Here are the references to E-cigs I can find in this document:
(18b) The FCTC in article 16 points to the responsibility of Parties to the Convention to address products aimed at underage consumers, such as food products and toys in the form of tobacco products that may be appealing to minors. In recent years, several products, such as shisha vaping sticks, have been placed on the market that do not contain nicotine but have the form of cigarettes and try to imitate the smoking process through vaporising substances, the harmless nature of which is not yet scientifically proven, and through an electric light imitating the burning process of a cigarette. Such products are clearly produced to be appealing to young and underage consumers, and are increasingly popular by minors in several Member States. Increasing concern is expressed at the habits created by young consumers and minors by the use of such imitation cigarettes. Therefore, these products should be prohibited through this directive.
Text proposed by the Commission
(33) Nicotine-containing products are sold on the Union market. The different regulatory approaches taken by Member States to address health and safety concerns associated with these products have a negative impact on the functioning of the internal market, in particular considering that these products are subject to significant cross-border distance sales including via the internet.
Amendment
(33) Nicotine-containing products - including e-cigarettes - are sold on the Union market. However Member States have taken different regulatory approaches to address health and safety concerns associated with these products. There is a need for harmonized rules, and all nicotine-containing products should be regulated through a medicines regime which recognises the well-established use of nicotine. Given the potential of such products to aid with smoking cessation, Member States should ensure that they can be made available outside pharmacies.
Text proposed by the Commission
(34) 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 provides a legal framework to assess the quality, safety and efficacy of medicinal products including nicotine containing products. A significant number of nicotine-containing products were already authorised under this regulatory regime. The authorisation takes into account the nicotine content of the product in question. Subjecting all nicotine-containing products, whose nicotine content equals or exceeds the content of a nicotine containing product previously authorised under Directive 2001/83/EC, to the same legal framework clarifies the legal situation, levels out differences between national legislations, ensures equal treatment of all nicotine containing products usable for smoking cessation purposes and creates incentives for research and innovation in smoking cessation. This should be without prejudice to the application of Directive 2001/83/EC to other products covered by this Directive if the conditions set by Directive 2001/83/EC are fulfilled.
Amendment
(34) 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 provides a legal framework to assess the quality, safety and efficacy of medicinal products including nicotine containing products. A significant number of nicotine-containing products were already authorised under this regulatory regime. The authorisation takes into account the nicotine content of the product in question. However, measuring nicotine delivery has proven to be difficult, as it depends on the products and how they are being used. Therefore, making all nicotine-containing products, regardless of their nicotine content, subject to Directive 2001/83/EC, while recognising the well-established use of nicotine, clarifies the legal situation, levels out differences between national legislations, ensures equal treatment of all nicotine containing products usable for smoking cessation purposes and creates incentives for research and innovation in smoking cessation. This should be without prejudice to the application of Directive 2001/83/EC to other products covered by this Directive if the conditions set by Directive 2001/83/EC are fulfilled.
(35a) Member States should ensure that nicotine-containing products are not sold to persons below the age required for purchasing tobacco products or related products.
E-cigarettes
The existing TPD does not cover nicotine containing products, but their inclusion is now proposed in the scope of the new Directive. The main development since 2001 has been the introduction onto the market of electronic or “e” cigarettes which have a growing market. There is no common approach at EU level on the regulation of e-cigarettes. At present, only 2 Member States have specific laws, but in about half of Member States nicotine is considered a medicine by function so technically e cigarettes cannot be sold unless approved as a medicine- like other smoking cessation products. In other Member States there are no specific regulations, meaning e cigarettes are covered by the General Products Safety Directive. There were nine RAPEX alerts about problems with e-cigarettes last year. E-cigarettes not authorised as medicines cannot make claims that they help smoking cessation. The USA is currently developing its own laws on e cigarette regulation under tobacco control legislation.
The Commission proposes a twin track approach to the regulation of e-cigarettes and other NCP. Products with a nicotine content over a certain level – including most e-cigarettes currently on the market - would have to be authorised as medicines. Those below the threshold would be allowed on the market with health warnings.
Tobacco control experts’ views differ about e-cigarettes. There is a general consensus on the need for better regulation but questions arise on whether e-cigarettes are a useful replacement product for existing smokers assisting with harm reduction or simply a way to allow smokers to stay smokers by getting nicotine in smoke free areas and/or are a gateway product to attract new users to nicotine addiction and potentially to tobacco. There are also concerns that e-cigarettes could renormalize smoking. Your rapporteur has requested a study from the Parliament’s services to look at the evidence on e-cigarettes and will make proposals in this area once the study is available and after consulting colleagues and experts.
Nicotine-containing products as for example e-cigarettes contain toxic chemicals and tobacco-specific components suspected of being dangerous to consumers. Moreover, analyses in the field show that e-cigarette cartridges labelled as containing no nicotine in many cases do in fact contain low levels of nicotine. For that reason, all nicotine-containing products should be subject to control. Otherwise, products with levels of nicotine concentration just below the proposed thresholds, could reach the market without any authorisation. As indicated above, not only a concentration of nicotine is relevant, but also the mixture of all substances as such. Consumers indicate as well, that they mainly use e-cigarettes to quit smoking, what suggests that e-cigarettes are perceived as a medicinal product. Your Rapporteur proposes therefore, to authorise all nicotine-containing products in accordance with the Directive on the Community code relating to medicinal products for human use (2001/83/EC).
Relying on the strict jurisprudence of the CJEU, several national courts have already held that e-cigarettes cannot be qualified as a medicinal product by function under the Medicinal Products Directive, see e.g. Oberverwaltungsgericht Nordrhein-Westfalen, 24 April 2012, 16 L 2043/11.
