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Comments on "Modifications to Compliance Policy for Certain Deemed Tobacco Products; Draft Guidance for Industry"

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Comments on 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 Reg. 9,345, March 14, 2019) – Comments on “Modifications to Compliance Policy for Certain Deemed Tobacco Products; Draft Guidance for Industry” Altria Client Services (“ALCS”), on behalf of John Middleton Co. (“JMC”),1 submits these comments to the U.S. Food and Drug Administration (“FDA” or the “Agency”) in response to its proposed Modifications to Compliance Policy for Certain Deemed Tobacco Products: Draft Guidance for Industry (“Draft Guidance”)(March 13, 2019). Our comments focus on Part V of the Draft Guidance titled, “Changes to Compliance Policy Regarding Flavored Cigars (Other Than Tobacco Flavored) that Meet the Definition of a New Tobacco Product,” and the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evidence relevant to the issues before the FDA as well as other issues the FDA should consider before finalizing the Draft Guidance. As an initial matter, we reiterate our request that the Agency bifurcate the two distinctly separate parts of the Draft Guidance – electronic nicotine delivery systems (“ENDS”) and flavored cigars.2 We believe that the two components of the Draft Guidance are dramatically different in both substance and effect, and require different approaches by the FDA. Whereas the ENDS component of the Draft Guidance simply shortens a premarket application deadline that is still over two years away and proposes sales and marketing restrictions, the flavored cigar component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 The Agency’s Draft Guidance for flavored cigars, if implemented, would deprive adult tobacco consumers of products they prefer and inflict harm and disruption upon JMC and other regulated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; 3 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 Severely
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