Update March 17, 2014

26 February 2014. The European Parliament formally approved the revised EU Tobacco Products Directive which would, once it enters into force, do the following:

- Labeling - 1) Picture and text warnings will cover 65% of the front and the back of cigarette packs; 50% of the sides of packs will also be covered with health warnings (e.g. "smoking kills – quit now"; "tobacco smoke contains over 70 substances known to cause cancer"), replacing the current printing of tar, nicotine and carbon monoxide (TNCO) levels. The packs must be in a cuboid shape with a minimum of 20 pieces.2) Roll-your-own packages will be required to carry "65% combined health warnings on the front and back" and can be in a cuboid or cylindric shape, or be in pouch form, with each package containing a minimum of 30 grams of tobacco; Member States will have discretion regarding the labeling of less common tobacco products like pipe tobacco, cigars, cigarillos and smokeless products, but will need to ensure that the products still carry a general warning and an additional text warning.- Plain Packaging - Some space will remain available for branding, but Member States can introduce plain packaging "where they are justified on grounds of public health, are proportionate and do not lead to hidden barriers to trade between Member States.- Flavorings - 1) Cigarettes and RYO tobacco cannot have any distinguishable "characterizing" flavor other than tobacco; 2) Menthol will be banned after a phase-out period of four years; 3) Other tobacco products like cigars and smokeless tobacco are exempted from the flavors ban; and 4) Additives necessary for manufacturing, such as sugar lost during the curing process, can continue to be used. - E-cigarettes - 1) The TPD will cover e-cigs containing nicotine; 2) Nicotine liquids will have to be sold in child- and tamper-proof packaging and contain only "ingredients of high purity"; 3) E-cigs must deliver nicotine doses at "consistent levels under normal conditions of use" and come with health warnings, instructions for their use, information on "addictiveness and toxicity," an ingredients list, and information on nicotine content; 4) E-cig manufacturers will be required to notify Member States before placing new products on the market, report annually to Member States on their sales volumes, types of users and their "preferences and trends," and comply with existing rules for cross-border advertising and promotion of tobacco products.- Product information Manufacturers will be required to report on "certain frequently used substances found in cigarettes and RYO tobacco" through a standardized electronic format.- Illicit tobacco trade: The new Directive includes strong measures against illicit trade of tobacco products to ensure that only products complying with the Directive are sold in the EU. It introduces an EU-wide tracking and tracing system for the legal supply chain and visible and invisible security features (e.g. holograms) which should facilitate law enforcement and help authorities and consumers detect illicit products. The measures foreseen in the new Directive will help to redirect tobacco trade to legal channels, and may also help Member States restore lost revenue. Tracking and tracing of tobacco products will be phased in, with cigarettes and RYO the first required to comply, followed by all other tobacco products.- Cross-border distance sales will not be banned at EU-level, but individual Member States may choose to ban such sales. If they do, retailers may not supply consumers located in that Member State. If they do not choose to ban these sales, retailers that wish to sell tobacco products cross-border must notify their activity prior to the first sale in the Member State in which they are located and in those Member States to which they sell tobacco products. They also must also put in place an age-verification system to ensure that tobacco products are not sold to children and adolescents.

http://www.tma.org/tmalive/ArticleAbstract_CDA?type=A&pcode=NWSPCI&absfullpp=abs&purchased=y&articleid=NWSPCI0226145002&price=0&source=search_CDA&targeturl=ArticleAbstract_CDAhttp://www.tma.org/tmalive/ArticleRichtextDisplay_CDA?type=ftxt&aid=NWSPCI0226145002&source=search_CDA

Questions & Answers: New rules for tobacco products: http://europa.eu/rapid/press-release_MEMO-14-134_en.htm

The revised Tobacco Products Directive was adopted by the Council on March 14, 2014.

Entry into force will occur 20 days after the law has been published in the official journal of the EU. After Council adoption, each member state needs to individually ratify/approve a national law that adopts the language of the TPD and includes the new rules covering larger graphic health warnings with options for plain packaging, a ban on flavored tobacco products with menthol given a four-year phase-out period until 2020 and measures to combat illicit products, among other things.  The new law introduces proper regulation of e-cigarettes for the first time: e-cigarettes will not be required to seek a medicines licence unless they are marketed as an aid to quitting smoking. E-cigarette manufacturers have the option of having their products treated like tobacco products – i.e. they can be sold freely – as long as they meet certain safeguards. The new Directive should enter into force in May 2014. A transposition period of two years for Member States to bring national legislation into line with the revised Directive means that most of the new rules will apply in the first half of 2016. However, the Directive also foresees a transitional period for all product categories to give manufacturers and retailers time to sell off their existing stock insofar as it complies with the old Directive or other relevant legislation. A phase-out period of four years is foreseen for all products with more than a 3% market share in the EU, for example menthol cigarettes. http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/141527.pdf

Latest news: - The Lancet on March 4, 2014 reports that the revised Tobacco Products Directive, which passed the European Parliament on February 26th, will put in place more stringent rules for tobacco and related products in the EU in line with market and scientific developments in the sector and will focus on limiting the appeal of these products, particularly to young people, by banning "characterizing" flavors in cigarettes and RYO tobacco, introducing prominent graphic and textual health warnings, and regulating packaging, among other measures, but many observers wonder why the new directive took 5 years to work its way from conception to adoption, with most of them attributing the delay to alleged tobacco industry interference, which they claim has also weakened the final text, as the updated directive will require health labels on 65% of packaging, rather than 75% as originally proposed, grant menthol a temporary exemption from the flavorings ban until 2020, and classify e-cigs as consumer goods, rather than medical devices as proposed by the European Commission. . (>6-3)

- Voice of Russia reports that despite evidence showing that e-cigs help people quit smoking, the UK is expected to ban "strong re-usable" e-cigs in line with the EU's revised Tobacco Products Directive, which passed the European Parliament on February 26th and now faces a EU Council vote. Around 10 million adults in Britain smoke cigarettes, with two third of them starting before turning 18, the report said. Sweden, which negotiated an opt-out from the EU snus ban when it joined the bloc in 1995, has the lowest smoking rate among all member States and the country's lung cancer deaths in men aged over 35 is less than half the British rate, the Voice of Russia report noted. (>6-3)

- The Electronic Cigarette Industry Trade Association (ECITA) in the UK criticized the revised EU Tobacco Products Directive, which passed the European Parliament on February 26th and will introduce a number of restrictions on the sale and marketing of e-cigs, with ECITA's operations manager Katherine Devlin saying the directive "could not be challenged until the implementation stage in 2016, but it would prove unworkable and the industry will fight it."   (>6-3)

- British American Tobacco's legal director Neil Withington on February 28,2014 said in an interview after the company reported its 2013 results that he was not concerned by the regulation, much of which, he noted, is already implemented elsewhere in the world, but did not believe that banning menthol was appropriate. "There is no scientific evidence that banning menthol is going to bring any real public health benefit to the population," Durante added. (>6-2)

- Commenting on the European Parliament's February 26th passage of the compromise Tobacco

Products Directive, which would, once it enters into force, allow e-cigs with a nicotine content below 20 mg/ml for general sale at the European Union level, enable the EU to ban refillables if just three member States do so, while permitting member States to regulate the devices as medicines if they choose, and cap cartridge size at 2 ml, an editorial in the New York Times said the rules should serve as a model for the US Food and Drug Administration, which is expected to issue its proposed "deeming regulation" for e-cigs.  (>6-1)

- After the European Parliament on February 26th approved the revised Tobacco Products Directive, Patricia Kovacevic, advisory board member of eCig Europe and director of regulatory affairs at SKYCIG, said it is unfortunate that the EP "failed to give due consideration to the harm reduction opportunity presented by electronic cigarettes and, moreover, neglected to propose a well-reasoned, product-specific regulatory framework to adequately address consumer demand." (>6-3)

- Philip Morris International's EU Regional President Drago Azinovic on February 26, 2014 said that the Tobacco Products Directive adopted by the European Parliament "represents a worrying departure from the EU's basic standards of proportionate, evidenced-based policymaking, which will further erode intellectual property rights and undermine the EU Charter where these rights are protected," adding that the TPD measures will "make the EU less competitive and be a gift for the … black market." (>6-2)

- Stifel analysts on February 26, 2014 said that European Parliament's approval of the revised Tobacco Products Directive sets into motion a more regulatory-heavy policy in the EU over the next couple of years, but the TPD is not expected to have a meaningful effect on Philip Morris International's business or the tobacco category in the EU in general, adding that the TPD is "likely still less burdensome than the FDA-controlled US tobacco market," and the absence of a ban on slim cigarettes, which holds about 6% market share in the EU, is a positive for the industry.  While slim cigarettes represent about 6% of the EU market, they hold a large share in some countries like Poland, Stifel noted. (>6-1)

- Following the European Parliament's February 26th passage of the compromise Tobacco Products Directive, Ben Townsend, head of EU affairs at Japan Tobacco International's (JTI) Brussels office, said that the TPD "encompasses a series of complex measures that will affect the whole of our supply chain" and that some of the provisions would require important changes in product and pack design as well as machinery. (>6-2)

- After the European Parliament on February 26th approved the revised EU Tobacco Products Directive, Monika Kosińska, secretary general of the European Public Health Alliance, urged the European Council to endorse the revised TPD without delay, saying it will help EU member nations strengthen their tobacco control measures and ensure the product safety and quality of Nicotine Containing Products (NCPs), including e-cigs. . (>6-3)

- A report released by the UK-based economics consultancy London Economics and funded by Ecigwizard.com (Electronic Cigarettes Ltd) said the revised EU Tobacco Products Directive’s provision to ban e-cigs containing more than 20mg/ml of nicotine, a level which scientists say is equivalent to less than one-third of the nicotine in a standard cigarette, could lead to 105,000 additional smoking-related deaths every year, as the ban on higher-strength e-cigs would result in 210,000 fewer smokers quitting the habit per year and 9.6 million extra cigarettes being consumed every day . (>6-3)

- Commenting on the European Parliament's passage of the revised Tobacco Products Directive, Linda McAvan, the British Labour Party member of the European Parliament and rapporteur who guided the legislation through the chamber, said the original version of the TPD was stricter than what passed on February 26th and would have regulated e-cigs as medicines, but the passage is a victory nonetheless, as "the new law is [still] a huge step forward in tobacco control," adding that she is "totally confident that we'll be taken to court by the tobacco companies" over some issues," while British Conservative Party MEP Martin Callanan said the TPD's e-cig regulations are a "massive loss for public health in Europe" and he believes "a lot of [the details on e-cigs] will end up in the courts." . (>5)

- The U.K. smokers’ group Forest, which campaigned against revisions to the EU’s Tobacco Products Directive on February 27, 2014, questioned the need for standardized packaging of tobacco after the European Parliament voted yesterday to adopt the revised directive. “ “If health warnings are going to be even more prominent, dominating both sides of the pack, why on earth do we need plain packaging?” said Simon Clark, director of Forest, which ran

the No Thank EU campaign. “At the very least the government should wait and see what impact the larger warnings have before introducing standardized packs which are opposed by so many people.” of tobacco after the European Parliament voted yesterday to adopt the revised directive. “ (>6-3)

EU TOBACCO PRODUCTS DIRECTIVE: CLOSING STAGES OF DEVELOPMENT

- 22 January 2014. Compromise passed by the Parliamentary Committee on the Environment and Public Health (ENVI)

The compromise on the revised EU Tobacco Products Directive, which the European Parliament reached on December 16, 2013, passed the Parliamentary Committee on the Environment and Public Health (ENVI) on January 22nd in a 49-7 vote with 4 abstentions, with the agreed text to be debated and put to a plenary vote. The compromise version, confirmed on December 18, 2013, by the permanent committee of member States' representatives (COREPER), would ban the sale of cigarettes in packs containing fewer than 20 pieces and require combined textual and graphic health warnings on 65% of the front and back of cigarette packaging. The majority of member States do not require pictorial warnings at present. The draft TPD would regulate e-cigs as medicinal products if they are marketed as a quit aid, or alternatively as tobacco products, in which case, their nicotine concentration should not be more than 20 mg/ml. Refillable cartridges and e-cig flavorings would be allowed. E-cigs should be childproof and carry health warnings. E-cigs would be subject to the same advertising restrictions as traditional tobacco products. The legislation would ban the use of a "characterizing flavor" in cigarettes and roll-your-own tobacco. Menthol would be banned effective 2020. The European Commission would establish a "priority list" of additives allowed in cigarettes and RYO tobacco. The TPD would authorize additives essential to produce tobacco, such as sugar.At a meeting of the European Union Economic and Financial Council on January 28, 2014, EU ministers decided not to oppose the European Commission's directive to postpone for another two years the introduction of new larger health warnings on cigarette packs.  The directive would require EU nations to remove non-compliant cigarette packs by March 28, 2018. "In view of the complexity of the process of updating the electronic library of selected source documents and amending Decision C(2005)1452, there is a danger that the process will not be completed before the deadline," the European Commission said.

- 18 December 2013. European Council approves compromise on tobacco directive*

On December 18, 2013, in the Committee of Permanent Representatives (COREPER I) the EU Member States backed the final compromise text negotiated by the Lithuanian Presidency and the European Parliament on the Tobacco products Directive. The final agreement* includes regulation of electronic cigarettes.The agreed text will be debated and put to votes in the Health Committee and the plenary early next year.

The compromise text includes the following key measures to be brought into national law by member states:

–   A ban on the placing on the market of cigarettes and roll-your-own tobacco with characterising flavours such as fruit flavours, menthol or vanilla.

–   The ban on mentholated products will apply only four years after the directive being transposed by the member states.

Member states will also have to ban the placing on the market of tobacco products containing additives in quantities that increase in a significant or measurable manner the toxic or addictive effect, or the carcinogenic, mutagenic or reprotoxic properties. –  Combined picture and text health warnings would have to cover 65 % of the front and the back of packages of tobacco products for smoking. In addition, each packet of smoking tobacco must carry a general warning (such as "Smoking kills - quit now") and the information message: "Tobacco smoke contains over 70 substances known to cause cancer".

–   A ban on any misleading labelling (such as "natural" or "organic"). -    Packs of fewer than 20 cigarettes would be banned.–   Introduction of a tracking and tracing system, together with safety features in order to strengthen the fight against illicit trade and falsified products. -    Member states may decide to ban cross-border distance sales (through the Internet).–   Member states may introduce more stringent rules on additives or on packaging of tobacco products (such as plain-packaging), subject to certain conditions (such as notification of the Commission). –   The scope of the directive is extended to electronic cigarettes which will be subject of a number of safeguards: maximum concentration of nicotine of 20 mg/ml, maximum single use cartridge size of 2 ml). As regards to refillable electronic cigarettes, the Commission will have to report on their potential risk to public health at the latest two years after the entry into force of the directive. If for justified reasons related to a serious risk to human health at least three member states have banned refillable electronic cigarettes the Commission is allowed to extend the ban to all member states. A single cartridge should contain the equivalent in nicotine of a pack of cigarettes.E-cigarettes should be regulated either as medicinal products, if they are presented as having curative or preventive properties, or alternatively as tobacco products.Electronic cigarettes should be childproof and carry health warnings. They would be subject to the same advertising restrictions as tobacco products. * http://www.consilium.europa.eu/uedocs/cms_Data/docs/pressdata/en/lsa/140147.pdfhttp://www.europarl.europa.eu/news/en/news-room/content/20131216IPR31001/html/Tobacco-directive-MEPs-reach-agreement-with-Council-of-Ministers

- October 8, 2013. European Parliament Approves Revised Tobacco Products Directive, which would:

- increase the size of cigarette health warnings to at least 65% of the front and back of packs, up from the current requirement of at least 30% of the front and 40% of the back, and require the brand image to appear on the bottom of the pack;

- ban packs containing fewer than 20 cigarettes;- regulate e-cigs, but *not* subject them to the same rules as medicinal products unless they are

presented as having “curative or preventive properties,” with products with no such claims to contain under 30 mg/ml of nicotine, carry health warnings and sold only to consumers aged 18 and over;

- subject e-cigs to the same advertising restrictions as tobacco products;- require e-cig manufacturers and importers to supply authorities with a list of all ingredients in their

products;- ban flavors including menthol, with a 3-year deadline to phase out flavors except menthol, which has 8

years;- authorize “additives essential to produce tobacco,” such as sugar and other “explicitly listed substances

in stated concentrations”; and require “single packets and transport packaging” to be identified with a mark to enable supply chain track-and-trace to combat illegal trade.

Members of the European Parliament rejected a ban on slim cigarettes.

* Amendments adopted by the European Parliament on 8 October 2013 on the proposal for a directive of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products (COM(2012)0788 – C7-0420/2012 – 2012/0366(COD)) (1)

http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+TA+P7-TA-2013-0398+0+DOC+XML+V0//EN&language=EN

EU members have 18 months to translate the TPD into national laws. The deadline for phasing out flavours in general is three years, with five additional years for menthol (total eight years). Tobacco products that do not comply with the directive will be tolerated on the market for 24 months, and e-cigarettes for 36 months.

- July 2013. The European Parliament's Environment, Public Health, and Food Safety Committee (ENVI) on July 10, 2013 voted to back the European Commission's revised Tobacco Products Directive proposals:

- to require graphic health warnings to cover 75% of the front and back of cigarette packs, ryo and water pipe tobacco

- to ban distinctive flavorings including menthol, prohibit slim cigarettes- to classify all e-cigs as pharmaceuticals regardless of the nicotine content, rather than the

Commission's proposal for such a classification only for e-cigs with "4 milligrams or more of nicotine- to ban the sale of tobacco products through the Internet in any EU member countries

The Committee rejected plain packaging of tobacco products

A report published on July 24, 2013 provides the opinions of six European Parliamentary committees on the draft TPD. Three of them recommend that combined health warnings cover 50% of the front and back surface, rather than 75% as proposed.Report on the proposal for a directive of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products(COM(2012)0788 – C7-0420/2012 – 2012/0366(COD)), 24 July 2013http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-%2f%2fEP%2f%2fTEXT%2bREPORT%2bA7-2013-0276%2b0%2bDOC%2bXML%2bV0%2f%2fEN&language=EN

Revision of the Tobacco Products Directive 2001/37 EC

The revision addresses the following main issues:- labeling and packaging of tobacco products- additives, such as flavourings, used in tobacco products- how to regulate products which do not contain tobacco, but which are closely linked to smoking or tobacco consumption, for example electronic- and herbal cigarettes- internet sales of tobacco products and tracking and tracing of these products

1. Public consultation

On September 24, 2010, the European Commission launched a public consultation on   revising by 2012   the Tobacco Products Directive (2001/37/EC) * which set minimum standards for cigarette package labeling and 'tar,' nicotine and carbon monoxide content.  The current directive does not address products such as flavored products, electronic cigarettes and nicotine gum. The consultation invited stakeholders to submit their views on the types of changes they expect to see in the updated directive, and re-launches the debate on packaging by raising the question of whether more "forceful" pictorial warnings are necessary on cigarette packs, of plain packaging and the regulation of harmful, addictive and attractive substances in tobacco products. The European Commission's Directorate-General for Health and Consumers on July 27, 2011 published the results of its public consultation which ended December 17, 2010. The Directorate-General said the public consultation generated a record 85,000 responses, with the vast majority coming from individual citizens. The outcome of the public consultation, along with the legislative proposal to revise the directive, was presented in late 2012. *http://ec.europa.eu/health/tobacco/docs/consultation_report_en.pdf

[On May 27, 2011, the European Commission issued a press release relating to Q&A on tobacco control in the EU saying it is currently considering strengthening the Tobacco Products Directive in 2012 by regulating ingredients, especially "those which make tobacco products more attractive and addictive and appeal especially to young people;" introducing regulatory solutions to address novel smokeless tobacco and nicotine products, among others.http://europa.eu/rapid/pressReleasesAction.do?reference=MEMO/11/349&format=HTML&aged=0&language=EN&guiLanguage=frIn an interview with the German daily Die Welt on October 12, 2010, European Union Health Commissioner John Dalli said that the Commission may attempt to reduce the amount of nicotine and other toxic substances contained in the product. http://euobserver.com/19/31021]

The revision of the European Union's Tobacco Products Directive 2001/37/EC on the manufacture, presentation and sale of tobacco products was delayed until late 2012, a delay that was reported to be partly due to the "extremely complicated" impact study and Philip Morris International's challenge of Australia's plan to require plain cigarette packaging from January 2012, Europolitics reported on September 1, 2011.

2. EU Tobacco bribery scandal

On October 16, 2012, EU Health Commissioner John Dalli resigned after an investigation by the EU's anti-fraud office OLAF connected him to an attempt by a Maltese businessman to influence EU tobacco legislation: Swedish Match filed a complaint to the EU Commission about receiving a proposal to influence the outcome of the ongoing review of the Tobacco Products Directive, in exchange for financial compensation: comments by Swedish MatchOLAF's chief Giovanni Kessler comments.John Dalli on December 13, 2012 filed a defamation lawsuit in the Brussels Court of First Instance against Swedish Match, accusing the company of having circulated false information, particularly a false chronology of the facts of the case, to members of the European Parliament's Committee on Budgetary Control, among others.

European Parliament President Martin Schulz requested to see EU anti-fraud body OLAF's report that led to the resignation of John Dalli as health commissioner, Schulz also invited European Commission President José Manuel Barroso and OLAF Director General Giovanni Kessler to meet in the next Conference of Presidents, a spokesman for the Greens said. The Greens proposed that a special committee investigate issues including the commission's relationship with tobacco lobbyists and the role of Michel Petite as chief legal adviser to Commission Presidents Jacques Delors, Romano Prodi and José Manuel Barroso before joining in 2008 the international law firm Clifford Chance, which has acted as an adviser to Philip Morris International. The commission reappointed Petite to its ethics committee on lobbying on December 28, 2012.

Transparency watchdog Corporate Europe Observatory filed a complaint with the Transparency Register secretariat against Swedish Match, claiming that the company violated the EU Code of Conduct for lobbyists by going to Malta to find former EU health commissioner John Dalli's personal contacts, hiring unregistered lobbyists, and "[lying] to MEPs about Dalligate" concerning the EU Tobacco Products Directive, while the watchdog also filed a complaint with the European Ombudsman against EU anti-fraud office OLAF for denying access to the investigation report on the Dalli case, Malta Today reported on April 2, 2013.

A European Commission spokesperson said on June 10, 2013 that the EC’s position regarding Dalli remains unchanged despite the Maltese police’s announcement, noting that Dalli’s resignation was based not on whether legal proceedings would be launched against him or not, but on the fact that his position became “politically untenable” after the OLAF investigation connected him to a bribery scandal involving revisions to the EU Tobacco Products Directive.

> Former EU health commissioner John Dalli said he is considering launching cases for human rights violations before the European Court of Human Rights, as well as other cases against individuals in their personal capacities. He has also filed a defamation lawsuit against Swedish Match, Malta Independent reported on June 16, 2013. "The pressures of the ordeal were enormous," and "I have also suffered serious health problems as a result of all this, after having been ridiculed and my reputation smeared globally," Dalli said. The Maltese Police Commissioner's statement that there was no evidence to incriminate him came as "a big relief," Dalli added. He also said he does not rule out the possibility of his reinstatement to the European Commission as a result of a case he has filed in the European Court of Justice challenging his October 2012 dismissal, but, if there is no reinstatement, he could seek material damages, such as loss of salary and pension, and also moral damages. http://www.tma.org/tmalive/ArticleAbstract_CDA?type=A&pcode=NWSBEF&absfullpp=abs&purchased=y&articleid=NWSBEF0617135004&price=0&source=search_CDA&targeturl=ArticleAbstract_CDA

EU Health Commissioner Tonio Borg maintained that his predecessor John Dalli's resignation in October 2012 amid an alleged bribery scandal did not derail the directive, despite claims to that effect by some MEPs, Malta Today reported on July 3, 2013. Furthermore, in a July 1st letter to Members of the European Parliament, John Dalli, who resigned as EU health commissioner in October 2012 after an OLAF investigation connected him to a € 60 million (US$ 78.2 mn) bribery scandal involving revisions to the EU Tobacco Products Directive, denied having transferred up to US$ 100 million in the Bahamas.

In what is the latest development in the € 60 million (US$ 81.0 mn) bribery scandal involving revisions to the TPD, OLAF has begun a new investigation into two or more trips that Dalli made to the Bahamas last year before his resignation allegedly to transfer tens of millions of dollars for an unspecified venture, though Dalli has said that he did not have any accounts in the Bahamas and that he was acting on behalf of friends who wanted to set up a trust for a philanthropic project to help people in Africa

Tobacco for oral use

In May 1992, the European Union (EU) prohibited the placing on the market of tobacco for oral use, excepted those destined to be smoked or chewed (including Swedish snus). The prohibition was introduced by Directive 92/41/EEC amending Directive 89/622/EECIn early September 2011, EU Health Commissioner John Dalli said the European Commission does not believe changes should be made to the EU ban on snus except in Sweden. read more    Pierre Schellekens, head of the European Commission's representation in Sweden on April 19, 2012 rejected rumors in Swedish media that snuff will be banned under the revised EU Tobacco Directive, explaining that the current focus is on additives used in cigarettes.  Swedish Match's head of corporate information Patrik Hildingsson said on September 12, 2012 that the company is not particularly concerned about the European Commission's proposal to continue its ban on smokeless tobacco products outside Sweden, as the final version of the proposal, due in November or December, is unlikely to be presented in its current form.

Under its new Tobacco Products Directive (TPD), the European Commission reportedly wants all tobacco products to contain at least 85% tobacco, with Swedish snus containing about 50%, and wants to ban "added aromas" like herbs or fruits, according to documents obtained by Aftonbladet, though Maria Larsson, Swedish Minister for Children and the Elderly, called them "rumours" since the "Commission hasn't taken a decision" about the TPD and the Swedish government has yet to see it.  Larsson should meet EU Health Commissioner Tonio Borg in Brussels. Many snus manufacturers in Sweden have added flavors like orange, juniper berries, mint, licorice and eucalyptus in recent years. Commenting on the Aftonbladet report, Swedish MEP Christoffer Fjellner said the commission "[does] not object to any potential health risks of snus, just to snus." (Source: TheLocal.se December 5/2012).

After Swedish newspaper Dagens Nyheter reported that the European Commission is considering restricting the use of flavorings in snus as part of the revision of the 2001 Tobacco Products Directive, Swedish Match AB spokesman Johan Wredberg said if the media report was accurate, it indicated an indirect attempt to ban the product in Sweden, which is the only country to enjoy an exemption from EU's existing ban on snus.  Banning or restricting the use of flavors would prevent Swedish Match from producing snus in the way it wanted to and which was best for consumers, he said. "To allow Sweden's exception (from the ban) on paper, but make manufacturing impossible via law, can only be interpreted as a way also to try to ban snus in Sweden," Wredberg added. According to Dagens Nyheter, the EC proposal would allow national regulators to decide if the content of flavorings is too high, but the EC could intervene if necessary, Reuters reported on December 5, 2012.

Sweden's Minister for Public Health Maria Larsson said December 7, 2012 that Swedish snus must be exempt from the new EU Tobacco Products Directives' regulations on additives if the export ban remains.  The minister said it is illogical that a product that is excluded from the EU's inner market is still subject to its controls, adding that the government would agree to follow regulations on snus content if the export ban is lifted.

Under the proposal for revising the 2001 Tobacco Products Directive that was issued on December 19, 2012, the ban on oral tobacco products (snus) is maintained, except for Sweden which has an exemption.

Gerry Stimson, director of health policy research group Knowledge-Action-Change, writes in Nicotine Science and Policy that the EU proposal to continue with its ban on snus except in Sweden “ranks as public health folly of the highest order,” as those responsible for shaping public health in the EU believe “The Only Way is Prohibition” (TOWIP) when it comes to tobacco control due to their fear that snus could become a gateway to smoking for young people, deter cessation attempts and allow for dual use, though the experience in Sweden in Norway suggests that “snus is a gateway out of smoking.”

The European Commission on November 30, 2012 launched an inter-service consultation on the revision of the 2001 Tobacco Products Directive.

3. Publication of the proposal

The European Commission on December 19, 2012 published the proposal for revising the 2001 Tobacco Products Directive*.

Main elements of the proposal:The proposal foresees major revisions of the current Directive. It addresses in particular the following areas:• Labeling and Packaging: All cigarette and Roll Your Own packages must contain a combined picture and text health warning covering 75% of the front and the back of the package and must carry no

promotional elements. The current information on tar, nicotine and carbon monoxide, which is perceived as misleading, is replaced by an information message on the side of the pack that tobacco smoke contains more than 70 substances causing cancer. Plain packaging. Member States remain free to introduce plain packaging in duly justified cases.A unit packet of cigarettes must include at least 20 cigarettes. A unit packet of roll-your-own tobacco must contain tobacco weighing at least 40 g.• Ingredients: An electronic reporting format for ingredients and emissions will be introduced. The proposal foresees a prohibition for cigarettes, roll your own tobacco and smokeless tobacco that have characterising flavours and a prohibition of products with increased toxicity and addictiveness.• Smokeless tobacco: The ban on oral tobacco products (snus) is maintained, except for Sweden which has an exemption. All smokeless tobacco products must carry health warnings on the main surfaces of the package and products with characterising flavours cannot be sold. Novel tobacco products require prior notification.• Extension of the scope of the Directive : Nicotine Containing Products (e.g. electronic cigarettes) below a certain nicotine threshold are allowed on the market, but must feature health warnings; above this threshold such products are only allowed if authorised as medicinal products, like nicotine replacement therapies.Herbal cigarettes will have to carry health warnings.• Cross border distance sales: A notification for internet retailers and age verification mechanism are foreseen to ensure that tobacco products are not sold to children and adolescents.• Illicit trade: A tracking and tracing system and security features (e.g. holograms) are foreseen to ensure that only products complying with the Directive are sold in the EU.

* Proposal for a Directive of the European Parliament and Of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products, 19 December 2012

Proposal for a Directive - COM(2012) 788 final   

European Parliament Forecasts: Indicative plenary sitting date, 1st reading/single reading: 8 October 213

► At a European Parliament hearing on November 13, 2012, EU health commissioner-designate Dr. Tonio Borg vowed not to water down the EU Tobacco Products Directive, although he noted that he personally does not favor plain packaging for cigarettes. Dr. Borg said if elected, his top priority would include an "ambitious" tobacco products directive which could be delivered in January 2013.

EU Health Commissioner Tonio Borg on February 25, 2013 said at a European Parliament Environment and Public Health Committee hearing about the draft Tobacco Products Directive that the economic benefits of the tougher directive would outweigh its costs. "This is a balanced directive. Balanced but ambitious," he added. However, it would be up to the EU member States to adopt plain packaging, Borg said.Commenting on the snus ban, Borg said Sweden was given an exception during membership negotiations on the condition that they would not market the product in any other EU nation. Changing this stipulation "would require a treaty change," he said. Supporting the plan to continue the EU ban on snus, Swedish Greens MEP Carl Schlyter said he was "one of the few Swedes who did not want to export the product." Schlyter called on the EC to regulate any type of nicotine product, whether it is cigarettes, e-cigarettes or smokeless tobacco.

EU lawmakers ready to confront tobacco industry “Goliath”. A majority of European lawmakers appear to back further EU proposal for tobacco regulation but face opposition from tobacco pro-industry colleagues and the 100-strong cohort of Brussels tobacco lobbyists nicknamed ‘Goliath” by anti-smoking campaigners, Euractiv reported on February 27, 2013.http://www.euractiv.com/consumers/meps-confront-tobacco-goliath-eu-news-518071

EU Health Commissioner Tonio Borg said in an interview with EurActiv on March 5, 2013 that while "[i]t is not directly my responsibility" to find replacement jobs for workers if they are left unable to grow tobacco because of new rules in the revised EU Tobacco Products Directive, he said that one possible area for compromise is on the issue of "additives" in burley tobacco, much of which is grown in Romania, Bulgaria and Portugal, as "the definition of 'additives' will be determined by experts appointed within the individual member states, and supervised by the Commission."  Burley tobacco requires more additives than Virginia tobacco because the former loses more sugar during the drying process, according to Hermanus Versteijlen, director of the economics of agricultural markets at the European Commission. Versteijlen said in August 2011 that banning the addition of sugars and flavors to burley tobacco could cause large losses to the European market. Borg said "characterising flavours in tobacco products will be prohibited, but not all flavours or additives will be prohibited." He also said "we can find compromises so long as there is a basic understanding that tobacco should look and taste like tobacco."

During an informal meeting of the EU Health Council on March 4-5, 2013 in Dublin, Ireland, ministers for Poland, Italy, the Czech Republic and Greece called on the European Commission to consider the impact of the revised Tobacco Products Directive proposal on member States and regions where tobacco is cultivated.  However, no member State openly opposed the proposed directive, according to a diplomatic source. Twelve ministers were in favor of the directive, while Finland, Belgium, Slovenia and France said the proposed revisions do not go far enough. Health ministers also discussed their experience of implementing smoke-free environments in line with a 2009 Council recommendation.

► Europolitics reported on March 19, 2013 that the draft of the revised EU Tobacco Products Directive has passed the "subsidiary test" - the principle that the EU may make laws only when action of individual countries is insufficient - as only eight national parliaments sent a reasoned opinion claiming non-conformity of the text with the principles of subsidiarity, which was 11 short of the required number to give the European Commission a yellow card and force it to re-examine the proposal.  The presidents of the European Parliament, Council and Commission received seven reasoned opinions before the March 4th deadline from Sweden, Czech Republic, Italy, Greece, Denmark, Romania and Portugal. Sweden said the TPD should cover tobacco products that are traded freely on the common European market, but should not cover snus, the regulation of which should be a national matter. Czech MPs said the goals of the directive could be better fulfilled with actions carried at member state level. The Czech MPs are also against the ban on flavored tobacco products, larger health warnings and graphic health warnings. The Italian Senate voiced its opposition to the wide-ranging executive powers granted to the Commission, and said "the EU is seeking, for the first time, to take almost total control of the appearance, shape and design of the product and packaging, without there being, inter alia, any valid scientific evidence in support of the effectiveness of these measures in health terms." The Greek parliament said "the proposal for a directive fails to comply with the principle of subsidiarity, since there is nothing in the explanatory memorandum or the impact assessment report to suggest that the intended objectives can in fact be achieved more effectively at EU level," and specifically criticized the ban on menthol cigarettes and cigarettes with a diameter smaller than 7.5 mm. The Danish and Portuguese parliaments and the Romanian chamber complained about the non-conformity of the proposal with the principles of subsidiarity. After the March 4th deadline, the Chamber of Italian MPs sent a reasoned opinion, while the Hungarian parliament and the Polish senate also expressed their views. Key measures in the revised TPD include banning slim and flavored cigarettes, requiring health warnings to cover 75% of the front and back of packs, and further regulating the appearance of packs.

4. MEP Linda McAvan’s proposal

Socialist MEP Linda McAvan, rapporteur of the European Parliament Environment, Health and Food Security Committee on the revised Tobacco Products Directive proposal, issued a draft proposal including 56 amendments tightening the text of the EU TPD proposal on March 28, 2013.

♦ EP main changes proposed in the EU draft directive:

- Labeling (plain packaging), M. Linda McAvan, the rapporteur, proposes to go further than the EU draft proposal for cigarettes and RYO by proposing a form of standardization : “where combined health warnings are used, the rest of the tobacco package should be standardised and free from any branding, in order to maximise the impact of the health warning ».

- Ingredients, the proposal does not ban additives seen as essential to production of tobacco and it exempts cigars, cigarillos, pipe tobacco and water pipes from the flavourings ban as long as these continue to be mainly used by older smokers: the rapporteur supports all these measures but is concerned about recent trends in the use of water-pipes by young people and wants the Commission to monitor this carefully.

- Novel tobacco products, the rapporteur believes that prior authorisation should be the rule for all novel tobacco products rather than prior notification as proposed in the TPD and has tabled amendments accordingly.

- E-cigarettes, the Commission proposes a twin track approach to the regulation of e-cigarettes and other nicotine-containing products, with those products containing nicotine above a certain level to obtain authorization as medicines and those containing the substance below the threshold to be allowed on the market with health warnings. The 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.

The rapporteur supports the proposal to retain the existing ban on snus.

- Cross-border distance sales of tobacco products, the Parliament rapporteur believes that the best policy option would be to ban online sales as well as free giveaways of cigarettes via the internet and other channels.

- Illicit trade, the rapporteur added amendments to strengthen the anti-counterfeit security, and ensure that traceability on individual packets also feature on multipacks.

Proposal 3.28.2013 http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&reference=PE-508.085&format=PDF&language=EN&secondRef=01

Report 7.24.2013http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-%2f%2fEP%2f%2fTEXT%2bREPORT%2bA7-2013-0276%2b0%2bDOC%2bXML%2bV0%2f%2fEN&language=EN

Statement of Linda McAvan, Rapporteur on the Tobacco Products Directive, on February 27, 2014: http://ec.europa.eu/health/newsletter/124/newsletter_en.htm

5. EP Committees

As European Parliament was proposing amendments to the European Tobacco Products Directive proposal, the European Commission working group consisting of experts from EU Member States met on April 8, 2013. Ireland - that currently holds the European Union presidency - was reported to have asked for an official position on the text of the Directive right now. But Poland and apparently Spain are concerned by the proposal and everybody is waiting for the position of Germany, Italy and France. In Spain, the province of Estrémadure opposes the EU TPD along with the Socialist Party . France announced that it will give its position on the Directive on April 25, 2013.

As the European Parliament Environment, Health and Food Security Committee was debating the revised Tobacco Products Directive proposal, the draft opinion of the EP Industry, Research and Energy Committee (ITRE) appears more balanced, le Monde du Tabac reported on April 15, 2013. Regarding plain packaging, the Committee considers that the Commission doesn’t succeed in explaining how the standardisation of tobacco product packs could be efficient to decrease the consumption of tobacco products, especially among the youngest.MEP Linda McAvan, the European Parliament's rapporteur on the revised TPD proposal, told Reuters in a telephone interview that she recommended that the EU follow Australia's example by banning all distinctive branding from tobacco packaging, while backing most of the European Commission's other proposals, including bans on tobacco flavorings such as menthol and clove, slim cigarettes and novelty cigarette packs, Reuters reported on April 19, 2013.http://www.tma.org/tmalive/ArticleAbstract_CDA?type=A&pcode=NWSBNT&absfullpp=abs&purchased=y&articleid=NWSBNT0422135001&price=0&targeturl=ArticleAbstract_CDA

The European Parliament Committee on Legal Affairs published on April 29, 2013 a draft opinion on amendments to be incorporated to the draft EU TPD, for the Committee on the Environment, Public Health and Food Safety. http://www.tma.org/tmalive/BillAbstract_CDA?type=B&pcode=PPOBIL&absfullpp=abs&purchased=y&articleid=PPOBIL0510135001&price=0&targeturl=BillAbstract_CDARegarding the packaging of tobacco products, the rapporteur – Klaus-Heiner Lehne – considered that the proposed increase in size of the health warnings to 75 % of both sides of the pack would severely reduce the space available for trademarks and product description. In practice, not even 25 % of the front and back surface would be available for the information provided by the producer, as national law requires additional features such as tax stamps and security features. “Reducing the space available on the front and back surfaces to less than 25% would, however, make it difficult to sufficiently distinguish the products of one producer from those of others, thereby depriving the trade marks of one of their main functions. The panel recommends that health warnings cover 50% of the front and back surface.Regarding menthol and slim cigarettes, Klaus-Heiner Lehne considered that it is up to the Member States

and not the European Union to take measures in that regard. The committee does not support the proposed ban on slim and menthol cigarettes.Also, by prohibiting any labelling that suggests that a particular tobacco product is less harmful than others, the proposal causes an additional problem. Manufacturers must be able to communicate that a certain product is less harmful than others if this is scientifically proven and if it is not misleading. In addition, “Article 18 of the proposal prohibits nicotine-containing products (NCP) such as e-cigarettes containing a certain nicotine level if they are not authorised pursuant to Directive 2001/83/EC (the Medicinal Products Directive). It is, however, quite unclear if these products (which are much less harmful than tobacco products) even fall under the scope of the Medicinal Products Directive. For products which do not fall under the Directive, this would effectively constitute a ban. Banning products which are less harmful than tobacco products and which can be a means of smoking cessation is certainly not in line with the public health aims of the proposal”.http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-%2f%2fEP%2f%2fNONSGML%2bCOMPARL%2bPE-510.591%2b01%2bDOC%2bPDF%2bV0%2f%2fEN)

Linda McAvan told theparliament.com on May 17, 2013, that MEPs have "taken a lot of evidence about E-Cigarettes and the evidence I've seen tells me that for people that smoke e-cigarettes can help in terms of harm reduction," and therefore "[w]e need to make sure they're available widely on the market so that they can compete with cigarettes," which, she noted, is why a "medicines regulation wouldn't work in many countries, because in many countries you can only buy medicines at a pharmacy." Explaining the proposal for a pre-authorization process for all new tobacco products on the EU market, McAvan said it would be similar to the US system for new tobacco products, which is managed by the Food and Drug Administration (FDA).

The revised EU Tobacco Products Directive now proposes to permit e-cigs containing over 2 mg of nicotine on the market if authorized as a medicinal product, rather than banning them altogether, while e-cigs with a nicotine level below that threshold would be required to carry a health warning stating that the product contains nicotine and could be harmful. The measure would be effective 2016, Europolitics reported on June 17, 2013.E-cigs are currently treated differently by different EU State: Ireland, Lithuania and Spain are yet to regulate them, while Belgium, France, Luxembourg, Austria, Slovenia, the Czech Republic and Cyprus liken the device to medical products on the argument that they help smokers quit.

The European Parliament's Environment, Health and Food Safety Committee (ENVI) in early June 2013 discussed the nearly 1,500 amendments proposed to the European Commission's plans to revise the Tobacco Products Directive, but MEPs are struggling to achieve a consensus, with the most serious disagreements having arisen over proposals to ban flavored cigarettes and require graphic health warnings to cover 75% of cigarette packaging.British MEP Linda McAvan, who is guiding the legislation through Parliament, has suggested that the EU go further than the Commission proposal by requiring plain packaging and banning cross-border sales of cigarettes. A committee vote on the proposal was scheduled for July 10, 2013, with a plenary vote set for September. Ireland is pushing for a general agreement between member States before it hands over the rotating presidency of the EU Council of Ministers to Lithuania in July.

The Irish Presidency of the EU Council is hoping to have a "general approach" to the EU Tobacco Products Directive's (TPD) revisions adopted before its term ends on June 30th, while the European Parliament's Committee on Public Health is scheduled to hold a vote on July 10th, despite differences of views on the measure, with some giving priority to public health and others concerned about the social and economic impacts on the retail tobacco products business, Europolitics reported on June 17, 2013.

Both Ireland, which holds the Council presidency until June 30th, and Lithuania, which takes over the presidency in July 2013, are "very strict on tobacco," but Greece and Italy, which will successively take over the Council presidency, account for 75% of the EU's leaf production and have a "very different approach" to the tobacco directive, Europolitics said. A survey by Corporate Europe Observatory found that the tobacco industry, which is "not enthusiastic" about the proposals, has about 97 lobbyists working full time to protect its interests.

MEPs on the European Parliament's International Trade Committee on June 18, 2013 voted 15-12 in favor of less stringent rules on tobacco product packaging and health warnings and for menthol to remain a permitted ingredient in cigarettes.  MEP Paul Murphy, who submitted amendments that aimed to have stricter rules, said the "tobacco industry invested millions of euros to lobby for less stringent rules on health warnings and more neutral packaging obligations for tobacco products." The committee's opinion will now go the European Parliament's Environment, Public Health and Food Safety Committee before it goes to the full plenary of the Parliament.

In a non-binding opinion adopted in a 36-4 Vote, the European Parliament's Committee on Agriculture (AGRI) on June 19, 2013 rejected the European Commission's plan to prohibit menthol and slim cigarettes in the EU,

but supported a proposed ban on the cross-border and internet sales of tobacco products, with MEPs contending that the new rules should not hurt the tobacco growing sector as there is no direct link between leaf cultivation and the number of smokers. The AGRI committee argued that pictorial health warnings should cover 50% of the front and back of cigarette packs rather than 75% as proposed by the EC. The committee rejected the commission's proposal to ban snus and maintained that the product should be regulated at the national level. The Committees on Legal Affairs (JURI) and on Industry, Research and Energy (ITRE) also rejected the commission's plan to ban menthol and slim cigarettes. ITRE opposed the proposed plain packaging of cigarettes. AGRI's opinion will be submitted to the Committee on the Environment, Public Health and Food Safety, which will vote on the proposed revisions to the EU Tobacco Products Directive on July 10th.

All five European Parliamentary Committees that gave their non-binding opinions on the revision of the Tobacco Products Directive to the Environment, Public Health and Food Safety (ENVI) Committee rejected the Commission's proposal for graphic and textual health warnings to cover 75% of tobacco packaging, with the Internal Market and Consumer Protection (IMCO) Committee proposing to reduce the size of the labels to 70% of the pack surface, while the Committees on International Trade (INTA), Agriculture and Rural Development (AGRI), Legal Affairs (JURI), and Industry, Research and Energy (ITRE) all opted for 50%, Europolitics reported on June 24, 2013.

At the June 21st meeting led by Irish Health Minister James Reilly, EU health ministers agreed to ease certain restrictions on tobacco products to overcome some governments' opposition to the revised Tobacco Products Directive, leading the way for the rules to be potentially finalized before the start of European Parliament elections in May 2014 and enter force in 2016.  Specifically, ministers rejected a ban on slim cigarettes proposed by the European Commission; agreed to ban menthol and other flavorings in cigarettes; reduced the size of graphic and text health warnings on cigarette packs to 65% of the surface area from the 75% proposed by the Commission; agreed that EU member nations should be free to impose plain packaging if they choose; agreed to keep snus sales illegal except in Sweden; dropped a proposal that would have forced snus manufacturers to reformulate their products to remove distinctive flavorings; and tightened proposed controls on e-cigs by agreeing that those containing 1 mg of nicotine or more would be classified as medicinal products and require prior EU marketing approval. For devices that mix nicotine with water, the threshold would be 2 mg or more per milliliter. The ministers also said cigarettes should be sold in "normal-sized" packs to reduce their appeal. The talks pitted western European nations that support tough controls against central and eastern European countries like Poland that are concerned about the TPD's impact on jobs. Poland, Bulgaria, Romania and the Czech Republic did not support the compromise, but their opposition is insufficient to block the law's adoption. Reilly rejected economic arguments against tougher restrictions, saying "[i]t can never be - never - a choice between jobs and lives." EU Health Commissioner Tonio Borg said after the talks that while ministers needed a compromise to reach an agreement, the spirit of the Commission's original proposals was retained.

EU Health Commissioner Tonio Borg said the possibility is "very high" that the revised Tobacco Products Directive will be approved before the next MEP elections take place in May 2014, Malta Today reported on July 7, 2013. The Council of Health Ministers last month agreed to a general approach on a revised TPD. The risk of the TPD not being approved in the current legislature will increase the closer it gets to May 2014. Borg has vowed to push the TPD to be approved in the current legislature.

The European Parliament's Environment, Public Health, and Food Safety Committee (ENVI) on July 10, 2013 voted to back the European Commission's revised Tobacco Products Directive proposals to ban distinctive flavorings including menthol, prohibit slim cigarettes, and require graphic health warnings to cover 75% of the front and back of cigarette packs; voted to classify all e-cigs as pharmaceuticals regardless of the nicotine content, rather than the Commission's proposal for such a classification only for e-cigs with "4 milligrams or more of nicotine"; and rejected plain packaging of tobacco products, European Voice reported on July 10, 2013.  http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-%2f%2fEP%2f%2fTEXT%2bIM-PRESS%2b20130708IPR16824%2b0%2bDOC%2bXML%2bV0%2f%2fEN&language=EN

The ENVI Committee voted to classify e-cigs as pharmaceuticals despite a demonstration by e-cig advocates outside the Parliament. EU member states in June voted to require the medicinal product classification on e-cigs with nicotine content over 1 milligram. The medicinal product will need a prescription. However, e-cigs would have to undergo an approval process before they can go on the market. E-cig company Totally Wicked warned that the classification will result in small companies going out of business and create a "default prohibition and requirement for approval," leaving conventional cigarettes as the only easily marketed source of nicotine. Sweden seemed to believe it had support from MEP Linda McAvan to get an ingredients exemption which would continue to allow baking soda (fondly known as E500) to be used in Swedish snus. This exemption was voted down, reported SnusCentral.org on July 10, 2013. The fight is not over but the future of Swedish snus and e-cigarettes are now very much in doubt, they added.

Karl Heinz Florenz, a German centre-right member of the European Parliament's Environment, Public Health, and Food Safety Committee, said the committee backed the European Commission's proposal for larger health warnings on cigarette packs but stopped short of a plain packaging mandate, Reuters reported on July 10, 2013. The committee supported the Commission's proposal that EU countries that want to mandate plain packaging should be free to do so. Ireland has voiced support for plain packaging. While the committee voted for graphic health warnings to cover 75% of the front and back of packs, the size could still be reduced before it is finalized by EU countries and the full parliament, as a majority or EU member states last month agreed to a size of 65%. Florenz predicted that the parliament and governments will eventually reach a compromise size of 60%.

The full European Parliament was expected to vote on the revised Tobacco Products Directive in plenary session in Strasbourg between September 9-12, 2013, to be followed by negotiations with the EU Council on a compromise version, with the new rules finalized in the first half of 2014 before the EU elections to be held between May 22-25, 2014. If the directive approved, it could become law in 2016.

Center-right German Members of the European Parliament asked for a delay in the European Parliament vote on the revised EU Tobacco Products Directive, currently scheduled for September 10th, citing insufficient time to review the proposal following MEPs' return from their summer break next week and the expected absence of many German MEPs because of the upcoming German election on September 22nd, European Voice reported on August 30, 2013.

In an interview with Europolitics on September 5, 2013, British MEP Linda McAvan said a push by certain MEPs from the European People's Party and European Conservatives and Reformists to delay the Parliament vote on the revised TPD, currently scheduled for September 10th, is nothing more than a tobacco industry-backed attempt to weaken the directive because "the later the vote takes place, the less time the co-legislators will have to negotiate," but added that "I don't see why we should put off the vote" and that she expects an outcome similar to that in the Environment, Public Health, and Food Safety Committee (ENVI).

Group leaders in the European Parliament on September 5, 2013 decided to defer their vote on the revised EU Tobacco Products Directive from September 10th to October 8th after centre-right German and British MEPs pushed for the delay, citing insufficient time provided to digest the position of the Environment, Public Health and Food Safety Committee, adopted in July, and concerns about how the vote could affect - or be affected by - Germany's Federal election on September 22nd.  Some German MEPs were going to be absent from the upcoming plenary because of campaigning duties. The German and British MEP's push for the delay had support from the ALDE group of Liberals. Opposing the delay were Linda McAvan, a centre-left British MEP who is leading the Parliament's work on the issue, and German MEP Karl-Heinz Florenz, shadow rapporteur for the EPP.

Europolitics reported on September 6, 2013 that the European Parliament's decision to postpone its vote on the revised EU Tobacco Products Directive from September 10th to October 8th is sparking rumors that policymakers have given in to pressure from the tobacco industry.  "The industry's strategy is clear: the later the vote, the less time the co-legislators will have to negotiate," TPD rapporteur Linda McAvan said. "The industry hopes in this way to demolish the directive," the British MEP added. Brussels-based Smoke Free Partnership described the postponement as "outrageous." Ever since John Dalli ceased to be EU health commissioner in October 2012,"we have repeatedly expressed concern over the delaying tactics of the tobacco industry and what a delay of the directive would mean for public health in Europe," the group said. However, sources in the European Parliament denied having acted under pressure. The European People's Party group said the delay is aimed only at giving more time to study the draft TPD more thoroughly. Group leaders in Parliament decided to defer the vote over concerns that the TPD report was made available online only "four or five days before the vote." Several MEPs also expressed concerns that McAvan included only the position of the Environment, Public Health, and Food Safety Committee and did not take into account the opinions of the other committees that were consulted on the issue. German MEPs were also reportedly concerned about having a vote ahead of Germany's Federal election on September 22nd.

Speaking to reporters in Brussels on October 3, 2013, German Green MEP Rebecca Harms said Philip Morris International spent € 1.5 million (US$ 2.0 mn) in the past year to host lunches and dinners for around a third of MEPs in an alleged effort to persuade them to weaken the draft Tobacco Products Directive, which is scheduled to come up for a vote in the European Parliament on October 8th, adding that amendments tabled by mostly centre-right, conservative, and some liberal MEPs align with PMI's "wish-list" of legislative changes, including eliminating the proposed ban on menthol, having health warnings only at the bottom of the pack and reducing the size of the labels, relaxing restrictions on "next-generation" products like e-cigs, and removing several of the so-called delegated acts that make it easier for the European Commission to update the directive after it becomes law.

After the European Parliament on October 8, 2013 passed the revised Tobacco Products Directive, British

MEP Linda McAvan, the TPD rapporteur, said the parliament's position is "close" to that of EU governments, although there are some differences that have to be ironed out, adding that she is "hopeful that we will get a tobacco products directive for Christmas if we're lucky."  E-cig regulation is "probably the biggest difference left on the table," McAvan said. While MEPs voted to regulate e-cigs, but not subject them to the same rules as medicinal products unless they are presented as having "curative or preventive properties," most member States would like more stringent regulations, she noted. MEPs also voted to increase the size of cigarette health warnings to at least 65% of the front and back of packs, up from the current requirement of at least 30% of the front and 40% of the back; ban packs containing fewer than 20 cigarettes; and ban flavors including menthol. They rejected a ban on slim cigarettes.

Commenting on the European Parliament's October 8th passage of the revised EU Tobacco Products Directive, Monika Kosinska, secretary general of the European Public Health Alliance (EPHA) said the "strong mandate given to take the next step of negotiations forward is a good signal that despite the intense lobbying, the weakening of the provisions and the failure to ensure a high level of health protection, the overall strategy of the tobacco industry to delay this directive has so far failed."  Kosinska said that while the vote to require health warnings on 65% of the cigarette pack, instead of 75% as originally proposed, reject the proposed ban on slim cigarettes, and provide a eight-year deadline to phase out menthol (three years for other flavors) was disappointing, the MEPs' support for requiring warnings at the top and not bottom of the pack, adopting traceability features and continuing the ban on snus are all welcome. "Most importantly, member states were approved to be able to move further than the provisions of the directive, meaning that those that want to introduce mandatory plain packaging will be able to do so," she added. Kosinska said EPHA hopes that some of its concerns are "adequately resolved" in negotiations with the EU council.

≥ It was reported on November 25, 2013 that the EU Commission circulated a "confidential" new e-cig proposal to representatives of the European Parliament and European Council, which is not a final proposal but contains for discussion "troubling features" that would among other things: allow only single-use cartridges; allow only flavors already approved for use in nicotine replacement therapy products; limit nicotine density to a maximum of 20 mg/ml; allow only devices that "deliver nicotine doses consistently and uniformly"; ban ads in printed publications (except trade publications), on the radio/TV, and online; ban e-cig sponsorships that have a cross border impact; apply warning and labeling requirements that are "disproportionate to risk"; ban cross border sales; require manufacturers to track "adverse effects"; require submission of "irrelevant technical and commercial data"; and assert that e-cigs "simulate smoking behavior and are increasingly used and marketed to young people and non-smokers." http://www.tma.org/tmalive/FrmMain?type=A&pcode=NWSPCI&articleid=NWSPCI1126135001&absfullpp=abs&targeturl=ArticleAbstract_CDA&target=ArticlePaymentConfirm_CDA&EmailType=MYTMAREP The MEPs' negotiators discussed the text on November 27, 2013, but sent questions to the Commission with concerns about some of the proposed restrictions. Linda McAvan, the British centre-left MEP who is leading the negotiations for the Parliament, said the Parliament is "standing by its position" to regulate e-cig as tobacco products. Negotiators from the European Parliament and the Council of Ministers met in Brussels in the first week of December to finalize the text of the revised Tobacco Products Directive. Regulation of e-cigs is the "biggest remaining obstacle" to an agreement between MEPs and the member States since MEPs rejected the Commission's original proposal to regulate e-cigs as medicinal products.

The third session of talks between the European Parliament, European Commission and EU Council on the review of the Tobacco Products Directive took place on December 3, 2013 and mainly addressed the issue of e-cigs, which remains controversial, with the EC and EU Council both in favor of subjecting e-cigs to the same rules that apply to medicines, while the Parliament has voted to regulate e-cigs like tobacco products, prompting the EC to draft a compromise proposal for discussion, which the "e-cig lobby" claims includes provisions that would lead to an "unjustified moratorium" on the devices.At the three-way talks held December 3, 2013 on the review of the EU Tobacco Products Directive, representatives of the European Parliament, EU Council and European Commission remained divided on the issue of regulating e-cigs - which remains controversial, with the EC and EU Council both in favor of subjecting e-cigs to the same rules that apply to medicines, while the Parliament has voted to regulate e-cigs like tobacco products - including the question of what should be the maximum permissible level of nicotine concentration, with MEPs having already voted for a limit of 30 mg/ml, while the EC suggested lowering that limit to 20 mg/ml in its latest compromise proposal circulated for discussion at the December 3rd meeting, when the Lithuanian Presidency of the EU Council went further and proposed a threshold of 5 mg/ml, reportedly at Germany's request. . It was reported that some Member States are calling for a solution to face

the current blockage: i.e. remove of the text article 18 (relating to e-cigarettes) for the final vote, in order to save the rest of the directive, at least measures on which there is consensus such as graphic health warnings on 65% of the surface area of cigarettes packs. The issue of e-cigs was discussed again at a technical meeting of the EU Council on December 6th. A Brussels source close to the mediation said he “personally” was optimistic negotiators from the European Parliament and Council would reach a compromise by the end of this year, Tobacco Journal International reported on December 8, 2013. Mediation shifted from the trilogue (representatives from the 766-seat Parliament, the Council representing EU countries and the European Commission administrative body) to another EU organ, the Permanent Representatives Committee (Coreper), which is a body headed by the country holding the revolving presidency that can meet to address technical matters. Coreper met last week to discuss technical issues, according to the source. Among those issues were technical aspects of e-cigarette cartridges, he said. “One or two steps have been made”, he said. Trilogue meetings took place on December 11 and 16 December. The controversial issue of regulating e-cigs (Article 18) continued to dominate discussions at the December 11th three-way talks, Europolitics reported on December 12, 2013.

Europolitics reported on December 13, 2013 that at the three-way talks between the European Parliament, Council and Commission on December 11th, the three sides tentatively agreed to add flexibility to provisions on e-cigs by giving member states and manufacturers the option of choosing their own rules from the three scenarios of 1) the manufacturer presenting the product as a medicinal product covered by Directive 2001/83/EC (European Directive on medicinal products) and requiring market authorization; 2) the member state considering e-cigs to be medicinal products and subjecting them to Directive 2001/83/EC; or 3) the member state considering e-cigs *not* to be a medicinal product and subjecting them to the directive under discussion.  The solution is intended to allow the 14 member states that regulate e-cigs as a medicinal product to retain their current system. E-cig regulations are current uneven in the EU, with no regulations in Ireland, Lithuania, Spain and the UK, or classified as a medicinal product based on certain factors in Belgium, France, Luxembourg, Austria, Slovenia, the Czech Republic and Cyprus. E-liquid refills would not be allowed to exceed 10 milliliters, and the container would have to be child-proof. The tentative compromise also authorizes slim cigarettes and reduces the size of image and text health warnings from 75% to 65% of the front and back of packs. The compromise maintains the Commission's proposal to phase out characteristic flavorings, but introduces a transitional period of three years for all flavorings except menthol, which will be allowed until January 1, 2020. None of the negotiated content is definitive, and a final three-way meeting will take place on December 16th.

Trilogue negotiations resumed on December 16, 2013 but no compromise was reached. Other meetings were scheduled up to December 18, 2013.EU diplomats said that disagreement over how to regulate e-cigs is holding up the deal on the revised Tobacco Products Directive, as negotiators are in agreement on most elements of the legislation like graphic health warnings (65% of the surface area of the pack), flavoring bans (ban on menthol in 2020) and pack sizes, but debate continues on e-cigs, particularly on whether to allow refillable products, with the European Parliament pushing for a light touch approach while EU governments seek more restrictive rules, in a dispute that could delay by up to two years the adoption of the wider package of measures unless a compromise can be reached in two final rounds of talks this week.The compromise on article 18 (electronic cigarettes) would lower the nicotine level (clarifying the assimilation to a pharmaceutical product or not) and provide for a “temporary” authorization only for e-cigarette cartridges, AFP reported on December 17, 2013.On December 18, 2013, the European Council approved a final compromise on tobacco products directive.

Commenting on the agreement reached between the European Commission, Parliament and Council on the revised Tobacco Products Directive, European Conservatives and Reformists Group leader and shadow rapporteur on the directive Martin Callanan on December 19, 2013 said the "perverse" deal "risks sending more people back to real, more harmful, cigarettes."  Callanan said refillable e-cigs would most likely be banned and "only the weakest products will be generally available." As many smokers start using e-cigs with higher nicotine strengths and gradually reduce their dosage, restricting the availably of stronger e-cigs will encourage smokers to continue

smoking, he added. Liberal Democrat MEP and health spokeswoman in the European Parliament Rebecca Taylor said: "Significant ground had been won in the rejection of Europe wide medicines licensing," but "the decision to potentially ban refillable cartridges and devices in future would be a backward step." The Parliament is believed to be comfortable with the use of refillable nicotine cartridges, but member States such as the UK and Germany have raised concerns that one 10 milliliter refill cartridge could contain more nicotine than a carton of 200 cigarettes, if an e-cig liquid has a nicotine concentration level of 20 mg/ml. Euromonitor currently estimates the value of the e-cig market at £ 2 billion (US$ 3.3 bn), but investments in the category by major tobacco companies, including British firms BAT and Imperial Tobacco Group, indicates the category's huge growth potential.

Commenting on the European Parliament's passage of the revised Tobacco Products Directive, Linda McAvan, the British Labour Party member of the European Parliament and rapporteur who guided the legislation through the chamber, said the original version of the TPD was stricter than what passed on February 26th and would have regulated e-cigs as medicines, but the passage is a victory nonetheless, as "the new law is [still] a huge step forward in tobacco control," adding that she is "totally confident that we'll be taken to court by the tobacco companies" over some issues," while British Conservative Party MEP Martin Callanan said the TPD's e-cig regulations are a "massive loss for public health in Europe" and he believes "a lot of [the details on e-cigs] will end up in the courts."

6. Comments on the EU TPD proposal

6-1. Analysts

Goldman Sachs analysts Judy Hong and Fulvio Cazzol said the MEPs’ vote on the EU Tobacco Products Directive was broadly in line with expectations, though some facets were slightly less stringent than the original proposal, specifically: continuing to allow slim cigarettes is broadly viewed as positive for the industry, as slims constitute a greater proportion of the market than menthol in the EU; rejection of the European Commission’s proposal to classify e-cigs as medicines is a “win for the burgeoning e-cigarette market” though individual member nations could apply their own e-cig regulatory policies; and the health warning size of 65% is less than the originally proposed 75%.

Nomura analysts on December 19, 2012, said the various proposals in the revised EU Tobacco Products Directive aim to make tobacco products less attractive and reduce cigarette prevalence in the EU by 2% in the next five years.  The analysts noted that there would not be much change to the current situation on snus, as all snus in Sweden already carry health warnings on one side, adding that based on what has been observed about health warnings in the past, the potential impact of the new warning requirement is unlikely to be significant. The biggest impact on snus is likely the ban on characterizing flavors, since snus with such flavors make up about 30% of total market volumes in Sweden, the analysts added. Nomura analysts, like Michael Siegel, said the provision that nicotine-containing products above a certain threshold are allowed only with authorization as medicinal products could be a de-facto ban on e-cigarettes, as most e-cigs contain more than the expected threshold of nicotine. Since authorization as medicinal products would require long series of clinical trials that cost tens of millions of dollars, this provision could therefore hold back development of the e-cig category in the EU, the analysts said. Non-US e-cig players could therefore try to launch their products in the US, which is classifying e-cigs as a tobacco product, the analysts added. On the expansion of health warnings on cigarettes to 75% from the current requirement of 30-35% on one side and 40-50% on the other side, Nomura analysts said the impact from this provision is not expected to be significant, given what they have seen from health warnings in the past. Cigarette packs would be required to have a cuboid shape and contain at least 20 cigarettes, and RYO would have to be sold in pouches of no less than 40 grams, which Nomura said are intended to make the health warnings easier to see. Slim cigarettes, which make up about 2% of total EU volumes, would be banned because of the European Commission's belief that they are more attractive and give the impression that they are less harmful, Nomura said. On the ban on "characterizing flavors," Nomura analyst said this refers to "flavours that help tobacco not taste like tobacco," and it does not appear to include American Blend cigarettes, which make up about 80% of volumes in continental Europe. Menthol makes up about 4% of current EU cigarette volumes, though some markets have higher rates, including Poland at 20%. On the track-and-trace system, Nomura analysts said it is hoped that the requirement would help tackle illegal trade, which had a market penetration of 10.4% in 2011 compared with 8.9% in 2009.

Commenting on media reports about flavorings and additives in the EU Tobacco Products Directive revisions, Nomura analysts said on December 18, 2012 that the proposed new restrictions on flavorings and certain additives like vitamins, caffeine and other substances associated with energy and vitality "perhaps create the biggest uncertainty and anxiety," as the lack of clarity on what will be included makes the potential impact

unclear.  Some cigarette brands are likely to be more impacted by the ingredients restrictions than others, but all manufacturers would be required to change blend formulations in the medium term, the analysts said. American blend cigarettes like Marlboro, Gauloises and Pall Mall, which hold over 80% of volume in continental Europe, could be most impacted, as they require more additives for flavor control, the analysts added. Virginia blend cigarettes, which do not have the same need for additives, dominate the UK with a 90% share, which would help UK market leader Imperial Tobacco, they said. The release of the proposed revisions is sooner than expected, as both BAT and Imperial Tobacco had outlined late 1Q13 as the expected timing, given the resignation of John Dalli as EU health commissioner, the analysts said.

Commenting on the European Commission's proposed revisions to the Tobacco Products Directive, on December 19, 2012, Stifel Nicolaus analysts said implementation of the revised directive would not take place until 2015 or 2016, with approval likely in 2014, but anticipated legal challenges from the industry to the proposed ban on flavorings, particularly menthol, and to the requirement to increase the size of warning labels to 75% of the pack surface could delay implementation beyond the 2015/16 timeframe, adding that they believe that the proposals outlined in the revised directive are likely to have only a marginal effect on volume for the industry in the EU and that they are retaining their "Buy" rating and US$ 95 target price on Philip Morris International, which derives about 20% of its volume from the EU.

The Tobacco Products Directive (TPD) could adversely affect Europe’s economy, resulting in up to 175,000 job losses and lost tax revenue of up to EUR 5 billion throughout Europe, according to a new study published by Roland Berger Strategy Consultants on April 29, 2013.The study, commissioned by Philip Morris International Inc. and undertaken by Roland Berger, measures the potential economic impact of several of the proposals under consideration by the EU including standardizing the packaging and labeling of cigarettes and a ban on menthol and slim cigarettes. It concludes that these measures have the potential to reduce prices across the whole tobacco market and to fuel the illicit trade in tobacco products, resulting in significant job losses and reduction in tax revenues.http://www.rolandberger.com/media/press_releases/513-press_archive2013_sc_content/Studie_zu_Auswirkungen_der_Tabakprodukt-Richtlinie.html

Fitch Ratings on October 11, 2013 said the European Parliament's rejection of a proposal to regulate e-cigs as medicine could spur "major tobacco companies" to accelerate the roll-out or increase investment in their own products, as "we believe [the category's] growth prospects could be substantial" though much depends on pricing, availability and the consumer experience compared with conventional cigarettes.  E-cigs account for under 2% of smoking in the EU. Fitch said that while the Tobacco Control Directive will introduce some curbs, such as ad restrictions, MEPs' rejection of the most stringent proposal to treat the device as medicine means there would be no impact on the product's availability. Further regulation or demand for scientific studies could also make it easier for major players to enter the category, as they already have experience dealing with a highly regulated environment, and tougher regulation would result in higher e-cig prices, thereby limiting their attraction for smokers and slowing the decline in cigarette sales, Fitch added. The EU or individual governments could also choose to tax e-cigs, especially if there is a more rapid decline in smoking rates as a result, Fitch said.

Prof. Michael Siegel of Boston University's School of Public Health on October 9, 2313 said the European Parliament's rejection of a measure that would have subjected e-cigs to the same rules as medicinal products suggests that the "tide is starting to turn,” and credited the "vaping community" for drowning out the "ideological hysteria of anti-smoking groups” by changing attitudes towards e-cigs.  Siegel also noted that Armando Peruga, a tobacco control expert at the World Health Organization, also said regulating e-cigs would not necessarily be a bad thing and that the agency is evaluating their safety and effectiveness. Siegel said the vaping community built a movement to have its voice heard through forums, advocacy actions and the public presence of vapers. He asks whether the FDA has also heard the voices of the vaping community, as deeming regulations on e-cigs are expected shortly.

Stifel analysts on February 26, 2014 said the European Parliament's approval of the revised Tobacco Products Directive sets into motion a more regulatory-heavy policy in the EU over the next couple of years, but the TPD is not expected to have a meaningful effect on Philip Morris International's business or the tobacco category in the EU in general, adding that the TPD is "likely still less burdensome than the FDA-controlled US tobacco market," and the absence of a ban on slim cigarettes, which holds about 6% market share in the EU, is a positive for the industry.  While slim cigarettes represent about 6% of the EU market, they hold a large share in some countries like Poland, Stifel noted.

Commenting on the European Parliament's February 26th passage of the compromise Tobacco Products Directive, which would, once it enters into force, allow e-cigs with a nicotine content below 20 mg/ml for general sale at the European Union level, enable the EU to ban refillables if just three member States do so, while permitting member States to regulate the devices as medicines if they choose, and cap cartridge size at 2 ml, an editorial in the New York Times on February 3, 2014, said the rules should serve as a model for the US Food and Drug Administration, which is expected to issue its proposed "deeming regulation" for e-cigs.  The editorial noted that although some users believe the device has helped them quit smoking, health

experts have expressed concerns that these products might be a gateway for future tobacco use, especially among teens. Research conducted by the FDA has found that some e-cigs contain certain harmful chemicals that are used in antifreeze, according to the article. The editorial said a recent study by the Centers for Disease Control and Prevention showed increasing e-cig use among US teens, while there is growing evidence that the e-cig industry is targeting children by introducing a range of child-friendly flavors. The editorial concluded that while e-cigs could be useful to some people who are looking for an alternative to conventional cigarettes, "regulators still have a duty to make sure that these devices are not causing harm, especially to children".

6-2. Tobacco Industry

Drago Azinovic, EU region president for Philip Morris International Inc, said the European Parliament’s October 8th vote on the EU Tobacco Products Directive “introduced marginal improvement in some areas, but has still failed to take into account the views of millions of EU citizens, including our employees, retailers, tobacco growers and adult consumers who will be impacted by these measures … [as MEPs] voted to ban an entire segment of the legal market despite the inevitable increase in illegal trade that this will fuel, [while failing] to provide a workable framework for reduced harm products and … continu[ing] to include oversized graphic health warnings … without apparent concern for property rights that the EU Charter protects.”

Charles Hamshaw-Thomas, legal & corporate affairs director of British e-cigs company E-Lites, said the MEP’s rejection of a proposed ban on e-cigs that are not licensed as medicines is “a fantastic result for public health and the millions of smokers around Europe who are switching to e-cigarettes. We would have been in the absurd position of the EU making it much harder to make and sell e-cigarettes than tobacco cigarettes which are vastly more harmful,” and “we now hope to work with the EU Commission and national governments to agree [to] appropriate regulations for e-cigarettes which reinforce existing consumer protection rules.”

Commenting on the European Commission's proposed revisions to the Tobacco Products Directive, Philip Morris International's Vice President for Communications Julie Soderlund said on December 19, 2012 that an "initial reading of the proposal suggests that many of the recommended measures will not achieve the Commission's public health goals and will result in numerous unintended adverse consequences," including an expansion in the black market, which, she noted, already costs member States €10 billion (US$ 13.3 bn) annually, adding that the proposal would stifle innovation by limiting "consumer access to, and information about, products that have the very real potential to reduce the harm caused by conventional tobacco products."  Soderlund said the proposed directive would ban cigarette products that account for about 10% of the EU cigarette market and more than 30% of the market in some member States, despite lack of evidence that these products are more harmful than others or that their ban will reduce smoking rates. "We trust that the hostility of some towards our industry will not blind them to the important economic, legal and societal issues that this proposed Directive raises. We believe that its numerous flaws need to be addressed to ensure that the EU implements a regulatory framework for tobacco products in Europe that is fair, science-based and effective in reducing the harm caused by smoking without imposing unnecessary burden on the economy," Soderlund said.http://www.pmi.com/eng/media_center/press_releases/Pages/201212190902.aspx

BAT Latvia spokeswoman Marita Jansone said on December 20, 2012 that the proposed ban on menthol cigarettes would fuel the trade in illegal cigarettes, which, she claimed, already account for more than 30% of Latvia's cigarette market.  Jansone said it is important that the EU ensures that the revisions are evidence-based, are proportionate, and do not threaten the interests of legal players, both large and small. Aili Herkel, a representative of the Estonian tobacco producers association, said the proposed ban on menthol and slim cigarettes would have a negative impact as these products have a 15% market share in the country.

Commenting on the proposal, Imperial Tobacco notes that “these proposals are by no means final and Imperial Tobacco’s immediate focus will be on reviewing the Directive proposals and engaging constructively at EU and national level to seek rational regulation based on credible and robust evidence”.http://www.imperial-trade.co.uk/proposed-regulations/

Immediately after the vote by the European Parliament's Environment, Public Health, and Food Safety Committee (ENVI) on July 10, 2013, backing the European Commission's revised Tobacco Products Directive proposals, Seita/Imperial Tobacco expressed its position through a communiqué: http://www.lemondedutabac.com/directive-tabac-reaction-de-seita-2/ (French).According to Eric Sensi, Seita Corporate Affairs Manager France, the standardisation of tobacco product packs with graphic health warnings to cover 75% of the front and back of cigarette packs, is equivalent to disguised plain packaging; the standardisation of taste and packages is an unjustified attack on consumer freedom.

Imperial Tobacco Group and JT International are calling on retailers and consumers to write to Members of the European Parliament to oppose the proposed Tobacco Products Directive, which includes provisions for

a ban on 10-piece packs of cigarettes, any pack of roll-your-own tobacco under 40 grams, slim cigarettes, and flavors like menthol, Grocer reported on August 17, 2013. Imperial said it is nonsensical for the EU to essentially "supersize" the category while it discourages larger packaging sizes in other sectors like soda and snacks. JTI said the proposal could drive community stores out of business and help the illegal grade, as banning 10-piece packs and smaller RYO packaging would mean the cheapest price will be the street price sold by criminals.

JTI warns Britain against "sleepwalking" into tough EU Rules, the Telegraph reported on August 25, 2013. Japan Tobacco International estimates that more than 50% of overall cigarette pack sales in the UK would be hit by proposals in the draft Tobacco Products Directive to ban menthol and slim cigarettes and prohibit the sale of 10-piece cigarette packs which currently account for 38% of total industry volumes in the UK, with JTI UK’s head of corporate affairs Paul Williams warning Britain against "sleepwalking" into a situation where the EU adopts legislation "even more severe" than plain packaging, which the David Cameron government abandoned last month, while BAT's EU regulatory affairs manager Ronan Batty said the proposals carry "an enormous risk," pointing out that a menthol ban alone would drive almost a million British smokers to the black market, which is estimated to already account for more than 20% of all cigarettes smoked in the country.

With the European Parliament scheduled to examine next week the revised EU Tobacco Products Directive, e-cig companies and consumers forming the Save E-cigs Campaign issued a statement warning on September 3, 2013 that classifying the device as a medicinal product would condemn "Europe's seven million e-cigarette users to a premature death" by limiting availability, raising costs, reducing innovation and making more people smoke tobacco products. They "will all be forced back to a nightmare we thought we had left behind," the campaigners said. The World Health Organization says the safety of e-cigs "has not been scientifically demonstrated [and] the potential risks they pose for the health of users remains undetermined." However, e-cig users say the product is a "public health revolution that has the potential to save millions of lives" because e-cigs are safer than conventional cigarettes.

Commenting on the European Parliament's decision to postpone its vote on the EU Tobacco Products Directive to October 8th, British e-cig company E-Lites' legal and corporate affairs director Charlie Hamshaw-Thomas on September 5, 2013 said Linda McAvan, a centre-left British MEP who is leading the EU Parliament's work on the issue, gave MEPs only three days to propose amendments to the draft TPD text, which included a requirement that all e-cigs be regulated as "medicines," potentially imposing "crushing costs" on the European e-cig industry.  Hamshaw-Thomas said Europe has about 12 million e-cig users, and regulating the product as a medicine could lead to five-fold price increases. He said it is hoped that the deferral of the vote will provide the time needed for MEPs to agree to a "sensible and workable regulatory framework," as it would be "ludicrous" for e-cigs to come under tougher regulations than tobacco products.

The UK cigarette maker Totally Wicked said on September 10, 2013 if the TPD is approved as proposed, the company will file lawsuits domestically and at the EU level to challenge "the perversity of being forced to make a medicinal claim for a confirmed non-medicinal product, while tobacco companies continue to sell their own nicotine containing products unimpeded by the medicinal regulatory regime." Totally Wicked CEO Fraser Cropper said: "Electronic cigarettes are transforming smokers’ habits by the thousands each week. That our government and its regulators are knowingly attempting to destroy this product’s utility, whilst continuing to endorse the ongoing endemic of tobacco availability, is one of the most incredible and concerning matters of our time" .

Documents obtained by UK weekly the Observer reportedly say Philip Morris International employed 161 people to fight the revised EU Tobacco Products Directive. Drago Azinovic, president of Philip Morris International EU Region on September 9, 2013, said "[c]ontrary to the impression that our critics attempt to create, PMI does support sound, effective regulation" and allocates resources to present its views like the need for a regulatory framework for reduced risk products and laws to fight the black market, as it is "illogical" for PMI to remain silent on a proposal that directly concerns the company and its 12,500 employees in the EU, adding that PMI voluntarily reported, on the EU's Transparency Register, PMI employees' meetings with EU officials to share the company's views and industry expertise on the TPD and other policy issues, and "surveyed" using the EU's recommended methodology a total of 161 employees who "potentially spent a portion of their time, in addition to their other job responsibilities, with EU officials." http://www.pmi.com/eng/media_center/pages/eu_tobacco_products_directive_tpd.aspx

On September 21, 2013, Philip Morris International exercised its right of reply to the statement by the French Newspapers “le Parisien” that the company asked European deputies for their comments on the EU TPD and published the following Communiqué: “« PMI conteste formellement les allégations diffusées ce jour dans un article du Journal Le Parisien.  Dans le cadre de ses activités, PMI place l’intégrité et le respect de la vie

privée au premier rang de ses priorités. Les dossiers dont il est fait mention reflètent simplement une perception des opinions exprimées par les élus amenés à discuter et adopter des textes de lois. Ceci est en adéquation avec les usages et conforme à ce que font d’autres entreprises, ONG ou autres groupes d’intérêt dans le cadre d’un processus législatif normal afin de porter à la connaissance des élus les problématiques et enjeux.  En effet, il nous appartient donc de participer à ce processus afin d’informer les Députés des impacts d’une proposition sur nos activités, sur les centaines de milliers d’emplois de notre industrie ainsi que sur les Gouvernements des Etats membres et les consommateurs qui en subiront les conséquences. Ainsi, nous entendons continuer à exprimer nos opinions de façon proactive et en toute transparence ».

- Deutsche Welle on December 2, 2013 reported that as the European Parliament and the European Council of Ministers seek to finalize the EU Tobacco Products Directive before it is presented to member States, the "extent of the tobacco industry's lobby … has not only caused a stir, but has also likely affected the directive's outcome" as leaked internal briefing papers reportedly indicate that Philip Morris Int'l employed 161 people to fight the TPD by profiling and targeting specific persons within the EU government and to generate negative opinions on health and consumer protection directives.

Commenting on the agreement reached between the European Commission, Parliament and Council on the revised Tobacco Products Directive (TPD) on December 18, 2013, Japan Tobacco International’s Head of EU Affairs Ben Townsend said the directive "has been negotiated hastily, pushed by political agendas, with little consideration given to the effectiveness of the numerous measures and the cost entailed for EU Member States and businesses."  Townsend said policies "that are not supported by strong evidence and that do not consider market dynamics are bound to fail - they do not deliver any public health benefits." Many of the TPD provisions are disproportionate and will threaten innovation, competition and consumer choice, he claimed. The provisions requiring large health warnings that cover 65% of the pack and setting the minimum pack size at 20 pieces for cigarettes and 30 grams for roll-your-own tobacco will not work, because people already understand the health risks of smoking, he said. These restrictions will instead confuse retailers and consumers by making it difficult for them to distinguish brands, he added. These restrictions will also "give counterfeiters a blueprint on how to fake a pack," Townsend said. The proposal to ban entire product categories such as menthol cigarettes is not based on sound evidence and will only drive consumers to illegal channels, he argued. Townsend called on EU decision-makers to carefully evaluate the measures before the TPD is placed before Parliament and Council for a final vote in 2014.

BAT reacted sharply to the agreement on the EU Directive: « The ban on menthol is disproportionate and may encourage million smokers to purchase cigarettes in parallel smuggling or counterfeiting networks, Massimiliano Di Domenico (Director of Institutional Relations BAT France) said to the French newspaper Les Echos on December 19, 2013, “there is no scientific proof of the harmful or attractive character of the menthol”. “The size of health warnings is an attack against the brand and close to an infringement of intellectual property”, added Di Domenico.

Philip Morris International Inc.’s (PMI) EU Region President Drago Azinovic made the following comment regarding the agreement for the revision of the TPD:“The EU has ignored its own standards for proportionate, evidenced-based policymaking during the five years that the Tobacco Products Directive has been under consideration.“Discussions in Council and the European Parliament might have marginally amended the original text, but the EU’s failure to do its homework will be a gift for the criminals profiting from the black market in tobacco, and a blow to the hundreds of thousands of people working in the legal industry and member state governments now faced with filling budget gaps.“Instead of further harmonizing the internal market, a stated objective of the Directive, measures in the TPD will further erode property rights that the EU Charter protects. This sends a worrying signal to other sectors of the economy that depend on legal certainty and a rigorous defense of intellectual property rights.”

Philip Morris International's EU Regional President Drago Azinovic on February 26, 2014 said that the Tobacco Products Directive adopted by the European Parliament "represents a worrying departure from the EU's basic standards of proportionate, evidenced-based policymaking, which will further erode intellectual property rights and undermine the EU Charter where these rights are protected," adding that the TPD measures will "make the EU less competitive and be a gift for the … black market."

Following the European Parliament's February 26th passage of the compromise Tobacco Products Directive, Ben Townsend, head of EU affairs at Japan Tobacco International's (JTI) Brussels office, said that the TPD "encompasses a series of complex measures that will affect the whole of our supply chain" and that some of the provisions would require important changes in product and pack design as well as machinery. Townsend said the company will focus on getting clarity about timelines to ensure smooth implementation of the TPD in the different member States. JTI will also be following the discussions on tracking and tracing, as the new requirements could affect the company's new Codentify system, he added.

British American Tobacco's legal director Neil Withington on February 28,2014 said in an interview after the company reported its 2013 results that he was not concerned by the regulation, much of which, he noted, is already implemented elsewhere in the world, but did not believe that banning menthol was appropriate. "There is no scientific evidence that banning menthol is going to bring any real public health benefit to the population," Durante added

6-3. European countries (governments, tobacco associations) Positions

From December 2012 onward

(BASCAP) Negative consequences. Commenting on the revised EU Tobacco Products Directive proposal, which was released on December 19, 2012, the International Chamber of Commerce's Business Action to Stop Counterfeiting and Piracy (BASCAP) unit on December 19, 2012, said the proposal includes "wide-ranging restrictions on the use of trademarks, including the drastic minimization of package space available to the brand and other trademark characteristics," which, if approved, would result in unintended negative consequences, undermining intellectual property rights and fueling counterfeiting throughout the EU.

Bulgaria. Support to leaf tobacco growersTsvetan Filev, chairperson of the Bulgarian National Association of Tobacco Producers on January 14, 2013, urged the European Commission to examine its revised Tobacco Products Directive (TPD) proposal, released on December 19, 2012, and introduce "a regulatory framework for the tobacco products in Europe that is fair, scientifically-grounded and efficient, as far as diminishing the harm caused by smoking is concerned, without imposing unnecessary burden on the economy and employment."Leaf tobacco. In a letter sent to the Bulgarian National Association of Tobacco Producers (NATP) on January 21, 2013, Mariela Gabriel, MEP from Citizens for European Development of Bulgaria (CEDB) and member of the European Commission's Directorate-General for Agriculture and Rural Development, thanked NATP Chairperson Tsvetan Filev for his efforts to protect the interest of Bulgarian leaf growers, and said that she will vote in support of the amendments proposed to the EU's Tobacco Product Directive proposal to boost the domestic tobacco sector.

Ireland. Requests consultation on the proposal Irish Health Minister James Reilly on January 16, 2013 said he closed Ireland's public consultation on the proposal for a new EU Tobacco Products Directive (TPD), which aimed to inform Ireland's position on the TPD including ingredients and emissions, labeling and packaging, traceability and security, tobacco products for oral use, cross-border sales, and novel tobacco products.

Ireland. Support Following an informal meeting of the EU Health Council on March 4-5, 2013 in Dublin, which discussed the revised Tobacco Products Directive (TPD) proposal, among other things, Irish Minister for Health James Reilly said the Irish Presidency of the EU Council has prioritized a plan to ban certain flavorings in tobacco products and regulate cigarette packaging even if these measures would hurt jobs in tobacco-producing countries, while adding that the EU should help these member States "get out of tobacco production" and develop alternative livelihood opportunities, Reilly said he was hoping to win agreement from other health ministers on the revised TPD during the Irish Presidency, which lasts until June. The measure would then be submitted to the European Parliament for approval, Irish Times reported on March 5, 2013.Complaint related to RYO. In a complaint filed with the European Commission, the Convenience Stores & Newsagents Association (CSNA) of Ireland on February 23, 2013 described as "illogical and disproportionate" the proposal in the draft EU Tobacco Products Directive, which would increase the minimum weight of a pouch of roll-your-own tobacco from 12.5 gm to 40 gm, saying the larger packs would result in reduced footfall for its members, with their current average rate of 55,325 daily visits from customers estimated to fall by over 60% to 20,385 visits, potentially costing small shop owners about € 12.7 million (US$ 16.7 mn) annually, or € 5,000 (US$ 6,600) per store per year, as the fewer retail visits would lead to a decline in ancillary purchases made by RYO customers, such as a newspaper, a drink, a lottery ticket or

confectionery, which CSNA noted were worth € 4.00-5.00 (US$ 5.30-6.60) in sales on average, with a profit of between 80 cents (US$ 1.05) and € 1.00 (US$ 1.30).

Poland. No support. Poland's health ministry spokesman Krzysztof Bak said January 31, 2013 in an interview with Polish Radio that the government is not supporting the revised EU Tobacco Products Directive.  The health ministry was instructed to prepare a document outlining the government's position on the TPD, and was required to take into account opinions from the ministries of agriculture, finance and economy. The Ministry of Agriculture said tobacco exports account for 36% of all revenues from agricultural and food-related products. Polish tobacco growers have already urged Prime Minister Donald Tusk to oppose the legislation.

Estonia. Concerns about labelingThe Estonian Ministry of Finance and the Ministry of Economic Affairs and Communications on February 14, 2013 raised concerns about the revised EU Tobacco Products Directive proposal, saying a provision to require combined graphic and textual health warnings on 75% of the front and back of cigarette packaging would disproportionately restrict manufacturers' right to use their trademarks, while the proposed ban on menthol and slim cigarettes would fuel the illicit market, thus depriving governments of tax revenues.  The Ministry of Education and Science and the Ministry of Internal Affairs have also expressed their opinions on the TPD. The Ministry of Social Affairs is drafting Estonia's position on the TPD proposal and is expected to present it to the government in March.Ivi Normet, deputy secretary general for health affairs of the Estonian Ministry of Social Affairs, said the ministry is supporting the revised EU Tobacco Products Directive proposals to ban the sale of menthol cigarettes and require pictorial health warnings covering at least 75% of the surface area of cigarette packs. The ministry has forwarded its position on the EU TPD to the work group of tobacco policy experts, which will decide on it by March 12, 2013.

UK. No regulation on electronic cigarettesUK Independence Party (UKIP) member Janice Atkinson on March 7, 2013 said the EU Tobacco Products Directive should not regulate electronic cigarettes because the device is a safer alternative for cigarette smokers and delivers the same amount of nicotine as a cigarette without containing tobacco, smoke, tar and other harmful chemicals. Article 18 of the EU TPD states that "[n]icotine containing products that either have nicotine level exceeding 2mg, a nicotine concentration exceeding 4mg per ml or whose intended use results in a mean maximum peak plasma concentration exceeding 4mg per ml may be placed on the market only if they have been authorized as medicinal products." UKIP's Godfrey Bloom, who is likely to vote against EUTPD, said that "[t]his new piece of legislation made in Brussels is so counterproductive and illogical one must ask oneself the question, who is really behind it?" Bloom said that e-cigarettes are in direct competition with nicotine replacement therapy products and even anti-depressants, adding that if all smokers in the UK switch to e-cigarettes, it would be a "massive potential public health prize." Some vested interests have turned to the EU after efforts to regulate the e-cigarette industry in Holland and Germany were overturned in court, Bloom added.

Finland. Classification of electronic cigarettesFinland is proposing that the revised EU Tobacco Products Directive proposal classify all electronic smoking products containing nicotine as medicine. The Finnish Ministry of Social Affairs and Health said such a classification would ensure that these products are comprehensively tested before they go on sale and would also restrict their sales to pharmacies, Helsingin Sanomat reported on March 8, 2013.

MEP Portugal. Size of health warningsIn a written question to the European Commission on March 23, 2013, Nuno Melo, a member of the European Parliament representing Portugal, raised concerns that a proposal in the draft Tobacco Products Directive to require health warnings not less than 64 mm in height and 55 mm in width on 75% of the surface area of cigarette packaging would have the effect of banning "regular-sized" cigarette packs, measuring 69 mm by 54 mm, produced in two factories in the Azores and sold in the Azores and Portugal.  Melo said the labeling stipulation would affect about 50% of the output of the Azores factories, which directly employ 133 people. The proposal "ignores the fact that the cigarette market in Portugal, and especially the Azores, would be badly affected by the possible disappearance of 'regular-sized' packs, unlike the markets in other Member States, where this size pack is hardly ever sold," Melo added. In response, the EC said that the proposal to revise the TPD was based on a thorough analysis of the scientific evidence base for the proposed measures proposed, as well as their potential economic, social and health effects. "The proposal foresees a minimum size for the dimension of health warnings to ensure the visibility and effectiveness of the health warnings," the EC said. Subsequently, another MEP from Portugal Nuno Teixeira followed up with further questions, pointing out that since the size of a "regular-sized" pack is 69 mm by 54 mm, the proposed height of the heath warnings would leave only 5 mm for trademarks on the front and the proposed width would be wider than the width of these regular packs.http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-%2f%2fEP%2f%2fTEXT%2bWQ%2bE-2013-003188%2b0%2bDOC%2bXML%2bV0%2f%2fEN&language=EN

Latvia. Size of health warnings/Flavored cigarettesThe Latvian government on April 16, 2013 endorsed the country's national position prepared by the Ministry of Health in support of the revised EU Tobacco Products Directive proposals, which among other things would ban flavored cigarettes and smokeless tobacco products, and require pictorial health warnings covering at least 75% of the surface area of cigarette packs, the health ministry's spokesperson Oskars Sneiders said.

Uk supports the EU DirectiveThe House of Lords Home Affairs, Health and Education EU Sub-Committee on April 24, 2013, welcomed plans to update EU’s Tobacco Products Directive. They wrote to Anna Soubry MP, Public Health Minister, saying that it supports the aim of the revisions, particularly its focus on the protection of young people.The Committee is asking the Government for further information in a number of areas: - clarification of its position on how compatible the proposal is with the international treaty obligations of Member States and the EU; more detail on is intentions on the prohibition of certain tobacco products and the regulation of packaging and labelling; and further information on the present scale of the illicit tobacco trade in the UK and the effectiveness of  EU and UK efforts in combating this.Non-tobacco nicotine containing products (NCPs): this includes e-cigarettes, and the Committee believes that although some regulation of NCPs is necessary, it should be based on the results of scientific research into the physiological effects of nicotine, whilst also considering the possible health benefits that NCPs can offer to smokers.The Committee is expecting a response from the Government within the standard 10 days.http://www.parliament.uk/business/committees/committees-a-z/lords-select/eu-home-affairs-sub-committee-f-/news/tobacco-enhanced-scrutiny-letter/

Greece. Consequences of a ban of flavorings on tobacco growersIn a statement backed by Spain, Poland, the Czech Republic, Hungary, Cyprus, Italy, Bulgaria, Romania and Croatia, Greek Minister of Rural Development and Food Athanasios Tsaftaris told the EU Agriculture Council on May 13, 2013 that the European Commission's proposal to ban flavorings in tobacco products as part of revisions to the Tobacco Products Directive was "disproportionate" and would threaten the livelihoods of over 500,000 EU citizens involved in harvesting and processing tobacco.

France. Euro-deputies ask for a smaller size of pictorial health warningsFive French euro-deputies on May 14, 2013 transmitted to European Parliament an amendment to the EU TPD proposal requesting that pictorial health warnings only cover 50% of the front and back sides of cigarettes packs instead of the proposed 75%.

Lithuania: will oppose any attempt to postpone enforcement of a revised Tobacco Products DirectiveDuring its presidency of the Council of the European Union in the second half of 2013, Lithuania will oppose any attempt to postpone enforcement of a revised Tobacco Products Directive, Audrius Sceponavicius of the Lithuanian Ministry of Health's Public Health Department said on May 13, 2013.

EU. EPHA’s positionIn a position paper released May 28, 2013 on the proposed revisions to the EU TPD, the European Public Health Alliance (EPHA) recommended that the new TPD require plain packaging for tobacco products, along with combined graphic and textual health warnings that cover 80% of both front and back of tobacco packaging; prohibit the use of all additives, including flavorings; maintain the existing ban on snus; ban online sale of tobacco products; and apply an appropriate regulatory regime for novel nicotine containing products, including e-cigarettes, noting that while EPHA believes that the EU medicines directive could provide an appropriate framework for regulating the quality, safety and efficacy of NCPs, "we do not exclude other approaches that could equally achieve the objectives outlined above."

EU. EU countries balanced support to the DirectiveAs the European Parliament considers proposed revisions to the EU Tobacco Products Directive, some member States, including France, Belgium, Finland, Ireland and the UK on May 29, 2013, expressed strong support for the European Commission's proposal, while other nations, mostly from eastern and southern Europe, are opposing the measure, claiming it would harm their economies and hurt thousands of families that depend on tobacco cultivation for their living, commenting on which EU Health Commissioner Tonio Borg said he is concerned that economic concerns are starting to dominate what is predominantly a health issue.

Europe. Electronic cigarettes. E-Cigarette Trade Group Argues Against Medicinal RegulationIn its position statement concerning the proposed revisions to the EU Tobacco Products Directive (TPD), the Electronic Cigarette Industry Trade Association argued against reclassifying e-cigarettes, currently regulated under the EU General Product Safety Directive (GPSD), as medicinal products, saying reclassification would hurt the small and medium-sized enterprises that comprise the e-cigarette industry by requiring expensive and time-consuming clinical trials, while also damaging public health because it would require a change in the

operation and performance of the products, thereby reducing their appeal and effectiveness for consumers. ECITA said the vast majority of EU consumers view medicinal regulation as a de facto ban on electronic cigarettes.The product has been available in the EU for more than five years, but no problems have been identified that are not covered by the GPSD, ECITA said. Various court cases around the EU, most recently in Estonia, have found that e-cigarettes cannot be legally classified as medicinal products under the EU definition of a medicinal product, ECITA said. To avoid any legal challenges to the revised TPD over the “inappropriate inclusion” of non-tobacco e-cigarettes, EU policymakers should either remove the product from the TPD and leave it under the GPSD, or raise the specified nicotine threshold over which e-cigarettes would have to be authorized as medicinal products “from 0.4 per cent, as drafted, to 5 per cent weight by volume, with some clarity on this level, so as to ensure that it is easily enforceable,” ECITA said.The position statement came after ECITA representatives were invited to attend a meeting with the European Parliament on March 19th concerning the TPD revisions, Public Service Europe reported on March 25, 2013.http://www.ecita.org.uk/ecita%20position%20statement%20march%202013.pdfIn an expert opinion provided in response to the Electronic Cigarette Industry Trade Association's (ECITA) request, Sir Francis Jacob, former Advocate-General to the European Court of Justice on July 8, 2013, said the draft EU Tobacco Products Directive proposal to regulate e-cigs with nicotine levels above a certain threshold as medicines "represents a very extreme and intrusive form of regulation" and "is liable to be annulled as being contrary to the principle of proportionality and/or the principle of non-discrimination" because the provision would have the "draconian effect of excluding them from the EU market altogether."  He also noted that national courts that have addressed this issue to date have held that e-cigs are not medical devices. Commenting specifically on the UK Medicines and Healthcare Products Regulatory Agency's proposal to subject e-cigs to medicines regulation by 2016, he said "we would expect future [court] decisions to follow the clear trend of the existing case law, which excludes them from the definition of medicinal products by function on the basis that they are effectively a substitute, not a cure, for conventional smoking".

EU. Endeavour Public Affairs concerned by e-cigs regulated as a "medicinal product" European public affairs specialist group Endeavour Public Affairs announced July 8, 2013 that over 1,000 former cigarette smokers from across the EU have added their names to an open letter addressed to MEP Matthias Groote, chairman of the European Parliament's Environment, Public Health, and Food Safety Committee (ENVI), that states their concern that the amended Tobacco Products Directive proposing to regulate e-cigs as a "medicinal product" would effectively ban the product. The ENVI Committee is scheduled to vote on the TPD amendments on July 10th.

WHO. Are electronic cigarettes safe?Are electronic cigarettes (ENDS) safe? Until such time as a given ENDS is deemed safe and effective and of acceptable quality by a competent national regulatory body, consumers should be strongly advised not to use any of these products, including electronic cigarettes, said the WHO in a statement on July 9, 2013. The safety of ENDS has not been scientifically demonstrated. The potential risks they pose for the health of users remain undetermined. Furthermore, scientific testing indicates that the products vary widely in the amount of nicotine and other chemicals they deliver and there is no way for consumers to find out what is actually delivered by the product they have purchased. http://www.who.int/tobacco/communications/statements/eletronic_cigarettes/en/index.html

EU. European Economic And Social Committee opinion on TPDIn its opinion released July 11, 2013 on the draft Tobacco Products Directive, the European Economic and Social Committee (EESC), a consultative body of the EU composed of representatives of economic and social interest groups, argued that the European Commission's proposals would have serious consequences for jobs, the economy and tax revenues, considering that the tobacco sector employs almost 1.5 million people in the EU. The EESC also said regulating packaging could lead to an increase in illegal tobacco trade, which already costs the EU € 10 billion (US$ 13.1 bn) in tax revenue every year.

EU. Dr Renate Sommer of Germany, MEP for the Ruhr, sharply critical of the vote. The vote endangers others trademarks and property rights of the manufacturer and had come into existence by manipulating the vote, she said on July 12, 2013. “What the red-red-green alliance, however, has pushed through the Environment Committee today, goes far beyond the objective and has nothing to do with the protection of consumers. The vote ignored internal market rules, violated trademark and property rights of the manufacturer, prohibits products and would this text should become law, destroys many thousands of jobs in the EU, including Germany

Europe: Critics Call ENVI Vote To Regulate E-Cigs As Medicines "Short-Sighted"Following the July 10th vote by the European Parliament's Environment, Public Health, and Food Safety Committee to regulate all e-cigs as medicines, regardless of their nicotine content, British Conservative MEP Martin Callanan said on July 14, 2013, it is "completely counter-productive and hypocritical" to over-regulate a product "designed to end tobacco use," adding that the ENVI vote "is not the end of this process and we will be working with vapers to make other MEPs see sense and support e-cigarette producers and users." 

Europe. Lithuania’s position on TPDLithuanian daily Lietuvos Rytas reported that even before Lithuania took over the rotating EU Council Presidency on July 1st, the country’s ambassador to the US Zygimantas Pavilionis received separate letters from US lawmakers and business representatives criticizing Lithuanian Health Minister Vytenis Andriukaitis’ unreserved support for the European Commission’s proposal to revise the Tobacco Products Directive and warning that passage of the revised TPD in its current form would violate international trade rules and could jeopardize a potential free trade agreement (FTA) between the EU and the US, but Lithuanian officials appear to be unaware of these developments, BBC Monitoring Service reported on July 23, 2013.

Europe. A ban on menthol and slim cigarettes will significantly hurt the Polish economyAn article published in Polityka on July 30, 2013 said that the European Commission’s proposed ban on menthol and slim cigarettes as part of revisions to the Tobacco Products Directive will significantly hurt the Polish economy considering that the country is the biggest cigarette producer in the EU and the State collects nearly 24 billion zloty (US$ 7.5 bn) in annual tax revenue from cigarettes, representing around 10% of the country's total budgetary income.  With menthol and slim cigarettes accounting for 40% of the domestic market, a ban on these products would lead to a significant decline in the government's tax revenue, the article noted.

MEP seeks Tobacco Directive Amendment in battle to save jobs at JTI factoryAfter negotiators of the revised EU Tobacco Products Directive recently agreed to increase the minimum pack size for RYO pouches to 30 grams, Ulster Unionist Party MEP Jim Nicholson said he would work to secure the 40 signatures needed to table an amendment to the proposed measure, as it would remove a production line at Japan Tobacco International's plant in Ballymena, Northern Ireland, and threaten hundreds of jobs in the plant once it is implemented.  Nicholson said the revised EU TPD is intended to discourage young people from smoking, but “these important concerns have not been sufficiently balanced with the implications for local jobs.” The proposed measure would hurt about 200-300 jobs in the factory, which currently employs around 1,000 workers, Tobacco Reporter reported on December 23, 2013.

Europe. First joint declaration by European electronic cigarette user associationsIn a joint declaration issued January 15, 2014, e-cig consumer associations in Europe, including AIDUCE of France, the Electronic Cigarette Consumers Association (ECCA) of the UK, Acvoda of the Netherlands, and Helvetic Vape of Switzerland, said that the European Commission and the EU Council are trying to force the European Parliament to accept a version of the Tobacco Products Directive that would "remove all effective electronic cigarette products from the market," forcing "thousands of people back to tobacco, causing the premature death of half of them," and called on MEPs to remove from the TPD any reference that treats e-cigs as tobacco products and to "initiate, in consultation with all interested parties including users, an objective process based on hard evidence, which within 24 months would lead to proposals for sector-specific regulation within the General Product Safety Directive."  The European Commission's evidential basis for their e-cig regulatory proposal "reveals a distortion of scientific research that is so gross that one wonders whether it is duplicitous," the declaration said. Existing scientific evidence clearly indicates that the e-cig "is the most formidable weapon ever devised to reduce harm to public health," the associations said, adding that e-cig regulation should be "based on proper and objective research and not on unproven prejudice".http://saveecigs.wordpress.com/tag/joint-declaration/

Europe: scientific errors in the EU proposed tobacco products directiveIn a January 16, 2014 letter to the European Commission, a group of tobacco and e-cig researchers said that several of the recitals and provisions of Article 18 (nicotine-containing products) of the Tobacco Products Directive, including the comparison of nicotine delivery from traditional cigarettes with that from e-cigs, the assumption on nicotine toxicity, the requirement for consistent nicotine delivery, and the assumption that e-cigs are a gateway to smoking, "lack or misrepresent the scientific understanding of the relevant issues."  The researchers noted that the TPD would allow the sale of liquid nicotine where the nicotine concentration does not exceed 20 mg/ml, with the EC citing a study by Dr. Konstantinos Farsalinos of the Onassis Cardiac Surgery Center in Greece to justify the claim that this level of concentration is similar to the dose of nicotine derived from a standard cigarette smoked for the same duration. However, Dr. Farsalinos’ research actually showed that a 20 mg/ml e-liquid refill provides less than one-third of the nicotine delivered by one conventional cigarette, the researchers pointed out. Heavy smokers, who would benefit most from switching to e-cigs, need more than 20mg/ml to switch from smoking to "vaping," they added. One justification for limiting nicotine levels to 20mg/ml is that higher levels would be "dangerously toxic," but this is not the case, the researchers said. Poisoning from e-cig liquid or overdosing through inhalation is "extremely rare," they noted. As with conventional cigarettes, excessive doses cause nausea. Thus, a user stops inhalation long before any overdosing occurs, they said. Childproof caps are enough to protect young children from

swallowing e-liquids, they added. The concept of consistent nicotine delivery is inappropriate because consumers of cigarettes, smokeless tobacco products or e-cigs determine their nicotine intake based on individual and momentary needs, the researchers said. The researchers also questioned the TPD requirement that e-cig manufacturers provide data, including "information on nicotine dosing and uptake," six months before a product or substantial modification goes to market. Such information "would be of no benefit to consumers, but would incur large unnecessary costs," they said. No such requirement is imposed on cigarette manufacturers, they added. This mandate, along with other regulatory proposals, "would create a market advantage for the much more dangerous tobacco cigarettes," they said. E-cigs have a "very good safety profile" and existing data suggest that e-cigs are not a gateway to smoking, but may actually serve as a gateway out of smoking, the researchers said. "If wisely regulated, electronic cigarettes have the potential to obsolete cigarettes and to save millions of lives worldwide," they concluded.

Europe: European Council urged to endorse revised TPD without delayAfter the European Parliament on February 26th approved the revised EU Tobacco Products Directive, Monika Kosińska, secretary general of the European Public Health Alliance, urged the European Council to endorse the revised TPD without delay, saying it will help EU member nations strengthen their tobacco control measures and ensure the product safety and quality of Nicotine Containing Products (NCPs), including e-cigs. The revised EU TPD will ban flavored cigarettes and roll your own (RYO) tobacco and prohibit features on cigarette packaging that play down the health effects of smoking. The revised TPD will make tobacco product packaging less attractive particularly for women and children, Kosi ska said, adding that it attempts to ensure that the NCPs “remain accessible to smokers while ensuring that they are unappealing and inaccessible to minors.”

Uk: report says TPD restrictions on e-cigarettes could cause more smoking-related deathsA report released by the UK-based economics consultancy London Economics and funded by Ecigwizard.com (Electronic Cigarettes Ltd) said the revised EU Tobacco Products Directive’s provision to ban e-cigs containing more than 20mg/ml of nicotine, a level which scientists say is equivalent to less than one-third of the nicotine in a standard cigarette, could lead to 105,000 additional smoking-related deaths every year, as the ban on higher-strength e-cigs would result in 210,000 fewer smokers quitting the habit per year and 9.6 million extra cigarettes being consumed every day.  Currently, 25% of e-cig users in the EU consume the device having over 20mg/ml of nicotine to stay away from regular cigarettes, the report said, adding that the ban would prompt users of stronger e-cigs to revert back to cigarettes and lead to less people quitting smoking as the weaker strengths of the device would not be sufficient for them to switch to e-cigs. Aaron Taylor, managing director of Ecigwizard.com, said that "Typically these are highly dependent smokers whose history of heavy tobacco use makes them very vulnerable to fatal outcomes if they revert back to tobacco." E-Cigarette Forum Managing Director Oliver Kershaw said that "[w]hen the Commission ignores the science, it's no surprise that the real world impact of their policies is so serious", EU Reporter reported on February 2, 2014.

UK: Directive negates need for plain packagingThe U.K. smokers’ group Forest, which campaigned against revisions to the EU’s Tobacco Products Directive on February 27, 2014, questioned the need for standardized packaging of tobacco after the European Parliament voted yesterday to adopt the revised directive. “ “If health warnings are going to be even more prominent, dominating both sides of the pack, why on earth do we need plain packaging?” said Simon Clark, director of Forest, which ran the No Thank EU campaign. “At the very least the government should wait and see what impact the larger warnings have before introducing standardized packs which are opposed by so many people.” of tobacco after the European Parliament voted yesterday to adopt the revised directive. “

Europe: eCig Europe's Advisory Board Member Disappointed At Passage Of Revised EU-TPDAfter the European Parliament on February 26th approved the revised Tobacco Products Directive, Patricia Kovacevic, advisory board member of eCig Europe and director of regulatory affairs at SKYCIG, said it is unfortunate that the EP "failed to give due consideration to the harm reduction opportunity presented by electronic cigarettes and, moreover, neglected to propose a well-reasoned, product-specific regulatory framework to adequately address consumer demand."  The revised TPD would, once it enters into force, allow e-cigs with a nicotine content below 20 mg/ml for general sale at the European Union level, enable the EU to ban refillables if just three member States do so, while permitting member States to regulate the devices as medicines if they choose, and cap cartridge size at 2 ml. Kovacevic said more procedural steps must be followed before the revisions to the TPD are deemed effective. Kovacevic said it is likely that implementation of Article 18 (nicotine-containing products) of the TPD "at the national level will continue to face opposition from multiple interested stakeholders," adding that "clear direction and transparency (is expected) from UK authorities with regard to the TPD implementation pathway" in the country

Europe: ECITA to challenge TPDThe Electronic Cigarette Industry Trade Association (ECITA) in the UK on March 8, 2014 criticized the

revised EU Tobacco Products Directive, which passed the European Parliament on February 26th and will introduce a number of restrictions on the sale and marketing of e-cigs, with ECITA's operations manager Katherine Devlin saying the directive "could not be challenged until the implementation stage in 2016, but it would prove unworkable and the industry will fight it."  Devlin allayed concerns that the e-cig market will be stymied by the TPD, saying it would be "business as usual for e-cigarettes." Brett Horth, managing director of British e-cig and e-liquid maker Vapouriz, said he believes that the revised TPD would effectively impose "an outright ban on all electronic cigarettes as they currently are." Althouhg the MEPs' vote "is a setback for vapours, it is far from over and there will be appeals and I’m confident common sense will prevail," Horth added.

UK: Voice of Russia comments on e-cig regulationVoice of Russia on March 4, 2014 reports that despite evidence showing that e-cigs help people quit smoking, the UK is expected to ban "strong re-usable" e-cigs in line with the EU's revised Tobacco Products Directive, which passed the European Parliament on February 26th and now faces a EU Council vote. Around 10 million adults in Britain smoke cigarettes, with two third of them starting before turning 18, the report said. Sweden, which negotiated an opt-out from the EU snus ban when it joined the bloc in 1995, has the lowest smoking rate among all member States and the country's lung cancer deaths in men aged over 35 is less than half the British rate, the Voice of Russia report noted. However, the sale of snus is illegal in the UK, where smokers are increasingly turning to e-cigs, with a report by Mintel showing that e-cig sales in 2013 grew by 340% over 2012, the report said. British addiction expert and clinical physiologist Prof. David Nutt describes the e-cig as "a remarkable invention" and believes that "if everyone switched from cigarettes to e-cigarettes it would be the greatest health advance since the invention of the vaccine." Noting that smoking claims about 6 million lives worldwide every year, Prof. Nutt said e-cigs "will at a stroke, stop those people dying." In January 2014, England made illegal to sell e-cigs to anyone aged below 18. Amanda Sandford of Action on Smoking and Health UK said the group's surveys found little evidence that young people who are non-smokers are starting to use e-cigs. Sandford said teens that are trying e-cigs are probably those who already smoke. "If they're going to use e-cigarettes rather than tobacco ones, that's a better thing," she added. However, ASH is concerned about the way e-cigs are marketed, which is "why we support strong regulation of these products," Sandford said.

Europe: Lancet Articles Comments On Revised EU TPDThe Lancet on March 4, 2014 reports that the revised Tobacco Products Directive, which passed the European Parliament on February 26th, will put in place more stringent rules for tobacco and related products in the EU in line with market and scientific developments in the sector and will focus on limiting the appeal of these products, particularly to young people, by banning "characterizing" flavors in cigarettes and RYO tobacco, introducing prominent graphic and textual health warnings, and regulating packaging, among other measures, but many observers wonder why the new directive took 5 years to work its way from conception to adoption, with most of them attributing the delay to alleged tobacco industry interference, which they claim has also weakened the final text, as the updated directive will require health labels on 65% of packaging, rather than 75% as originally proposed, grant menthol a temporary exemption from the flavorings ban until 2020, and classify e-cigs as consumer goods, rather than medical devices as proposed by the European Commission. Martin McKee at the London School of Hygiene & Tropical Medicine in the UK said the directive revision was "a long-drawn-out, tortured process from the start and exposed the disproportionate power still wielded by the tobacco industry and the lobby groups they fund." Roberto Bertollini, WHO representative at the EU and chief scientist of the WHO's Regional Office for Europe, said while there were about 20 people working on behalf of health advocates, the industry had more than 160 lobbyists "working aggressively to influence and delay the process." Bertollini said one major company is believed to have spent more than € 1 million (US$ 1.4 mn) over a year to lobby EU lawmakers. The Lancet report noted that the "forced" resignation of John Dalli as EU health commissioner in October 2012 is believed to have not only delayed, but also threatened to halt work on the new directive. The report said the industry's "massive lobbying" effort is "understandable, if not excusable," considering that the new directive, according to EU analysts' estimate, will cut smoking prevalence by around 2% over the next 5 years, causing the industry an estimated revenue loss of € 376 million (US$ 517.7 mn). The report said a major industry argument against a stronger directive is that it will drive the market underground, but Kristina Mauer-Stender, program manager of the Tobacco Control Program at WHO's Regional Office for Europe, dismissed this contention, saying the black market has existed for many years and has not increased in European countries that have adopted strong tobacco control policies. To curb illicit tobacco trade, the new directive called for the introduction of a high-tech track-and-trace system for use by EU member States and the EC, but Anna Gilmore at the University of Bath in the UK said she was disappointed that "tobacco lobbyists" were successful in their push to amend the directive to enable the industry to implement its own track-and-trace system. "Given industry involvement in smuggling, this amendment is incredibly naive," Gilmore said. Mauer-Stender said e-cigs are a major cause of concern as tobacco companies are entering the market and "and we are seeing an alarming unregulated expansion of these devices on the European market and beyond," which, she said, could undermine the progress many governments have made in curbing tobacco use