2007 johns hopkins bloomberg school of public health regulation of tobacco products mitch zeller, jd...
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2007 Johns Hopkins Bloomberg School of Public Health
Regulation of Tobacco ProductsRegulation of Tobacco Products
Mitch Zeller, JDPinney Associates
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Competing Visions
The status quo A different path
Unregulated products
Unfettered access to the marketplace
Unproven claims to reduce exposure and risk
Massive consumer confusion
- How the “lights” disaster happened
Public health–based and science-driven regulation can change the status quo
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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Image source: Physicians for a Smoke-Free Canada. (2007).
Label Disclosures
Determine what ingredient and smoke constituent information should be disclosed on the label
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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