Government to ban e cigs?

Is the EU going to ban e cigarettes?

Electronic Cigarette close up

What is the future for the e cigarette industry?

E-cigarettes (or vapour cigarettes as they are also known), are an increasingly popular product, often used as an alternative to smoking real cigarettes (a smoking cessation device).  The Electronic Cigarette Consumer Association estimates the industry was worth between £5m-£10m in 2011, and that current UK growth is around 50% per year.  This popularity is a real predicament to regulatory bodies, (the WHO, FDA, EU etc.) as it is an unregulated industry.  This is especially poignant given the health risks associated with smoking and the huge financial losses the any dent to the tobacco industry would have on its stakeholders (including the government).  Consequently there has been a lot of speculation around these legalities, namely whether or not the EU will try and ban electronic cigarettes next year, or whether they will regulate the industry instead.

 

The future of the e-cigarette industry depends on the following:


• Revised FDA and other government guidance
• Approval as a medicinal nicotine replacement therapy
• The acquisition of e-cig companies by large tobacco companies
• UK regulatory body (MHRA) decisions


FDA Guidance on Modified Risk Tobacco Products

The Food and Drug Administration (FDA) has released its draft guidance for industry on applications for modified risk tobacco products in April this year (2012).  Essentially this guidance denoted three things:
• It makes it almost impossible for new reduced risk products, (e-cigs) to be successfully developed and marketed
• It makes it extremely difficult for existing potentially-reduced risk products to successfully achieve a modified risk status
• It makes it extremely unattractive for existing potentially-reduced risk products to successfully achieve modified exposure status.


Clearly implications such as having to run clinical trials to prove safety etc. are implausible for small e-cig companies.  Therefore these revisions are barriers to entry to the smoking cessation market for e-cig companies.
In these guidelines there are also inferences to re classifying e-cig products as tobacco products and medical products.  Wilson, the family behind Freshcig, a huge online e-cig company has warned of the risks to the industry if this happens:


“any government interference to reclassify the product as a tobacco one, and therefore apply tobacco duty, could kill off its popularity and eliminate any money saving advantages.”


“And if they are classified as a medicinal product, they will be subject to different regulation which could also force the price up, resulting in fewer people switching from tobacco products.”


It is worth noting also the huge revenue that governments across the globe receive from taxation on tobacco products.  Therefore any dent in this market share hinders this revenue, causing a significant conflict of interest.


Approval as a medicinal nicotine replacement therapy

A large percentage of the e-cigarette industry is the use of e-cigs as a smoking cessation device. The nicotine replacement therapy industry which includes huge efforts of the part of pharmaceutical companies (who produce nicotine replacement chewing gum and patches) is worth £150 million a year.
Clearly the draft FDA guidance document goes against the prospect of e-cigs being approved as a smoking cessation device.  Coupled with this, in September 2012, a working document was leaked to the Tobacco Journal International.  This document was the European Union's revised Tobacco Products Directive and contained a recommended ban on the marketing of all electronic cigarettes.
Despite this, there continues to be enormous evidence evolving from scientific research, which proves that e-cigs are effective as a smoking cessation device. Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 25 years of experience in the field of tobacco control and has published nearly 70 papers in support of this.
Most recently he has written papers in response to the World Health Organisations (WHO) request to ban electronic cigarettes on the basis that they:


• Cause second hand smoke exposure
• Ecigs are harmful because smokers may use these products in attempts to quit smoking.
• Ecigs are harmful because they ‘normalise smoking
Using his previous research and scientific evidence he categorically denounces the claims.  He describes the WHO claims as:


“What a bunch of crap.”


There have been several clinical trials conducted to establish the efficacy and safety of e-cigarettes.  There is overwhelming evidence in favour of them as a smoking cessation device including one of the most recent trials carried out in New Zealand by Dr Murray Laugeson.  The test found that the e-Cigarette tested was:
"[The E-Cigarette] is very safe relative to cigarettes, and also safe in absolute terms on all measurements we have applied. Using micro-electronics it vaporizes, separately for each puff, very small quantities of nicotine dissolved in propylene glycol, two small well-known molecules with excellent safety profiles, – into a fine aerosol. Each puff contains one third to one half the nicotine in a tobacco cigarette’s puff. The cartridge liquid is tobacco-free and no combustion occurs."

The acquisition of e-cig companies by large tobacco companies

Clearly the increasing size and popularity of the e-cig poses a significant risk to tobacco companies.  There has already been movement in the industry as FTSE 100 Company Imperial Tobacco has acquired an undisclosed stake in an e-cigarette company, and Japan Tobacco International has signed an agreement to commercialise the nicotine “vaporisers” made by San Francisco-based Ploom abroad.
It is very likely that this industry will see more of these acquisitions and agreements in the near future, which will shape the future of the e-cig industry significantly.

The UK industry

The WHO and the FDA seem to be taking a more negative stance towards the e-cig industry than the UKs own regulatory body the Medicines and Healthcare products Regulatory Agency (MHRA).  Therefore whilst no e-cigarette has yet gained UK approval as a medicinal nicotine replacement therapy, the MHRA is investigating the devices and is scheduled to report back next year.
However, early indications are that despite concerns over their safety, the MHRA wants to regulate their use rather than ban them and push smokers back to tobacco cigarettes.


There is stakeholder activity in all corners of the e-cig industry, which is currently shaping its future.  Firstly, there is a huge conflict of interest for tobacco companies and the government as any reduction in the size of the tobacco industry would dent their financial gains and secondly, a number of the regulatory bodies appear to be making it all but impossible for this industry to exist.  Both of these factors indicate a complete ban on the product.  However clinical trials are producing clear results to support the e-cig as a smoking cessation device.  Therefore rather than ban them altogether, regulatory bodies (as the UKs MHRA seems to be doing) should test them for their efficacy and safety so that they might be approved as a medicinal nicotine replacement therapy.  This is the best possible outcome for the future of this industry.

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Written by Rob Patrick

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