The elimination of all trade barriers by 1992 in the European Community requires the harmonization of national provisions governing the maximum tar yield of cigarettes and the labelling of tobacco products. The concern on people's health must also be accounted for as tobacco is the main cause of mortality through cancer in the European Community. This is the reason why the programme "Europe against Cancer" (O.J. C50 of 26.02.1987) has given priority, with regard to prevention, to the struggle against the abuse of tobacco (see annex I). In this context, and at the initiative of the Vice President Mr. Manuel MARIN, Commissioner responsible of the Programme, the European Commission has just adopted two series of proposals for the attention of the Council of Ministers of the European Community in order to harmonize, before 31 December 1992, legislative, administrative and regulatory national measures concerning the limitation of tar yield in cigarettes and the labelling of tabacco products. With Europe in 1992, a better labelling of tobacco products ... In order to better inform smokers of the risks incurred, the European Commission requests the harmonization of national measures with the Irish model which is the most advanced in the matter (see annex II and pictures of Irish packets of cigarettes). This proposal provides that before the end of 1992 every packet of tobacco products bears the indication "Tobacco seriously damages your health" packets of cigarettes as well as this general health warning should moreover include 2 . a specific message in rotation, to be chosen from a list (see annex III), but which must include one of the two following messages "Smoking causes cancer" and "Smoking causes heart diseases". . tar and nicotine yield. ... and cigarettes less noxious for the health. If every cigarette is noxious for the health, whatever its tar yield, it is however indisputable that the risks of lung cancer are higher if the cigarettes smoked have a high tar yield. Two countries of the European Community already forebade cigarettes with a high tar content Spain (24 mg maximum) and Portugal (28 mg). Experts of the Word Health Organization further recommend the reduction of these limit values to 15 mg. This is why the second proposal requests the harmonization of national measures in this respect in the European Community, establishing as a uniform limit value 15 mg of tar per cigarette before 31 December 1992. Finally, following the recommendations of the Committee of Cancer Experts to the European Commission, it is also recommended to further reduce this limit to 12 mg before the end of 1995. These different proposals should not create adaptation problems for the tobacco industry or retailers. Recent experience shows that manufacturers are able to reduce the tar yield of cigarettes by using better tobaccos, better papers, better filters and a better preparation. As an example, the tar yield of Gauloises varies from 22,8 mg to 5,9 mg (see annex IV). The European Community is conscious of the fact that the limitation of tar yield of cigarettes will pose serious adaptation problems to producers of tobacco varieties with a high tar yield. Therefore, the European Community has already begun to stimulate the adaptation of productions in the more concerned countries of Southern Europe. Thus, within the framework of Common Agricultural Policy or Mediterranean Integrated Programmes, the European Community will reinforce its actions seeking to promote the reorientation towards the production of tobaccos which are less dangerous to health or the reconversion to other productions such as cotton, corn or fruits and vegetables (see annex I). ANNEX I LIST OF 14 MEASURES FOR A CAMPAIGN AGAINST TOBACCO "EUROPE AGAINST CANCER" PROGRAMME Proposed action 1(1) Upwards alignment of taxation on tobacco manufactured in the European Community. Proposed action 2 Financing of preventive actions at national level by the use of increased fiscal measures on tobacco. Action 3(2) Publication of indices excluding tobacco by the Statistical Office of the European Community. Proposed action 4 Harmonization of cigarette labelling in the European Community. Proposed action 5 Prohibition of cigarettes with a high tar content. Proposed action 6 Harmonization of the standards for the components of tobacco smoke. Proposed action 7 Prohibition of tax free sales of tobacco in the European Community. Proposed action 8 Protection of children from tobacco sales. Proposed action 9 Reorientation of tobacco production towards less toxic varieties and study of the possibilities of reconversion. Proposed action 10 Information and public awareness campaign in the struggle against tobacco. Proposed action 11 Study of national provisions and development of proposed Community regulations on tobacco smoking in public places. Proposed action 12 Study of national provisions and development of proposed Community regulations on the limitation of tobacco publicity. Action 13 Comparative analysis of anti smoking campaigns. Action 14 Information exchange in the struggle against smoking (1) These proposed actions will be prepared by the Commission of the European Community and submitted to the European Parliament, for consultation, and to the Council of Ministers of the European Community, for adoption. (2) The actions as stated will be put into effect by the Commission of the European Community using its management powers. ANNEX 3 PROPOSAL FOR A COUNCIL DIRECTIVE ON THE LABELLING OF TOBACCO PRODUCTS List of Health warnings I. Shall be included in the list of warnings to be drawn by Member States a. Smoking causes cancer b. Smoking causes heart desease. II. May be included in the list of warnings to be drawn by the Member States a. Smoking causes fatal deseases b. Smoking can kill you c. Smoking when pregnant can injure your baby and cause premature birth d. Stopping smoking reduces the risk of serious deseases e. Smoking causes lung cancer, bronchitis and other chest deseases f. More than ( ) people die each year in (name of the country) from lung cancer 

g. Smokers die younger.

Electronic cigarettes: the future or the end of smoking? – alberto alemanno – risk regulation – eu law – wto

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At a time of increasing suspicion vis vis e cigarettes, the UK government sides with this controversial type of product. The battle fought on the regulation of electronic cigarettes epitomizes the philosophical divide over health policy today and is likely to determine the future (or the end) of the century old habit of smoking in Western societies.

Introduction The battle fought on the regulation of electronic cigarettes, i.e. recreational devices that deliver vaporized nicotine without combusting tobacco, epitomizes the philosophical divide over health policy today. Although initial scientific studies suggest that e cigarettes are safer than conventional tobacco products, the health and anti smoking communities seems split over the issue. As summed up by Michael Siegel, one of the few anti smokers in favor of e cigarettes, the anti smoking movement’s ideology which is guided by an abstinence only type of philosophy just doesn’t have room for a product that looks and acts like a cigarette but happens to be orders of magnitude safer . As a result an increasing number of countries across the world are banning e cigarettes. It is against this backdrop that the UK government, notably the Cabinet Office s Behavioral Insight Team, better known as Nudge Unit, surprised the health community by coming out in favor of e cigarettes. The genesis of e cigarettes Alternatives to tobacco smoking exist since cigarette consumption came under the scrutiny of scientists back in the 1960s. The most promising, yet most controversial, is the electronic cigarette, which obtained patent protection in 1963, in the United States of America, as a device aimed at providing a safe and harmless method of smoking by replacing burning tobacco and paper with heated, moist, flavored air… . Amid the high social acceptance benefited by tobacco throughout the last decades, this device never reached manufacturing and it took almost 50 years before a Chinese pharmacist, Hon Lik, invented the modern e cigarette in 2003. Today an e cigarette may be defined as an electrical device that simulates the act of tobacco smoking by producing an inhaled mist bearing the physical sensation, appearance, and often the flavor and nicotine content of inhaled tobacco smoke. E cigarettes and their discontents Since their first appearance e cigarettes have sparked controversy not only among scientists, who still research on their health effects, but also within the health and tobacco control communities. At a time in which several studies regarding the long term health effects of nicotine vapor, both inhaled directly and second hand, are currently in progress, an increasing number of governments across the world, supported by the anti smoking community, are trying to stop the sale of e cigarettes by either banning them or treating them as drug delivery devices in order to control their placing on the market. The prohibitionist stance Behind such a prohibitionist stance lies the concern that e cigarettes may not only reduce the incentive for people to quit nicotine but could also return cigarettes the old allure of smoking, thus attracting young people and non smokers to become nicotine addicts. Besides these concerns, an increasing number of actors not only anti smoking groups express scientific doubts about the health effects of these nicotine devices. Yet, no agency has been able to present evidence that these devices may actually cause harm. Rather, most scientific studies seem to suggest that these devices are safer than conventional cigarettes. Facing such an uncertain regulatory environment, manufacturers of e cigarettes which are typically small or medium companies, independent from tobacco companies don t receive incentives to further develop this technology or invest into new smokeless devices. This is particularly true if one considers that as soon as a manufacturer makes a health claim in relation to e cigarettes ( it does not endanger your health ) then such a product automatically becomes a drug or a medical device, and as such it requires a market authorization and tight controls. It is therefore not surprising that, besides Australia, Canada, Brazil, Singapore and Thailand where e cigarettes are expressly prohibited) these devices tend not to carry health claims and, as a result, are freely sold. This is clearly the case for most EU countries where the legal status of e cigarettes and other smokeless products is to say the least a significant source of uncertainty, as recently discussed here. E cigarettes find themselves in a similar legal limbo in the US where the FDA intends to make them undergo scientific vetting before they could be sold in the United States. The FDA regulates smoking cessation devices, such as patches, so e cigarette manufacturers are careful to market their devices only as substitutes for cigarettes, not quitting aides. FDA did not appeal the decision by the U.S. Court of Appeals for the D.C. Circuit in Sottera, Inc. v. Food & Drug Administration, holding that e cigarettes and other nicotine containing products are not drugs or devices unless they are marketed for therapeutic purposes, but that other nicotine containing products can be regulated as “tobacco products” under the Federal Food, Drug, and Cosmetic Act. Normal 0 21 false false false EN GB JA X NONE The UK Nudge Unit s support for alternative smokeless devices What makes the prohibitionist stance against e cigarettes even more doubtful today is the role played by the pharmaceutical industry, which produces the most commercially successful alternative to tobacco smoking (nicotine replacements), in questioning the health effects of the electronic devices. Yet, the only government in the world that seems unimpressed by the e cigarettes bashing campaign led by the tobacco control community as well as Big Pharma is the UK government. The Cabinet Office s Behavioral Insight Team recently advised the UK government to encourage the use of new products that deliver nicotine to people s lungs without harmful toxins and carcinogens in tobacco smoke. In its annual update 2010 11, the Behavioral Insight Team suggests to explore new products for people addicted to nicotine products that deliver nicotine quickly in a fine vapour instead of as harmful smoke could prove an effective substitute for conventional smoking . The same report also recommends getting the regulatory framework for these products right, to encourage new products, which smokers can use as safer nicotine alternatives, to be made available in the UK . The Unit reaches this conclusion by reminding that A tenet of behaviour change is that it is much easier to substitute a similar behaviour than to extinguish an entrenched habit (an example was the rapid switch from leaded to unleaded fuel). If more alternative and safe nicotine products can be developed which are attractive enough to substitute people away from traditional cigarettes, they could have the potential to save tens of thousands of lives a year . The language used by the report is rather broad so as to encompass all safe alternatives to tobacco smoking. This is an important caveat the report contrary to mainstream media coverage should probably not to be interpreted as an unconditional endorsement of the actual electronic cigarettes. E cigarettes in the EU In the meantime, as reported here and here, the EU is revising its Tobacco Products Directive and it is considering whether to extend its scope of application to e cigarettes (which are defined as electronic nicotine delivery system ) as well as to some smokeless products, such as herbal cigarettes and snus. The latter product is prohibited within the EU with the notable exception of Sweden where it is traditionally manufactured and consumed. Although the European Commission recognizes that an individual substitution of smoking by the use of smokeless tobacco products would probably decrease the incidence of some tobacco related diseases and act as a way to quit smoking , it also held that at this moment there is not enough scientific evidence available on the
efficacy of these instruments, snus in particular, as quitting aids. Conclusion why not to embrace e cigarettes as a harm reduction strategy ?

While more and more countries consider banning electronic cigarettes, there is a clear need to produce more independent scientific research on their health effects. For the time being, the criticisms formulated against e cigarettes seem more ideological than science based and clash with equally strong arguments for the value of e cigarettes as a harm reduction strategy. In particular, the stance adopted by mainstream health and tobacco control communities against these devices has more to do with an ideological rejection of the harm reduction approach (which has instead been embraced in alcohol) than with scientific arguments about the adverse effects of those products. Most health advocates reluctance in endorsing a harm reduction approach finds its origin in their genuine distrust vis a vis tobacco manufacturers (just think about their historical record of lies) which are perceived as incapable to produce and market safe products (just think about the light/mild saga). Yet electronic cigarettes are not manufactured and marketed neither by the tobacco industry nor by the pharmaceutical industry. At least for now. The commercial success of electronic cigarettes, as recreational nicotine devices capable of closely mimicking the act of smoking, might indeed represent the new frontier of smoking, rectius vaping. It would be surprising should the tobacco companies won t seize this chance by developing safer technologies and progressively begin marketing ‘brand e cigarettes’. Should society be against safer alternative to tobacco just because this will guarantee big tobacco future revenues?

Future regulatory policy on e cigarettes and other alternatives to tobacco should be guided more by scientific evidence, i.e. how these products score as compared to conventional tobacco products, than by an ideological and revanchist approach against Big Tobacco. This is especially the case should e cigarettes prove capable of reducing toxic exposure and help individual smokers to quit.