Tobacco Packaging and LabellingTechnical guide

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ContentsIntroduction P3

1. The basis for action: evidence review P4

1.1 The importance of the package P4

1.2 Health messages on packaging P5

1.2.1 Impact of messages on attitudes, knowledge and smoking behaviour P6

1.2.2 Factorsthatinfluencetheeffectivenessofmessages P7

1.3 Constituents and emissions information on packaging P9

1.4 Misleading labelling P11

1.5 Plain packaging of tobacco products P13

1.6 Conclusion P14

2. Pre-implementation: development of legislation and warnings P15

2.1 Development of legislation and regulations P15

2.2 Development of health warnings and constituent/emissions messages P22

2.2.1 Development of health warnings P22

2.2.2 Development of emissions and constituent messages P32

2.3 Pre-testing health warnings and constituent/emissions messages P36

2.3.1 Pre-testing: layout and design P37

2.3.2 Concept and content testing P39

3. Implementation: promoting policies and countering opposition P41

3.1 Prepare and disseminate evidence and information to key audiences P41

3.2 Develop earned media strategies to promote information and strategic messages P42

3.3 Develop and implement a mass media campaign to promote and support policies P43

3.4 Consult as necessary with stakeholders and the public P43

3.5 Anticipate and counter tobacco industry arguments (and use them to gain earned media) P44

3.6 Prepare for potential industry litigation P45

4. Post-implementation: enforcement, monitoring and evaluation P46

4.1 Monitor compliance P46

4.2 Monitor implementation success and institute a review process to improve regulations P46

4.3 Evaluate impact P46

Acknowlegements P48

References P48

Cover based on tobacco package warnings from around the world.This guide is funded by Bloomberg Philanthropies with support from World Lung Foundation.

Edited by Heather Selin

The main reference text for the Guide is David Hammond “Tobacco labelling and packaging toolkit: a guide to FCTC Article 11, 2009.”

Review board: Fouad Aslam, Rob Cunningham , Burke Fishburn, Lara Garrido Herrero, Fiona Godfrey, Mirta Molinari, Gihan El-Nahas, Francis Thompson.

ISBN: 978-2-914365-60-4

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InTroduCTIon

The Technical Guide on Tobacco Labelling and Packaging is intended to assist governments in implementing effective packaging and labelling measures that are required and recommended by the WHO Framework Convention on Tobacco Control (FCTC), and included in the World Health Organization (WHO) Report on the Global Tobacco Epidemic, 2008 – the MPOWER package.

Itistargetedprimarilyatpolicymakersresponsiblefordevelopingpolicyproposalsandatgovernmentofficialschargedwithimplementingthe development process for packaging and labelling measures.

However, it will also be of use to civil society organisations, academic institutions, and others playing a role in promoting the implementation of graphic health warnings and the elimination of misleading labelling.

TheGuidedrawsonthecontinuallyaccumulatingscientificresearchontheeffectivenessofhealthwarningsandothermeasures,aswellas the warnings, legislation, and documented experiences of dozens of countries that have pioneered these policies.

It will complement existing resources, in particular:

• GuidelinesforimplementationofWHOFCTCArticle11adoptedbytheConferenceofthePartiesatitsThirdSessionin November 2008. • Compilationsofwarnings,legislationandevidenceavailableatwww.tobaccolabels.organdwww.smoke-free.ca/warnings/ default.htm. • ExchangeofinformationandexperiencesfacilitatedthroughWHOFCTCmechanisms,andthroughotherinternational agencies and mechanisms.

The Guide has four sections that aim to mirror the normal stages of implementation of packaging and labelling policies. However, as many readers will know, policy development does not always proceed in a logical, orderly manner, and many phases proceed simultaneously.

1. The basis for action: evidence review This detailed overview of the evidence provides a reference tool to support recommended policies, including graphic health warnings, provision of constituent and emissions information, elimination of misleading labelling, and plain packaging.

2. Pre-implementation: development of legislation and warnings This section covers the pre-implementation steps needed to develop packaging and labelling policies, including:

• Developmentoflegislationandregulations. • Developmentofhealthwarningsandconstituents/emissionsinformation. • Pre-testingofthewarningsandconstituents/emissionsinformation.

3. Implementation: promoting policies and countering opposition This section covers strategies to ensure smooth implementation of policies and maximise the impact of and support for the measures. It includes discussion of common tobacco industry arguments and possible responses.

4. Post-implementation: enforcement, monitoring and evaluation This section covers how to evaluate the implementation and impact of policies, and how to maintain and improve policies.

The Guide refers to a wide variety of implementation experiences from around the globe, in order to provide relevant examples to as many countries as possible. Although most examples in the Guide come from the English language, wherever possible references and links are provided to resources in other languages. It should be noted that:

• WHOFCTCdocumentsareavailableinthesixofficialWHOlanguages. • EuropeanUnion(EU)regulationsandofficialreportsareavailableinallofficialEUlanguages. • CanadianlegislationandofficialreportsareavailableinEnglishandFrench.

The Guide also provides a virtual library of source documents, through electronic links, to supplement the information provided. Readers are urged to refer to this invaluable information to guide their own processes.

Any comments or questions about the Guide should be sent to: tobaccofreeunion@theunion.org

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1. The basIs for aCTIon: evIdenCe revIew

1.1 The importance of the packagePackaging is an important part of the overall marketing strategy of consumer goods.4 5 6 Packaging helps to establish brand identity in competitive markets and serves as an effective form of promotion both at the point of sale and while the product is being used.7 8 9 Packaging is particularly important for consumer products such as cigarettes, which have a high degree of social visibility.10Unlikemanyother consumer products, cigarette packages are displayed each time the product is used and are often left in public view between uses.11

As John Digianni, a former cigarette package designer noted: “A cigarette package is unique because the consumer carries it around with him all day… It’s a part of a smoker’s clothing, and when he saunters into a bar and plunks it down, he makes a statement about himself.” 12 As a result, the package serves as a badge product that says something about its owner, and an important form of advertising in its own right.8 Badge products are particularly important among the adolescent market.13

brown & williamson (1985)“… if you smoke, a cigarette pack is one of the few things you use regularly that makes a statement about you. A cigarette pack is the only thing you take out of your pocket 20 times a day and lay out for everyone to see. That’s a lot different than buying your soap powder in generic packaging.” 14

british american Tobacco (1978)“One of every two smokers is not able to distinguish in blind (masked) tests between similar cigarettes …for most smokers and the decisive group of new, younger smokers, the consumer’s choice is dictated more by psychological, image factors than by relatively minor differences in smoking characteristics.” 15

Cigarette packages – as well as packages of other tobacco products – also serve as an important link to other forms of tobacco advertising.16 Package designs help to reinforce brand imagery that is communicated through other media, and play a central role in point-of-sale marketing, which now accounts for a majority of the industry’s promotional spending in Canada.17IntheUS,pointofsalepromotionissecondonlytoeconomicpromotional incentives, such as price discounts and coupons, among all tobacco promotional expenditures.18 Indeed, tobacco “power walls” – rows of cigarette packages prominently displayed behind retail counters – have been shown to be an effective form of marketing, particularly among young people.19 Moreover, the marketing value of tobacco packaging increases as other forms of marketing are restricted.20, 21 The following quote from a Phillip Morris executive highlights the importance of the package under increasingly restrictive advertising environments:

“Ourfinalcommunicationvehiclewithoursmokeristhepackitself.Intheabsenceofanyothermarketingmessages, our packaging... is the sole communicator of our brand essence. Put another way – when you don’t have anything else - our packaging is our marketing.” 22

Internal documents from British American Tobacco (BAT) also indicate that packages have been designed to compensate for restricted forms of advertising:

“… given the consequences of a total ban on advertising, a pack should be designed to give the product visual impact as well as brand imagery... The pack itself can be designed so that it achieves more visual impact in the point of sale environment than its competitors.” 23

Legal courts have added weight to the concept of the tobacco package as a form of advertising. In France, civil society organisations have on numerous occasions brought legal challenges against tobacco companies over the use of novelty packages known as “fun packs”, claiming that they violate the Loi Evin, which prohibits most tobacco promotion in France.

Fun packs are tobacco packages that carry imagery, colours and design features different from the usual brand imagery. The packs, often

described by the industry as “limited series”, invite smokers to collect them and, as the images here show, leave little doubt that they are targeted at young people. In recent years, the French courts have ruled that these novelty packs do indeed constitute advertising and are therefore illegal under French law. 24, 25 Tobacco companies continue to develop new packaging to attempt to circumvent the law.

Cigaratte powerwall. Source: Canadian Cancer for Tobacco Control

“Fun Packs” (France) Photos courtesy of E. Beguinot, CNCT

Source: Alex Lee

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Beyond the retail environment, packages also help to increase the reach of “below the line”, or non-media marketing activities.26Forexample,cigarettepackagesoftencontainspecificreferencesto sponsorship and promotional activities, such as Formula 1 racing series, concerts, and nightclub promotions. As Pollay has noted, “the package is the last and most critical link in an integrated chain of promotional communications.”8 Overall the package is the cornerstone of tobacco marketing strategy, and an effective means of targeting key sub-groups of smokers, including young adults and women.8 27

28 29

Manufacturers continue to explore new possibilities for exploiting the package, including increased use of the plastic over-wrapping, slides or inserts inside of packages, and inserts attached to the outside of packages. Packages are also being designed so that they open like a book in order to create more display surface and, in some cases, so that they can be detached into two smaller packages (see images on right).30

world Tobacco (2006)“With the uptake of printed inner frame cards what we will increasingly see is the pack being viewedasatotalopportunityforcommunications–fromprintedouterfilmandteartapethroughtothe inner frame and inner bundle. Each pack component will provide an integrated function as part of a carefully planned brand or information communications campaign.” 31

freeman et al, university of sydney (2007)“Advances in printing technology have enabled printing of on-pack imagery on the inner frame card,outerfilmandteartape,andtheincorporationofholograms,collectableart,metallicfinishes,multi-fold stickers, photographs, and retro images in pack design. In the early 1900s, collectable cigarette cards were a major form of in-pack promotion. A contemporary return to the package as the primary source of advertising is apparent in the following examples.” 32

In short, the package is a vital marketing channel for the tobacco industry and its value will continue to increase as more traditional forms of marketing are subject to increasing restrictions.

1.2 health messages on packaging

who framework Convention on Tobacco Control (who fCTC) article 11.1(b)“1. Each Party shall, within a period of three years after entry into force of this Convention for that Party, adopt and implement, in accordance with its national law, effective measures to ensure that:….(b) Each unit packet and package of tobacco products and any outside packaging and labelling of such products also carry health warnings describing the harmful effects of tobacco use, and may include other appropriate messages. These warnings and messages: (i) shall be approved by the competent national authority; (ii) shall be rotating; (iii) shall be large, clear, visible and legible; (iv) should be 50% or more of the principal display areas but shall be no less than 30% of the principal display areas; (v) may be in the form of or include pictures or pictograms.”1

In addition to serving as a marketing vehicle for the tobacco industry, tobacco packages potentially provide governments with a direct means of communicating with smokers. Health messages on packaging are primarily intended to communicate the health risks of smoking. However, effective package messages also decrease tobacco consumption by motivating smokers to make more quit attempts or to smoke less. They also reduce the attractiveness of packaging to young people.

Smokersaroundtheworldare,byandlarge,unawareofthespecifichealthrisksoftobaccouseandoftheconsequencesofthoserisks.This is true even in developed countries.33 Tobacco companies claim that smokers have been adequately warned about the dangers of tobacco use because, “Everybody knows smoking is bad for you.” But this is not the case. In many legal systems, manufacturers have a duty to warn that carries an obligation to provide much more detailed information, including:

• Thespecifictypeofriskfromsmoking(forexample,lungcancer,heartdisease,stroke,addiction). • Themagnitudeofrisk(Whatarethechancesofapack-a-daysmokergettingaspecifictobacco-relateddisease?). • Consequencesofrisk(Whatarethecomplicationsoflungcancer,andwhatarethechancesofsurvivingit?). • Thebenefitsofchangingbehaviour(Ifsmokersquit,byhowmuchdotheyreducetheirrisks?Willsmokingoutdoors reducetherisksofexposingtheirfamilytosecondhandsmoke?).34

Tobacco packages are an excellent medium for communicating health information because of their reach and frequency of exposure – they are virtually guaranteed to be seen by every single smoker, usually several times per day. ‘One-pack-a-day’ smokers are potentially exposed to the warnings more than 7000 times per year. Health warnings on packages are also unique among tobacco control initiatives in that they are delivered at the time of smoking and at the point of purchase. As a result, health warnings on cigarette packages are among the most prominent sources of health information for smokers: more smokers report getting information about the risks of smoking from packages than from any other source except television.35 Findings from Canada, Thailand, and elsewhere, indicate that a considerable proportion of non-smokers also report awareness and knowledge of package health warnings.36 37 38 Therefore, health warnings are an extremely cost-effective public health intervention and have tremendous reach.

Kent (Chile). Source: Alex Lee

Source: Alex Lee

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At present, cigarette packages in the vast majority of countries carry a health warning.39 However, the position, size, and general strength of these warnings vary considerably across jurisdictions, and few could be said to meet the above criteria for adequately informing smokers.

Fortunately, more and more countries – nearly 20 as of mid-2008 – are requiring large pictorial health warnings that cover at least 50% of the package, consistent with the recommendations in WHO FCTC Article 11.

1.2.1 Impact of messages on attitudes, knowledge and smoking behaviourImpact on health knowledgeTobaccopackagehealthmessageshaveasignificantimpactonsmokers’understandingoftherisksoftobaccouse. Several studies have shown that large text-based warnings are associated with increased perceptions of risk. In cross-sectional surveys conducted in Canada during the 1990s, the majority of smokers reported that package warning labels were an important source of health information and had increased their awareness of the risks of smoking.40 An Australian study found that, relative to non-smokers, smokers demonstrated an increaseintheirknowledgeofthemainconstituentsoftobaccosmokeandidentifiedsignificantlymorediseasegroups following the introduction of new Australian warning labels in 1995.41 A study of Spanish university studentsconcludedthattextwarningsbasedupontheEUdirectivefortext-basedmessages42significantlyincreased perceptions of risk.43ThesefindingswereconsistentwithresultsfromastudyofarepresentativesampleofUKsmokersontheeffectsofsimilartextwarningsthatwereintroducedin2003.44 The study found that smokers’ awareness of the warnings and thoughts about the health risks of smoking increased following the new warnings.

Quitting smoking, smoking less, and motivation to quitAsignificantproportionofadultandyoungsmokersreportthatlargepackagewarningshavereducedtheirconsumptionlevels,increasedtheir likelihood of quitting, increased their motivation to quit, and increased the likelihood of remaining abstinent following a quit attempt.37 45 46 47 48 49 49 50 51 52 53 54 55 56 57 At least three longitudinal studies have demonstrated an association between reading and thinking about health warnings and subsequent quitting behaviour.47 58 59 Increases in the use of cessation services have also been associated with the introductionoflargepackagehealthmessageswithreferralinformationtotheseservices.ResearchintheUK,theNetherlands,Australia,Brazil, and New Zealand has examined changes in the use of national telephone “quitlines” after the contact information was included in packagehealthmessages.Eachofthesestudiesreportedsignificantincreasesincallvolumes.55 60 61 62 63 For example, calls to the toll-free quitline in the Netherlands increased more than 3.5 times after the number was printed on the back of one of 14 package warnings.59

Surveys of smokers conducted following implementation of picture-based messages on packages indicate an impact on quitting motivation andnumberofcigarettessmoked.ApollconductedshortlyaftertheimplementationofBrazil’sfirstroundofpictorialmessagesinearly2002 found that 54% of smokers reported that they had changed their opinion on the health consequences of smoking as a result of the warnings, and 67% of smokers said that the warnings made them want to quit smoking.64 A poll conducted in Singapore in late 2004 by the Health Promotion Board, a government agency, following implementation of pictorial messages in that country found that nearly half (47%) of smokers reported smoking fewer cigarettes or smoking less frequently after seeing the graphic warnings.65 In Thailand, nearly half (44%) of smokers said that the new pictorial warnings made them “a lot” more likely to quit over the next month. Combined with the AustralianandCanadianfindingsreportedbelow,theseresultssuggestbroadculturaleffectivenessofstrongpictorialpackagemessages.

Impact of package messages on brand appealProminenthealthwarningsthatcoverasignificantproportionofthepackagealsohavethepotentialtoundermine a brand’s appeal and the impact of package displays at retail outlets.67, 68, 69, 70 A Quebec Superior Court judge remarked upon this phenomenon in a ruling regarding the industry’s challenge to pictorial warnings in Canada: “Warnings are effective and undermine tobacco companies’ efforts to use cigarette packages as badges associated with a lifestyle.” Given the importance of package branding in the marketing mix for tobacco products, such undermining of brand appeal could reasonably be expected to have an impact on consumption, particularly among younger people.

Credibility of and public support for package messagesResearch indicates that smokers report graphic warnings to be a credible source of information, particularly when attributed to a well-respected Department of Health or non-governmental authority, such as a cancer society.72 73 74

Although tobacco companies have suggested that pictorial warnings “harass” smokers, research suggests that, overall, smokers welcome more health information on their packages, including information that presents the health consequences of smoking in a vivid, arousing manner.

Several studies report high levels of public support for graphic pictorial warnings.47 75 In Brazil a national survey indicated that 76% of those interviewed approved of picture warnings, including 73% of smokers.55 Two years aftertheintroductionoflargepictorialwarningsinUruguay,only8%ofadultsmokersreportedtheywouldpreferless health information to appear on packages, whereas 62% reported they would like more health information on packages.76 Similar levels of popular support have been observed following the introduction of pictorial warnings in Canada and Thailand.48 77

Bulgaria. Source: Alex Lee

Chile. Source: Alex Lee

Brazil. Source: Alex Lee

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1.2.2 Factors that influence the effectiveness of messagesPackage health messages clearly have an impact on knowledge and behaviour. However, the extent to which smokers read and think about, and act upon the warnings is highly dependent on their size, position, and design. Large pictorial warnings are particularly important in this regard. The Conference of the Parties of the WHO FCTC recently approved guidelines for implementation of Article 11 that reinforce the importance of well-designed warning labels.78

use of pictures and symbols A wide variety of research has clearly demonstrated the effectiveness of using pictures and imagery in health communications.79 80 81 82 83 This research has demonstrated that warnings withpicturesaresignificantlymorelikelytodrawattentionandresultingreaterinformationprocessing, and to improve memory for the accompanying text. Picture warnings also encourage individuals to imagine health consequences and are also more likely to be accessed when an individual is making relevant judgments and decisions. As a result, the use of pictorial symbols is a common and effective feature of health warnings for a wide variety of consumer products.84 85 86

87 88 89 90

Experimental research on tobacco warnings has also found that picture-based warnings are rated as being more effective than text-only warnings, both as a deterrent for new smokers and as a means to increase cessation among current smokers.45 91

Extensive focus group testing and market research commissioned by government health agencies in several countries underscores the importance of using pictures in package health warnings. This research consistently demonstrates that health warnings with pictures are rated by smokers and non-smokers as more effective, and are associated with greater impact and memory for health risks than text-only warnings. The following summary statementsreflectthekeyfindings.

summary of health Canada research conducted prior to 2000“Participantsfeltthatthenewlargerhealthwarningmessages,featuringcolourphotographs,wereadefiniteimprovementoverthecurrent warning messages. Teenagers were particularly impressed with the use of pictures and the larger size of the messages that allow for the dissemination of more information”. Overall responses to new warning messages, p.5 92

summary of research commissioned by health Canada since 2000“It also appears that messages have to be credible and supported by facts and visual depictions wherever possible.” “Other graphic approaches showing dramatic negative health effects, although not necessarily liked, were effective in garnering notice among a number of participants.” Executive summary, p.3 93

“Thepicturewasgenerallythefirstthingpeoplelookedatandrelatedto.Itdeterminedthestrengthofthewarning’semotionalimpactand noticeability. For many participants, the picture played the key role in understanding the message, and tended to override the meaning conveyed by the words in the headline. Therefore, those warnings with a clear, simple and effective headline to support or complement the emotionally strong visual were the ones that consistently generated positive and almost enthusiastic feedback from participants.” Executive summary, p.4 94

summary of research commissioned by the australian department of health“The graphic packs were more informative about health effects and more effective in general in conveying health information regarding the contents of cigarettes and cigarette smoke than were the “text only” alternatives. They were also more likely to elicit an emotional response from smokers. They will generate controversy and discussion about smoking and its health and social effects. The graphic packsaremorelikelyto:createimpact;attractattention;beconfrontinganddifficulttoignore;makeitmoredifficultforsmokerstodeflectthehealthmessage.Overall,the“textonly”packswerenotconsideredasimpactfuloraseffectiveinconveyingthepotentialnegative health consequences of smoking as the graphic pack alternatives.” Executive summary, p.5 95

summary of research commissioned by the new Zealand Ministry of health“All experience and evidence suggests that a combination of visual and text provides the best possible communication; the visual element to attract attention and telegraph a strong message, the text to expand and provide information.” Summary, p.14 96

“Respondents consistently mentioned visuals as being the crucial element-i.e. clear pictorial evidence of the consequences of smoking or the potential gains of quitting.” Summary, p.6 97

“Bywayofahigh-levelsummaryoffindings,thefollowingkeyconsiderationemergedfromtheresearch:-Pictorialmessagesarelikelytohavesignificantlymoreimpactthantext-onlymessages.- The larger the pictorial message, the greater its impact.” Summary p.6 98

article 11 Guidelines: developing effective packaging and labelling requirementsEvidence demonstrates that the effectiveness of health warnings and messages increases with their prominence. In comparison with small, text-only health warnings, larger warnings with pictures are more likely to be noticed, better communicate health risks, provoke a greater emotional response and increase the motivation of tobacco users to quit and to decrease their tobacco consumption. (Paragraph 7)

Australia. Source: Alex Lee

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Since2000,whenthefirstpictorialwarningsintheworldwereintroducedinCanada,aseriesofpopulation-basedsurveyshavecomparedtheeffectivenessbetweentextandpictorialwarnings.Thesefindingsareconsistent with both the experimental and government-commissioned research: graphic warnings are more likely to be noticed and read by smokers, and are associated with stronger beliefs about the health risks of smoking and increased motivation to quit smoking.44 45 46 47 48 57 86 87 88 89 90 91 92 93 99 100

Picture warnings appear to be especially effective among young people: more than 90% of young people in Canada agree that picture warnings on Canadian packages have provided them with important information about the health effects of tobacco use, are accurate, and make smoking seem less attractive.37 Other national surveys of Canadian young people suggest similar levels of support and self-reported impact.36 A recent longitudinal evaluation of pictorial warnings among Australian school children found that students were more likely to read, attend to, think about, and talk about health warnings after Australia’s pictorial warnings were implemented in 2006.57 In addition, experimental and established smokers were more likely to think about quitting and forgoing cigarettes, while intention to smoke was lower among those students who had talked about the warning labels

andhadforgonecigarettes.RecentexperimentalresearchconductedamongyoungpeopleinGreeceisconsistentwiththesefindings.101

size and position of health messagesSmokers are more likely to recall larger warnings than smaller ones, and tend to equate the size of the warning with the magnitude of the risks of tobacco use.102 103 104 105 106 107 108 Research also suggests that larger warnings are perceived as more credible than smaller warnings.109 One Canadian survey found that smokers judged warnings that covered 80% of the package to be most effective.110 More recent Canadian research showed that incremental increases in the size of the warnings would increase their impact: 75% of the surface area would be more effective than 50%, 90% would be more effective than 75%, and 100% would be more effective than 90%. These findingsheldtrueforbothyoungpeopleandadults.111 112

Smokers also report greater recall for warnings that appear on the front, compared to the side of packages.102 105 107 108 110 For example, severalstudiesindicatethattheUStextwarningsonthesideofpackagesdemonstratelowlevelsofsalienceamongsmokers. 113 114 115 116 InacomparativestudyofstudentsinCanadaandtheUScarriedoutin1995,atatimewhenCanadianpackagescarriedtextwarningsonthe front of packages, 83% of Canadian students mentioned health warnings in a recall test of cigarette packages, compared to only 7% of

USstudents.117 A Phillip Morris document also highlights the importance of positioning on the front of packages: “Government required warnings placed on the largest packaging panel, often called the front and/or back, are the biggest marketing threat to all of us in Asia.”16

Warnings placed at the top portion of the main package faces are more noticeable than those placed at the bottom.118 The top of the front face of the package is considered by tobacco companies to be the “prime real estate” on the package.

Features that distinguish the warning messages from the package design have also been found to increase the salience and recall of warnings.119 Messages with contrasting colours, such as black lettering on a white background are the easiest to read, whereas the legibility of silver or gold text messages is comparatively poor.99

120

Graphic warnings and fear-arousing informationAlthough pictorial warnings that contain graphic images of health effects have been criticised on the grounds that threatening information may cause defensive reactions among smokers that lessen the likelihood of quitting121, existing evidence shows exactly the opposite. Graphic warnings labels, such as those on Canadian packages, do indeed cause strong emotional reactions among a considerable proportion of smokers.47 122 However, there is no evidence that graphic warnings labels decrease the effectiveness of the warnings in terms of intentions or attempts to quit, or in thinking about health risks. On the contrary, strong emotional reactions are associated with increases

in each of these measures of effectiveness.47

A recent experimental study compared picture warnings that showed graphic depictions of disease (considered a “loss-framed” message) with picture warnings that emphasised the positive aspects of abstaining from smoking (“gain - framed”). Adolescents in the study had more favourable attitudes toward the loss-framed warnings and perceived them as more effective than the gain-framed warnings. Further,smokersexposedtotheloss-framedwarningfeaturingdecayingteethhadsignificantlylowerintentions to smoke in the future.123

It has also been suggested that smokers will simply avoid warnings that are too strong and will tune out the health messages. Although several studies indicate that a considerable portion of smokers attempt to avoid graphic pictorial health warnings by covering or hiding the warnings or putting cigarettes inanothercase,theseexamplesoffearcontrolbehaviourdonotnecessarilyreflectanegativeside effect of strong package warnings. Research shows that avoidant behaviours and attempts at thought suppression often have the opposite effect of increasing the presence of the unwanted thoughts.124 One study found that smokers who attempted to avoid the warning were no less likely than other smokers to see the warnings, think about them, or to try to quit smoking at three-month follow-up.47 Preliminaryfindingsfrom a longitudinal study of the pictorial warnings in Australia also demonstrate a positive association between “avoidant’ behaviour and self-reported measures of effectiveness, such as forgoing a cigarette and increases in motivation to quit smoking as a result of the warnings.125 In the context of the warning labels, avoidant behaviour might be more reasonably interpreted as a measure of effectiveness. Indeed, if the warnings were ineffective in communicating the threatening consequences of smoking there would be no reason for smokers to avoid them.126

Thailand. Source: Alex Lee

Singapore.

Canada.

Australia. Source: Alex Lee

Belgium. Australia

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Moregenerally,researchinthefieldofhealthcommunicationindicatesthatmessageswithemotionallyarousing content are more likely to be noticed and processed by smokers.126Themostconsistentfindingfromthisfieldisthatfearappealsareeffectivewhenpairedwithstrongefficacymessagesforaspecificoutcome (i.e. quitting smoking). A recent meta-analysis of the literature on public health communications concludedthat‘strongfearappealsandhigh-efficacymessagesproducethegreatestbehaviorchange’,and found no evidence of any adverse or ‘boomerang’ effects for strong fear appeals.

Graphic warnings in Canada, Australia, Singapore, Brazil and other countries are entirely consistent with this literature: in addition to information on health risks, they include messages designed to increase self-efficacytoquit.Thesemessagesincludegeneralmessagesofsupport,aswellasconcreteinformationonwaystoquitsmokingandspecificsourcesofhelp,includingwebsiteaddressesandtoll-freequitlinenumbers.

The effectiveness of graphic fear-inducing images is further supported by surveys and focus groups withsmokers.Forexample,anextensivepublicconsultationconductedbytheUKDepartmentofHealthreceived more than 20,000 responses and found that the highest rated warnings were generally those that included the hardest-hitting messages and images, including graphic pictures of the health effects of smoking (see opposite).127 Research conducted on behalf of the Australian, New Zealand, and Canadian governments yielded similar results:

Qualitative testing of picture warnings in Canada (Les etudes de Marche Createc)“Participants in all groups consistently expected or wanted to be shocked by HWMs [health warning messages], or emotionally affected in some way. Even if the feelings generated were unpleasant ones to tolerate, such as disgust, fear, sadness or worry, the emotional impact of a warning appeared to predict its ability to inform and/or motivate thoughts of quitting. HWMs which worked on emotions rather than on knowledge or beliefs were often acknowledged as effective and noticeable, and actually motivated thinking. When a strong emotion generated by a HWM was supported by factual information, that was the best combination possible.” Overview of findings,p.389

focus-group testing of picture warnings in Canada (environics research Group)“Most participants were moved by the dramatic and scary pictures and messages, such as the woman smoking through a hole in her throat, the sick baby, the cemetery with grieving loved ones, and warnings that depicted the physical and health consequences of smoking, such as the diseased mouth.” Overall responses to new warning messages, p.5 87

Literacy level of messagesThemessagecontentoftext-basedwarningsmusttargetanappropriateliteracylevel.ThecurrentUSwarnings,forexample,requireacollege reading level and may be inappropriate for young people and Americans with poor reading abilities.129 This is particularly important considering that, in most countries, smokers report lower levels of education than the general public. Picture-based warnings may be particularly important in communicating health information to populations with lower literacy rates.118 130 Preliminary evidence suggests that countries with pictorial warnings demonstrate fewer disparities in health knowledge across educational levels.131

wear-out and impact over timeIt is widely accepted that the salience of advertising and health communications is typically greatest upon initial exposure.132 133 For example,arecentstudyfoundthatnewtext-basedwarningsintroducedintheUnitedKingdomin2003wereconsiderablymorelikelytobe noticed than Australian text-based warnings that were only slightly smaller, but had been in place for more than eight years at the time of the survey.46 The frequency with which smokers read and attend to warnings has been shown to lessen over time as smokers become desensitized to the warnings.134 135 136 As a result, health warnings must be regularly updated to maintain their maximum impact over time. 1.3 Constituents and emissions information on packaging

who fCTC article 11.2: “Each unit packet and package of tobacco products and any outside packaging and labelling of such products shall, in addition to the warningsspecifiedinparagraph1(b)ofthisArticle,containinformationonrelevantconstituentsandemissionsoftobaccoproductsasdefinedbynationalauthorities.”1

Disclosure of constituents and emissions in tobacco smoke and in tobacco products has presented a unique challenge to regulators. Tobacco smoke contains approximately 4000 chemicals, including over 250 carcinogens and toxins such as polonium 210, benzene, and arsenic.137 138 Cigarettes are highly engineered products with sophisticated design features and, often, numerous additives.139 140 Although there is general agreement that tobacco packages should include some information on these emissions and ingredients, regulators continue to struggle with how best to feasibly communicate this information in a way that is meaningful to consumers.

? what is the difference between a constituent and an emission?Constituents generally refer to the chemicals and other substances in un-burnt tobacco. This includes additives as well as chemicals naturally present in tobacco. Emissions usually refers to the chemicals and other substances found in the smoke of combustible products.

EuropeanUnion.

EuropeanUnion.

10

Indeed, the primary rationale given for the disclosure of emissions and constituents is to inform consumers about the contents of tobacco products. However, the way in which this information has been typically communicated to consumers has caused far more harm than good.

The most common regulatory practice has been to require manufacturers to print levels for just three components of emissions in mainstream smoke (smoke exhaled by the smoker]: tar, nicotine, and carbon monoxide (CO). These numbers are typically printed on the side of packages, either voluntarily by the manufacturer or as required by national law. In fact, communicating emissions numbers to consumers was originally a voluntary industry practice. Tobacco manufacturers have communicated tar and nicotine numbers directly to smokers ever since the health risks of smoking became publicly known.141 These early forms of product disclosure – as limited as they were – were motivated less by consumer protection than by a marketing strategy intended to capitalise upon widespread misperceptions of “lower tar” products. Despite early objections by regulatory authoritiessuchastheU.S.FederalTradeCommission,142 this industry practice was adopted by regulatory agencies throughout the world, including (due in large part to tobacco industry lobbying) the International Organization for Standardization (ISO).

Measurement of tobacco smoke emissionsQuantities of tar, nicotine, and carbon monoxide emissions typically reported on tobacco packages are misleading. They represent neither the quantity of chemicals or substances present in the

tobacco product itself, nor the amounts actually inhaled by human smokers. This is because the emission numbers are determined by a machine that “smokes” cigarettes according toafixedpuffingregime.Thismachinemethoddoesnotpredicttheamountofsmokeinhaledbyindividualsmokersoraccuratelyreflectrelativedifferencesinemissionslevelsbetweenbrands. Nordoesthemachinemethodaccountfordesignelementssuchas“filterventilation”-tinyholespokedinthefilterthat yield low emission levels under machine smoking, but much higher levels to real smokers. This is due to compensatorybehaviourbysmokersincluding:coveringtheventilationholeswithfingersorlips;takingmorepuffsof each cigarette; smoking more of the cigarette; or inhaling longer or more deeply on each puff. 143

There is no association between the machine-generated numbers printed on packages and the health risk of smoking different brands. Smokers of lower-yield cigarettes are at similar risk of contracting disease as smokers of higher-yield cigarettes.

In short, the underlying rationale for communicating tar and nicotine numbers directly to consumers – so that they can choose to smoke “low tar” cigarettes that may be less harmful – has long been rejected.

Consumer perceptions of informationDespitethescientificconsensusthattarandnicotineemissionsnumbersmisleadconsumers,thepracticeofcommunicating these numbers to consumers remains widespread. Not only have manufacturers continued to communicate tar and nicotine levels directly to consumers on the package and via advertising, but many regulatory authorities reinforce the practice through packaging and labelling regulations. This situation harms smokers and public health. Research has repeatedly shown that a substantial proportion of smokers equate lower tar and nicotine numbers with a reduction in exposure and health risk, and many use these numbers to guide their choice of brands.144

145 146 147 148 Worse, there is substantial evidence that many smokers who would otherwise try to quit instead switch to a lower-tarbrandinthebeliefthatitislessharmful(see1.4Misleadinglabellingformoreinformation).Recentfindingssuggestthatsmokers,eveninthemostaffluentandeducatedcountries,continuetoholdfalsebeliefsaboutemissionnumbers: • 75%ofsmokersfromAustralia,Canada,theU.S.andtheUKreportthatthetarnumbersonpacks are related to exposure.149

• Amongsmokersinthesamestudywhobelievethatsomebrandsarelessharmfulthanothers,81% believe that the tar and nicotine levels indicate the brands that are less harmful.138

• WhenshownemissionlabelsontwocigarettebrandsfromtheEuropeanUnion,whichrequires emission levels to be printed on packaging, 92% of smokers report that the 4mg product would deliver less tar than the 10mg product, and 90% reported that they would buy the 4mg product if they were trying to reduce the risks to their health.95

• Thesefindingsareconsistentwiththewaysinwhichsmokershavebeenshowntoperceiveemission numbers when conveyed through advertising.130

Overall, printing emission numbers on packages reinforces the tobacco industry’s deceptive marketing campaigns and the false belief that low-tar cigarettes are less hazardous.

Thepracticeofmanufacturersvoluntarilyprintingemissionlevelsonpackagesreflectstheirunderstandingoftheadvantageoflower-yieldbrandsfromamarketingperspective.Forexample,intheUnitedStatesmanufacturersvoluntarilyprintemissionlevelsinahighlyselectivefashion.In2004and2005tarlevelswereprintedonthepackagesofmorethan90%ofU.S.brandswithlessthan3mgoftar,comparedtoprinting them on less than 2% of brands with 8-11mg of tar.16 Similar practices have occurred in other jurisdictions, such as Brazil, where regulators have removed the requirement to print numbers, but have not prohibited manufacturers from doing so (although manufacturers are prohibited from associating numbers with brand names).150

Inlightofthesefindings,somejurisdictionshaveattemptedtomakeemissioninformationmoreaccurate and meaningful. In 2000 Canada increased the list of substances for which emissions must be reported and required reporting on packages to include a second set of emission numbers generated under the “Health Canada” testing method, a more intensive machine smoking method (see right).151 Unfortunatelythisemissiontestingmethodisnobetteratpredictingactualnicotineuptake by smokers measured by biomarkers of exposure than the ISO - based numbers.152 SubsequentresearchconductedonbehalfofHealthCanadafoundthat,althoughfouroutoffive

EuropeanUnion.Source: Alex Lee

Canada. Source: Alex Lee

article 11 Guidelines: Information on constituents and emissionsParties should prohibit the displayoffiguresforemissionyields, such as tar, nicotine and carbon monoxide, on packaging and labelling, including when used as part of a brand name or trademark... (Paragraph 44)

China. Source: Alex Lee

Filter ventilation. Source: Alex Lee

11

smokers did not understand the emission information, more than half reported that they would use thesenumbers“tofindalessharmfulbrand”.133

This consumer reaction is not surprising: Even though the Canadian system provides ranges of numbers for each brand, it perpetuates the concept that different brands deliver different quantities of emissions. Changing the metric of cigarette emissions by using more intensive testing methods provides little insurance against the likelihood that consumers will interpret brands with lower numbers as lower risk. In reality the behaviour of an individual smoker is far more predictive of uptake of nicotine and other substances than the brand they smoke.

Insummary,thescientificconsensusisthatthereisnomeasurabledifferenceinhealthriskbetweenconventional cigarette brands based on reported tar and nicotine numbers. Furthermore consumers perceivethesenumberstoreflectrelativeriskand,asaresult,makechoicespotentiallyverydamaging to their health (eg. switching to a “low-tar” brand instead of quitting). This evidence has promptedleadingscientificbodiestocallfortheremovalofemissionnumbersfrompackages.153

non-numerical or descriptive emission labellingTo date, several countries have stopped requiring quantitative emission information from packages and instead require descriptive information about toxic constituents in smoke and their effects on health. Preliminary research suggests that this information is more meaningful to consumers and less likely to result in misperceptions about the relative risk of different cigarette brands.95 154 Further work is required to examine what types of descriptive product information are most useful toconsumers.Theextenttowhichinformationaboutadditivesordesignfeatures(suchasfilterventilation) might serve as effective consumer messaging is also unclear, mainly because these approaches have yet to be explored. Several suggestions of approaches to descriptive product information that may be effective are discussed in section 2.

1.4 Misleading labelling

who fCTC article 11.1(a):“Each Party shall, within a period of three years after entry into force of this Convention for that Party, adopt and implement, in accordance with its national law, effective measures to ensure that:(a) tobacco product packaging and labelling do not promote a tobacco product by any means that are false, misleading, deceptive or likely to create an erroneous impression about its characteristics, health effects, hazards or emissions, including any term, descriptor, trademark,figurativeoranyothersignthatdirectlyorindirectlycreatesthefalseimpressionthat a particular tobacco product is less harmful than other tobacco products. These may include terms such as “low tar”, “light”, “ultra-light”, or “mild.” 1

Tobacco companies have made extensive use of cigarette packages to convey information regarding the relative risks of different brands of cigarettes. Prior to the 1950s, tobacco packages rarelyincludedinformationabouttarlevelsorotherinformationthatmightcausesmokerstoreflectuponhealthrisks.However,followingthepublicationintheUSAofthefirstSurgeonGeneral’sreport on the health risks of smoking in 1964, tobacco companies have sought much more actively reassure consumers about the potential risks of their products. A central feature of this marketing strategy has been to expand brands and extend brand families, while promoting differences in the relative risk of brands and integrating thismarketingstrategyintothedesignofproductsthemselves,largelythroughthepromiseofimprovedfiltrationandlowerreportedemissions of tar and nicotine. Nicotine -addicted consumers embraced these brands as a welcome alternative to quitting, as well as a means of easing the guilt and cognitive dissonance from smoking.130 155

The package has served as an essential medium for executing this marketing campaign. In general, tobacco companies have relied upon implicit means to promote differences in risk, rather than overt health claims on the package.130 This has been accomplished using a number of packaging elements, including references to product design, the use of misleading descriptors (often incorporated into brand names), as well as the use of colours and symbols.

brand descriptorsTobacco manufacturers incorporate a variety of common descriptive terms into the names of their cigarette brands. Words such as “light” and“mild”areostensiblyusedtodenoteflavourandtaste;however,“light”and“mild”brandsareoftenpromotedeithersubliminallyorovertly as “healthier” products and have been closely integrated with product design in order to maximize their impact.11 140 142 Descriptors suchas“light”and“mild”areusuallyappliedtobrandswithhigherlevelsoffilterventilationthatgeneratelowermachine-measuredlevelsoftar.Asdiscussedabove,notonlydoesfilterventilationdilutecigarettesmoketoproducedeceptivelylowemissionnumbersundermachine testing, but it also produces “lighter” tasting smoke and other sensory properties that reinforce the misleading descriptors and imagesonpackages.Indeed,smokersassociatethe“flavour”andharshnessofthesmokewiththelevelofrisk.156 The synergistic effect of brand descriptors, low emission numbers, and the “lighter” tasting smoke has proven extremely effective in promoting different levels of risk to smokers.132 157 158 159 160 161 These deadly misperceptions have forestalled quitting among many “health concerned” smokers and persist to this day among a considerable proportion of smokers.132 163 For example, more than 50% of Chinese smokers believe that brands labelled as “light” are less harmful than regular cigarettes.164

To date, at least 44 countries have prohibited the use of the terms “light”, “mild”, and “low tar” on packaging, including 27 countries from the EuropeanUnion.165 Although “light”, “mild”, and “low tar” are the most notable examples of misleading brand descriptors, they are by no means the only ones. Indeed a wide variety of other descriptors have been designed to reinforce the same false beliefs and perceptions.

Australia. Source: Alex Lee

Brazil. Source: Alex Lee

Chile. Source: Alex Lee

Thailand. Source: Alex Lee

Canada. Source: JTI Descriptor Reference Guide, JTI-MacDonald Corp

12

For example, the term “smooth” has been used alongside “light” and “mild” at least since the mid-1990s, and more recently as a replacement for “light” and “mild” in a number of jurisdictions with prohibitions on those terms.166 Other common (and effective) substitutes for “light” and “mild” include the names of colours, such as “silver” and “blue”, which capitalise on the perceptions of these colours as being “lighter”.

In Brazil, just prior to the coming into force in 2002 of a prohibition on the use of “light” and “mild” and other misleading terms on packaging, tobacco companies put inserts into packages explaining very clearly to their customers how to interpret different colours (see below). Brazil’s experience in attempting to eliminate misleading labelling is discussed in greater detail in Chapter 2.

Unsurprisingly,particularlyinthecontextofsuchcreativeindustrymarketing,manyreplacementwordshavethesamemisleading effect as “light” and “mild”: a recent study found that more than 70% of smokers reported that packages with wordssuchas“smooth”and“silver”wouldhavelowerhealthrisksthan“regular”and“fullflavour”brands.95

Numbers are also used in the name of cigarette brands to distinguish between different varieties. These numbers often correspond to the machine levels of tar emissions.130 When shown packages with different numbers in the brand name, as many as 80% of smokers report that the brand with the lower number would deliver less tar and may lower risk.95

Colour, symbols and imageryColour is routinely used in package design to shape consumer perceptions of risk.8 9 Even withoutthebenefitoftobaccocompanymarketingasdescribedabove,researchhasshownthat consumers associate the “lightness” and “strength” of a brand with different colours. For example, blue tones are perceived as “lighter” than red, while products in grey and white packages are perceived to be the “lightest.”

Different shades of the same colour, as well as the proportion of white space on the package, can also be used to manipulate perceptions of the strength and acceptability of the product itself. The following quote from a Philip Morris researcher describes this phenomenon:9

Philip Morris“Lower delivery products tend to be featured in blue packs. Indeed, as one moves down the delivery sector, then the closer to white a pack tends to become. This is because white is generally held to convey a clean healthy association.” 167

In addition to the use of colour, packaging often includes imagery and symbols with strong associations with health, including images of nature scenes, physical activity, and sport.8 130

Asoneindicationofthepowerofcolourandimagery,theCanadiansubsidiaryofPhilipMorrisrecentlyintroducedtheU.S.Marlborocigarette in the Canadian market without the Marlboro name because the right to use the Marlboro trademark in Canada is owned by a competitor.168Thisproductcarriesnoidentifiablenameonthepackage(seebelow).ThisspeaksnotonlytothefamiliarityoftheMarlborochevron logo, but also to how colour alone can be used to distinguish between brand varieties and emission levels.

ResearchconductedwithadultsmokersintheUK,wherepackscarry the name Marlboro, but use only colour to distinguish between differentvarieties,foundsignificantlevelsoffalsebeliefsassociatedwith these brands. Compared to Marlboro packs with a red logo, Marlboro packs with a gold logo were rated as lower health risk by 53% and easier to quit by 31% of adult smokers.

A number of studies have shown that the colour and design of the package are effective to the point where they can affect sensory perceptions of a cigarette, a process known as “sensory transfer.” Imperial Tobacco Canada Ltd, a subsidiary of British American Tobacco, summarised extensive research on brand imagery that demonstrates how the design of the package alone can affect sensory perceptions of the product. The following provides a description of similar research conducted by Philip Morris:

Japan. Source: Alex Lee

Canada. Source: Alex Lee

“Rooftop”brandwithoutidentifiablenameonpackage,butwithcolourvariationsreadilyassociatedwithMarlboro“Red”,“Light”and“UltraLight”Canada.Source:AlexLee

Example of colour segmentation within a brand family in the Canadian market. Source: Alex Lee

Brazil.

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Wakefield et al.Philip Morris marketing research department compared smokers’ responses to cigarette packages in a blue and red pack. Despite the cigarettes being identical in composition, smokers appraised the cigarettes in the blue pack as “too mild” and “not easy drawing”. Others felt that the cigarettes in the red pack were “too strong” and “harsher”.11

Overall,thecolourandbrandimageryofabrandhasasignificantimpactuponproductperceptions.AsImperialTobaccoLtd’sthen-Vice-PresidentofMarketing,DonBrown,testifiedinaCanadiancourt:“It’sverydifficultforpeopletodiscriminateblind-tested.Put it in a package and put a name on it, then it has a lot of product characteristics.” 171

references to product designProducts that are positioned as “low yield” or “low-tar” brands often carry images or references to product design on the package.172Referencestofiltrationareamongtheoldestandmostcommonexamplesofthisstrategy.Formorethan50years,tobaccocompanieshavecommunicatedfilterpropertiestoconsumersastangibleevidenceofemissionsreductionandlowerrisks.Indeed,theriseoffilteredcigarettesintheU.S.paralleledtheriseinhealthconcernsamong consumers.126FromKent’sMicronitefilter,toBarclay’sACTRONfilter,tothecharcoalfilterscurrentlybeingtestmarketedinMarlboroUltraSmooth–whateverthefiltrationpropertiesofthesedesignsmaybe,theyreassuresmokerswhen displayed on the package.173 As Myron Johnston and W.L. Dunn of Philip Morris stated in 1966, “the illusion of filtrationisasimportantasthefactoffiltration.”174

The images at right provide a contemporary example of this packaging strategy from China, where twoleadingbrandsfeatureimagesofhigh-techfiltersandreferencesto“laserholes,”“activecarbon particles,” and “colour cellulose particles.” Packages with pictures and references to special cigarettefilterssuchastheseareratedbyamajorityofsmokersashavinglesstarandlowerhealthrisk.95Thesereferencestoproductdesignandchemicalprofilearemeaninglessintermsofactualrisk.However,asinternaltobaccoindustrydocumentsindicate,theillusionofimprovedfiltrationandtechnology falsely reassures consumers.162

evaluating the impact of eliminating misleading labellingBrand descriptors and other design elements used to communicate risk represent a considerable challenge for regulators. Although the removal of misleading terms such as “light”, “mild”, and “low tar” representsanimportantfirststepinremovingmisleadingproductinformationfrompackages,recentresearchinAustraliaandtheUK,wherethesetermshavebeenprohibited,suggestsonlymodestbenefitsinreducingfalsebeliefsabouttherisksofdifferentcigarettebrands.175 This marginal impact is likely due to greater colour segmentation, the substitution of other misleading terms such as “smooth”, and the tar and nicotine numbers onUKpackages.

One challenge in evaluating the impact of the removal of brand information is that the beliefs associated with “light” and “mild” cigarettes are likely to persist for some time after the descriptors disappear from packages. This situation is similar to advertising, promotion, and sponsorship bans: one should not expect beliefs to change immediately upon the implementation of the policy, but more gradually over time. Indeed, anecdotal evidence suggests that many retailers and consumers continue to use the terms “light” and “mild” well after their removal from packages. This issue is distinct from, but complicated by, the effect of new descriptors, which are often designed to act as substitutes for the banned terms. These considerations are important in terms of how the effectiveness of light and mild policies is measured and conceptualised.

A partial solution might be to require tobacco companies to pay for corrective advertising and promotion that would attempt to undo some of the impact of decades of misleading labelling. However, the ultimate solution to the problem of misleading labelling is plain packaging, the subject of the next section.

1.5 Plain packaging of tobacco productsThe preceding section on misleading labelling clearly illustrates that alternative approaches are needed to address the problem. A requirement for “plain” packaging of tobacco products has been proposed as a comprehensive and – very likely – a more effective alternative to tinkering with previous approaches to misleading labelling.176 Plain packaging would not only eliminate misleading labelling, it would also close the door on industry attempts in France and other countries to manipulate package design to more effectively promote tobacco products, particularly to young people.

Plain packaging would standardise the appearance of cigarette packages by requiring the removal of all brand imagery, including corporate logos and trademarks. Packages would display a standard background colour and manufacturers would be permitted only to print the brand name in a mandated size, font and position. Other mandated information, such as health warnings, would remain. Ideally plain packaging would be combined with much larger graphic warnings than currently exist (up to 90% of all main package faces).

China. Source: Alex Lee

China. Source: Alex Lee

article 11 Guidelines: Plain packagingParties should consider adopting measures to restrict or prohibit the use of logos, colours, brand images or promotional information on packaging other than brand names and product names displayed in a standard colour and font style (plain packaging). This may increase the noticeability and effectiveness of health warnings and messages, prevent the package from detracting attention from these and address industry package design techniques that may suggest that some products are less harmful than others. (Paragraph 46)

Branding Packaging. Source: Alex Lee Plain Packaging. Source: Alex Lee

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Potential impact of plain packaging on tobacco use*

Several studies in Canada and Australia have explored the potential impact of plain packaging. Research to date suggests that plain packages are less attractive and engaging, particularly to young people.32 For example, a survey of young people in Canada found that strong majorities “liked” regular packages better than plain packages, and indicated that plain packages were more “boring” and “uglier” than regular packages.177 Approximately one third of respondents also reported that young people their age would be less likely to start smokingifalltobaccoweresoldinplainpackages.AsimilarstudyofCanadianandU.S.youngpeoplefoundthatplainpackagesreducedthe positive imagery associated with packages and were associated with greater negative imagery.178 Research with adults also suggests that plain packaging reduces some of the appeal of smoking, as the following quote indicates:

Trachtenberg (forbes Magazine, 1987)“…when we offered them Marlboros at half price – in generic brown boxes – only 21% were interested, even though we assured them that each package was fresh, had been sealed at the factory and was identical (except for the different packaging) to what they normally boughtattheirlocal,tobacconistorcigarettemachine.’Howtoaccountforthedifference?Simple.Smokersputtheircigarettesinandout of their pockets 20 to 25 times a day. The package makes a statement. The consumer is expressing how he wants to be seen by others.”179

Plain packaging may also increase the effectiveness of health warnings.180Inonestudy,youngpeopleinNewZealandweresignificantlymore likely to recall health warnings when presented on plain packs compared to the health warnings presented on branded packages.181 A series of surveys and experiments conducted in Canada also demonstrate that health warnings on plain packages are more noticeable, easier to recall, and more believable.167 182 In 1995 an expert panel from Canada summarised its conclusion on plain packaging based on a comprehensive review:

expert panel report on plain and generic packaging (Canada, 1995)“Plain and generic packaging of tobacco products (all other things being equal), through its impact on image formation and retention, recall and recognition, knowledge, and consumer attitudes and perceived utilities, would likely depress the incidence of smoking uptake by non - smoking teens, and increase the incidence of smoking cessation by teens and adult smokers.” 171

status of plain packaging as a policy measureSerious discussions of plain packaging as a tobacco control policy measure started two decades ago. It was suggested as early as 1989 in New Zealand by the Health Department’s Toxic Substances Board and recommended in Australia in 1992.32 In 1994 in Canada the Health Committee of the House of Commons held hearings and issued a report on plain packaging, noting its potential to decrease tobacco use, particularly among young people.183 MostrecentlytheUnitedKingdomDepartmentofHealthincludedplainpackaginginaconsultation paper on the future of tobacco control as a possible policy option to be explored.184 However plain packaging regulations have yet to be adopted anywhere in the world.

Industry opposition to plain packaging measures has been and can be expected to be robust. A “plain packs group” was created in 1993 with representatives from leading tobacco companies.185 186 Documents from this group clearly state that the group did not “want to see plain packaging introduced anywhere regardless of the size and importance of the market.” 187

In1994UStobaccocompanieshiredaformerUnitedStatesTradeRepresentative(USTR)tosubmit to a Canadian parliamentary committee a signed legal opinion asserting that required plainpackagingwouldviolatevarioustradeagreements.AformerdeputyUSTRdeliveredthisopinion in person to the committee.188

The tobacco industry’s fear of plain packaging is perhaps best summarised in a tobacco trade journal article from 1994, which described Australia’s proposed progression to larger warnings and, ultimately, plain packaging, as the “evolution of a marketing nightmare”.189

WithdiscussionofplainpackagingbackonthepolicyagendaintheUKandelsewhereaftermore than a decade of dormancy, the industry must be experiencing a disconcerting sense of déjà vu. In 2008 another trade journal took up the plain packaging issue once again, with the cover headline in the form of a warning: “Plain packaging can kill your business.”190

1.6 ConclusionThe tobacco package is a critical promotional vehicle for tobacco companies, as well as a powerful medium for communicating health messages on the risks of tobacco use.

Smokers,aswellasthegeneralpublic,benefitgreatlyfromgraphic,clearandconspicuoushealthmessagesontobaccopackagingthat include large graphic pictures. These messages increase motivation to quit among smokers. Conversely, smokers are misled by quantitative smoke emission information and by deceptive brand descriptors and designs on tobacco packaging. This misleading information and imagery undermines accurate perceptions of risk and reduces the likelihood of quitting for many tobacco users.

Thereisamplescientificevidencetosupporttheimplementationofgraphichealthmessagesontobaccopackagingandtheremovalofquantitative emission information and misleading brand descriptors from packages. There is also substantial evidence that plain packaging of tobacco products would increase the salience of health messages, minimize or eliminate deceptive information and imagery on the package, and reduce brand appeal, particularly among young people.

Tobacco Journal International, 2008

Tobacco International, 1994.

* Several quotes and sources in this section are drawn from a recent review prepared by Freeman, Chapman, & Rimmer 32

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2. Pre-IMPLeMenTaTIon: deveLoPMenT of LeGIsLaTIon and warnInGs

Most of the success in implementing and ensuring compliance with effective packaging measures is a product of preparation done before the implementation.

This part of the Guide addresses the key areas of preparation for implementation of packaging and labelling policies:

•Developingaclearunderstandingofyourpolicygoals. •Developinglegislationorimplementingotherstrategiesthatwilleffectivelyachievethesegoals. •Developinganddesigninghealthwarningsandothermessagesthatarelikelytohaveanimpactonyourtargetaudiences.

2.1 development of legislation and regulationsThissectionfocusesonthegeneralandspecificissuesthatneedtobeconsideredwhendevelopinganddraftinglegislation or regulations to implement packaging and labelling measures. It includes:

•Adiscussionofpotentialpolicygoalsonwhichtobaselegislation,andthepossiblelegislativemeansto achieve goals. •Linkstolegislationandregulationsfrommostcountriesthatcurrentlyrequirepicturewarnings. •Anoverviewofgeneralconsiderationsindevelopinglegislationtoenablefurtherregulationofpackaging and labelling. •Detailedguidanceandexamplesoflegislativelanguage:definitions;sizeandlocation;rotation;contentspecifications;preventing warningsfrombeingobscured;andprohibitionofinformation.

step 1: Identify your policy goals

Development of packaging and labelling measures, like any policy development process, requires a clear understanding of policy goals andtheoptionsavailabletoachievethosegoals.Thisunderstanding,andtheprocessofdeterminingpolicygoals,willguidemorespecificdecisions about the content of health warnings, the drafting of legislation, and other elements of policy implementation.

Common policy outcome goals are listed below:

•Convey information about health risks of tobacco use and exposure to secondhand smoke to smokers AND non-smokers. Increasing the knowledge and understanding of risk by tobacco users is a primary goal of package warnings. •Motivate smokers to quit or to smoke outdoors, away from family. Behaviour change resulting from the warnings has occurred in many jurisdictions. •Direct smokers to a quitline or other services to quit smoking. Provision of this information in a warnings system can help promote behaviour change. •Dissuade experimental or potential smokers from starting to smoke regularly. Health warnings can serve a preventative purpose, as well as promoting quitting. •Generate a public debate about the health risks of tobacco use and secondhand smoke exposure. Debates in the media and among smokers can increase awareness of warnings and their impact. • Decrease the likelihood that smokers will switch to “lower tar” products instead of quitting. Removal of misleading information and provision of accurate information can help lead smokers to healthier choices. • Decrease smokers’ misperceptions about emissions levels, product ingredients and differential product risks. Higher awareness of thetoxicsubstancesintobaccosmokeandtobaccoproducts,andoftheirhealthconsequences,caninfluencebehaviour. •Decrease or eliminate the ability of tobacco packaging to serve as a promotional vehicle. Larger, graphic warnings detract from the promotional value of the package and can help meet the goal of reducing or eliminating tobacco advertising and promotion.

step 2: Identify the best means to achieve these goals

Legislation and regulations specific to tobacco packaging and labellingIdeally governments should pass legislation and regulations that effectively implement the strongest packaging and labelling measures possible: graphic health warnings and information on packaging, elimination of misleading labelling and, perhaps, plain packaging. This Guidefocusesontobacco-specificlegislationtoachievepackagingandlabellingpolicies.Adetaileddiscussionoftheprocessandissuesinvolved follows.

Other means: existing consumer protection and other lawsInsomecaseslegislationspecificallytoachievethesemeasuresmaynotbefeasible,oritmayonlybepossibletoachievelegislationthatimplements partial or weak measures. This can happen for a variety of reasons: strong opposition from tobacco companies; unintentional loopholes in existing legislation and inertia to close them; and lack of political support within the government for strong measures.

In these situations, other legal and administrative mechanisms to help achieve your policy goals should be investigated. Consumer protection legislation exists in many countries that can be applied to tobacco products and packaging. In many countries, there are specialised tribunals or specialised prosecutors for consumer protection issues.

Health ministries that are preparing to address tobacco packaging and labelling should investigate the consumer protection system in their country and see how it could be used to advance their policy goals. An action brought against tobacco manufacturers for failure to warn or for misleading consumers may not only achieve a policy outcome, but can also help build a political environment more favourable to the passage and implementation of effective legislation requiring pictorial health warnings.

InCanada,AustraliaandItaly,complaintswerefiledwitheachcountry’scompetitionauthorityontheissueofmisleadingdescriptors(“light”and “mild”). In Italy the courts ruled against the manufacturers. In Canada and Australia, the competition authority settled out of court with the industry, in return for withdrawal of the descriptors. In both countries, the industry was required to pay for corrective advertising.191 192 193

194 195

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step 3: review legislation from other countries

Legislation from countries with effective regulations and with legal systems similar to your own will provide a good basis for developing your own legislation. Reviewing this legislation will help ensure that you have addressed all of the issues, and will provide you with examples of legislative language.

In addition to reviewing the legislation itself, you should consult with:

•Thoseinvolvedindevelopingthelegislationtoseewhathasworkedwell,andwhattheywouldrecommenddoingdifferently. •Legislativeandtobaccocontrolexpertsinyourowncountrytoseehowthelegislationcanbestbeadaptedtoaddressyour country’s situation. •Internationaltobaccocontrolexpertswhohaveexperienceinpackagingandlabellinglegislationandwhoarefamiliarwithyour country’s situation.

TheUnion’sTobaccoControlteam(www.tobaccofreeunion.org), the WHO Tobacco Free Initiative (www.who.int/tobacco/en/), and the WHO Framework Convention Secretariat (www.who.int/fctc/secretariat/en/) are excellent resources to help you identify the appropriate contacts in other countries.

The table below links to most legislation and regulations around the world mandating pictorial warnings and other packaging and labelling measures.

Jurisdiction Legislative instrument Languagesaustralia Trade Practices regulations 2004

www.health.gov.au/internet/main/publishing.nsf/Content/health-pubhlth-strateg-drugs-tobacco-warnings.htm. See link under heading: Health Warnings on Tobacco Product packaging - Trade Practices (Consumer Product Information Standards) (Tobacco) Regulations 2004

English

belgium royal arrêté 13 aouT 1990arrêté ministériel 27 oct 2005

French

brazil rdC nº 46, de 28 de março de 2001http://www.anvisa.gov.br/legis/resol/46_01rdc.htmrdC no 335, 21 nov 2003http://e-legis.anvisa.gov.br/leisref/public/showAct.php?id=8190regulation 335, 21 nov 2003http://anvisa.gov.br/eng/legis/resol/335_03rdc.htmresoLuÇÃo no 54 agosto 2008http://anvisa.gov.br/institucional/ouvidoria/boletim/2008/31_190908/utilidade_10.htm

Portuguese, English

brunei Tobacco Labelling regulations 2007www.tobaccolabels.ca/legislat/brunei2007

English

Canada Tobacco Products Information regulations 2000 (en français)www.hc-sc.gc.ca/hl-vs/pubs/tobac-tabac/rc/index-eng.php (English)www.hc-sc.gc.ca/hl-vs/pubs/tobac-tabac/rc/index-fra.php (français)

English, French

Chile decreto no.95 de 2006www.minsal.cl/juridico/decreto_95_06_tabaco.doc

Spanish

djibouti arrêté n°2008-491/Pr/Ms 2008www.presidence.dj/jo/2008/arr0491pr08.phpdécret n°2008-0183/Pr/Ms 2008http://www.presidence.dj/jo/2008/decr0183pr08.phpannexes

French

egypt Law 2007www.tobaccolabels.ca/legislat/egypt2007t

Arabic

european union eu Commission directive 2001_37 Warningseu Commission decision of 5sept2003Useofpictureseu Commission decision of 26May2005 Library of warningshttp://ec.europa.eu/health/ph_determinants/life_style/Tobacco/legal_smoking_prevention_tobacco_en.htm

AllEUlanguages,including English, French, Russian, and Spanish

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hong Kong (China)

smoking (Public health) (amendment) ordinance 2006www.smokefree.hk/cosh/ccs/detail.xml?lang=en&fldrid=365 (English)www.smokefree.hk/cosh/ccs/detail.xml?lang=tw&fldrid=365 (Chinese)

English, Chinese

Iran 2008 Tobacco Packaging regulationswww.tobaccolabels.ca/legislat/iran2008to

Persian

Malaysia Control of Tobacco Product (amendment) regulations 2008www.tobaccolabels.ca/legislat/malaysia20

English, Malay

Mauritius Public health (restrictions on Tobacco Products) regulations 2008www.gov.mu/portal/goc/moh/file/tobacco1.pdf

English

new Zealand smokefree environments regulations 2007www.legislation.govt.nz/regulation/public/2007/0039/latest/DLM427193.html

English

Panama decreto ejecutivo no 17 de 11 de marzo de 2005 www.tobaccolabels.ca/legislat/panama20Resolución No 471 de 23 de mayo de 2005 www.tobaccolabels.ca/legislat/panama20~3Decreto ejecutivo 230, de 6 de mayo de 2008 www.tobaccolabels.ca/legislat/panama2008

Spanish

Peru reglamento de la ley 28705, 2008www.minsa.gob.pe/portada/Especiales/2007/tabaco/default.asp

Spanish

romania ordIn nr 764 l5 June 2004www.smoke-free.ca/warnings/laws/Romania2004JuneOrderLabeling.rtf

Romania

singapore smoking (Control of advertisements and sale of tobacco) (Labelling) regulations 2003www.smoke-free.ca/warnings/laws/singaporeregs.pdfsmoking (Control of advertisements and sale of tobacco) (Labelling) (amendment) regulations 2006www.smoke-free.ca/warnings/laws/Singapore%20Regulation%20Amendment%202006.pdf

English

Taiwan (China) Tobacco Labelling regulations 2008www.bhp.doh.gov.tw/bhpnet/English/Class.aspx?Sub=research&No=200705180022

English, Chinese

Thailand Ministry of Public health´s announcement (no.8) b.e. 2547www.tobaccolabels.ca/legislat/thailand

Thai, English

united Kingdom Tobacco Products (Manufacture, Presentation and sale) (safety) (amendment) regulations 2007www.opsi.gov.uk/si/si2007/uksi_20072473_en_1

English

uruguay decreto 20 oct 2005decreto para reglamentar la Ley n.18.256 de 6 de marzo 2008www.tobaccolabels.ca/currentl/uruguay

Spanish

venezuela resolución 109 de 22 Mar 2004www.tsj.gov.ve/gaceta/marzo/230304/230304-37904-14.htmlresolución no 56 de 3 de abril 2009www.tsj.gov.ve/gaceta/abril/030409/030409-39153-13.html

Spanish

step 4: develop legislation to achieve your goals

In parallel to identifying the goals of your package information system, you will need to develop legislation that effectively implements those goals. Some of the questions that will need to be addressed in developing legislation include the following, although the list is far from exhaustive:

•Howmanywarnings? •Shouldyouborrowexistingcontentandimagesforwarningsordevelopyourown? •Shouldyouusedifferentwarningsfordifferentproducts? •Shouldyouusedifferentwarningsfordifferenttypesofpackages(eg.individualpackagesvs.cartons)? •Howwillyouaddressproductswithoutexteriorpackaging,orwith“challenging”packaging(eg.singlecigarettes,waterpipe)? •Howoftendoyouwanttorevisewarnings?Whatmechanismwillbeused? •Whattypeofconstituentandemissionsinformationisneeded? •Whatinformationistobeprohibited? •Howquicklydoyouwantpoliciesimplemented?

Questions of legislative content will link closely to the warnings development considerations discussed in section 2.2. Many of the questionswilloverlapwiththoseaskedinthewarningsdevelopmentprocess,althoughtheresponseswillbereflectedinlegislativelanguage rather than in design concepts.

Specific drafting components and issues

Many legislative/regulatory approaches have been used to achieve effective packaging and labelling measures. For this reason, it is difficulttorecommendasinglemodelregulation.Instead,thissectionidentifiesthekeyissuesaroundlegislativelanguageandprovidesexamples of options most likely to be effective.

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Normally, you will need to amend or introduce enabling legislation that permits you to regulate tobacco packaging and labelling. This legislation should be quite broad (see box Checklist for enabling legislation).

However, an important factor in the success of implementation is the specificity within regulations. It is critical that regulations specify the content and form (appearance) of warningsandotherrequiredinformationasmuchaspossible.Lackofspecificityallowstobacco manufacturers to exploit loopholes that undermine the intent and spirit of the legislation or regulations, even if they are technically compliant with the requirements.The Guidelines for implementation of Article 11 of the WHO FCTC highlight the following areasrequiringspecificityinlegislationorregulations:

• Packagingandproducts. • Language(s)tobeused,includinghowlanguagesshouldappearifthereis more than one language. • Rotationpracticeandtimeframes. • Distributionpractices,inordertoobtainequaldisplayofhealthwarningsand messages on retail packages. • Howtext,picturesandpictogramsofhealthwarningsandmessagesshould actuallyappearonpackaging(includingspecificationoflocation,wording,size, colour, font, layout, print quality), including package inserts, onserts and interior messages. • Differenthealthwarningsandmessagesfordifferenttypesoftobaccoproducts. • Sourceattribution,ifappropriate,includingplacement,textandfont. • Prohibitionofpromotionbymeansthatarefalse,misleading,deceptiveorlikely to create an erroneous impression, in accordance with Article 11.1(a).196

CheCKLIsT: enabling legislation The legislation that provides the authority to government to implement packaging and labelling measures will greatly determine theeffectivenessofthemeasuresthemselves,andoftheregulationstofurtherdefinethemeasures.Themostimportantitemstoinclude in enabling legislation are listed below:

DO: Set a floor, not a ceiling. Ensure legislation sets minimum requirements, but does not limit regulatory scope to go further. For example: •Defineaminimumsizeforwarnings,butdonotlimitthesize:“Thehealthmessagesprovidedforbyregulationsunderthis Act shall cover not less than 50% of all main faces of tobacco packaging, and may cover more.” •Specifythatimagesmust be required by the regulations: “The health messages provided for by regulations under this Act shallincludepictorialrepresentationssuchasgraphicsorpicturesonallmainfacesoftobaccopackaging,asdefined by regulation.”

DO: Ensure definitions are sufficiently comprehensive.Thedefinitionofatobaccoproductshouldcovereverytypeofproductthat could conceivably be sold or promoted as a tobacco product. Any packaging that is used or visible at retail sale should be includedinthedefinitionofpackaging.Wheretobaccoproductsareservedinsocialsettings(suchasshisha or narghile in cafes), definitionsshouldbebroadenoughtoensurethatwarningsarerequiredonproductaccessoriesdisplayedorservedinthatsetting.TheWHOFCTCprovidesgooddefinitionsfortobaccoproductsandtobaccopackaging.

do: Make it clear that labelling requirements do not absolve manufacturers from legal liability. Legislation requiring health warnings on tobacco packaging should not shield tobacco companies from legal liability due to harm caused by their products or by failure to warn. For example, Canada’s Tobacco Act says, “This Part does not affect any obligation of a manufacturer or retailer at law or under an Act of Parliament or of a provincial legislature to warn consumers of the health hazards and health effects arising from the use of tobacco products or from their emissions.” (Part III, Article 16)

do: write effective enforcement mechanisms and deterrent penalties into legislation. •Holdmanufacturers,importers,wholesalersandretailsellersresponsibleforensuringthatpackagingiscompliant. •Setpenaltiesthattodeterviolations,andarenotcountedsimplyasthecostofdoingbusiness.Thiswillmean proportionately higher penalties for large sellers and manufacturers. For example, in Canada, the penalty for a retailer violating the packaging provisions is $50,000; for a manufacturer it is $300,000 and jail time. •Identifytheenforcementauthority,orprovidescopefortheregulationstodoso. •Ensureadequateauthorityforinspectorstoenterandinvestigatemanufacturingandotherfacilities. •Ensureauthorityforinspectorstoseizenon-compliantproducts. •Ensureastreamlined,efficientadministrativeenforcementprocess. •Enablethepublictoreportviolations.

do: set deadlines.Enablinglegislationitselfcansetstrong,specificrequirementsforwarningsandotherlabellingmeasures,and can specify a deadline for entry into force. If it does not, it should require regulations to be written and to come into force by a specificdeadline.Forexample:“RegulationsrelatedtopackagingandlabellingunderthisActshallbepublishedwithin180daysofpublicationofthisAct.Measuresspecifiedbyregulationshallcomeintoforcenolaterthan180daysfollowingpublicationoftheregulations.”

Article 11 Guidelines: Specificity in legislationParties should ensure that clear, detailed specificationsareprovided...tolimittheopportunity for tobacco manufacturers and importers to deviate in the implementation of health warnings and messages, as well as to prevent inconsistencies among tobacco products. (Paragraph 52)

article 11 Guidelines: source documentParties should consider providing a “source document”, which contains high-quality visual samples of how all health warnings and messages and other information are to appear on packaging. A source document is particularly useful in the event that the language used in the legal measures [legislationorregulations]isnotsufficientlyclear. (Paragraph 53)

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To avoid unintentional loopholes, regulations should not only include a detailed textual description of the content, text, font size and type, colours, location, etc, required for warnings or other information, but also a source document (a visual annex, usually in electronic form) that illustrates how the information is to appear.

Singapore’s 2003 regulations provide an elegant example of using a combination of text and visual annexes to lay out requirements.197 Theresultisaconciseregulationwithsufficientspecificitytominimisethepotentialforloopholes.

DefinitionsAsdiscussedinthebox,definitionsshouldbebroadenoughtoencompassunforeseenproducts,packagesandsituations.However,theymayalsoneedtobeveryspecificinordertoaddressspecificissues.Normally,enablinglegislationwillprovidebroaddefinitions,whileregulationsprovidemorespecificity.

For example, Canada’s Tobacco Actprovidesregulatoryauthoritytomandatehealthmessagesandotherrequirements.Itdefinesatobacco product as:

“… a product composed in whole or in part of tobacco, including tobacco leaves and any extract of tobacco leaves. It includes cigarettepapers,tubesandfiltersbutdoesnotincludeanyfood,drugordevicethatcontainsnicotinetowhichtheFoodandDrugs Act applies.” 198

regulations passed in 2000undertheActdefinespecifictypesoftobaccoproductsandrelatedproducts,suchastobaccotubesforrollingcigarettes.Themorespecificdefinitionsdecreaseuncertaintyabouthowtherequirementsapplytodifferenttypesoftobaccoproducts.

“cigarette” includes any roll or tubular construction that contains tobacco and is intended for smoking, other than a bidi, cigar, kretek or tobacco stick.

“cigar” includes:

(a) a cigarillo or cheroot.

(b)naturalorreconstitutedleaftobacco,abinderofnaturalorreconstitutedleaftobaccoinwhichthefilleriswrapped,anda wrapper of natural or reconstituted leaf tobacco. “kit” means a package that includes any of the following tobacco products together with another tobacco product, which products are intended to be assembled by a consumer for their use: (a) cigarettes.

(b) cigarette tobacco.

(c) leaf tobacco.

(d) cigars.

(e) pipe tobacco.

(f) tobacco sticks.

(g) chewing tobacco.

(h) snuff.

(i) kreteks; or (j) bidis.

Itisalsopossibletodefineproductsandpackagesgenerally,incombinationwithdetailedspecificationsforrequirementselsewhereintheregulations.

Size and locationIt is critical that legislation or regulations specify the minimum size (normally, a proportion of one of more surfaces of the package) for warnings and other information.

Locationofallrequiredinformationshouldalsobespecified:Ifregulationsdonotspecifythatwarningsmustappearonthetopportionof the main faces of the packaging, as recommended by best practice, the tobacco industry will choose to place the warnings in the less visible bottom portion.

For example, Canada’s 2000 regulations specify the size, location, and direction of text:

“5. (2) The health warnings must… (b) occupy at least 50 percent of the principal display surfaces and be positioned parallel to the top edge of the package, towards the top part of the package as much as possible while satisfying the requirements of paragraph (c), and in the same direction as the other information that is on the package;198

Definitions: closing a loophole in Canada

In Canada tobacco manufacturers produce pre-rolled sticks for loose tobacco under tobacco brand names. For some time the manufacturers avoided warnings on these products because they weren’t includedintheexistinglaw’sdefinitionoftobacco products. These products featured prominently in point-of-sale displays without the marketing disadvantage of a warning.ThiswasrectifiedwhenCanadianlawexpandedthedefinitionoftobaccoproducts.

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Specificationsforsizeandlocationofwarningsshouldtakeintoaccountdifferent types of products and packaging. For example, regulations that specify that warnings are required only on the “front and back” of packaging leave a large loophole for any packaging with more than two main faces, such as cigarette cartons, or book-style packages that open up to reveal additional package faces. If this type of packaging is only required to carry warnings on the front and back, other large display surfaces will be permitted without warnings.

warnings on tobacco accessories: water pipe

Water pipe smoking (shisha or narghile) presents a challenge for so-called “package” warnings. Often, the only packaging of these products seen by consumers is the water pipe in which the shisha is served. Countries where water pipe smoking is common will need to carefully consider how to prescribe warnings on this novel type of packaging.

Although some countries require warnings on tobacco for water pipe, no country to date requireswarningsonwaterpipesthemselves.ResearchersatAmericanUniversityinBeirut(AUB)havedonepreliminaryresearchonsomeoptions,includingtestingspecificwarnings images and suggesting how warnings could be placed on water pipes.

Read the brochure produced by aub (English, French, Arabic) for further information. TobaccoControlResearchGroup,AmericanUniversityof Beirut. Advocacy Brief. Act Now, Narghile, dangerous, unregulated.Lebanon,AUB,November2008.

It is much better to specify that the required warnings appear on all main faces or principal display areas of packaging.

Placementofwarningsmayneedtobedefinedseparatelyforeachdifferenttypeofproductandpackaging.Certaintypesofproductsand packaging may present particular challenges, such as water pipe (see box above) and tobacco wrapped in betel leaves. Warnings on these products and packaging must be addressed in regulations.

Separatespecificationsshouldalsobesetoutfor:

•Theproportionofthewarningspaneltakenupbytextorbyanimage.Forexample,“Thespecifiedimageshallcoverthetophalf ofthewarningspanel.Thespecifiedtextshallbecenteredhorizontallyandverticallyinthepartofthepanelnotcoveredbythe image,inthefonttypeandsizespecifiedinthesourcedocument,andshallinanycasecomprisenolessthan80%oftheportion of the panel not covered by the image, whichever takes up the larger area of the panel.” • Thesizeofanyborderaroundthewarningspanel,whichshouldbeINADDITIONtothesizeofthewarning.Forexample (adapted from the eu 2001 directive) 200 “The warnings panel shall be surrounded by a black border not less than 3mm and not more than 4 mm in width. The area covered by the border shall not be included in the calculation of the percentage described in clause X.X.” Content, font, colour and print qualityThecontent(textorimages),fonttypeandsize,coloursandprintqualityofwarningsandotherrequiredinformationshouldbedefinedinthetextoftheregulations.However,asdiscussedabove,implementationwillbemosteffectiveiftheseelementsarealsodefinedinanelectronically-available source document that visually illustrates, to scale, the required warnings.

Regulations should require that the warnings messages and images are to be reproduced directly from the electronic source document withoutmodificationandusingthesameimagequalityasthesourcedocument.

Refer to the legislation tablefornumerousregulatoryexamplesoftextualspecificationscombinedwithvisualillustrationsinasourcedocument, including from Australia, Belgium, New Zealand, Hong Kong SAR (China), and Singapore.

RotationRotation refers to the requirement for multiple warnings to appear on packages concurrently, and to the requirement for a new set of warningstobeimplementedregularly.Bothofthesetypesofrotationneedtobedefinedclearlyintheregulations.

Concurrent rotation ensures that multiple warnings are displayed equally often on all brands of tobacco products. australia’s 2004 regulationsusetwoseparatelegislativeclausestoclearlysetoutrotationrequirementsamongseparatebrands.Thefirstclause(Art.36.1)specifiesequalrotationofallrequiredmessagesonallkindsoftobaccoproducts.Thesecondclause(Art.Art.39)defineskindtoensure that messages rotation occurs among all brand and product variations:

Part 4 Division 2, 36.1.(b) each warning message, corresponding explanatory message and, if required, the corresponding graphic, mentioned in items 201 to 207 of Schedule 2 must be printed in rotation on relevant retail packages, so that, during the period[definedincurrentregulationsasyearly],eachmessageappearsasnearlyaspracticableonanequalnumberofrelevant retail packages of each kind of cigarette and of loose or pipe tobacco.

39 Different kinds of cigarettes or tobacco A cigarette or loose or pipe tobacco is of a different kind for paragraphs 36 (1) (b) and (2) (b) if:

(a) It is sold under different brand names.

(b) It is sold under one brand name but is distinguished in one or more of the following ways:

(i) Containing or not containing menthol.

(ii)Beingotherwisedifferentlyflavoured.

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(iii) Having different contents of tar.

(iv) Allegedly differing in ‘mildness’.

(v)Havingornothavingfiltertipsorcorktips.

(vi) Being sold in retail packages containing different numbers of pieces.

(vii) Being of different length or mass.201

Regulations should require regular renewal of warnings in order to avoid wear-out and to sustain impact. One option is to amend regulations every few years to require implementation of a new set of warnings. However, it may not be practical to amend regulations this often.

Another option is to build two or more sets of warnings into a single regulation, requiring two or more sets of warnings to be rotated within specifiedtimeperiodsdefinedbyaschedule.Thisapproachhasbeentakenbyaustralia and belgium.201 202

One advantage of this approach is that regulations can be written just once while ensuring regular renewal of the warnings over several years. It also avoids the inevitable battles with the tobacco industry every time new regulations are proposed.

A disadvantage of this approach is that, if the warnings turn out not to be as effective as hoped, a country may be locked into using warnings that could be substantially improved. Pre-testing of warnings, as well as use of warnings that have proven effective in a variety of countries, will help avoid this scenario.

Permanent, not destroyed when opened, and not obscuredRegulations should ensure that the warnings and other required information are permanent, and remain clearly visible on the package before and after the package is opened. In particular, regulations should:

•Preventthetobaccoindustryfromobscuringtherequiredinformationwithonsertsattachedtothepackage. •Preventcompanies(particularlyimporters)fromputtingrequiredinformationonlyonremovablestickersthatwilldisappearwhen the package is opened. •Preventwarningsfrombeingdestroyedormadepermanentlyunreadablewhenthepackageisopened.

Avoid language similar to the following: “The required warnings shall be printed so as to not be severed when the package is opened.” Thisphraseisunnecessaryandlimitstheflexibilityofdesignofwarningsmessagesandimages.Tobaccocompaniespreferthislanguagebecauseitstrengthenstheirargumentthatwarningsonthefrontofstandardflip-toppacksshouldbenolargerthanthetopportionofthefliptopsor,inotherwords,farlessthantherecommended50%ormoreofeachmaindisplayareaofthepack.

Australia’s 2004 regulations guard against obscuration of the messages as follows:

15 Messages not to be obscured etc 1. If a message that is required by this Part to be printed on a retail package is likely to be obscured or obliterated by a wrapper on the package, the message must be printed on both the wrapper and the package.

2. A message (other than a message on a carton) must not be likely to be obliterated, removed or rendered permanently unreadable when the retail package on which it is printed is opened in the normal way.201

In addition, regulations could require warnings messages to be visible on packages:* “Where display of tobacco products is permitted at point of sale, the warnings on the front main face of the package required by these regulations must not be obscured during display of the products.”

Regulationsalsocouldspecificallyprohibituseofonserts(messagesattachedtotheoutsideofpackages)bymanufacturers.brazil’s 2003 regulations prohibit the use of wrappers and other devices that cover the warnings image:

Article4.Theuseofanyothertypeofwrappingordevicethatmakesthevisualizationofthestandardimageimpossibleordifficult or of resources such as cards or stickers that may be used by the consumer to cover the image on the packs of the products mentioned in this Resolution is hereby forbidden.203 [English translation of original resolution in Portuguese provided on ANVISA website]

Permitting use of adhesive warning labels can neutralise opposition from manufacturers or importers whose packaging does not facilitate direct printing of warnings. However, adhesives should not be easily removable. From New Zealand’s 2007 regulations:

23 Use of adhesive labels 1. A warning message, corresponding explanatory message, or corresponding graphic that is required by this Part to be printedonaretailpackage(exceptaflip-toppack,softpackorcartoncontainingcigarettes)maybeprintedonan adhesivelabelthatisaffixedtotheretailpackage.

2. An adhesive label must: (a)ComplywiththisPartinallrespectsexceptasspecificallypermittedbythisregulation.

(b)Beaffixedtothefaceoftheretailpackageonwhichthemessagethatitdisplaysisrequiredtobeprinted.

(c)Befastenedfirmlytotheretailpackagesoasnottobeeasilyremovablewithoutsignificantdestructionofthepackage.204

article 11 Guidelines: rotationRotation of health warnings and messages and changes in their layout and design are important to maintain saliency and enhance impact. Parties should consider establishing two or more sets of health warnings and messages toalternateafteraspecifiedperiod,suchas every 12-36 months. (Paragraphs 20 & 22)

* Obviously this should only be required where packages themselves are permitted to be displayed at point of sale. Many jurisdictions now follow the best practice of prohibiting the display of tobacco packaging at point of sale.

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Misleading labelling in brazil: a moving targetIn March 2001, Brazil prohibited misleading terminology, such as “ultra light” and “low tar”, on packaging. Despite this, the tobacco companies continued “light” and “mild” messaging through numbers.

before:FreeOne,UltraLightsandLowTarafter: Free “1”, “4” and “6”

In January 2003, Brazil prohibited the use of numbers associated with tar, nicotine and carbon monoxide levels in the brand name of the product. This proved a mere inconvenience to the tobacco companies: they used colours to continue their messaging. The industry also promoted the colour schemes – and their meaning – to consumers through ads and package inserts.

still misleading: Carlton Silver, Blue and Red

Many public health experts conclude that the only effective response to misleading labelling is to require all tobacco products to be sold in plain packaging. Plain packaging is recommended as an option by the Guidelines on implementation of Article 11.

Read more on Brazil’s experience: Cavalacante T. Labelling and Packaging in brazil. who. undated.

Prohibition of informationArticle 11.1(a) of the WHO FCTC requires Parties to eliminate misleading labelling and providesspecificexamplesoftermsthatmaybeprohibited.205

Regulations should expand on the language in Article 11.1(a) to be even more prescriptive andspecific.Inadditiontoprohibitingmisleadingterminology,regulationsshouldprohibittheuse of numbers and colours or patterns of colours associated with different tar or nicotine numbers or so-called “strengths”.

However, eliminating misleading labelling through the prohibition of individual elements such as words, numbers and colours is not a straightforward task. As demonstrated in Brazil (see box, Misleading labelling in brazil: a moving target) and other countries, tobacco companies have consistently exploited legislative loopholes in this area.

Ideally, misleading labelling should be addressed by requiring all tobacco products to be sold in plain packaging, as recommended by the Guidelines on implementation of Article 11.

See the evidence review for a detailed discussion of evidence to support plain packaging as an effective public health measure.

2.2 development of health warnings and constituent/emissions messages

2.2.1 development of health warningsThere are a variety of approaches to the design and selection of health warning messages. Some countries, such as Canada and Australia, have invested considerable time and resources in the development of health warnings, whereas other countries – in order to minimise delay, save resources or both – have adopted warnings very quickly, often adapting warnings used in other countries.

Soon your Derby is going to change the name of its versions King Size, Suave (Mild) and Lights. Now besides the different yeilds, the traditional colours are going to mark the difference among them:Red for those that prefer a intense tasteBlue forthose who want mildnessSilver light taste, the lighter of the family

ads and inserts promote the colour schemes

article 11 Guidelines: Plain packagingParties should consider adopting measures to restrict or prohibit the use of logos, colours, brand images or promotional information on packaging other than brand names and product names displayed in a standard colour and font style (plain packaging). This may increase the noticeability and effectiveness of health warnings and messages, prevent the package from detracting attention from these and address industry package design techniques that may suggest that some products are less harmful than others. (Paragraph 46)

resourceRefer to the checklists at the end of this section to help you develop your warning labels.Checklist 1: Layout and designChecklist 2: Themes and contentChecklist 3: Constituent and emissions messages

Source: Alex Lee

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This section attempts to simplify this process into a series of steps that can be adapted to local needs and the availability of resources. However, readers should note that all of the steps are inter-related, and often take place simultaneously.

step 1: review warnings used in other jurisdictions

Before developing new health warnings, you should look at existing health warnings in other jurisdictions to help generate ideas and identify possible themes. Many countries have implemented large pictorial warnings that satisfy the general recommendations for layout and design.

The WHO FCTC Conference of the Parties has asked the Convention Secretariat (FCS) to invite WHO’s Tobacco Free Initiative (TFI) to establish a database of pictorial warnings. It has also asked the FCS to facilitate the granting of licenses between countries for use of warnings.206 Consult the TFI and FCS websites for the current status of the database:www.who.int/fctc/secretariat/en/www.who.int/tobacco/en/index.html

In the meantime, collections of picture warnings and other images used in testing are available at:www.tobaccolabels.org(UniversityofWaterloo,FrameworkConventionAlliance,andTheUnion)www.smoke-free.ca/warnings/default.htm (Physicians for a Smoke-Free Canada).

Some countries grant permission to use their images and have a quick process for doing so. In other countries, the Ministry of Health does not own the rights to the images, and it maybedifficultand/orexpensivetousetheimages.

If the images or warnings you want to use are not easily available, another option is to adapt and re-create image ideas from another country. You can work with a creative agency or photographer and medical specialists in your country to create similar images, even if the original images are copyrighted. In doing so, you may even be able to improve the relevance and impact of the message for your country.

The table below summarises the availability of many images currently in use. Countries for which the availability of images was unknown at time of printing are not included in the table.

Jurisdiction Images available? Comments / restrictions Contact information Link to images – government internet source

australia Yes – most images Licensing agreement must be signed with the Ministry of Health and Ageing – no cost. Agreement may require a copyright statement where the images appear and the opportunity to inspect the finalproductinwhichtheimagesappear. List of warnings and copyright holders: set a set b

Mr. John Mohoric, Ministry of Health and Ageing john.mohoric@health.gov.au

set a set b

brazilRounds 1 & 2 No Ministry of Health does not hold

copyright to the images

Round 3 Yes – most images Ministry of Health owns copyright to most images for a period of 5 years. Contact INCA for more details

Dr. Tania Cavalcante, National Cancer Institute (INCA) Ministry of Healthtaniac@inca.gov.br

Canada Yes Licensing agreement must be signed with Health Canada – no cost

Ms. Christine Belle-Isle, Health CanadaOfficeofRegulationsandCompliancechristine_belle-isle@hc-sc.gc.ca

european union

Yes – most images Licensing agreement must be signed with the European Commission – no cost. There are five warnings that cannot be licensed to third parties.

Ms. Anna Jassem-Staniecka, European Commission Directorate-General for Health and Consumersanna.JasseM@ec.europa.eu

new Zealand

No – most images Many images are used under copyright permission from other sources. Contact the Ministry of Health for details on individual images.

Mr. John Stribling, Ministry of Health john_stribling@moh.govt.nz

Where to find examples of warningsCurrently:www.tobaccolabels.orgwww.smoke-free.ca/warnings/default.htm

In future:www.who.int/fctc/secretariat/en/www.who.int/tobacco/en/index.html

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Panama No Images are adapted from other countries,includingVenezuela,Canada and Brazil. See information for these countries.

singaporeRounds 1 & 2 Yes Contact the Ministry of Health to

request permission to use – no cost

Ms. Annie Ling, Health Promotion Boardannie_ling@hpb.gov.sg

ThailandRounds 1 & 2 Yes Contact the Ministry of Health to

request permission to use – no cost

To obtain high-resolution images: Dr.PrakitVathesatogkit,ASHThailand prakit@ashthailand.or.th Ministry of Health contact email: heaw72@yahoo.com

uruguayRounds 1, 2 & 3

Yes Contact the Ministry of Health to confirmavailabilityandconditionsof use.

Dr. Winston Abascal, Ministerio de Salud Públicawabascal@msp.gub.uy

venezuelaRounds 1 & 2 (Round 2 anticipated 2009-2010)

Yes Images are in the public domain. Contact the Pan American Health Organization/WHO to obtain high-resolution images.

Ms. Natasha Herrera, PAHO/WHOVenezuela,natasha@ven.ops-oms.org, with copies of request to PAHO/WHO HQ: Dr. Adriana Blanco & Ms. Rosa Sandoval, blancoad@paho.org, sandovar@paho.org

Inchoosinganddesigningwarnings,youshouldalsodrawonexistingresearchshowingwhichspecificmessageshavemosteffectiveinother jurisdictions. Evaluation information can be requested from the contacts above.

Step 2: Determine general design and specific layout elements

After reviewing existing warnings, the next step is to determine the general design parameters – such as size and location of warnings and useofimages–aswellasspecificlayoutelements.Thefiguresbelowillustratethreedifferentexamplesofdesignandlayoutofpictorialwarnings.

Canada front (50% size) back (50% size)

Marker word

TaglineBlack-bordered letters

English text

Attribution to health authority

Source: Alex Lee

Same warning with French text

belgium / european union front (48% size) back (63% size)

Text (three languages)

Bolder border

Source: Alex Lee

Picture with border

 

 

 

 

 

 

 

 

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australia front (30% size) back (90% size)Tagline white letters /

black background

Picture with title

Attribution to health authority

Source: Alex Lee

Tagline white letters / red background

Attribtion to health authority

Picture with title

Cessation information

Explanation

Size of warningsThe FCTC requires warnings to cover a minimum of 30% of the principal display areas of packaging and recommends that they cover at least 50%. The Article 11 guidelines recommend that the warnings be as large as possible.

In many cases, the size of the warnings is the same on both the front and back of packages; however, some jurisdictions have used different sizes for each side. In Australia, for example, pictorial warnings cover 30% of the front of the package, and 90% of the back; in Brazil, warnings cover 100% of one main face.

In any case, warnings should cover at least 50% of all principal display surfaces. This ensures that the warnings are visible regardless of which package face is displayed. This is especially important if tobacco products are displayed at the point-of-sale in retail outlets, where cigarette packages and other tobacco products are often seen by children and young people.

Location of warnings Health warnings should be positioned at the top (upper portion) of all principal display surfaces in order to maximise their effectiveness at the point-of-sale, and because the upper part of packaging draws more consumer attention than the lower part.

While the external display surfaces of the package are the most effective space for health warnings or any other information, jurisdictions can also consider using the inside of packages for health messages. Canada currently requires one of 16 messages to appear on the inside of packages – see right. Although less noticeable than the health warnings on the exterior of the package, interior messages nevertheless represent an added opportunity to communicate with the smoker. Similar opportunities exist with respect to onserts (messages attached to the outside of packages).

Design and layout options to accommodate different types of packaging or productsAlthough the most prevalent examples of health warnings are those required on manufactured cigarette packages, in most countries there are numerous types of tobacco products and packaging on the market. These include cigarette cartons, packaging of loose tobacco, cigar boxes, water pipes, and packaging for locally-made products such as gutkha or bidi. You will need to determine design and layout options for all types of products and packaging on the market in your country.

The images below illustrate how the layout and design of Canadian health warnings have been adapted tofitdifferentformsofpackaging.

Use of images or picturesWarnings with images are far more effective than warnings that use text alone. A major design consideration is whether or not images will be used (images are highly recommended). How to use images most effectively is discussed in more detail in Presentation styles.

article 11 Guidelines: sizeHealth warnings should cover more than 50% and should “aim to cover as much of the principal display areas as possible.” (Paragraph 12) [emphasis added]

article 11 Guidelines: LocationHealth warnings should appear on all main principal display areas, at the top of those areas. (Paragraph 8)

article 11 Guidelines: Types of packagingParties should indicate... how the proposed health warnings and messages will apply to each type and shape of packaging, such as tins, boxes,pouches,flip-tops,slide and shell packages, cartons, transparent wrappers, clear packaging or packages containing one product unit. (Paragraph 37)

 

  

 

  

 

 

Source: Alex Lee

Source: Alex Lee

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Position and relative proportion of pictures and textThe amount of space dedicated to pictures versus text, as well as their position relative to each other, varies across jurisdictions. Warnings can position the picture and the text side-by-side, with the picture to the left and the text to the right (see the front of Australian packages), or place the picture above the text description (see the back of Australian packages). Text can also be superimposed on the image, as illustrated in the warning from Taiwan.

Whatever layout is chosen, picture should appear on all major faces of packages and occupy at least half of the space devoted to warnings. This is because the picture is the most effective component of the warning.

Marker wordMarkerwords,suchas“CAUTION”,“DANGER”,or“WARNING”areacommonfeatureofwarninglabels. Packages in several jurisdictions use “WARNING” as a marker word - (see the example from Singapore). In most cases, the font size of the marker word is larger and printed in a different colour than other text in the warning.

TaglineThe headline or tagline serves as a summary of the main message and is used in conjunction with the picture to attract attention. The tagline should be relatively concise (e.g., no more than a sentence) and provide a clear summary of the warning presented in direct, unequivocal language.

The tagline can be displayed either at the top of the warning, above the image, or beside the image, immediately preceding the more detailed explanatory text (see example from Canada). The tagline shouldhaveasufficientlylargeandboldfonttobeclearlylegibleandtostandoutfromthewarning.Note that the colour of the font and background should contrast in order to maximise legibility. Black lettering on white background and white lettering on black background are examples of effective contrast.

Explanatory textMany warnings include one or more sentences of text to help explain the health risk depicted in the picture and the tagline. Although the amount of explanatory text differs considerably across jurisdictions, it should be considered an important element of the warnings. The font size of the explanatory text will typically be smaller than the tagline, but must still be large enough to be easily read. As with the tagline, the colour of the font and background should contrast in order to maximise legibility.

General guidelines for explanatory text:

•Textshouldbeconsistentwiththethemesandsubjectdepictedinthepicture. •Textshouldbeclear,simpleanddirect:lesstextthatiseasiertoreadwillbemoreeffectivethanlongsentenceswithconfusing detail. •Technicallanguageshouldbeavoidedandalltextshouldbeatanappropriateliteracylevelforthetargetaudiences. •Textshouldavoidlanguagethatmaycreateuncertaintyordoubtabouttherisksdepictedinmessages,suchas“can”,“may”,or “might”. For example, warnings should read “Tobacco causes lung cancer”, rather than “Tobacco can cause lung cancer”. •Statisticsandnumbersshouldbeusedonlyinrarecases.Mostsmokersdonotunderstandevensimplestatisticsand,ontheir own, numbers may prove misleading. If numbers or statistics are used, they should be presented as simply as possible and should be tested with focus groups during the development of warnings.

Attribution of messageWarnings in many countries include text attributing the health warning to the government or some other source. Often the name of the health ministry is printed in small font following the warning. In other cases, the attribution is part of the preamble to the warning, such as: “The Department of Health and Welfare advises…”

In countries where the government health ministry is well regarded and has high credibility, attribution to a government source may increase the believability of the information. However, if the government is generally disliked or mistrusted, attribution to government sources may result in rejection of the health warning. Attributions also require valuable space that could be devoted to other information.

It should be noted that the tobacco industry often favours government attribution, perhaps to distance itself from the health messages, or because inclusion of an attribution takes away space available for the warning. Overall, however, there is no clear consensus as to whether attributions increase or decrease the credibility of warnings. If attributions are included as part of the warning, the attribution should be made to a health authority rather than the government in general. The attribution should also be relatively small to minimise the space it occupies and should appear at the bottom or end of the text message.

Multiple languagesJurisdictions need to consider how many and which languages their warnings need to accommodate, and the best way to incorporate multiplelanguagesintothedesign.Warningscouldincludeofficiallanguagesofthecountry,aswellasotherwidelyusedlanguagesthatwould make the warnings more accessible to more people.

article 11 Guidelines: Pictorials (images)Parties should mandate culturally appropriate pictures or pictograms, in full colour, in their packaging and labelling requirements. Parties should consider the use of pictorial warnings on all principal display areas of packaging. (Paragraph 14)

Taiwan.

Singapore.

Canada.

article 11 Guidelines: attributionParty-specificcircumstances...willdetermine whether the use of source attribution is likely to increase credibility or reduce impact. If required, [it] should specify a credible, expert source, such as the national health authority. The statement should be small enough so as not to detract from the overall noticeability and impact of the message, while being large enough to be legible. (Paragraphs 30 & 31)

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In Canada the same warning appears in French on one face of the package and in English on the other. The Belgium warnings, shown here, display the text in Dutch, French, and German. Because this requires additional space, the sizeoftheBelgianwarningsislargerthantheminimumEuropeanUnionstandard.

step 4: select number of warnings and rotation period

The FCTC requires health warnings to be rotated on packaging. This can be done either by requiring multiple warnings to appear on packages concurrently, or by requiring a new set of warnings to be implemented regularly. Ideally jurisdictions should implement both types of rotation by determining a number of warnings to appear concurrently, and a schedule for implementing new sets of warnings. These decisions must be made early in the process in order to determine how many warnings will need to be developed.

There is no consensus on either the ideal number of health warnings within each set or the ideal rotation period between sets. However, a general guideline is that each set of warnings should include eight to 12 individual warnings that appear concurrently. A new set of warnings should be introduced every one to three years, and no less than every four years, to ensure continued effectiveness of the warnings.

See section 2.1 on addressing rotation in legislation.

step 5: Content - identify themes and subjects

Healthwarningsshouldbethoughtofasacommunicationstrategy.Beforedevelopingspecificwarnings,thebasicobjectives,targetaudiences,andbroadthemesshouldbeidentified.Themesmightincludeaddiction,healtheffectsoftobacco,cessation,andothercostsoftobaccouse,includingfinancial,socialandenvironmentalcosts.

While it is possible to target many or even all of these broad themes within a set of health warnings, jurisdictions may want to give priority to certain themes in terms of the number of warnings devoted to each. The decision should be guided in part by the following:

• Whataretheexistinglevelsofhealthknowledgeinthepopulation? • Whatmessagesareincludedinpreviousandexistingsetsofhealthwarnings? • Aretherespecificdiseasesorareasofhealthknowledgethatareconsideredapriority? • Whatthemesaremostlikelytoresultinbehaviourchange?

The table below presents common themes and subjects addressed in health warnings, each of which are addressed in detail:

Possible themes and subjects for health warningsTheme Sub-theme SubjectAddiction Addictive substances

TestimonialsFacts and statistics

Cessation Benefitsofquitting •Healthbenefits•Otherbenefits

SupportiveefficacymessagesQuitting tipsCessation services and sources of support

•Telephonehelpline•Internetsites

Health effects Effects on self •Generalmorbidityandmortality•Specifictypesofdisease•Qualityoflife

Effects on others •Secondhandsmokeandtypesofdisease•Sufferingoffamily

Toxic constituents List of chemicalsEffects of chemicals

•Specificchemicals

Other costs Financial costsSocial costsAesthetic costsEnvironmental costsManipulation

Source: Alex Lee

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Notethatallhealthwarningsandmessagesmustbesupportedbyscientificevidence,notonlytoensurecredibilityandaccuracyofmessages, but also to defend against legal and political challenges by tobacco companies. While identifying the themes and subjects of messages,youshouldcompilealistofscientificreferencesthatsupportthestatementsmadeinthewarnings.Thisinformationmayalsobe of interest to smokers, and could be disseminated to the public through a website.

Many countries have already compiled this evidence, and references can be accessed:

Australiawww.quitnow.info.au/internet/quitnow/publishing.nsf/Content/fact-sheet-health-warnings

BrazilBrazil - Health warnings on tobacco products – 2009 (see health warnings references on p53 - 56 of the document)

Canadawww.hc-sc.gc.ca/hl-vs/tobac-tabac/legislation/label-etiquette/graph/index-eng.php

Health effectsDepictions of health effects include messages on the general risks of tobacco use (e.g. “Smoking kills” or pictures of a corpse or skull), as well as messages on specifichealtheffectsordiseases.Specifichealtheffects often include the leading causes of toabcco - related death and disability, including cancer, lung disease, heart disease, and stroke.

Less well-known diseases may also be featured in order to communicate the wide range of health effects associated with tobacco use. For example, Australia includes warnings for blindness and peripheral vascular disease (gangrene) alongside the more commonly-known health effects, such as cancer.

Health warnings should not simply promote a basic awareness that smoking causes disease. Messages should focus on the perceived likelihood and the perceived severity or consequences of health effects – two critical components of risk communication. Overall health warnings that increase smokers’ perceived likelihood and severity of risks are likely to be most effective. For example, although many smokers know that smoking causes lung cancer, effective and novel communication of the suffering, loss, and personal experience of lung cancer will make this knowledge more salient and meaningful to the smoker.

Perceived severity also needs to be communicated in relevant way. From a public health perspective, severity is usually calculated in terms of the number of lives lost attributable to a particular disease.

However, from an individual’s perspective, perceived severity is probably more closely related to quality of life or the consequences to physical appearance. For example, the health warning for mouth diseases that originally appeared on Canadian packages in 2000 (see image left) has been copied in jurisdictions throughout the world. It is among the most recognisable and effective package warnings developed, not because mouth cancer is any more common or severe than lung cancer or stroke, but

because it depicts a gross, aesthetically displeasing health effect. To many smokers, gross effects to one’s physical appearance may be perceived as more severe than more lethal health effects. Different techniques and presentation styles for making health effects more vivid and personally relevant are discussed below.

Cessation Effective risk communication requires two other critical elements: the perceivedbenefitof changing behaviour (for example, quitting smoking, or smoking outside away from others) and concrete information on how to change. Therefore, cessation should be regarded as a critical theme of health warning messages. Cessation informationcanbebrokendownintofoursub-themes:(1)Informationonthebenefitsofquitting(includingboththedirecthealtheffects,aswellasrelatedbenefits,suchasimprovedqualityoflife);(2)Supportivemessagesintendedtobuildconfidenceandmotivateaquitattempt;(3)Tipsforquittingsmoking,and(4)Information on cessation services, such as telephone helpline numbers and internet services. Telephone helpline numbers have proven an especially effective type of information to include.

Toxic constituents and product-related messagesThere is general consensus that health warnings should help to inform smokers about the toxic chemicals in tobacco products. Many jurisdictions require a separate set of health messages on the side of packages to communicate this information (see section 2.2.2 Development of emissions and constituent labelling). However, this theme has also been featured in the main health warnings on package faces – see example here from Australia.

Health warnings could also be used to communicate other important product information. For example, warnings could target widespread misconceptions, such as the belief that “low-tar” products are less hazardous.

Canada.

Australia

Australia

Australia

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Other effectsMessages can address other, non health-related consequences. For example, messages reinforcing the financialcostsofsmokinghelptoremindsmokersofaverypowerfulincentiveforquitting.Warningshavealso highlighted the aesthetic effects of smoking, usually physical appearance. These include physical effects thatmaynotbeparticularlysignificantintermsofhealth,butmayneverthelessbevaluedbysmokers:stainedteeth, wrinkled skin and other aspects of ageing. Some health warnings have also sought to highlight the socialconsequencesofsmoking.Forexample,thewarningdevelopedintheEuropeanUnion(imageshownhere) highlights the potential embarrassment associated with impotence from smoking (although impotence itself is a health effect) and may help to undermine the social desirability of smoking.

Combined themesMany health warnings combine more than one message theme within the same warning. In fact, research suggests that health warnings are most effective when fear-arousing information on health effects is paired with supportive messages to encourage behaviour change. In other words, each warning should include themes of cessation information along with messages on health effects. Health warnings from Australia, shown below, provide a good illustration of this principle.

Health effectstheme

EuropeanUnion

Cessationefficacyand services

Target groupsManyhealthwarningsaretailoredtoparticularsub-groupsofsmokers.Somewarningsaregender-specificortargetedtowardsaparticularage-group,suchaswarningsontherisksofsmokingwhilepregnant.Manywarningsrelatedtosecond-handsmokealsofocusspecificallyon smokers with children in the household. The decision to target sub-groups should be part of the general discussion regarding priority themes and subjects.

Warnings appropriate to specific tobacco product typesAlthough all tobacco products carry health risks, different products may carry different types or levels of risk. The messages chosen should be appropriate and accurate for the type of tobacco product. For example, smokeless tobacco products carry a much lower risk of heart disease than smoked tobacco products. Therefore, an oral cancer warning may be a greater priority for smokeless tobacco products.

step 6: select images and determine presentation style

The quality and style of the picture is the most important determinant in the effectiveness of a health warning. Even though a warning may include informative text for an important health effect, the impact of the warning can be limited by the wrong image. Images are particularly important in the long-term effectiveness of warnings.

Oncethethemeandsubjectofawarninghavebeenidentified,imagesmustbedevelopedtomaketheinformationasvividandpersonallyrelevant as possible. Neutral images that fail to elicit an emotional reaction should be avoided. The effectiveness of picture warnings is oftenhighlyspecifictotheparticularimage–evensmalldifferencesinthecontentandconfigurationoftheimagecanhavealargeimpacton its effectiveness.

General principlesInadditiontothespecificpresentationstyleoptionsdescribedbelow,thereareseveralgeneralprinciplesfordevelopingtheimagesinhealth warnings:

• Picturesshouldbeasstrikingandcolourfulaspossible,andhavehighresolution. • Peopledepictedinwarningsshouldbeyounger,ratherthanolder.Whereasolderadultsareabletorelatetopicturesofyounger adults,thereverseisnotnecessarilytrue.Usingyoungeradultsinpicturesalsomakesthehealtheffectssomewhatmore immediate for younger smokers. • Althoughthereisnoevidencethathealthwarningsactuallyincreasesmoking,itisneverthelessimportanttoavoidpicturesthat may serve as smoking cues for some individuals. For example, some focus groups have found that pictures of smoke from a lit cigarette or pictures of ashtrays may serve as a cue for some participants.

EuropeanUnion.

 

 

 

 

Source: Alex Lee

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Graphic depictions of diseaseResearch in health communication indicates that messages with emotionally arousing content are more likely to be noticed and processed by smokers. Research also indicates that one of the most effective ways of arousing emotion is to use graphic pictures of health effects. Some jurisdictions, such as Singapore, have adopted this approach for the entire set of warnings (see images right). Focus group testing shows that graphic pictures that also show the victim’s face add personal relevance to the graphic depictions. As noted previously, graphic depictions are most effective when combined with supportive cessation information.

Depictions of human impact and suffering Although graphic depictions of disease may be the most reliable way of eliciting an emotional response, there are other ways of doing so. These often involve pictures depicting the human consequences of disease or messages that connect directly with the smoker. (Three examples are shown below). In all cases, the warnings appeal directly to the viewer and add a poignant human element to the costs of tobacco use. In the examples, the warnings also highlight the consequences for important others, such as the family and children of tobacco users.

TestimonialsTestimonials are an excellent way to increase the personal relevance of health warnings. Testimonials are often used to communicate a health effect, but they do so within the context of a narrative or story. Providing personal information about real victims adds important context and attaches a human face to health effects. Health warnings in Chile have featured Don Miguel, a victim of larynx cancer from smoking (right).

Testimonialsarealsohighlycredible-itisverydifficultforscepticstorejecthealthriskswhentheyarepresentedwitharealexample.Indeed, one of the most common questions asked by smokers during focus group testing is whether the people depicted in the health warnings are real. For this reason, even warnings that do not adopt a testimonial style should use real people as often as possible. Testimonials may also be effective in communicating addiction and cessation themes.

Aesthetics (impact on physical appearance)Warningscanhighlighttheeffectsofsmokingonphysicalappearance,suchasyellowedfingers,stainedteeth, wrinkled skin, and other effects on ageing. Negative effects on physical appearance may be particularly effective among young people and younger adults, given that the long-term health effects are more remote and may seem less relevant for younger populations.

Cultural symbols and iconsThe use of pictorial symbols is a common and effective feature of health warnings for a wide variety of consumerproducts.Forexample,thegloballyharmonisedsystem(GHS)ofclassificationandlabellingofhazardous chemicals (GHS) uses the skull and crossbones as the universal symbol for toxic substances.

Some jurisdictions have used symbols or icons, such as a skull, to communicate the risks of smoking (see Venezuelanwarningatright).Usingwidelyrecognisedsymbolsofdeathanddangermaybeaneffectiveapproach to risk communication, particularly in regions with low levels of literacy and little existing knowledge ofspecificdiseasesorhealtheffects.

However, cultural symbols must also be used cautiously, so as not to cause offence or lead to rejection. In Thailand, for example, a warning using a culturally sensitive symbol of a burial ceremony met with some public resistance and was subsequently removed from the warning.

Singapore.

Don Miguel.

Australia

Venezuela

© Corporate Research Associates Inc, 2005

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HumourHumour is another option for presentation style. Warnings for impotence that use the image of a limp cigarette are the most common example to date (see Brazilian example at right). Although humour may be an effective presentation style in some cases, it should be used with great care so as not to trivialise the importance of health risks.

step 7: develop warnings

After taking into account all of the previous considerations, the individual warnings can be developed for testing. Several concepts should be developed for each theme and subject in order to determine the best creative execution of each. In other words, several different warnings should be designed that take slightly different approachestocommunicatingthesamemessage.Forexample,theUnitedKingdomDepartmentofHealthtestedthree concepts for each main message or theme to identify which of the three concepts should be selected (see below for the three options for one message; the middle option was selected as the most effective, by far).

“Smoking can cause a slow and painful death.”

As noted above, countries may choose to adapt warnings and images in use in other countries. However, where resources permit, countries should attempt to develop warnings tailored for their own country. This may be important for several reasons. For example, warningsthatincludepicturesofpeopleshouldbroadlyrepresenttheethnic/racialprofileofeachcountry.Certainimages,symbolsorotherreferencesmayalsobeculturallyspecific.

Where resources allow, the best option is to hire an advertising agency or other communication expert to develop new messages. Specialised agencies can bring a wealth of creative resources to the table to develop high-quality, creative concepts that will most effectively communicate messages to the target population. However, outside agencies cannot create effective warnings without adequate guidance.

You will need to determine what you want the agency to do, for example:

• Developmessageconcepts? • Pre-testmessagesamongdifferentaudiences? • Designlayoutsofsuccessfulconceptsfordifferentpackagingtypes?

You will also need to provide clear information and guidance to the agency so that it can produce the best, most effective creative concepts. A brief will need to be prepared for an agency based on all of the considerations discussed in this section, and others, including:

• Overallgoalofwarningsystemandmessages. • Targetaudience(s). • Numberofwarningsormessagestobedeveloped. • Thematicconceptstobeaddressed. • Anyrelevantresearchorguidancetobeincorporatedintocreativeconcepts.

In evaluating the submission from an agency you should:

• Askifthebriefhasbeensuccessfullyinterpreted? • Askifitdemonstratesinsightintothetargetaudience? • Askifthecreativeisstrong?Willitgetnoticed? • Bewareofinterestingconceptsthatdon’tmeetthebrief. • Notbeafraidtoaskforconceptstobere-worked.

Finally the success of the creative development will be determined by pre-testing of materials with the target audience. This is discussed in section 3 Pre-testing health warnings and constituent/emissions messages.

Source: Alex Lee

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CheCKLIsT 1: Layout and design of health warnings1. General

Numberofsetsofwarnings?Rotationtimeperiodperset?Numberofwarningsperset?Totalnumberofwarningstobedeveloped?

2. Layout of warningsGeneral•Sizeofwarnings(%ofeachmainfaceorsurface)?•Locationorpositionofwarnings?•Borders?•Pictureortextonly?•Backgroundcolour?•Positionoftextandpicture?•Textcolour?•Numberoflanguagestobeused?

Marker word (Yes/No)•Position•Fontsize•Fontcolour

Tagline•Position•Fontsize•Fontcolour

Explanatory text•Position•Fontsize•Fontcolour

Attribution (Yes/No)•Attributionsource•Position•Fontsize•Fontcolour

3. Priority themes and subjects•Whataretheprioritythemesandsubjectmatters?

4. Types of tobacco products•Whattobaccoproductsarecommonlysoldinthemarket?•Howshouldthecontentofwarningsbeadaptedtodifferentproducts?•Howshouldthesizeandpositionofwarningsbeadapted to suit different forms of packaging in which theseproductsaresold?

CheCKLIsT 2: health warning concepts1. Themes?

What are the general themes and sub-themes of this warning?

2. subjectWhatisthemainsubjectofthiswarning?

3. Target audienceIsthereaparticulartargetaudienceforthiswarning?

4. Presentation styleWhatisthegeneralpresentationstyleofthewarning?

5. PictureIsthepictureclearandeasytounderstand?Doesithaveimmediateimpact?Doesitarouseemotionorinterest?Doesitleadtointerestorcuriosityintheexplanatorytext?

6. TaglineDoes the tagline provide a concise summary of the warning?Doesitstandoutfromtherestofthetext?Isitconsistentwiththepicture?Is it at the appropriate literacy level for the target audience?Isitsimple,direct,andeasytounderstand?

7. explanatory textIsthetexteasytounderstand?Isitbelievable?Arethereanyconfusingelements?Is it at the appropriate literacy level for the target audience?

8. Cessation messageIscessationinformationincludedineachwarning?

2.2.2 development of emissions and constituent messagesThis topic summarises recommendations and steps for designing emission and constituent messages on packages. Although this aspect of labelling may seem more straightforward than designing health warnings, it presents unique challenges.

Cigarette smoke contains approximately 4,000 chemicals, including over 250 carcinogens and other toxins, such as formaldehyde, benzene, and hydrogen cyanide. Although there is general agreement that cigarette packages should provide some information on these chemicals, regulators continue to struggle with how best to communicate this information in a practical and meaningful way to consumers.

? what is the difference between a constituent and an emission?Constituents generally refer to the chemicals and other substances in unburnt tobacco. This includes additives as well as chemicals naturally present in tobacco. Emissions usually refers to the chemicals and other substances found in the smoke of combustible products. A detailed discussion of issues related to emissions is included in section 1.

Article11oftheFCTCrequiresthatpackagescontain“informationonrelevantconstituentsandemissionsoftobaccoproductsasdefinedby national authorities”. However, there is considerable confusion regarding what constitutes “relevant” information. Many countries require manufacturers to print the levels of three emissions (tar, nicotine, and carbon monoxide) on the side of packages, and this remains the most common practice throughout the world.

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However, evidence shows that printing emission numbers on packages should be immediately abandoned, given that it reinforces the tobacco industry’s deceptive marketing practices and the false belief that low tar cigarettes are less hazardous. A more complete explanation of these issues is provided in section 1 evidence review. Article 11 guidelines recommend that Parties provide non-numerical (non-quantitative), descriptive information on emissions and constituents. This section provides recommendations on how to follow and improve upon existing practices in descriptive emission and constituent messages.

step 1: review existing constituent and emissions messages

Existing emission and constituent messages in other jurisdictions should be reviewed to help generate ideas. Many countries have implemented descriptive emission and constituent warnings, including Brazil, Uruguay,Venezuela,Chile,Australia,Thailand,andNewZealand.

An extensive list of emission and constituent warnings that have been implemented throughout the world can be found at: www.tobaccolabels.org(UniversityofWaterloo,Canada)

step 2: determine layout and design

Thefigurebelowillustratestwoapproachestothedesignandlayoutoftheemissionandconstituentmessages.

brazil australia

Number of chemicals

Specificchemicals

Effects of chemicals

Number of chemicals

Effects of chemicals

Cessation message

Size and positionEmission and constituent messages are typically located on one side of the package. Many jurisdictions have used most of one side, up tothepointwherethepackageseparatesforflip-toppackages,toavoidcuttingoffthemessageatthebreakpoint.However,thereisnoreason why an entire side, and more than one side (including the top and bottom), of the package could not be used for this information.

The picture below illustrates how an entire side of a package could be used for the message, without the text being interrupted by the package break.

Contrasting coloursAs with health warnings, it is important to ensure high contrast between the wording and the background. White letters on black backgroundorblacklettersonwhitebackgroundareeffectivecombinations.Thefontsizeshouldbesufficientlylargetobelegible.

Use of symbols and picturesTo date no jurisdictions have included symbols or pictures in messages for emissions and constituents. However, given the overwhelming evidence that pictures or images enhance the effectiveness of health warnings, jurisdictions should explore the use of pictures and symbols in constituent and emissions messages.

Research on international hazard symbols shows that a picture with a signal word, a hazard/marker word, and a precautionary statement is most effective. Pictures can be used in at least two ways to increase the vividness of emissions and constituent messages.

First, a symbol that is widely recognised as a warning for poisonous or dangerous goods could be included with the messagetext.Theskullandbonesusedbythegloballyharmonisedsystem(GHS)ofclassificationandlabellingofhazardouschemicalsisone example (see right).

Extensive evidence shows that the GHS toxic symbol increases the salience and comprehension of toxic chemical warning messages 207:

• Symbolsallowconsumerstoavoidhazardsintheirenvironmentbecausetheyattractattention.208 209 • Symbolsactasreminderstoperformnecessarysafetybehaviourbycueingexistingknowledgewithinmemory.210

• Widely-recognisedsymbols,suchasaskull,havebeenfoundtobeespeciallyeffectiveindiversepopulations,includingamong individuals with low literacy and education; 211 and • Inarecentstudy,morechildrenrecognisedtheskullsymbolthananotherhazardsymbol. 212

Where to find examples of constituent and emissions messages

www.tobaccolabels.org

 

 

 

 

 

 

Source: Alex Lee

Source: Alex Lee

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Second, different images could be used for each warning. Finding an image that smokers readily associate with a substance may be easier insomecasesthanothers.Forexample,formaldehydeiscommonlyusedasanembalmingfluidandlendsitselfwelltoanimage(seeexample below). In contrast, chemicals such as benzene may have no recognisable associations or images.

Marker words Marker words, such as “WARNING” may also be an effective addition to emission and constituent messages, as in each of the examples above. As with health warnings, marker words should have a larger font size and distinct font colour to attract attention.

step 3: select number of messages and rotation period

Only one country currently requires more than one emission and constituent message to appear on packages (Djibouti, planned implementationJune2009).Themorecommonrequirementforonlyonemessage(norotationofdifferentmessages)isasignificantlimitation of most existing practices. Jurisdictions should design sets of multiple emission and constituent messages – between four and eight messages is appropriate – that would appear concurrently, in equal rotation. The rotation period for different sets of warnings should be the same as for other health warnings – ideally every one to three years.

Step 4: Define content

There are a number of ways to communicate emission and constituent information, including the number, type, and effects of chemicals.

General principlesMessagesshouldbepersonalisedasmuchaspossibleandshouldlinkinformationtospecificproductsandbehaviour.

Theexplanatorytextshoulddirectlymentiontheactofinhalingorpuffing(or,ifrelevanttotheproduct,chewing)tohelptobaccousersvisualise the process of taking in chemicals. Recent testing in Canada found that the following phrase was the most effective: “Every time you inhale, this product releases [chemical name] into your body”.

As with all health warnings, the text in emission and constituent messages should be as clear and direct as possible. Technical language should be avoided. For example, rather than saying that a substance is “carcinogenic”, messages should say that it “causes cancer.” Text should be at an appropriate literacy level for the target audiences.

Quantities or levels of substancesMessages should not include numbers that refer to the quantities or levels of emissions (such as tar, nicotine, and carbon monoxide). These numbers are typically derived from machine testing and are not related to the quantity of these emissions taken in by actual smokers.

range and types of substances, with health effectsOne way to communicate the range or types of constituents and emissions is to include a general statement about the range or number of toxic or dangerous substances. For example, Australian messages mention “more than 40 harmful chemicals”, while the Brazilian messages mention “4700 toxic substances.” Focus group testing suggests that this may be effective in communicating the magnitude of toxic chemicals in tobacco smoke.

A second approach is to identify specific substances or chemicals in constituents or emissions. Research conducted among Canadian smokerssuggestthatthisspecificityismoreinformativeandeffective.

Bothtypesofmessagescanbeimprovedbyaddingasecondsentencethatreferstospecifichealtheffectsofthesubstance(s).Researchcommissioned by Health Canada found that the most common recommendation to improve the emissions message was ““explaining the harmful effects of the chemicals found in cigarettes.” 213 Participants in focus groups also preferred this approach: “When shown a series of possible statements, smokers in a qualitative study were most supportive of texts that were short, clear, and simple and that presented only one substance with information on the impact that substance has on health. 214

Source: Alex Lee

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Severalexamplesareprovidedbelow,combinedwithastatementlinkingingestionofchemicalstoaspecificbehaviourandproduct.

? how should I choose what substances to display? Asafirststep,themosteffectiveapproachistoselectchemicalsthatsmokersalreadyrecogniseaspoisonousortoxic.Insomecountries, the general public is aware that chemicals such as arsenic and hydrogen cyanide are very dangerous, although few may be aware that they are present in tobacco smoke. Future versions or “rotations” of emission and constituent messages might also include chemicals that may be very dangerous, but for which there is less awareness. Descriptions of the effects of these chemicals will be particularly important in increasing the effectiveness of the information.

step 5: develop the messages

At this point, the layout and content of the messages should be established and the individual messages can be developed for testing.

As with health warnings, there is considerable value in pre-testing emission and constituent messages prior to implementation. This is particularly important given that less research has been conducted on these messages. It is highly recommended that resources be set aside for at least some pre-testing to ensure that the messages are not only noticeable and vivid, but also clear and easily understood. Pre-testingshouldalsofocusupontheeffectivenessofusingimagesanddescriptionsofspecifichealtheffects.Pre-testingisthesubjectofsection 3.

Source: Alex Lee

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CheCKLIsT 3: designing emission and constituent messages1. Layout and design

•Howmanysides?Whatproportionofeachside?•Location?•Textonly?•Textwithpicturesandotherelements?•Markerwords?•Whichcontrastingcolours?•Whichfontsandwhatsizeoffont?

2. number of messages and rotation period•Howmanymessagesperset?(aimfor4-8)•Rotationperiodfordifferentsetsofwarnings?(aimforsamerotationperiodasforthe“main”healthwarningsonthefaceof packages)

3. Content•Typesofchemicals • Chooseapproach: Approach 1: general statement about the range of toxic or dangerous substances Approach 2: More effective approach is to identify specific chemicals in constituents or emissions

•Effectsofchemicals • Selectchemicalsthatsmokersalreadyrecogniseaspoisonousortoxic •Useofsymbolsandpictures • Considerasymbolthatiswidelyrecognisedasawarningforpoisonousordangerousgoods • Considerusingdifferentimagesassociatedwithaspecificchemicalforeachwarning

•Markerwords • Usemarkerwordsuchas“WARNING” • Largefontandnoticeablecolour

•Generalprinciples • Clearanddirectlanguage • Avoidtechnicallanguage • Uselanguageappropriatetotheliteracyleveloftargetaudiences

4. develop the message•Developandtestindividualmessages

2.3 Pre-testing health warnings and constituent/emissions messages

This section describes how to pre-test the impact of health warnings and messages. Some jurisdictions have conducted extensive evaluation work before implementing health warnings, while others have selected and implemented warnings with no pre-implementation testing.

The extent of pre-testing usually depends on the resources and time constraints in a given jurisdiction. While pre-testing is not absolutely necessary, particularly if warnings are designed based on existing best practice, even modest evaluation work is likely to increase the effectiveness of warnings.

Pre-testing of health warnings should be as rigorous as possible, given available resources, but should not create anysignificantdelaysinimplementation.Itispossibletocompletetheentireprocessofdevelopmentandpre-testing in a few months if necessary, although you should allow at least six months for the process if possible.

Pre-testing of layout and design and pre-testing of concept and content testing are discussed separately here because different methods and objectives may apply. However, both types of pre-testing can be completed in the same surveys or focus groups.

Inmanycases,testingoflayoutanddesignisconductedpriortospecificconceptandcontenttestingonlybecause basic decisions about layout of text and pictures need to be made before developing concepts. However, jurisdictions that wish to examine only a few novel layout or design features can incorporate elements of layout/design evaluation and concept/content evaluation in the same survey or focus group. Regardless, the process should be as systematic as possible with respect to the variations of information and presentation, and the types of questions that are asked.

resourceRefer to the Checklist at the end of this section to help you plan your pre-testing evaluation.

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2.3.1 Pre-testing: layout and design

Primary objectives and prioritiesJurisdictions that wish to explore new design features, or jurisdictions that require evidence of the impact of larger, pictorial warnings may wish to evaluate individual components of layout and design. Priority features for pre-testing may include:

• Text-onlyvs.picturewarning. • Positionoftextvs.picture. • Inclusionofagovernmentattribution. • Inclusionofamarkerword. • Overallsizeofwarnings,andrelativesizeondifferentpackagefaces. • Colourschemes,includingcontrastbetweenbackgroundandtext.

MethodsLayout and design testing should systematically evaluate each design feature in order to draw strong conclusions about their effectiveness. This involves creating different versions of the same warning that are identical, except for the feature being examined. For example, if the value of pictures vs. text-only warnings were being evaluated, two warnings should be created that are identical, except for the addition of the picture. The picture vs. text-only example should be the same size, have the same text message, same border width, similar colours, etc. An example is provided below.

Set A: Picture vs. text-only

Set B: Picture vs. text-only

This approach ensures that any differences in ratings can be attributed to the use of pictures – the only point of difference between the twowarnings.Notethatthepicturethatisselectedtoaccompanythetextwillhavesomeinfluenceonwhetherthepicturewarningsarerated as more effective. Therefore, it is important to repeat the process more than once, to ensure that the success or failure of the picture warnings is not simply due to a particular image. The best option is to use pairs of text-only and picture warnings across different themes. If thesamepatternofresultsisfoundforbothSetsAandBabove,forexample,thefindingswillbemorerobust(stronger).

Presentation of warnings to participantsTherearetwoapproachestopresentingthewarningsormessagestoparticipants.Thefirstistoshowbothwarningsineachsetatthesame time, and ask participants to directly compare the two. In the example above, participants would be shown both warnings from Set A or from Set B, and asked which of the two warnings had greater immediate impact.

The second approach is to show participants each warning one at a time and have participants rate the warnings separately. Each warning would receive a score for immediate impact using a standard rating scale (see next page), and these scores could then be compared to see which warning was rated more highly.

The advantage of the second approach – having participants rate each warning individually – is that warnings can then be compared across sets or themes fairly easily, without using statistical techniques. In other words, the impact ratings for each of the warnings in Set A could be compared with each of the warnings from Set B.

Developing questions and rating scalesThe design and layout of health warnings can be evaluated on a range of different outcomes, including the overall effectiveness of a warning, immediate impact, noticeability, and the credibility of the information. The choice of outcomes should be guided by what is being evaluated. For example, if you are testing whether a government attribution should be included, you may be most interested in the credibility of the warning.

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Rating scales are a useful response format. Participants may be asked to rate each warning by selecting a number or symbol that corresponds to a particular category. The category is often written directly below the number or symbol, and typically ranges from “Verybad”to“Verygood”,orsomevariationofthesewords.

Ratings can also measure valence (positive, neutral or negative) and strength of emotional impact, which are indicators of effectiveness. This type of scale (see example at right) was used with the International Affective Picture System (IAPS) to test and develop Brazil’s third round of warnings images 215 (top scale measures indicates valence, from negative to positive; bottom scale indicates strength of arousal from none to high).

The use of a number or symbol along with the category helps to ensure that the rating scale is easily understood by low literacy smokers.

1 2 3 4 5

g gg ggg gggg ggggg

LL L K J JJ

Verybad Bad In the middle Good Verygood

Different questions should use the same rating scale for consistency. In other words, questions about immediate impact, noticeability, and credibility can all use the same 5-point rating scale. At the end of the process, each warning or layout presentation will have a set of ratings that can be compared across questions.

Notethatinadditiontoquestionsspecificallyrelatedtothehealthwarnings,basicdemographicvariablesshouldalsobecollectedfromparticipants, including smoking status, age, gender, and education level. Demographic variables can help to indicate whether different types of participants are providing different patterns of scores or ratings.

? focus groups or surveys?A focus group is a form of qualitative research in which a group of people are asked about their attitude towards a product or concept. Questions are asked in an interactive group setting where participants are free to talk with other group members, usually guided by a trained facilitator. Focus groups are effective in generating new ideas and concepts, particularly during the earlystagesofdevelopment.Onelimitationoffocusgroupsisthatthefindingscanbesomewhatdifficulttosummarise,giventheunstructurednatureofthegroupsetting.Inaddition,individualresponsescanbeinfluencedbythegroupsetting.

In contrast to focus groups, surveys collect responses from each respondent individually, using structured word and response options. The main advantage of a survey is that responses can be collected more systematically for each individual, without the socialinfluenceofothergroupmembers.Onedisadvantageisthatsurveysarelesseffectivethanfocusgroupsinexploringnew ideas and concepts, although open-ended questions can do this to some extent.

Surveys used to evaluate warnings will need to be conducted in - person (face-to-face) so that respondents can view images. Internetsurveysareanotherpossibility(seeCasestudybelow:Usingtheinternettoresearchandevaluate).However,response rates will likely be lower, and respondents will be more likely to come from higher socio-economic groups, since these groups have greater access to the Internet and use it more.

a combined approach–Themosteffectiveandefficientapproachmaybetocombineofsurveysandfocusgroups.Forexample, participants can be recruited to a group setting, beginning with a brief survey on smoking status and demographics. The group can then be presented with the series of warning labels to be evaluated and instructed to answer written survey questions individually after each presentation. The warnings can then be presented a second time with group discussion following each presentation. All of the warnings should be presented and all survey questions completed before beginning any group discussion; otherwise opinions from different group members may affect how each individual responds to subsequent survey items.

Other testing methodsMany other types of studies and techniques are available to evaluate the layout and design of health warnings, and include eye-tracking, functional Magnetic Resonance Imaging (fMRI), and other physiological responses which measure general levels of attention and the strengthoffirstimpressions.Eachofthesemethodscanbeinformative,buttheyarecostlyandarenotnecessaryaspartofastandardapproach.

Target audienceA primary goal is to ensure that health warnings are easily understood by most smokers. Given that in many countries smokers are more likely to have lower levels of education than the general public, it is absolutely critical that testing includes participants with diverse levels of literacy and from diverse socio-economic (SES) backgrounds.

In order to ensure a suitable mix of participants, participants can be recruited from public areas with a cross - section of people, such as shoppingareasandotherpublicmeetingplaces.ParticipantscanalsobespecificallyrecruitedfromlowerSESareasoroccupations.Although many individuals are willing to participate in surveys, providing some compensation in the form of a small gift or small amount of money can help to increase participation rates.

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resourCe: how to conduct focus groupsThe International Development Research Centre has published an overview of how to conduct focus groups, as well as general guides on developing surveys, recruiting participants, and basics of data analysis. The book is available free of charge on the internet: www.idrc.ca/en/ev-56615-201-1-do_ToPIC.html

Therearealsoanumberofgovernmentreportsthatdescribefindingsfrompreviousfocusgroupsconductedtotesthealthwarnings, available at: www.tobaccolabels.org

2.3.2 Concept and content testing

Primary objectives and prioritiesThe main objective of concept and content testing is to evaluate the most effective health warning concepts for each theme and subject. Jurisdictionswithsufficienttimeandresourcesoftenconductthistypeofevaluationinseveralstages:Initiallytogeneratefeedbackonearly concepts; and later on to test advanced versions before implementation.

Concept testing should ensure that each warning under consideration meets the following criteria:

• Stronginitialimpact. • Consistencybetweentextandpicture. • Alltextisclearandeasilyunderstood. • Engagingandinterestingtext. • Personalrelevanceandemotionalimpact. • Credibilityofmessage. • Overallperceptionsofeffectiveness.

MethodsAs with testing for layout and design, the process should be as systematic as possible, while also allowing for broad feedback. Early testing of concepts and content is usually somewhat less structured. Often very different concepts will be presented to participants to collectgeneralfeedbackonwhichdirectiontopursue.However,asthecontentinthewarningsbecomesmoredefined,testingshouldbecomemoresystematic:thebestwaytotestaspecificconceptistodevelopsimilarversionsofthesamewarningthatdifferonlyononeaspect of the content (such as image presentation).

Presentation of concepts to participantsSeveral concepts should be developed for each theme or “message”. See examples below, where three concepts were tested for each message.

Set A: “Smoking causes a slow and painful death.”

Set B: “Smoke contains benzene, nitrosamines, formaldehyde, and hydrogen cyanide.”

European Union

Aswithtestingthedesignandlayout,therearetwoapproachestopresentingthewarningstoparticipants.Thefirstapproachistoshow each set of concepts at the same time, and ask participants to indicate their preference. In the example above, participants would be shown all three warnings from Set A simultaneously and asked which of the three warnings had the greatest immediate impact, for example. The second approach is to show participants each warning one at a time and have participants rate the warnings separately. The advantage of the second approach is that it allows warnings from different sets to be compared without using statistical analyses. This is especially important to identify whether certain themes or subjects are performing poorly compared to others. In other words, it tells you not only which concept is the best execution of a particular theme, but which themes are the most effective overall. Pre-testing of picture warningsintheUKusedbothoftheseapproachesintwodifferentstudies.

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Case sTudY: using the internet to engage and evaluateIn2006,theDepartmentofHealthintheUnitedKingdomdevelopedawebsitetoengagethepublicontheissueofpictorialwarningsandtosolicititsfeedbackondifferentalternatives.Visitorstothewebsitewereaskedtocompleteanumberofdemographic questions and to select the warnings they felt would be effective. Over 20,000 people completed the survey during thethreemonthsthewebsitewasinoperation.Theresultswereusedtoinformthefinalselectionofimages,andreceivedconsiderable media attention in the process. 216

Developing questions and rating scalesThe main difference between layout/design and content/concept testing is the types of questions that will be asked. The questions should focus to a greater extent on how the information and content is received. Questions should measure immediate noticeability and impact, consistency between text and picture, clarity and meaning of text, interest in text, personal relevance, emotional impact, credibility of the information, and overall perception of effectiveness.

Itisoftenhelpfultoaskaboutspecificcomponentsofthewarnings,suchasthepicture,textmessage,thecohesivenessofthepicturesvs.text,etc.Thesetypesofquestionsprovideimportantfeedbackabouthowtoimprovespecificaspectsofthewarning.Atypicalapproachwould be to begin with a general question on the overall effectiveness of a warning before asking separate questions about each main component.

CheCKLIsT: evaluating health warnings and messages

Pre-implementation:

Pre-testing the layout and design of warnings •Priorities • Text-onlyvs.picturewarning • Positionoftextvs.picture • Inclusionofagovernmentattribution • Inclusionofamarkerword • Overallsizeofwarningandrelativesizeoneachmajorfaceorsurface • Colourschemes,includingcontrastbetweenbackgroundandtext

•Methods • Choosegeneralapproach • Focusgroups • Survey • Combinedapproach • Comparelayoutoptionsthatvaryonlytheelement(s)youwanttotest • Chooseapproachtopresentwarningsandobtainparticipantratings •Approach1:Showbothwarningsineach“set”atthesametime •Approach2:Showparticipantseachwarningoneatatimeandhaveparticipantsratethewarnings separately

• Developquestionsandratingscales • Differentquestionsshouldusethesameratingscaleforconsistency • Collectbasicdemographicinformation

• Targetaudience • Ensuresuitablemixofparticipants • Includeparticipantswithlowlevelsofliteracyanddiversesocio-economicbackgrounds

Concept and content testing

•Priorities •Stronginitialimpact •Consistencybetweentextandpicture •Alltextisclearandeasilyunderstood •Engagingandinterestingtext •Personalrelevanceandemotionalimpact •Credibilityofmessage •Overallperceptionsofeffectiveness

•Methods •Similartotestinglayoutanddesign •Developsimilarversionsofthesamewarningthatdifferonlyononeaspectofthecontent •Developthequestionsandratingscales

•Concepttestingandevaluationoflayoutanddesigncanbecompletedinsamesurveysorfocusgroups

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3. IMPLeMenTaTIon: ProMoTInG PoLICIes and CounTerInG oPPosITIon

This section focuses on actions that will facilitate the implementation of packaging and labelling policies and that will promote and build support for these policies. These actions include:

• Disseminationofinformationtokeyaudiences. • Earnedmediaactivities. • Paidpublicinformationcampaigns. • Consultationwithstakeholders. • Strategiestocountertobaccoindustryargumentsandtactics,includinglitigation.

Promotion of policy proposals through these means will not only help build political and public support for the proposals, but also enhance the impact of the measures and facilitate compliance. The steps described here will usually take place concurrently.

3.1 step 1: Prepare and disseminate evidence and information to key audiencesBackground materials should be prepared to disseminate policy makers, opinion leaders, media, and stakeholder allies, targeted appropriately to each audience. For these audiences materials should be no more than 1-4 pages long, and should use visuals, clean layout and bullet points.

The content will vary, depending on the audience and on the stage of implementation, but should include:

• Rationalefortheproposals,includingrelevantdatafromyourcountry(suchastobaccouseandtobaccomortality;knowledgeof health risks), and potential effectiveness of warnings and other packaging measures. • Informationandevidencefromotherjurisdictionsrelevanttoyourproposals. • Anyendorsementsoftheproposalsthatyoualreadyhave,suchasfromkeycivilsocietyalliesoracademicinstitutions. • Asummaryofthemaincomponents. • Responsestothemostsalientorcommontobaccoindustryargumentsinyourcountry.

Oncetheregulationsarefinalisedandthereisasetimplementationdate,compliancecanbefacilitatedbydisseminatinginformationtostakeholders about:

• Whatisrequired(i.e.therequiredmeasures). • Whoisresponsibleforensuringtherequirementsareinplace(i.e.manufacturers,importers,retailers). • Bywhatdatethemeasuresarerequired. • Howtoobtainmoreinformation(forexample,contactinformationfortheregulatoryagency,linktothelegislationandsource document).

There are numerous cost-effective options for getting this information to your audiences. The best options will depend on the audience.

Policy makers and media are best reached directly by in-person communication, combined with very strategically designed and targeted written information. High-level, one-on-onebriefingsforkeypolicymakersandmembersofthemediashouldbeusedwherever possible. Of course, the media itself is a highly effective route to reaching policy makers (see Earned media on next page).

Allies in civil society, such as medical associations and consumer groups, should also be briefed face-to-face as often as possible, in part because these groups can help further disseminate your messages to their memberships, policy makers, the media, and members of the public.

Straightforward information about the requirements of the legislation can be disseminated through the Internet, given that many stakeholders, such as manufacturers, will usually have the staff and infrastructure to access web-based information. For retailers, who will be responsible for selling packages that carry the information mandated by law, additional strategies may be needed, for example:

• Meetingswithanddisseminationofinformationtoretailertradeassociations. • Radioadvertisementstargetedatretailers. • One-on-onedisseminationofinformationtoretailersbyenforcementofficersandcivilsocietypartners.

what’s the difference between paid mass media and earned media?Paid mass media refers to professionally-developed media spots (such as television or radio ads) that are strategically placed inspecificmediaforafee.Thistypeofmedia gives you control over when, where, and how often promotional materials are broadcast or placed.

Earned media refers to media coverage generated through news releases, events, orinterviewsandbriefingswiththemedia.This type of media gives you less control over content and placement. However, it is very cost-effective and is often the best way toinfluencepolicymakers.

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Getting out the message about health messages: website examples

australiaDepartment of Health and Ageingwww.health.gov.au/internet/main/publishing.nsf/Content/health-pubhlth-strateg-drugs-tobacco-warnings.htm

The National Tobacco Campaign website (Quit Now)www.quitnow.info.au/internet/quitnow/publishing.nsf/content/warnings-lp

ThesetwositesarecomplementaryandprovidefactsheetsonthewarningsinArabic,Chinese,Greek,ItalianandVietnamese.

new ZealandMinistry of Healthwww.moh.govt.nz/moh.nsf/indexmh/tobacco-warnings

.

The public will primarily be informed through the media, either by seeing or listening to news stories, or by seeing or hearing mass media campaigns on television, radio, outdoor media and print media. In some countries, web-based information may be useful, particularly if it is combined with media messages directing the public to the appropriate web sites. Civil society allies, particularly those that are community based, can be valuable partners in disseminating information to the public.

3.2 step 2: develop earned media strategies to promote information and strategic messages

Earnedmedia–unpaidmediacoveragegeneratedthroughnewsreleases,events,ormediainterviewsandbriefings–isaverycost-effective way of getting information out to all audiences.217 A front-page story in a major daily newspaper is one of the best ways to get the attention of policy makers and opinion leaders. Radio and television interviews and stories can reach an incredibly wide range of audiences. Earned media can be used to promote policies when they are introduced, or to build political and public support to make their introduction more likely. Topics that are of interest to the media include:

• Noveleventsthatprovideinterestingvisuals. Examples: A human chain (with eye-catching banners) in Bangladesh in front of the National Museum to demand graphic health warnings (see www.bata.globalink.org/).

•Releaseofnewresearchdataorreports Example: Coverage of research in Canada 218

showing that warnings covering up to 100% of the package would be most effective in deterring young people from smoking.

• Releaseofpublicopiniondata Example: Coverage of a poll in China 219 showing that 90% of respondents would refuse to give cigarette packs as gifts if they carried graphic health warnings.

•Opinioneditorials(op-eds)andnewsreleasesthatdiscusstimelypoliticalissues Example: a news release 220 and related opinion editorial 221 picked up by several news agencies in India highlighting more potential delays in implementation of picture warnings in the run up to a government meeting.

• Uncoveringofillegalorunethicalbehaviourbythepowerful Example: a news story 222 highlighting a call to action Thai public health authorities for the government to investigate attempts by tobacco companies to undermine the graphic labelling requirements.

resourceHealthBridge (formerly PATH Canada) has produced a Guide to using earned media to promote tobacco control measures, focusing on strategies and examples from lower-income countries: using the media for tobacco control.223

Medical students in Ottawa, Canada, delivering black boxes of cigarettes and toy bunnies to politicians, pointing out that the toy bunnies were subject to stricter regulatory controls, including warnings, than cigarettes.

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3.3 step 3: develop and implement a mass media campaign to promote and support policiesThe most certain way to enhance the impact of package warnings is through a professionally-developed paid mass media campaign. Mass media campaigns have been shown to independently reduce tobacco use, but they are even more effective when combined with policy measures. The investment in an effective mass media campaign is very cost-effective when measured against its impact in increasing the effectiveness of the warnings themselves.

Australia has used mass media effectively to support its graphic health warnings, launching an advertising campaign on television and public transportation during the introduction of the new warnings (see box).

australia: supporting health warnings with mass media

Australia provides a good example of how the impact of packages warnings can be increased by linkingthemwithothermassmediaoreducationcampaigns.NewSouthWales,oneoffiveAustralianstates, used the new national pictorial health warnings on packages as a basis of advertisements on buses (see example), and on television.

The advertisements helped make the information in health warnings more vivid and provided a compelling narrative to the new warnings. Smokers who see these advertisements are likely to recall them each time they see the related images on the pack.

All print and television ads from the campaign can be viewed at:www.cancerinstitude.org.au/cancer inst/campaigns/healthwarnings2006.html

Australia.

In Malaysia, the Ministry of Health placed full-page ads in major newspapers coinciding with the introduction of new graphic warnings in early 2009 (see example).

Click on the links below for additional examples of campaign media to support health warnings:

Australia: national promotional ad for introduction of picture warningswww.quitnow.info.au/internet/quitnow/publishing.nsf/Content/warnings-lp

Brazil: “Euclides” & “Renata” television spots downloadwww.inca.gov.br/tabagismo/frameset.asp?item=multimidia&link=videos.swf

resourceTheUnionandtheWorldLungFoundationhavepublishedadetailedGuidetodevelopingmass media campaigns for tobacco control. It is available at:www.worldlungfoundation.org/mmr/eng_index.html

3.4 step 4: Consult as necessary with stakeholders and the publicIt can be useful to hold public consultations on regulatory proposals for packaging and labelling, either through hearings or through inviting written comments on the proposals. The consultation process will likely be guided by the legislative consultation norms in each country.

The advantage of such consultations is that:

• Governmentmayreceiveusefulcommentsfrompublichealthalliesandexperts. • Tobaccocompanieshaveanopportunitytosubmitcommentsinatransparentfashion (rather than behind closed doors), and cannot claim later that they were not consulted. • Mediacoverageoftheconsultationscanhelppromotethemeasuresinadvanceoftheir implementation.

However, tobacco industry attempts to use the consultation period should be used as an opportunity to delay implementation and to build political momentum against the proposed measures should be countered. To facilitate the process:

• Ensurethattheconsultationpaperandproposalsarebasedoncurrentevidence,andthattheevidenceandrationaleforthe proposals are set out clearly and simply. • Knowinadvancethegeneralparametersofyourdesiredpolicybasedontheevidence,andsetclearparametersforcomment (for example, if you know you want picture warnings, don’t ask whether stakeholders support picture warnings, but ask them which picture warnings they think would be most effective). • Providealimitedcommentperiod(90daysisreasonable).

article 11 Guidelines: supporting communication activityThe introduction of new health warnings and messages is more effective when it is coordinated with a broader, sustained public information and education campaign. Timely information should be provided to the media, as media coverage can increase the educational impact of new health warnings and messages. (Paragraph 42)

Malaysia.

article 11 Guidelines: supporting communication activityThe introduction of new health warnings and messages is more effective when it is coordinated with a broader, sustained public information and education campaign. Timely information should be provided to the media, as media coverage can increase the educational impact of new health warnings and messages. (Paragraph 42)

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• Ensurethatthepublicandkeystakeholdershaveconvenientaccesstoconsultationdocuments,alongwithanefficient, accessiblecommentsystem.Inmanycountries,aweb-basedoremailsystemmaybemostefficient;inothers,community forums may be more appropriate. • Mobiliseanallianceofstakeholderstospeakupinthemediaandtosubmitcommentssupportiveofthestrongestmeasures possible. • Donotcommittorespondingtoallcomments,buttoprovideanoverallresponsetothemaincategoriesofcommentsreceived.

examples of consultation processes on packaging and labelling measures

Ireland department of health and Childrenwww.dohc.ie/press/releases/2008/200805013.html

new Zealand Ministry of healthwww.ndp.govt.nz/moh.nsf/indexcm/ndp-publications-smokefreeregsconsultation2006Consultation Paper Consultation Results

uK department of healthhttp://www.dh.gov.uk/en/Consultations/Responsestoconsultations/DH_077960Consultation Paper Consultation Results

3.5 step 5: anticipate and counter tobacco industry arguments (and use them to gain earned media)The main opponents of effective packaging and labelling policies are tobacco companies. Although their arguments and tactics against these policies are extensive, they are usually predictable and can often be turned to your advantage.

Countering the tobacco industry’s arguments should always be viewed as an opportunity for earned media that promotes strong packaging and labelling policies. The evidence and arguments in support of graphic warnings, and in support of eliminating misleading information, aresostrongthatitisdifficultfortheindustrytowintheminthepublicsphere.Thisisnottosaythattheindustrywon’tsucceedinswayingdecisionmakersbehindcloseddoors,butitwillbemuchmoredifficultifthepublicisinformedaboutandsupportstheplannedpolicies.

By becoming familiar with the most common tobacco industry arguments, you can be ready to quickly counter them with colleagues and in the media. These efforts will complement other public education strategies. Some common arguments, along with suggested responses and resources to counter them, are summarised below.

“Image-based warnings will cost too much to implement”Not true. Tobacco companies constantly update their packaging. Their costs for implementing health warnings are minimal. In any case the costisjustifiedrelativetothepublichealthbenefit.Australia,CanadaandtheUKestimatethenetbenefitofpicturewarningstobeAU$2billion, CD$4 billion, and £206 million, respectively.224 225 226 Most of the costs result from decreased sales, which means that the warnings will have their intended impact: reducing tobacco use.

Read the studies here: australia Canada uK

“We can’t implement picture warnings in such a short time period”Not true.Tobaccocompaniescanandhaveimplementedpicturewarningrequirementsinaslittleassixmonthsafternotification,includinginBrazil,Canada,Uruguay,andSingapore(implementationofSingapore’ssecondroundwasfivemonthsfromnotification).Canada’srebuttal to the industry’s claim that they cannot implement picture warnings quickly, including claims of limitations in printing technology, is documented in its regulatory Impact analysis statement.225

“There is no evidence that picture warnings work. Graphic warnings will just scare smokers”Not true. Dozens of studies show that smokers read the warnings, appreciate the warnings, and change their behaviour in response to the warnings (eg. by trying to quit; smoking outdoors to avoid harming their families). Evidence also shows that graphic warnings that arouse fear or other emotions are MOST effective, particularly when combined with information to help or empower smokers to quit smoking. See the evidence review.

“Quantitative emissions information is valuable to smokers”Not true. Quantitative information about smoke emissions – such as tar and nicotine – misleads smokers. Measurements of smoke emissions by the ISO and similar methods bear no relationship to the quantities of those substances ingested by the smoker. Read the study here.227

“Large warnings and removal of misleading labelling violate freedom of speech and trademark rights”Not true. Countries with various legal traditions have implemented picture warnings and prohibited misleading terms such as “light” and “mild” without legal challenges from the industry.

In addition, the tobacco industry lost both of its major court challenges on these issues, in the European Court of Justice and in the Supreme Court of Canada (see Step 6).

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3.6 step 6: Prepare for potential industry litigationHaving countered tobacco industry arguments, countries should prepare for tobacco industry threats of litigation against strong packaging requirements.

Fortunately actual litigation against packaging measures is less common than threats. Furthermore the industry has lost the two most significantcourtchallengesithasbroughtagainstthesemeasures:

• InDecember2002theEuropeanCourtofJustice(ECJ)upheldthevalidityoftheEUDirectiverequiring(text-only)health warnings on packaging and prohibiting the use of misleading terms on packaging.228 read the full eCJ judgment.

• InJune2007theSupremeCourtofCanadaruledthatCanada’srequiredpicturewarningsandprohibitionsonmisleading promotion were constitutionally valid (see box).229 It should be noted that Canada is party to GATTS, NAFTA, TRIPS, WTO, and most other trade agreements that the industry commonly mentions as preventing strong packaging health measures. Yet the industry has not brought a case against the Canadian measures to the tribunals of any of these trade agreements. Read the full supreme Court of Canada’s 2007 ruling. en français.

Canada: Tobacco industry loses constitutional challenge to packaging measures

Regulations under Canada’s Tobacco Act to implement picture warnings and packaging measures were written in 2000. Canada’s major tobacco companies launched a legal challenge to the Act and its regulations. On 20 June 2007, the Supreme Court of Canada upheld in full the Act and its Regulations.

The industry’s challenge centered around these sections of the Canadian Charter of Rights and Freedoms (part of Canada’s Constitution): s.1 The Canadian Charter of Rights and Freedoms guarantees the rights and freedoms set out in it subject only to such reasonablelimitsprescribedbylawascanbedemonstrablyjustifiedinafreeanddemocraticsociety.[emphasis added] s.2 Everyone has the following fundamental freedoms:... b) freedom of thought, belief, opinion and expression, including freedom of the press and other media of communication.

The Supreme Court weighed the importance of the limiting measures against whether the measures were “reasonable and demonstrably justified”inlightoftheimportanceoftheobjective.TheCourtheldthatwhilemanyprovisionsofthelawdo 231 infringe the industry’s right tofreedomofexpression,theinfringementisjustifiedunders.1oftheCharter.Inotherwords,thelawsetsreasonable,justifiablelimitsto protect public health.

The Supreme Court’s ruling on false and misleading promotion:Section 20 of the Tobacco Act, which bans “false, misleading or deceptive” promotion, as well as promotion “likely to create an erroneous impression about the characteristics, health effects or health hazard of the tobacco product or its emissions”, clearly infringes the guaranteeoffreedomofexpression.However,theban,andmorespecificallythebanonpromotion“likelytocreateanerroneousimpression”,arejustifiedunders.1….Theobjectiveisofgreatimportance,nothinglessthanamatteroflifeordeathformillionsofpeople who could be affected, and the evidence shows that banning advertising by half-truths may help reduce smoking. The expression at stake — the right to invite consumers to draw an erroneous inference as to the healthfulness of a product that, on the evidence, will almost certainly harm them — is of low value. (58-59, pp 4-5) [emphasis added]

The Supreme Court’s ruling on picture warnings:The requirement in the Tobacco Products Information Regulations that the government’s health warnings occupy at least 50 percent oftheprincipaldisplaysurfacesofpackagesinfringess.2(b)oftheCharter,buttheinfringementisjustifiedunders.1Parliament’sgoal, notably to inform and remind potential purchasers of the product of the health hazards it entails, is pressing and substantial. The evidence as to the importance and effectiveness of such warnings establishes a rational connection between Parliament’s requirement for warnings and its objects of reducing the incidence of smoking and of the disease and death it causes. Regarding minimal impairment, the requirement for warning labels, including their size, falls within a range of reasonable alternatives. The reasonableness of the government’s requirement is supported, notably, by the fact that many countries require warnings at least as large as Canada’s. Finallythebenefitsflowingfromlargerwarningsareclear,whilethedetrimentstothemanufacturers’expressiveinterestincreativepackagingare small. (130-140, pp 7-8) [emphasis added]

Tobacco companies also challenged picture warnings in Belgium, where they argued against the feasibility of implementing the 42 required warnings within the proposed time period. The regulation was amended to provide the industry more time to implement the series of warnings, and the legal challenge was not continued. 230

Regardless of this happy track record for public health, potential litigation should be prepared for by:

• Ensuringthatregulatoryrequirementsarebasedonscientificevidenceandbestpractice. • Providingclearinformationaboutregulatoryrequirementstotobaccocompaniesinadvanceofimplementation. • Ensuringaconsultativeprocessconsistentwithlegalobligationsinyourcountry.

You should also become familiar with the most common categories of legal arguments used by the industry against packaging measures. Many of these arguments are addressed in The case for plain packaging of tobacco products. 231 The paper includes references to original legal sources.

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4. PosT-IMPLeMenTaTIon: enforCeMenT, MonITorInG and evaLuaTIon

Please note that while enforcement, monitoring and evaluation activities take place after legal measures come into force, countries will need to prepare for most of these activities well before that date.

4.1 step 1: Monitor complianceEnforcement of packaging and labelling policies is considerably less resource-intensive than for other tobacco control policies, such as smoke-free legislation. This is because most monitoring will occur at a relatively small number of locations, mainly manufacturing and importing facilities. Efforts should focus on the immediate post-implementation period, after which relatively little monitoring is typically required.

Inadditiontoensuringthateffectiveenforcementprovisionsarewrittenintolaw(seesection2,firstbox),countriesshould:

• Identifyanenforcementauthorityoragency. • Trainenforcementstaffandprovidethemwithclearinspectionprotocols. • Assignsufficientresourcestoensureregularrandominspectionsoftobaccomanufacturing,wholesaleandimporterfacilities,and of retail outlets in different parts of the country.

Manufacturing and wholesale facilities should be the focus of inspections. For retail inspections, priority should be given to locations more likely to be non-compliant. For example, if there are retailers or commercial areas known for carrying contraband tobacco products, these might be a top priority for inspections with regard to packaging provisions.

4.2 step 2: Monitor implementation success and institute a review process to improve regulationsCountries should monitor not only compliance, but also identify areas where the regulations need to be strengthened in order to implement theintendedmeasuresmoreeffectively.Specificallythemonitoringprocessshouldincludemechanismstoidentifyloopholesintheregulations and make recommendations for closing these loopholes. For example, manufacturers could be following the letter of the law, butyoumayfindthattheregulationshavebeenwrittenlooselyenoughtopermitmanufacturerstoprintwarningsinawaythatmakesthemhard to see. This is a question of amending the regulations. All enforcement and monitoring information should feed into a review process to ensure that regulations are regularly amended to improve effectiveness and to address new issues.

Brazil, through a full-time agency charged with enforcing, monitoring and updating regulations on tobacco packaging and labelling (ANVISA),issuesnewresolutionsonaregularbasistocloseloopholesandensurethatpackagingandlabellingmeasuresareconsistentwiththelatestscientificevidenceandevaluations.SeeanvIsa’s tobacco website (Portuguese; more limited information is available in English and Spanish).

TheEuropeanCommissionpublishesregularreportsonimplementationofEUpackagingandlabellingdirectives,includingidentificationoffuture regulatory issues, at: http://ec.europa.eu/health/ph_determinants/life_style/Tobacco/keydo_tobacco_en.htm See the first (2005) and second (2007) implementation reports.232 233

4.3 step 3: evaluate impactThe packaging and labelling measures should also be evaluated for their impact on public health, particularly on the knowledge, attitudes and behaviour of smokers, potential smokers, and non-smokers exposed to tobacco smoke.

In general, impact evaluations are not used to evaluate the effectiveness of individual warnings, but rather the impact of the health warnings system as a whole.

Although the objectives of health warning systems may differ to some extent across jurisdictions, common objectives to be measured include the following:

• Anincreaseinhealthknowledgeandperceptionofrisk. • Greaterawarenessofcessationservices. • Anincreaseinmotivationtoquitandinsuccessfulquitting. • Adecreaseinexposureofotherstosecondhandtobaccosmoke.

Countries may also want to measure public support for packaging and labelling policies, as well as potential wear-out of the warnings to determine when new warnings are needed (see Timing of surveys on next page).

MethodsPopulation - based surveys provide the most comprehensive method for evaluating the impact of health warnings. Ideally, surveys should be conducted before and after the implementation of new warnings. These surveys should also use similar questions and methodology so that changes in key outcomes can be examined.

Some jurisdictions have conducted entire surveys devoted to evaluating the impact of health warnings. However, it is also possible to insert a smaller number of questions into on-going surveys (conducted by the government or private companies) that include other topics.

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QuestionsQuestions to evaluate warnings should be designed to address potential outcomes of interest. Common outcomes include the following:

• Arethehealthwarningsbeingnoticed? • Howdotheycomparewithothersourcesofhealthinformationabouttobaccouseintermsofsalienceorlevelofexposureto messages?(forexample,versusinformationfromtelevision,healthcareprofessionals,oreducationcentres). • Towhatextentdosmokersprocessthewarnings,intermsofthinkingaboutanddiscussingwarnings? • Dosmokersbelievetheinformationinthewarningsiscredible? • Havethewarningsincreasedlevelsofhealthknowledgeandperceivedrisk? • Havethewarningsmadesmokersthinkmoreoftenaboutthehealthrisks? • Aresmokersmorelikelytoquitduetothehealthwarnings?(Havetheythoughtmoreabouttryingtoquit,oractuallytriedtoquit asaresultofthewarnings?) • Havethewarningsinfluencedsmokerstosmokeoutsidemoreofteninordertoavoidexposingtheirfamily,friendsand co-workerstosecondhandtobaccosmoke? • Dohealthwarningsreducetheappealofthepackage? • Whatisthelevelofpublicsupportforhealthwarnings?

Impact evaluations from other countries can help you design your own survey. Many of these studies can be found at:www.tobaccolabels.org

In addition, a detailed discussion of questions used to evaluate the impact of health warnings is included in a new publication from the International Agency for Research on Cancer (IARC), Methods for Evaluating Tobacco Control Policies. This publication can be ordered from IARC (www.who.int/bookorders/anglais/detart1.jsp?sesslan=1&codlan=1&codcol=76&codcch=28), or you can request the chapter from: dhammond@uwaterloo.ca

Timing of surveysSeveral months often pass between the implementation date of new health warnings and the time at which they appear on most packages. In addition, the cumulative impact of health warnings may build over time, with repeated exposures to the different messages.

Therefore, surveys that seek to measure the impact of warnings should take place about six months after the implementation date. Ideally, regular surveys should be conducted to examine potential wear-out of the warnings, perhaps at 12 or 24-month intervals, if necessary.

Target groupsImpact evaluations should include both smokers and non-smokers. The extent to which non - smokers notice and recall health warnings is a very good indication of the overall effectiveness of the warnings in the general population.

Governments may also want to measure the impact of the warnings among different demographic groups, such as by sex, age, or socioeconomic level.

other indicators of impactOther indicators may add insight into the impact of warnings. For example, several jurisdictions have tracked the use of telephone quit smoking services, or quitlines, before and after the inclusion of the quitline number on tobacco packages.

TheUK,theNetherlands,Brazil,NewZealandandAustraliaallfoundthatcallstothequitlinenumberincreasedsignificantlyimmediatelyafter the number appeared on packages in each country.

The graph below shows the increase in calls to the Netherlands quitline service after the number was printed on the back of one of 14 package warnings, beginning in Week 19 of 2002. This data source indicates that, at the very least, the health warnings helped to increase the use of cessation services.

Source: Willemsen M., Simons C, Zeeman g. Tobacco Control 2002;11: 381-2.

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? Can I use prevalence rates to evaluate the impact of warnings?Tobacco use prevalence rates from national surveys provide an estimate of population-wide changes in smoking behaviour. However, there are several limitations to using prevalence data to measure the effectiveness of health warnings in reducing tobacco use. The Canadian experience provides a good illustration of these limitations.

Since large pictorial warnings were implemented in Canada in 2001, the prevalence of smoking has decreased from 22% to 18%, a decline of approximately 18%. This is a considerable public health achievement. However, it would be inaccurate to say that the health warnings were responsible for all or even most of this decrease. Over the same time period, the price of tobacco products increased, several mass media campaigns were conducted, and smokefree legislation became considerably stronger in Canada. All of these interventions will have had an impact on prevalence, as will have other factors (level of tobacco promotional expenditures, for example).

Therefore,whilehealthwarningsmayhaveplayedanimportantroleinreducingsmokinginCanada,itisdifficulttoestimatetheproportion of the impact caused by the warnings versus other factors. To try to determine this, any study would need to examine all of the likely factors contributing to changes in prevalence.

The tobacco industry may try to use prevalence rates to its advantage, claiming that graphic warnings don’t work if smoking prevalence doesn’t decrease after they are implemented. In reality, it may be that the implementation of warnings prevented what would have been an even greater increase in prevalence. Again, it is impossible to say without examining multiple factors.

aCKnowLedGeMenTs

Much of the material in the Guide is drawn from the Packaging and Labelling Toolkit developed by David Hammond (www.tobaccolabels.org). Additional material was written by Heather Selin.

OverallcoordinationoftheproductionoftheGuidewasprovidedbyTuijaTengvallandCatalinaVoroneanuunderthedirectionofSinéadJones.

TheUnionwishestothanknumerousUnionstaffandconsultantswhoreviewedtheGuideandprovidedvaluablecommentsandinsights:Fouad Aslam, Rob Cunningham, Burke Fishburn, Lara Garrido Herrero, Fiona Godfrey, Mirta Molinari, Gihan El-Nahas, Francis Thompson.

Penny Marshall provided very helpful early feedback about useful information to include in the Guide. Too many people to name provided great assistance in determining which images of health warnings are available for use, and the process for requesting permission to use them.

Finally, the Guide owes a great debt of gratitude to the countries that have implemented strong packaging and labelling policies and have been kind enough to document and share their experiences. Without this experience, the Guide would be a very slim volume.

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230 Luk Joosens, personal communication, 31 July 2007.

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233 Commission of the European Communities. Report from the Commission to the European Parliament, the Council and the European Economic and Social Committee. Second report on the application of the Tobacco Products Directive. Brussels, 27 November 2007. http://ec.europa.eu/health/ph_determinants/life_style/Tobacco/keydo_tobacco_en.htm

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Contact usDepartment of Tobacco ControlInternationalUnionAgainstTuberculosisandLungDisease(TheUnion)10QueenStreet,EdinburghEH21JQ,UK

Tel: +44 131 226 2428 fax: +44 131 220 0529tobaccofreeunion@theunion.orgwww.theunion.orgwww.tobaccofreeunion.org

Isbn: 978-2-914365-60-4

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