cigarette and tobacco harm reduction, and you can find interviews with doctors and scientists on its website as well as summaries of recent research.