We’re nearly there – the finishing line is in sight!
Section 4 explains the legal definitions of both medicinal and tobacco products under EU law, so as to demonstrate why these are not appropriate regulatory classifications for electronic cigarettes.
- What are the legal definitions of ‘medicinal product’ and ‘tobacco product’ in EU law, and how do these affect the classification of electronic cigarettes for regulation?
- Medicinal products
The EU definition of a ‘medicinal product’ is split into two limbs:
“[a)] Any substance or combination of substances presented as having properties for treating or preventing disease in human beings.
[b)] Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.”
Effectively, limb (a) above means that if any product is marketed with a claim that it is a medicine, it is legally-defined as one. ‘Quitting smoking’ is regarded as a medicinal process, since both ‘tobacco addiction’ and ‘nicotine addiction’ are classified by the World Health Organisation as ‘diseases’ requiring ‘treatment’. (Interestingly, ‘caffeine addiction’ is listed in the same diseases index.) Therefore, providing electronic cigarettes are not marketed as ‘quit smoking’ products, and do not make any other therapeutic claims, they cannot be legally defined as medicinal products under limb (a).
Limb ( covers products which act as medicinal products by function. If electronic cigarettes were classified as medicinal products by function, under this limb of the legal definition, this would lead to the absurd situation of tobacco cigarettes also being classed as medicinal products by function. (It would also have serious implications for coffee, all foods, air, water, etc., etc.)
Therefore, it is quite clear that it is not possible to classify electronic cigarettes as medicinal products, unless they are marketed with medicinal claims.
- Tobacco products
The EU definition of a ‘tobacco product’ is as follows:
“‘tobacco products’ means products for the purposes of smoking, sniffing, sucking or chewing, inasmuch as they are, even partly, made of tobacco, whether genetically modified or not;”
Furthermore, the stated purpose of the EU Tobacco Directive is as follows:
“The aim of this Directive is to approximate the laws, regulations and administrative provisions of the Member States concerning the maximum tar, nicotine and carbon monoxide yields of cigarettes and the warnings regarding health and other information to appear on unit packets of tobacco products, together with certain measures concerning the ingredients and the descriptions of tobacco products, taking as a basis a high level of health protection.”[ii]
The fact that electronic cigarette products often contain nicotine is not, in itself, sufficient justification for classifying them as tobacco products, even though the nicotine is (necessarily) derived from the tobacco plant. If this were the case, then existing medicinal nicotine products, such as NRT patches, gum, etc., would also have to be classified as tobacco products. In fact, eliquid for electronic cigarettes is made with pharmaceutical grade nicotine, to ensure high quality and safety standards.
Considered in the context of the stated aim of the Tobacco Products Directive, it is very clear that it is not the intent of the legislation to ‘capture’ clean, harm reduction products – which have not come from the Tobacco Industry – within this legal classification, or regulatory process, nor could there be any justification for doing so.
It is worth noting that, in the event that new legislation is enacted to cover nicotine products specifically, the General Product Safety Directive would still apply to the sale of electronic cigarette products, because of all the other components and ingredients:
“Where a product is subject to specific safety requirements imposed by rules of Community law other than the GPS Directive, these Regulations shall apply only to the aspects and risks or category of risks not covered by those requirements.”[iii]
This is further supporting evidence that the current regulatory framework, as used in the ECITA ISE Auditing Programme, is the most appropriate and proportionate ‘fit’ for electronic cigarette products, and that there is no need nor justification for adding extra layers of regulatory complexity. Already, public sector regulatory agencies are struggling to provide monitoring and enforcement in regulating the electronic cigarette industry, therefore we believe there will be an ongoing need for programmes like ECITA’s, offering valuable support and assistance to government regulators and the industry.
Belgium, (2009), Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use, L-311, 28/11/2004, p.67-128
[ii] Belgium, (2001), [i]Directive 2001/37/EC of the European Parliament and of the Council of June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products, L194/26
[iii] Great Britain, (2005), [i]The General Product Safety Regulations 2005, 2005 No. 1803
OK, so to round it all off for now, Section 5 (coming next) addresses the scientific facts, going into a little more detail than the Open Letter to Cyprus Mail. I hope some of you may find this useful.