1.  2007 Johns Hopkins Bloomberg School of Public Health Regulation of Tobacco Products Mitch Zeller, JD Pinney Associates

2.  2007 Johns Hopkins Bloomberg School of Public Health 2 Competing Visions The status quoA different path Unregulated products Unfettered access to the marketplace Unproven claims to reduce exposure and risk Massive consumer confusion - How the “lights” disaster happened Public health–based and science-driven regulation can change the status quo 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 - Case in point: nicotine and addiction

3.  2007 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 happened when the U.S. Food and Drug Administration (FDA) tried to regulate tobacco products?  The tobacco industry’s previously secret admissions about nicotine and addiction What is the future of global tobacco regulation? What are the basic building blocks for effective regulation of tobacco products?

4.  2007 Johns Hopkins Bloomberg School of Public Health 4 Why Regulate Tobacco Products? Image source: Institute for Global Tobacco Control. (2007).

5.  2007 Johns Hopkins Bloomberg School of Public Health 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.  2007 Johns Hopkins Bloomberg School of Public Health 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 regulation model such as the one employed by the U.S. FDA, tobacco 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.  2007 Johns Hopkins Bloomberg School of Public Health 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. (2007).

8.  2007 Johns Hopkins Bloomberg School of Public Health 8 What Would Tobacco Product Regulation Consist Of? Under a regulation model such as the one employed by the U.S. Food and Drug Administration (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.  2007 Johns Hopkins Bloomberg School of Public Health 9 U.S. FDA and Tobacco Regulation 1994: FDA investigates nicotine in tobacco products  If there was sufficient evidence that tobacco companies deliberately designed their products to create and sustain an addiction to nicotine, FDA could have the basis to assert jurisdiction and begin to regulate those products

10.  2007 Johns Hopkins Bloomberg School of Public Health 10 The Industry on Nicotine and Addiction “Nicotine is addictive. We are, then, in the business of selling nicotine—an addictive drug.” — Brown and Williamson, 1963 “The cigarette should be conceived not as a product but as a package. The product is nicotine … Think of the cigarette pack as a storage container for a day’s supply of nicotine … Think of a cigarette as a dispenser for a dose unit of nicotine. Think of a puff of smoke as the vehicle of nicotine.” — Philip Morris, 1972

11.  2007 Johns Hopkins Bloomberg School of Public Health 11 The Industry on Nicotine and Addiction “In a sense, the tobacco industry may be thought of as being a specialized, highly ritualized, and stylized segment of the pharmaceutical industry. Tobacco products uniquely contain and deliver nicotine, a potent drug with a variety of physiological effects.” — R. J. Reynolds, 1972 “BAT should learn to look at itself as a drug company rather than as a tobacco company.” — British American Tobacco, 1980

12.  2007 Johns Hopkins Bloomberg School of Public Health 12 The Industry on Nicotine and Addiction “[T]he entire matter of addiction is the most potent weapon a prosecuting attorney can have in a lung cancer/cigarette case. We can’t defend continued smoking as ‘free choice’ if the person was ‘addicted.’” [emphasis added] — The Tobacco Institute, 1980

13.  2007 Johns Hopkins Bloomberg School of Public Health 13 U.S. 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

14.  2007 Johns Hopkins Bloomberg School of Public Health 14 U.S. FDA and Tobacco Regulation In 2000, the U.S. 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  To regain the powers in the U.S., Congress must pass new law  Legislation currently pending Tobacco industry argument  If the FDA had this power, they would have to ban tobacco products in U.S.

15.  2007 Johns Hopkins Bloomberg School of Public Health 15 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) 2005: affiliation of dozens of testing laboratories around the world strengthening capacity to test tobacco product contents and emissions

16.  2007 Johns Hopkins Bloomberg School of Public Health 16 Building Blocks for Effective Regulation of Tobacco Products Source: Zeller, M. (2007).

17.  2007 Johns Hopkins Bloomberg School of Public Health 17 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

18.  2007 Johns Hopkins Bloomberg School of Public Health 18 Pre-Market Evaluation Program In the U.S., breakfast cereal manufacturers cannot make health claims for their cereals until they prove to the FDA that there is sufficient scientific evidence to support the claim 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

19.  2007 Johns Hopkins Bloomberg School of Public Health 19 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

20.  2007 Johns Hopkins Bloomberg School of Public Health 20 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

21.  2007 Johns Hopkins Bloomberg School of Public Health 21 Partnership with Drug Regulatory Authorities Forge a partnership with national drug regulatory authorities; here in the U.S. 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

22.  2007 Johns Hopkins Bloomberg School of Public Health 22 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

23.  2007 Johns Hopkins Bloomberg School of Public Health 23 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

24.  2007 Johns Hopkins Bloomberg School of Public Health 24 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

25.  2007 Johns Hopkins Bloomberg School of Public Health 25 Image source: Physicians for a Smoke-Free Canada. (2007). Label Disclosures Determine what ingredient and smoke constituent information should be disclosed on the label

26.  2007 Johns Hopkins Bloomberg School of Public Health 26 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  Reinstate those rules; only a few had gone into effect before the FDA’s entire effort was shut down by the courts in 2000 In the U.S., rebuild the nationwide enforcement program to reduce youth access that the Agency had put into place before the program was shut down  Other countries should follow suit

27.  2007 Johns Hopkins Bloomberg School of Public Health 27 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

28.  2007 Johns Hopkins Bloomberg School of Public Health 28 Summary A combination of these building blocks 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