regulation of tobacco products
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2011 Johns Hopkins Bloomberg School of Public Health
Regulation of Tobacco ProductsRegulation of Tobacco Products
Mitch Zeller, JDPinney Associates
2011 Johns Hopkins Bloomberg School of Public Health 2
Competing Visions
The status quo A different path
Unregulated products
Unfettered access to the marketplace
Evolving marketplace and morphing industry
Proliferation of the “light cigarettes” disaster in LMICs
Unproven claims to reduce exposure and risk
Public health–based and science-driven regulation can change the status quo
- Under FCTC Articles 9-11 or relevant national legislation (as in the United States)
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
2011 Johns Hopkins Bloomberg School of Public Health 3
Key Questions
Why regulate tobacco products?
What would tobacco product regulation consist of? The problem with unregulated health claims
What are the key provisions in the US Food and Drug Administration (FDA) tobacco bill?
What is the future of global tobacco regulation?
What are the basic building blocks for effective regulation of tobacco products?
2011 Johns Hopkins Bloomberg School of Public Health
Rationale for Tobacco Product Regulation
Section ASection A
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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 traditional regulation model, such as the one employed by the US FDA for foods, 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. (2011).
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What Would Tobacco Product Regulation Consist Of?
Under a regulation model such as the one employed by the US 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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US 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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US FDA and Tobacco Regulation
In 2000, the US 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 The only way for the FDA to get back in the business of
regulating tobacco products was to be through new legislation
Tobacco industry argument If the FDA had this power, they would have to ban
tobacco products in the United States
In 2009, Congress passed and President Obama signed into law the Family Smoking Prevention and Tobacco Control Act (FSPTCA)
2011 Johns Hopkins Bloomberg School of Public Health
Key Provisions
Five things to know about the FSPTCA
Important to global tobacco efforts—even those legally limited to the United States
FDA’s approach is likely to influence global action under FCTC Articles 9, 10, 11
So let’s hope the FDA gets it right
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2011 Johns Hopkins Bloomberg School of Public Health
1. New Chapter, New Standard
Not “safety and efficacy” but “appropriate for the protection of public health”
With the right set of population-level considerations (impact on initiation, cessation, reduction of harm)
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2011 Johns Hopkins Bloomberg School of Public Health
2. Pre-Market Evaluation … with Some Exceptions
Key principle of all food and drug law
Will apply to new tobacco products and health-related claims
Exception for “substantially equivalent” products
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2011 Johns Hopkins Bloomberg School of Public Health
3. Product Standards
Powerful regulatory tool to control emissions
Includes authority to reduce nicotine to non-addictive levels
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2011 Johns Hopkins Bloomberg School of Public Health
4. Disclosure of Industry Knowledge
“Hey Philip Morris … tell us what you know”
FDA to receive brand-specific information on ingredients, nicotine delivery, and any smoke constituent FDA identifies as harmful or potentially harmful
Companies must also provide FDA with documents related to health, toxicological, behavioral, or physiologic effects of current or future products
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2011 Johns Hopkins Bloomberg School of Public Health
5. Program Security
Funding for the new FDA Tobacco Center is assured (we think)
Funded through “user fees” on the companies … really a market share assessment on each company
Budget rises from $85 million to $712 million annually over first 11 years
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2011 Johns Hopkins Bloomberg School of Public Health 17
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): affiliation of
dozens of testing laboratories around the world strengthening capacity to test tobacco product contents and emissions
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