Comments on "Modifications to Compliance Policy for Certain Deemed Tobacco Products; Draft Guidance for Industry"

Jose Luis Murillo Senior Vice President Regulatory Affairs April 30, 2019

Via Electronic Submission

Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852

Re: Docket No. FDA-2019-D-0661 (84 Fed. Reg. 9,345, March 14, 2019) – Comments on “Modifications to Compliance Policy for Certain Deemed Tobacco Products; Draft Guidance for Industry”

Altria Client Services (“ALCS”), on behalf of John Middleton Co. (“JMC”),1 submits these comments to the U.S. Food and Drug Administration (“FDA” or the “Agency”) in response to its proposed Modifications to Compliance Policy for Certain Deemed Tobacco Products: Draft Guidance for Industry (“Draft Guidance”)(March 13, 2019). Our comments focus on Part V of the Draft Guidance titled, “Changes to Compliance Policy Regarding Flavored Cigars (Other Than Tobacco Flavored) that Meet the Definition of a New Tobacco Product,” and the evidence offered in support of it. We provide science and evidence relevant to the issues before the FDA as well as other issues the FDA should consider before finalizing the Draft Guidance.

As an initial matter, we reiterate our request that the Agency bifurcate the two distinctly separate parts of the Draft Guidance – electronic nicotine delivery systems (“ENDS”) and flavored cigars.2 We believe that the two components of the Draft Guidance are dramatically different in both substance and effect, and require different approaches by the FDA. Whereas the ENDS component of the Draft Guidance simply shortens a premarket application deadline that is still over two years away and proposes sales and marketing restrictions, the flavored cigar component proposes a new policy that would immediately and entirely force many flavored cigars from the market.

The Agency’s Draft Guidance for flavored cigars, if implemented, would deprive adult tobacco consumers of products they prefer and inflict harm and disruption upon JMC and other regulated

1 JMC is a wholly-owned subsidiary of Altria Group, Inc. (“Altria”). JMC manufactures 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 JMC. 2 http://www.altria.com/About-Altria/Federal-Regulation-of-Tobacco/Regulatory-Filing/FDAFilings/ALCS-and- JMC-Request-for-Extension-to-Draft-Guidance-Docket-No-FDA-2019-D-0661.pdf

Altria Client Services LLC 2325 Bells Road Richmond, Virginia 23234 (804) 335-2879 [email protected]

entities, with virtually no notice and in complete disregard of their reliance on the FDA’s existing compliance policy. Moreover, implementing the FDA’s abrupt policy reversal on flavored cigars will have an annual effect on the economy that can only be calculated in the hundreds of millions of dollars3 – far exceeding the threshold for “significant regulatory action”4 that should be reviewed by the Office of Management and Budget’s (“OMB”) Office of Information and Regulatory Affairs (“OIRA”). The cigar-related provisions of the Agency’s Draft Guidance, if finalized, would also constitute a “major rule” requiring Congressional review,5 as we explain further at Attachment 1.

I. EXECUTIVE SUMMARY

In the nearly 10 years the Family Smoking Prevention and Tobacco Control Act (“TCA”) has been in effect, the FDA has not finalized foundational rules setting forth the requirements for premarket authorization of tobacco products, despite continual acknowledgement by the FDA of the need to do so. Consistent with this, the FDA has repeatedly pointed to the lack of foundational rules for premarket pathways as a basis for granting a series of extensions to regulatory deadlines for cigars, including deadlines for submitting premarket applications. Manufacturers, including JMC, have relied on these extended deadlines in making business and regulatory decisions while waiting for the FDA to establish the rules of the road. Yet in this Draft Guidance, the FDA has completely and suddenly reversed course, announcing its intention to swiftly begin taking enforcement action against flavored cigars that meet the definition of a new tobacco product but have not yet received premarket authorization.

The enforcement actions proposed in the Agency’s Draft Guidance are not supported by available science and evidence and violate statutorily-guaranteed procedural protections. To that end, our comments demonstrate that the FDA:

 Violates statutorily-guaranteed procedural protections by attempting to issue regulations through draft guidance;

 Offers no substantial scientific evidence supporting its policy reversal and ignoring evidence contradicting its preferred policy outcome;

 Fails to consider countervailing effects and unintended consequences; and

 Fails to consider any reasonable alternatives.

3 We provide a more detailed explanation of the potential negative annual effect on the economy at Attachment 1. 4 Executive Order 12,866 requires that agencies submit “significant regulatory actions” to OIRA (part of OMB) for review and clearance, including cost benefit analysis, at both the proposed and final rulemaking stages. Executive Order 12,866, Regulatory Planning and Review, 58 Fed. Reg. 51,735 (Sept. 30, 1993). 5 Memorandum from Acting Director, Office of Management and Budget (“OMB”) re: Guidance on Compliance with the Congressional Review Act (April 11, 2019), available at: https://www.whitehouse.gov/wp- content/uploads/2019/04/M-19-14.pdf . 2

The FDA’s attempt at issuing regulations through draft guidance violates statutorily- guaranteed procedural protections and is arbitrary and capricious The Draft Guidance proposes a new policy that would immediately force many flavored cigars from the market, depriving adult tobacco consumers of products they prefer and inflicting harm and disruption upon JMC and other regulated entities, with virtually no notice and in complete disregard of their reliance on the FDA’s existing compliance policy. Such radical regulatory intervention requires more than a mere guidance. Forcing a category of tobacco products off the market based on their flavor, in both substance and effect, is a tobacco product standard. If the FDA chooses to pursue this policy, it must satisfy the procedural requirements set forth in the TCA and the Administrative Procedure Act (“APA”).

The FDA has not satisfied TCA requirements by failing to:

 Consider scientific evidence regarding the risks and benefits to the population as a whole, including users and nonusers of tobacco products;

 Consult with other federal agencies concerning the standard;

 Invite appropriate participation by informed persons representative of scientific, professional, industry, agricultural, or consumer organizations who in the Secretary’s judgment can make a significant contribution;

 Allow at least one year to pass before a standard becomes effective unless a shorter time period is necessary to protect the public health;

 Publish in the Federal Register a notice of proposed rulemaking for the establishment, amendment, or revocation of any tobacco product standard and provide certain information about that standard;

 Provide for a comment period of not less than 60 days; and

 Consider information concerning the countervailing effects of the tobacco product standard.

The FDA has not satisfied APA requirements by failing to:

 Allow interested parties adequate notice and an opportunity to meaningfully comment on the Agency’s proposal through submission of written data, views, or arguments;

 Provide substantial justification for deviating from its current policy when its new policy rests upon factual findings that contradict those which underlay its prior policy, or when its prior policy has engendered serious reliance interests that must be taken into account;

 Disclose to the public analysis and data supporting the Agency’s conclusion;

 Ensure its policies do not have any retroactive requirements;

 Define critical terms6; and

 Obtain formal approval by the OMB.

The FDA has not offered substantial scientific evidence in support of its policy reversal and has ignored evidence contradicting its preferred policy outcome

The FDA has not provided substantial evidence to support its radical and abrupt reversal from the policy it adopted toward flavored cigars less than two years ago, following an extensive notice-and-comment period. To the contrary, the scientific evidence presented in the Draft Guidance simply restates well-known and understood information regarding the health risks and use behaviors associated with cigars as if newly discovered. This science and evidence was insufficient to justify restrictions on flavored cigars in 2017 and remains insufficient today.

Our comments show that:

 The scientific evidence regarding the health risks and use behaviors of flavored cigars has not materially changed since the FDA issued its existing policy;

 The FDA’s claim that youth might migrate to flavored cigars from flavored ENDS is speculative and contradicts available government data;

 The FDA conflates association with causation;

 The FDA has mischaracterized its own cited references;

 Youth cigar smoking rates are low and prevalence continues to decline;

 Flavored cigars have not been shown to play a unique role in cigar smoking initiation, dependence or cessation; and

 There is no evidence to suggest that flavored cigars differentially impact morbidity and mortality as compared to non-flavored cigars.

The FDA has failed to consider countervailing effects and unintended consequences

6 The Draft Guidance would effectively change the compliance date for “flavored cigars” but not for “tobacco flavored cigars.” It is worth noting, as discussed infra Section IV.B, that the Agency has never defined these critical terms or otherwise explained what cigars are included within its scope. 4

continuation. In addition, the enforcement actions proposed in the Draft Guidance could have a dramatic economic impact on small businesses.

The FDA has failed to consider any reasonable alternatives

The FDA’s failure to solicit and consider alternative proposals, let alone explain why it chose not to adopt them, is arbitrary and capricious. Indeed, the FDA should consider other viable regulatory alternatives to combat youth use of flavored cigars while preserving flavored cigars for adult tobacco consumers who prefer them. The Draft Guidance proposes significant restrictions on flavored cigars, without substantial evidence. At a minimum, the Agency should consider:

 Supporting legislative efforts to raise the minimum legal age to purchase tobacco products to 21 years old. We are actively advocating for this change at the state and federal levels, and believe it will help to prevent youth from obtaining tobacco products through social sources;

 Pursuing a public education campaign specifically directed at the use of flavored cigars by youth. The Agency has educational campaigns for other categories of tobacco products directed at youth broadly, multicultural youth, LGBTQ young adults and adults who tried to quit smoking in the last year. The FDA describes the results of these campaigns as “impressive,” and could have similar success here; and

 Holding discussions with manufacturers to determine what targeted efforts are capable of reducing youth access to flavored cigars – an approach similar to the one taken for flavored ENDS products. The Draft Guidance does not consider this type of approach and the Agency has not held meetings with manufacturers.

The FDA should consider these and other reasonable alternatives if it attempts to finalize the Draft Guidance.

II. BACKGROUND

A. John Middleton Co.

Founded in 1856 as a pipe tobacco retailer, JMC is a leading manufacturer of cigars and pipe tobacco, operating facilities in Pennsylvania and Virginia. JMC’s cigar portfolio is led by the Black & Mild® brand family. The majority of JMC’s cigars are tipped, with a plastic or wood mouthpiece. JMC’s cigars are machine made with machines used for rod making, tip application and final packaging. Building upon JMC’s tradition as a retailer and manufacturer of pipe tobacco, the majority of JMC’s cigars use pipe tobacco filler.

All of JMC’s cigars are classified as large cigars for federal excise tax purposes.7

B. The FDA’s inconsistent approach to rulemaking and guidance for flavored cigars has caused manufacturers to adjust their business strategies and FDA filing and submission plans to their own detriment

In the nearly 10 years the TCA has been in effect, the FDA has not finalized foundational rules setting forth the requirements for premarket authorization of tobacco products, despite repeated acknowledgment by the FDA of the need to do so. Yet in that time, it has received and acted upon thousands of Substantial Equivalence (“SE”) Reports and hundreds of Premarket Tobacco Product Applications (“PMTA”) seeking premarket authorization. In the absence of foundational rules, applicants have faced uncertainty, lack of transparency and evolving requirements from the FDA that have been applied inconsistently over time.

Foundational rules are critical for all tobacco products. For the cigar category, they are critical for a number of reasons, including the wide variety of products within the category, the dearth of accepted analytical methods for product testing and the lack of a robust historical dataset of smoke constituents. Consistent with this, the FDA has repeatedly pointed to the lack of foundational rules for premarket pathways as a basis for granting a series of extensions to regulatory deadlines for cigars, including deadlines for submitting premarket applications. In the absence of clearly-established rules, manufacturers have relied on these extended deadlines in making business and regulatory decisions while waiting for the FDA to establish the rules of the road. Yet in this Draft Guidance, the FDA has completely and suddenly reversed course, announcing its intention to swiftly begin taking enforcement action against flavored cigars that meet the definition of a new tobacco product but have not yet received premarket authorization.

7 The Internal Revenue Code defines “cigar” for federal excise tax purposes. See 26 U.S.C. § 5702(a) (“‘Cigar’ means any roll of tobacco wrapped in leaf tobacco or in any substance containing tobacco (other than any roll of tobacco which is a cigarette within the meaning of subsection (b)(2).”) When specifying the tax rate applicable to cigars, the Internal Revenue Code distinguishes between “small cigars” and “large cigars,” with the former defined as not weighing more than three pounds per thousand and the latter defined as weighing more than three pounds per thousand. See 26 U.S.C. § 5701(a). 6

1. Deeming Rule issued May 2016

In June 2009, the TCA granted the FDA authority over cigarettes, cigarette tobacco and smokeless tobacco products. The TCA also gave the FDA the authority to issue regulations deeming other products subject to the requirements of the TCA if they met the statutory definition of a tobacco product under Section 901(b). The FDA exercised this authority on May 10, 2016, by issuing its final Deeming Rule and gaining jurisdiction over other tobacco products, including ENDS and cigars.8 Prior to issuing the final Deeming Rule, the FDA contemplated a staggered compliance policy framework based on whether the newly deemed tobacco product contained a “characterizing flavor.”9 In that draft rule, newly deemed tobacco products containing a “characterizing flavor” were to be subject to enforcement beginning 90 days after the effective date of the final rule.10 The OMB’s OIRA deliberately removed the enforcement policy from the draft, and it does not appear in the final Deeming Rule.11

Under the final Deeming Rule:

 SE Exemption Requests were to be submitted no later than 12 months after the effective date of the rule;

 SE Reports were to be submitted no later than 18 months after the effective date of the rule;

 PMTAs were to be submitted no later than 24 months after the effective date of the rule; and

 Flavored and non-flavored products did not receive differential treatment.

The final Deeming Rule also established a 12-month continued compliance period for products with timely submitted premarket applications still pending a final determination. However, at

8 Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act as Amended by the Family Smoking Prevention and Tobacco Control Act: Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products (“Deeming Rule”), 81 Fed. Reg. 28,974 (May 10, 2016). 9 TAB B 2014-850 Deeming Final Rule Redline Changes, p. 23. https://www.regulations.gov/document?D=FDA- 2014-N-0189-83193 (“OMB Redline”). 10 Id. 11 Executive Order 12,866 requires that agencies submit “significant regulatory actions” to OIRA (part of OMB) for review and clearance, including cost benefit analysis, at both the proposed and final rulemaking stages. Executive Order 12,866, Regulatory Planning and Review, 58 Fed. Reg. 51,735 (Sept. 30, 1993). OMB Redline changes to proposed rules can trump agency proposals. See id. As part of this process, the OMB Redline struck the FDA’s proposal in the Deeming Rule to ban flavored cigars in 2016. 7

the expiration of the period, those products could not be marketed if the Agency’s review remained incomplete and a marketing order had not been issued.12

2. The FDA’s comprehensive plan for nicotine and tobacco regulation

On July 28, 2017, former FDA Commissioner Scott Gottlieb announced a new Comprehensive Plan for Nicotine and Tobacco Regulation (the “Comprehensive Plan”) to serve as the Agency’s multi-year roadmap to reduce the harm associated with tobacco products. The FDA asserted that the Comprehensive Plan would “make certain that the FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes.” 13 Its stated goal was to “ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act.”14 The FDA also solicited comments related to its Comprehensive Plan on various issues, including:

 Regulation of Flavors in Tobacco Products (“Flavors ANPRM”);15

 Tobacco Product Standard for Nicotine Level of Combusted Cigarettes;16

 Regulation of “Premium Cigars”;17 and

 Draft Concept Paper: Illicit Trade in Tobacco Products After Implementation of a Food and Drug Administration Product Standard (“Illicit Trade Concept Paper”).18

We submitted extensive comments to each of these dockets, and they are available on our website.19 In total, the FDA received 525,438 comments to its Flavors ANPRM docket.20

The Comprehensive Plan provided “targeted relief on some timelines described in the May 2016 final rule that extended the FDA’s authority to additional tobacco products.”21 Specifically, the Comprehensive Plan’s new compliance and enforcement policies:

12 The FDA reserved the right to “if at the time of the conclusion of the continued compliance period, the applicant has provided the needed information and review of a pending marketing application has made substantial progress toward completion, the FDA may consider, on a case-by-case basis, whether to defer enforcement of the premarket authorization requirements for a reasonable time period.” The FDA did not define the criteria for this determination. See Deeming Rule at 28,978. 13 FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death. (July 28, 2017) available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm. 14 Id. 15 Regulation of Flavors in Tobacco Products, 83 Fed. Reg. 12,294 (March 21, 2018). 16 Tobacco Product Standard for Nicotine Level of Combusted Cigarettes, 83 Fed. Reg. 11,818 (March 16, 2018). 17 Regulation of Premium Cigars, 83 Fed. Reg. 12,901 (March 26, 2018). 18 Draft Concept Paper: Illicit Trade in Tobacco Products After Implementation of a Food and Drug Administration Product Standard; Availability; Request for Comments, 83 Fed. Reg. 11,754 (March 16, 2018). 19 http://www.altria.com/About-Altria/Federal-Regulation-of-Tobacco/Regulatory Filing/Pages/default.aspx?src=leftnav. 20 https://www.federalregister.gov/documents/2018/03/21/2018-05655/regulation-of-flavors-in-tobacco-products. 8

 Extended the application deadline to August 8, 2021 for newly-deemed combustible products;

 Extended the application deadline to August 8, 2022 for newly-deemed non-combustible products;

 Allowed products with timely premarket applications to remain on the market until the FDA had taken final action on an application; and

 Did not include any differential treatment for flavored and non-flavored products.

The Agency’s announcement of the Comprehensive Plan again reiterated its intentions “to issue foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers, while upholding the agency’s public health mission.”22 As former Commissioner Gottlieb stated in the announcement, the “[Agency’s] regulatory efforts need to be accompanied by a firm foundation of rules and standards for newly-deemed products. Among other things, we will advance rules that will lay out what needs to be in applications for Substantial Equivalence, Modified Risk Tobacco Product, and Pre-Market Tobacco Product applications….”23 The former Commissioner repeated this point yet again while addressing the National Press Club, saying “[t]he foundational regulations for the tobacco program were never put in place and so we’re going to take the time to put those in place so we have a firm foundation from which to regulate.”24

3. The FDA’s compliance policy extension history

The FDA has issued seven compliance policy guidances since the Deeming Rule was issued on May 10, 2016, each of which has extended deadlines, announced a stay of enforcement or both. All of these extensions have applied equally to flavored and non-flavored, deemed products:

 In May 2017, a year after the Deeming Rule was published, the Agency extended the compliance requirements under the Deeming Rule by three months;25

 In August 2017, pursuant to its Comprehensive Plan, the FDA issued its most far- reaching compliance policy guidance that further extended the deadlines for submitting

21 FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death. (July 28, 2017) available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm. 22 Id. 23 Scott Gottlieb, Commissioner, U.S. Food and Drug Administration, Protecting American Families: Comprehensive Plan for Nicotine and Tobacco (July 28, 2017), available at https://www.fda.gov/newsevents/speeches/ucm569024.htm. 24 Scott Gottlieb, Commissioner, U.S. Food and Drug Administration, Address at National Press Club (November 3, 2017) available at https://www.c-span.org/video/?436197-1/fda-commissioner-scott-gottlieb-addresses-national- press-club. 25 See Guidance: Extension of Certain Tobacco Products Compliance Deadlines Related to the Final Deeming Rule (Revised)(March 2019) at 15. 9

premarket applications for newly deemed tobacco products. This guidance announced an enforcement deferral policy and established a submission deadline of August 8, 2021 for combustible tobacco products and August 8, 2022 for non-combustible tobacco products;

 In October 2017, the FDA extended the compliance deadlines for other statutorily- mandated requirements, including: registration and listing – extended to align with date established in the Agency’s September 2017 “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments” guidance; ingredient listings – extended by six months; and tobacco health document submissions – extended by six months for those affected by then recent natural disasters;

 In November 2017, the FDA issued yet another compliance guidance that extended the ingredient listing deadline for an additional six months;

 In August 2018, the FDA issued another compliance policy resulting from a court order26 that stayed enforcement of cigar and pipe tobacco warning requirements. This compliance policy also announced the FDA’s intention to exercise its enforcement discretion over statutory requirements for cigar and pipe tobacco until the injunction is lifted;

 In November 2018, the FDA again extended the ingredient listing compliance deadline by six months for small-scale manufacturers dealing with the then recent natural disasters; and

 Most recently, in March 2019, the FDA issued compliance policy guidance extending the harmful and potentially harmful constituent (“HPHC”) reporting deadlines by six months for manufacturers and nine months for small-scale manufacturers from the issuance of final HPHC guidance.

As a result of these new compliance policies and repeated extensions of deadlines, manufacturers, including JMC, have adjusted their business strategies and FDA filing and submission plans to their own detriment while awaiting the foundational rules they have been assured are forthcoming.

III. THE FDA’S APPROACH BY DRAFT GUIDANCE VIOLATES STATUTORILY- GUARANTEED PROCEDURAL PROTECTIONS

The Draft Guidance proposes a new policy that would immediately force many flavored cigars from the market, depriving adult tobacco consumers of products they prefer and inflicting harm and disruption upon JMC and other regulated entities, with virtually no notice and in complete disregard of their reliance on the FDA’s existing compliance policy. Such radical regulatory intervention requires more than a mere guidance. If the FDA chooses to pursue this policy, it

26 See Cigar Ass’n of America v. FDA, No. 1:16-cv-01460 (D.D.C. May 15, 2018) (granting plaintiff’s motion for injunctive relief pending its appeal). 10

must satisfy the procedural requirements set forth in two distinct statutory regimes: those of the TCA and the APA.

A. The FDA’s proposal would enact a tobacco product standard without satisfying the procedural protections required by the TCA

1. The FDA’s proposal would enact a tobacco product standard

The TCA authorizes the FDA to promulgate tobacco product standards where “appropriate for the protection of the public health.”27 Tobacco product standards include, among other things, “provisions respecting the construction, components, ingredients, additives, constituents, including smoke constituents, and properties of the tobacco product.”28 The proposed regulatory action, by forcing a category of tobacco products off the market based solely on their flavor, plainly amounts to a tobacco product standard. It must be treated as such and the FDA understands as much.

The Draft Guidance tries to downplay this action as nothing more than an exercise of discretion, but the FDA has repeatedly recognized that its authority to prohibit categories of tobacco products that share certain attributes arises from its authority to establish tobacco product standards. For example, as early as May 2016, when the FDA deemed cigars subject to its jurisdiction, it announced its intent “in the future to issue a proposed product standard that would, if finalized, eliminate characterizing flavors in all cigars including cigarillos and little cigars.”29 Again, in November 2018, the FDA reiterated its intent “to propose a product standard that would ban flavors in all cigars.”30

Now, the FDA is looking for a shortcut to avoid regulatory procedures put in place by the TCA to quickly advance its objective to ban flavored cigars.31 That the FDA brands this shortcut as a “guidance” and “enforcement policy” is irrelevant. The substance of its action – and not the Agency’s label for it – determines whether procedural requirements apply.32 The FDA cannot short circuit the procedural protections and deliberative process designed by Congress by calling its action something other than what it is. In both substance and effect, the FDA proposes a tobacco product standard, and it should be treated as such.

27 21 U.S.C. § 387g(a)(3)(A). 28 Id. § 387g(a)(4)(B)(i). 29 See Deeming Rule at 29,014. 30 Statement from FDA Commissioner Scott Gottlieb, M.D., on Proposed New Steps to Protect Youth by Preventing Access to Flavored Tobacco Products and Banning Menthol in Cigarettes (Nov. 15, 2018), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm625884.htm 31 It is worth noting that the FDA has not defined “flavored cigars” now or ever. 32 See, e.g., Appalachian Power Co. v. EPA, 208 F.3d 1015, 1024 (D.C. Cir. 2000) (“It is well-established that an agency may not escape the notice and comment requirements . . . by labeling a major substantive legal addition to a rule a mere interpretation.”); Hearth, Patio, & Barbecue Ass’n v. U.S. Dep’t of Energy, 706 F.3d 499, 507-08 (D.C. Cir. 2013) (agency could not engage in “backdoor regulation” to bring additional products under its purview). 11

2. The FDA proposes to enact this tobacco product standard without satisfying the TCA’s requirements

Congress recognized that tobacco product standards are among the FDA’s most coercive regulatory tools, with the potential to infringe on adult tobacco consumer choice, intrude on the legitimate business of regulated manufacturers, injure tobacco retailers and others across the tobacco product distribution chain and fuel black markets and other unintended consequences. To guard against these concerns, Congress included multiple procedural protections, beyond the baseline requirements set forth in the APA, that the FDA must satisfy in order to promulgate a tobacco product standard. The FDA’s proposal regarding flavored cigars ignores these important protections.

The TCA, for example, includes provisions to ensure broad consultation between agencies and interested parties potentially affected by a tobacco product standard, before it becomes final. Specifically, the FDA should “consult with other Federal agencies” regarding the proposed standard.33 It also should “invite appropriate participation, through joint or other conferences, workshops, or other means, by informed persons representative of scientific, professional, industry, agricultural, or consumer organizations who in the Secretary’s judgment can make a significant contribution.”34 There are no indications that the FDA has initiated, let alone completed, these important steps.

The TCA also governs the timetable for imposing tobacco product standards. Recognizing the broad impacts of such standards on manufacturers and the economy, Congress mandated that at least one year must pass before a standard becomes effective unless a shorter time period is necessary to protect the public health35 – a showing that the FDA has not made. Congress further directed that the effective dates for a product standard “shall be established so as to minimize, consistent with the public health, economic loss to, and disruption or dislocation of, domestic and international trade.”36 In complete disregard of these directives, the FDA proposes to reduce the current compliance timeline by as much as a factor of twelve – making the requirements in the Draft Guidance take effect just 30 days after issuance of a final guidance.

The TCA further directs the FDA to “publish in the Federal Register a notice of proposed rulemaking for the establishment, amendment, or revocation of any tobacco product standard,” provide certain information about that standard, and “provide for a comment period of not less than 60 days.”37 Again, the FDA has not satisfied these requirements. It did not publish a notice of proposed rulemaking in the Federal Register and has provided only 45 days to comment on the Draft Guidance.

33 See 21 U.S.C. § 387g(a)(6). 34 Id. 35 Id. § 387g(d)(2). 36 Id. 37 Id. § 387g(c). 12

Giving stakeholders sufficient time to provide meaningful, science-based comments is important because of the complex, interrelating factors that the FDA must balance in order to establish a tobacco product standard. Under the TCA, the FDA must “consider scientific evidence concerning. . . (I) the risks and benefits to the population as a whole, including users and nonusers of tobacco products, of the proposed standard,” “(II) the increased or decreased likelihood that existing users of tobacco products will stop using such products;” and “(III) the increased or decreased likelihood that those who do not use tobacco products will start using such products.”38 The TCA also requires the FDA to consider “information concerning the countervailing effects of the tobacco product standard on the health of adolescent tobacco users, adult tobacco users, or nontobacco users, such as the creation of a significant demand for contraband or other tobacco products.”39 The Draft Guidance does not come close to addressing these requirements.

Furthermore, the TCA is clear that the FDA must make data underlying a proposed tobacco product standard available for public inspection and comment.40 The Draft Guidance relies, in part, on FDA’s analysis of non-public data from the National Institutes of Health’s Population Assessment of Tobacco and Health41 (“PATH”) Wave 4. The FDA, however, has failed to make these data available to the public, and our requests to obtain them during the comment period were declined.42

The FDA’s belief that it need not comply with these requirements here is incorrect. The FDA’s eleventh hour policy reversal, if finalized, would force all non-grandfathered, flavored cigars without premarket approval from the market, effectively imposing a tobacco product standard in an end run around the TCA. It would also be an end run around the statutorily-mandated review process conducted by OMB’s OIRA, which rejected the FDA’s attempt to ban flavored cigars as part of the Deeming Rule.43 The outcome here should be no different. Adopting what, in substance, is a tobacco product standard without satisfying the TCA’s procedural requirements would be impermissible and subject to rescission by the courts.44

38 Id. § 387g(a)(3)(B)(i). 39 Id. § 387g(b)(2). 40 Id. § 387f(b) (“Each notice of proposed rulemaking . . . shall set forth . . . the manner in which interested persons may examine data and other information on which the notice . . . is based.”). 41 “The Population Assessment of Tobacco and Health (PATH) Study is a national longitudinal study of tobacco use and how it affects the health of people in the United States. People from all over the United States will take part in this study. The PATH Study is the first large research effort undertaken by the National Institutes of Health (“NIH”) and the Food and Drug Administration (“FDA”) since Congress gave FDA authority to regulate tobacco products in 2009.” PATH, Home, https://pathstudyinfo.nih.gov/UI/HomeMobile.aspx (last updated Dec. 1, 2017). 42 See infra Section IV.C.1.e. 43 Executive Order 12866 requires that agencies submit “significant regulatory actions” to OIRA (part of OMB) for review and clearance, including cost-benefit analysis, at both the proposed and final rulemaking stages. Executive Order 12,866, Regulatory Planning and Review, 58 Fed. Reg. 51,735 (Sept. 30, 1993). OIRA changes to proposed rules can trump agency proposals. See id. As part of this process, the OMB Redline struck the FDA’s proposal in the deeming rule to ban flavored cigars in 2016. 44 Indeed, courts routinely vacate agency rules that are adopted without meeting applicable procedural requirements. See, e.g., Daimler Trucks N. Am. LLC v. EPA, 737 F.3d 95, 103 (D.C. Cir. 2013) (“the court typically vacates rules 13

B. The FDA’s proposal would violate the APA by enacting a substantive rule without providing notice and comment

The regulatory action proposed by the Draft Guidance also would be subject to restrictions and requirements in the APA. The FDA seeks to enact what amounts to a substantive rule. It therefore must satisfy the APA’s notice-and-comment requirements.45 The FDA’s failure to do so in a sufficient manner violates the APA and provides further grounds for judicial challenge.

Substantive rules under the APA include agency actions that “grant rights, impose obligations, or produce other significant effects on private interests.”46 To determine whether an action is a substantive rule, “courts must look at [the action’s] effect on those interests ultimately at stake in the agency proceeding.”47 Where a change in agency policy “encodes a substantive value judgment,” it is a substantive rule.48

Here, there can be no reasonable dispute that the FDA’s proposed change in policy would be a substantive rule. The FDA seeks to prohibit an entire class of products – non-grandfathered, flavored cigars without premarket authorization – from being sold and would force those products from the market within 30 days of issuing a final guidance when the FDA had repeatedly stated its intent to allow these products to remain on the market. Banning a whole category of products is “substantive.”49 This action would severely harm JMC’s “rights” and “private interests.” It would eliminate well-established interests and reasonable expectations of cigar manufacturers, consumers, retailers and distributors. And, it would “encode” the FDA’s “substantive value judgment” that flavored cigars are somehow not only worse for public health now than they were in 2017, but so much worse that the FDA should revisit and fundamentally change a policy adopted less than two years ago.50

In its rush to force flavored cigars from the market, the FDA provides a mere 45 days to comment on its proposal. This period is insufficient because it does not provide JMC or other interested parties with an adequate “opportunity to participate in the rule making through

when an agency ‘entirely fail[s]’ to provide notice and comment”) (citation and quotation omitted); Heartland Reg’l Med. Ctr. v. Sebelius, 566 F.3d 193, 199 (D.C. Cir. 2009) (“Failure to provide the required notice and to invite public comment . . . is a fundamental flaw that normally requires vacatur of the rule.”) (internal quotation marks omitted). 45 5 U.S.C. § 553. 46 Batterton v. Marshall, 648 F.2d 694, 701-02 (D.C. Cir. 1980); see also, e.g., Reeder v. FCC, 865 F.2d 1298, 1305 (D.C. Cir. 1989) (holding agency policy change was substantive rule because it “encodes a substantive value judgment”). 47 Neighborhood TV Co. v. FCC, 742 F.2d 629, 637 (D.C. Cir. 1984). 48 Reeder, 865 F.2d at 1305. 49 See, e.g., Hi-Tech Pharmaceuticals, Inc. v. Crawford, 505 F. Supp. 2d 1341, 1353 (N.D. Ga. 2007) (observing that “FDA’s decision to ban all [dietary supplements with ephedrine alkaloids] is a substantive rule and thus subject to the APA’s notice and comment requirements”); Nutraceutical Corp. v. Von Eschenbach, 477 F. Supp. 2d 1161 (D. Utah 2007) (similar); Minard Run Oil Co. v. U.S. Forest Serv., 670 F.3d 236, 255 (3d Cir. 2011) (finding that settlement that imposed a ban on drilling in Allegheny National Forest was a substantive rule requiring notice-and- comment). 50 Reeder, 865 F.2d at 1305. 14

submission of written data, views, or arguments” required by 5 U.S.C. § 553(c).51 The APA prohibits agencies from enacting substantive rules without providing interested parties notice and an opportunity to comment.52 This means the FDA must provide both “sufficient factual detail and rationale for the rule to permit interested parties to comment meaningfully” and “adequate time for comments.”53 These requirements are critically important, because they “improve[] the quality of agency rulemaking by exposing regulations to diverse public comment, ensure[] fairness to affected parties, and provide[] a well-developed record that enhances the quality of judicial review.”54

In addition, the FDA has not disclosed the PATH Wave 4 data that purportedly supports its proposal, thus preventing us from replicating the FDA’s analysis or conducting our own analyses.55 This further underscores the inadequacy of the FDA’s notice and interested parties’ opportunity to comment. Courts “have held for many years that an agency’s failure to disclose critical material, on which it relies, deprives commenters of a right under § 553 to participate in rulemaking.”56 These principles have particular force for agency decisions ostensibly grounded in science: “[w]hen the basis for a proposed rule is a scientific decision, the scientific material which is believed to support the rule should be exposed to the view of interested parties for their comment.”57 Compounding this error, the FDA’s failure to provide these data violates the TCA as well.

The FDA’s indifference to the APA when enacting what, in effect, is a substantive rule would render its new policy subject to judicial rescission. The FDA cannot evade this outcome by characterizing its action as a “guidance” or change to an “enforcement policy.” As noted above, notice-and-comment requirements are determined based on the nature of the regulatory action,

51 See, e.g., National Lifetime Ass’n v. FCC, 915 F.3d 19 (D.C. Cir. 2019) (finding 30 day period insufficient because it did not permit time to comment “meaningfully”); Prometheus Radio Project v. FCC, 652 F.3d 431, 453 (3d Cir. 2011) (finding 28 days insufficient: “APA requires that the public have a meaningful opportunity to submit data and written analysis regarding a proposed rulemaking”). Moreover, Executive Order 12866, which provides for presidential review of agency rulemaking via the OIRA, states that “each agency should afford the public a meaningful opportunity to comment on any proposed regulation, which in most cases should include a comment period of not less than 60 days.” Exec. Order No. 12,866, § 6(a), 58 Fed. Reg. 51,735 (Oct. 4, 1993). 52 See, e.g., Appalachian Power, 208 F.3d at 1024; see also 5 U.S.C. § 553(b)-(c). 53 Florida Power & Light Co. v. United States, 846 F.2d 765, 771 (D.C. Cir. 1988) (emphasis added). 54 Sprint Corp. v. FCC, 315 F.3d 369, 373 (D.C. Cir. 2003); see also, e.g., Conn. Light & Power Co., 673 F.2d at 530–31 (notice and comment ensures “a genuine interchange”). 55 The specific data and information that the FDA has not provided or disclosed is discussed in greater detail, see infra Section IV.C.1.e. 56 Allina Health Servs. v. Sebelius, 746 F.3d 1102, 1110 (D.C. Cir. 2014); see also, e.g., Portland Cement Ass’n v. Ruckelshaus, 486 F.2d 375, 393 (D.C. Cir. 1973) (“It is not consonant with the purpose of a rule-making proceeding to promulgate rules on the basis of inadequate data, or on data that, [to a] critical degree, is known only to the agency.”). 57 United States v. Nova Scotia Food Prods. Corp., 568 F.2d 240, 252 (2d Cir. 1977); see also, e.g., Am. Radio Relay League, Inc. v. FCC, 524 F.3d 227, 237 (D.C. Cir. 2008) (“It would appear to be a fairly obvious proposition that studies upon which an agency relies in promulgating a rule must be made available during the rulemaking in order to afford interested persons meaningful notice and an opportunity for comment.”). 15

not how an agency chooses to label it.58 The FDA cannot achieve the functional equivalent of a substantive rule by wielding enforcement discretion without providing notice and comment in accordance with the APA.59

Substantive rulemaking through a guidance document would also violate the FDA’s governing regulations. The FDA promulgated “Good Guidance Practices” to set forth “FDA’s policies and procedures for developing, issuing and using guidance documents.”60 These regulations are clear: “Guidance documents do not establish legally enforceable rights or responsibilities. They do not legally bind the public or FDA.”61 Yet, that is precisely what the FDA is trying to accomplish through this Draft Guidance, which would “bind” regulated parties by subjecting them to enforcement action, including potential civil and criminal penalties, if they fail to remove particular products from the market.

Notably, the Department of Justice (“DOJ”), which exercises judicial enforcement powers on behalf of the FDA, similarly prohibits using guidance documents to impose substantive rules. In its “Prohibition on Improper Guidance,” the DOJ explains that “guidance may not be used as a substitute for rulemaking and may not be used to impose new requirements on entities outside the Executive Branch.”62 The DOJ has extended this principle to guidance documents issued by other agencies, forbidding the use of its “enforcement authority to effectively convert agency guidance documents into binding rules.”63

In short, the FDA proposes to enact, through a guidance document, what in substance would be both a tobacco product standard under the TCA and a substantive rule under the APA. The FDA’s proposal reflects a fundamental and critical departure from existing law and would require the immediate removal from the market of products that until now were assured a market presence until at least August 2021 and likely beyond that time. Because it would effectively ban these products and fundamentally change existing law with respect to them, the proposed rule is substantive and must comply with the TCA and APA procedural requirements set forth above.

58 See, e.g., U.S. Telecom Ass’n v. FCC, 400 F.3d 29, 35 (D.C. Cir. 2005) (“[F]idelity to the rulemaking requirements of the APA bars courts from permitting agencies to avoid those requirements by calling a substantive regulatory change an interpretative rule.”) 59 See, e.g., Chamber of Commerce v. U.S. Department of Labor, 174 F.3d 206, 210 (D.C. Cir. 1999) (finding agency’s use of leverage was the “practical equivalent of a rule”); Mendoza v. Perez, 754 F.3d 1002, 1020-25 (D.C. Cir. 2014) (agency violated APA by issuing “training and employment guidance letters” without notice-and- comment, because they were substantive rules that “imposed specific duties”). 60 21 C.F.R. § 10.115. 61 Id. 62 Memorandum from Attorney General re: Prohibition on Improper Guidance Documents (Nov. 16, 2017) (https://www.justice.gov/opa/press-release/file/1012271/download). 63 Memorandum from Assoc. Attorney General re: Limiting Use of Agency Guidance Documents in Affirmative Civil Enforcement Cases (Jan. 25, 2018) (https://www.justice.gov/file/1028756/download). 16

IV. THE REGULATORY ACTION PROPOSED BY THE FDA IN THE DRAFT GUIDANCE IS ARBITRARY AND CAPRICIOUS UNDER THE APA

A. The proposed regulatory action is subject to the arbitrary and capricious standard of the APA

Any agency action, whether formal or informal, can be challenged under the APA as “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”64 Accordingly, even if the policy reversal proposed by the Draft Guidance did not amount to a tobacco product standard or substantive rule, its implementation would still be subject to judicial review on these grounds.

Agency action is “arbitrary and capricious if the agency has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.”65 This standard requires that an agency decision be the result of “reasoned analysis.”66 It also requires that an agency provide record of support for its decision. When agency action is “bound up with a record-based factual conclusion,” that conclusion must be “supported by substantial evidence,”67 and “an agency’s refusal to consider evidence bearing on the issue before it constitutes arbitrary agency action.”68 Likewise, agency action is arbitrary and capricious if there is insufficient evidence that the action was “necessary to protect the public interest” or that the purpose of the rule “would be accomplished.”69 An agency cannot escape these requirements by arguing that its time or resources were too constrained to abide by them.70

When an agency deviates from current policy, reliance on that policy can trigger review under the arbitrary and capricious standard. As explained by the Supreme Court, “the APA requires an agency to provide more substantial justification when ‘its new policy rests upon factual findings

64 5 U.S.C. § 706; see also, e.g., Eagle Broadcasting Group, Ltd. v. F.C.C., 563 F.3d 543, 551 (D.C. Cir. 2009) (“[I]t does not matter whether it is a formal or informal adjudication or a formal or informal rulemaking proceeding—all are subject to arbitrary and capricious review under § 706(2)(A).”) (citation and quotation omitted); Olenhouse v. Commodity Credit Corp., 42 F.3d 1560, 1573-74 (10th Cir. 1994) (similar). 65 Motor Vehicle Mfrs. Ass’n of the United States v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983). 66 Ramaprakash v. FAA, 346 F.3d 1121, 1124-25 (D.C. Cir. 2003); see also, e.g., Prof’l Drivers Council v. Bureau of Motor Carrier Safety, 706 F.2d 1216 (D.C. Cir. 1983) (“The [reviewing] court’s task is to discern whether the relevant factors were considered and whether the ultimate decision reflects reasoned decision-making.”). 67 Dickinson v. Zurko, 527 U.S. 150, 164 (1999) (internal quotation marks omitted). 68 BellSouth Corp. v. FCC, 162 F.3d 1215, 1222 (D.C. Cir. 1999). 69 Fox Television Stations, Inc. v. FCC, 280 F.3d 1027, 1043-44 (D.C. Cir. 2002); see also, e.g., Business Roundtable v. SEC, 647 F.3d 1144, 1148-49 (D.C. Cir. 2011) (agency cannot finalize rule or action based on “inconsistent[] and opportunistic[]” assessment of costs and benefits). 70 See, e.g., Am. Min. Congress v. EPA, 907 F.2d 1179, 1191 (D.C. Cir. 1990) (“That an agency has only a brief span of time in which to comply with a court order cannot excuse its obligation to engage in reasoned decisionmaking under the APA.”). 17

that contradict those which underlay its prior policy; or when its prior policy has engendered serious reliance interests that must be taken into account.’”71

These principles are implicated here. The FDA’s current policy, adopted after the receipt of extensive comments, does not require premarket applications until 2021 and allows products to remain on the market until the FDA has reviewed and taken final action on an application. This policy has “engendered serious reliance interests” by JMC, and likely by other interested parties. Of necessity, JMC has reasonably based its regulatory compliance, research and production planning on the existing regulatory landscape, including the extended filing timelines. The FDA has not provided “substantial justification” for departing from this policy. As demonstrated below, the proposed policy change is vague, lacks scientific justification, fails to consider harmful countervailing effects and unintended consequences, ignores less drastic alternatives, and proposes retroactive and other unreasonable requirements.

B. The proposed regulatory action is arbitrary and capricious because it fails to define critical terms

As a threshold matter, the FDA’s proposal is flawed because it does not define key terms. The Draft Guidance would effectively change the compliance date for “flavored cigars” but not for “tobacco flavored cigars.”72 The FDA does not define either of these terms, here or elsewhere, or otherwise explain what cigars are included within its scope. As a result, it is unclear which products would need to be removed from the market 30 days after the Draft Guidance is finalized. Given the risk of civil and criminal penalties for noncompliance, this lack of clarity and the immediacy of the FDA’s proposed action would force JMC and other regulated entities into a high-stakes guessing game when attempting to comply with the new policy.

This is improper and unlawful. A law that makes certain conduct unlawful “is void for vagueness if its prohibitions are not clearly defined.”73 Under this doctrine, a law that regulates conduct is arbitrary if it does not provide the public with “a reasonable opportunity to know what is prohibited” and “explicit standards for those who apply them.”74 Agency action will be arbitrary and capricious if “it is so vague and ambiguous as to defy reasonable efforts to predict how it will or may be applied.”75 Indeed, courts have invalidated FDA regulations where the Agency failed to give “some definitional content” to the key phrase in the regulation because “refus[ing] to define the criteria it is applying is equivalent to simply saying no without explanation.”76 The need for clarity also makes sense from a policy perspective. Providing

71 Perez v. Mortg. Bankers Ass’n, 135 S. Ct. 1199, 1209 (2015) (citation omitted). 72 Concerns with this and other definitional issues were raised in our comments to the Flavors ANPRM. 73 Nyeholt v. Sec’y of Veterans Affairs, 298 F.3d 1350, 1356 (Fed. Cir. 2002) (quoting Grayned v. City of Rockford, 408 U.S. 104, 108, (1972)). 74 Grayned, 408 U.S. at 108-09; see also Johnson v. United States, 135 S. Ct. 2551, 2556 (2015) (holding that the government violates the Fifth Amendment “by taking away someone’s life, liberty, or property under a criminal law so vague that it fails to give ordinary people fair notice of the conduct it punishes, or so standardless that it invites arbitrary enforcement”). 75 Hospital Therapy Serv. v. Shalala, No. 95-cv-2951, 1997 WL 1068207, at *9 (N.D. Ga. Aug. 14, 1997). 76 Pearson v. Shalala, 164 F.3d 650, 660 (D.C. Cir. 1999). 18

regulated parties with a clear understanding of what conduct is subject to regulations and how they apply ensures greater compliance with an agency’s policies.

Accordingly, the FDA must clearly define “flavored cigar” and any other key terms. The Agency must also provide objective standards for determining which current and future cigars comply. The Draft Guidance does none of these things.

To the extent the FDA intends to define “flavored cigars” as cigars having a “characterizing flavor,” it should adopt a definition of “characterizing flavor” consistent with its ordinary meaning. The ordinary meaning of “characterizing” is “to describe the character or quality of.”77 Thus, a “characterizing flavor” of a particular tobacco product must be (1) identifiable and (2) the predominant flavor that characterizes that tobacco product. In addition, consistent with Congress’ recognition when promulgating the “Special Rule”78 for cigarettes, the FDA should clarify that the mere presence of a flavoring additive does not, in and of itself, mean the tobacco product has a characterizing flavor.79

C. The proposed regulatory action is arbitrary and capricious because it is not supported by the science and evidence

An agency must provide science and evidence to substantiate its conclusions. Agency action must be “supported by substantial evidence,”80 the agency must articulate a “rational connection between the facts found and the choice made,”81 and an agency acts arbitrarily and capriciously if it “offer[s] an explanation for its decision that runs counter to the evidence before the agency.”82 Based on these principles, where an agency adopts an action or policy that is informed by scientific findings, such as the FDA’s proposal here, a reviewing court will “ensure that the [agency] has examined the relevant data and has articulated an adequate explanation for its action.”83

77 Merriam-Webster’s Collegiate Dictionary 207 (11th ed. 2004). 78 Federal Food, Drug, and Cosmetic Act § 907(A)(1)(a). 79 See H.R. Rep. No. 111-58, pt. 1, at 37, 38 (“Section 907(a)(1) is not intended to prohibit the use of specific ingredients, including those found in some American blend cigarettes, so long as those additives or constituents are not a characterizing flavor (other than tobacco or menthol) of the cigarette or its smoke. A cigarette . . . or its smoke should not be determined to have a prohibited characterizing flavor based solely on the presence of an ingredient in the product or its smoke.”). 80 Safe Extensions, Inc. v. FAA, 509 F.3d 593, 604 (D.C. Cir. 2007). 81 Burlington Truck Lines v. United States, 371 U.S. 156, 168 (1962). 82 Motor Vehicle Mfrs., 463 U.S. at 43; Defendants of Wildlife v. Babbitt, 958 F. Supp. 670, 679 (D.D.C. 1997) (“the presumption of agency expertise may be rebutted if its decisions, even though based on scientific expertise, are not reasoned”). 83 Motor Vehicle Mfrs., 463 U.S. at 43; see also, e.g., Chem. Mfrs. Ass’n v. EPA, 28 F.3d 1259, 1261 (D.C. Cir. 1994) (vacating agency decision listing chemical as high risk air pollutant that was made “on the basis of a model that bears no rational relationship to the physical properties of the chemical,” among other reasons); Tex Tin Corp. v. EPA, 992 F.2d 353, 354-55 (D.C. Cir. 1993) (holding that EPA’s reliance on generic studies in the face of conflicting detailed and specific scientific evidence was arbitrary and capricious); Nat’l Gypsum Co. v. EPA, 968 F.2d 40, 41 (D.C. Cir. 1992) (vacating action where agency failed to “support its decisions with the necessary scientific findings”); Asbestos Info. Ass’n v. O.S.H.A., 727 F.2d 415, 427 (5th Cir. 1984) (staying enforcement of 19

The FDA has not met these requirements. There is no “substantial evidence” to support the FDA’s radical and abrupt reversal from the policy it adopted toward flavored cigars less than two years ago, following an extensive notice-and-comment period and input from a multitude of interested parties. To the contrary, the FDA’s stated rationale and evidence bear no “rational connection” to the proposed policy change and “run[] counter to the evidence” concerning flavored cigars, including scientific evidence not considered by the FDA. It therefore would be arbitrary and capricious. Indeed, this is particularly true given that JMC has substantially relied upon the policy adopted by the FDA less than two years ago, and the FDA must therefore provide “more substantial justification” to depart from that policy.84

Below, we explain why the science and evidence is inadequate to support the proposed regulatory action. First, we demonstrate that the science and evidence cited by the FDA in the Draft Guidance does not justify its proposal. Second, we provide additional science and evidence that the FDA has not addressed, and that is contrary to its proposal.

1. The FDA fails to cite any science and evidence that justifies reversing its existing policy towards flavored cigars

The FDA has not provided “substantial evidence” for unraveling its existing policy, let alone the “more substantial justification” required due to JMC’s reliance on that policy. The information presented in the Draft Guidance is insufficient and, broadly speaking, falls into two categories. First, the FDA points to general information about the potential health risks and use behaviors associated with cigars, including flavored cigars. But this information is not new. To the contrary, it is demonstrably the same as information known to and described by the FDA years ago, even before it established its existing policy. Second, the FDA speculates that its actions to curtail flavored ENDS “could” push youth to “migrate” to flavored cigars. This argument is purely conjectural, based on flawed assumptions and contradicts available evidence. Although these two failings are, by themselves, enough to establish that the FDA’s proposal is arbitrary and capricious, its arguments suffer from additional flaws as well. Generally, the Agency’s arguments are flawed because they conflate association with causation and inaccurately characterize source citations. In addition, the Agency relies on nonpublic analyses and data. We address each of these failings below.

emergency standard because “the record considered as a whole does not substantially support [agency’s] conclusion”). 84 Perez, 135 S. Ct. at 1209. 20

a. The scientific evidence regarding the health risks and use behaviors of flavored cigars has not materially changed since the FDA issued its existing policy in August 2017

The FDA did not justify its policy reversal with new scientific evidence.85 To the contrary, the scientific evidence regarding the health risks and use behaviors of flavored cigars has not materially changed since the FDA issued its existing compliance policy in August 2017.

Long before the FDA issued its August 2017 compliance policy, the substantive scientific findings cited in the Draft Guidance were known to and described by the FDA in other documents. For example, from 2014-2016, during the process of deeming cigars and before adopting the current deadlines for premarket approval, the FDA emphasized that: (1) cigars have similar chemical and toxicological profiles as cigarettes; (2) smoking cigars increases the risks of many of the same diseases as cigarettes; (3) the levels of some carcinogens in the mainstream smoke of cigars exceed those in cigarettes; and (4) little cigars deliver similar levels of nicotine compared to cigarettes. Similarly, FDA expressed concerns that flavored cigars appeal to youth and that polytobacco use is a public health concern. In support of these findings, the FDA cited scientific publications dating to as early as the 1980s. Even with this evidence in hand, the FDA’s Deeming Rule did not treat flavored and non-flavored tobacco products differently.

In the Draft Guidance, the FDA points to previously-known scientific findings as if they are newly discovered, going so far as to rely almost exclusively on recently-published (2017-2018) articles that restate them.

This transparent attempt to rewrite history does not justify the FDA’s policy reversal.

Table 1 below demonstrates that scientific findings cited by the FDA in the Draft Guidance were previously known to and stated by the FDA years ago, even before it adopted the existing deadlines for premarket approval.

85 Nor has the FDA presented any evidence to suggest that the cigar marketplace and array of available products has materially changed. 21

Table 1: Draft Guidance Statements Versus Historical FDA Statements

Statements in the Draft Guidance Previous FDA Statements

“Moreover, recent studies regarding the chemical The FDA made this point in 2014 (Proposed Deeming and toxicological evaluations of cigarettes and cigars Rule), citing 1998 evidence: demonstrate that certain types of cigars (i.e., little “The tobacco smoke from both cigars and cigarettes is cigars and cigarillos) have a chemical and carcinogenic to humans, and the toxicants in cigar toxicological profile that is similar to that of smoke may be even more dangerous than those in combustible cigarettes.47” (p. 18) cigarette smoke (Ref. 28). The smoke from both tobacco products is formed largely from the incomplete 47Cecil et al., 2017; Erythropel et al., 2018; Hamad et al., combustion of tobacco, resulting in cigar smoke being 2017, Pickworth et al., 2018 composed of the same toxic and carcinogenic constituents as are in cigarette smoke (Ref. 28 at 3).” (79 Fed. Reg. 23142, 23169)

Ref. 28: 1998 NCI Monograph 9

“As a result, regular users are at increased risk (as The FDA made this point in 2016 (“final Deeming compared to nonusers) for many of the same diseases Rule”), citing 1984-2013 evidence: as cigarette smokers, including oral, esophageal, “All cigar smokers have an increased risk of oral, laryngeal, and lung cancer; cardiovascular diseases; esophageal, laryngeal, and lung cancer compared to non- and chronic obstructive pulmonary disease tobacco users (Refs. 35, 69). Among those who report (COPD).48” (p. 18) inhaling cigar smoke, there are significantly elevated levels of many types of cancer and other adverse health 48Chang, et al., 2015 effects, such as increased risk of heart and pulmonary disease (Refs. 69, 70). Cigar smokers also are at a marked increase in risk for chronic obstructive pulmonary disease (COPD) and experience higher mortality risk from COPD than nonsmokers (Refs. 70, 71). In addition, cigar smokers have a higher risk of fatal and nonfatal stroke than nonsmokers (Ref. 72).” (81 Fed. Reg. 28974, 29020)

Ref 35: Baker et al., 2000 Ref 69: NCI Monograph 9. 1998 Ref 70: Ibrahim et al. 1999 Ref 71: Surgeon General’s Report, 1984 Ref 72: Katsiki et al., 2013

“Although little cigars deliver similar levels of The FDA made this point in 2014 (Proposed Deeming nicotine compared to cigarettes . . .36” (p. 16) Rule), citing 2011 evidence: “The nicotine exposure from inhaling the smoke from a 36Hamad et al., 2017; Goel et al., 2018 single cigarillo is similar to exposures from inhaling smoke from single cigarettes (Ref. 64).” (79 Fed. Reg. 23142, 23154)

Ref. 64: Fabian et al., 2011

“. . .the levels of some carcinogens in the mainstream The FDA made this point in 2014 (Proposed Deeming smoke exceed those in cigarettes.36” (p. 16) Rule), citing 1998 evidence: “Although the data to demonstrate a similar causal 36Hamad et al., 2017; Goel et al., 2018 relationship is not available, FDA believes it is

reasonable to expect that cigar smoke would produce similar effects, given that data from the NCI cigar monograph showed that some carcinogens determined to cause lung cancer are present at higher levels in cigar smoke than in cigarette smoke and at comparable levels of other carcinogens linked to lung cancer (Ref. 28 at 76-93).” (79 Fed. Reg. 23142, 23170)

Ref. 28: NCI Monograph 9, 1998

The FDA made this point again in 2016 (Final Deeming Rule), citing 1998 evidence: “Although data particular to cigars are not available, FDA believes it is reasonable to expect that cigar smoke would produce similar effects as cigarette smoke, given that data from the National Cancer Institute (NCI) cigar monograph shows that some carcinogens determined to cause lung cancer are present at higher levels in cigar smoke than in cigarette smoke and are present at levels comparable to other carcinogens linked to lung cancer (Ref. 69 at 76-93).” (81 Fed. Reg. 28974, 29070)

Ref. 69: NCI Monograph 9, 1998

“Existing and emerging evidence illustrates the Here, the FDA admits new/emerging evidence is importance of flavors among cigar users and the fact consistent with 2005 evidence that such flavored cigars are appealing to minors. (see statement to the left). Data from the PATH Study (Wave 4 Youth) illustrate the continued importance of flavors among The FDA made this point in 2016, citing pre-2015 first-time cigar users. Recent data from this study evidence. “… [I]t is more likely that a tobacco product indicate that 25.9 percent of ever traditional cigar with a characterizing flavor would appeal to youth and youth users reported that their first cigar was young adults than a product without characterizing flavored, 33.5 percent of ever filtered cigar users flavors.” (OMB Redline, p. 168) reported that their first cigar was flavored, and 56.8 percent of ever cigarillo users said that their first “Flavoring also can make [tobacco] products easier to cigarillo was flavored.38 This evidence is consistent use and increases their appeal among new users, most with earlier research demonstrating that flavors notably among young people (Ref. 9, Carpenter; Ref. 10, increase youth appeal of tobacco products.39” (p. 16) Cummings; Ref. 11, Manning)”. (OMB Redline, p. 170) 38FDA internal analysis 39Carpenter et al., 2005 Ref. 9: Carpenter et al., 2005 [NB: about flavored cigarettes] Ref. 10: Cummings et al., 2007 [NB: about internal company documents] Ref. 11: Manning et al., 2009 [NB: about flavored cigarettes]

“[Y]outh continue to use cigars, particularly flavored cigars. Youth and young adults appear to be particularly interested in cigarillo and little cigars, in part because they are available in flavors. . . . . Recent research indicates that the proportion of the cigar market that is flavored has continued to rise since 2011 and, in 2014, flavored cigars accounted for more than half of all cigar

sales (53.3 percent), with fruit (20.9 percent), sweet or candy (12.8 percent) and wine (9 percent) being the most popular flavor types (Ref. 70B, Viola).” (OMB Redline, pp. 174)

Ref. 70B: Viola et al., 2015 “FDA also notes that minors have a tendency to be The FDA made this point in 2014 (Proposed Deeming polytobacco users and, therefore, may switch to other Rule), citing 2008-2012 evidence: flavored tobacco products like flavored cigars if “A non-cigarette ‘tobacco product’ can be a starter flavored ENDS are no longer available. In 2018, product for new tobacco users before they migrate to NYTS data indicate that 2.4 percent of middle school cigarettes or other tobacco products, or for existing users students (or 33.3 percent of current tobacco product to become dual users. In a 2008 study, researchers users) and 11.3 percent of high school students (or estimated that there were 7.3 million adolescent cigarette 41.7 percent of current tobacco product users) used smokers in the United States in 2002 and 2004, and two or more tobacco products on at least one day in almost half of them were polytobacco users (users of the past month.37” (p. 16) more than one type of tobacco product) (Ref. 124). Of the estimated 3.3 million polytobacco users, 1.9 million 37Grentzke et al., 2019 used one other tobacco product and 1.4 million used two or more other products (id.). The 2012 Surgeon General’s Report found that ‘‘among adolescent and young adult tobacco users, concurrent use of cigarettes, smokeless tobacco, and/or cigars is common’’ (Ref. 54 at 209). According to the 2009 Youth Risk Behavior Surveillance, among high school males who use tobacco, 13.2 percent smoke cigars (i.e., cigars, cigarillos, or little cigars) only, 21.2 percent smoke cigars and cigarettes, and 19.2 percent smoke cigarettes and cigars and also use smokeless tobacco (Ref. 54 at 155, Figure 3.13).” (79 Fed. Reg. 23142, 23159)

Ref. 124: Bombard et al., 2008 Ref. 54: Surgeon General’s Report, 2012

The FDA made this point again in 2016 (OMB Redline), citing 2012 evidence: “FDA is aware of dual use of ENDS and combusted tobacco products and is concerned about the potential impact of this practice on nicotine addiction and cessation. The FDA also is concerned because this dual and polytobacco use pattern appears to be common among adolescents and young adults (Ref. 159, Rath).” (OMB Redline at 297)

Ref. 159: Rath et al., 2012

The FDA made this point in 2016 (final Deeming Rule), citing 2015evidence: “FDA shares similar concerns that youth may initiate tobacco use with ENDS, become addicted, and then dual use or move on to traditional tobacco products. FDA discussed available data regarding dual and polytobacco use in the NPRM and is unaware of long-term studies finding that dual or polytobacco users eventually switch to using just one tobacco product (79 FR 23142 at 23159

and 23160). However, findings from a recent study of 694 participants aged 16 to 26 years old suggest that youth e-cigarette users might transition to smoking traditional cigarettes (Ref. 203). Therefore, FDA remains concerned that youth may use one of the newly deemed products, whether it be an ENDS or any other tobacco product, and dual use with other tobacco products in the future.” (81 Fed. Reg. 28974, 29040-41)

Ref. 203: Primack et al., 2015

b. The FDA’s claim that youth might migrate to flavored cigars from flavored ENDS is speculative, not rationally connected to its proposal, and unsupported by PATH data

The FDA asserts that, “…there is a likelihood that reduced availability of flavored ENDS products to minors could result in those minors migrating from flavored ENDS products to flavored combustible products, including flavored cigars. Historical evidence suggests that flavored tobacco product users might be willing to move to other flavored tobacco products if their preferred product is no longer available.”86 As an initial matter, there is no “rational connection”87 between this hypothesis and the FDA’s proposal to remove flavored cigars from the market. It is irrational to force flavored cigars off the market now in anticipation of a hypothetical migration from flavored ENDS that might occur, if at all, years from now. In its efforts to justify the action, the FDA repeatedly uses words including “might,” “may,” “potential for” and “could” to describe the possible impact of the reduced availability of flavored ENDS on youth cigar use. The FDA’s own words in the Draft Guidance – tentative, uncertain, speculative and laden with caveats – are telling. In fact, the Draft Guidance presents no evidence that youth who use flavored ENDS products will migrate from these noncombustible products to combustible flavored cigars just to maintain their use of flavored tobacco. The FDA assumes that the tobacco product’s form (e.g., combusted vs. noncombusted) does not matter, and only its flavor matters, an uncorroborated assumption that is inconsistent with the scientific evidence. The FDA does not cite evidence that cigar use has grown in popularity among youth, even in the presence of flavored ENDS. To the contrary, the overall prevalence of youth cigar smoking and the proportion of those reporting the use of flavors has declined over time.

Simply put, the FDA’s claim about “migration” is speculative, unfounded and does not justify its policy reversal. We demonstrate why this is so, based on our analyses of the FDA’s and the PATH national longitudinal study data. As we mentioned previously, the FDA has not disclosed PATH Wave 4 data that purportedly supports its proposal, which prevented us from replicating

86 Modifications to Compliance Policy for Certain Deemed Tobacco Products: Guidance for Industry. Draft Guidance (“Draft Guidance”) at pp.16-17. Retrieved from https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM633281.pdf 87 Burlington Truck Lines v. United States, 371 U.S. 156, 168 (1962)(requiring a “rational connection between the facts found and the choice made”). 25

the Agency’s analysis or conducting our own analysis of that data. Therefore, we rely on PATH data through Wave 3.

First, we examined PATH data for youth (age 12-17) transitions from exclusive flavored ENDS use at Wave 2 to flavored and non-flavored cigar use at Wave 3. At Wave 2, we identified 109 youth who exclusively used flavored ENDS and continued to Wave 3 youth. At Wave 3, none of those youth had transitioned to exclusive flavored cigar use; three of them used a cigar in addition to other products, two used a non-flavored cigar, and one used a flavored cigar. These results are in line with the low prevalence (1.2%) of cigar use among youth in PATH Wave 3,88 as well as with the low long-term prevalence of cigar use among youth in The National Youth Tobacco Survey (“NYTS”) and the Youth Risk Behavior Survey (“YRBS”) described below in Figures 1-6.

Second, we analyzed PATH data for adult transitions from exclusive flavored ENDS usage at Wave 2 to flavored and non-flavored cigar usage in Wave 3. At Wave 2, we identified 410 adults who exclusively used flavored ENDS and continued to Wave 3 adult. At Wave 3, four of those adults had transitioned to exclusive cigar use, two transitioned to flavored cigars and two to non-flavored cigars. An additional eight adults used a cigar in addition to other products at Wave 3 – three of whom used a non-flavored cigar, and five of whom used a flavored cigar. This analysis shows that 1.4% of the 410 adult exclusive ENDS consumers transition from flavored ENDS use at Wave 2 to flavored cigar use (exclusively or in addition to other products) at Wave 3.89 These data demonstrate an approximately equal proportion of flavored ENDS users transitioned to using flavored cigars as transitioned to using non-flavored cigars.

These findings from PATH contradict the FDA’s hypothesis regarding migration from flavored ENDS to flavored cigars.

In addition, we examined various studies cited by the FDA. These studies have little bearing, if any, on the theoretical migration of youth from flavored ENDS to flavored cigars.

The FDA cites several studies related to the federal cigarette excise tax increase imposed in 2009 by the Children’s Health Insurance Program Reauthorization Act (“CHIPRA”). These studies examined the impact of the tax increase on consumer behavior, such as cigarette smokers using lower-priced cigars to avoid the rising cost of cigarettes.90 But they do not provide any data about youth use, do not differentiate between flavored and non-flavored products, and do not examine transitions from noncombustible to combustible tobacco products. They also do not indicate that youth “might,” “could” or “will” migrate from flavored ENDS to flavored cigars.

Additionally, the FDA’s reliance on a 2017 publication by Courtemanche et al. is misplaced. The Courtemanche study cannot and does not support claims that the statutory “Special Rule” banning characterizing flavors in cigarettes led to “price sensitive cigarette smokers [who] are

88 See Attachment 2 for definitions and explanations of PATH analysis. 89 See Attachment 3 for definitions and explanations of PATH analysis. 90 Gammon et al. (2016); Agaku & Alpert (2016); Morris & Tynan (2012); Tynan et al. (2015); Wang et al. (2016) 26

smoking cigars as a flavored, less expensive alternative to cigarettes.”91 The analyses by Courtemanche et al. suffer from a series of limitations that undermine the validity of their conclusions and were outlined in our response to the Flavors ANPRM. However, the most germane limitation of this study in this context is that data from a nationally-representative survey establishes that both cigarette and cigar smoking prevalence was declining long before enactment of the “Special Rule” and that the rate of decline did not significantly change thereafter.

This research did not look specifically at youth who used flavored cigarettes and their use behavior after the flavor ban. Moreover, the article does not provide direct evidence that youth who used flavored cigarettes moved to other types of flavored tobacco products after the ban. The reference is inappropriate and its conclusions implausible given the accelerated rate of decline in the cigarette and cigar categories prior to implementation of the “Special Rule” and the fact that the rate of decline did not change substantially after that time.

We present data from the National Survey on Drug Use and Health (“NSDUH”) in Figure 1 below showing that the “Special Rule” had no apparent effect on the trajectory of cigarette or cigar use.

Figure 1: NSDUH Tobacco Prevalence Among Youth

Other studies cited by the FDA relied on ecological sales data (e.g., scanner or tax data) and/or cross-sectional surveys (e.g., NSDUH), both of which have important limitations in this context. Sales data are not a proxy for consumption, because some products purchased may not actually be used by the purchaser. This is particularly true for youth. Data show that youth under age 18 obtain tobacco products primarily through social sources, like friends or siblings who are 18 or

91 Courtemanche et al. (2017) 27

older.92 Cross-sectional surveys have limitations as well. As discussed in the section below, cross-sectional studies do not allow for inferences of causality, may not account for background factors affecting changes in tobacco sales, and cannot observe changes in tobacco use behavior among the same individuals before and after policy implementation.

The FDA also relies on inappropriate, unscientific references such as a 2005 article by Carpenter et al.93 This article is not a research study; it is an amalgamation of industry documents selected by its authors, and all of its scientific conclusions are opinions based on the author’s review. The FDA relies on this article to support its assertion that “flavors increase youth appeal of tobacco products.” In fact, Carpenter et al. reference industry documents that refer repeatedly to 18-24 year olds, not youth.

c. The FDA conflates association with causation

The FDA should evaluate the science and evidence related to potential regulatory actions on flavored cigars based on a classification system that assesses causation. The United States Surgeon General’s Report described a standardized four-tiered system to classify the strength of scientific evidence for assessing causation:

 Evidence sufficient to infer a causal relationship;  Evidence suggestive but not sufficient to infer a causal relationship;  Evidence inadequate to infer the presence or absence of a causal relationship, which encompasses evidence that is sparse, of poor quality, or conflicting; and  Evidence suggestive of no causal relationship.94

We use this approach in our evaluation of the impact of flavored cigars on initiation, dependence and cessation, and we urge the FDA to do the same. Association is an insufficient basis for regulatory actions.

An approach evaluating cause and effect is particularly important in contemplating the role of flavored cigars, if any, on tobacco product initiation and established use. The Draft Guidance cites cross-sectional studies and other sources as evidence that flavors cause youth to use cigars and to support its speculation that restricting flavored ENDS products would cause youth to migrate to flavored cigars.95 Longitudinal studies, when available, are a better tool to investigate whether the availability of flavored cigars drives decisions to use the tobacco product in the first

92 Substance Abuse and Mental Health Services Administration (“SAMSA”) (2017). 93 Carpenter et al. (2005) 94U.S. Surgeon General’s Report (2004). This approach builds on the work of Sir Austin Bradford Hill, who proposed a set of nine “aspects of association” to evaluate epidemiologic evidence of a causal relationship. These criteria, strength of association, consistency, specificity, temporality, biological gradient, plausibility, coherence, experiment, and analogy, “have been used to evaluate countless hypothesized relationships between occupational and environmental exposures and disease outcomes” (Fedak, Kristen M. et al., 2015). 95 See e.g., Courtemanche, Palmer & Pesko, (2017); Dai (2019); Gentzke et al. (2019); and Villanti et al. (2017). 28

place, or whether the decision to use cigars precedes the choice of which flavor to use. Surprisingly, the FDA did not use the available PATH study dataset to look at longitudinal behaviors relative to flavored and non-flavored cigar use.

The FDA’s use of cross-sectional population studies and ecological data is inadequate because they cannot identify causal relationships between flavors and cigar use behaviors. Such studies, at most, are capable of identifying point-in-time associations. The FDA also cites simple proportions (i.e., “… 25.9% of ever traditional cigar youth users reported that their first cigar was flavored, 33.5% for filtered cigars, and 56.8% for cigarillos.”96) to illustrate “the importance of flavors among cigar users.” Without any proper controls, simple proportions alone do not support the claim that “flavors increase youth appeal.” In another example, the FDA states, “. . .there is a likelihood that reduced availability of flavored ENDS products to minors could result in those minors migrating from flavored ENDS products to flavored combustible tobacco products, including flavored cigars.”97 However, the evidence the FDA cites is based on sales data showing possible transitions within the combustible category (e.g., cigarettes to cigar, or roll-your-own to pipe tobacco). These data are at an ecological level, which cannot identify causal relationships between flavors and cigar use behaviors. It is also not clear whether these data apply to youth or transitions between combustible and noncombustible categories.

Longitudinal panels with optimally timed pre- and post-test measurements should be used to evaluate the impact of a tobacco control policy on tobacco use behaviors.98 Further, rigorous policy evaluation should include data from municipalities/states with the policy to matched controls without the policy. These design issues also apply to evaluations of flavored product restrictions (“flavor bans”) on youth behavior. Flavor bans are assumed to impact youth behavior by limiting the inventory of flavored tobacco products in a community, thereby reducing youth appeal and access. However, evidence on the effect of flavor bans on actual behavior is very limited, and recent evidence focuses instead on process outcomes such as retailer compliance and availability of flavored products.99

d. Evidence cited by the FDA does not align with its conclusions or proposed regulatory actions

Many statements in the Draft Guidance are not supported by their cited references, do not support the FDA’s proposed policy reversal or both. We provide an evaluation of some of these references in Table 2 below.

96 Draft Guidance at 16. 97Id. 98 International Agency on Research for Cancer (“IARC”) (2009) 99 Brock et al. (2019); Farley & Johns (2017); Kingsley et al. (2019) 29

Table 2: Evaluation of FDA Statements That Are Unsupported or Irrelevant FDA Statement and Cited Literature Comments “Current information shows that minors continue The Dai article shows a significant decline in flavored cigar to use these dangerous combustible tobacco use and does not address use of specific flavors. products due, in part, to the availability and Furthermore, this secondary analysis of cross-sectional appeal of fruit and other flavors.”(Dai, 2019) NYTS data cannot show causality. “Although little cigars deliver similar levels of The Hamad et al., study results apply to little cigars only nicotine compared to cigarettes, the levels of some and no conclusions can be drawn regarding the impact of carcinogens in the mainstream smoke exceed flavors on carcinogen levels in mainstream smoke. those in cigarettes.” (Hamad et al., 2017) In addition, the 3R4F reference cigarette used in this study was not designed to be an exposure standard or representative of human exposure for cigarettes or any other tobacco product. The 3R4F Cigarette is a certified reference cigarette for use in laboratory proficiency testing programs https://ctrp.uky.edu/home The International Standards Organization (“ISO”) and Health Canada (“HC”) methods described in this paper are not fit for use for cigar products. The authors also deviated from the ISO methodology. The authors noted that, "…the tobacco in each rod was smoked to a butt length of 41.1 – 43.2 mm, or the length of the externally visible cigarette filter over-wrap plus 8 mm. This is a difference of 5.2 ± 0.07 mm longer butt length compared to the ISO methodology" “Moreover, recent studies regarding the chemical Results of the Pickworth et al. study apply to little cigars and toxicological evaluations of cigarettes and and cigarillos only and no conclusions can be drawn cigars demonstrate that certain types of cigars regarding the impact of flavors on carcinogen levels in (i.e., little cigars and cigarillos) have a chemical mainstream smoke. In addition, this study did not measure and toxicological profile that is similar to that of directly the toxicological profile of little cigars/cigarillos. combustible cigarettes.” (Pickworth et al., 2018) No in vitro or in vivo testing was conducted. Furthermore, Pickworth et al. concluded that, "Despite its limitations, this study demonstrates that there is a wide variability in cigar smoking behavior that causes significant differences in toxicant generation. The research that addresses the variability using puff by puff replication and by adjusting the toxicant yields for grams of tobacco burned and by nicotine delivery. [sic] Differences between cigar products and the smoking behavior of their consumers support the notion that cigars are not a single entity and cigar smoking is not a single behavior.” (emphasis added) “Moreover, recent studies regarding the chemical No conclusions can be drawn regarding the chemical and and toxicological evaluations of cigarettes and toxicological profile of cigars from this analytical methods cigars demonstrate that certain types of cigars development paper. (i.e., little cigars and cigarillos) have a chemical and toxicological profile that is similar to that of The 3R4F reference cigarette used in this study was not combustible cigarettes.” (Cecil et al., 2017) designed to be an exposure standard or representative of human exposure for cigarettes or any other tobacco product. “Moreover, recent studies regarding the chemical Results of the Goel et al. study apply only to small filtered and toxicological evaluations of cigarettes and cigars and no conclusions can be drawn regarding the effect cigars demonstrate that certain types of cigars of flavor on nicotine yields. (i.e., little cigars and cigarillos) have a chemical According to Goel et al., nicotine yield per puff was similar 30

and toxicological profile that is similar to that of among the eight brands and the two reference cigarette combustible cigarettes.” (Goel et al., 2018) products, "When the differences in puff count are taken into account, nicotine yields per puff averaged 0.07 mg (range: 0.05 mg from Cheyenne and Dean’s to 0.12 mg from Djarum) under the ISO method and 0.23 mg (range: 0.11 mg from Dean’s to 0.35 mg from Djarum) under the CI method. On a per puff basis, nicotine yield was similar in research cigarettes (mean = 0.08 mg under the ISO method and 0.25 mg under the CI method) as in small cigars." “Moreover, recent studies regarding the chemical Erythropel measured levels of sweeteners in cigars relative and toxicological evaluations of cigarettes and to a snus product and a confectionary gum. It is unclear cigars demonstrate that certain types of cigars how this paper relates to the FDA’s statement. (i.e., little cigars and cigarillos) have a chemical and toxicological profile that is similar to that of combustible cigarettes.” (Erythropel, 2018) “FDA also notes that minors have a tendency to The reference to NYTS data is extraneous – it has nothing be polytobacco users and, therefore, may switch to do with the cigar category generally nor flavored cigars to other flavored tobacco products like flavored specifically. Showing the percentage of middle and high cigars if flavored ENDS are no longer available. school students who use two or more products on at least In 2018, NYTS data indicate that 2.4 percent of one day in the past 30 days does not demonstrate that youth middle school students (or 33.3 percent of current will transition to flavored cigars if flavored ENDS products tobacco product users) and 11.3 percent of high were no longer available. These data show that use of more school students (or 41.7 percent of current than one tobacco product is common among youth who use tobacco product users) used two or more tobacco tobacco and, thus, what might appear to be transitions products on at least one day in the past month.” between products may instead largely reflect their trial and (2018 NYTS) experimental behavior and have little to do with flavors per se. In addition, we were unable to replicate the exact numbers reported for NYTS 2018. Specifically, we were not able to match the percent of middle school students reported. Rather than 33.3% as stated in the in the document, we found 32.9%. “By modifying its compliance policy regarding This statement conflates availability of a product with flavored cigars that meet the definition of new minors’ access to a product (i.e., appropriate retail access tobacco products, FDA is helping to limit minors’ enforcement) and a product ban that affects adult cigar access to a tobacco product that presents consumers. substantial risks and provides no public health benefit.” “Recent data from this study indicate that 25.9 Simple proportions cannot show a causal relationship percent of ever traditional cigar youth users between flavored cigars and initiation. Additionally, PATH reported that their first cigar was flavored, 33.5 Wave 4 data has not been released to the public and the percent of ever filtered cigar users reported that memo released by FDA describing their analysis is their first cigar was flavored, and 56.8 percent of insufficient to recreate their analysis. ever cigarillo users said that their first cigarillo was flavored.”(PATH Wave 4) “This evidence is consistent with earlier research The Carpenter et al. paper was not original research, but demonstrating that flavors increase youth appeal rather a review of a small number of historical industry of tobacco products.” (Carpenter et al., 2005) documents related to flavor development in cigarettes. The documents reviewed related to adult cigarette smokers and not youth appeal. There was no discussion of cigars aside from a few types listed in a table describing available flavored tobacco products. “For example, due to both the Tobacco Control This statement by the FDA conflates the effect of a ban on Act’s prohibition on cigarettes with characterizing flavors in cigarettes with that of increased 31

characterizing flavors (except menthol) and the cigarette pricing. pressure placed on smokers by increased taxation The Gammon et al. paper is cited inappropriately in FDA’s of cigarettes resulting from the 2009 Children’s Draft Guidance because the paper does not include any Health Insurance Program Reauthorization Act flavored product attributes in the analysis and focuses only (CHIPRA) (Pub. L. 111-3), price sensitive on the impact of pricing. Also, the paper focused cigarette smokers are smoking cigars as a exclusively on little cigars (in fact the authors made every flavored, less expensive alternative to cigarettes.” effort to exclude any other type of cigar). (Gammon et al., 2016) These data cannot apply to individual behavior because sales/scan data do not provide demographic or behavioral data. The limitations of the Gammon et al. study are significant enough to limit the credibility of the findings. None of the research or findings included in this paper are sufficient to even tangentially support the argument that flavors are a driving factor OR that the relationship would hold when looking at interaction with categories other than cigarettes. Due to the price differential (index or absolute gap) between cigarettes and little cigars, it is conceivable that properly conducted research utilizing an appropriately robust dataset would potentially show evidence of adult tobacco users’ interaction between forms – measurable by price elasticity of demand and x-form elasticity. This relationship would be similar to the common intra-cigarette interaction between premium and discount/deep-discount brand consumers. “A review of publicly available internal This paper has nothing to do with clove cigarettes, flavors documents from a clove cigarette company found or internal industry documents. There is absolutely no that the company started to develop a clove cigar information in this article that supports the statement in the product in 2007 in anticipation of the Tobacco Draft Guidance. Control Act and its ban on flavored cigarettes, including clove-flavored cigarettes.” . . . “Immediately following the prohibition on cigarette characterizing flavors (except menthol), sales of the clove cigar developed by the company increased more than 1,400 percent between 2009 and 2012.” (Casseus et al. 2016) “Similarly, several studies assessed changes in The studies cited by this statement are related to loose tobacco sales following a large tax increase pricing activity and not flavor. in RYO tobacco and found decreases in RYO tobacco sales as soon as the tax rate changed, but a dramatic increase in pipe tobacco sales. Researchers analyzing publicly available federal excise tax data from 2000–2015 found that total RYO tobacco sales significantly decreased by 70.0 percent; however, total pipe tobacco sales increased by 556.4 percent.” (Agaku et al, 2016; Morris and Tynan, 2012; Tynan, Morris, Weston, 2015; Wang et al, 2016) "FDA understands that tobacco-flavored cigars The Villanti et al. secondary analysis of PATH Wave 1 data are not as appealing to minors as other flavored focused on all tobacco products (with sufficient sample). cigars. Accordingly, all tobacco-flavored cigars From the authors’ analysis: 65% of youth ever users of any will continue to be subject to the extended cigar used a flavored product as their first product, with a compliance dates announced in the August 2017 breakdown by cigar type of: 48% of traditional cigar ever Compliance Policy." (Villanti et al., 2017) users, 64% of cigarillo ever users, and 65% of filtered cigar

ever users. While this article captured the percentage of youth reporting any use of a flavored cigar product, it does not necessarily show increased appeal. The authors noted limitations to the PATH Wave 1 data, “… as youth typically do not have established regular brands, the question about current flavored tobacco use referenced any of the particular products youth respondents used in the past 30 days, whereas adults were asked to identify whether their usual or regular brand was flavored.” As such, youth flavor use may be inflated due to recall error and opportunistic youth behaviors. “Because regular cigar smokers are at increased FDA provides no evidentiary support for this statement. risk (as compared to nonusers) for many of the same diseases as cigarette smokers, there is no similar potential public health benefit to new mint- and menthol-flavored cigars remaining on the market.”

e. The FDA improperly relies on nonpublic evidence

The Draft Guidance relies, in part, on the FDA’s internal analysis of data from Wave 4 of the PATH Study to “illustrate the continued importance of flavors among first-time cigar users.”100 The FDA admits that this analysis is “consistent with” prior findings known to the FDA at the time it established its existing policy for flavored cigars. As such, this analysis does not provide a rational basis to abandon that policy.

In addition, the FDA’s reliance on these data is improper and unfair. PATH Wave 4 data, including restricted files, are not publicly available and are not expected to become available during the comment period. Without access to the underlying data and specific methodologies used by the FDA in its analyses, including code and base sizes, stakeholders cannot replicate and evaluate the FDA’s analysis. Nor can they conduct their own analyses.

We tried to obtain the nonpublic information cited in the Draft Guidance and formally requested access to the restricted PATH Wave 4 files on March 21, 2019.101 NAHDAP staff102 responded that the “…PATH Study Wave 4 [Restricted Use Files] are not yet available. While we do not yet have a public release date, we anticipate that they will become available sometime this year.”103 The FDA has likewise admitted it does not anticipate releasing the PATH Wave 4 “Restricted Use” and “Public Use” datafiles until May 2019 and Fall 2019, respectively.104 We

100 Draft Guidance at 16. 101 Email to National Addiction & HIV Data Archive Program (“NAHDAP”) Claire Cepuran on March 21, 2019. 102 The FDA directs “qualified researchers” to apply to access to restricted, nonpublic PATH data through the National Addiction & HIV Data Archive Program (“NAHDAP”) website. See https://www.fda.gov/tobaccoproducts/publichealthscienceresearch/research/ucm337005.htm 103 Email response from NAHDAP Staff member, Claire Cepuran on March 22, 2019. 104 Memorandum from Office of Science, Center for Tobacco Products, Summary of Internal Analyses from Wave 4 of the PATH Study, dated March 13, 2019 (posted to the docket for the Draft Guidance). 33

have also submitted FOIA requests for both the PATH Study Wave 4 data and other nonpublic information cited by the Draft Guidance (an “in-progress” manuscript by Liu, et al.). The FDA should not base regulatory action on science that is not publicly available and has not been critically reviewed by all stakeholders. Reliance on nonpublic data and analyses violates the APA, the TCA, the right of all stakeholders to fair notice and a meaningful opportunity to be heard, principles of good governance and due process. Before finalizing the Draft Guidance, the FDA must make nonpublic data and information available and provide adequate time and opportunity for stakeholders to review and comment on them.

2. Additional science and evidence, not addressed by the FDA, confirms that there is no basis to reverse existing policy towards flavored cigars

The Draft Guidance ignores available science and evidence that contradicts the FDA’s desired policy outcome. In this section, we present additional science and evidence that the FDA must consider and address, including analyses of PATH data and other publicly available information. This science and evidence contradicts the FDA’s plan to immediately force flavored cigars off the market.

a. Youth cigar smoking rates are low and prevalence continues to decline

Nationally representative survey data indicate that the prevalence of cigar smoking overall among youth is relatively low and continues to decline. We provide analyses of these data below:

 The Monitoring the Future (“MTF”) Survey shows past 30-day use of flavored little cigars among 8th, 10th & 12th graders combined declined from 7.4% to 5.5% from 2014 to 2018. Past 30-day use of regular little cigars declined from 4.5% to 3.4% in the same period (Figure 2).

 The NSDUH shows that lifetime cigar use among 12-17 year olds decreased by 60.7% between 2002 (16.3%) and 2017 (6.3%) and past 30-day cigar use among youth declined from 4.5% to 1.9% (Figure 3).

 The NYTS shows a downward trend in the percentage of past 30-day cigar users among youth 12-14 and 15-17 years old from 2011 to 2018 (Figure 4 and Figure 5).105

 An analysis of NYTS data shows that from 2011–2018, significant linear declines occurred for cigar use among high school students (from 11.6% to 7.6%) and middle school students (from 3.5% to 1.6%).106 With respect to flavored cigars specifically, Dai conducted a secondary analysis of cross-sectional data from NYTS 2014-2017 and found a significant decline in flavored cigar use among youth current cigars users from 2014 to

105 See Attachment 4 for definitions and explanation of NYTS analysis. NYTS Survey, Centers for Disease Control and Prevention (2018) https://www.cdc.gov/tobacco/data_statistics/surveys/nyts/index.htm 106 Gentzke et al. (2019) 34

2016 (from 63.5% to 51.3%), with a continued decline (to 49%; not statistically significant) in flavored cigar use from 2016 to 2017.107

 The YRBS shows that, among male high school students, past 30-day cigar use declined from 31.2% in 1997 to 10.5% in 2017. Past 30-day cigar use among female high school students has declined from 10.8% in 1997 to 5.4% in 2017. Overall, past 30-day cigar use declined from 22% in 1997 to 8% in 2017 (Figure 6).

Figure 2: Past 30-day Cigar Use Among 8th, 10th and 12th Grades Combined: Percentages, 2014-2018. Monitoring the Future108

107 Dai (2019) 108 See http://monitoringthefuture.org/data/18data/18drtbl7.pdf 35

Figure 3: Past 30-day Cigar Use Among 12- to 17-Year-Olds: Percentages, 2002-2017. National Survey on Drug Use and Health (“NSDUH”)109

Figure 4: Past 30-day Cigar Prevalence Among Youth 12-14: 2011-2018. National Youth Tobacco Survey (NYTS)110

109 Substance Abuse and Mental Health Services Administration (SAMSA) (2017) https://www.samhsa.gov/data/nsduh/reports-detailed-tables-2017-NSDUH 110 See Attachment 5 for definitions and explanation of NYTS analysis. Centers for Disease Control and Prevention (2018) https://www.cdc.gov/tobacco/data_statistics/surveys/nyts/index.htm 36

Figure 5: Past 30-day Cigar Prevalence Among Youth 15-17: 2011-2018. NYTS111

Figure 6: Past 30-day Cigar Use among High School Students: Percentages, 1997-2017. Youth Risk Behavior Survey (YRBS)112

111 Id. 112 YRBS began in 1991 but did not include cigars until 1997 37

In addition, Kasza et al.113 reported on PATH Wave 1 data regarding the prevalence of ever smoking by youth of any cigar (7.5%), traditional cigars114 (2.3%), cigarillos (6.5%) and filtered cigars (2.3%). These prevalence rates are less than half of those for other tobacco products as reported by the authors. Further, Kasza et al. show that the prevalence of daily cigar smoking was too low to be quantified in all but the cigarillo category, which registered at 0.1%.

We examined PATH Wave 3 youth data to assess reported smoking of “flavored cigarillos” in the past 30 days.115 Our analyses focused on cigarillos because (1) cigarillos are the most correctly categorized of the different sub-categories within PATH surveys (i.e., for the most part, PATH correctly identifies the cigarillo brand names), and (2) “premium” cigars are largely non- flavored. Among youth aged 15-17 who identified a cigarillo as the type of cigar smoked in the past 30 days, approximately 58% responded affirmatively that at least one of the cigarillos they smoked in the past 30 days were flavored, while among youth aged 12-14 years old, 67% reported smoking at least one flavored cigarillo in the past 30 days. These responses may be due in part to bias in the question. An accurate answer to that question must be “yes” if just one cigar smoked in the past 30 days was flavored – even if the majority or the vast majority of cigars smoked in the past 30 days were non-flavored.116

In contrast to PATH, NYTS data from 2018 show that less than half of 15-17 year olds and 12- 14 year olds who smoked a cigar in the past 30 days indicated that they smoked a flavored cigar. Moreover, an overall decline in flavored cigar product use was observed from 2014 to 2018 (Figure 7).117

113 Kasza, et al. (2017) 114 Inferred to mean premium cigars 115 We relied on data from Wave 3, rather than Wave 1 or 2, because the Wave 3 data are more recent. 116 See Attachment 6 for definitions and explanation of PATH analysis. 117 See Attachment 7 for definitions and explanation of NYTS analysis. 38

Figure 7: Past 30-day Cigar Prevalence and Flavor Usage Among Youth 12-14 and 15-17: 2011-2018 NYTS118

b. Flavored cigars have not been shown to play a unique role in cigar smoking initiation, dependence or tobacco cessation

Flavored cigars are not a new marketplace phenomenon, as they have been in the market for many decades. In this section, we summarize available literature and provide secondary analyses of PATH data119 to examine evidence related to the role flavored cigars play, if any, on initiation,

118 NYTS did not include flavored cigars until 2014. See Attachment 8 for definitions and explanation of NYTS analysis. 119 We focused our analysis on cigarillos because they are the most correctly categorized cigar in PATH and premium cigars are largely non-flavored. 39

dependence and cessation. The available literature and data are sparse, which hinders definitive conclusions regarding the presence or absence of a causal relationship between the use of flavored cigars and increased initiation, severity of dependence or impeded cessation. Even so, available data suggest that relative to non-flavored cigar users, consumers of flavored cigars: are no more likely to become regular users; smoke the same number of cigars per day; have the same time to first cigar of the day; and are no less likely to quit all tobacco within a one-year period.

i. Recent evidence indicates that flavors in cigars do not necessarily play a unique role in smoking initiation

Longitudinal data from PATH shows that youth (12-17 years old) trial of cigarillos120 does not necessarily lead to continued cigarillo smoking. To assess the role of flavors in trial of cigarillos, we examined the first wave of the PATH survey data, which provides a baseline of tobacco product use among a nationally representative sample of youth. We analyzed Wave 1 youth data to assess if there was a relationship between the flavor of the first cigarillo tried and subsequent use after an initial trial. These analyses found that the majority of youth (79%) who had “ever tried” a cigarillo, and whose first product tried was flavored, were either not currently using these products (63%) or had met PATH’s definition of a “very light” consumer (16%).121 We conducted a similar analysis of Wave 2 and Wave 3 data for first cigarillo smoked among those respondents who had initiated cigarillo smoking since Wave 1 and Wave 2 respectively.122 In PATH Wave 2, 13% of youth who initiated since Wave 1 indicated they “don’t know” if the first cigarillo they smoked was flavored. Among youth in Wave 2 who have ever tried cigarillos, almost all (92%) do not currently smoke cigarillos or had smoked only 10 or fewer cigarillos in their lifetime. 123 Our analyses of PATH Wave 3 found fewer youth had initiated on cigarillos as compared to Wave 2 (W2=219 and W3=138). Of those youth who initiated since Wave 2, 20% of youth who tried a cigarillo indicated they “don’t know” if the cigarillo they smoked was flavored. Among youth in Wave 3 who have ever tried a cigarillo, almost all (92%) do not currently smoke cigarillos or had only smoked 10 or fewer cigarillos in their lifetime. 124

Our analyses of PATH longitudinal Wave 2 and Wave 3 data among adults provides additional perspective on whether the trial of flavored cigarillos is more likely than trial of non-flavored cigarillos to lead to ongoing cigarillo smoking.125 We examined the current status of cigarillo smokers grouped by whether the first cigarillo tried was flavored or not flavored. We used product initiation information for adults (18‐24 years old and total adults 18+) at PATH Waves 2

120 We focused our analysis on cigarillos because they are the most correctly categorized cigar in PATH and premium cigars are largely non-flavored. 121 PATH defines “very light” as having used 10 or fewer cigarillos in their lifetime. See Attachment 9 for definitions and explanation of PATH analysis. 122 In the PATH survey, trial of a single cigar “even one or two puffs” is classified as “ever used” a cigar. PATH defines initiation as “no,” never tried in Wave 1 and “yes,” ever tried “even one or two puffs” in Wave 2. PATH asks this for each category of tobacco product (e.g., cigarettes, e-cigarettes, smokeless tobacco, snus, and cigars). 123 See Attachment 10 for definitions and explanation of PATH analysis. 124 See Attachment 11 for definitions and explanation of PATH analysis. 125 PATH Wave 2 and Wave 3 identifies adults who “initiated using cigarillos” since their last completed interview in the previous Wave. 40

and 3 who initiated on cigarillos since the previous wave (i.e., had never consumed cigarettes, e- cigarettes, smokeless tobacco, snus, cigarillos, traditional cigars, and filtered cigars). Cigarillo consumption was grouped by “Ever but Not Current,” “Current Experimental” and “Current Established.” Within each group, the weighted percentage of those who initiated on flavored and non‐flavored cigarillos is given in addition to “Don’t Knows.” Statistical testing was performed using a Two Sample t‐test comparing the percentage of consumers who initiated with flavored versus non‐flavored products and became “Current Established” consumers. There were no significant differences (at the 95% confidence level) between the percentages of consumers who initiated on flavored cigarillos and became “Current Established” consumers and the percentages of consumers who initiated on non-flavored cigarillos and became “Current Established” consumers (Tables 3 and 4).126

Table 3: Current Status of Cigarillo Use by Reported Flavor of Cigarillo Tried Among Young Adult (18-24) Respondents Who Were “Never Users” of Tobacco in Previous Wave127 Young Adults (18‐24 Years Old) who “initiated” since Wave 1 by flavor of first cigarillo and status of current use

%"Ever Used" and “Not % "Current % "Current

Current” Experimental" Established" First Cigarillo N

Flavored 58 60% 25% 16% Non‐ 47 Flavored 71% 26% 3%

Don't Know 26 90% 4% 6% Young Adults (18‐24 Years Old) who “initiated” since Wave 2 by flavor of first cigarillo and status of current use

First Cigarillo N %"Ever Used" and “Not % "Current % "Current Current” Experimental" Established"

29 Flavored 67% 29% 4% Non‐ 37 70% 23% 7% Flavored 13 Don't Know 68% 25% 8%

126 With a p‐value of 0.07 for 18‐24 year olds and 0.87 for total adults at Wave 2, and 0.47 and 0.71 respectively for Wave 3. A t-test comparing the percentage of “Current Established” consumers found no significant differences at the 95% confidence level between the flavored and non-flavored groups. 127 See Attachment 12 for definitions and explanation of PATH analysis. 41

Table 4: Current Status of Cigarillo Use by Reported Flavor of Cigarillo Tried Among Total Adult (18+) Respondents Who Were “Never Users” of Tobacco in Previous Wave128

Total Adult (18+) who “initiated” since Wave 1 by flavor of first cigarillo and status of current use

%"Ever Used" and “Not % "Current % "Current First Cigarillo N Current” Experimental" Established"

Flavored 65 50% 40% 10%

Non‐ 50 70% 22% 8% Flavored Don't Know 28 75% 21% 4% Total Adult (18+) who “initiated” since Wave 2 by flavor of first cigarillo and status of current use

First Cigarillo N %"Ever Used" and “Not % "Current % "Current Current” Experimental" Established"

Flavored 31 53% 44% 3% Non‐ 41 57% 39% 4% Flavored Don't Know 13 68% 25% 8%

Given the findings of our analyses of the PATH data and the sparseness of the published literature, we conclude that the evidence is inadequate to infer the presence or absence of a causal relationship between the use of flavored cigars and initiation.

ii. Recent evidence suggests that flavors in cigars do not necessarily play a unique role in dependence

Strong et al.129 analyzed data from PATH to assess indicators of dependence across product categories, including cigars. With cigarette smokers as a reference, the authors observed a range of tobacco dependence, with cigar only users showing the lowest level of dependence. A recent study conducted among a small sample of adult, exclusive cigar users demonstrated that cigar smokers generally showed low levels of dependence and that cigar type and smoking behaviors affected the level of dependence, with inhalation behaviors associated with higher dependence.130 A secondary analysis of the National Adult Tobacco Survey 2012-2013 revealed

128 See Attachment 13 for definitions and explanation of PATH analysis. 129 Strong, et al. (2017) 130 Claus et al. (2018) 42

lower dependence among exclusive cigar smokers than other tobacco product users.131 While these studies demonstrate the relatively low dependence potential of cigars, they do not address the role of flavors in cigar dependence.

Self-reported number of cigarettes smoked per day and time to first cigarette of the day are two measures comprising the Heaviness of Smoking Index (“HSI”), a validated measure of cigarette dependence.132 Using the PATH study data, we compared mean cigarillos per day and time to first cigarillo (“TTFC”) among adult respondents age 18-24 years old and 25+ who reported using flavored or non-flavored cigarillos in the past 30 days.

Our analyses of cigarillo consumption (cigarillos per day, or “CPD”) from PATH133 extend findings from the above-cited literature. Overall, adult cigarillo consumers smoke five or fewer cigarillos per day. Tables 5, 6, and 7 below present consumption results for adult cigarillo smokers in PATH Waves 1 through 3, respectively, showing that flavored and non-flavored cigarillo smokers do not differ significantly with respect to reported total mean CPD. We applied Student’s t‐test to determine whether there were significant differences in average consumption between respondents whose regular/last brand was flavored compared to non‐ flavored. The p-values in Wave 1 were p=0.84 for adults 18-24 years old and p=0.48 for adults 25+; in Wave 2, these p-values were p=0.66 and p=0.28, respectively; in Wave 3, these p-values were p=0.80 and p=0.62, respectively. Among daily and non-daily consumers, regardless of flavor, adult cigarillos consumers smoked, on average, one to five cigarillos per day on days smoked.

131 Rostron et al. (2016) 132 Kozlowski et al. (1994) 133 We focused our analysis on cigarillos because they are the most correctly categorized cigar in PATH and premium cigars are largely non-flavored. 43

Table 5: PATH Wave 1 Reported Cigarillos Smoked Per Day – Flavored Versus Non- Flavored Cigarillos134 Wave 1 adult cigarillo current established consumer 18-24 years old – “yes” flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 105 253,790 1.4 5-15 days 104 243,201 1.9 16-26 days 28 62,923 5.5 27+ days 27 65,767 5.0 Every day 65 136,740 4.9 Total 332 768,446 2.8 Wave 1 adult cigarillo current established consumer 18-24 years old – not flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 45 104,338 2.4 5-15 days 44 107,059 1.7 16-26 days 21 42,187 1.8 27+ days 17 35,428 2.8 Every day 47 95,851 4.7 Total 175 386,856 2.7 Wave 1 adult cigarillo current established consumer 25+ years old – “yes” flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 72 291,629 1.3 5-15 days 90 351,164 2.2 16-26 days 27 101,748 3.6 27+ days 25 87,880 4.3 Every day 84 322,738 4.9 Total 301 1,172,158 3.6 Wave 1 adult cigarillo current established consumer 25+ years old – not flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 46 207,591 1.3 5-15 days 41 161,077 2.1 16-26 days 18 64,923 2.9 27+ days 23 100,502 6.1 Every day 63 271,798 7.6 Total 194 820,924 4.4

134 See Attachment 14 for definitions and explanation of PATH data analysis. A t-test comparing mean consumption between total flavored and non-flavored “Current Established” cigarillo consumers shows no significant differences at the 95% confidence level. Individual base sizes for the “Days Used” groups may not add up to the “Total” due to missing values and responses of “0 days.” 44

Table 6: PATH Wave 2 Reported Cigarillos Smoked Per Day – Flavored Versus Non- Flavored Cigarillos.135 Wave 2 adult cigarillo current established consumer 18-24 years old – “yes” flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 62 173,957 1.1 5-15 days 54 156,421 1.6 16-26 days 6 17,106 3.0 27+ days 3 6,637 3.9 Every day 22 55,954 2.9 Total 147 410,075 1.6 Wave 2 adult cigarillo current established consumer 18-24 years old – not flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 32 82,468 1.1 5-15 days 37 112,400 1.4 16-26 days 4 7,664 1.1 27+ days 4 13,504 1.0 Every day 12 33,973 3.3 Total 90 251,543 1.5 Wave 2 adult cigarillo current established consumer 25+ years old – “yes” flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 77 377,159 1.1 5-15 days 58 264,614 2.5 16-26 days 17 71,144 3.8 27+ days 13 64,370 5.9 Every day 41 185,257 7.9 Total 207 965,011 3.3 Wave 2 adult cigarillo current established consumer 25+ years old – not flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 54 258,207 1.2 5-15 days 48 229,539 1.5 16-26 days 13 61,545 2.8 27+ days 11 47,228 2.3 Every day 44 204,270 5.1 Total 170 800,789 2.5

135 See Attachment 15 for definitions and explanation of PATH data analysis. A t-test comparing mean consumption between total flavored and non-flavored “Current Established” cigarillo consumers shows no significant differences at the 95% confidence level. Individual base sizes for the “Days Used” groups may not add up to the “Total” due to missing values and responses of “0 days.” 45

Table 7: PATH Wave 3 Reported Cigarillos Smoked Per Day – Flavored Versus Non- Flavored Cigarillos136 Wave 3 adult cigarillo current established consumer 18-24 years old – “yes” flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 42 143,148 1.0 5-15 days 38 117,493 2.6 16-26 days 10 29,337 3.1 27+ days 4 9,972 2.3 Every day 9 16,252 3.4 Total 104 317,699 1.9 Wave 3 adult cigarillo current established consumer 18-24 years old – not flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 30 85,079 1.5 5-15 days 17 41,568 1.6 16-26 days 10 23,856 1.9 27+ days 4 10,760 2.0 Every day 19 55,135 2.6 Total 81 219,984 1.9 Wave 3 adult cigarillo current established consumer 25+ years old – “yes” flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 58 266,207 1.7 5-15 days 63 290,577 1.8 16-26 days 8 34,092 2.0 27+ days 9 31,028 4.1 Every day 39 189,852 5.3 Total 177 811,756 2.7 Wave 3 adult cigarillo current established consumer 25+ years old – not flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 55 278,988 1.2

136 See Attachment 16 for definitions and explanation of PATH data analysis. A t-test comparing mean consumption between total flavored and non-flavored “Current Established” cigarillo consumers shows no significant differences at the 95% confidence level. Individual base sizes for the “Days Used” groups may not add up to the “Total” due to missing values and responses of “0 days.” 46

5-15 days 38 219,957 1.6 16-26 days 6 41,737 3.1 27+ days 8 32,016 4.2 Every day 57 317,545 3.8 Total 164 890,244 2.4

Our analyses of TTFC from PATH further extend findings from the above-cited literature. Overall, adult cigarillo consumers’ average time to first cigarillo of the day is over one hour after waking. We analyzed TTFC data among adults, ages 18-24 years and 25+ years, who were current consumers of flavored and non-flavored cigars. Table 8 below shows no significant differences in TTFC between non-flavored and flavored cigarillo smokers across age categories. We applied Student’s t‐test to compare TTFC between the flavored and non‐flavored groups. The p-values in Wave 1 were p=0.17 for adults 18-24 year olds and p=0.70 for adults age 25+; in Wave 2, these p-values were p=0.15 and p=0.50, respectively; in Wave 3, these p-values were p=0.85 and p=0.82, respectively. Across all age groups and flavor categories, average TTFC ranged from approximately one hour to over two hours.

Table 8: Average Time to First of Flavored Versus Non-Flavored Every Day Cigarillo Smokers137

Wave 1 Adult Cigarillo Age Group Regular/Last Brand of Minutes to First Cigarillo After Waking N Weighted Cigarillo Smoked (Confidence Interval) N Flavored? 18 to 24 Yes 123.7 (70.8 – 176.7) 64 134,066 Years Old 18 to 24 No 81.6 (51.1 – 112.1) 46 93,510 Years Old 25+ Years Yes 90.4 (61.3 – 119.6) 82 314,598 Old 25+ Years No 100.2 (59.5 – 140.8) 61 254,372 Old Wave 2 Adult Cigarillo Age Group Regular/Last Brand of Minutes to First Cigarillo After Waking N Weighted Cigarillo Smoked (Confidence Interval) N Flavored? 18 to 24 Yes 139.8 (63.0 – 216.6) 22 55,954 Years Old

137 See Attachment 17 for definitions and explanation of PATH analysis. A t-test comparing time to first between flavored and non-flavored “Current Every Day” cigarillo consumers shows no significant differences at the 95% confidence level. 47

18 to 24 No 76.5 (35.1 – 118.0) 12 339,723 Years Old 25+ Years Yes 73.9 (30.9 – 117.0) 41 185,257 Old 25+ Years No 57.7 (36.2 – 79.2) 44 204,270 Old Wave 3 Adult Cigarillo Age Group Regular/Last Brand of Minutes to First Cigarillo After Waking N Weighted Cigarillo Smoked (Confidence Interval) N Flavored? 18 to 24 Yes 93.8 (18.2 – 169.5) 9 16,252 Years Old 18 to 24 No 102.8 (47.0 – 158.6) 19 55,135 Years Old 25+ Years Yes 100.0 (40.8 – 159.2) 39 189,852 Old 25+ Years No 109.1 (55.9 – 162.2) 56 308,663 Old

Given the findings of our analyses of the PATH data and the sparseness of the published literature, we conclude that the evidence is suggestive but not sufficient to infer the absence of a causal relationship between the use of flavored cigars and severity of dependence.

iii. Recent evidence suggests that flavors in cigars do not necessarily impede cessation

We are not aware of any literature assessing cigars or the role of flavors in cigars specific to measures of tobacco cessation. We examined PATH Waves 1 through 3 to determine whether differences exist regarding cessation between smokers of flavored versus non-flavored cigarillos.138 Tables 9 and 10 below show that, among current cigarillo smokers at Wave 1 who were no longer using tobacco at Wave 2, and among current cigarillo smokers at Wave 2 who were no longer using tobacco at Wave 3, there are no statistically significant differences between flavored and non-flavored cigarillo users among any age group. Cessation was defined as a current established user of cigarillos in the previous PATH Wave who no longer used any tobacco products (i.e., cigarettes, e‐ cigarettes [e-products in Wave 3], smokeless tobacco, snus, cigarillo, traditional cigars, and filtered cigars) in the subsequent PATH Wave. We reported cessation rates by the regular/last flavor of cigarillo smoked and respondent age in the previous wave. Results of Two Sample t-tests indicated that in Wave 2 the p-values were p=0.24 for adults 18-24 years old and p=0.73 for adults 25+; in Wave 3 these p-values were p=0.62 and p=0.49 respectively.

138 We focused our analysis on cigarillos because they are the most correctly categorized cigar in PATH and premium cigars are largely non-flavored. 48

Table 9: Cessation Outcome Among Young Adults (18-24)139 Cessation Outcomes at Wave 2 of Smokers of Flavored and Non‐Flavored Cigarillos Among Young Adults (18‐24 Years Old) % No Longer Use N Weighted N Product in Wave 1 Tobacco

Flavored 321 913,717 18.7%

Non‐Flavored 157 432,652 24.3% Cessation Outcomes at Wave 3 of Smokers of Flavored and Non‐Flavored Cigarillos Among Young Adults (18‐24 Years Old) % No Longer Use Product in Wave 2 N Weighted N Tobacco Flavored 155 478,302 22.1%

Non‐Flavored 101 295,048 19.6%

Table 10: Cessation Outcome Among Adults (25+)140

Cessation Outcomes at Wave 2 of Smokers of Flavored and Non‐Flavored Cigarillos Among Adults (25+)

Product in Wave 1 N Weighted N % No Longer Use Tobacco

Flavored 296 1,342,494 13.1%

Non‐Flavored 197 1,042,924 11.9% Cessation Outcomes at Wave 3 of Smokers of Flavored and Non‐Flavored Cigarillos Among Adults (25+ Years Old) Product in Wave 2 N Weighted N % No Longer Use Tobacco

Flavored 220 1,082,104 12.3%

Non‐Flavored 191 940,532 9.5%

Given the findings of our analyses of the PATH data and the lack of any published literature examining the role of cigar flavors in cessation outcomes, we conclude that the evidence is suggestive but not sufficient to infer the absence of a causal relationship between the use of flavored cigars and decreased cessation.

139 See Attachment 18 for definitions and explanation of PATH analysis. A t-test comparing cessation outcomes in the current wave, between flavored and non-flavored “Current Established” cigarillo consumers in the previous wave shows no significant differences at the 95% confidence level. 140 See Attachment 19 for definitions and explanation of PATH analysis. 49

iv. Limitations of PATH survey questions related to flavor and cigar type

Like any data source, PATH Waves 1 through 3 data have limitations. The PATH survey has an inconsistent cigar questionnaire structure and response options between Waves, limiting the interpretability of Wave-to-Wave comparisons. In addition, the PATH survey coding for some derived variables do not account for alternative behaviors. The PATH survey also misidentifies and mischaracterizes cigar products, potentially introducing additional response error. As noted above, we focused our PATH analysis on cigarillos because they were the most correctly categorized cigar in PATH. Finally, the PATH survey program logic contains skip pattern errors and inconsistent routing logic across Waves that, again, limit interpretability and comparability of survey responses. We provide greater detail on these limitations in Attachment 20.

c. There is no evidence to suggest that flavored cigars differentially impact morbidity and mortality associated with cigar use

In the Draft Guidance, the FDA compares the potential health risks of cigars with those of cigarettes, stating that, “little cigars and cigarillos have a chemical and toxicological profile that is similar to that of combustible cigarettes” and “as a result, regular users are at increased risk (as compared to nonusers) for many of the same diseases as cigarette smokers.”141 To be sure, all cigars pose health risks. The question here, however, is whether the health risks of flavored cigars differ from those of non-flavored cigars. The FDA does not address that question, and we are not aware of any scientific evidence that flavored cigars differentially impact the morbidity and mortality associated with cigar use.

The FDA cited one paper, Chang et al. 2015, to support its assertion that cigar smokers are at risk of many of the same diseases as cigarette smokers. However, that paper was a systematic review of published literature from 1966-2003 that revealed health risks of cigar and/or pipe use broadly – its results cannot be used to distinguish flavored versus non-flavored cigar use. A recent paper by Rostron et al. examined self-report data of health outcomes among relatively small samples of current and former cigar consumers who responded to the National Health Interview Survey.142 This paper does not provide information on the specific role of flavored versus non-flavored cigars in disease prevalence.

Because the Draft Guidance compares cigars with cigarettes, it should be noted that the FDA has previously examined the impact of flavor (menthol) on the health risks of cigarettes. The extent to which congruence exists between cigarettes and little cigars or cigarillos is unclear. On the one hand, both cigars and cigarettes are combustible tobacco products, high on the continuum of risk. On the other hand, cigars and cigarettes have different patterns of use, with cigar consumption being far more intermittent than cigarette consumption. The FDA’s Preliminary

141 Draft Guidance at 18. 142 Rostron et al. (2016) 50

Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Non-menthol Cigarettes143 concluded that the weight of evidence supports that:

 “from a nonclinical toxicity standpoint, menthol in cigarettes is not associated with increased or decreased smoke toxicity

 menthol in cigarettes is likely not associated with increased or decreased levels of biomarkers of exposure

 menthol in cigarettes is not associated with an increase in disease risk to the user compared to non-menthol cigarette smokers”

We are not aware of any published studies, nor has the FDA provided any reference to publications, that have addressed human exposure to HPHCs or human health effects as a function of flavored versus non-flavored cigar usage. Ghosh et al.144 compared the effect of flavored and non-flavored little cigar smoke exposure on cultured pulmonary epithelial cells, concluding that, “both flavored and non-flavored little cigar smoke caused similar levels of toxicity and activation of apoptosis, suggesting that flavored and non-flavored little cigars are equally harmful.”

The FDA raised the issue of health and disease risk across the broad cigar category in the context of their proposed regulatory actions against flavored cigars, but failed to provide any evidence demonstrating a differential risk profile of flavored versus non-flavored cigars. The available evidence is inadequate to infer the presence or absence of a causal relationship between flavored cigars and health outcomes.

3. Conclusions: The proposed regulatory action is arbitrary and capricious because it is not supported by the science and evidence

The science and evidence cited by the FDA does not support its proposal to abandon the carefully-considered policy toward flavored cigars that it adopted two years ago. We have demonstrated that:

 The scientific evidence regarding the health risks and use behaviors of flavored cigars has not materially changed since the FDA issued its existing policy;

 The FDA’s claim that youth might migrate to flavored cigars from flavored ENDS is speculative and unsubstantiated;

 The FDA conflates association with causation;

143 FDA. Preliminary scientific evaluation of the possible public health effects of menthol versus nonmenthol cigarettes, 2013 144 Ghosh et al. (2017) 51

 Evidence cited by the FDA does not align with its scientific conclusions or proposed regulatory actions; and

 The FDA improperly relies on non-public evidence.

Additional science and evidence, not addressed by the FDA, is contrary to its proposal and confirms that there is no basis to reverse existing policy. To this end, we have demonstrated that:

 Youth cigar smoking rates are low, and prevalence continues to decline;

 Flavored cigars have not been shown to play a unique role in cigar smoking initiation, dependence or cessation; and

 There is no evidence to suggest that flavored cigars differentially impact the morbidity and mortality associated with cigar use.

In sum, the Draft Guidance does not furnish the science and evidence necessary to support the FDA’s proposal. The FDA has not presented the “substantial evidence” required to reverse its existing policy, established the “more substantial justification” necessitated by reliance on its existing policy or articulated a “rational connection” between this proposal and the facts. Nor has the Agency considered science and evidence that “runs counter” to this proposal. For these reasons, implementing this proposal would be arbitrary and capricious.

The proposed regulatory action is arbitrary and capricious because the FDA fails to consider countervailing effects and unintended consequences 1. The FDA has not considered how its policy change will impact illicit markets and public health

Agency action is arbitrary and capricious if the agency “entirely failed to consider an important aspect of the problem.”145 Agencies should consider the real-world implications and consequences of their actions. “Unforeseen detrimental consequences” are one of the things that the procedural protections provided by the APA are designed to avoid.146 Consistent with these principles, two years ago, the FDA solicited and considered comments from interested parties concerning, among other things, the practical implications associated with setting a deadline for the premarket approval process. The FDA’s proposal to change that policy and adopt an entirely new approach would raise many of the same real-world problems that drove the FDA’s original decision as well as additional concerns, yet the Draft Guidance is silent on the issues of countervailing effects and unintended consequences.

145 U.S. Sugar Corp. v. EPA, 830 F.3d 579, 606 (D.C. Cir. 2016). 146 Chamber of Commerce of U.S. v. Occupational Safety & Health Admin., 636 F.2d 464, 470 (D.C. Cir. 1980). 52

Severely restricting the sale of flavored cigars as contemplated in the FDA’s Draft Guidance will likely encourage the further development of black markets. Expanding tobacco black markets pose a number of dangers to young people, including increased smoking initiation and continuation. Researchers have noted that “the illicit market may increase underage smoking, and thus contribute to public health costs, through several mechanisms.”147

Rather than realizing a public health benefit, the FDA will likely further exacerbate youth use of flavored cigars should it proceed as stated in the Draft Guidance. Thus, the FDA should conduct additional research and further analyze the unintended consequences or risks associated with proceeding with this abrupt policy reversal. Our response to the Illicit Trade Concept Paper148 provides additional information for the FDA to consider before it finalizes the Draft Guidance.

2. The FDA failed to consider the economic impact of its proposed policy change on small businesses

The Draft Guidance amounts to de facto rulemaking through an expedited guidance process. If the FDA proceeded through notice-and-comment rulemaking, it would have to consider the economic impacts to small businesses as set forth in the Regulatory Flexibility Act,149 APA, and basic due process.150 The FDA bypassed these requirements by issuing regulation through guidance. Therefore, the FDA has failed to take into account the impact to small businesses, including the upstream and downstream supply chain impacts – from farms to retail. As noted in our response to the Illicit Trade Concept Paper, there are approximately 250,000 retail stores in the United States that sell flavored and non-flavored tobacco products.151 Moreover, retail stores such as convenience stores and tobacco stores rely on flavored cigar products for their gross profits.152

E. The proposed regulatory action is arbitrary and capricious because the FDA has less drastic means to accomplish the objective

An agency also acts arbitrarily and capriciously when it does not consider “reasonable alternatives” or explain why it did not adopt such measures.153 Accordingly, “where a party raises facially reasonable alternatives . . . the agency must either consider those alternatives or

147 See Illicit Trade Concept Paper, 83 Fed. Reg. 11,754. 148 Comments to Docket No. FDA-2018-N-0529 (83 Fed. Reg. 11,754)( March 16, 2018) Draft Concept Paper: Illicit Trade in Tobacco Products After Implementation of a Food and Drug Administration Product Standard, available at http://www.altria.com/About-Altria/Federal-Regulation-of-Tobacco/Regulatory- Filing/FDAFilings/ALCS%20Comments%20to%20Dkt%20No%20FDA-2018-N- 0529%20Draft%20Concept%20Paper%20Illicit%20Trad.pdf 149 See 5 U.S.C. § 604(A)6) (requiring agencies to address “the steps the agency has taken to minimize the significant economic impact on small entities.”) 150 Comments to Docket No. FDA-2017-N-6565 (83 Fed. Reg. 12,294)(March 21, 2018) Advance Notice of Proposed Rulemaking on the Regulation of Flavors in Tobacco Products (“Flavor Comments”) at 87. 151 Id. at 98. 152 Id. at 99. 153 Am. Gas Ass’n v. FERC, 593 F.3d 14, 19 (D.C. Cir. 2010). 53

give some reason . . . for declining to do so.”154 The intended restrictions for flavored cigars go much further and have a more immediate impact than those for flavored ENDS, but with far less evidence. Yet, the Draft Guidance does not even consider less drastic approaches for flavored cigars, including strategies applied by the FDA to reduce youth use of other tobacco product categories and the less restrictive policies it proposes for flavored ENDS products. The FDA’s failure to consider these alternatives, let alone explain why it chose not to adopt them, is arbitrary and capricious.

1. The FDA solicited comments on the regulation of flavors in tobacco products and should review that information before pursuing any action on flavored cigars

As a part of the Comprehensive Plan, the FDA issued the Flavors ANPRM,155 which asked numerous questions that were broad in scope, and sought data, research and other information responsive to their questions. The questions covered six categories on diverse topics ranging from behavioral, toxicity, and consumer perception issues to potential tobacco product standards and sales restrictions. In response, we and other stakeholders submitted extensive comments and data to the docket including cigar-specific analyses for NYTS, PATH, and the available science and evidence. Even though the Flavors ANPRM overlaps with many of the issues raised in the Draft Guidance, there is no indication that the FDA reviewed any of the evidence provided. Before taking any action on flavors, the Agency should review the extensive information provided to it within the Flavors ANPRM docket and consider the comments before taking the actions proposed in the Draft Guidance. 2. The FDA should permit lawfully flavored cigars to remain on the market until the FDA has an opportunity to review and make a final determination on the manufacturer’s premarket application

The FDA has alternative tools to address youth use of flavored cigars, such as a premarket review of flavored cigars while legally marketed products remain on the market. This approach will afford the FDA an opportunity to evaluate on a case-by-case basis each flavored cigar product using its 905 and 910 premarket authority instead of an outright ban on all non- grandfathered, flavored cigars. Not only is this consistent with the Deeming Rule, but the FDA previously permitted such an approach when the TCA premarket provisions took effect for cigarette and smokeless tobacco products, which required SE Reports to be filed by March 2011.156 Additionally, this was an alternative tool previously suggested in our Flavor Comments.157 The FDA should reconsider and permit lawfully flavored cigars to remain on the

154 Laclede Gas Co. v. FERC, 873 F.2d 1494, 1498 (D.C. Cir. 1989); see also, e.g., Chamber of Commerce v. SEC, 412 F.3d 133, 145 (D.C. Cir. 2005) (finding agency acted arbitrarily and capriciously where it failed to consider “alternative [that] was neither frivolous nor out of bounds”); Yakima Valley Cablevision, Inc. v. FCC, 794 F.2d 737 (D.C. Cir. 1986) (finding agency’s failure to consider “less drastic alternative” was arbitrary and capricious). 155 See Flavors ANPRM, 83 Fed. Reg. 12,294 (March 21, 2018). 156 See Guidance for Industry and FDA Staff, Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products (January 5, 2011). 157 See Flavor Comments at 86. 54

market until the FDA has an opportunity to review and make a final determination on the manufacturer’s premarket application.

3. The FDA ignores an extensive body of research that supports effective alternative strategies to curbing youth tobacco use

a. There is a growing consensus that supports the common liability theory of addiction. Banning products does not change the individual or their environment, only the availability of their preferred product.

It is becoming more and more evident that risk-taking behavior manifests in individuals with similar personality traits. These individuals exhibit “disinhibited personality traits such as impulsivity, sensation seeking, rebelliousness, and aggression.”158 The Common Liability Theory explains risky behaviors in the context of socio-cultural, structural and heritable traits159 and positions itself in the context of a wider net, linking data from brain imaging studies with analyses of social motivators. In general, this line of research finds substance use as “a function of a common factory of substance-use vulnerability” and “conceptualizes substance use as one of a number of behaviors…associated with a deviant lifestyle in rejection of the conventional values of society.”160 This theory takes into consideration the contextual basis for and concurrent use of a variety of risky and/or illicit behaviors. The Common Liability Theory emphasizes individual liability rather than product attributes as contributing to tobacco use. The FDA’s proposed regulatory actions against flavors in cigars limits access to a preferred set of products but will not change the individual or population itself. History has demonstrated that banning or reducing access to products is an inefficient way to address public health concerns. The failure of alcohol prohibition in the U.S. from 1920-1933 is one example. The FDA further demonstrated this in their summary of unintended consequences of previous regulatory actions, such as banning clove cigarettes.

b. The FDA has not considered less drastic alternatives to combat youth use of flavored cigars

The FDA should consider other viable regulatory alternatives to combat youth use of flavored cigars that will avoid countervailing effects and unintended consequences while preserving flavored cigars for adult tobacco consumers who prefer them. One alternative is for the FDA to support a federal requirement increasing the minimum legal age to purchase tobacco products to 21 years old.161 With the FDA’s support for this initiative, it may be possible to enact federal legislation quicker and avoid a patchwork of state legal minimum age requirements. Another alternative is for the FDA to pursue educational campaigns. The Agency previously mounted extensive public education campaigns focused on cigarettes, e-cigarettes and smokeless

158 Hicks et al. (2012) 159 See e.g., Jackson et al. (2009); Vanyukov, Kirisci, et al. (2003); Vanyukov, Tarter, et al. (2003) 160 Jackson et al. (2009) 161 https://thehill.com/opinion/healthcare/431651-raise-the-legal-age-for-all-tobacco-products-to-21 55

tobacco products.162 It directed these campaigns at youth broadly, multicultural youth, LGBTQ young adults and adults who tried to quit smoking in the last year. The FDA describes the results of these campaigns as “impressive,” pointing, for example, to the Real Cost Campaign, which it estimates prevented 350,000 teens (11-18 years old) from initiating smoking between 2014 and 2016. The FDA has not, however, mounted a public education campaign specifically directed at the use of flavored cigars by youth or youth most likely to use them. The FDA could also employ an approach similar to the one taken on ENDS, where the Agency had discussions with manufacturers and considered targeted efforts capable of reducing youth access to flavored cigars. This type of approach was not considered in the Draft Guidance and the Agency has not held meetings with manufacturers. The Agency should consider this as a viable alternative to finalizing the Draft Guidance. F. The proposed regulatory action is arbitrary and capricious because it imposes a retroactive requirement that would be impossible to meet

The FDA’s proposal fundamentally changes the Deeming Rule and current law so as to impose a retroactive deadline upon manufacturers that would be impossible to meet. Currently, the deadline for submitting premarket applications, including PMTAs and SE Reports, is August 2021, and products are permitted to remain on the market pending review of the applications.163 This compliance policy and these dates were arrived at following an extended notice-and- comment period and reflected the consideration and balancing of multiple factors, including the amount of time necessary to prepare these submissions. As the Agency recognized when setting the deadlines in the Deeming Rule, “applicants may need additional time to gather information for certain premarket submissions that may require additional data,”164 and providing additional time to submit reports would allow “manufacturers to prepare high quality applications addressing the requirements in the statute.”165

If the Draft Guidance becomes final, however, the deadline for submitting premarket applications for flavored cigars would immediately be past due, because the date to comply with the FDA’s requirements would necessarily be in the past.166 Thus, after considering the matter at length, formally informing manufacturers that their deadline for applications was in the distant future, and inducing reliance by manufacturers still awaiting guidance on premarket pathways for cigars,167 the FDA is now proposing to tell manufacturers that their deadline has already passed and that their products must therefore immediately be removed from the market.

162 See https://www.fda.gov/TobaccoProducts/PublicHealthEducation/default.htm 163 See supra Section II.B. 164 Deeming Rule at 29,011. 165 Id. at 29,012, 29,014. 166 The effective date for the final Deeming Rule was August 8, 2016. 81 Fed. Reg. 28,974 (May 10, 2016). The rule provided a deadline of August 8, 2017 (12 months from the effective date of the final rule) for SE exemptions, a deadline of February 8, 2018 (18 months from the effective date) for SE reports and a deadline of August 8, 2018 (24 months from the effective date) for PMTAs. Id. at 29,011 167 While the FDA recently issued a Proposed Rule on Substantial Equivalence, it provides inadequate direction on what information is required for cigars to be determined to be substantially equivalent. Rather than statin gthe 56

There are limits on an agency’s ability to set short deadlines for applications.168 Setting a deadline that is impossible to achieve because it is in the past unquestionably transgresses those limits.169 Likewise, “retroactive legislation has always been looked upon with disfavor,”170 and thus “the APA requires that legislative rules be given future effect only.”171 The FDA’s proposal to impose impossible and retroactive deadlines after having previously induced reliance on the now expired deadline further exacerbates the illegality. While the FDA may claim that changing compliance dates falls within its discretion, doing so in this manner and under these circumstances would be an abuse of that discretion, at the very least.

G. The proposed implementation period is arbitrary and capricious

Finally, the FDA’s proposal would provide only 30 days to remove from the market non- grandfathered cigars that lack premarket approval. Even if this 30-day implementation were theoretically possible, which is no certainty, it would impose a severe burden upon manufacturers, distributors and retailers. Agency actions that force regulated parties to meet deadlines that are extraordinarily challenging, if not impossible, are arbitrary and capricious. Moreover, because the science does not support the drastic change in policy proposed by the FDA, the wasted products and materials that would result in the absence of a sell-off period is further reason why the FDA’s proposed implementation plan would be arbitrary and capricious.

Additionally, the FDA does not mention a manufacturer or retailer sell-off policy in the Draft Guidance. Given the gravity and economic impact to flavored cigar manufacturers and retailers, the FDA should include a retailer sell-off policy if the Draft Guidance becomes final.

parameters that are needed to support and SE report for these products, the FDA merely “invites comments and information on the parameters that may be needed to support and SE report.” The Proposed Rule does not specify which HPHC and other constituents to test and fails to provide a list of characteristics and design parameters to compare for cigars, even though it has done so for other tobacco products. Without adequate guidance, manufacturers would be left to guess at what may satisfy the FDA in a SE report. Indeed, this lack of guidance was one of the driving factors behind the extended filing deadlines announced in August 2017 and it is no closer to being resolved today than it was then. 168 See, e.g., AFL-CIO v. Chao, 298 F. Supp. 2d 104, 126-28 (D.D.C. 2004) (vacating new DOL accounting requirements that forced unions to make “far-reaching changes” to the accounting reports they are required to submit in two months), aff’d in part, vacated in part, rev’d in part, 409 F.3d 377 (D.C. Cir. 2005). 169 See, e.g., All. for Cannabis Therapeutics v. DEA, 930 F.2d 936, 940 (D.C. Cir. 1991) (“Impossible requirements imposed by an agency are perforce unreasonable.”); Messina v. U.S. Citizenship & Immigration Servs., 2006 WL 374564, at *6 (E.D. Mich. 2006) (“It is arbitrary and capricious to require compliance with a regulation when compliance is impossible.”); cf. Campbell v. Bennett, 212 F. Supp. 2d 1339, 1343 (M.D. Ala. 2002) (holding due process violated by impossible deadline because “any law that requires you to do something by a certain date must give you adequate time to do it; otherwise, the law would be irrational and arbitrary for compliance with it would be impossible”). 170 Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 224 (1988). 171 Georgetown Univ. Hosp. v. Bowen, 821 F.2d 750, 757 (D.C. Cir. 1987), aff’d Bowen v. Georgetown Univ. Hosp., 488 U.S. 204 (1988). 57

Historically, the FDA has permitted either a 30-day or 60-day sell off for manufacturers and retailers.1~2

V. CONCLUSION

We appreciate the opportunity to provide our views and look forward to continuing to engage with the FDA. If you have questions, please feel free to contact me. I can be reached at 804- 335-2879.

S1 erely,

"Z See Guidance for Industry and FDA Staff, "Use of `Light,' `Mild,' `Low,' or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products," at 4 (June 2010) (permitting 30 day sell ofd. Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products, 82 Fed. Reg. 8,004, 8,037 (January 23, 2017) (permitting 60-day sell ofd.

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APPENDIX

Attachment 1

Applicability of the Congressional Review Act to the Agency’s Anticipated Guidance on Flavored Cigars The actions proposed by the FDA in Part V of the Draft Guidance, if finalized and fully implemented, will effectively ban a major category of cigars from the U.S. market and have wide-ranging adverse effects on the U.S. economy, as well as on competition, employment, investment, and productivity. While the FDA purports to act by “guidance,” we believe this action, as it relates to flavored cigars, plainly constitutes a “major rule” under the CRA and OMB Mem. No. M-19-14 issued on April 11, 2019, and, as such, must undergo both the process set forth in the CRA and the process set forth under Executive Order 12866 requiring economic analysis by the OMB’s OIRA. We base our stance on the following considerations:  In the Draft Guidance, the FDA advises that it intends to withdraw a previously announced compliance policy providing manufacturers of flavored cigars until August 8, 2021 to submit premarket authorization applications under the TCA. The effect of withdrawing the August 8, 2021 deadline is to render most flavored cigars unlawful to sell in the U.S. for failure to have obtained a marketing order, a process that can take years to secure. Thus, once finalized, the FDA’s rule will effectively ban a significant number of cigars currently being marketed in the U.S.

 OMB Mem. No. M-19-14 reminded executive departments and agencies that not only conventional notice-and-comment regulations, but a “wide range of other regulatory actions, including, inter alia, guidance documents” can qualify as “rules” subject to the requirements of the CRA under the “expansive definition” in the statute.173 The CRA largely adopts the APA’s definition of “rule,” which includes any “agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy.”174 We believe that position is sound and well-supported by authority.175

 If finalized, the FDA’s Draft Guidance on flavored cigars will certainly constitute a “rule” under the APA’s and CRA’s expansive definition, and will not qualify for any of the CRA’s “limited and explicit exemptions.”176

 The flavored cigar provisions of the FDA’s Draft Guidance should also be designated as a “major rule” for several reasons:

173 Office of Management and Budget, Mem. No. M-19-14, Guidance on Compliance with the Congressional Review Act (Apr. 11, 2019), https://whitehouse.gove/wp-content/uploads/2019/04/M-19-14.pdf 174 5 U.S.C. § 804(3); 5 U.S.C. § 551(4). 175 See, General Elec. Co. v. E.P.A., 290 F.3d 377, 385 (D.C. Cir. 2002)(involving APA definition of “rule,” which is incorporated with minor modifications by the CRA); Appalachian Power Co. v. E.P.A., 208 F.3d 1015 (D.C. Cir. 2000)(same); GAO Letter to Sen. Pat Toomey (Oct. 19, 2017), B-329272; GAO Letter to Rep. Doug Ose (May 14, 2001), B-287557. 176 Mem. No. M-19-14 at 3. 64

o First, the rule will have an annual effect on the economy of $100 million or more177 by prohibiting the sale of most flavored cigars currently on the market and resulting in substantial lost sales for cigar manufacturers, including many small businesses, and will result in significantly diminished tax revenues for state and federal governments. For example, recent analysis by Barclays estimates that FY18 domestic cigar revenues for Imperial Brands, Swedish Match and Altria totaled $1,741,000,000.178 Barclays further noted that flavored cigars represent half of the U.S. cigar market.179 This means that the approximate annual loss in revenues for these three manufacturers alone could represent over $870,000,000. But, in all likelihood, the potential annual economic loss to the economy will be far higher than $870,000,000 because: (1) this figure only represents three cigar manufacturers with a combined market share of less than 60% of the total U.S. cigar market;180 (2) it does not account for economic losses incurred by others in the U.S. tobacco distribution chain (i.e., growers, distributors, wholesalers and retailers); and (3) the Agency has not yet provided a definition of what constitutes a flavored cigar.

o Second, the rule will have significant negative adverse effects on competition, employment, investment, and productivity.181 The rule hurts competition by selectively favoring the business prospects for a limited number of manufacturers at the expense of other manufacturers; the rule does not impact manufacturers of non-flavored cigars that were already on the market as of February 15, 2007 (which are grandfathered), but will have a devastating impact on manufacturers who sell flavored cigars introduced after that date and before the Deeming Rule took effect on August 8, 2016. Manufacturers affected by the rule also face significant investment losses, as they no longer will be able to market significant portions of their cigar portfolio, including products that have been marketed for well over a decade. These manufacturers will have to cut production of cigars precipitously, leading to decreased productivity and likely job layoffs within the industry. These negative effects will, in turn, exacerbate the rule’s adverse effect on the economy at both the federal and state levels.

 As OMB Mem. No. M-19-14 makes clear, the CRA requires the FDA to submit rules like this one to Congress, and prohibits the FDA from publishing the final guidance before OIRA has made the “major rule” determination.182 In addition, properly designating the flavored cigar rule as major, among other things, requires the FDA to delay the effective date of the rule by 60 days from the later of the date of the rule’s submission to Congress or the date the rule is published in the Federal Register, if so published.

177 5 U.S.C. § 804(2)(A). 178 Barclays Equity Research, European Consumer Staples, Smoke Signals 10: Underappreciated flavored cigar ban risk (March 29, 2019). 179 Id. 180 Id. 181 5 U.S.C. § 804(2)(B). 182 Mem. No. M-19-14 at 4. 65

Attachment 2

Definitions and explanation of PATH analysis: Transitions from exclusive flavored ENDS use at Wave 2 to flavored and non-flavored cigar use at Wave 3 (12-17 years old) Methodology

This analysis looked at the number of respondents who transitioned from exclusive flavored e- cigarette to any cigar use in Wave 3. Cigar use in Wave 3 is further broken out by flavor and exclusive versus non-exclusive cigar use. We define exclusive flavored ENDS use as “Past 30 Day” users of only ENDS products who indicated that their regular/last brand of e-cigarettes used was flavored to taste like menthol, mint, clove, spice, fruit, chocolate, alcoholic drinks, candy or other sweets. Finally, we looked at the weighted proportion of cigar transitions using Wave 2 weights. Source and Data Setup

PATH Wave 2 and Wave 3 Youth Public Use Files were used. Analysis weights were used to account for selection probabilities, differential non-response rates and possible deficiencies in the sampling frame (e.g., under coverage of certain population groups). Variance estimation was implemented to account for multi-stage complex sampling using balanced repeated replication weights with Fay’s method, as recommended by the PATH Study Public Use Files User Guide. Summary of Outcomes Assessed

We conducted analysis for outcomes using PATH Wave 2 and Wave 3 Youth Public Use Files. These outcomes are listed in the table below along with the survey questions and the variables used to derive the outcome variables.

Outcome Measure Variable Question Past 30 day youth R03R_Y_CUR_GRILLO DERIVED ‐ Wave 3 Youth Current Cigarillo Smoker consumer Past 30 day youth R03R_Y_CUR_EPRODS DERIVED ‐ Wave 3 Youth Current Electronic Nicotine Product consumer User Past 30 day youth R03R_Y_CUR_GFILTR DERIVED ‐ Wave 3 Youth Current Filtered Cigar Smoker consumer Past 30 day youth R03R_Y_CUR_CIGS DERIVED ‐ Wave 3 Youth Current Cigarette Smoker consumer Past 30 day youth R03R_Y_CUR_SMKLS DERIVED ‐ Wave 3 Youth Current Smokeless Tobacco User consumer Past 30 day youth R03R_Y_CUR_GTRAD DERIVED ‐ Wave 3 Youth Current Traditional Cigar Smoker consumer

Consumer Groups

This section describes the definition of the consumer groups and variables used to identify these groups, which are used as filters to define sub-samples.

Consumer Groups Definition Variables/Syntax Past 30 day In past 30 days, used e‐cigarettes/cartridges/e‐liquid flavored to R02_YE1130 flavor taste like menthol, mint, clove, spice, fruit, chocolate, alcoholic

drinks, candy or other sweets Past 30 day DERIVED ‐ Wave 2 Youth Current Cigarillo Smoker R02R_Y_CUR_GRILLO == youth consumer "Yes" Past 30 day DERIVED ‐ Wave 2 Youth Current E‐Cigarette User R02R_Y_CUR_ECIG == youth consumer "Yes" Past 30 day DERIVED ‐ Wave 2 Youth Current Filtered Cigar Smoker R02R_Y_CUR_GFILTR == youth consumer "Yes" Past 30 day DERIVED ‐ Wave 2 Youth Current Cigarette Smoker R02R_Y_CUR_CIGS == youth consumer "Yes" Past 30 day DERIVED ‐ Wave 2 Youth Current Smokeless Tobacco User R02R_Y_CUR_SMKLS == youth consumer "Yes" Past 30 day DERIVED ‐ Wave 2 Youth Current Traditional Cigar Smoker R02R_Y_CUR_GTRAD == youth consumer "Yes"

Total sample sizes for consumer groups are reported at the beginning of the results section. Sample sizes may vary from one analysis to another due to missing values (“don’t know” and “refused” answers as well as improbable responses removed by PATH team) on the outcome variables. Actual sample size for each analysis is shown in the outcome tables next to the outcome measures (i.e., “n” and “sum_wts” in the output).

Grouping Variables

This section describes the definition of the grouping variables, which are used to classify the outcome measures. Grouping variables are usually categorical variables in PATH (i.e., demographic variables) or derived categorical variables.

Grouping Variable Definition Variables/Syntax Past 30 day In past 30 days, smoked cigarillos flavored to taste like menthol, mint, clove, R03_YG1130CL flavor spice, fruit, chocolate, alcoholic drinks, candy or other sweets Past 30 day In past 30 days, smoked filtered cigars flavored to taste like menthol, mint, R03_YG1130FC flavor clove, spice, fruit, chocolate, alcoholic drinks, candy or other sweets Past 30 day In past 30 days, smoked traditional cigars flavored to taste like menthol, mint, R03_YG1130TC flavor clove, spice, fruit, chocolate, alcoholic drinks, candy or other sweets

Results: Script Output

In this section, we present R script output tables.

The base for this analysis was all continuing youth respondents who had been exclusive flavored e-cigarette consumers in Wave 2. We determine cigar flavor and usage in Wave 3 then cross this information with our Wave 2 base to calculate counts and weighted percentages. Due to a lack of youth respondents transitioning to flavored cigars the wave 3 population prevalence of “Past 30 Day” cigar use is given.

Wave 2 Youth Exclusive Flavored ENDS Consumers to Cigar Transitions in Wave 3 Youth Wave 3 Outcome N Non‐exclusive flavored cigar 1 Non‐exclusive non‐flavored cigar 2 Not current cigar 106

Total Cigar Past 30 Days Consumers Among Wave 3 Youth variable level mean se ci_l ci_u n sum_wts cur_cigar NA 0.011782 0.000974 0.009983 0.013901 11728 24603636

Attachment 3

Definitions and explanation of PATH analysis: Transitions from exclusive flavored ENDS use at Wave 2 to flavored and non-flavored cigar use at Wave 3 (Adults) Methodology

This analysis looked at the number of respondents who transition from exclusive flavored e- cigarette to any cigar use in Wave 3. Cigar use in Wave 3 is further broken out by flavor and exclusive versus non-exclusive use. We define exclusive flavored e-cigarette use as “Current Established” users of only ENDS products who also said that their regular/last brand of e- cigarettes used was flavored to taste like menthol, mint, clove, spice, fruit, chocolate, alcoholic drinks, candy or other sweets. Because of differences in the way youth are asked flavor and usage questions in the PATH study, age-ups were not included in this analysis. Finally we looked at the weighted proportion of cigar transitions using Wave 2 weights. Source and Data Setup

PATH Wave 2 and Wave 3 Adult Public Use Files were used. Analysis weights were used to account for selection probabilities, differential non-response rates, and possible deficiencies in the sampling frame (e.g., under coverage of certain population groups). Variance estimation was implemented to account for multi-stage complex sampling using balanced repeated replication weights with Fay’s method, as recommended by the PATH Study Public Use Files User Guide. Summary of Outcomes Assessed

We conducted analysis for outcomes using PATH Wave 2 and Wave 3 Adult Public Use Files. These outcomes are listed in the table below along with the survey questions and the variables used to derive the outcome variables.

Outcome Measure Variable Question Current Established R03R_A_CUR_ESTD_GRILLO DERIVED ‐ Wave 3 Adult Current Established Cigarillo consumer Smoker Current Established R03R_A_CUR_ESTD_EPRODS DERIVED ‐ Wave 3 Adult Current Established Electronic consumer Nicotine Product User Current Established R03R_A_CUR_ESTD_GFILTR DERIVED ‐ Wave 3 Adult Current Established Filtered consumer Cigar Smoker Current Established R03R_A_CUR_ESTD_CIGS DERIVED ‐ Wave 3 Adult Current Established Cigarette consumer Smoker Current Established R03R_A_CUR_ESTD_SMKLS DERIVED ‐ Wave 3 Adult Current Established Smokeless consumer Tobacco User Current Established R03R_A_CUR_ESTD_GTRAD DERIVED ‐ Wave 3 Adult Current Established Traditional consumer Cigar Smoker

Consumer Groups

This section describes the definition of the consumer groups and variables used to identify these groups, which are used as filters to define sub-samples.

Consumer Groups Definition Variables/Syntax Current DERIVED ‐ Wave 2 Adult Current Established Cigarillo R02R_A_CUR_ESTD_GRILLO == Established Smoker "Yes" consumer Current DERIVED ‐ Wave 2 Adult Current Established E‐Cigarette R02R_A_CUR_ESTD_ECIG == Established User "Yes" consumer Current DERIVED ‐ Wave 2 Adult Current Established Filtered Cigar R02R_A_CUR_ESTD_GFILTR == Established Smoker "Yes" consumer Current DERIVED ‐ Wave 2 Adult Current Established Cigarette R02R_A_CUR_ESTD_CIGS == Established Smoker "Yes" consumer Current DERIVED ‐ Wave 2 Adult Current Established Smokeless R02R_A_CUR_ESTD_SMKLS == Established Tobacco User "Yes" consumer Current DERIVED ‐ Wave 2 Adult Current Established Traditional R02R_A_CUR_ESTD_GTRAD == Established Cigar Smoker "Yes" consumer Regular/last flavor Regular/last brand of e‐cigarettes used was flavored to R02_AE1050 taste like menthol, mint, clove, spice, fruit, chocolate, alcoholic drinks, candy or other sweets Total sample sizes for consumer groups are reported at the beginning of the results section. Sample sizes may vary from one analysis to another due to missing values (“don’t know” and “refused” answers as well as improbable responses removed by PATH team) on the outcome variables. Actual sample size for each analysis is shown in the outcome tables next to the outcome measures (i.e., “n” and “sum_wts” in the output).

Grouping Variables

Grouping Variable Definition Variables/Syntax Regular/last Regular/last brand of cigarillos smoked was flavored to taste like menthol, R03_AG1050CG flavor mint, clove, spice, fruit, chocolate, alcoholic drinks, candy or other sweets Regular/last Regular/last brand of filtered cigars smoked was flavored to taste like R03_AG1050FC flavor menthol, mint, clove, spice, fruit, chocolate, alcoholic drinks, candy or other sweets Regular/last Regular/last brand of traditional cigars smoked was flavored to taste like R03_AG1050TC flavor menthol, mint, clove, spice, fruit, chocolate, alcoholic drinks, candy or other sweets Results: Script Output

In this section, we present R script output tables.

The base for this analysis was all continuing adult respondents who had been exclusive flavored e-cigarette consumers in Wave 2. We determine cigar flavor and usage in Wave 3 then cross this information with our Wave 2 base to calculate counts and weighted percentages. The following table examines Wave 2 to 3 continuing adults.

Wave 2 Adult Exclusive Flavored ENDS Consumers to Cigar Transitions in Wave 3 Adult Wave 3 Outcome N Exclusive flavored cigar 2 Exclusive non‐flavored cigar 2 Non‐exclusive flavored cigar 5 Non‐exclusive non‐flavored cigar 3 Not current cigar 398

Wave 2 Adult Exclusive Flavored ENDS Consumers % Transitioned to Flavored Cigar in Wave 3 Adult variable level mean se ci_l ci_u n sum_wts transitioned NA 0.013888 0.00664 0.005556 0.034285 410 1885308

Attachment 4

Definitions and explanation of National Youth Tobacco Survey (“NYTS”) analysis: percentage of past 30-day cigar (12-14 years old and 15-17 years old from 2011 to 2018) Methodology

This analysis looks at the percentage of respondents who used cigars during the past 30 days grouped by “12-14 years old” and “15-17 years old.” Source and data setup

NYTS, 2011 - 2018. A weighting factor (wt in 2011 - 2014 datasets, finwgt in 2015 - 2018 datasets) was applied to each respondent. Summary of Outcomes Assessed We conducted analysis for outcomes using the NYTS. These outcomes are listed in the table below along with the survey questions and the variables used to derive the outcome variables.

Outcome Measure Variables Question Past 30 day 2011‐2014: ccigar_r, 2015‐ RECODE: The percentage of all students who reported they use 2018: CCIGAR smoked cigars on >= 1 of the past 30 days Age Group age_group Age group is ‘12‐14 years old’ or ‘15‐17 years old’ Grouping Variables

This section describes the definition of the grouping variables, which are used to classify the outcome measures. Grouping variables are usually categorical variables (i.e., demographic variables) or derived categorical variables.

Grouping Variable Definition Syntax Age Group Age group is ‘12‐14 if_else(age %in% c(“12 years old”, “13 years old”, “14 years old”), “12‐ years old’ or ‘15‐17 14”, if_else(age %in% c(“15 years old”, “16 years old”, “17 years old”), years old’ “15‐17”, NA_character_)

Results: Script Output In this section, we present R script output for the statement above.

This is the script output for the percentage of respondents who used cigars in the past 30 days grouped by “12-14 years old” and “15-17 year olds.”

Percentage of Respondents Who Used Cigars in Past 30 Days by Age Group year age_group P30D n pct 2011 12‐14 Yes 428098 0.037063 2012 12‐14 Yes 348706 0.030493 2013 12‐14 Yes 394270 0.034315 2014 12‐14 Yes 236158 0.020697 2015 12‐14 Yes 184803 0.015886 2016 12‐14 Yes 263466 0.022492 2017 12‐14 Yes 199897 0.017448 2018 12‐14 Yes 227393 0.019971 2011 15‐17 Yes 1240252 0.106989 2012 15‐17 Yes 1375443 0.119265 2013 15‐17 Yes 1281225 0.112199 2014 15‐17 Yes 825696 0.073923 2015 15‐17 Yes 902410 0.080214 2016 15‐17 Yes 819434 0.072752 2017 15‐17 Yes 791994 0.069988 2018 15‐17 Yes 785029 0.070593

Attachment 5

Definitions and explanation of NYTS analysis: Cigar Prevalence by Age Group Figures

Figure 4: Past 30-day Cigar Prevalence Among Youth 12-14: 2011-2018, NYTS

Figure 5: Past 30-day Cigar Prevalence Among Youth 15-17: 2011-2018, NYTS

Methodology This analysis looks at the percentage of respondents who used cigars during the past 30 days grouped by “12-14 years old” and “15-17 years old.” Source and data setup

NYTS, 2011 - 2018. A weighting factor (wt in 2011 - 2014 datasets, finwgt in 2015 - 2018 datasets) was applied to each respondent.

Summary of Outcomes Assessed We conducted analysis for outcomes using the NYTS (National Youth Tobacco Survey) for the NYTS Cigar Prevalence. These outcomes are listed in the table below along with the survey questions and the variables used to derive the outcome variables.

Grouping Variables This section describes the definition of the grouping variables, which are used to classify the outcome measures. Grouping variables are usually categorical variables (i.e., demographic variables) or derived categorical variables.

Results: Script Output In this section, we present R script output.

The following are the script output figures for “Past 30 Day” cigar use by age group.

Attachment 6

Definitions and explanation of PATH analysis: Reported smoking of “flavored cigarillos” in the past 30 days (12-14 years old and 15-17 years old) Methodology

This analysis looks at flavored cigarillo usage of PATH Wave 3 Youth “Past 30 Day” cigarillo users. We define “Past 30 Day” flavored cigarillo use as respondents who said that in the past 30 days they smoked cigarillos flavored to taste like menthol, mint, clove, spice, fruit, chocolate alcoholic drinks, candy or other sweets. PATH weights were used to determine percentages. This analysis was done by youth age subgroups of “12 to 14 years old” and “15 to 17 years old.” Source and Data Setup

PATH Wave 3 Youth Public Use Files were used. Analysis weights were used to account for selection probabilities, differential non-response rates, and possible deficiencies in the sampling frame (e.g., under coverage of certain population groups). Variance estimation was implemented to account for multi-stage complex sampling using balanced repeated replication weights with Fay’s method, as recommended by the PATH Study Public Use Files User Guide. Summary of Outcomes Assessed

We conducted analysis for outcomes using PATH Wave 3 Youth Public Use Files. These outcomes are listed in the table below along with the survey questions and the variables used to derive the outcome variables.

Outcome Measure Variable Question Past 30 day R03_YG1130CL In past 30 days, smoked cigarillos flavored to taste like menthol, mint, clove, flavor spice, fruit, chocolate, alcoholic drinks, candy or other sweets Consumer Groups

This section describes the definition of the consumer groups and variables used to identify these groups, which are used as filters to define sub-samples.

Consumer Groups Definition Variables/Syntax Past 30 day youth consumer DERIVED ‐ Wave 3 Youth Current Cigarillo Smoker R03R_Y_CUR_GRILLO == "Yes" Total sample sizes for consumer groups are reported at the beginning of the results section. Sample sizes may vary from one analysis to another due to missing values (“don’t know” and “refused” answers as well as improbable responses removed by PATH team) on the outcome variables. Actual sample size for each analysis is shown in the outcome tables next to the outcome measures (i.e., “n” and “sum_wts” in the output).

Results: Script Output

In this section, we present R script output tables.

This analysis looks at the percentage of PATH Wave 3 youth who report using a flavored cigarillo in the past 30 days.

Percentage of Wave 3 Youth using Flavored Cigarillos in Past 30 Days variable level mean se ci_l ci_u n sum_wts reg_flavor Yes 0.583314 0.060312 0.464602 0.693092 89 184725 reg_flavor No 0.283828 0.054119 0.191863 0.398157 89 184725 reg_flavor I don’t know 0.132858 0.035252 0.077355 0.218743 89 184725

This analysis looks at the percentage of PATH Wave 3 youth who report using a flavored cigarillo in the past 30 days by age break.

Percentage of Wave 3 Youth using Flavored Cigarillos in Past 30 Days by Age Break age variable level mean se ci_l ci_u n sum_wts 12 to 14 years old reg_flavor Yes 0.668544 0.212984 0.323408 0.894859 10 16187.6 12 to 14 years old reg_flavor No 0.239008 0.212033 0.054680 0.630364 10 16187.6 12 to 14 years old reg_flavor I don’t know 0.092448 0.095544 0.015612 0.395502 10 16187.6 15 to 17 years old reg_flavor Yes 0.575128 0.064845 0.448509 0.692600 79 168537.7 15 to 17 years old reg_flavor No 0.288133 0.057027 0.191898 0.408248 79 168537.7 15 to 17 years old reg_flavor I don’t know 0.136739 0.037668 0.077706 0.229462 79 168537.7

Attachment 7

Definitions and explanation of NYTS analysis: Percentage of respondents who used cigars, past 30 days (12-14 years old and 15- 17 years old) Methodology

This analysis looks at the percentage of respondents who used cigars during the past 30 days grouped by “12-14 years old” and “15-17 years old,” and the percentage of respondents among current users of cigars who used flavored cigars during the past 30 days, grouped by “12-14 years old” and “15-17 years old.” Source and data setup

NYTS (National Youth Tobacco Survey), 2011 - 2018. A weighting factor (wt in 2011 - 2014 datasets, finwgt in 2015 - 2018 datasets) was applied to each respondent. Summary of Outcomes Assessed

We conducted analysis for outcomes using the NYTS (National Youth Tobacco Survey). These outcomes are listed in the table below along with the survey questions and the variables used to derive the outcome variables.

Outcome Measure Variables Question Past 30 day 2011‐2014: ccigar_r, RECODE: The percentage of all students who reported they smoked cigars use 2015‐2018: CCIGAR on >= 1 of the past 30 days Past 30 day 2014: qn38a, 2015: Which of the following tobacco products that you used in the past 30 days flavor use Qn41b, 2016‐2018: were flavored to taste like menthol(mint), alcohol(wine, cognac), candy, Qn49a fruit, chocolate or any other flavors? (Select one or more) ‐ Cigars, cigarillos, or little cigars Age Group age_group Age group is ‘12‐14 years old’ or ‘15‐17 years old’ Grouping Variables

Results: Script Output

In this section, we present R script output.

This is the script output for the percentage of respondents among current users of cigars who used flavored cigars in the past 30 days, grouped by “12-14 years old” and “15-17 year olds”.

Percentage of Respondents Among Current Users of Cigars Using Flavored Cigars in the Past 30 Days by Age Group year age_group flavor n pct 2014 12‐14 Yes 138342.3 0.585803 2015 12‐14 Yes 83086.1 0.449593 2016 12‐14 Yes 90640.1 0.344029 2017 12‐14 Yes 101780.6 0.509165 2018 12‐14 Yes 93045.9 0.409186 2014 15‐17 Yes 545498.5 0.660653 2015 15‐17 Yes 569785.5 0.631404 2016 15‐17 Yes 438726.2 0.535401 2017 15‐17 Yes 368830.3 0.465698 2018 15‐17 Yes 359021.4 0.457335

Attachment 8

Definitions and explanation of NYTS analysis: Cigar prevalence and flavor usage by age group

Figure 7: Past 30-day Cigar Prevalence and Flavor Usage Among Youth 12-14 and 15-17: 2011-2018 NYTS

Methodology

Source and data setup

NYTS, 2011 - 2018. A weighting factor (wt in 2011 - 2014 datasets, finwgt in 2015 - 2018 datasets) was applied to each respondent. Summary of Outcomes Assessed

We conducted analysis for outcomes using the NYTS for the NYTS Cigar Prevalence and Flavor Usage Figures. These outcomes are listed in the table below along with the survey questions and the variables used to derive the outcome variables.

Grouping Variables

Results: Script Output

In this section, we present R script output.

The following are the script output figures for “Past 30 Day” cigar use and flavor percentage by age group.

Attachment 9

Definitions and explanation of PATH analysis: Wave 1 youth who had ever used cigarillos Methodology

Analysis looked at Wave 1 youth who had ever used cigarillos. Cigarillo usage groups were determined by past 30 day use and the PATH defined ‘Not Light’ usage threshold for cigarillos. The weighted percentage of respondents who fell into each of the usage buckets was given. Source and Data Setup

PATH Wave 1 Youth Public Use Files were used. Analysis weights were used to account for selection probabilities, differential non-response rates, and possible deficiencies in the sampling frame (e.g., under coverage of certain population groups). Variance estimation was implemented to account for multi-stage complex sampling using balanced repeated replication weights with Fay’s method, as recommended by the PATH Study Public Use Files User Guide. Summary of Outcomes Assessed

We conducted analysis for outcomes using PATH Wave 1 Youth Public Use Files. These outcomes are listed in the table below along with the survey questions and the variables used to derive the outcome variables.

Outcome Measure Variable Question Youth Consumption Groups Detail R01_YG1005CL Number of cigarillos smoked in entire life Youth Consumption Groups Detail R01R_Y_CUR_GRILLO DERIVED ‐ Wave 1 Youth Current Cigarillo User Youth Consumption Groups Detail R01R_Y_EVR_GRILLO DERIVED ‐ Wave 1 Youth Ever Cigarillo User Consumer Groups

This section describes the definition of the consumer groups and variables used to identify these groups, which are used in Statement 6 as filters to define sub-samples.

Consumer Groups Definition Variables/Syntax Ever DERIVED ‐ Wave 1 Youth Ever Cigarillo User R01R_Y_EVR_GRILLO consumer %among% "Yes" First flavor Was first cigarillo smoked flavored to taste like menthol, mint, R01_YG1108CL clove, spice, candy, fruit, chocolate, alcohol or other sweets Total sample sizes for consumer groups are reported at the beginning of the results section. Sample sizes may vary from one analysis to another due to missing values (“don’t know” and “refused” answers as well as improbable responses removed by PATH team) on the outcome

variables. Actual sample size for each analysis is shown in the outcome tables next to the outcome measures (i.e., “n” and “sum_wts” in the output).

Results: Script Output

In this section, we present R script output tables.

The base was filtered to PATH Wave 1 youth who had ever used cigarillos. Consumer groups were defined by “Ever but Not Past 30 Day” cigarillo consumption, “Past 30 Day” cigarillo users not exceeding 10 cigarillos in their lifetime (the PATH defined usage threshold for ‘Not Light’), and “Past 30 Day” cigarillo ‘Not Light’ consumers. The weighted percentage of respondents in each consumer group was then calculated.

Wave 1 Youth Who Initiated on Flavored Cigarillos Usage Groups variable level mean se ci_l ci_u n sum_wts usage_gp Past 30 Day Not Light Consumer 0.209676 0.019365 0.174008 0.250440 548 992769 usage_gp Past 30 Day Very Light Consumer 0.158913 0.014982 0.130692 0.191882 548 992769 usage_gp Not Past 30 Day Consumer 0.631411 0.021015 0.589022 0.671864 548 992769

Attachment 10

Definitions and explanation of PATH analysis: Wave 2 youth who had ever used cigarillos Methodology

This analysis looked at Wave 2 youth who had ever used cigarillos. Cigarillo usage groups were determined for these respondents by past 30 day use and the PATH defined ‘Not Light’ usage threshold for cigarillos. The weighted percentage of respondents who fell into each of the usage groups and the weighted distribution of respondents’ first cigarillo flavor was given. The count of youth initiating cigarillos since Wave 1 is also supplied. Source and Data Setup

PATH Wave 2 Youth Public Use Files were used. Analysis weights were used to account for selection probabilities, differential non-response rates, and possible deficiencies in the sampling frame (e.g., under coverage of certain population groups). Variance estimation was implemented to account for multi-stage complex sampling using balanced repeated replication weights with Fay’s method, as recommended by the PATH Study Public Use Files User Guide. Summary of Outcomes Assessed

We conducted analysis for outcomes using PATH Wave 2 Youth Public Use Files. These outcomes are listed in the table below along with the survey questions and the variables used to derive the outcome variables.

Outcome Measure Variable Question New consumer R02R_Y_NEW_GRILLO DERIVED ‐ Wave 2 Youth Never to Ever Cigarillo Smoker Youth Consumption Groups R02_YG1005CL Number of cigarillos smoked in entire life Detail Youth Consumption Groups R02R_Y_CUR_GRILLO DERIVED ‐ Wave 2 Youth Current Cigarillo Smoker Detail Youth Consumption Groups R02R_Y_EVR_GRILLO DERIVED ‐ Wave 2 Youth Ever Cigarillo Smoker Detail

Consumer Groups

This section describes the definition of the consumer groups and variables used to identify these groups, which are used in Statement 7 as filters to define sub-samples.

Consumer Groups Definition Variables/Syntax Ever DERIVED ‐ Wave 2 Youth Ever Cigarillo Smoker R02R_Y_EVR_GRILLO consumer %among% "Yes" First flavor Was first cigarillo smoked was flavored to taste like menthol, mint, R02_YG1108CL clove, spice, fruit, chocolate, alcoholic drinks, candy or other sweets Total sample sizes for consumer groups are reported at the beginning of the results section. Sample sizes may vary from one analysis to another due to missing values (“don’t know” and “refused” answers as well as improbable responses removed by PATH team) on the outcome variables. Actual sample size for each analysis is shown in the outcome tables next to the outcome measures (i.e., “n” and “sum_wts” in the output). Results: Script Output

In this section, we present R script output tables.

The base was filtered to PATH Wave 2 youth who had ever used cigarillos. Consumer groups were defined by “Ever but Not Past 30 Day” cigarillo consumption, “Past 30 Day” cigarillo users not exceeding 10 cigarillos in their lifetime (the PATH defined usage threshold for ‘Not Light’), and “Past 30 Day” cigarillo ‘Not Light’ consumers. The count of new initiators is also provided.

Wave 2 Youth Who Initiated Cigarillos since Wave 1 n 219 We then look at the distribution of usage groups among Wave 2 ever cigarillo consumers and the distribution of Wave 2 respondents who indicated their first cigarillo product was flavored.

Wave 2 Youth Who Ever Smoked Cigarillos variable level mean se ci_l ci_u n sum_wts usage_gp Ever Consumer 0.103635 0.014586 0.078210 0.136105 635 1283737 usage_gp Past 30 Day Consumer 0.005978 0.003039 0.002267 0.015665 635 1283737 usage_gp Past 30 Day Not Light Consumer 0.078149 0.010117 0.059718 0.101653 635 1283737 usage_gp Past 30 Day Very Light Consumer 0.109267 0.013228 0.085774 0.138223 635 1283737 usage_gp Not Past 30 Day Consumer 0.702971 0.021549 0.658730 0.743707 635 1283737 usage_gp Never Consumed 0.000000 0.000000 0.000000 0.000000 635 1283737

Wave 2 Youth First Cigarillo Product Flavor variable level mean se ci_l ci_u n sum_wts first_flav Yes 0.507006 0.038108 0.427569 0.586090 149 313698 first_flav No 0.360253 0.036282 0.287575 0.439955 149 313698 first_flav I don’t know 0.132742 0.027416 0.087395 0.196549 149 313698

Attachment 11

Definitions and explanation of PATH analysis: Wave 3 youth who had ever used cigarillos Methodology

Analysis looked at Wave 3 youth who had ever used cigarillos. Cigarillo usage groups were determined by past 30 day use and the PATH defined ‘Not Light’ usage threshold for cigarillos. The weighted percentage of respondents who fell into each of the usage buckets and the weighted distribution of respondents’ first cigarillo flavor was given. The count of youth initiating cigarillos since Wave 2 is also supplied. Source and Data Setup

Outcome Measure Variable Question New consumer R03R_Y_NEW_GRILLO DERIVED ‐ Wave 3 Youth Never to Ever Cigarillo Smoker Youth Consumption Groups R03_YG1005CL Number of cigarillos smoked in entire life Detail Youth Consumption Groups R03R_Y_CUR_GRILLO DERIVED ‐ Wave 3 Youth Current Cigarillo Smoker Detail Youth Consumption Groups R03R_Y_EVR_GRILLO DERIVED ‐ Wave 3 Youth Ever Cigarillo Smoker Detail

Consumer Groups

This section describes the definition of the consumer groups and variables used to identify these groups, which are used as filters to define sub-samples.

Consumer Groups Definition Variables/Syntax Ever DERIVED ‐ Wave 3 Youth Ever Cigarillo Smoker R03R_Y_EVR_GRILLO consumer %among% "Yes" First flavor First cigarillo smoked was flavored to taste like menthol, mint, R03_YG1108CL clove, spice, fruit, chocolate, alcoholic drinks, candy or other sweets Total sample sizes for consumer groups are reported at the beginning of the results section. Sample sizes may vary from one analysis to another due to missing values (“don’t know” and “refused” answers as well as improbable responses removed by PATH team) on the outcome variables. Actual sample size for each analysis is shown in the outcome tables next to the outcome measures (i.e., “n” and “sum_wts” in the output). Results: Script Output

In this section, we present R script output tables.

The base was filtered to PATH Wave 3 youth who had ever used cigarillos. Consumer groups were defined by “Ever but Not Past 30 Day” cigarillo consumption, “Past 30 Day” cigarillo users not exceeding 10 cigarillos in their lifetime (the PATH defined usage threshold for ‘Not Light’), and “Past 30 Day” cigarillo ‘Not Light’ consumers. The count of new initiators is also provided.

Wave 3 Youth Who Initiated Cigarillos since Wave 2 n 138 We then look at the distribution of usage groups among Wave 3 ever cigarillo consumers and the distribution of Wave 3 respondents who indicated their first cigarillo product was flavored.

Wave 3 Youth Who Ever Smoked Cigarillos variable level mean se ci_l ci_u n sum_wts usage_gp Ever Consumer 0.081267 0.013177 0.058834 0.111242 481 1008799 usage_gp Past 30 Day Consumer 0.008343 0.003823 0.003254 0.021223 481 1008799 usage_gp Past 30 Day Not Light Consumer 0.081289 0.011422 0.060056 0.109156 481 1008799 usage_gp Past 30 Day Very Light Consumer 0.098577 0.015142 0.072531 0.132637 481 1008799 usage_gp Not Past 30 Day Consumer 0.730526 0.020623 0.687950 0.769241 481 1008799 usage_gp Never Consumed 0.000000 0.000000 0.000000 0.000000 481 1008799

100

Wave 3 Youth First Cigarillo Product Flavor variable level mean se ci_l ci_u n sum_wts first_flav Yes 0.557139 0.054000 0.451629 0.657734 101 213382 first_flav No 0.240164 0.043528 0.166191 0.333880 101 213382 first_flav I don’t know 0.202696 0.038376 0.135871 0.291308 101 213382

101

Attachment 12

102

Definitions and explanation of PATH analysis: Current status of cigarillo use by reported flavor of cigarillo tried among young adult (18-24) respondents who were “never users” of tobacco in previous Wave Table 3: Current Status of Cigarillo Use by Reported Flavor of Cigarillo Tried Among Young Adult (18-24) Respondents Who Were “Never Users” of Tobacco in Previous Wave Young Adults (18‐24) who “initiated” since Wave 1 by flavor of first cigarillo and status of current use

%"Ever Used" and “Not % "Current % "Current

Current” Experimental" Established" First Cigarillo N

Flavored 58 60% 25% 16%

Non‐ 47 71% 26% 3% Flavored Don't Know 26 90% 4% 6% Young Adults (18‐24) who “initiated” since Wave 2 by flavor of first cigarillo and status of current use

First Cigarillo N %"Ever Used" and “Not % "Current % "Current Current” Experimental" Established"

29 67% 29% 4% Flavored Non‐ 37 70% 23% 7% Flavored 13 68% 25% 8% Don't Know

Methodology

This analysis examined product initiation in Young Adults (18‐24) at PATH Wave 2 and Wave 3. The base was all new cigarillo consumers who initiated on cigarillos since the previous Wave. These new cigarillo consumers were “clean” initiates – i.e. had never consumed cigarettes, e‐ cigarettes, filtered cigars, traditional cigars, cigarillos, snus, or smokeless tobacco in the previous Wave. Cigarillo status of current use was categorized as either “Ever but Not Current”, “Current Experimental”, or “Current Established”. The weighted distribution of current status was reported by respondents’ first cigarillo flavor.

Statistical testing was performed using a two-sample t‐test comparing the percentage of consumers who initiated on flavored versus non‐flavored products and became “Current Established” consumers.

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Source and Data Setup PATH Wave 1 and Wave 2 Youth and Adult Public Use Files, as well as Wave 3 Adult Public Use Files were used. Analysis weights were used to account for selection probabilities, differential non-response rates, and possible deficiencies in the sampling frame (e.g., under coverage of certain population groups). Variance estimation was implemented to account for multi-stage complex sampling using balanced repeated replication weights with Fay’s method, as recommended by the PATH Study Public Use Files User Guide. Summary of Outcomes Assessed We conducted analysis for outcomes using PATH Wave 1 and Wave 2 Youth and Adult Public Use Files, as well as Wave 3 Adult Public Use Files. These outcomes are listed in the table below along with the survey questions and the variables used to derive the outcome variables.

Outcome Measure Variable Question Wave 2 First R02_AG1008CG When first started smoking cigarillos, smoked cigarillos flavored to taste like flavor menthol, mint, clove, spice, fruit, chocolate, alcoholic drinks, candy or other sweets Wave 3 First R03_AG1008CG When first started smoking cigarillos, smoked cigarillos flavored to taste like flavor menthol, mint, clove, spice, fruit, chocolate, alcoholic drinks, candy or other sweets

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Consumer Groups This section describes the definition of the consumer groups and variables used to identify these groups, which are used as filters to define sub-samples.

Consumer Groups Definition Variables/Syntax Clean initiators Wave 1 Adults who R01R_A_NVR_CIGS, R01R_A_NVR_ECIG, R01R_A_NVR_GRILLO, have never used any R01R_A_NVR_GFILTR, R01R_A_NVR_GTRAD, R01R_A_NVR_SMKLS, tobacco product. R01R_A_NVR_SNUS Clean initiators Wave 1 Youth who R01R_Y_EVR_CIGS, R01R_Y_EVR_ECIG, R01R_Y_EVR_GRILLO, R01R_Y_EVR_GFILTR, have never used any R01R_Y_EVR_GTRAD, R01R_Y_EVR_SMKLS, R01R_Y_EVR_SNUS tobacco product. Clean initiators Wave 2 Adults who R02R_A_EVR_CIGS, R02R_A_EVR_ECIG, R02R_A_EVR_GRILLO, R02R_A_EVR_GFILTR, have never used any R02R_A_EVR_GTRAD, R02R_A_EVR_SMKLS, R02R_A_EVR_SNUS tobacco product. Clean initiators Wave 2 Youth who R02R_Y_EVR_CIGS, R02R_Y_EVR_ECIG, R02R_Y_EVR_GRILLO, R02R_Y_EVR_GFILTR, have never used any R02R_Y_EVR_GTRAD, R02R_Y_EVR_SMKLS, R02R_Y_EVR_SNUS tobacco product. Current DERIVED ‐ Wave 2 R02R_A_CUR_ESTD_GRILLO == "Yes" Established Adult Current consumer Established Cigarillo Smokers Current DERIVED ‐ Wave 2 R02R_A_CUR_EXPR_GRILLO == "Yes" Experimental Adult Current consumer Experimental Cigarillo Smokers Current DERIVED ‐ Wave 3 R03R_A_CUR_ESTD_GRILLO == "Yes" Established Adult Current consumer Established Cigarillo Smokers Current DERIVED ‐ Wave 3 R03R_A_CUR_EXPR_GRILLO == "Yes" Experimental Adult Current consumer Experimental Cigarillo Smokers Total sample sizes for consumer groups are reported at the beginning of the results section. Sample sizes may vary from one analysis to another due to missing values (“don’t know” and “refused” answers as well as improbable responses removed by PATH team) on the outcome variables. Actual sample size for each analysis is shown in the outcome tables next to the outcome measures (i.e., “n” and “sum_wts” in the output).

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Results: Script Output In this section, we present R script output tables.

The following script output reports base sizes of Young Adult (18-24) cigarillo initiates by their first cigarillo flavor.

Young Adults (18-24) New to Tobacco Who Initiated Cigarillos in Wave 2 age flavor n sum_wts pct 18 to 24 years old Yes 58 201722.2 0.446925 18 to 24 years old No 47 155389.7 0.344273 18 to 24 years old I don’t know 26 94243.9 0.208802

Young Adults (18-24) New to Tobacco Who Initiated Cigarillos in Wave 3 age flavor n sum_wts pct 18 to 24 years old Yes 29 78176.4 0.349494 18 to 24 years old No 37 113748.9 0.508524 18 to 24 years old I don’t know 13 31759.4 0.141983

The following script output reports the percentage of “Current Established,” “Current Experimental” and “Ever but Not Current” groups for Young Adults (18-24).

Young Adults (18-24) New to Tobacco Who Initiated Cigarillo in Wave 2 Flavor and Usage Groups flavor variable level mean se ci_l ci_u n sum_wts age 18 to Yes end_wave_group Current 0.155554 0.061291 0.071613 0.305507 58 201722.2 24 Established years Consumer old 18 to Yes end_wave_group Current 0.247219 0.068378 0.141021 0.396478 58 201722.2 24 Experimental years Consumer old 18 to Yes end_wave_group Ever not 0.597227 0.079464 0.442318 0.734896 58 201722.2 24 Current years old 18 to No end_wave_group Current 0.030807 0.030347 0.005650 0.150974 47 155389.7 24 Established years Consumer old

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18 to No end_wave_group Current 0.260575 0.073215 0.147529 0.417792 47 155389.7 24 Experimental years Consumer old 18 to No end_wave_group Ever not 0.708617 0.075926 0.549743 0.828882 47 155389.7 24 Current years old 18 to I end_wave_group Current 0.056320 0.038133 0.012917 0.213952 26 94243.9 24 don’t Established years know Consumer old 18 to I end_wave_group Current 0.041277 0.030483 0.007693 0.192963 26 94243.9 24 don’t Experimental years know Consumer old 18 to I end_wave_group Ever not 0.902403 0.047104 0.732193 0.969011 26 94243.9 24 don’t Current years know old 18 to NA end_wave_group Current 0.000000 0.000000 0.000000 0.000000 9 19479.3 24 Established years Consumer old 18 to NA end_wave_group Current 0.000000 0.000000 0.000000 0.000000 9 19479.3 24 Experimental years Consumer old 18 to NA end_wave_group Ever not 1.000000 0.000000 1.000000 1.000000 9 19479.3 24 Current years old Young Adults (18-24) New to Tobacco Who Initiated Cigarillos in Wave 3 Flavor and Usage Groups flavor variable level mean se ci_l ci_u n sum_wts age 18 to Yes end_wave_group Current 0.038797 0.027369 0.007466 0.178022 29 78176.4 24 Established years Consumer old 18 to Yes end_wave_group Current 0.288370 0.076815 0.156228 0.470021 29 78176.4 24 Experimental years Consumer old 18 to Yes end_wave_group Ever not 0.672833 0.081657 0.490885 0.814348 29 78176.4 24 Current years old

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18 to No end_wave_group Current 0.067246 0.028816 0.021022 0.194878 37 113748.9 24 Established years Consumer old 18 to No end_wave_group Current 0.229650 0.083164 0.111809 0.413822 37 113748.9 24 Experimental years Consumer old 18 to No end_wave_group Ever not 0.703104 0.088689 0.519689 0.838275 37 113748.9 24 Current years old 18 to I end_wave_group Current 0.077781 0.079078 0.013973 0.334201 13 31759.4 24 don’t Established years know Consumer old 18 to I end_wave_group Current 0.246514 0.122652 0.090532 0.518133 13 31759.4 24 don’t Experimental years know Consumer old 18 to I end_wave_group Ever not 0.675705 0.129346 0.408497 0.862758 13 31759.4 24 don’t Current years know old 18 to NA end_wave_group Current 0.000000 0.000000 0.000000 0.000000 9 19592.1 24 Established years Consumer old 18 to NA end_wave_group Current 0.000000 0.000000 0.000000 0.000000 9 19592.1 24 Experimental years Consumer old 18 to NA end_wave_group Ever not 1.000000 0.000000 1.000000 1.000000 9 19592.1 24 Current years old

Young Adults (18-24) New to Tobacco Who Initiated Cigarillos in Wave 2 Flavor and Usage Groups (Unweighted Counts) Ever not Current Experimental Current Established age flavor Current Consumer Consumer 18 to 24 years Yes 35 14 9 old 18 to 24 years No 34 12 1 old 18 to 24 years I don’t 22 2 2 old know 18 to 24 years NA 9 NA NA old

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Young Adults (18-24) New to Tobacco Who Initiated Cigarillos in Wave 3 Flavor and Usage Groups (Unweighted Counts) Ever not Current Experimental Current Established age flavor Current Consumer Consumer 18 to 24 years Yes 20 7 2 old 18 to 24 years No 26 7 4 old 18 to 24 years I don’t 8 4 1 old know 18 to 24 years NA 9 NA NA old Below is the script output for the two-sample t-test comparing the percentage of “Current Established” cigarillo consumers who initiated on flavored versus non‐flavored cigarillo products within the Young Adults (18 to 24) group.

Wave 2 p.value 0.068155 Wave 3 p.value 0.474087

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Attachment 13

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Definitions and explanation of PATH analysis: Current status of cigarillo use by reported flavor of cigarillo tried among total adult (18+) respondents who were “never users” of tobacco in previous Wave Table 4: Current Status of Cigarillo Use by Reported Flavor of Cigarillo Tried Among Total Adult (18+) Respondents Who Were “Never Users” of Tobacco in Previous Wave

Total Adult (18+) who “initiated” since Wave 1 by flavor of first cigarillo and status of current use

%"Ever Used" and “Not % "Current % "Current First Cigarillo N Current” Experimental" Established"

Flavored 65 50% 40% 10%

Non‐ 50 70% 22% 8% Flavored Don't Know 28 75% 21% 4% Total Adult (18+) who “initiated” since Wave 2 by flavor of first cigarillo and status of current use

First Cigarillo N %"Ever Used" and “Not % "Current % "Current Current” Experimental" Established"

31 53% 44% 3% Flavored Non‐ 41 57% 39% 4% Flavored 13 68% 25% 8% Don't Know

Methodology This analysis examined product initiation in Total Adults (18+) at PATH Wave 2 and Wave 3. The base was all new cigarillo consumers who initiated on cigarillos since the previous wave. These new cigarillo consumers were “clean” initiates – i.e. had never consumed cigarettes, e- cigarettes, filtered cigars, traditional cigars, cigarillos, snus, or smokeless tobacco in the previous Wave. Cigarillo status of current use was categorized as either “Ever but Not Current,” “Current Experimental” or “Current Established.” The weighted distribution of current status was reported by respondents’ first cigarillo flavor.

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Outcome Measure Variable Question When first started smoking cigarillos, smoked cigarillos flavored to taste like Wave 2 First menthol, mint, clove, spice, fruit, chocolate, alcoholic drinks, candy or other flavor R02_AG1008CG sweets When first started smoking cigarillos, smoked cigarillos flavored to taste like Wave 3 First menthol, mint, clove, spice, fruit, chocolate, alcoholic drinks, candy or other flavor R03_AG1008CG sweets

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Consumer Groups This section describes the definition of the consumer groups and variables used to identify these groups, which are used as filters to define sub-samples.

Consumer Groups Definition Variables/Syntax Clean Wave 1 Adult who have R01R_A_NVR_CIGS, R01R_A_NVR_ECIG, R01R_A_NVR_GRILLO, initiators never used any tobacco R01R_A_NVR_GFILTR, R01R_A_NVR_GTRAD, R01R_A_NVR_SMKLS, product. R01R_A_NVR_SNUS Clean Wave 1 Youth who R01R_Y_EVR_CIGS, R01R_Y_EVR_ECIG, R01R_Y_EVR_GRILLO, R01R_Y_EVR_GFILTR, initiators have never used any R01R_Y_EVR_GTRAD, R01R_Y_EVR_SMKLS, R01R_Y_EVR_SNUS tobacco product. Clean Wave 2 Adult who have R02R_A_EVR_CIGS, R02R_A_EVR_ECIG, R02R_A_EVR_GRILLO, R02R_A_EVR_GFILTR, initiators never used any tobacco R02R_A_EVR_GTRAD, R02R_A_EVR_SMKLS, R02R_A_EVR_SNUS product. Clean Wave 2 Youth who R02R_Y_EVR_CIGS, R02R_Y_EVR_ECIG, R02R_Y_EVR_GRILLO, R02R_Y_EVR_GFILTR, initiators have never used any R02R_Y_EVR_GTRAD, R02R_Y_EVR_SMKLS, R02R_Y_EVR_SNUS tobacco product. Current DERIVED ‐ Wave 2 R02R_A_CUR_ESTD_GRILLO == "Yes" Established Adult Current consumer Established Cigarillo Smoker Current DERIVED ‐ Wave 2 R02R_A_CUR_EXPR_GRILLO == "Yes" Experiment Adult Current al Experimental Cigarillo consumer Smoker Current DERIVED ‐ Wave 3 R03R_A_CUR_ESTD_GRILLO == "Yes" Established Adult Current consumer Established Cigarillo Smoker Current DERIVED ‐ Wave 3 R03R_A_CUR_EXPR_GRILLO == "Yes" Experiment Adult Current al Experimental Cigarillo consumer Smoker Total sample sizes for consumer groups are reported at the beginning of the results section. Sample sizes may vary from one analysis to another due to missing values (“don’t know” and “refused” answers as well as improbable responses removed by PATH team) on the outcome variables. Actual sample size for each analysis is shown in the outcome tables next to the outcome measures (i.e., “n” and “sum_wts” in the output).

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Results: Script Output In this section, we present R script output tables.

The following script output reports base sizes of Total Adult (18+) cigarillo initiates by their first cigarillo flavor.

Total Adults (18+) New to Tobacco Who Initiated Cigarillos in Wave 2 flavor n sum_wts pct Yes 65 320448 0.502120 No 50 188292 0.295041

I don’t know 28 129449 0.202838

Total Adults (18+) New to Tobacco Who Initiated Cigarillos in Wave 3 flavor n sum_wts pct Yes 31 102415.6 0.317069 No 41 188832.2 0.584607 I don’t know 13 31759.4 0.098324

The following script output reports the percentage of “Current Established”, “Current Experimental” and “Ever but Not Current” groups for the Total Adults (18+) age group.

Total Adults (18+) New to Tobacco Who Initiated Cigarillos in Wave 2 Flavor and Usage Groups flavor variable level mean se ci_l ci_u n sum_wts Yes end_wave_group Current 0.097921 0.046420 0.039303 0.223615 65 320447.9 Established Consumer Yes end_wave_group Current 0.402774 0.068465 0.281517 0.537209 65 320447.9 Experimental Consumer Yes end_wave_group Ever not 0.499305 0.075453 0.359449 0.639269 65 320447.9 Current No end_wave_group Current 0.084804 0.063790 0.021372 0.282211 50 188292.1 Established Consumer No end_wave_group Current 0.215042 0.058353 0.123763 0.346983 50 188292.1 Experimental Consumer

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No end_wave_group Ever not 0.700154 0.073921 0.546297 0.819111 50 188292.1 Current I end_wave_group Current 0.041003 0.029461 0.008002 0.184754 28 129449.4 don’t Established know Consumer I end_wave_group Current 0.206729 0.158458 0.049212 0.567493 28 129449.4 don’t Experimental know Consumer I end_wave_group Ever not 0.752268 0.154360 0.423473 0.926220 28 129449.4 don’t Current know NA end_wave_group Current 0.000000 0.000000 0.000000 0.000000 10 35159.4 Established Consumer NA end_wave_group Current 0.000000 0.000000 0.000000 0.000000 10 35159.4 Experimental Consumer NA end_wave_group Ever not 1.000000 0.000000 1.000000 1.000000 10 35159.4 Current

Total Adults (18+) New to Tobacco Who Initiated Cigarillos in Wave 3 Flavor and Usage Groups flavor variable level mean se ci_l ci_u n sum_wts Yes end_wave_group Current 0.029615 0.022411 0.004938 0.158016 31 102415.6 Established Consumer Yes end_wave_group Current 0.439167 0.148764 0.210344 0.697151 31 102415.6 Experimental Consumer Yes end_wave_group Ever not Current 0.531218 0.144469 0.286143 0.762106 31 102415.6 No end_wave_group Current 0.040508 0.019945 0.010021 0.149722 41 188832.2 Established Consumer No end_wave_group Current 0.387064 0.171129 0.149189 0.694583 41 188832.2 Experimental Consumer No end_wave_group Ever not Current 0.572429 0.164103 0.287213 0.816452 41 188832.2 I don’t end_wave_group Current 0.077781 0.079078 0.013973 0.334201 13 31759.4 know Established Consumer I don’t end_wave_group Current 0.246514 0.122652 0.090532 0.518133 13 31759.4 know Experimental Consumer

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I don’t end_wave_group Ever not Current 0.675705 0.129346 0.408497 0.862758 13 31759.4 know NA end_wave_group Current 0.000000 0.000000 0.000000 0.000000 11 39370.8 Established Consumer NA end_wave_group Current 0.000000 0.000000 0.000000 0.000000 11 39370.8 Experimental Consumer NA end_wave_group Ever not Current 1.000000 0.000000 1.000000 1.000000 11 39370.8

Total Adult (18+)New to Tobacco Who Initiated Cigarillos in Wave2 Flavor and Usage Groups (Unweighted Counts) Ever not Current Experimental Current Established flavor Current Consumer Consumer Yes 38 18 9 No 36 12 2 I don’t 23 3 2 know NA 10 NA NA

Total Adults (18+) New to Tobacco Who Initiated Cigarillos in Wave 3 Flavor and Usage Groups (Unweighted Counts) flavor Ever not Current Experimental Current Established Current Consumer Consumer Yes 21 8 2 No 29 8 4 I don’t 8 4 1 know NA 11 NA NA Below is the script output for the two-sample t-test comparing the percentage of “Current Established” cigarillo consumers who initiated on flavored versus non‐flavored cigarillo products within the Total Adult (18+) group.

Wave 2 p.value 0.867948

Wave 3 p.value 0.716534

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Attachment 14

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Definitions and explanation of PATH analysis: PATH Wave 1 reported cigarillos smoked per day – flavored versus non-flavored cigarillos Table 5: PATH Wave 1 Reported Cigarillos Smoked Per Day – Flavored Versus Non- Flavored Cigarillos Wave 1 adult cigarillo current established consumer 18-24 years old – “yes” flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 105 253,790 1.4 5-15 days 104 243,201 1.9 16-26 days 28 62,923 5.5 27+ days 27 65,767 5.0 Every day 65 136,740 4.9 Total 332 768,446 2.8 Wave 1 adult cigarillo current established consumer 18-24 years old – not flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 45 104,338 2.4 5-15 days 44 107,059 1.7 16-26 days 21 42,187 1.8 27+ days 17 35,428 2.8 Every day 47 95,851 4.7 Total 175 386,856 2.7 Wave 1 adult cigarillo current established consumer 25+ years old – “yes” flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 72 291,629 1.3 5-15 days 90 351,164 2.2 16-26 days 27 101,748 3.6 27+ days 25 87,880 4.3 Every day 84 322,738 4.9 Total 301 1,172,158 3.6 Wave 1 adult cigarillo current established consumer 25+ years old – not flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 46 207,591 1.3 5-15 days 41 161,077 2.1 16-26 days 18 64,923 2.9 27+ days 23 100,502 6.1 Every day 63 271,798 7.6 Total 194 820,924 4.4

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Methodology The following analysis looked at product use among PATH Wave 1 adult “Current Established” cigarillo users by age group. “Current Established” cigarillo users who now use cigarillos every day were classified as the “Every day” group. “Current Established” cigarillo users who now use cigarillos some days were classified into different “days of use” groups based on their responses to “Number of days smoked cigarillos in the past 30 days.” Respondents who selected “0 days,” or didn’t answer the days used question, were excluded from the analysis. PATH weights were used to determine the mean and standard error of each usage group by reported flavor of the regular/last used brand. Mean consumption was determined by reported average number of cigarillos used per day for “Current Every Day” users and reported average number of cigarillos used per day on days used for “Current Some Days” users. In order to include values that are meaningful (e.g., “less than 1 per day”), but coded as missing in the consumption calculation, the missing values for those who are asked the consumption questions were assigned a value of 0.25. This corrects the bias introduced by the missing value coding. A Student’s t-test was applied to test whether there’s a significant difference in average consumption between respondents whose regular/last brand was flavored or non-flavored. Source and Data Setup PATH Wave 1 Adult Public Use Files were used. Analysis weights were used to account for selection probabilities, differential non-response rates, and possible deficiencies in the sampling frame (e.g., under coverage of certain population groups). Variance estimation was implemented to account for multi-stage complex sampling using balanced repeated replication weights with Fay’s method, as recommended by the PATH Study Public Use Files User Guide.

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Summary of Outcomes Assessed We conducted analysis for outcomes using PATH Wave 1 Adult Public Use Files. These outcomes are listed in the table below along with the survey questions and the variables used to derive the outcome variables.

Outcome Measure Variable Question Number of product consumed R01_AG1021CG Average number of cigarillos now smoked each day per day Number of product consumed R01_AG1022CG Number of days smoked cigarillos in past 30 days per day Number of product consumed R01_AG1023CG Average number of cigarillos smoked per day on days per day smoked in past 30 days Number of product consumed R01R_A_EDY_GRILLO DERIVED ‐ Wave 1 Adult Current Everyday Cigarillo User per day

Consumer Groups This section describes the definition of the consumer groups and variables used to identify these groups, which are used as filters to define sub-samples.

Consumer Groups Definition Variables/Syntax Current Established DERIVED ‐ Wave 1 Adult Current Established R01R_A_CUR_ESTD_GRILLO == consumer Cigarillo User "Yes"

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Grouping Variables This section describes the definition of the grouping variables, which are used to classify the outcome measures. Grouping variables are usually categorical variables in PATH (i.e., demographic variables) or derived categorical variables.

Grouping Variable Definition Variables/Syntax Days consumed in Number of days smoked cigarillos in past 30 days if_else(R01R_A_EDY_GRILLO == the past 30 days "Yes", 30, R01_AG1022CG) Days consumed in DERIVED ‐ Wave 1 Adult Current Everyday Cigarillo if_else(R01R_A_EDY_GRILLO == the past 30 days User "Yes", 30, R01_AG1022CG) Regular/last flavor Regular / last brand of cigarillos smoked / smoked as R01_AG1050CG blunts flavored to taste like menthol, mint, clove, spice, candy, fruit, chocolate, alcohol or other sweets

Results: Script Output In this section, we present R script output tables.

The following script output reports Wave 1 Adult “Current Established” cigarillo consumers’ base sizes by flavor status.

Base Sizes for Wave 1 Current Established Users of Cigarillo by Regular/Last Flavor flavor n Yes 750 No 436

The following script output reports Wave 1 consumption of “Current Established” users by age and regular/last flavor of cigarillo.

Wave 1 Consumption of Cigarillo by Age and Regular/Last Flavor flavor age variable level mean se ci_l ci_u n sum_wts Yes 18 to 24 years old consumption NA 2.80148 0.270692 2.26444 3.33853 332 768446 Yes 25 years old or older consumption NA 3.56117 0.653293 2.26506 4.85729 301 1172158 No 18 to 24 years old consumption NA 2.72321 0.285442 2.15690 3.28952 175 386856 No 25 years old or older consumption NA 4.38546 0.954942 2.49089 6.28004 194 820924

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Below is the script output for the two-sample t‐test comparing mean consumption between total flavored and non-flavored current cigarillo users for age groups 18 to 24 and 25+. age p.value 18 to 24 years old 0.842279 25 years old or older 0.476204

This script output reports Wave 1 consumption of “Current Established” users by age, regular/last flavor of cigarillo, and days used cigarillo in the past 30 days.

Wave 1 Consumption of Cigarillo by Age, Flavor and Days Used Cigarillo flavor age days_used variable level mean se ci_l ci_u n sum_wts Yes 18 to 0 days consumption NA NaN NaN NaN NaN 0 0.00 24 years old Yes 18 to 1‐4 days consumption NA 1.35477 0.102971 1.150483 1.55906 105 253790.33 24 years old Yes 18 to 5‐15 days consumption NA 1.86054 0.184274 1.494942 2.22613 104 243201.03 24 years old Yes 18 to 16‐26 consumption NA 5.51588 1.993948 1.559944 9.47181 28 62922.68 24 days years old Yes 18 to 27‐30 consumption NA 4.97962 2.187651 0.639381 9.31986 27 65767.31 24 days years old Yes 18 to Every day consumption NA 4.85702 0.642879 3.581569 6.13248 65 136739.74 24 years old Yes 18 to NA consumption NA 2.94710 1.122218 0.720649 5.17354 3 6024.86 24 years old Yes 25 0 days consumption NA NaN NaN NaN NaN 0 0.00 years old or older

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Yes 25 1‐4 days consumption NA 1.30405 0.136218 1.033798 1.57430 72 291628.72 years old or older Yes 25 5‐15 days consumption NA 2.18574 0.544632 1.105210 3.26628 90 351164.11 years old or older Yes 25 16‐26 consumption NA 3.60775 0.968192 1.686886 5.52862 27 101748.25 years days old or older Yes 25 27‐30 consumption NA 4.28745 0.949508 2.403650 6.17124 25 87879.65 years days old or older Yes 25 Every day consumption NA 4.92938 0.542989 3.852105 6.00666 84 322737.72 years old or older Yes 25 NA consumption NA 40.68533 35.350921 NA NA 3 16999.91 years old or older No 18 to 0 days consumption NA NaN NaN NaN NaN 0 0.00 24 years old No 18 to 1‐4 days consumption NA 2.41590 0.698696 1.029707 3.80209 45 104338.27 24 years old No 18 to 5‐15 days consumption NA 1.67423 0.158568 1.359637 1.98883 44 107058.94 24 years old No 18 to 16‐26 consumption NA 1.79131 0.204314 1.385961 2.19667 21 42186.85 24 days years old No 18 to 27‐30 consumption NA 2.79562 0.516378 1.771136 3.82009 17 35428.32 24 days years old

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No 18 to Every day consumption NA 4.66415 0.757149 3.161987 6.16631 47 95851.12 24 years old No 18 to NA consumption NA 0.25000 0.000000 0.250000 0.25000 1 1992.17 24 years old No 25 0 days consumption NA NaN NaN NaN NaN 0 0.00 years old or older No 25 1‐4 days consumption NA 1.31905 0.148643 1.024146 1.61395 46 207590.73 years old or older No 25 5‐15 days consumption NA 2.05476 0.515949 1.031133 3.07839 41 161076.71 years old or older No 25 16‐26 consumption NA 2.91433 0.951569 1.026442 4.80221 18 64923.30 years days old or older No 25 27‐30 consumption NA 6.11757 2.495202 1.167162 11.06798 23 100501.97 years days old or older No 25 Every day consumption NA 7.55865 2.548548 2.502405 12.61490 63 271797.90 years old or older No 25 NA consumption NA 9.10465 6.377881 NA NA 3 15033.25 years old or older

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Attachment 15

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Definitions and explanation of PATH analysis: PATH Wave 2 reported cigarillos smoked per day – flavored versus non-flavored cigarillos Table 6: PATH Wave 2 Reported Cigarillos Smoked Per Day – Flavored Versus Non- Flavored Cigarillos Wave 2 adult cigarillo current established consumer 18-24 years old – “yes” flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 62 173,957 1.1 5-15 days 54 156,421 1.6 16-26 days 6 17,106 3.0 27+ days 3 6,637 3.9 Every day 22 55,954 2.9 Total 147 410,075 1.6 Wave 2 adult cigarillo current established consumer 18-24 years old – not flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 32 82,468 1.1 5-15 days 37 112,400 1.4 16-26 days 4 7,664 1.1 27+ days 4 13,504 1.0 Every day 12 33,973 3.3 Total 90 251,543 1.5 Wave 2 adult cigarillo current established consumer 25+ years old – “yes” flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 77 377,159 1.1 5-15 days 58 264,614 2.5 16-26 days 17 71,144 3.8 27+ days 13 64,370 5.9 Every day 41 185,257 7.9 Total 207 965,011 3.3 Wave 2 adult cigarillo current established consumer 25+ years old – not flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 54 258,207 1.2 5-15 days 48 229,539 1.5 16-26 days 13 61,545 2.8 27+ days 11 47,228 2.3 Every day 44 204,270 5.1 Total 170 800,789 2.5

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Methodology The following analysis looked at product use among PATH Wave 2 adult “Current Established” cigarillo users by age group. “Current Established” cigarillo users who now use cigarillos every day were classified as the “Every day” group. “Current Established” cigarillo users who now use cigarillos some days were classified into different “days of use” groups based on their responses to “Number of days smoked cigarillos in the past 30 days.” Respondents who selected “0 days,” or didn’t answer the days used question, were excluded from the analysis. PATH weights were used to determine the mean and standard error of each usage group by reported flavor of the regular/last used brand. Mean consumption was determined by reported average number of cigarillos used per day for “Current Every Day” users and reported average number of cigarillos used per day on days used for “Current Some Days” users. In order to include values that are meaningful (e.g., “less than 1 per day”), but coded as missing in the consumption calculation, the missing values for those who are asked the consumption questions were assigned a value of 0.25. This corrects the bias introduced by the missing value coding. A Student’s t-test was applied to test whether there’s a significant difference in average consumption between respondents whose regular/last brand was flavored or non-flavored. Source and Data Setup PATH Wave 2 Adult Public Use Files were used. Analysis weights were used to account for selection probabilities, differential non-response rates, and possible deficiencies in the sampling frame (e.g., under coverage of certain population groups). Variance estimation was implemented to account for multi-stage complex sampling using balanced repeated replication weights with Fay’s method, as recommended by the PATH Study Public Use Files User Guide.

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Summary of Outcomes Assessed We conducted analysis for outcomes using PATH Wave 2 Adult Public Use Files. These outcomes are listed in the table below along with the survey questions and the variables used to derive the outcome variables.

Outcome Measure Variable Question Number of product consumed R02_AG1021CG Average number of cigarillos now smoked each day per day Number of product consumed R02_AG1022CG In past 30 days, number of days smoked cigarillos per day Number of product consumed R02_AG1023CG In past 30 days, average number of cigarillos smoked per per day day on days smoked Number of product consumed R02R_A_EDY_GRILLO DERIVED ‐ Wave 2 Adult Current Everyday Cigarillo per day Smoker

Consumer Groups This section describes the definition of the consumer groups and variables used to identify these groups, which are used as filters to define sub-samples.

Consumer Groups Definition Variables/Syntax Current Established DERIVED ‐ Wave 2 Adult Current Established R02R_A_CUR_ESTD_GRILLO == consumer Cigarillo Smoker "Yes"

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Grouping Variables This section describes the definition of the grouping variables, which are used to classify the outcome measures. Grouping variables are usually categorical variables in PATH (i.e., demographic variables) or derived categorical variables.

Grouping Variable Definition Variables/Syntax Days consumed in In past 30 days, number of days smoked cigarillos if_else(R02R_A_EDY_GRILLO == the past 30 days "Yes", 30, R02_AG1022CG) Days consumed in DERIVED ‐ Wave 2 Adult Current Everyday Cigarillo if_else(R02R_A_EDY_GRILLO == the past 30 days Smoker "Yes", 30, R02_AG1022CG) Regular/last flavor Regular/last brand of cigarillos smoked was flavored R02_AG1050CG to taste like menthol, mint, clove, spice, fruit, chocolate, alcoholic drinks, candy or other sweets

Results: Script Output In this section, we present R script output tables.

The following script output reports Wave 2 Adult “Current Established” cigarillo consumers’ base sizes by flavor status.

Base Sizes for Wave 2 Current Established User of Cigarillo by Regular/Last Flavor flavor n Yes 428 No 323 I don’t know 26 NA 13

The following script output reports Wave 2 consumption of “Current Established” users by age and regular/last flavor of cigarillo.

Wave 2 Consumption of Cigarillo by Age and Regular/Last Flavor flavor age variable level mean se ci_l ci_u n sum_wts Yes 18 to 24 year consumption NA 1.63172 0.148884 1.336333 1.92710 147 410074.87 olds Yes 25 year olds or consumption NA 3.30121 0.703557 1.905369 4.69704 207 965010.56 older No 18 to 24 year consumption NA 1.52725 0.180338 1.169462 1.88503 90 251543.23 olds

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No 25 year olds or consumption NA 2.49720 0.250963 1.999300 2.99511 170 800789.23 older I don’t 18 to 24 year consumption NA 1.64094 0.535553 0.578416 2.70346 5 10781.74 know olds I don’t 25 year olds or consumption NA 1.39264 0.438081 0.523496 2.26178 13 79898.84 know older NA 18 to 24 year consumption NA 8.44393 3.351167 1.795307 15.09255 2 7043.73 olds NA 25 year olds or consumption NA 4.98255 2.521910 0.000000 10.00713 3 13779.05 older Below is the script output for the two-sample t‐test comparing mean consumption between total flavored and non-flavored current cigarillo users for age groups 18 to 24 and 25+.

age p.value 18 to 24 year olds 0.655076 25 year olds or 0.281775 older This script output reports Wave 2 consumption of “Current Established” users by age, regular/last flavor of cigarillo, and days used cigarillo in the past 30 days. Wave 2 Consumption of Cigarillo by Age, Flavor and Days Used Cigarillo flavor age days_used variable level mean se ci_l ci_u n sum_wts Yes 18 to 24 0 days consumption NA NaN NaN NaN NaN 0 0.00 year olds Yes 18 to 24 1‐4 days consumption NA 1.080012 0.099788 0.882035 1.27799 62 173957.30 year olds Yes 18 to 24 5‐15 days consumption NA 1.549056 0.259759 1.033701 2.06441 54 156421.16 year olds Yes 18 to 24 16‐26 consumption NA 2.955927 0.492905 1.978018 3.93384 6 17105.90 years old days Yes 18 to 24 27‐30 consumption NA 3.928606 1.244864 1.458831 6.39838 3 6636.97 years old days Yes 18 to 24 Every day consumption NA 2.900737 0.555350 1.798938 4.00253 22 55953.53 years old Yes 25 years 0 days consumption NA NaN NaN NaN NaN 0 0.00 old or older Yes 25 years 1‐4 days consumption NA 1.103616 0.097868 0.909448 1.29778 77 377158.76 old or older Yes 25 years 5‐15 days consumption NA 2.485731 0.526376 1.441416 3.53005 58 264614.29 old or older

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Yes 25 years 16‐26 consumption NA 3.784934 1.674847 0.462084 7.10778 17 71144.22 old or days older Yes 25 years 27‐30 consumption NA 5.908001 2.324146 1.296961 10.51904 13 64370.28 old or days older Yes 25 years Every day consumption NA 7.889089 3.363983 1.215043 14.56314 41 185256.82 old or older Yes 25 years NA consumption NA 0.250000 0.000000 0.250000 0.25000 1 2466.18 old or older No 18 to 24 0 days consumption NA NaN NaN NaN NaN 0 0.00 years old No 18 to 24 1‐4 days consumption NA 1.079802 0.236790 0.610018 1.54959 32 82468.27 years old No 18 to 24 5‐15 days consumption NA 1.429984 0.200578 1.032043 1.82793 37 112400.24 years old No 18 to 24 16‐26 consumption NA 1.118299 0.444671 0.236083 2.00051 4 7664.33 years old days No 18 to 24 27‐30 consumption NA 1.049785 0.460350 0.136465 1.96311 4 13503.84 years old days No 18 to 24 Every day consumption NA 3.274905 0.619823 2.045195 4.50462 12 33972.93 years old No 18 to 24 NA consumption NA 0.250000 0.000000 0.250000 0.25000 1 1533.62 years old No 25 years 0 days consumption NA NaN NaN NaN NaN 0 0.00 old or older No 25 years 1‐4 days consumption NA 1.240829 0.124472 0.993879 1.48778 54 258207.32 old or older No 25 years 5‐15 days consumption NA 1.523959 0.178282 1.170253 1.87766 48 229539.30 old or older No 25 years 16‐26 consumption NA 2.807727 0.754966 1.309895 4.30556 13 61545.04 old or days older No 25 years 27‐30 consumption NA 2.318928 0.633445 1.062191 3.57566 11 47227.86 old or days older No 25 years Every day consumption NA 5.126629 0.841001 3.458106 6.79515 44 204269.71 old or older I 18 to 24 0 days consumption NA NaN NaN NaN NaN 0 0.00 don’t years old know

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I 18 to 24 1‐4 days consumption NA 2.190593 0.695157 0.811421 3.56976 2 4227.41 don’t years old know I 18 to 24 16‐26 consumption NA 0.918585 0.617467 NA NA 2 4324.91 don’t years old days know I 18 to 24 yr Every day consumption NA 2.000000 0.000000 2.000000 2.00000 1 2229.43 don’t old know I 25 years 0 days consumption NA NaN NaN NaN NaN 0 0.00 don’t old or know older I 25 years 1‐4 days consumption NA 1.240551 0.390035 0.466734 2.01437 3 8984.12 don’t old or know older I 25 years 5‐15 days consumption NA 0.890131 0.481527 0.000000 1.93413 6 44503.82 don’t old or know older I 25 years 16‐26 consumption NA 2.000000 0.000000 2.000000 2.00000 1 5998.16 don’t old or days know older I 25 years 27‐30 consumption NA 1.000000 0.000000 1.000000 1.00000 1 10703.85 don’t old or days know older I 25 years Every day consumption NA 3.894408 0.719266 2.467405 5.32141 2 9708.89 don’t old or know older NA 18 to 24 0 days consumption NA NaN NaN NaN NaN 0 0.00 years old NA 18 to 24 1‐4 days consumption NA 8.443927 3.351167 1.795307 15.09255 2 7043.73 years old NA 25 years 0 days consumption NA NaN NaN NaN NaN 0 0.00 old or older NA 25 years 1‐4 days consumption NA 10.000000 0.000000 10.000000 10.00000 1 5228.73 old or older NA 25 years 5‐15 days consumption NA 1.000000 0.000000 1.000000 1.00000 1 4641.69 old or older NA 25 years 16‐26 consumption NA 3.000000 0.000000 3.000000 3.00000 1 3908.63 old or days older

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Attachment 16

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Definitions and explanation of PATH analysis: PATH Wave 3 reported cigarillos smoked per day – flavored versus non-flavored cigarillos Table 7: PATH Wave 3 Reported Cigarillos Smoked Per Day – Flavored Versus Non- Flavored Cigarillos

Wave 3 adult cigarillo current established consumer 18-24 years old – “yes” flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 42 143,148 1.0 5-15 days 38 117,493 2.6 16-26 days 10 29,337 3.1 27+ days 4 9,972 2.3 Every day 9 16,252 3.4 Total 104 317,699 1.9 Wave 3 adult cigarillo current established consumer 18-24 years old – not flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 30 85,079 1.5 5-15 days 17 41,568 1.6 16-26 days 10 23,856 1.9 27+ days 4 10,760 2.0 Every day 19 55,135 2.6 Total 81 219,984 1.9 Wave 3 adult cigarillo current established consumer 25+ years old – “yes” flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30 1-4 days 58 266,207 1.7 5-15 days 63 290,577 1.8 16-26 days 8 34,092 2.0 27+ days 9 31,028 4.1 Every day 39 189,852 5.3 Total 177 811,756 2.7 Wave 3 adult cigarillo current established consumer 25+ years old – not flavored Days Smoked in N Weighted N Mean Cigarillos per Day Past 30

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1-4 days 55 278,988 1.2 5-15 days 38 219,957 1.6 16-26 days 6 41,737 3.1 27+ days 8 32,016 4.2 Every day 57 317,545 3.8 Total 164 890,244 2.4 Methodology This analysis looked at product use among PATH Wave 3 adult “Current Established” cigarillo users by age group. “Current Established” cigarillo users who now use cigarillos every day were classified as the “Every day” group. “Current Established” cigarillo users who now use cigarillos some days were classified into different “days of use” groups based on their responses to “Number of days smoked cigarillos in the past 30 days”. Respondents who selected “0 days”, or didn’t answer the days used question, were excluded from the analysis. PATH weights were used to determine the mean and standard error of each usage group by reported flavor of the regular/last used brand. Mean consumption was determined by reported average number of cigarillos used per day for “Current Every Day” users and reported average number of cigarillos used per day on days used for “Current Some Days” users. In order to include values that are meaningful (e.g., “less than 1 per day”), but coded as missing in the consumption calculation, the missing values for those who are asked the consumption questions were assigned a value of 0.25. This corrects the bias introduced by the missing value coding. A Student’s t-test was applied to test whether there’s a significant difference in average consumption between respondents whose regular/last brand was flavored or non-flavored. Source and Data Setup PATH Wave 3 Adult Public Use Files were used. Analysis weights were used to account for selection probabilities, differential non-response rates, and possible deficiencies in the sampling frame (e.g., under coverage of certain population groups). Variance estimation was implemented to account for multi-stage complex sampling using balanced repeated replication weights with Fay’s method, as recommended by the PATH Study Public Use Files User Guide.

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Summary of Outcomes Assessed We conducted analysis for outcomes using PATH Wave 3 Adult Public Use Files. These outcomes are listed in the table below along with the survey questions and the variables used to derive the outcome variables.

Outcome Measure Variable Question Number of product consumed R03_AG1021CG Average number of cigarillos now smoked each day per day Number of product consumed R03_AG1022CG In past 30 days, number of days smoked cigarillos per day Number of product consumed R03_AG1023CG In past 30 days, average number of cigarillos smoked per per day day on days smoked Number of product consumed R03R_A_EDY_GRILLO DERIVED ‐ Wave 3 Adult Current Every Day Cigarillo per day Smoker

Consumer Groups

This section describes the definition of the consumer groups and variables used to identify these groups, which are used as filters to define sub-samples.

Consumer Groups Definition Variables/Syntax Current Established DERIVED ‐ Wave 3 Adult Current Established R03R_A_CUR_ESTD_GRILLO == consumer Cigarillo Smoker "Yes" Total sample sizes for consumer groups are reported at the beginning of the results section. Sample sizes may vary from one analysis to another due to missing values (“don’t know” and “refused” answers as well as improbable responses removed by PATH team) on the outcome variables. Actual sample size for each analysis is shown in the outcome tables next to the outcome measures (i.e., “n” and “sum_wts” in the output).

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Grouping Variables

Grouping Variable Definition Variables/Syntax Days consumed in In past 30 days, number of days smoked cigarillos if_else(R03R_A_EDY_GRILLO == the past 30 days "Yes", 30, R03_AG1022CG) Days consumed in DERIVED ‐ Wave 3 Adult Current Every Day Cigarillo if_else(R03R_A_EDY_GRILLO == the past 30 days Smoker "Yes", 30, R03_AG1022CG) Regular/last flavor Regular/last brand of cigarillos smoked was flavored R03_AG1050CG to taste like menthol, mint, clove, spice, fruit, chocolate, alcoholic drinks, candy or other sweets

Results: Script Output

In this section, we present R script output tables.

The following script output reports Wave 3 Adult “Current Established” cigarillo consumers’ base sizes by flavor status.

Base Sizes for Wave 3 Current Established Cigarillo Users by Regular/Last Flavor flavor n Yes 338 No 298 I don’t know 44 NA 2 The following script output reports Wave 3 consumption of “Current Established” users by age and regular/last flavor of cigarillo.

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Wave 3 Consumption of Cigarillo by Age and Regular/Last Flavor flavor age variable level mean se ci_l ci_u n sum_wts Yes 18 to 24 years consumption NA 1.94478 0.221865 1.504603 2.38495 104 317698.7 old Yes 25 years old consumption NA 2.67222 0.403429 1.871831 3.47261 177 811755.9 or older No 18 to 24 years consumption NA 1.85398 0.283781 1.290962 2.41699 81 219984.3 old No 25 years old consumption NA 2.43721 0.254612 1.932062 2.94235 164 890244.1 or older I don’t 18 to 24 years consumption NA 2.35720 0.697113 0.974152 3.74026 19 51419.6 know old I don’t 25 years old consumption NA 1.85828 0.723271 0.423329 3.29323 16 69742.3 know or older NA 25 years old consumption NA 6.17262 1.960204 2.283633 10.06161 2 11288.5 or older

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This script output reports Wave 3 consumption of “Current Established” users by age, regular/last flavor of cigarillo, and days used cigarillos in the past 30 days.

Wave 3 Cigarillo Consumption by Age, Flavor and Days Used Cigarillo flavor age days_used variable level mean se ci_l ci_u n sum_wts Yes 18 to 0 days consumption NA NaN NaN NaN NaN 0 0.00 24 years old Yes 18 to 1‐4 days consumption NA 1.009696 0.120325 0.770974 1.248417 42 143147.86 24 years old Yes 18 to 5‐15 days consumption NA 2.590678 0.337465 1.921157 3.260198 38 117492.93 24 years old Yes 18 to 16‐26 consumption NA 3.063036 1.357313 0.370166 5.755907 10 29337.45 24 days years old Yes 18 to 27‐30 consumption NA 2.333304 0.540543 1.260881 3.405727 4 9971.57 24 days years old Yes 18 to Every day consumption NA 3.410604 1.023590 1.379830 5.441377 9 16251.76 24 years old Yes 18 to NA consumption NA 0.250000 0.000000 0.250000 0.250000 1 1497.16 24 years old Yes 25 0 days consumption NA NaN NaN NaN NaN 0 0.00 years old or older Yes 25 1‐4 days consumption NA 1.660026 0.404806 0.856901 2.463150 58 266207.47 years old or older

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Yes 25 5‐15 days consumption NA 1.827320 0.232169 1.366704 2.287936 63 290577.12 years old or older Yes 25 16‐26 consumption NA 1.986367 0.857641 0.284832 3.687902 8 34091.80 years days old or older Yes 25 27‐30 consumption NA 4.070469 1.797854 0.503579 7.637359 9 31027.79 years days old or older Yes 25 Every day consumption NA 5.279317 1.269978 2.759717 7.798917 39 189851.68 years old or older No 18 to 0 days consumption NA NaN NaN NaN NaN 0 0.00 24 years old No 18 to 1‐4 days consumption NA 1.540756 0.415513 0.716390 2.365123 30 85079.18 24 years old No 18 to 5‐15 days consumption NA 1.581356 0.391894 0.803850 2.358863 17 41568.21 24 years old No 18 to 16‐26 consumption NA 1.851368 0.343390 1.170091 2.532645 10 23855.71 24 days years old No 18 to 27‐30 consumption NA 2.016379 1.018405 0.000000 4.041005 4 10760.28 24 days years old No 18 to Every day consumption NA 2.616610 0.845931 0.938306 4.294914 19 55134.69 24 years old

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No 18 to NA consumption NA 0.250000 0.000000 0.250000 0.250000 1 3586.19 24 years old No 25 0 days consumption NA NaN NaN NaN NaN 0 0.00 years old or older No 25 1‐4 days consumption NA 1.245986 0.169488 0.909727 1.582245 55 278988.06 years old or older No 25 5‐15 days consumption NA 1.638315 0.296402 1.050261 2.226368 38 219957.34 years old or older No 25 16‐26 consumption NA 3.120473 1.001511 1.133504 5.107442 6 41737.31 years days old or older No 25 27‐30 consumption NA 4.156767 3.000109 NA NA 8 32016.19 years days old or older No 25 Every day consumption NA 3.773982 0.497006 2.787937 4.760027 57 317545.21 years old or older I 18 to 0 days consumption NA NaN NaN NaN NaN 0 0.00 don’t 24 know years old I 18 to 1‐4 days consumption NA 0.510298 0.214728 0.084284 0.936312 5 13920.01 don’t 24 know years old I 18 to 5‐15 days consumption NA 4.563857 1.928125 0.738513 8.389201 5 13644.50 don’t 24 know years old

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I 18 to 16‐26 consumption NA 0.616244 0.266008 0.088491 1.143996 2 3987.84 don’t 24 days know years old I 18 to 27‐30 consumption NA 1.551129 0.350415 0.855916 2.246341 2 8621.39 don’t 24 days know years old I 18 to Every day consumption NA 3.201288 1.323551 0.575401 5.827176 5 11245.86 don’t 24 know years old I 25 0 days consumption NA NaN NaN NaN NaN 0 0.00 don’t years know old or older I 25 1‐4 days consumption NA 1.167910 0.327908 0.517351 1.818470 10 43964.33 don’t years know old or older I 25 5‐15 days consumption NA 2.000000 0.000000 2.000000 2.000000 1 4462.35 don’t years know old or older I 25 16‐26 consumption NA 3.631878 2.924154 NA NA 3 15557.03 don’t years days know old or older I 25 Every day consumption NA 2.227684 0.302575 1.627384 2.827983 2 5758.62 don’t years know old or older NA 25 5‐15 days consumption NA 6.172622 1.960204 2.283633 10.061610 2 11288.51 years old or older

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Attachment 17

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Definitions and explanation of PATH analysis: Average time to first of flavored versus non-flavored every day cigarillo smokers

Table 8: Average Time to First of Flavored Versus Non-Flavored Every Day Cigarillo Smokers Wave 1 Adult Cigarillo Age Group Regular/Last Brand of Minutes to First Cigarillo After N Weighted Cigarillo Smoked Waking (Confidence Interval) N Flavored? 18 to 24 Yes 123.7 (70.8 – 176.7) 64 134,066 Years Old 18 to 24 No 81.6 (51.1 – 112.1) 46 93,510 Years Old 25+ Years Yes 90.4 (61.3 – 119.6) 82 314,598 Old 25+ Years No 100.2 (59.5 – 140.8) 61 254,372 Old Wave 2 Adult Cigarillo Age Group Regular/Last Brand of Minutes to First Cigarillo After N Weighted Cigarillo Smoked Waking (Confidence Interval) N Flavored? 18 to 24 Yes 139.8 (63.0 – 216.6) 22 55,954 Years Old 18 to 24 No 76.5 (35.1 – 118.0) 12 339,723 Years Old 25+ Years Yes 73.9 (30.9 – 117.0) 41 185,257 Old 25+ Years No 57.7 (36.2 – 79.2) 44 204,270 Old Wave 3 Adult Cigarillo Age Group Regular/Last Brand of Minutes to First Cigarillo After N Weighted Cigarillo Smoked Waking (Confidence Interval) N Flavored? 18 to 24 Yes 93.8 (18.2 – 169.5) 9 16,252 Years Old 18 to 24 No 102.8 (47.0 – 158.6) 19 55,135 Years Old 25+ Years Yes 100.0 (40.8 – 159.2) 39 189,852 Old 25+ Years No 109.1 (55.9 – 162.2) 56 308,663 Old

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Methodology

This analysis looks at the time to first use (in minutes) of cigarillo usage among “Current Every Day” users of cigarillos in PATH Wave 1, Wave 2 and Wave 3 adult data. “Current Every Day” cigarillo users were defined as having ever used cigarillos, used cigarillos fairly regularly and now use them every day. Time to first use was derived by PATH from minutes to first cigarillo use after waking. This analysis was broken out by age group and whether the regular/last cigarillo brand was flavored or non-flavored. A Student’s t-test was used to compare time to first use between the flavored and non-flavored groups. Source and Data Setup

PATH Wave 1, Wave 2 and Wave 3 Adult Public Use Files were used. Analysis weights were used to account for selection probabilities, differential non-response rates, and possible deficiencies in the sampling frame (e.g., under coverage of certain population groups). Variance estimation was implemented to account for multi-stage complex sampling using balanced repeated replication weights with Fay’s method, as recommended by the PATH Study Public Use Files User Guide. Summary of Outcomes Assessed We conducted analysis for outcomes using PATH Wave 1, Wave 2 and Wave 3 Adult Public Use Files. These outcomes are listed in the table below along with the survey questions and the variables used to derive the outcome variables.

Outcome Measure Variable Question Time to first consumption in R01R_A_EDY_GRILLO DERIVED ‐ Wave 1 Adult Current Everyday Cigarillo minutes ‐ Wave 1 User Time to first consumption in R01R_A_MINFIRST_GRILLO DERIVED – Wave 1 Adult number of minutes from minutes ‐ Wave 1 waking to smoking first cigarillo Time to first consumption in R02R_A_EDY_GRILLO DERIVED ‐ Wave 2 Adult Current Everyday Cigarillo minutes ‐ Wave 2 Smoker Time to first consumption in R02R_A_MINFIRST_GRILLO DERIVED ‐ Wave 2 Adult number of minutes from minutes ‐ Wave 2 waking up to smoking first cigarillo Time to first consumption in R03R_A_EDY_GRILLO DERIVED ‐ Wave 3 Adult Current Every Day Cigarillo minutes ‐ Wave 3 Smoker Time to first consumption in R03R_A_MINFIRST_GRILLO DERIVED ‐ Wave 3 Adult Number of Minutes from minutes ‐ Wave 3 Waking Up to Smoking First Cigarillo

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Consumer Groups This section describes the definition of the consumer groups and variables used to identify these groups, which are used as filters to define sub-samples.

Consumer Groups Definition Variables/Syntax Current Every Day consumer DERIVED ‐ Wave 1 Adult Current Everyday R01R_A_EDY_GRILLO == Wave 1 Cigarillo User "Yes" Current Every Day consumer DERIVED ‐ Wave 2 Adult Current Everyday R02R_A_EDY_GRILLO == Wave 2 Cigarillo Smoker "Yes" Current Every Day consumer DERIVED ‐ Wave 3 Adult Current Every Day R03R_A_EDY_GRILLO == Wave 3 Cigarillo Smoker "Yes" Total sample sizes for consumer groups are reported at the beginning of the results section. Sample sizes may vary from one analysis to another due to missing values (“don’t know” and “refused” answers as well as improbable responses removed by PATH team) on the outcome variables. Actual sample size for each analysis is shown in the outcome tables next to the outcome measures (i.e., “n” and “sum_wts” in the output). Grouping Variables This section describes the definition of the grouping variables, which are used to classify the outcome measures. Grouping variables are usually categorical variables in PATH (i.e., demographic variables) or derived categorical variables.

Grouping Variable Definition Variables/Syntax Regular/last flavor Regular / last brand of cigarillos smoked / smoked as blunts flavored to R01_AG1050CG ‐ Wave 1 taste like menthol, mint, clove, spice, candy, fruit, chocolate, alcohol or other sweets Regular/last flavor Regular/last brand of cigarillos smoked was flavored to taste like menthol, R02_AG1050CG ‐ Wave 2 mint, clove, spice, fruit, chocolate, alcoholic drinks, candy or other sweets Regular/last flavor Regular/last brand of cigarillos smoked was flavored to taste like menthol, R03_AG1050CG ‐ Wave 3 mint, clove, spice, fruit, chocolate, alcoholic drinks, candy or other sweets

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Results: Script Output In this section, we present R script output tables.

Wave 1 Average time to first of flavored versus non‐flavored every day cigarillo smokers.

Base Sizes for Wave 1 Every Day User of cigarillos by Age and Regular/Last Flavor age flavor n 18 to 24 years old Yes 65 18 to 24 years old No 47 25 years old or older Yes 84 25 years old or older No 63

Base Sizes for Wave 2 Every Day User of cigarillos by Age and Regular/Last Flavor age flavor n 18 to 24 years old Yes 22 18 to 24 years old No 12 18 to 24 years old I don’t know 1 25 years old or older Yes 41 25 years old or older No 44 25 years old or older I don’t know 2

Base Sizes for Wave 3 Every Day User of cigarillos by Age and Regular/Last Flavor age flavor n 18 to 24 years old Yes 9 18 to 24 years old No 19 18 to 24 years old I don’t know 5 25 years old or older Yes 39 25 years old or older No 57 25 years old or older I don’t know 2

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Wave 1 Time to First Use of cigarillos among Every Day Users age flavor variable level mean se ci_l ci_u n sum_wts 18 to 24 years old Yes time_to_first NA 123.7301 26.7026 70.7529 176.707 64 134066 18 to 24 years old No time_to_first NA 81.5632 15.3787 51.0523 112.074 46 93510 25 years old or older Yes time_to_first NA 90.4463 14.6865 61.3088 119.584 82 314598 25 years old or older No time_to_first NA 100.1752 20.4907 59.5221 140.828 61 254372

Wave 2 Time to First Use of cigarillos among Every Day Users age flavor variable level mean se ci_l ci_u n sum_wts 18 to 24 years Yes time_to_first NA 139.7784 38.6960 63.0066 216.5502 22 55953.53 old 18 to 24 years No time_to_first NA 76.5195 20.8829 35.0886 117.9505 12 33972.93 old 18 to 24 years I don’t time_to_first NA 240.0000 0.0000 240.0000 240.0000 1 2229.43 old know 25 years old Yes time_to_first NA 73.9244 21.6872 30.8977 116.9512 41 185256.82 or older 25 years old No time_to_first NA 57.7073 10.8273 36.2261 79.1884 44 204269.71 or older 25 years old I don’t time_to_first NA 233.6645 43.1560 148.0443 319.2847 2 9708.89 or older know

Wave 3 Time to First Use of cigarillos among Every Day Users age flavor variable level mean se ci_l ci_u n sum_wts 18 to 24 years Yes time_to_first NA 93.8364 38.1176 18.2123 169.461 9 16251.76 old 18 to 24 years No time_to_first NA 102.7848 28.1169 47.0016 158.568 19 55134.69 old 18 to 24 years I don’t time_to_first NA 41.3727 24.3932 0.0000 108.523 5 11245.86 old know 25 years old or Yes time_to_first NA 100.0140 29.8281 40.8359 159.192 39 189851.68 older 25 years old or No time_to_first NA 109.0686 26.7780 55.9417 162.195 56 308662.81 older 25 years old or I don’t time_to_first NA 92.9056 36.0064 21.4700 164.341 2 5758.62 older know

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T-test P-Values for Time to First Use of cigarillos by Age Group in Wave 1 age test.p.value 18 to 24 years old 0.171184 25 years old or older 0.699567

T-test P-Values for Time to First Use of cigarillos by Age Group in Wave 2 age test.p.value 18 to 24 years old 0.150253 25 years old or older 0.503475

T-test P-Values for Time to First Use of cigarillos by Age Group in Wave 3 age test.p.value 18 to 24 years old 0.850154 25 years old or older 0.821289

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Attachment 18

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Definitions and explanation of PATH analysis: Cessation outcome among young adults (18-24) Table 9: Cessation Outcome Among Young Adults (18-24)

Cessation Outcomes at Wave 2 of Smokers of Flavored and Non‐Flavored Cigarillos Among Young Adults (18‐24) % No Longer Use N Weighted N Product in Wave 1 Tobacco Flavored 321 913,717 18.7% Non‐Flavored 157 432,652 24.3% Cessation Outcomes at Wave 3 of Smokers of Flavored and Non‐Flavored Cigarillos Among Young Adults (18‐24) % No Longer Use Product in Wave 2 N Weighted N Tobacco Flavored 155 478,302 22.1% Non‐Flavored 101 295,048 19.6%

Methodology The following analysis looked at tobacco cessation from Wave 1 to Wave 2 and from Wave 2 to Wave 3 among Young Adults (18-24). Cessation is defined as a “Current Established” user of cigarillos in the previous wave and neither “Current Established” nor a “Current Experimental” user of any one of the following categories in the following Wave: cigarettes, e-cigarettes, smokeless tobacco, snus, cigarillos, traditional cigars, and filtered cigars. The cessation rates are reported by the regular/last flavor of the cigarillos respondents used, and their age, in the previous wave. Source and Data Setup PATH Wave 1, Wave 2 and Wave 3 Adult Public Use Files were used. Analysis weights were used to account for selection probabilities, differential non-response rates, and possible deficiencies in the sampling frame (e.g., under coverage of certain population groups). Variance estimation was implemented to account for multi-stage complex sampling using balanced repeated replication weights with Fay’s method, as recommended by the PATH Study Public Use Files User Guide.

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Summary of Outcomes Assessed We conducted analysis for outcomes using PATH Wave 1, Wave 2 and Wave 3 Adult Public Use Files. These outcomes are listed in the table below along with the survey questions and the variables used to derive the outcome variables.

Outcome Measure Variable Question Current Established R02R_A_CUR_ESTD_CIGS, R02R_A_CUR_ESTD_ECIG, Current Established user of any tobacco R02R_A_CUR_ESTD_GRILLO, R02R_A_CUR_ESTD_GFILTR, user of any tobacco product ‐ Wave 2 R02R_A_CUR_ESTD_GTRAD, R02R_A_CUR_ESTD_SMKLS, product. R02R_A_CUR_ESTD_SNUS Current Experimental R02R_A_CUR_EXPR_CIGS, R02R_A_CUR_EXPR_ECIG, Current user of any tobacco R02R_A_CUR_EXPR_GRILLO, R02R_A_CUR_EXPR_GFILTR, Experimental user of product ‐ Wave 2 R02R_A_CUR_EXPR_GTRAD, R02R_A_CUR_EXPR_SMKLS, any tobacco product. R02R_A_CUR_EXPR_SNUS Current Established R03R_A_CUR_ESTD_CIGS, R03R_A_CUR_ESTD_EPRODS, Current Established user of any tobacco R03R_A_CUR_ESTD_GRILLO, R03R_A_CUR_ESTD_GFILTR, user of any tobacco product ‐ Wave 3 R03R_A_CUR_ESTD_GTRAD, R03R_A_CUR_ESTD_SMKLS, product. R03R_A_CUR_ESTD_SNUS Current Experimental R03R_A_CUR_EXPR_CIGS, R03R_A_CUR_EXPR_EPRODS, Current user of any tobacco R03R_A_CUR_EXPR_GRILLO, R03R_A_CUR_EXPR_GFILTR, Experimental user of product ‐ Wave 3 R03R_A_CUR_EXPR_GTRAD, R03R_A_CUR_EXPR_SMKLS, any tobacco product. R03R_A_CUR_EXPR_SNUS

Consumer Groups This section describes the definition of the consumer groups and variables used to identify these groups, which are used as filters to define sub-samples.

Consumer Groups Definition Variables/Syntax Current Established consumer DERIVED ‐ Wave 1 Adult Current Established R01R_A_CUR_ESTD_GRILLO == ‐ Wave 1 Cigarillo User "Yes" Current Established consumer DERIVED ‐ Wave 2 Adult Current Established R02R_A_CUR_ESTD_GRILLO == ‐ Wave 2 Cigarillo Smoker "Yes"

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Grouping Variables This section describes the definition of the grouping variables, which are used to classify the outcome measures. Grouping variables are usually categorical variables in PATH (i.e., demographic variables) or derived categorical variables.

Grouping Variable Definition Variables/Syntax Adult age group IMPUTED ‐ Age range (7 levels) if_else(R01R_A_AGECAT7_IMP == "18 to 24 at Wave 1 years old", "18 to 24 years old", "25 years old or older") Regular/last Regular / last brand of cigarillos smoked / R01_AG1050CG flavor at Wave smoked as blunts flavored to taste like 1 menthol, mint, clove, spice, candy, fruit, chocolate, alcohol or other sweets Adult age group DERIVED ‐ Age range when interviewed (7 if_else(R02R_A_AGECAT7 == "18 to 24 years at Wave 2 levels) old", "18 to 24 years old", "25 years old or older") Regular/last Regular/last brand of cigarillos smoked was R02_AG1050CG flavor at Wave flavored to taste like menthol, mint, clove, 2 spice, fruit, chocolate, alcoholic drinks, candy or other sweets

Results: Script Output In this section, we present R script output tables.

The following script output table reports the base size for “Current Established” cigarillo users in Wave 1 .

Wave 1 Cigarillo Current Established Young Adult (18-24) Users by Flavor flavor age n Yes 18 to 24 years old 393 No 18 to 24 years old 193

Wave 2 Cigarillo Current Established Young Adult (18-24) Users by Flavor flavor age n Yes 18 to 24 years old 180 No 18 to 24 years old 111 I don’t know 18 to 24 years old 10 NA 18 to 24 years old 5

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Among the base defined above who completed Wave 2 as Adults, tobacco cessation is defined as not a “Current Established” or a “Current Experimental” user of cigarettes, e-cigarette, traditional cigars, cigarillos, filtered cigars, snus and smokeless tobacco in Wave 2. The following table reports the cessation rate by age and regular/last flavor of cigarillo in Wave 1.

Wave 2 Young Adult (18-24) Cessation Rate by Age and Wave 1 Flavored Cigarillo Use age flavor variable level mean se ci_l ci_u n sum_wts 18 to 24 years Yes quit_tobacco NA 0.186732 0.025252 0.142087 0.241457 321 913717 old 18 to 24 years No quit_tobacco NA 0.242573 0.040320 0.172789 0.329321 157 432652 old

Among the base defined above who completed Wave 3 as Adults, tobacco cessation is defined as not a “Current Established” or a “Current Experimental” user of cigarettes, e-cigarette, traditional cigars, cigarillos, filtered cigars, snus and smokeless tobacco in Wave 3. The following table reports the cessation rate by age and regular/last flavor of cigarillo in Wave 2.

Wave 3 Young Adult (18-24) Cessation Rate by Age and Wave 2 Flavored Cigarillo Use age flavor variable level mean se ci_l ci_u n sum_wts 18 to 24 Yes quit_tobacco NA 0.221003 0.033561 0.162463 0.293250 155 478302.5 years old 18 to 24 No quit_tobacco NA 0.196147 0.036855 0.130461 0.284099 101 295048.5 years old 18 to 24 I don’t quit_tobacco NA 0.459933 0.166598 0.199064 0.744774 9 23864.7 years old know 18 to 24 NA quit_tobacco NA 0.000000 0.000000 0.000000 0.000000 4 11465.4 years old

Below is the script output for the two-sample t‐test comparing the cessation rate between the flavored and non-flavored cigarillo product consumers.

T-test P-Value between the Flavored and Non-Flavored Groups at Wave 2 age test.p.value 18 to 24 years old 0.240494

T-test P-Value between the Flavored and Non-Flavored Groups at Wave 3 age test.p.value 18 to 24 years old 0.618020

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Attachment 19

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Definitions and explanation of PATH analysis: Cessation outcome among adults (25+) Table 1011: Cessation Outcome Among Adults (25+)

Cessation Outcomes at Wave 2 of Smokers of Flavored and Non‐Flavored Cigarillos Among Adults (25+)

Product in Wave 1 N Weighted N % No Longer Use Tobacco

Flavored 296 1,342,494 13.1% Non‐Flavored 197 1,042,924 11.9% Cessation Outcomes at Wave 3 of Smokers of Flavored and Non‐Flavored Cigarillos Among Adults (25+) Product in Wave 2 N Weighted N % No Longer Use Tobacco Flavored 220 1,082,104 12.3% Non‐Flavored 191 940,532 9.5%

Methodology The following analysis looked at tobacco cessation from Wave 1 to Wave 2 and from Wave 2 to Wave 3 among Adults (25+). Cessation is defined as a “Current Established” user of cigarillos in the previous wave and neither “Current Established” nor a “Current Experimental” user of any one of the following categories in the following Wave: cigarettes, e-cigarettes, smokeless tobacco, snus, cigarillos, traditional cigars and filtered cigars. The cessation rates are reported by the regular/last flavor of the cigarillos respondents used, and their age, in the previous wave. Source and Data Setup PATH Wave 1, Wave 2 and Wave 3 Adult Public Use Files were used. Analysis weights were used to account for selection probabilities, differential non-response rates, and possible deficiencies in the sampling frame (e.g., under coverage of certain population groups). Variance estimation was implemented to account for multi-stage complex sampling using balanced repeated replication weights with Fay’s method, as recommended by the PATH Study Public Use Files User Guide.

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Outcome Measure Variable Question Current Established R02R_A_CUR_ESTD_CIGS, R02R_A_CUR_ESTD_ECIG, Current Established user of any tobacco R02R_A_CUR_ESTD_GRILLO, R02R_A_CUR_ESTD_GFILTR, user of any tobacco product ‐Wave 2 R02R_A_CUR_ESTD_GTRAD, R02R_A_CUR_ESTD_SMKLS, product. R02R_A_CUR_ESTD_SNUS Current Experimental R02R_A_CUR_EXPR_CIGS, R02R_A_CUR_EXPR_ECIG, Current user of any tobacco R02R_A_CUR_EXPR_GRILLO, R02R_A_CUR_EXPR_GFILTR, Experimental user of product ‐ Wave 2 R02R_A_CUR_EXPR_GTRAD, R02R_A_CUR_EXPR_SMKLS, any tobacco product. R02R_A_CUR_EXPR_SNUS Current Established R03R_A_CUR_ESTD_CIGS, R03R_A_CUR_ESTD_EPRODS, Current Established user of any tobacco R03R_A_CUR_ESTD_GRILLO, R03R_A_CUR_ESTD_GFILTR, user of any tobacco product ‐ Wave 3 R03R_A_CUR_ESTD_GTRAD, R03R_A_CUR_ESTD_SMKLS, product. R03R_A_CUR_ESTD_SNUS Current Experimental R03R_A_CUR_EXPR_CIGS, R03R_A_CUR_EXPR_EPRODS, Current user of any tobacco R03R_A_CUR_EXPR_GRILLO, R03R_A_CUR_EXPR_GFILTR, Experimental user of product ‐ Wave 3 R03R_A_CUR_EXPR_GTRAD, R03R_A_CUR_EXPR_SMKLS, any tobacco product. R03R_A_CUR_EXPR_SNUS

Consumer Groups This section describes the definition of the consumer groups and variables used to identify these groups, which are used as filters to define sub-samples.

Consumer Groups Definition Variables/Syntax Current Established consumer DERIVED ‐ Wave 1 Adult Current Established R01R_A_CUR_ESTD_GRILLO == in Wave 1 Cigarillo User "Yes" Current Established consumer DERIVED ‐ Wave 2 Adult Current Established R02R_A_CUR_ESTD_GRILLO == in Wave 2 Cigarillo Smoker "Yes"

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Grouping Variables This section describes the definition of the grouping variables, which are used to classify the outcome measures. Grouping variables are usually categorical variables in PATH (i.e., demographic variables) or derived categorical variables.

Grouping Variable Definition Variables/Syntax Adult age IMPUTED ‐ Age range (7 levels) if_else(R01R_A_AGECAT7_IMP == "18 to 24 group ‐Wave 1 years old", "18 to 24 years old", "25 years old or older") Regular/last Regular / last brand of cigarillos smoked / R01_AG1050CG flavor ‐ Wave 1 smoked as blunts flavored to taste like menthol, mint, clove, spice, candy, fruit, chocolate, alcohol or other sweets Adult age DERIVED ‐ Age range when interviewed (7 if_else(R02R_A_AGECAT7 == "18 to 24 years group ‐ Wave 2 levels) old", "18 to 24 years old", "25 years old or older") Regular/last Regular/last brand of cigarillos smoked was R02_AG1050CG flavor ‐ Wave 2 flavored to taste like menthol, mint, clove, spice, fruit, chocolate, alcoholic drinks, candy or other sweets

Results: Script Output In this section, we present R script output tables.

The following script output table reports the base size for “Current Established” cigarillo users in Wave 1.

Wave 1 Cigarillo Current Established Adult (25+) Users by Flavor flavor age n Yes 25 years old or 357 older No 25 years old or 243 older

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Wave 2 Cigarillo Current Established Adult (25+) Users by Flavor flavor age n Yes 25 years old or 248 older No 25 years old or 212 older I don’t 25 years old or 16 know older NA 25 years old or 8 older Among the base defined above who completed Wave 2 as Adults, tobacco cessation is defined as not a “Current Established” or a “Current Experimental” user of cigarettes, e-cigarette, traditional cigars, cigarillos, filtered cigars, snus and smokeless tobacco in Wave 2. The following table reports the cessation rate by age and regular/last flavor of cigarillo in Wave 1.

Wave 2 Adult (25+) Cessation Rate by Age and Wave 1 Flavored Cigarillo Use age flavor variable level mean se ci_l ci_u n sum_wts 25 years old or Yes quit_tobacco NA 0.130788 0.022188 0.093076 0.180735 296 1342494 older 25 years old or No quit_tobacco NA 0.119315 0.024181 0.079603 0.175068 197 1042924 older

Wave 3 Adult (25+) Cessation Rate by Age and Wave 2 Flavored Cigarillo Use age flavor variable level mean se ci_l ci_u n sum_wts 25 years old Yes quit_tobacco NA 0.122608 0.031031 0.073889 0.196630 220 1082104.2 or older 25 years old No quit_tobacco NA 0.094649 0.026356 0.054474 0.159457 191 940532.4 or older 25 years old I don’t quit_tobacco NA 0.151907 0.117392 0.039448 0.438582 16 101320.2 or older know 25 years old NA quit_tobacco NA 0.133023 0.155054 0.022695 0.503412 7 39401.7 or older

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Below is the script output for the two-sample t‐test comparing the cessation rate between the flavored and non-flavored cigarillo product consumers.

T-test P-Value between the Flavored and Non-Flavored Groups at Wave 2 age test.p.value 25 years old or 0.726626 older

T-test P-Value between the Flavored and Non-Flavored Groups at Wave 3 age test.p.value 25 years old or 0.492247 older

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Attachment 20

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Limitations of PATH Survey Questions Related to Flavor and Cigar Type

PATH Waves 1 through 3 data have limitations. The PATH survey has an inconsistent cigar questionnaire structure and response options between Waves, limiting the interpretability of Wave-to-Wave comparisons. Below we provide additional details about those limitations.

1. PATH survey questions from Wave to Wave have inconsistent question structure.

The cigar product examples in the “Which type of cigar have you ever smoked?” vary from Wave 1 to Wave 3. For example, in the Wave 1 traditional cigar survey question – R01_YG9104_01 – the cigar product examples are: “Traditional cigars like Macanudo, Romeo y Julieta, Arturo Fuente, or others.”; whereas, in the Wave 3 equivalent survey question for new baseline participants – R03_YG9104_NB_01 – the cigar product examples are “Traditional cigars like Macanudo, Romeo y Julieta, Arturo Fuente, Cohiba, or others.” Therefore, with the addition of “Cohiba” in Wave 3, unequal question parameters exist. This inconsistency is again observed across Wave 1 – Wave 3 for the cigarillo cigar survey questions, R01_YG9104_02 and R03_YG9104_NB_02, respectively. In the Wave 1 cigarillo cigar survey question – R01_YG9104_02 – the cigar product examples are: “Cigarillos or Filtered Cigars: Black & Mild, Swisher Sweets, Dutch Masters, Phillies Blunts, Prime Time, Winchester, or others;” whereas in the Wave 3 equivalent survey question for new baseline participants – R03_YG9104_NB_02 – the cigar product examples are “Cigarillos or Filtered: Cigarillos or filtered cigars like Black & Mild, Swisher Sweets, Dutch Masters, Phillies Blunts, Zig Zag, Prime Time, Cheyenne, or others.” Therefore, with the addition of “Zig Zag” and “Cheyenne” in Wave 3, unequal question parameters exist. Furthermore, Zig Zag offers a portfolio of popular tobacco paper wrappers – which may be used for roll-your-own tobacco products and non-tobacco products (i.e., marijuana cigarettes) – and youth may misclassify their non-tobacco behavior as a result of the question design of R03_YG9104_NB_02. Additionally, as described above, the first few questions put “traditional cigar” and “cigarillo or filtered cigar” at the same level with cigarillo and filtered cigar (two different cigar formats) not being separated until later in the survey. This can potentially mislead respondents into answering the wrong cigar category (e.g., respondents may select a cigarillo brand as their regular filtered cigar brand and vice versa). If a bias is introduced at a high level, it is hard to measure the reliability of the lower-level estimates.

2. Cigar flavor questions in Wave 1 do not have a ‘Choose all that apply’ structure.

In Wave 1, for each cigar – traditional cigar, cigarillo, and filtered cigar – a flavor question asks whether the respondents’ first [Cigar] was flavored: “Was the first [[CIGARFILL] you smoked |cigarillo you smoked as a blunt| |filtered cigar you smoked as a blunt| flavored to taste like menthol, mint, clove, spice, candy, fruit, chocolate, alcohol (such as wine or cognac), or other sweets?”; however, unlike Waves 2 and 3, Wave 1 does not ask single-flavor specific ‘choose all

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that apply’ follow-up questions. Furthermore, in Waves 2 and 3, the routing logic for single- flavor specific questions are “New baseline youth respondents who have ever smoked traditional cigars/cigarillos/ filtered cigars or traditional cigars/cigarillos/filtered cigars as blunts-only and whose first traditional cigar/cigarillo/filtered cigar or traditional cigar/cigarillo/filtered cigar as blunt was flavored, or continuing youth respondents who initiated smoking traditional cigars/cigarillos/filtered cigars or traditional cigars/cigarillos/filtered cigars as blunts-only since their last completed interview and whose first traditional cigar/cigarillo/filtered cigar or traditional cigar/cigarillo/filtered cigar as blunt was flavored.” Therefore, given that the single- flavor specific questions are asked among new baseline ever cigar smokers and continuing youth who initiated cigar smoking between waves, Wave 1 cigar using youth will not be asked this question, and thus, the first cigar use – flavor specific information cannot be discerned from the Wave 1 youth cohort. Rather, only a high-level, any-flavor perspective is attainable from the Wave 1 youth cohort. Therefore, these data provide incomplete flavor specific information.

3. Derived variables do not consider blunt-only use.

Some codebook-derived variables do not consider blunt use, and consequently, analyses may over estimate tobacco use and may misrepresent actual cigar use behavior. For example, R01R_Y_CUR_GRILLO – the derived variable representing current cigarillo use for the youth population – does not incorporate R01_YG9106 – a questionnaire item that asks participants “[How] often has tobacco been replaced with any marijuana?” – and as a result, analysts may not dissect blunt-use from tobacco-only use. Only in Waves 2 and 3 is blunt use considered in the codebook cigar derivations.

4. Skip pattern errors limit analysis.

In Waves 2 and 3, a total of three cigar use behavior questions have skip pattern errors, three cigar flavoring questions have skip pattern errors, and one cigar awareness question has a skip pattern error.

5. Inconsistency in routing logic exists among waves.

Some cigar flavor questions in Wave 2 and 3 do not share the same routing logic. For example, R02_YG9146 asks “Are flavored traditional cigars easier to smoke, about the same, or harder to smoke than unflavored traditional cigars?” among “New baseline youth respondents who have ever seen or heard of traditional cigars, cigarillos, or filtered cigars, or continuing youth respondents.” Whereas the equivalent Wave 3 questionnaire item – R03_YG9146 – is asked among “All youth respondents.” Likewise, this Wave 2 and 3 unequal skip logic is also observed for cigarillo cigars (R02_YG9147 and R03_YG9147) and filtered cigars (R02_YG9148 and R03_YG9148).

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