Destroying the appeal of a product to its current and potential users might as well be a ban….
by Tom Pruen and Katherine Devlin
As the debate on e-cigs has moved on, it is clear that Linda McAvan, MEP, Rapporteur on the TPD for the ENVI Committee, has recognised that medicines regulation is not the best approach, and her amendment reflects this. It does, however, still include a number of proposals which are problematic – both in terms of the products themselves, and the practicalities of implementation and enforcement.
Mrs McAvan proposes that:
1. Nicotine-containing products may only be placed on the market if they are authorised pursuant to:
(a) Directive 2001/83/EC, or
(b) The simplified procedure as set out in paragraph 2 and 3.
Off to a good start, (although an ‘either’ wouldn’t go amiss after ‘pursuant to’) but unfortunately, things go downhill in the simplified procedure:
2. Under the simplified procedure, Member States shall require manufacturers and importers of nicotine-containing products to submit an application for a marketing authorisation, which shall contain the following:
(a) Evidence that the product is manufactured in accordance with the principles and guidelines of Good Manufacturing Practice;
(b) A detailed description of the product in question, including all ingredients and quantities thereof, as well as information on emissions;
(c) A Risk-Management Plan, including a system for monitoring and recording any adverse reactions; Member States shall be entitled to charge a fee for processing the application. They may also require manufacturers or importers to carry out additional tests or submit additional information.
Each Member State shall take due account of authorisations previously granted by another Member State.
Evidence of the implementation of a form of good manufacturing practice makes sense – but not necessarily the GMP that is used for pharmaceuticals; neither food, drink nor indeed tobacco cigarettes are manufactured to such an exacting standard. Something that encourages suppliers to improve their standards and helps to improve standards at the point of manufacture (which, for the majority of hardware, is in China) would be useful, but a subset of medicines regulation is not the way to do it.
Disclosure of ingredients and testing for emissions are also a good idea – in principle. However, without a standard with which to compare them, how is it possible to make any judgement of what these should be? Research (particularly a study by Goniewicz et al[i]) strongly suggests that the emissions are more dependent on the liquid constituents than the hardware, and it is common for users to use different liquid than that supplied by the initial hardware vendor. It is worth noting that the levels of toxicant emissions reported this study are low, with the most prevalent, formaldehyde, below the NOEL (No observable effect level) reported by Heath Canada[ii], except in one instance. Even then, the levels compared with those found in smoke are low, with Goniewicz et al reporting a level nine times lower in vapour than in smoke.
As a result of this, we need more research if we are to reduce emissions to even lower levels (although it is not immediately apparent why this is deemed necessary for most products) and following this research, a standard could be set against which to evaluate products. Without such research, any attempt to evaluate the emissions (except by comparison with tobacco smoke) is largely meaningless, and since there is no conceivable way in which emissions could be as high as cigarette smoke, there is little point in making such a comparison.
As far as I am aware, there is no requirement for tobacco products to have a Risk Management Plan – rather fortunately for the tobacco industry. It’s also unclear how someone would differentiate between risks from the hardware, and risks from the refill liquid.
Setting an open-ended requirement for additional testing or evidence would ensure a total lack of harmonisation across the Member States. Member States would be able to set the level of evidence required at any level – including effectively requiring a full medicines application.
3. For products authorised under the simplified procedure, Member States shall ensure that the following conditions are fulfilled:
(a) the product is clearly labelled with the nicotine content, instructions for use, instructions for reporting adverse reactions, and details of the manufacturer;
(b) each unit packet and any outside packaging shall carry the following health warning: This product is intended for use by existing smokers aged 18 or over as an alternative to tobacco cigarettes. It contains nicotine which is a highly addictive substance. Consult your doctor if you are pregnant, breast feeding, allergic to nicotine or propylene glycol, or have high blood pressure.
The suggested warning falls far short of the information required under the current chemical labelling regulations – particularly the warnings to keep to products out of reach of children, and a requirement for child resistant packaging. Furthermore, it is already a legal requirement to label the nicotine content.
The warning statement also potentially contradicts the variable limit to match the age limit to that of the sale of tobacco products in different Member States.
We heartily support the advice to consult a medical professional if a consumer has any concerns about using the product. Since nicotine is known to cross the placental barrier and into breast milk, pregnant women should be able to make an informed choice with the advice of their healthcare team. Although nicotine is potentially harmful to the foetus/baby, switching from smoking – with the significant harms that can cause – to a non-combustible nicotine source is likely to be an improvement for the majority of those who find themselves unable to stop using nicotine. This is why pregnant women who cannot quit may be offered NRT products.
It seems somewhat bizarre to suggest that a smoker may be aware that they are allergic to nicotine, and yet be able to continue to smoke! Rather than this rather quaint notion, it would be far more relevant and useful to include a nut allergy warning, since some tobacco-flavoured electronic cigarettes contain nut flavourings. (You will find such warnings on ECITA members’ products.)
But then again…
(c) flavourings shall not be allowed;
The proposed removal of all flavourings is clearly aimed at making the product less appealing as a means of initiating nicotine addiction. However, since a nicotine solution does not have a significant inherent flavour of its own, this would be a ban on all types of flavouring, including tobacco. It is not hard to see that this would reduce the appeal of the product to smokers – a rather problematic unintended consequence of an attempt to protect young people and/or non-smokers who, the evidence suggests, (i.e. studies recently conducted by ASH (UK), as well as in the US) have no interest in the product anyway.
It also creates a situation where users will be driven away from the flavourings they are currently using, which have a chemical composition intended to be safe to inhale supplied by specialist companies, to using food flavourings which can contain substances that are known inhalation risks. (Many food flavours are in an oil base, which should not be inhaled, and diacetyl and related diketones – common in food flavourings, and entirely safe for digestion, but not inhalation – are known to cause damage to the lungs).
(d) the sale of the product shall be restricted in line with the legal age for sale of tobacco products in the relevant Member State;
This contradicts the proposal to mandate a warning specifying 18 as the age limit. There are different age restrictions on the sale of tobacco products in different Member States.
(e) the products shall be available to be sold outside pharmacies;
What is the purpose of this proposal? Electronic cigarette products are currently sold in pharmacies, as well as in tobacconists, supermarkets, corner shops, concession stands, and in dedicated retail shops. (And yet it is still easier to find tobacco cigarettes to purchase than to find electronic cigarette products….) Only classification as a medicinal product could limit the sale of electronic cigarettes exclusively to pharmacies.
(f) advertising and promotion shall be appropriately regulated;
The statement that advertising and promotion shall be appropriately regulated is effectively meaningless; unless the products are a clearly-defined product type (e.g. medicine or consumer product) how is it possible to decide what regulations are appropriate? Under the current situation, with electronic cigarette products classified as consumer products, there is ample legislation in place to regulate their advertising and promotion – specifically to ensure that the act of smoking is not glamourised in any way. These, and all the other regulations already in place, merely need better enforcement across the Member States.
4. Member States shall monitor the development of the nicotine-containing products market, including any progress made in harm reduction, as well as any evidence of gateway use amongst young people. Based on the evidence, the Commission shall report back to the European Parliament and the Council 5 years after the transposition date of this Directive. The report shall assess whether amendments to this Directive are necessary.
This form of monitoring makes a great deal of sense, in theory. However since this proposal would result in significant differences in regulation across the Member States, (and simultaneously achieve an effective ban on the current range of products with the proposed restrictions on flavourings), the data gathered would not be of great value in making assessments about the situation in Europe as a whole.
As most of the users of these products are middle-aged smokers, it is also debateable whether five years is long enough for any significant epidemiological changes to be seen as a result of harm reduction.