Transcript `free choice` if the person was `addicted.`

Regulation of Tobacco Products
Mitch Zeller, JD
Pinney Associates
 2007 Johns Hopkins Bloomberg School of Public Health
Competing Visions
The status quo
Unregulated products
A different path
Public health–based and science-driven
regulation can change the status quo
Unfettered access to the marketplace
Unproven claims to reduce exposure
and risk
Massive consumer confusion
- How the “lights” disaster
happened
It will end the historical marketplace
free-for-all
- Where the tobacco industry
controlled much of the evidence
hiding what they didn’t want the
public to see
- Where government and the public
health community were forced to
play “catch-up” with the science
- Case in point: nicotine and
addiction
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Key Questions
Why regulate tobacco products?
What would tobacco product regulation consist of?
 The problem with unregulated health claims
What happened when the U.S. Food and Drug Administration (FDA)
tried to regulate tobacco products?
 The tobacco industry’s previously secret admissions about
nicotine and addiction
What is the future of global tobacco regulation?
What are the basic building blocks for effective regulation of
tobacco products?
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Why Regulate Tobacco Products?
Image source: Institute for Global Tobacco Control. (2007).
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Why Regulate Tobacco Products?
Some believe the public is already aware of the health risks
associated with tobacco products, so regulation is not needed
Others question why tobacco products are sold at all if they are so
dangerous
Prohibition will not work because most tobacco users are addicted
to nicotine
A “black market” could be more dangerous because of
questionable ingredient quality and product purity
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What Would Tobacco Product Regulation Consist Of?
Traditional regulation of consumer products is designed to ensure
that ingredients and components are safe and products work as
promised
Under a regulation model such as the one employed by the U.S.
FDA, tobacco product regulation would include:
 Independent evaluation of health claims
 Scientific support for product claims
 Evidence submitted before claims are made
 The Agency deciding if there is adequate scientific evidence to
support the claim
 Example: the cereal industry
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The Problem with Unregulated Health Claims
In the current unregulated market for
tobacco products, cigarette
manufacturers are free to make any
claims about their products
 Smokers have no way of knowing
whether claims promising to reduce
exposure to cancer-causing
chemicals in smoke are actually
true
 Example: “lights” cigarettes
Source: Institute for Global Tobacco Control. (2007).
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What Would Tobacco Product Regulation Consist Of?
Under a regulation model such as the one employed by the U.S.
Food and Drug Administration (FDA), tobacco product regulation
would include:
 Independent evaluation of health claims
 Independent evaluation of the safety of new ingredients
before they can be added to a tobacco product
 Restriction of the level of harmful compounds to which
tobacco users are exposed
 Marketplace surveillance to ensure products are being used as
intended
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U.S. FDA and Tobacco Regulation
1994: FDA investigates nicotine in tobacco products
 If there was sufficient evidence that tobacco companies
deliberately designed their products to create and sustain an
addiction to nicotine, FDA could have the basis to assert
jurisdiction and begin to regulate those products
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The Industry on Nicotine and Addiction
“Nicotine is addictive. We are, then, in the business of selling
nicotine—an addictive drug.”
— Brown and Williamson, 1963
“The cigarette should be conceived not as a product but as a
package. The product is nicotine … Think of the cigarette
pack as a storage container for a day’s supply of nicotine …
Think of a cigarette as a dispenser for a dose unit of
nicotine. Think of a puff of smoke as the vehicle of
nicotine.”
— Philip Morris, 1972
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The Industry on Nicotine and Addiction
“In a sense, the tobacco industry may be thought of as being
a specialized, highly ritualized, and stylized segment of the
pharmaceutical industry. Tobacco products uniquely contain
and deliver nicotine, a potent drug with a variety of
physiological effects.”
— R. J. Reynolds, 1972
“BAT should learn to look at itself as a drug company rather
than as a tobacco company.”
— British American Tobacco, 1980
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The Industry on Nicotine and Addiction
“[T]he entire matter of addiction is the most potent weapon
a prosecuting attorney can have in a lung cancer/cigarette
case. We can’t defend continued smoking as ‘free choice’ if
the person was ‘addicted.’” [emphasis added]
— The Tobacco Institute, 1980
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U.S. FDA and Tobacco Regulation
In 1996, the FDA asserted jurisdiction, determining that:
 Nicotine in tobacco products was a drug
 Tobacco products were devices for the delivery of the drug
nicotine
1996 FDA regulation restricted sales and marketing of tobacco
products to young people
FDA was sued by tobacco manufacturers, growers, retailers, and
advertisers, claiming the agency’s actions were illegal
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U.S. FDA and Tobacco Regulation
In 2000, the U.S. Supreme Court stripped the FDA of legal authority
over tobacco products
 Court ruled that it was not intended that the FDA should have
these powers
 To regain the powers in the U.S., Congress must pass new law
 Legislation currently pending
Tobacco industry argument
 If the FDA had this power, they would have to ban tobacco
products in U.S.
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What Is the Future of Global Tobacco Regulation?
World Health Organization (WHO) Framework Convention on
Tobacco Control
 Opportunity to bring about global tobacco regulation
WHO taking significant steps to prepare the science base for
effective product regulation around the world
WHO created two entities
 Tobacco Regulation (TobReg): study group on tobacco product
regulation
 Tobacco Laboratory Network (TobLabNet) 2005: affiliation of
dozens of testing laboratories around the world strengthening
capacity to test tobacco product contents and emissions
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Building Blocks for Effective Regulation of Tobacco Products
Source: Zeller, M. (2007).
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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
In the U.S., breakfast cereal manufacturers cannot make health
claims for their cereals until they prove to the FDA that there is
sufficient scientific evidence to support the claim
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 U.S. 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
 Reinstate those rules; only a few had gone into effect before
the FDA’s entire effort was shut down by the courts in 2000
In the U.S., rebuild the nationwide enforcement program to reduce
youth access that the Agency had put into place before the
program was shut down
 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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Summary
A combination of these building blocks 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
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