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July 16, 2018 Commissioner Scott Gottlieb, MD C/O Division of Dockets

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July 16, 2018 Commissioner Scott Gottlieb, MD C/O Division of Dockets July 16, 2018 Commissioner Scott Gottlieb, MD c/o Division of Dockets Management HFA-305 Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20825 Re: Tobacco Product Standard for Nicotine Level of Combusted Cigarettes Docket No. FDA-2017-N-6189 Dear Commissioner Gottlieb: The Public Health Law Center is pleased to submit these comments to the U.S. Food and Drug Administration (FDA) on the potential regulation of nicotine levels in combustible tobacco products. The Public Health Law Center is the coordinating center of the Tobacco Control Legal Consortium, a national network of nonprofit legal centers providing legal technical assistance to public health professionals and advocates concerning legal issues related to tobacco and public health.1 There is no question that commercial tobacco use is the greatest public health crisis facing our country. Despite incredible progress made over the last sixty years, commercial tobacco use is still the largest cause of preventable death and disease in the U.S. Over 480,000 people die every year as a result of first or secondhand tobacco exposure. By far, the largest portion of that death and disease is attributable to cigarettes and other combustible tobacco products. Taking nicotine out of the equation should dramatically reduce tobacco use. Disincentivizing the use of combustible tobacco products has been the goal of many tobacco control policies that have been initiated by all levels of government. Never before has any government attempted such a bold step as targeting the very agent that creates and 1 The Tobacco Control Legal Consortium’s activities are coordinated by the Public Health Law Center at Mitchell Hamline School of Law in St. Paul, Minnesota. The Consortium’s affiliated legal centers include: ChangeLab Solutions, Oakland, California; Legal Resource Center for Tobacco Regulation, Litigation & Advocacy, at University of Maryland Francis King Carey School of Law, Baltimore, Maryland; Public Health Advocacy Institute and the Center for Public Health and Tobacco Policy, both at Northeastern University School of Law, Boston, Massachusetts; Smoke-Free Environments Law Project, at the University of Michigan, Ann Arbor, Michigan; and Tobacco Control Policy and Legal Resource Center at New Jersey GASP, Summit, New Jersey. 2 sustains addiction to tobacco products. Such a step should bring about a seismic shift in the commercial tobacco epidemic. We strongly support the FDA’s action and recommend that the agency make the rule as strong as is possible in order to maximize the public health benefits of such a rule. We encourage the FDA to propose a truly comprehensive nicotine reduction rule. First and foremost, a rule reducing nicotine levels in any tobacco products must apply to all combustible tobacco products, not just cigarettes. Second, the rule must reduce nicotine to a level that maximizes the public health benefits. These measures would be best implemented through an immediate one-time reduction in nicotine for combustible products, followed by a step-down reduction in nicotine for non- combustible products to finally break the cycle of nicotine addiction for all tobacco product users. Furthermore, the agency will achieve the greatest public health benefit by simultaneously implementing an educational campaign to explain the effects of nicotine reduction, highlighting the fact that, while combustible products are no longer addictive, they are certainly still deadly. Finally, the opportunity presented by a nicotine product standard to dramatically increase cessation requires several related agency actions to be fully realized. The FDA must take steps to increase access to and innovation of nicotine replacement therapies. The agency also needs to establish product standards that will make non- combustible products safer. The FDA must also use its specific authority under the Tobacco Control Act to establish a track-and-trace system to mitigate the potential for illicit trade to undermine the public health benefits of such a rule. Finally, the agency must take any other necessary steps to ensure that the tobacco industry is unable to undermine the potential benefits of the rule. I. A Product Standard for Nicotine in Tobacco Products Must Be Comprehensive. With a mandate to protect public health, the FDA must design a product standard for nicotine that eliminates addiction and maximizes cessation. The scope of the commercial tobacco epidemic in the U.S. warrants comprehensive agency action that is the most protective of public health. Swift action is also warranted. The agency has faced litigation challenging nearly all of its past efforts to regulate tobacco products. This industry tactic delays the regulatory process at every stage. No amount of agency caution can forestall the inevitable industry lawsuits. a. A Product Standard for Nicotine Must Apply to All Commercial Combustible Tobacco Products. 3 While many tobacco control policies have rightly focused on the impact of cigarettes as the most significant disease vector in tobacco control, in taking a robust approach to nicotine reduction, the FDA must recognize that all tobacco products that partially combust cured, processed tobacco, as cigarettes do, have the potential to be equally toxic and carcinogenic. Cigarettes have historically been the largest cause of public health harm because they are the most popular combustible tobacco product. However, despite minor differences in curing and processing methods, almost all commercial tobacco products utilize the same tobacco plant species, Nicotiana tabacum.2 Consequently, the tobacco in cigarettes is fundamentally the same as the tobacco used in cigars, pipe tobacco, roll-your-own tobacco, and shisha/waterpipe tobacco, creating the same types of health harms.3 These health harms are also likely present in contemporary products that also rely on the imperfect combustion of processed, cured tobacco leaf (for example, heated cigarettes like Phillip Morris International’s iQOS). In addition, if the FDA were to establish a product standard that covers only cigarettes or only some combustible tobacco products, we know from past practices that the tobacco industry would quickly exploit such a loophole to maximize its profits through the sale of combustible products that are not subject to a nicotine product standard but have significant or indistinguishable health harms. i. The Health Harms of Different Classes of Combustible Products Are the Same or Similar. While there may be some varying levels of exposure to particular toxicants or carcinogens between different types of combustible tobacco products, ultimately, the level of risk of harm between these products is not distinguishable. When compared to cigarettes, the severity of the potential negative health outcomes combined with the probability of developing those outcomes are not distinguishably less for other types of combustible tobacco products. Two of the main reasons that these products still present significant and severe health risks is that they are 1) comprised of processed tobacco leaf and 2) partially or imperfectly combusted. This is not surprising given the fact that the tobacco in these products is essentially the same.4 The processing of tobacco leaf through curing and fermentation play an important role in determining the level of toxicants in tobacco and its smoke. Typically, tobacco carcinogens referred to as tobacco-specific nitrosamines (TSNAs), including the most carcinogenic N'-nitrosonornicotine, NNN, and 4-(methylnitrosamino)-1-(3- 2 WORLD HEALTH ORG. INT’L AGENCY FOR RESEARCH ON CANCER, Tobacco Smoke and Involuntary Smoking, 83 IARC MONOGRAPHS ON THE EVALUATION OF CARCINOGENIC RISKS TO HUMANS (2004), at 58. 3 Id. at 58-59. 4 See e.g. TRP: TOBACCO RAG PROCESSORS, INC., http://tobaccorag.com/products/cut-rag (last visited July 10, 2018). 4 pyridyl)-1-butanone, NNK, are created through the processing of tobacco leaf.5. In several studies, the levels of NNN and NNK in cigars and little cigars are equal to or exceed the levels in combustible cigarettes.6 Polycyclic Aromatic Hydrocarbons or PAHs are formed when any organic matter is not completely burned.7 This process is often referred to as imperfect combustion. Many PAHs are highly volatile and present significant risks to both smokers and those who are exposed to secondhand smoke. While not much research has focused specifically on little cigars, at least one study has found that with both human testers and automated smoking machines, the levels of PAHs in little cigars are similar or greater than the level of PAHs in cigarette smoke.8 Additionally, in at least one environmental study of the level of secondhand PAH exposure, the total levels of PAH emissions were greater for cigar social events than for comparable cigarette measures.9 When comparing particulate matter from cigars and cigarillos to cigarette smoke, at least one study found that the cigar and cigarillo matter was 200% more mutagenic, or more capable of damaging the user’s DNA, per unit of nicotine.10 In fact, smokers who switch to cigar smoking have little benefit in terms of mortality.11 It is also important to note that a significant percentage of tobacco users believe that cigars and little cigars are less harmful than combustible cigarettes.12 FDA action on nicotine levels that exempts any type of cigars could potentially reinforce this misbelief and encourage cigarette smokers to switch to these equally harmful products. 5 See Buddy G. Brown et al., An Analysis of the Role of Tobacco-Specific Nitrosamines in the Carcinogenicity of Tobacco Smoke, 1 NONLINEARITY IN BIOLOGY, TOXICOLOGY, AND MED. 179 (2003). Samera H. Hamad et al., Little Cigars vs 3R4F Cigarette: Physical Properties and HPHC Yields, 3 TOBACCO REG. SCI. 459 (2017). 7 U.S. DEP’T OF HEALTH AND HUMAN SERV., HOW TOBACCO SMOKE CAUSES DISEASE: THE BIOLOGY AND BEHAVIORAL BASIS FOR SMOKING-ATTRIBUTABLE DISEASE: A REPORT OF THE SURGEON GENERAL 37 (2010). 8 Bartosz Koszowski et al., Polycyclic Aromatic Hydrocarbons Levels in Mainstream Smoke of Little Cigars and Cigarettes Differ for ISO and Human Smoking (SRNT Annual Meeting 2015).
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