Jose Luis Murillo Vice President Regulatory Affairs July 16, 2018 VIA ELECTRONIC SUBMISSION AND HAND DELIVERY Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. FDA-2017-N-6189 (83 Fed. Reg. 11,818, March 16, 2018) Advance Notice of Proposed Rulemaking on Tobacco Product Standard for Nicotine Level of Certain Tobacco Products Altria Client Services (“ALCS”), on behalf of Philip Morris USA Inc. (“PM USA”), John Middleton Company (“JMC”), and Sherman Group Holdings LLC and its subsidiaries (“Nat Sherman”),1 submits these comments to the Food and Drug Administration’s (“FDA’s” or the “Agency’s”) Advance Notice of Proposed Rulemaking (“ANPRM”) on a Tobacco Product Standard for Nicotine Level of Certain Tobacco Products. The ANPRM comes within the context of an industry in the midst of transformative change. Cigarette smoking is at historically low levels and continues to decline. At the same time, a new market is emerging in innovative noncombustible tobacco products that are potentially less harmful than cigarettes. There is now a scientific consensus that noncombustible products, like e-vapor, are substantially less risky than conventional cigarettes. It is smoke, and not nicotine, that causes most tobacco- related harm. And adult smokers are increasingly expressing interest in switching from cigarettes to less risky alternatives. We agree that a nicotine product standard of some sort may make sense in a future regulatory system, but this requires the pre-existence of a marketplace with alternative, FDA-authorized, reduced risk products; more information about the relative risks of those products; and a regulatory system that respects the rights of adults to make decisions based on accurate information. 1 PM USA, JMC, and Nat Sherman are wholly-owned subsidiaries of Altria Group, Inc. (“Altria”). PM USA manufactures cigarettes, JMC manufactures cigars and pipe tobacco, and Nat Sherman manufactures cigarettes, cigars, and pipe tobacco. ALCS provides certain services, including regulatory affairs, to the Altria family of companies. “We” and “our” are used throughout to refer to PM USA, JMC, and Nat Sherman. Altria Client Services LLC 2325 Bells Road Richmond, Virginia 23234 (804) 335‐2879 [email protected] What is not clear at this time, however, is whether substantially reducing the nicotine content in cigarettes is technically achievable on a commercial basis, is necessary, or would lead to reduced smoking. Nicotine is addictive and adult smokers primarily smoke to obtain nicotine. As noncombustible tobacco products improve, and accurate information about them is disseminated, adult smokers may well migrate to these new products without regard to a nicotine ceiling in cigarettes. And to the extent that is not the case, if adult smokers cannot get the experience they want from legally produced tobacco products, they will likely seek it from illegal sources such as the black market. We support the Commissioner’s overarching goal; however, much work remains ahead in exploring if or how a nicotine reduction standard would work, and under what conditions: First, FDA must ensure that adult smokers have greater access to noncombustible product alternatives and accurate information about switching to them. For a nicotine ceiling on cigarettes to work, adult smokers must have satisfying and less harmful alternatives. Innovations aimed at providing adult smokers with more choices have greatly increased, but the current regulatory system imposes too many barriers to bringing these new products to the market and to adults learning the facts about them. Second, any nicotine product standard must conform to the law. Among other things, FDA may not adopt nicotine standards that are technically unachievable, that ban cigarettes, or that reduce nicotine effectively to zero. Third, there must be a strong scientific basis to conclude that a mandatory reduction in nicotine levels would be successful, given the scope, scale, and potential risks of this proposal. Among other things, the science needs to demonstrate that reducing nicotine will make cigarettes less addictive and that adult smokers faced with these alterations to the product will not change their behavior in a way that ultimately hurts public health. Fourth, a nicotine product standard must take into account adult consumer choice to avoid serious countervailing effects like the emergence of a new black market. Previous attempts to market cigarettes with very low levels of nicotine – though much higher than the 0.3 – 0.5 mg/g under consideration – have failed in the marketplace. Adults deprived of their preferences – especially without satisfying alternatives – are likely to create demand that will fuel illicit trade. As with Prohibition, black markets impose serious costs on society, including harms to public health resulting from consumer demand being met with products manufactured, distributed, and sold entirely outside the regulated system. Finally, in addition to evaluating whether to force reductions in nicotine, FDA must carefully weigh how any such reductions would be implemented. Sudden or severe reductions in nicotine are far more likely to result in an outbreak of black market activities to meet adult smoker demand, in comparison to more moderated or gradual steps that would allow the Agency to monitor how adults are responding to them. We will actively engage in the regulatory process. 2 EXECUTIVE SUMMARY This submission responds to the ANPRM on developing a product standard to set a maximum nicotine level for cigarettes. The ANPRM asks more than 80 detailed questions covering multiple categories on diverse topics ranging from addiction science to downstream economic impacts. We organized our submission to respond to the categories of information in which FDA expressed interest.2 As detailed below, we provide this information to assist the Agency in understanding the scientific and other evidence it should consider and further evaluate before it proposes a product standard for nicotine levels in cigarettes. This information demonstrates that: a marketplace of FDA-authorized, noncombustible, nicotine-containing products with accompanying modified risk claims must exist before implementing a product standard on the maximum nicotine level in combustible cigarettes; a product standard of 0.3-0.5 mg nicotine per gram in tobacco – or any nicotine ceiling even remotely close to that ceiling – is not technically achievable; a product standard of 0.3-0.5 mg nicotine per gram in tobacco – or any nicotine ceiling even remotely close to that ceiling – constitutes a threshold level that is not adequately supported by science and evidence; a product standard of 0.3-0.5 mg nicotine per gram in tobacco – or any nicotine ceiling even remotely close to that ceiling – will have an enormous economic impact and countervailing effects; and a product standard of 0.3-0.5 mg nicotine per gram in tobacco – or any nicotine ceiling even remotely close to that ceiling – will likely create a substantial illicit market. To guide the Agency in the materials that follow, we provide an overview of the topics listed above: A Marketplace of FDA-Authorized, Noncombustible, Nicotine-Containing Products with Accompanying Modified Risk Claims Must Exist Before Implementing a Product Standard on the Maximum Nicotine Level in Combustible Cigarettes Since the Family Smoking Prevention and Tobacco Control Act (“FSPTCA,” “TCA” or “the Act”) went into effect nearly nine years ago, a strong public health consensus has formed that there is a continuum of risk among tobacco products. We have urged FDA to acknowledge and regulate along the continuum of risk since the passage of the Act and believe the Agency should focus resources on a comprehensive plan to reduce harm through proven strategies to prevent initiation, encourage cessation, and foster the development of reduced risk alternatives. There 2 We include a chart that cross-references questions posed in the ANPRM with our responses in the Appendix at Attachment 2. 3 are currently approximately 44 million adult cigarette smokers in the U.S.3 According to recent PATH data, more than half of these adult smokers are interested in satisfying, less harmful alternatives to cigarettes.4 Even more may be persuaded to switch to products lower on the continuum of risk when FDA provides accurate relative risk information. We were encouraged by Commissioner Gottlieb’s acknowledgement of the risk continuum in his announcement of the Agency’s Comprehensive Plan, which detailed a multi-year roadmap meant to strike “an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes.”5 Although FDA may view a nicotine product standard as an important component of the Agency’s Comprehensive Plan, it is unlikely to be successful if promulgated before (1) there is a diverse market of FDA-authorized, noncombustible products with accompanying modified risk claims and (2) FDA finalizes a clear set of achievable requirements for new and modified risk tobacco product applications. A Product Standard of 0.3-0.5 mg Nicotine per gram in Tobacco – or Any Nicotine Ceiling Even Remotely Close to That Ceiling – Is Not Technically Achievable The ANPRM states that FDA “is particularly interested in comments about the merits of nicotine levels like 0.3, 0.4, and 0.5 mg nicotine/g of tobacco filler” and “the technical achievability of