EXECUTIVE SUMMARY Government-mandated health warnings have been required to appear on cigarette packages for more than 50 years and on cigarette advertisements for more than 45 years. Today, cigarette smoking is at an all-time low. PM USA and Nat Sherman believe that adult smokers should have the right to make informed choices about the use of tobacco products and that there should be a single, consistent public health message about the risks of smoking that should help guide these choices. While we recognize the need for health warnings on cigarette packages and advertisements, FDA’s second attempt at a regulation requiring graphic health warnings suffers from a number of fatal flaws. Our comments are organized into four sections. The first section urges FDA to exempt HeatSticks®, which are unique non-combustible “cigarettes” designed for use with the IQOS® tobacco heating system, from this rule. Although those products do not eliminate all health risks associated with tobacco and nicotine use, they are materially different from traditional combustible cigarettes, and, we believe, also significantly less harmful. Indeed, this Agency has already determined that the marketing of this product is “appropriate for the protection of public health.” The second section raises practical concerns impacting the implementation of the Proposed Rule. The third section explains that without substantial changes, the Proposed Rule would violate the Administrative Procedure Act (“APA”) on multiple grounds. The fourth, and final, section demonstrates that the text and graphic warnings proposed by this rule would violate free speech protections guaranteed by the First Amendment of the U.S. Constitution. To guide the Agency in the materials that follow, we provide an overview of the four sections listed above. Any Final Rule Should Exempt HeatSticks® from the Proposed Graphic-Warnings Requirements IQOS® is an electronic device that heats tobacco in HeatSticks® to generate nicotine-containing aerosol without combustion, fire, ash, or smoke. After a thorough science-based review, FDA granted marketing authorization for IQOS® and HeatSticks® in April 2019, concluding that marketing those products would be “appropriate for the protection of public health.”1 FDA based this conclusion on its rigorous assessment of the critical differences between HeatSticks® and traditional, combustible cigarettes. FDA noted several material differences—among them, that HeatSticks® do not combust or produce smoke; that HeatSticks® reduce exposures to harmful and potentially harmful constituents (“HPHCs”); that HeatSticks® are “likely to lead to less risk of tobacco-related diseases;” and that HeatSticks® have the potential to benefit current smokers who switch to them.2 Because HeatSticks® qualify as a “cigarette” as that term is defined in the Federal Cigarette Labeling and Advertising Act (“FCLAA”),3 FDA’s Marketing Order requires HeatSticks® packaging and advertising to bear the rotating Surgeon General’s warnings required by that Act. Significantly, however, based on the Agency’s recognition of significant differences 1 Attachment 1, CTP Technical Project Lead Review (TPL) Review of IQOS PMTA: PM0000424, PM0000425, PM0000426, and PM0000479 (April 29, 2019) (“IQOS® TPL Review”) at 12, available at https://www.fda.gov/media/124247/download. 2 Id. at 11-12, 92, 95; see also id. at 64-65. 3 15 U.S.C. § 1332(1). 2 between HeatSticks® and traditional combustible cigarettes, FDA also changed the mandated textual warnings that accompany HeatSticks®, for instance by excluding the Surgeon General’s carbon monoxide warning.4 Although IQOS® and HeatSticks® do not eliminate all health risks associated with tobacco and nicotine use, we believe they are significantly less harmful than traditional, combustible cigarettes, and FDA has determined that the marketing of this unique form of “cigarette” is “appropriate for the protection of public health.” Notwithstanding the differences between HeatSticks® and combustible cigarettes, the Proposed Rule would apply the graphic-warnings requirements to HeatSticks® even though those graphic warnings would not educate consumers about the health risks of using HeatSticks®. To the contrary, those warnings would misinform consumers by suggesting, inaccurately and without evidence, that HeatSticks® have the exact same health risks as traditional combustible cigarettes, and by describing HeatSticks® as involving “smoking” or “tobacco smoke.” Imposing the graphic-warnings requirements on HeatSticks®, in short, would undermine FDA’s stated policy goal of promoting greater public understanding of the negative health consequences of cigarette smoking. It would also frustrate FDA’s strategy of adopting policies to move smokers to non-combusted tobacco products lower on the continuum of risk. And, in addition to undermining important health policy objectives, imposing the graphic-warnings requirements on HeatSticks® would violate the APA and the U.S. Constitution on multiple grounds. For these reasons, we respectfully urge FDA to exempt HeatSticks® from the scope of any final rule. The Proposed Rule Raises Practical Concerns Impacting the Implementation of the Required Warnings on Cigarette Packages and Advertisements The Proposed Rule, if finalized in its current form, would create significant implementation problems for both regulated industry and FDA that would substantially hinder the ability of the regulated industry to comply with the requirements of the rule. FDA should modify the Proposed Rule to address each of these problems. First, as an initial matter, FDA should reduce the number of required graphic warnings from 13 to either 12 or 9. This modification is necessary due to extremely difficult and potentially insurmountable technical challenges with printing and distributing 13 warnings equally and randomly on cigarette packages. Second, FDA should address other issues, addressed in more detail below, impacting the implementation of the required warnings on cigarette packages to provide flexibility to manufacturers and to account for the variety of cigarette package shapes and sizes in the marketplace. Third, FDA should address issues impacting the implementation of the required warnings on cigarette advertisements. These issues include the need for FDA to account for and provide clear direction regarding different formats and sizes. 4 See Attachment 2, Philip Morris Products S.A. Marketing Order, FDA Submission Tracking Numbers (STNs): PM0000424-PM0000426, PM0000479 (April 30, 2019) (“FDA Marketing Order”) at 13 n.9, available at https://www.fda.gov/media/124248/download. 3 Finally, FDA should extend or toll the implementation deadline to account for the complex and interdependent chain of events necessary for manufacturers to implement graphic health warnings. The Proposed Rule, if Finalized Without Substantial Changes, Would Violate the Administrative Procedure Act The Proposed Rule, if adopted without substantial modifications, would violate the APA. Agency action, findings, and conclusions must be set aside where they exceed the Agency’s authority, fail to comply with statutory requirements, or are “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”5 The Proposed Rule cannot survive scrutiny under these standards. First, FDA failed to disclose sufficient information about referenced research studies to allow for meaningful evaluation of their validity, in violation of both the Family Smoking Prevention and Tobacco Control Act (“TCA”) and general principles of administrative law. Nor has FDA provided sufficient information for stakeholders to determine why it highlighted certain diseases over others in the graphic warnings; why it selected the particular graphics it chose; or how or why it determined that the proposed warning statements are comprehensible to consumers. Second, FDA relies upon unreliable evidence that does not adequately support the Proposed Rule. FDA’s core evidence consists of commissioned studies that are seriously flawed in their design. FDA’s other cited studies fare no better, relying on data from non-U.S. populations without justification and in disregard of FDA’s own scientific standards, and suffering from various methodological defects. Individually, and even more so collectively, these flaws call into question the reliability and soundness of FDA’s primary scientific justifications for the Proposed Rule. Third, even if FDA’s studies were reliable, their results do not support FDA’s conclusion that the proposed graphic warnings would be effective in improving public understanding of the health consequences of smoking. FDA’s own commissioned studies are the only scientific evidence invoked by the Proposed Rule that even purport to test the replicability of the actual proposed warnings. And their results do not support the Proposed Rule. Fourth, in violation of the APA, FDA does not adequately address science and evidence that runs contrary to its proposal. FDA either ignores or fails to adequately explain a litany of evidence that undermines virtually every premise of the Proposed Rule. This includes: (i) evidence that graphic warnings do not meaningfully influence consumer knowledge regarding the consequences of smoking; (ii) evidence that graphic warnings may backfire, prompting consumers to avoid or reject them in fear or disgust; (iii) evidence that the proposed size requirements for packaging and advertisements do not advance consumer understanding; (iv) evidence