Regulation of Tobacco Products
Mitch Zeller, JD
Pinney Associates
 2011 Johns Hopkins Bloomberg School of Public Health
Competing Visions
The status quo
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
 2011 Johns Hopkins Bloomberg School of Public Health
A different path
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
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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
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Section A
Rationale for Tobacco Product Regulation
 2011 Johns Hopkins Bloomberg School of Public Health
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
 2011 Johns Hopkins Bloomberg School of Public Health
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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
 2011 Johns Hopkins Bloomberg School of Public Health
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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).
 2011 Johns Hopkins Bloomberg School of Public Health
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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
 2011 Johns Hopkins Bloomberg School of Public Health
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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
 2011 Johns Hopkins Bloomberg School of Public Health
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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
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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
 2011 Johns Hopkins Bloomberg School of Public Health
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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)
 2011 Johns Hopkins Bloomberg School of Public Health
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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
 2011 Johns Hopkins Bloomberg School of Public Health
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3. Product Standards
Powerful regulatory tool to control emissions
Includes authority to reduce nicotine to non-addictive levels
 2011 Johns Hopkins Bloomberg School of Public Health
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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
 2011 Johns Hopkins Bloomberg School of Public Health
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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
 2011 Johns Hopkins Bloomberg School of Public Health
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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): affiliation of
dozens of testing laboratories around the world strengthening
capacity to test tobacco product contents and emissions
 2011 Johns Hopkins Bloomberg School of Public Health
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