Regulation of Tobacco Products

1. Regulation of Tobacco Products Mitch Zeller, JD Pinney Associates

2. Competing Visions

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?

4. Section A Rationale for Tobacco Product Regulation

5. 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

6. 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

7. 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).

8. 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

9. 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

10. 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)

11. 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

12. 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)

13. 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

14. 3. Product Standards • Powerful regulatory tool to control emissions • Includes authority to reduce nicotine to non-addictive levels

15. 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

16. 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

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