The European Tobacco Products

Directive

Constantine VardavasMD, RN, MPH, PHD

Declaration• No conflict of interest to declare.

• Scientific Team Leader (Framework contract: BRFAA-ENSP) responsible for:– Study on the development of a EU common reporting format for submission of data on ingredients contained in tobacco and related products, and disclosure of the collected data to the public– Study on the identification of potential risks to public health associated with the use of refillable electronic cigarettes and development of technical specifications for refill mechanisms– Report on the identification of assessment of available evidence on toxicity, addictiveness and attractiveness of ingredients contained in tobacco and related products on the basis of information submitted by the industry in the context of reporting obligations introduced by Directive 2001/37/EC

The content/interpretation of these slides are my own; it can in no way be taken to reflect the views of the European Commission and/or Chafea or any other body of the European Union.

The EU and the tobacco epidemic

• 28 EU MS • 508 million people• Premature deaths in the EU per year

– 700,000• Current burden to public health care:

– 25 billion per year• Productivity losses:

– 8 billion per year.

TOBACCO: from Design to Disease

Policy prioritiesThe EU+28 EU MS implement tobacco control measures in the form of legislation, recommendations and information campaigns.

These policy measures include:

the regulation of tobacco products on the EU market (e.g. packaging, labelling, and ingredients),

advertising restrictions for tobacco products, the creation of smoke-free environments , tax measures and activities against illicit trade , anti-smoking campaigns .

http://ec.europa.eu/health/tobacco/policy_en

Policy prioritiesThe EU+28 EU MS implement tobacco control measures in the form of legislation, recommendations and information campaigns.

These policy measures include:

the regulation of tobacco products on the EU market (e.g. packaging, labelling, and ingredients),

advertising restrictions for tobacco products, the creation of smoke-free environments , tax measures and activities against illicit trade , anti-smoking campaigns .

http://ec.europa.eu/health/tobacco/policy_en

The new EU Directive

The Tobacco Products Directive provides a mandate for stronger regulation of the manufacture, marketing and sales of tobacco products, ingredients, additives, disclosure to the public, oral tobacco and e-cigarettes. “… will improve the functioning of the internal market for tobacco and related products, while ensuring a high level of health protection for European citizens”

The Council of the European Union. Revision of the tobacco products directive.

Legislative actions in the EU

Taking into account the significant cross border trade of tobacco products and diverging national legislation, EU-wide rules are necessary for these products. The rules ensure that all consumers are equally protected across the EU.

The new Tobacco Products Directive governing the manufacture, presentation and sale of tobacco and related products was signed on 3 April 2014.

Transposition into national EU legislations

Designing of supportive and implementing acts

http://ec.europa.eu/health/tobacco/policy_en

Implementation timeline

Products under the Directive (TPD)

• Cigarettes• Roll Your Own/pipe tobacco• Smokeless tobacco (Austria, Finland and Sweden)

• Waterpipe tobacco• E-cigarettes• Novel tobacco• Herbal tobacco products

Regulation of ingredients (Art 5,6,7)

• TNCO reporting• Product characteristics reporting• Ingredient reporting• Toxicity reporting• Emissions• Sales data • Marketing

Structuring of a reporting format as a tool to collect data that can be useful to regulators and increase the utility of the collected data

Utility from a public health perspective

• While the main objective of the new common reporting format is to improve the functioning of the internal market, it also represents important benefits to public health.

• Unprecedented opportunity to increase the detail of information that is available to the regulators and the general public.

• This increased information will enable regulators to monitor design & product elements and would provide crucial information to regulators implementing EU or national legislations related to tobacco control.

Ingredient RegulationRegulation of ingredients that give a characterizing flavorIngredients that:• vitamins or other additives that create the impression that a tobacco

product has a health benefit or presents reduced health risks;• caffeine or taurine or other additives and stimulant compounds that are

associated with energy and vitality;• additives having colouring properties for emissions;• for tobacco products for smoking, additives that facilitate inhalation or

nicotine uptake; and• additives that have CMR properties in unburnt form

Priority Additives

Misleading cigarette design and packaging characteristics

• Suggest benefits in terms of weight loss, sex appeal, economic class, social life or qualities such as femininity, elegance or masculinity.

• Visual elements (color), may be used by the tobacco industry to cue or amplify the perceived sensory reward from smoking, or to indirectly communicate a misleading message of reduced harm.

Cigarette design and marketing features are associated with increased smoking susceptibility and perception of reduced harm among smokers in the EU

Design features and youth perceptions of reduced harm

• Menthol (OR 2.5*)• Flavours such as spicy, fruity (OR 1.5)• Shape and size of a cigarette (OR 2*)• “organic” or “natural” (OR 1.9*)• Additive free (OR 1.3)

Packaging as an industry advertising tool

• Although many factors influence tobacco use behavior, tobacco industry advertising and promotions stand out as a prominent factor encouraging tobacco use.

• Using striking colors, distinctive fonts and carefully crafted materials, cigarette packaging is defined to be highly attractive, especially among young people.

Packaging and Labelling

• PRE TPD

Packaging and Labelling

Packaging and Labelling

Tobacco PackagingCharacteristics Cognitive only

response1

aOR (95%CI)

Behavioral response 2

aOR (95%CI) Gender EU Region

Western Europe (Referent) Ref. Ref. Southern Europe 2.97 (2.06-4.26)* 1.29 (1-1.66)* Northern Europe 2.26 (1.57-3.25)* 1.46 (1.13-1.89)* Eastern Europe 1.71 (1.18-2.49)* 1.54 (1.2-1.96)*

Age 15-24 (Referent) Ref. Ref. 25-39 1.08 (0.74-1.58) 1.13 (0.85-1.51) 40-54 1.13 (0.76-1.66) 1.05 (0.78-1.41) 55+ 1.31 (0.87-1.95) 1.02 (0.75-1.39)

Presence of pictorial warnings on cigarettes4

Countries with text warnings Ref. Ref. Countries with pictorial warnings 1.11 (0.87-1.4) 1.31 (1.1-1.56)*

Effectiveness of Text versus Pictorial Health Warning Labels and Predictors of Support for Plain Packaging of Tobacco Products within the European Union. Eur Add Res 2015

E-CIGARETTES & NOVEL PRODUCTS

4 “Classical” stages of the tobacco epidemic: Prevalence-death “categorization”

Evolution of the global tobacco epidemicType 1

Oral tobacco and Cigarettes

Type 2

Dual use Type 3

Non combustible products

Vardavas & Agaku in “The Tobacco Epidemic-2nd edition” 2015 Karger. Editor(s): Loddenkemper R, Kreuter M

Hypothesis of 3 epidemic phenotypesType 1Smokeless and CigarettesStill increasing prevalence Regional production/useTraditional TC initiatives S+E Asia, Middle East, African Region

Type 2

Dual InfectivityLocated in countries with developing TC initiatives An environment potentially interested in other products but still at the apex of the epidemicSteady cigarette sales/consumptionGrowing awareness of the harm caused by tobaccoEastern and Southern Europe*,

Type 3

Modified Risk Tobacco ProductsAdvanced TCSteady reductions in cigarette sales/consumptionGreater awarenessMultiple product useConsumer pressureExamples: USA, Canada, Northwestern Europe,

Vardavas & Agaku in “The Tobacco Epidemic-2nd edition” 2015 Karger. Editor(s): Loddenkemper R, Kreuter M

Warning labels for e-cigarettes‘This product contains nicotine which is a highly addictive substance. It is not recommended for use by nonsmokers’.

Or‘This product contains nicotine which is a highly addictive substance.’

Appear on the two largest surfaces of the unit packet and any outside packaging and cover 30 % of the surfaces of the unit packet and any outside packaging (Art20.4)

Optional

each unit packet and any outside packaging of such products shall carry an additional text warnings

Safety/ Special mandates • Toxicological/addiction data regarding the product's ingredients and

emissions, including when heated• Information on the nicotine doses and uptake;• Only ingredients of high purity are used in the manufacture. • Electronic cigarettes deliver the nicotine doses at consistent levels;• Except for nicotine, only ingredients are used in the nicotine-containing liquid

that do not pose a risk to human health in heated or unheated form”

Other aspects of Article 20Regulating promoting and advertising Audiovisual (TV) ads; Radio ads; Radio programme sponsorship Any form of public or private contribution to any event, activity or individual

person Cross border advertising

Additional Reporting requirements• Comprehensive data on sales volumes, • Information on the preferences of various consumer groups, including young

people, non-smokers and the main types of current users;• The mode of sale of the products; (i.e. online vs in shop)• Executive summaries of any market surveys carried out in respect of the

above

Unit packets of electronic cigarettes and refill containers include a leaflet with information

TACKling SecondHand Smoke and electronic cigarettes aerosols – TACK SHS

Novel Tobacco Products• Information on ingredients and emissions• Available scientific studies on toxicity, addictiveness

and attractiveness • Available studies, executive summaries thereof and

market research on the preferences of various consumer groups, including young people and current smokers;

• Risk/benefit analysis of the product: – its expected effects on cessation of tobacco consumption, – its expected effects on initiation of tobacco consumption– predicted consumer perception.

Tracking and tracing

• Illicit trade is a threat to tobacco control.• Continuum of monitoring through all stages in

handling from production to the consumer.• A tamper proof security feature, composed of

visible and invisible elements.

Monitoring the TPD

• Maximise the wealth of data that will be collected

5 year follow up

Monitoring

Data Collection

Re-evaluation

Alteration of the

legislation

• To monitor and evaluate the impact of the TPD within the context of FCTC ratification at a European level.

• To evaluate the psychosocial and behavioral impact of TPD implementation and FCTC implementation,

• Collection of information from 28 EU MS.

WP2/3/4 - Through the creation of a cohort of adult smokers in 6 EU MS (n=6000) in a pre- vs. post-TPD study design (WP2-WP3)- part of the ITC study

•Greece (University of Athens)•Germany (German Cancer Research Center)•Hungary (Smoking or Health Hungarian foundation)•Poland (Health Promotion Foundation)•Romania (Aer Pur Romania)•Spain (Institut Catala d’Oncologia)

• WP5- Repeated cross sectional Eurobarometer Survey’s - 100,000 adults in 2009-2017

• WP6 – Evolution of the e-cigarettes

Evidence based decisions

Tobacco control regulatory science,

Evidence based decisions

lead to the implementation of tobacco control legislations

Thank you