全球烟草控制研究要先领域

1. Identifying Global Tobacco Control
Research Priorities:
Improving Research to Practice
W o r l d C o n f e r e n c e o n To b a c c o O r H e a l t h
March 22, 2012
Singapore
Cathy L. Backinger, PhD, MPH
Deputy Director for Research
Office of Science
Center for Tobacco Products
US Food and Drug Administration
No financial disclosures
This project was begun when employed with the U.S. National Cancer Institute

2. Framework Convention on Tobacco Control
 2005 – first global health treaty
 As of January 9, 2012 – 174 parties have ratified
 Successful implementation of FCTC provisions require
ongoing research and surveillance
 FCTC addresses need for research, but did not
include research priorities or topics

3. Objective
 Identify key priority research needs related to relevant
provisions of FCTC by developing and disseminating
scientific papers in order to improve global tobacco
control
 Funding by the U.S. National Cancer Institute to the
Society for Research on Nicotine and Tobacco
(SRNT)

4. Process
 Assemble core team:
– Lekan Ayo-Yusef, South Africa
– Cathy Backinger, US
– Ami Bahde, US
– Scott Leischow, US
– Bruce Wheeler, US

5. Process
 Identify internationally recognized scientific experts to
serve as lead authors to develop papers in 7 areas:
1. Joaquin Barnoya, US – Article 8 – protection from
exposure to tobacco smoke
2. Gary Giovino, US – Articles 20, 21 & 22 –
surveillance/epidemiology, information exchange,
infrastructure and capacity-building needs
3. Nigel Gray – Australia, Articles 9 & 10 – regulation of
tobacco product contents and disclosures

6. Process
4. David Hammond, Canada – Articles 11 & 12 – packaging
and labeling; education, communication and public
awareness
5. Haydon McRobbie, UK, Article 14 - treatment
6. Corne van Walbeek, South Africa, Articles 6 & 15 – price
and tax measures, illicit trade
7. Vish Viswaneth, US – Articles 13 & 16 – advertising,
promotion and sponsorship; and sales to minors

7. Process
 Draft papers:
– Review of relevant FCTC sections
– Include brief history of regulation related to topic
– Identify existing research
– Identify critical gaps in research
– Analysis of research expertise required to fill
knowledge gaps

8. Process
 Papers to pay particular attention to:
– Providing specific research questions
– Addressing cross-cutting issues, e.g., children;
other forms of tobacco; denormalization; industry
influence; inequalities such as gender and
cultural/regional issues; and low and middle income
countries
– Addressing infrastructure needs

9. Process
 Provide expert reviews:
– Ron Borland, Australia
– Mike Cummings, US
– Tom Glynn, US
– TH Lam, Hong Kong
– Mitch Zeller, US
 Presented at SRNT-Europe for feedback and input
 Finalize papers for submission to NTR
 Present synthesis at WCTOH

10. FCTC research Needs – Demand
reduction: Articles 6 -12&15
Lekan Ayo-Yusuf, DDS, MSc, MPH, PhD
Department of Community Dentistry
22nd March 2012, WCToH, Singapore
1

11. Presentation overview
Articles Lead author
Article 6 (Taxation & pricing ) & 15 (illicit C. van Walbeek (South Africa)
trade)
Article 8 (Protection from Secondhand J. Barnoya (US/Guatemala)
smoke)
Article 9 & 10 (regulation of content & N. Grey (Australia)
disclosure)
Article 11 (Packaging & Labeling) & 12 D. Hammond (Canada)
(public education & communication)
What we know and priority research needs
2

12. Article 8: Protection from Second hand smoke
3

13. Article 8: What we know
• 600,000 deaths as result of health
consequences of SHS - cardiovascular disease,
lung cancer, respiratory disease and
developmental effects on children (Oberg et al., 2011; US
Department of Health and Human Services, 2006).
• Economic burden of SHS exposure –
• In the US, in 2005, the annual costs of excess
medical care, mortality and morbidity exceeded
$10 billion and indirect costs have been
estimated to be $5 billion (Behan et al., 2005).

14. Article 8: What we know.
• A smoking ban is the only means of effectively eliminating
indoor exposure to SHS and no engineering approach
have been demonstrated or should be relied upon to
control health risk from ETS exposure (American Society of Heating, 2008).
• Separation of smokers from non-smokers, ventilation
systems, air cleaning and filtration are all ineffective
strategies to eliminate SHS exposure and its harmful
effects (Barnoya and Navas-Acien, 2012).
• The ventilation rate required to reduce SHS to acceptable
levels of cancer risk would have to be increased 22,500
times compared to current ventilation standards (Repace, 2005;
Repace and Johnson, 2006).

15. Article 8: Research priorities
• More research needed on key diseases suggested to be
associated with SHS and the impact of ban e.g Breast Ca
and spread of tuberculosis infection esp in LMIC.
• Improved exposure assessment with regards to 3rd hand
smoke assessment and its health effects.
• What is the best assessment approach to monitoring
exposure outdoors and in multi-unit housing especially
with a focus on low SES children and other vulnerable
groups?
• Airborne nicotine & PM2.5 or questionnaire on exposure
& measure of social support are still useful in LMIC.

16. Articles 9 and 10 –
Regulating content & Disclosure
7

17. Articles 9 and 10 - What we know
• Tobacco avoidance is the only way to prevent harm!
• Unlike smokeless products, combustible products can’t be
regulated by simply approving ingredients because of the
complexities of interaction between smoking behaviour and
combustion products from burnt tobacco and any additives present.
• Addictiveness = prolonged use = prolonged toxin exposure =
Harm
• 3 major regulatory possibilities to reduce harm:
 Regulate toxicant levels (setting upper limits)
 Regulate nicotine (part of reducing dependence potential)
 Regulate additives and engineering features such as ventilation
• Most independent chemistry work has focused on manufactured
cigarettes and not other forms like Bidi’s or waterpipe.
8

18. Articles 9 and 10 - What we know
• Only a small number of countries have legislated to
mandate various forms of disclosure from the tobacco
industry to provide for the regulation of tobacco products.
• Few have been able to use legislation to commence any
kind of regulatory process (now possible with FDA).
• The scientific basis for defining objective criteria for
defining types of tobacco products that might be subject to
different regulatory standards.
• A set of carcinogens/toxins to regulate and/or monitor
have been identified (TobReg 2009).
• Enough to establish appropriate standardized testing
regimes for the carcinogens/toxins that are to be regulated
and/or monitored.

19. Articles 9 and 10: What we need to
know/infrastructure.
• What standardized procedures and biomarkers should be
used to measure exposure as the basis for monitoring effect
of toxicant reduction?
• What other factors contribute to the risk of developing
addiction including packaging, marketing, sensory
perception, and environmental stimuli?
• Modelling to determine an algorithm to estimate the
percentage of the current market that would be prohibited if
upper limits were implemented (how low can we go?)
• What surveillance is required to ensure that no major
unintended consequences and to allow early action if signs
of such problems occur?

20. Articles 9 and 10: What we might need to know
• Farm level: tobacco company guides of requirements for
growing, curing and on-farm processing of tobacco.
• Manufacturing: disclosure, by product of design features
and all additives with information as to amount, recipes for
blends of tobaccos and any standardization of ingredients.
• Performance: levels of identified chemicals per
brand/variant using standardized testing and reporting
criteria.
• Marketing & post-marketing: disclosure of marketing
budgets & volume of sales by brand/variant on daily basis

21. Articles 9 and 10: Research priorities (for early stages)
• What empirical model can be developed to evaluate the
impacts of various levels of reduction in target
carcinogens/toxins, both by consumer market and overall?
• What M&E mechanism would be most appropriate to
assess the impacts of regulations when they occur e.g.
research to identify better ways of measuring toxin
exposure?
• If compensatory smoking was to be substantially reduced,
would it be possible to reduce average intakes of nicotine
to levels that would make quitting easier?
• How can governments and regulators best communicate
about their efforts to reduce tobacco-related harm in ways
that do not lead to unrealistic expectation about reduced
harm?

22. Articles 6 and 15: Taxation & pricing &
eliminating Illicit trade
13

23. Articles 6 and 15: What we know
• Studies have shown that an increase in cigarette prices is
effective in reducing cigarette consumption especially in
LMIC (Jha & Chaloupka, 1999; IARC,2011).
• Higher taxes and prices increases the possibility of illicit
trade in cigarettes.
• Tobacco taxes are regressive but the increase in the excise
tax reduces the regressivity of the tax (Jha & Chaloupka, 1999).
• Banning duty-free sales might reduce consumption as it
reduces ability to legally avoid taxes.
• Real, inflation-adjusted cigarettes prices increased in nearly
all HICs between 1990 and 2008, but they decreased in
more than half of the LMICs during the same period (Van Walbeek et
al, forthcoming).

24. Articles 6 and 15
• Industry attempts to influence tax levels & excise tax
structures in their favour.
• The tobacco industry uses profits from its more
expensive brands to offset potential losses on its
cheaper brands – ‘Under-shifting’ (Tavakoly, Taylor, Reed, & Gilmore, 2011).
• Price discounting is has been used to gain market
share in newly opened markets (Vateesatokit et al, 2000).
• Evidence of Industry change to ‘over-shifting’
following the recent tax increases in Ukraine (Ross et al., 2011)

25. Articles 6 and 15 – research priorities
• Monitoring tobacco consumption, prices and taxes.
• Assessing the effectiveness of the tax structure in
generating revenue and reducing tobacco use.
• Strengthening the tax administration system in order to
reduce tax evasion and tax avoidance.
• Improving our understanding of the political economy of
tobacco tax policy.
• Employing a multidisciplinary approach to assessing the
magnitude of illicit tobacco trade

26. Package labeling (Art 11) and
Communicate, Educate & Train on tobacco effects (Art 12)

27. Article 11: What we know
• Health warnings on tobacco packages are a source of
health information (Hammond et al.,2006).
• Health warnings must be large and prominent.
• Large and prominent warnings are more noticeable,
perceived as more effective and allows for more content
including additional text, larger images, and cessation
information such as telephone quitline numbers (Hammond,
2011).
• Evidence suggests that health warnings can promote
cessation behaviour and help to reduce smoking uptake.

28. Article 11: what we know contd...
• Findings from studies have shown that graphic warnings are
more effective than text warnings (BRC Marketing and Social Research, 2004;
Corporate Research Associates, 2005; Hammond 2011).
• Evidence suggests that health warnings can reduce the
general appeal of packages (Germain et al., 2010).
• Messages on specific toxic constituents with explanation of
their health effects are rated most effective (Health Canada, 2007).
• Banning a small number of descriptors ‘light’ is insufficient to
reduce false beliefs (Borland et al., 2008; Hammond et al., 2009).
• Removing colour & imagery reduces false beliefs & makes HW
more effective through increased noticeability, recall (Munafo et al., 2011)

29. Article 12: What we know (mass media
campaigns)
• Anti-tobacco mass media campaigns have the
potential to influence individual behaviours, social
norms and tobacco control policies, each of which
can affect population-wide tobacco use (Hopkins et al., 2001; Hornik,
2002).
• Reach & intensity: An average of at least 1,200
gross rating points (GRPs) per quarter for a total of
4,800 GRPs per year are needed to produce a
detectable reduction in adult smoking prevalence
(Wakefield et al., under review).
• Durability: The beneficial effects of tobacco control
advertising does not last beyond two months after
broadcasting ends (Borland & Balmford, 2003; Wakefield et al.,2011, Wakefield et al., 2008).

30. Article 12 (Mass media campaigns)
• Changing media environment posses challenge to achieving
adequate exposure to planned messages as people have
greater control.
• Televised messages receive higher advertising response
ratings than radio messages, are more likely to be recalled than
messages on other channels (e.g. radio and outdoor) and more
likely to be associated with reduced smoking initiation (US
Department of Health and Human Services, In Press).
• Studies have shown that tobacco ads which elicit strong
negative motions (e.g. fear, guilt, disgust, anger) can increase
attention, generate greater recall and appeal, and affect
adolescents' smoking related beliefs and intentions to smoke
(National Cancer Institute, 2008; US Department of Health and Human Services, In Press).

31. Research priorities (Article 11)
• Exploration of the interaction between health warnings
and pack branding.
• Research to identify the most cost-effective mix and best
practices for sustaining health communication over time.
• Research examining how pack shape and size interacts
with the effectiveness and legibility of health warnings
especially with cigarette packs with irregular shapes.
• Research on health warnings for other tobacco products,
including SLT.
• Effectiveness of graphic fear-arousing depiction of health
effects relative to other ‘themes’ or executional styles
including testimonials or narratives.

32. Research priorities (Article 12)
• Studies pertaining to media campaign investment strategy e.g.
What level of media campaign investment (GRPs) and over
what duration is needed to reliably detect sustained effects on
changing tobacco use behaviour?
• Studies to better understand how media messages are
processed by their audiences e.g. Which advertising response
measures, or efficient combinations of them (recall, perceived
argument strength, perceived effectiveness, emotional
response), best predict tobacco use behaviour change?
• Studies of different anti-tobacco message sources and target
audiences e.g. What are the effects of mass media campaigns
aimed at prompting adults to quit on youth smoking uptake?
• Studies of types of message for different media channels e.g.
(can radio ad elicit as high a negative emotion as TV ad?

33. Conclusions
• Given that much of the evidence-base underlying these articles (with
perhaps the exception of Article 6), derives from high-income and to a
lesser extent middle-income countries, there is need for evidence on the
extent to which consumer needs differ in much different social and
political contexts, including different social norms and pattern of tobacco
use that exist in several low-income countries.
• A prerequisite for advancing these research needs would be related to
stronger emphasis on capacity building for research and the demand for
research by policy makers in these LMICs.
• The growing innovation in product designs calls for vigilance in making
sure that research is also innovative and includes other forms of tobacco
use other than manufactured cigarettes as we know it today.
• The building of research infrastructure that would be required to advance
FCTC in LMIC would without doubt require international collaboration.
24

34. Thank You

35. Research priorities for effective
FCTC implementation
Ron Borland PhD
The Cancer Council Victoria
The Cancer Council Victoria

36. Articles covered
• Article 6 Price and tax measures and
Article 15 Illicit trade
• Article 13 Marketing restrictions and
Article 16 Sales to minors
• Article 14 Cessation
• Articles 20-22 Monitoring, information
sharing and infrastrructure
The Cancer Council Victoria

37. Common themes
• Needs for research and capacity
differ for High income, Middle
income and Low income countries
• Also vary by degree of progress in
implementation of FCTC provisions
The Cancer Council Victoria

38. Price, Tax and Illicit trade priorities
• Monitoring of tobacco consumption, prices and taxes.
• Assessing the effectiveness of the existing tax
structure in generating revenue and reducing tobacco
use.
• Strengthening the tax administration in order to reduce
tax evasion and tax avoidance.
• Improve our understanding of the political economy of
tobacco tax policy
• Employing a multidisciplinary approach to assessing
the magnitude of illicit tobacco trade
The Cancer Council Victoria

39. Improved monitoring
• Price and tax income
• Lack of consistency in collection of basic data
• Need for Agency other than COP to take role
• Consumption
• Gross taxed sales problematic if illicit trade
high
• Self-report surveys often underestimate use
• this may change over time
The Cancer Council Victoria

40. Tax increases
• Understanding determinants of pursuing tax
increases
• Value of earmarked taxes
• Effects of size and frequency of tax rises
• Effects of tax structure on avoidance and equity
‒Uniform seen as ideal
• Responses to tax rises among poor who don’t
quit
• Sensitivity of ANDs to price differences
The Cancer Council Victoria

41. Strengthening the tax
administration in order to reduce
tax evasion and tax avoidance.
The Cancer Council Victoria

42. Industry responses
• Impacts of price-related marketing
• Value of minimum price legislation
• How the industry influences tax
policy
• Role of market structure
• Under or over shifting of price in response to
tax
The Cancer Council Victoria

43. Illicit trade
• Employing a multidisciplinary approach to
assessing the magnitude of illicit tobacco
trade
‾ Improving estimates of its size
• Utility of containment strategies
‾ High tech stamping
‾ Licensing and tracking systems
The Cancer Council Victoria

44. Research Priorities for Article 14 –
Demand reduction measures
concerning tobacco dependence and
cessation
• Use of cessation in proportion to need
– Not very relevant to low income
countries
The Cancer Council Victoria

45. Priorities for Cessation research
• Monitoring tools
– Standardised measure of cessation outcomes
• Other priorities
– promote cessation of tobacco use
– assist healthcare workers provide better help
to smokers (e.g. through implementation of
TDT guidelines, and training)
– enhance population based TDT interventions
– assist people cease the use of other tobacco
products.
The Cancer Council Victoria

46. Monitoring
• This is a common need that spans all
countries and calls for international
collaboration with harmonisation of
research methodology and outcome
measures.
The Cancer Council Victoria

47. Improved promotion of cessation
• Investigate the effect of mass media campaigns
to promote cessation in an equitable way
– In MIC: just implement
• Monitor tobacco use among HPs in LMIC
• Investigate more effective ways to integrate the
provision of brief advice to quit smoking into
routine clinical practice of HPs
– Implement in MIC
• Investigate how advice to stop and referral to
cessation services can be implemented into non-
healthcare settings and determine the impact of
such advice
The Cancer Council Victoria

48. Improved services and aids
• Improving quitlines and use of
internet
– Implement in MIC
• Investigate role of cheap meds
– Efficacy in general use
– Cost-effectiveness in MIC
The Cancer Council Victoria

49. Research Priorities for FCTC Articles 13 & 16:
Tobacco Advertising, Promotion, and
Sponsorship and Sale to and by Minors
• Largely legislative agenda
• Many issues no-longer relevant for
leading nations
• No specific recommendations for
issues of minors
The Cancer Council Victoria

50. Promotion and marketing bans
• Reasons for variations in bans
across countries
• Case studies of implementation
successes and failures
• Monitoring exposures
– Especially in new media
• Promotion of ANDS to FMC
The Cancer Council Victoria

51. Articles 20-22 Monitoring,
Evaluation and Cooperation
• Article 20: Research, surveillance
and exchange of information
• Article 21: Reporting and exchange
of information
• Article 22: Cooperation in the
scientific, technical, and legal fields
and provision of related expertise
The Cancer Council Victoria

52. Monitoring and evaluation
• Validity of self-report
– Especially where socially unacceptable
• Validity of production and trade data
• Better measures of industry activity
• Finding better and less costly sampling strategies
• Calibrating to understand differences in estimated
between sources
• Internet surveillance
• Surveillance in special populations
• Understanding alternative crops
The Cancer Council Victoria

53. Cooperation
• Gaps and successes in collaboration
and cooperation
• Understanding the opposing networks
• Identify barriers to more effective
cooperation
• What infrastructure do we need?
The Cancer Council Victoria

54. Synthesis
• Good surveillance is critical
– Prevalence surveys
– Not just of outcomes, but of mechanisms
• Including of the vector
• Strong evaluation capacity
– Must be able to evaluate policies, not just
local and individual interventions
• Knowledge must be fed back to inform
action
The Cancer Council Victoria

55. Comments and Challenges
Scott Leischow, PhD
The University of Arizona
Tucson, Arizona

56. New research and synthesis of
existing research
• Expand economic analyses of policy impact, including
causal modeling
• Analysis and modeling of factors impacting illicit trade,
particularly in LMIC and when considering taxation
• Consumer perception research on warning label
content (inc. plain packaging, imagery) and
packaging? Impact on social norms and behavior?
• Communicating risk (eg on additives), and blending
media approaches
• Behavioral economic research…why do people make
decisions not may hurt them?

57. New research and synthesis of
existing research
• What channels of communication are best for
specific populations, products, message types?
• What types of mass media work in which groups
and situations, and how to effectively use social
media? How to blend mass media approaches
in targeted populations (eg via Facebook)?
• Assessing the impact and use of existing and
emerging technologies (eg text messaging), esp
in LMIC
• Dissemination and knowledge
transfer/translation research with emphasis on

58. New research and synthesis of
existing research
• Research on optimizing tobacco treatment with
different populations, brief support in LMIC
• What policy changes can increase desire to quit
(eg excise taxes), and what is the impact on
specific populations (eg low income) ?
• Improved monitoring of effective treatments
across LMIC and HIC, inc cost effectiveness
• How are social norms changed among
healthcare workers to quit tobacco, and to treat
different types of tobacco users

59. New research and synthesis of
existing research
• Analysis of unique tobacco constituents (eg
acetaldehyde), and differences by country, region,
etc, and what is the impact of nicotine delivery
and/or disease risk?
• Analysis of effective ways to reduce or eliminate
harmful constituents
• How to effectively reduce compensatory smoking
• Abuse liability/consumer appeal, eg nicotine
content/reducing addictive potential of cigarettes
• Research on the tobacco industry itself, eg on
pricing, government and other corporate influence

60. New and expanded surveillance
• Creation of a tobacco surveillance clearinghouse for
broad collections of data (products and their
constituents & performance, marketing, sales, tobacco
use, biospecimen, clinical, health outcomes,
documents, etc).
• Creation of databases of raw data, not just publications,
to allow for independent analyses of relationships.
• Expand existing surveillance systems (eg ITC) to collect
needed data (eg women use, providers, indigenous,
low income, new/expanding products like waterpipe, 3rd
hand smoke & its effects), including marketing data that
many scientists do not now use (eg GIS mapping of
sales data)

61. New and expanded surveillance
• Development of an rapid and extensive early warning
system for tracking, reporting, analysis, interpretation and
communication related to tobacco product tactics, use
patterns, health outcomes similar to that used for
communicable disease
• Creation of an international tracking system to assess
cross border trade, differences in product and marketing
• Minimum dataset for each country, eg pre/post policy
change
• Tracking cross-border advertising
• Reasons (other than secular trends) for different estimates
across surveys
• Tracking and analysis of illicit trade, inc health effects

62. Consensus efforts
• Development of and agreement on scientific
mechanisms for triangulating disparate data (eg epi,
clinical, animal, etc) to develop best estimates on
causality – both for individuals and populations
• Agreement on validity and reliability of other measures,
inc. industry activities
• Agreement on prioritizing biomarker indicators for
exposure and health outcomes that can be the focus of
regulatory efforts
• Agreement on use and expansion of existing tobacco
surveillance structures and functions to develop a
recommendation on what data are needed to understand
the impact of intersecting influences/factors

63. Consensus efforts
• Determination of which data are unique to each country,
and must be collected, and which can be generalized
• Develop and agree on methodologies to test consumer
perceptions
• How to prioritize research that has the best potential to
achieve the greatest public health gains, taking into
consideration factors that could lead to unintended
consequences
• How do we determine when we know enough (eg about
removal of certain constituents, reduction of nicotine, etc)
that action is warranted and can be defended? And what
are the criterion for determining that the weight of
evidence supports action, and what types of research are
needed (experimental, quasi-exper, surveillance, etc)?

64. Structural and Functional Factors
• Optimize communication and collaboration between
government agencies, and between government
agencies and the public health community (including
SRNT), to assure a consistent approach to the science-
to-policy needs
– How do we speed the flow of knowledge from discovery to
development to delivery?
• Creation, maintenance, and optimization of science
networks (national and international) to foster a ‘shared
situational awareness’ on the state of the science, and
rapid sharing of new data in a transparent fashion to
reduce ‘silos’
– Identify examples of relevant networks that are effective(eg
Tobacco Laboratory Network), and develop comparable ones for
other areas where needed.

65. Development
Analysis &
Interpretation Decision making
Synthesis
Delivery
TRAINING
Dissemination and Implementation of
Policy into Practice
Surveillance & Epi
Behavior Change and Health
Research
Outcomes:
•Individual
Evaluation
•Group
•Population
Discovery
Leischow, and see also NCI Monograph 17 Outcomes

66. Questions
• Given the heterogeneity of the research environment and
differing research needs, is it possible to develop research
priorities? How might that be done? How do we learn
from other domains, eg communicable disease, etc.
• Similarly, a dramatic increase in unique questions and
research needs is underway, driven in large measure by
the need to make policy decisions. With the lag between
research data and policy need, is it possible to develop
research priorities?
• How can time critical research questions be addressed?
What will that require? And who will fund it?
• How can research capacity be increased, particularly in
LMIC? And how can priorities be determined since we
cannot do it all?

67. Questions
• How do we expand training to increase the next generation
of independent translational and transdisciplinary scientists?
• How do we go about using our knowledge (eg from
behavioral science) to elevate research as a priority for
funding? How do we change the ‘it’s not our problem’
mentality?
• What is the role of organizations like WHO, civil society,
professional organizations (eg SRNT), government
agencies and the corporate community regarding
knowledge synthesis & dissemination, bringing together key
players, linking science to policy, etc.?
And…How do we best ‘plan’ for unintended consequences?

69. Science and Research to
Inform Regulation of
Tobacco Products
World Conference on Tobacco Or Health
Singapore
March 22, 2012
Cathy L Backinger, PhD, MPH
Deputy Director for Research
Office of Science, Center for Tobacco Products
1

70. CTP's Authority Under
the Tobacco Control Act
• Gives CTP, FDA authority to regulate tobacco products --
products made or derived from tobacco intended for human
consumption (but not those marketed for tobacco cessation
or other therapeutic uses)
• Recognized FDA as the “primary Federal regulatory
authority with respect to the manufacture, marketing, and
distribution of tobacco products”
• Gave FDA direct authority over cigarettes, roll-your-own and
smokeless tobacco products
• FDA can assert jurisdiction over other tobacco products
through rulemaking (cigars, pipe tobacco, hookah, e-
cigarettes, etc) – FDA has announced we intend to do that
2

71. CTP Must Use a Public Health/Population
Health Regulatory Standard
• Tobacco products cannot be regulated
using FDA‟s traditional „safety and
efficacy‟ standard
• The Tobacco Control Act mandates its
regulation using a population health
standard including impact on both users
and non-users of tobacco products
3

72. FDA's Authority Under
the Tobacco Control Act is Broad
• Premarket applications for new and modified risk
tobacco products
• Require post-market surveillance for modified risk
tobacco products
• Establish tobacco product standards to protect the
public health
• Require reporting of ingredients
• Health warnings on marketed products & ads
• Advertising and promotion restrictions
• Registration and listing
• Authority to conduct research to support tobacco 4
product regulation

73. Tobacco Control Act - Limitations
CTP does not have the authority to:
• Set nicotine levels to zero
• Require prescriptions for tobacco products
• Set price of tobacco products
• Regulate medications/products marketed to
treat tobacco dependence
• Regulate clean indoor air policies
• Regulate tobacco growing 5

74. FDA Tobacco Control Goals
1. Prevent youth tobacco use
2. Encourage those who use tobacco to quit
3. Promote public understanding of contents
and consequences of use of tobacco
products
4. Develop science base and continue
meaningful product regulation to reduce
the toll of tobacco-related disease,
disability, and death
6

75. CTP Research Priorities
• Diversity of Tobacco Products
• Reducing Addiction
• Reducing Toxicity and Carcinogenicity
• Adverse Health Consequences
• Communications
• Marketing of Tobacco Products
• Economics and Policies
7

76. 8
http://cancercontrol.cancer.gov/NIH-FDA/