Transcript PowerPoint Presentation - Global Tobacco Control

Section B
Building Blocks for Effective Tobacco Product Regulation
 2011 Johns Hopkins Bloomberg School of Public Health
Building Blocks for Effective Tobacco Product Regulation
Source: Zeller, M. (2007).
 2011 Johns Hopkins Bloomberg School of Public Health
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Scientific Research Priorities
Work with sister federal agencies (including your national cancer
research agencies), epidemiologic experts, and outside experts to
identify the priorities for scientific research that will help provide
the scientific framework needed to drive public health-based
product regulation. Examples include:
 Chemical biomarkers for exposure reduction
 Chemical biomarkers for risk reduction
 Determining what constitutes a significant reduction in
exposure
 Determining what constitutes a significant reduction in risk
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Pre-Market Evaluation Program
A cornerstone of public health–based regulation of tobacco
products has to be pre-market evaluation of new products, new
ingredients, and new claims
 This will protect the public from false or misleading claims
and unsafe product modifications
 This is a program that needs an infrastructure to be built
 The processes and criteria that agencies like the FDA will use
to conduct these reviews need to be defined so that
manufacturers know what obligations they are under
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Performance Standards
Build the infrastructure for the program to establish, over time,
performance standards that would specify acceptable levels for
added ingredients and the levels of substances produced during
combustion and delivered in smoke
Products cannot be sold if they exceed the maximum levels in the
performance standards
Performance standards could be used to regulate the content of
ammonia compounds (thought to affect nicotine delivery),
menthol, and even nicotine
They could be used to restrict the amount of carbon monoxide
permitted in smoke
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Marketplace Surveillance
Build the infrastructure for a marketplace surveillance program to
monitor and better understand the behavior of tobacco users and
how tobacco products are used in the real world
Enables regulatory agencies to observe the population level–effects
of tobacco products, especially the new generation of products
making promises to reduce exposure and risk
Enables agencies to begin to account for the potential unintended
consequences of regulatory action and industry behavior, such as:
 The impact on smoker attitudes toward quitting
 The impact on ex-smoker interest in re-initiating tobacco use
 The impact on never smokers’ interest in starting tobacco use,
including young people
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Partnership with Drug Regulatory Authorities
Forge a partnership with national drug regulatory authorities; here
in the United States, that would be the FDA’s Center for Drug
Evaluation and Research (CDER)
Agencies like FDA’s CDER are responsible for evaluating and
approving pharmaceutical-based products that are designed to
treat tobacco dependence and help tobacco users quit or reduce
their risk of using tobacco
Certainly, at the beginning a lot of the relevant expertise will
reside in CDER and will need to be shared with the tobacco
program
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Partnerships with Global Regulatory Agencies
The challenges any agency will face in building a truly effective
program of comprehensive tobacco product regulation are really
not unique to that agency or country
The task is daunting
Product regulation is one of the cornerstone concepts built into the
Framework Convention on Tobacco Control
Governments around the world interested in pursuing tobacco
product regulation will be facing many of the same challenges
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Partnerships with Global Regulatory Agencies
Each country’s lead agency should forge partnerships with sister
regulatory agencies abroad to pursue product regulation in a
collaborative way
 This would have the added benefit of presenting the tobacco
industry with more of a united front globally in a new age of
product regulation
Fortunately WHO is helping provide the foundation for much of this
work through the new network of laboratories around the world
that are linked and will work together to perform product analysis
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Ingredient and Combustion Products Review
Commission the systematic review of ingredients already added to
tobacco and substances that are produced during combustion
Work off of a list of priority compounds established by scientific
experts
Analyze safety issues
Evaluate how substances interact with each other
 Ammonia compounds and nicotine
 Menthol and nicotine
Provide important feedback to help and establish performance
standards
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Label Disclosures
Determine what ingredient and smoke constituent information
should be disclosed on the label
Image source: Physicians for a Smoke-Free Canada. (2007).
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Restrictions on Youth Access and Marketing
To deal with the problem of youth tobacco use and young people
being the replacement customers of the tobacco industry for the
addicted adults who die or quit each day
FDA had promulgated extensive final rules in 1996 restricting youth
access to tobacco products and making the advertising, marketing,
and promotion of those products in stores and publications less
appealing to young people
 Most of the 1996 rule went into effect in 2010 under a
provision of the FSPTCA
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Restrictions on Youth Access and Marketing
In the United States, rebuild the nationwide enforcement program
to reduce youth access that the Agency had put into place before
the program was shut down
 This is happening now under the FSPTCA
 Other countries should follow suit
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Vigilance and Flexibility
Regulatory agencies will probably not get it right the first time;
the tobacco industry will devise strategies to adapt and survive any
new regulatory initiatives
Vigilance is needed so that regulators can stay on top of changes in
the marketplace; product testing, surveillance, and consumer
research will be key
Flexible regulatory tools are needed so that new information can
be fed back to regulators, who can then respond and adapt to
changes in the marketplace
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The Evolving Tobacco Product Marketplace …
… and the morphing tobacco industry
Dissolvables
 Does FDA regulate them, or not?
E-cigarettes
 Implications of court ruling
Tobacco company ownership of drug subsidiaries; pharmaceutical
licensing arrangements
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Summary
A combination of the building blocks described will be a useful way
to orient regulators in thinking about how to tackle this challenging
public health policy issue
Policy makers must level the playing field by bringing regulatory
accountability to the manufacturing, sale, and distribution of
tobacco products
Public health-based regulation must be devised to address the
evolving marketplace and morphing tobacco industry
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