2011 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

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

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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

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)

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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

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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)

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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

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3. Product Standards

Powerful regulatory tool to control emissions

Includes authority to reduce nicotine to non-addictive levels

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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

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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

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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