Section B

1. Section B Building Blocks for Effective Tobacco Product Regulation

2. Building Blocks for Effective Tobacco Product Regulation Source: Zeller, M. (2007).

3. 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

4. Pre-Market Evaluation Program • 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

5. 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

6. 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

7. Partnership with Drug Regulatory Authorities • Forge a partnership with national drug regulatory authorities; here in the United States, 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

8. 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

9. 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

10. 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

11. Label Disclosures • Determine what ingredient and smoke constituent information should be disclosed on the label Image source: Physicians for a Smoke-Free Canada. (2007).

12. 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 • Most of the 1996 rule went into effect in 2010 under a provision of the FSPTCA

13. Restrictions on Youth Access and Marketing • In the United States, rebuild the nationwide enforcement program to reduce youth access that the Agency had put into place before the program was shut down • This is happening now under the FSPTCA • Other countries should follow suit

14. 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

15. The Evolving Tobacco Product Marketplace … • … and the morphing tobacco industry • Dissolvables • Does FDA regulate them, or not? • E-cigarettes • Implications of court ruling • Tobacco company ownership of drug subsidiaries; pharmaceutical licensing arrangements

16. Summary • A combination of the building blocks described 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 • Public health-based regulation must be devised to address the evolving marketplace and morphing tobacco industry