The document summarizes evidence from the International Tobacco Control Policy Evaluation Project (ITC Project) on the impact of health warnings on tobacco packaging. The ITC Project finds that large pictorial health warnings are more effective than text-only warnings at increasing awareness of health risks, motivating smoking cessation, and preventing smoking initiation. Studies from Australia, Thailand, Malaysia, and other countries show that implementing large graphic warnings significantly increases noticing of warnings and discourages cigarette consumption. Transitioning China from small text warnings to larger graphic warnings based on evidence from Malaysia could potentially impact the smoking behaviors of tens of millions of Chinese smokers.

1. Moving the WHO FCTC Forward in its
Second Decade: The Role of Evidence in
Strengthening and Accelerating the Fight
Against the Global Tobacco Epidemic
Geoffrey T. Fong (gfong@uwaterloo.ca)
University of Waterloo and
Ontario Institute for Cancer Research
Tobacco Control Unit,
Institut Català d'Oncologia,
Barcelona, Spain—March 21, 2017

2. The Global Tobacco Epidemic
 1.1 billion people smoke
(82% live in LMICs)
 20th
century: 100 million deaths
 21st
century: 1 billion deaths
 This year: 5.4 million users will die and
600,000 non-users will die of second-
hand smoke
 Tobacco (smoking) causes 1/6 of all
NCDs worldwide and is the only risk
factor that causes all 4 leading NCDs
 WHO: tobacco is the leading
preventable cause of death and
disability in the world

3. 3
“Tobacco is the most effective agent of death ever
developed and deployed on a worldwide scale.”
– John Seffrin, former CEO
American Cancer Society

4. 4
Tobacco:
$1 —> $6,280,237
15.3% annual rate
Stock Market:
$1 —> $38,255
10.1% annual rate

5. 5

6. 6
The only feasible way to combat such a
massive threat is by implementing
population-level interventions

7. 7
Huge Potential of Population Interventions
190
340
500
0
70
220
520
Estimated cumulative tobacco deaths
1950-2050
300
400
500
2025 205020001950
100
200
Year
Tobaccodeaths(millions)
World Bank. Curbing the epidemic: Governments and the economics of
tobacco control. World Bank Publications, 1999. p80.
Intervention impact
depends on two
main factors:
1. Timing
2. Strength

8. Key to Combating the Tobacco Epidemic:
1. Identify strong, evidence-based
measures that will reduce tobacco-
caused death and harm
2. Implement them as quickly as possible

9. 9
Framework Convention on Tobacco Control (FCTC)
 Legally binding international treaty: first under the WHO
 Came into force in Feb 2005; ratified by 180 countries
 Multisectoral: whole-of-government approach
 Includes broad range of tobacco control policies:
• Pictorial warnings
• Comprehensive smoke-free laws
• Higher taxes to reduce demand
• Bans/restrictions on marketing
• Support for cessation
• Measures to reduce illicit trade
• Tobacco product regulation
 Tobacco industry must be prevented from
influencing policies and measures
 Greatest disease prevention initiative in history

10. 10
Framework Convention on Tobacco Control (FCTC)
 180 Parties (179 countries +
European Union)
 7 Conferences of the Parties
 Guidelines have been developed
and adopted for many of the
Articles
 New protocol on illicit trade was
adopted at COP5 (2012)
 Implementation has been
slow:
(1) Lack of sufficient resources
(2) Low political will
(3) Tobacco industry influence

11. 11
Development Planning and Tobacco Control
Integrating the WHOFramework Convention on
Tobacco Control into UN and National Development
Planning Instruments

13. 13
Impact Assessment Report to COP7
 Global evidence review of 17 FCTC articles (ITC Project)
 Reports for the Expert Group on the use of FCTC in
tobacco control legislation and in defense of industry
challenges (McCabe Centre) and industry response to
FCTC (Stella Bialous)
 Country missions to 12 FCTC Parties

16. Agenda item n° 5.2 COP7 Document n° 6 y16
• Analysis of WHO data from
126 countries
• Predictor: number of highest-
level implementations of key
demand-reduction FCTC policies
between 2007 and 2014
• Outcome: WHO smoking
prevalence trend estimates from
2005 to 2015 (first decade of the
WHO FCTC)
• Results: Each additional
highest-level implementation
associated with 1.57 percentage
point decrease in smoking rate
(7.09% relative decrease)
Gravely et al.—
Lancet Public Health
(Released tonight)

17. Protect People From Tobacco Smoke (FCTC Article 8)
2012: 1.1 billion people in 43 countries (16% of the world's population)
are covered by complete smoke-free legislation.
2014: 1.3 billion people in 49 countries (18% of the world’s population)

18. Warn About The Dangers of Tobacco (FCTC Article 11)
2012: 1.0 billion people in 30 countries (14% of the world's population)
are exposed to strong graphic health warnings.
2014: 1.4 billion people in 42 countries (20% of the world’s population)

19. “Tobacco use is unlike other threats to global health.
Infectious diseases do not employ multinational
public relations firms. There are no front groups to
promote the spread of cholera. Mosquitoes have no
lobbyists.”
– WHO Zeltner Report (2000)
Why has FCTC implementation been so slow and
in many cases, at levels below the standards set
by the FCTC Article Guidelines?

20. 20
Tobacco Industry: Distorting Science
 Creation of front groups to cast doubt on the
evidence of the harms of smoking and then of
second-hand smoke
 Payment to “neutral” scientists for results-directed
research
 Creation of entire research programs to “generate
a body of scientific and technical knowledge
[through research] undertaken by whitecoats.”

21. 21
“Doubt is our product.”

22. 22
 Overt and covert political influence (donations, CSR)
 Misinformation and disinformation campaigns to spread and
perpetuate myths:
• Graphic warnings will make people defensive; they will be
MORE likely to smoke
• People, especially smokers, won’t support smoke-free laws
• Tobacco growing/manufacturing/sales are central to the
country’s economy
• Tobacco control laws will have negative economic impact
– “Smoke-free laws will hurt restaurants and bars.”
– “Higher taxes/graphic warnings/plain packaging will
increase smuggling.”
Tobacco Industry Interference

23. 23
The fight against the industry is
fought on the battlefield of evidence
 Supportive arguments: What evidence do we have that
tobacco control policies really do work?
 Counterarguments: What evidence do we have that
addresses the industry’s claims that policies won’t work
and that they will lead to negative impact?

24. “The FCTC is an evidence-based treaty
that reaffirms the right of all people to the
highest standard of health.”
– FCTC Foreword
“Evidence”
mentioned 5 times
“Scientific”
mentioned 13 times
“Effective(ness)”
mentioned 28 times

25. 25
What type of evidence is
needed to strengthen and
accelerate FCTC
implementation?

26. 26
The Path from Laws to Impact
Law is
passed
Law is
implemented,
communicated,
enforced
Regulations
are created
How
EFFECTIVE
is the law?

27. 27
Example: Smoke-free law in India
 National tobacco control law (Oct 2008)—COTPA:
Strong smoke-free law on paper.
 The ITC Project in India (TCP India Project):
Wave 1: Aug 2010–Sep 2011, 2-3 years > smoke-free law
 ITC Survey: what is the actual impact of the law?
1. Very high levels of smoking found in restaurants and bars
2. Very low awareness of the law:
Smokers in Maharashtra: only 35% were aware
Smokers in Madhya Pradesh: only 18% were aware
A very strong law on paper does not guarantee that it will have
impact. Legislative analysis = potential impact, not actual impact.

28. 28
There is an essential need for
research that evaluates the impact of
the FCTC

29. 29
Challenges to Evaluating Policies
 Not possible to conduct experiments (randomized
controlled trials (RCTs)) on policies
 But it is possible to evaluate the impact of policies using
natural experiments (“quasi-experiments”)
1. Multiple country comparisons: international studies
2. Common methods and measures across countries
3. Cohort studies: focus on impact on individuals

30. 3030
The International Tobacco Control Policy
Evaluation Project (the ITC Project)
Canada United States Australia United Kingdom
Ireland Thailand Malaysia South Korea
China New ZealandMexicoUruguay
France NetherlandsGermany Bangladesh
IndiaBhutanBrazil Mauritius
Zambia Kenya Abu Dhabi
Greece
Hungary
Poland
Romania
Spain

31. Key Features of the ITC Project
 Focus on science:
– First-ever international cohort study of tobacco use
– Focus on policy evaluation
– Rigorous research design
– Cross-country comparisons; health inequalities
 Focus on dissemination:
– National Reports, Policy Reports, etc., to communicate
ITC findings to policymakers & other health stakeholders
– Evidence to argue against myths of the tobacco industry
 Focus on collaboration, building research capacity:
– Over 100 research collaborators
– Building research capacity for tobacco control research
(especially within LMICs)

32. Content of the ITC Surveys
Unique ITC
Content:
150+ Qs
focusing on
policy impact
Surveillance
content
Surveillance
content
Mixed Surveillance
and policy content
Throughout
the policy
sections
there are
measures
relevant to
monitoring

33. 3333
ITC Surveys are being conducted in:
Over 50% of the world’s population
Over 60% of the world’s smokers
Over 70% of the world’s tobacco users

34. 343434
 Warning labels
– UK (2003): Text – India (2009): Graphic
– UK (2009): Graphic
– Thailand (2005, 2006, 2010): Graphic
– Australia (2006): Graphic
– Canada (2010): Graphic, Round 2
– China (2008): Text; (2015): Larger font text
– Mexico (2008): Graphic
– Uruguay (2006,09): Graphic
– Brazil (2008/09): Graphic, Round 3
– Malaysia (2008): Graphic
– Mauritius (2009): Graphic
– New Zealand (2008): Graphic
ITC Evaluation of FCTC Policies (Partial List)
 Product policies
– UK (EU): 10-1-10 regulation
– US/Canada: Reduced ignition propensity
– All countries: product; product x behavior  Light/mild bans
– UK (2003)
– Australia (2005)
– Canada (2006)
– Brazil + others (2009+)
 Smoke-free
– Ireland (2004) – Mexico (2008+)
– Scotland (2005) – Brazil (2008+)
– England (2007) – Bangladesh (2009+)
– Uruguay (2006) – Bhutan (2009+)
– France (2007/08) – India (partial)
– Germany (2008+) – Mauritius (2009)
– China (2008/09 + Olympics)
– Netherlands (Part 2–2008/09)
 Advertising/Promotion
– UK (2003): Comprehensive
– Canada (2003): Last part of Comp.
– Thailand (2006): POS bans
– Mexico (2008): Comprehensive
– Canada (2008+): Re-emergence of
“descriptive” ads & possible new ban
– China (2011): Comprehensive
– Many other countries: Partial
Taxation
– All countries
 Illicit trade
– China (2008): prevalence
– Additional in Canada/U.S.: close to reserves
– Bhutan (2009+): total ban on sales in country

35. 35
Tobacco Epidemic Evidence Systems
Tobacco-Related
Morbidity and
Mortality
FCTC
Ratification
FCTC Policy
Implementation
Policy Monitoring
Systems
FCTC Reports,
GTCR, CIvil Society
What policies have
been implemented?
Legislation, reports
from stakeholders
Legislative analysis of
strength/weakness
FCTC Policy
Impact
Impact Evaluation
Systems
ITC Project
What is the impact
of the policies?
Individuals from the
population
Measures of tobacco
use, SHS exposure,
policy-relevant
measures of impact,
mediators of behavior
Surveillance
Systems
GATS, STEPS,
country systems
Tobacco
Prevalence
What is tobacco
prevalence?
Individuals from the
population
Measures of tobacco
use, SHS exposure
Systems
Central
Question
Evidence
Source
Measures
& analysis

36. Shifting of focus for the FCTC in its
Second Decade
Treaty Building
• Increasing ratifications
• Developing strong
guidelines
Treaty Implementation
• Creating mechanisms to
support implementation
• Strengthening and
accelerating implementation

37. 3737
Focus on Science:
ITC Research on Tobacco Control Policies

38. 38
Creating Guidelines and Standards for Research
IARC Cancer Prevention
Handbook (2008):
Methods for Evaluating Tobacco
Control Policies
• Best practices in the evaluation
of tobacco control policies
• Preparation of Handbook led
by ITC Project investigators
• Conceptual Model of the ITC
Project used to frame the
evaluation methods of the
Handbook

39. 3939
39
ITC Economics Supplements
Iwillneedthesedimensions(widthandheight)ofthisbox
March 2014 July 2015

40. 4040
Focus on Science:
ITC Research on Health Warnings

41. Importance of Health Warnings
Cost-effective strategy for:
 Educating the public
 Motivating smokers to quit
 Preventing non-smokers from starting to smoke
 Combating industry use of packaging as marketing and
promotional tool
FCTC Article 11 Guidelines call for warnings that:
Appear on the top of front and back of the
package
Are as large as possible (>50% of the front and
back)
Include full colour pictures

42. Effectiveness of large pictorial warnings
 Conclusive evidence that large pictorial warnings are more
effective than text warnings. Pictorial warnings are more
likely to:
– Be noticed by smokers
– Increase awareness of health risks
– Promote quitting
– Prevent smoking initiation among non-smokers
THAILAND 2014
(85% front & back)
INDIA 2016
(85% front & back)
AUSTRALIA 2012
(75% front & 90% back on
plain packaging)
NEPAL 2016
(90% front & back)

43. Australia: March 2006 (30% front, 90% back)
3 million smokers in Australia:
After the introduction of pictorial
warnings:
• 870,000 more smokers noticed the
warnings
Noticing pre = 43%
Noticing post = 72%
Increase of 29%
Not smoking cig pre = 10%
Not smoking cig post = 21%
Increase of 11%
March 2006
Pictorial warnings
on 30% of front
and 90% on back

44. 44
In 2008, China & Malaysia
had the same poor text-
only warnings…
2009
China stayed text-only
2009
Malaysia went to graphic
Tobacco Control (2015); 24: iv6-iv13.

45. 45
ITC Evaluation: China’s Jan 2009 Text-Only Revision
About 300 million smokers in
China:
• 8.4 million more smokers noticed
Noticing pre = 41.8%
Noticing post = 44.6%
Increase of 2.8%
Forgoing cig pre = 16.8%
Forgoing cig post = 22.1%
Increase of 5.3%

46. Malaysia: June 2009 (40% front, 60% back)
June 2009
From text on side
to pictorial
warnings:
40% of front,
60% on back
3.6 million smokers in Malaysia
After the introduction of pictorial
warnings:
• 569,000 more smokers noticed
the warnings
Noticing pre = 51.4%
Noticing post = 67.2%
Increase of 15.8%
Not smoking cig pre = 21.2%
Not smoking cig post = 54.6%
Increase of 33.4%

47. If China implemented Malaysia’s graphic warnings...
9.5% x 300M = 28.5 million more smokers would have
noticed the warnings often
8.4% x 300M = 25.2 million more smokers would have
read the warnings closely
4.4% x 300M = 13.2 million more smokers would have
reported that the warnings made them think
about the health risks of smoking
7.7% x 300M = 23.1 million more smokers would have
reported that the warnings made them think
about quitting
17.6% x 300M = 52.8 million more smokers would have
reported that the warnings had stopped them
from smoking a cigarette at least once

48. China’s warning labels changed in April 2012
January 2009
Text warnings on
30% of front (Chinese)
& 30% of back (English)
April 2012: Revised
Font size doubled, but still
30% on front and back
English warning replaced
with Chinese

49. Decrease in warning label impact after
doubling font size of text warnings in China
Jan 2009
Text warnings
on 30% of front
(Chinese) and
back (English)
Thinking of harms pre = 13%
Thinking of harms post = 12%
Decrease of 1%
Likelihood quitting pre = 9%
Likelihood quitting post = 8%
Decrease of 1%

50. Evaluation of the 2012 change in Chinese warnings:
It was a failure
Out of the 300 million smokers in China:
•3 million FEWER smokers reported thinking about harms of
smoking because of warnings
•3 million FEWER smokers reported that warnings made them a
lot more likely to quit

51. 5151
Examples of ITC Project Findings
Smoke-Free Laws

52. Smoking in Restaurants
Decrease in restaurant
smoking in China is much
smaller than in other ITC
countries that have
implemented completely
comprehensive smoke-
free laws
Smoking Prevalence observed in restaurants in 7 ITC China cities from Wave 2 to 5 (2007
to 2015) compared to other countries before and after comprehensive smoke-free laws:
Ireland (2004), Scotland (2006), France (2008), Germany (2007-08), Netherlands (2008),
Mexico City (2008), Other Mexican Cities (2008), and Mauritius (2009)
•
•
69
11
Korea
Note: the percentage shown for Republic of Korea in 2016 is
based on a preliminary, unweighted, and unadjusted dataset
But Beijing’s comprehensive
smoke-free law shows that
comprehensive smoke-free
laws can work in China
(data from Xiao et al., 2016)
Strong Article 8 implementation leads to dramatic
decreases in tobacco smoke in public areas
15
•
•
40
Beijing

53. 5353
Support for smoking bans in bars
Pre-post in 6 ITC countries + China
Smokers’ support for
comprehensive
smoke-free laws in
China is already
MUCH higher than it
was in any other ITC
country before those
countries
implemented smoke-
free laws that were
successful.

54. 5454
Examples of ITC Project Findings
Plain/Standardized Packaging

55. Plain (Standardized) Packaging
 Tobacco packaging is a central component of marketing
 Plain/standardized packaging eliminates both the
graphic elements of branding and the structural
elements (size and shape of the package).
– All packages look the same
– All packages have the same shape
 Recommended in Article 11 and 13 Guidelines

56. 56
Industry challenges Australia’s plain packaging
1. Constitutional challenge: High Court finds for Australia 6-1
2. Bilateral Investment Treaty: Philip Morris Asia (based in
Hong Kong) brings a challenge via the BIT between Hong
Kong and Australia. Australia wins its jurisdictional
challenge.
3. World Trade Organization: Challenge from Honduras,
Dominican Republic, Cuba, and Indonesia. Over 40
countries exercised their third-party rights in this dispute:
by far the largest number ever for a WTO dispute

57. 575757
ITC Evidence on Australia Plain Packaging
Yong et al. (2016):
plain packaging
significantly increased
health warning
effectiveness
Swift et al. (2014):
Smokers’ support for
plain packaging rose
significantly after
implementation

58. 5858
Examples of ITC Project Findings
Health Warnings:
Defending Uruguay’s Large Pictorial
Warnings Against Challenge From
Philip Morris International

59. 59
Uruguay
 Uruguay increases warning size from 50%
(recommended minimum under the FCTC Article 11
Guidelines) to 80%.
 Philip Morris International claims these large warnings
are an infringement of the bilateral investment treaty
between Switzerland and Uruguay.
 PMI seeking $25 million in damage to their “brand”,
which they describe as their most valuable asset

60. 60
ITC Articles in Tobacco Control on the Impact
of Australia’s Plain Packaging Law
Borland et al: Health warnings are
more effective > plain packaging
Swift et al: Smoker support for plain
packs goes up > implementation

61. 61
61
PMI Uses Trade Treaty to Challenge Uruguay
Philip Morris International challenges 80% Uruguay’s warnings claiming that
warnings larger than 50% (Article 11 Guidelines) would not be more
effective.
Gravely et al., 2016 (Tob Control)
Size increased
from 50% to 80%
Size increased
from 50% to 80%

62. 62
 Arbitration panel rules against PMI on all counts
 PMI required to pay all court costs + $7M to
Uruguay for its legal costs

63. Broad Conclusions from the ITC Project
 The FCTC policies are effective if implementation and
enforcement are strong
 Policies in LMICs are effective IF governments are
supportive AND if the proper structures (e.g., enforcement)
are in place AND if tobacco industry is not so strong
– Impact of tax/price & health warnings may be greater in LMICs
 Policies in HICs/LMICs are NOT effective IF governments
are not supportive, i.e., where tobacco industry is strong
– Netherlands, China, India
 Evidence across different domains that policies lead to
reductions in tobacco use (warnings, smoke-free laws)
– US FDA’s analysis: Canadian pictorial warnings decreased prevalence by
only 0.088%. ITC reanalysis: estimated decrease = 2.87–4.68%.
Implies that pictorial warnings could reduce smokers by 5.3–8.6M.

64. 6464
Dissemination of ITC Project Findings:
Knowledge Transfer and Utilization
Products for researchers, policymakers,
and advocates

65. 6565
65
22 ITC National Reports Across 16 Countries
– France: Wave 1 National Report (Feb 2009)—English and French
– France: Wave 2 National Report (Oct 2011)—English and French
– Germany: Waves 1–2 National Report (Jan 2010)
– Bangladesh: Wave 1 National Report (Apr 2010)—English and Bengali
– Mauritius: Wave 1 National Report (May 2010)
– Mauritius: Wave 2 National Report (May 2011)
– Mauritius: Wave 3 National Report (May 2012)
– Netherlands: Waves 1–3 National Report (June 2010)
– Bhutan: Wave 1 ITC Bhutan Report (May 2011)
– Malaysia: Waves 1–4 National Report (March 2012)
– Uruguay: Waves 1–3 National Report (August 2012)—English and Spanish
– Republic of Korea: Waves 1–3 National Report (Nov 2012)—English, Korean
– China: Waves 1–3 ITC China Report (Dec 2012)—English and Chinese
– India: Wave 1 (Sep 2013)
– Canada: Waves 1–8 (Nov 2013)
– United States: Waves 1–8 (Feb 2014)
– Brazil: Waves 1–2 (May 2014)
– Zambia: Wave 1 (May 2014)
– Uruguay: Waves 1–4 National Report (Aug 2014)
– Netherlands: Waves 1–8 National Report (Sep 2015)
– Zambia: Waves 1–2 (Dec 2015)
– Kenya: Wave 1 (Dec 2015)
Additional National Reports in preparation: Brazil, France

66. 6666
66
ITC National Reports: France

67. 67
ITC National Reports: Bangladesh (April 2010)
Preface from the Prime Minister,
Sheikh Hasina

68. 68
ITC National Reports: China (Dec 2012)
China Report released in Beijing in Dec 2012 at
the Chinese Communist Party School and at the
China NCD Forum

69. 6969
Current and New Directions for the
ITC Project

70. 70
Product Regulation Research:
New and Emerging Nicotine Delivery Products

71. 71
New & Emerging Tobacco/Nicotine Products

72. What is the role of policies?

73. Trends in E-cigarette use

74. Trends in Using E-cigarettes at
Last Quit Attempt

75. New major grant from US
National Cancer Institute:
• 5 interlinked projects
• Extension and expansion of
ITC cohorts in Canada, US,
UK, Australia with addition of
measures of e-cig use.
• Impact of e-cigs on
smoking, quitting, dual use,
etc.

76. Yong et al (NTR 2017): impact of regulatory environment on
the effectiveness of e-cigarettes for cessation
• ≥ 30 day abstinence: E-cigarettes only vs. No meds/no ecigs
• More restrictive countries (Canada, Australia) vs.
Less restrictive countries (USA, United Kingdom)
20%
30%
40%
50%
60%
70%
80%
No Meds/
No E-Cigs
E-Cigarettes
Less Restrictive
(USA, UK)
More Restrictive
(Canada, Australia)
• Less restrictive countries:
E-cigs significantly higher
than No Aids
• More restrictive countries:
E-cigs significantly lower
than No Aids

78. 78
Conclusions
 There is a shift in focus to supporting stronger and more
rapid implementation of the FCTC
 Some countries have implemented the FCTC at high
levels; but many others have not
 There is now strong and building evidence that the FCTC
has accelerated implementation of strong tobacco control
measures and that this decreases tobacco use
 But progress is slow and measures are being weakened
by industry influence
 Evidence on impact of FCTC policies is critically important
to support stronger and more rapid implementation of the
FCTC.

80. Ontario Institute for Cancer Research
Senior Investigator Award
Canadian Institutes of Health Research
Foundation Grant
US National Cancer Institute
Research Grants
Support for the ITC Project
Geoffrey T. Fong: gfong@uwaterloo.ca
www.itcproject.org
University of Waterloo
Office of Research