Gerry Stimson | 23 May 2013
In a letter to MEPs on the EU Parliament ENVI Committee, regarding the proposed regulation of electronic cigarettes in the draft Tobacco Products Directive, Professor Gerry Stimson makes the case for ‘twin-track’ regulation
April 22, 2013
I am writing to you concerning the draft Tobacco Products Directive and in particular Article 18 which seeks to regulate nicotine containing products (NCP) - including electronic cigarettes - as medicinal products.
Declaration of interest
I am a public health social scientist formerly of Imperial College London where I ran a major research centre on social and epidemiological aspects of addiction; I am a visiting professor at the London School of Hygiene and Tropical Medicine; I am a member of the National Institute for Health and Clinical Excellence group which has prepared guidelines on tobacco harm reduction (due for publication 5 June 2013).
Electronic cigarettes (and other pipeline Nicotine Containing Products - NCPs) are marketed as consumer products, not as medicines. They are a new technology for the delivery of a legal, widely used drug - nicotine. The electronic cigarette is a truly disruptive technology. It delivers a satisfying "hit" of nicotine, but without the toxic tar and gasses of tobacco smoke, using a virtually harmless vapour instead. Starting from a minimal base, the EU market is estimated at around Euros 400-500m and the e-cigarette market has overtaken the market in nicotine replacement therapy (NRT) products - this itself is a telling comment on the attraction of e-cigarettes over medicinal nicotine treatments. This is a consumer-led, self-help initiative with many people switching from smoking to e-cigarettes, at no cost to the health service, and with no exhortation from public health experts.
A balanced summary of these products and the regulatory options can be found in the Library Briefing of the Library of the European Parliament 130494REV1 27/03/2013.
Proposed regulation as a medicinal product
In my view a medicines regulatory regime will impose limitations on NCPs, making them less attractive relative to cigarettes, and will limit availability, raise costs and reduce innovation. The process is costly and time consuming. Compliance burdens would wipe out small manufacturers, perversely giving market advantage to a few large manufacturers (such as tobacco companies) who can afford the costs of putting their products through medicines regulation.
Excessive regulation will not be in the best interests of consumers, as it would have the perverse effect of maintaining tobacco smoking, and current consumers deprived of these products would revert back to smoking cigarettes. The risk adverse regulation of nicotine will help perpetuate the cigarette market. Indeed the proposed health warning for NCPs under Article 18 - "this product contains nicotine and can damage your health" is questionable, and a more accurate statement might be "this product contains nicotine and may be addictive but prevents substantially lower risks to health than cigarettes".
Since these products are consumer products, regulators do not have to ensure that the product is an effective smoking cessation aid. Unless the maker makes a claim for some beneficial effect, there is no need for a medicines regulator to become involved in determining efficacy. Many smokers have found brands that have worked for them and competition will sort out the reliable products from the rest. Good regulation would build confidence in safety and quality and allow effective communication of the benefits.
TPD threshold levels for nicotine
The proposal in Article 18 to allow products below a certain concentration of nicotine to be on the market is unhelpful, both because that level is set so low, and also because setting nicotine levels for these products (except at the very highest level) is a leading misunderstanding of how these products are used (and indeed how cigarettes are smoked). The concentration of nicotine in the unit is largely irrelevant as people puff to achieve the level of nicotine that they desire. This has long been known by smoking researchers.
Regulation as consumer products
Good regulation of an NCP must ensure the product is safe, correctly described, including nicotine concentration, that the device works, and provide science-based accurate consumer information (including the decreased risk in comparison with the on-going smoking of cigarettes).
It is untrue to say that these electronic cigarettes are currently unregulated, or that the only option is medicines regulation or an unregulated market. Electronic cigarettes are already covered by many EC regulations including the General Product Safety Regulations 2005, Chemicals (hazard information and packaging for supply) Regulations 2009, Weights and Measures (packaged goods) Regulations 2006, Waste Electronic and Electrical Equipment Regulations 2006, Batteries and Accumulators (placing on the market) Regulations 2008, Consumer Protection (distant selling) Regulations 2000, Control of Misleading Advertising Regulations 1998, Business Protection from Misleading Marketing Regulations 2008, and Unfair Trading Regulations 2008. Hence already there are measures concerning general safety, packaging and labelling, chemical safety, electrical safety, weights and measures, commercial practice, and data protection. These current regulations are set out in the Industry Standard of Excellence (ISE) certification by the Electronic Cigarette Industry Trade Association.
Twin track regulation - option as consumer product or medicinal product
In my view, the TPD is the wrong place for any further regulatory framework for NCPs. The framework of the TPD - of controlling access to harmful tobacco products - is not the correct place for devices that have the potential for huge public health gains. The framing for NCPs must surely be to facilitate and encourage their uptake as competitors to cigarettes, at the same time ensuring safety.
In my view the way forward is dual track or parallel regulation. In this model, nicotine containing products such as electronic cigarettes shall be sold as either (a) consumer products in compliance with the General Product Safety Directive and other relevant consumer protections as above, or (b) in the case where a manufacturer wanted to make a therapeutic claim in terms of the product being a smoking cessation aid, the manufacturer should have the option (as now) to seek to have the product approved as a medicinal product in terms of the relevant sections of Medical Devices Directive.
Public health gains
As I said in a letter to the Times (14 March 2013) "it would be an appalling paradox if regulators, in the name of safety, ended up smothering the e-cigarette market with red tape, and so tip the competitive balance back in favour of cigarettes". We are only making small progress in further reducing the prevalence of cigarette smoking - encouraging current smokers to switch to electronic has the potential to speed up the process with consequent major public health gains.
With kind regards,
Professor Gerry Stimson