at this time<\/em>, we do not view this development as having any immediate impact\u00a0on industry\u2019s ability to continue marketing such products.\u00a0 We will continue to update you on any important developments.<\/p>\nBackground<\/u><\/strong><\/p>\nOn May 10, 2016, FDA issued a final rule deeming all products that meet the statutory definition of a tobacco product, except accessories of newly deemed tobacco products, to be subject to FDA\u2019s tobacco product authority (Deeming Rule).\u00a0 In conjunction with the Deeming Rule, FDA announced a compliance policy for newly deemed products (e.g., cigars, pipe tobacco, e-cigarettes) that qualify as \u201cnew tobacco products\u201d (i.e., products not commercially marketed in the United States as of February 15, 2007, or modified in any physical respect since) but that were on the U.S. market on the August 8, 2016, effective date of the Deeming Rule (Deemed Products).<\/p>\n
The initial policy allowed the continued marketing of Deemed Products until staggered deadlines for filing premarket review submissions for them (and for up to one year thereafter during FDA\u2019s review of such submissions) as follows:<\/p>\n
\n- Substantial equivalence (SE) exemption requests were due 12 months after the effective date (8\/8\/2017);<\/li>\n
- SE reports were due 18 months after the effective date (2\/8\/2018); and<\/li>\n
- Premarket tobacco applications (PMTAs) were due 24 months after the effective date (8\/8\/2018).<\/li>\n<\/ul>\n
In May 2017, FDA published a guidance document entitled \u201cThree-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule\u201d under which the Agency announced that it would extend by three months all future compliance dates for requirements under the Deeming Rule, including those for premarket submissions for Deemed Products.\u00a0 In July 2017, FDA announced a new comprehensive plan for tobacco and nicotine regulation intended, in part, to \u201censure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act\u201d and \u201c[t]o 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.\u201d\u00a0 In order to reach these goals, FDA further extended the compliance dates for the filing of premarket submissions for Deemed Products to August 8, 2021, for combustible products and to August 8, 2022, for noncombustible products (August 2017 Compliance Policy).\u00a0 FDA also modified the compliance policy by permitting the continued marketing of a Deemed Product after the applicable deadline throughout FDA\u2019s review of a timely filed submission.<\/p>\n
In March 2018, a number of health groups, including the American Academy of Pediatrics and Campaign for Tobacco-Free Kids, as well as a handful of pediatricians, challenged FDA\u2019s August 2017 Compliance Policy\u00a0on the basis that it: (1) conflicts with the Tobacco Control Act, exceeds FDA\u2019s statutory authority, and violates the Constitution\u2019s Take Care clause because premarket review of new tobacco products is required under the statute; (2) was promulgated without notice and comment in violation of the Administrative Procedure Act (APA); and (3) was not the product of reasoned decision-making and is therefore arbitrary and capricious in violation of the APA.<\/p>\n
On March 26, 2019, the District Court issued a Letter Order denying the parties\u2019 motions without prejudice in light of FDA\u2019s issuance of the March 2019 Draft Guidance proposing to revise the Compliance Policy.\u00a0 The court stated that because \u201cthe Draft Guidance, if finalized, will supplant the 2017 Guidance\u2014the focus of Plaintiffs\u2019 claims in this lawsuit\u2014and perhaps necessitate an amendment to Plaintiffs\u2019 Complaint, it is premature and would be neither efficient nor a wise allocation of resources to consider Plaintiffs\u2019 Motion for Summary Judgment at this time, when the very guidance that Plaintiffs\u2019 challenge is subject to possible imminent revision.\u201d\u00a0 However, after the plaintiffs filed a Motion for Reconsideration, the court changed course and decided the case on the merits.<\/p>\n
The Court\u2019s May 15 Decision<\/u><\/strong><\/p>\nOn May 15, 2019, the District Court in\u00a0American Academy of Pediatrics et al. v. FDA<\/em>\u00a0issued an order<\/a>\u00a0finding in favor of the plaintiffs and vacating the August 2017 Guidance.\u00a0 The court ordered: (1) plaintiffs to submit additional briefing regarding a remedy in fifteen pages or less within fourteen days; (2) defendants to respond in fifteen pages or less within fourteen days of the plaintiffs\u2019 submission; and (3) plaintiffs to reply in ten pages or less within five business thereafter.\u00a0 With respect to the \u201cremedy,\u201d the court acknowledged that the application deadlines set in the Deeming Rule and the May 2017 Guidance have passed and states that \u201c[a]ny Guidance providing for a compliance period will, of course, have to adhere to the notice and comment requirements of the APA [Administrative Procedure Act].\u201d\u00a0 The court concludes: \u201c. . . [I]n adopting new Guidance, [FDA] can propose that the deadlines can be set sufficiently soon beyond the end of the notice and comment period to afford relief to Plaintiffs and to attempt to combat the epidemic-level use of new tobacco products like e-cigarettes, especially by teenagers.\u201d<\/p>\nPotential Impact of the May 15 Decision<\/u><\/strong><\/p>\nIt appears that the court misunderstood the underlying facts and both misunderstood and misapplied the applicable law.\u00a0 Based on our initial review, we believe there exists a reasonable likelihood of reversal should FDA appeal the decision.\u00a0 Importantly, because this decision goes to the heart of FDA\u2019s authority to exercise enforcement discretion with respect to premarket review and other legal requirements\u2014a tool FDA commonly uses in implementing the Federal Food, Drug, and Cosmetic Act across all categories of products within the agency\u2019s jurisdiction, including drugs and medical devices\u2014we anticipate that FDA will appeal this decision.\u00a0 Even if FDA does not appeal this decision, however, the court\u2019s reference to the need to adhere to the notice and comment requirements of the APA in implementing the court\u2019s order indicates that industry may still not need to file premarket submissions for Deemed Products for many months if not years.\u00a0 We will continue to monitor this case and update you on any significant developments.<\/p>\n
Please let us know if you have any questions.<\/p>\n
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\nTony Abboud
\nExecutive Director<\/p>\n
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