USCA4 Appeal: 19-2130 Doc: 165 Filed: 05/04/2020 Pg: 1 of 20
`
`UNPUBLISHED
`
`UNITED STATES COURT OF APPEALS
`FOR THE FOURTH CIRCUIT
`
`
`No. 19-2130
`
`
`
`
`
`Appellants.
`
`
`
`
`
`Plaintiffs - Appellees,
`
`
`In re: CIGAR ASSOCIATION OF AMERICA; CIGAR RIGHTS OF AMERICA;
`PREMIUM CIGAR ASSOCIATION, f/k/a International Premium Cigar and Pipe
`Retailers Association,
`
`
`
`------------------------------
`
`AMERICAN ACADEMY OF PEDIATRICS; MARYLAND CHAPTER-
`AMERICAN ACADEMY OF PEDIATRICS; AMERICAN CANCER SOCIETY
`CANCER ACTION NETWORK; AMERICAN HEART ASSOCIATION;
`AMERICAN LUNG ASSOCIATION; CAMPAIGN FOR TOBACCO-FREE
`KIDS; TRUTH INITIATIVE; DR. LEAH BRASCH, MD; DR. CYNTHIA
`FISHMAN, MD; DR. LINDA GOLDSTEIN, MD; DR. STEVEN HIRSCH, MD;
`DR. DAVID MYLES, MD,
`
`
`
`
`v.
`
`
`UNITED STATES FOOD AND DRUG ADMINISTRATION; NORMAN E.
`SHARPLESS, in his official capacity as Acting Commissioner of Food and Drugs;
`UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES;
`ALEX M. AZAR, II, in his Official capacity as Secretary of Health and Human
`Services,
`
`
`
`------------------------------
`
`STATE OF MARYLAND; MARYLAND ASSOCIATION OF COUNTY
`HEALTH OFFICERS,
`
`
`
`Defendants.
`
`Amicus Supporting Appellees.
`
`

`

`USCA4 Appeal: 19-2130 Doc: 165 Filed: 05/04/2020 Pg: 2 of 20
`
`
`No. 19-2132
`
`
`
`
`
`
`AMERICAN ACADEMY OF PEDIATRICS; MARYLAND CHAPTER-
`AMERICAN ACADEMY OF PEDIATRICS; AMERICAN CANCER SOCIETY
`CANCER ACTION NETWORK; AMERICAN HEART ASSOCIATION;
`AMERICAN LUNG ASSOCIATION; CAMPAIGN FOR TOBACCO-FREE
`KIDS; TRUTH INITIATIVE; DR. LEAH BRASCH, MD; DR. CYNTHIA
`FISHMAN, MD; DR. LINDA GOLDSTEIN, MD; DR. STEVEN HIRSCH, MD;
`DR. DAVID MYLES, MD,
`
`
`
`
`Plaintiffs - Appellees,
`
` v.
`
`
`AMERICAN E-LIQUID MANUFACTURING STANDARDS ASSOCIATION;
`AMERICAN VAPING ASSOCIATION; SMOKE-FREE ALTERNATIVES
`TRADE ASSOCIATION- CALIFORNIA; ARIZONA SMOKE FREE BUSINESS
`ALLIANCE; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION-
`CONNECTICUT; INDIANA SMOKE FREE ASSOCIATION; SMOKE-FREE
`ALTERNATIVES TRADE ASSOCIATION- HAWAII;
`IOWANS FOR
`ALTERNATIVE TO SMOKING AND TOBACCO;
`SMOKE-FREE
`ALTERNATIVES TRADE ASSOCIATION- LOUISIANA; KENTUCKY
`SMOKE FREE ASSOCIATION; SMOKE-FREE ALTERNATIVES TRADE
`ASSOCIATION- RHODE ISLAND; MARYLAND VAPOR ALLIANCE;
`SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- TEXAS; NEW
`YORK STATE VAPOR ASSOCIATION; SMOKE-FREE ALTERNATIVES
`TRADE ASSOCIATION- WISCONSIN; OHIO VAPOR
`TRADE
`ASSOCIATION; RIGHT TO BE SMOKE-FREE COALITION; SMOKE FREE
`ALTERNATIVES TRADE ASSOCIATION; TENNESSEE SMOKE FREE
`ASSOCIATION; TEXAS VAPOR COALITION,
`
`
`
`
` Intervenors - Appellants,
`
`and
`
`
`UNITED STATES FOOD AND DRUG ADMINISTRATION; NORMAN E.
`SHARPLESS, in his official capacity as Acting Commissioner of Food and Drugs;
`UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES;
`ALEX M. AZAR, II, in his Official capacity as Secretary of Health and Human
`Services,
`
`
`
`2
`
`

`

`USCA4 Appeal: 19-2130 Doc: 165 Filed: 05/04/2020 Pg: 3 of 20
`
`
`
` Defendants,
`
`------------------------------
`
`WASHINGTON LEGAL FOUNDATION; CONSUMER ADVOCATES FOR
`SMOKE-FREE ALTERNATIVES ASSOCIATION; MICHAEL SIEGEL,
`
`
`
`STATE OF MARYLAND,
`
`
`
` Amici Supporting Appellants.
`
`Amicus Supporting Appellees.
`
`
`
`No. 19-2198
`
`
`AMERICAN ACADEMY OF PEDIATRICS; AMERICAN CANCER SOCIETY
`CANCER ACTION NETWORK; AMERICAN HEART ASSOCIATION;
`AMERICAN LUNG ASSOCIATION; LEAH BRASCH, MD; CAMPAIGN FOR
`TOBACCO-FREE KIDS; CYNTHIA FISHMAN, MD; LINDA GOLDSTEIN,
`MD; STEVEN HIRSCH, MD; DAVID MYLES, MD; TRUTH INITIATIVE;
`MARYLAND CHAPTER- AMERICAN ACADEMY OF PEDIATRICS,
`
`
`
`
`
`
`
`
`Plaintiffs - Appellees,
`
`v.
`
`
`UNITED STATES FOOD AND DRUG ADMINISTRATION; NORMAN E.
`SHARPLESS, in his Official capacity as Commissioner of Food and Drugs;
`UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES;
`ALEX M. AZAR, II, in his Official capacity as Secretary of Health and Human
`Services,
`
`
`
`------------------------------
`
`STATE OF MARYLAND; MARYLAND ASSOCIATION OF COUNTY
`HEALTH OFFICERS,
`
`
`Defendants - Appellants.
`
`
`
`3
`
`
`
`
`
`

`

`
`
`
`
`USCA4 Appeal: 19-2130 Doc: 165 Filed: 05/04/2020 Pg: 4 of 20
`
`
`
`
`Amici Supporting Appellees.
`
`
`No. 19-2242
`
`
` AMERICAN E-LIQUID MANUFACTURING STANDARDS
`re:
`In
`ASSOCIATION; AMERICAN VAPING ASSOCIATION; ARIZONA SMOKE
`FREE BUSINESS ALLIANCE; INDIANA SMOKE FREE ASSOCIATION;
`IOWANS FOR ALTERNATIVE TO SMOKING AND TOBACCO; KENTUCKY
`SMOKE FREE ASSOCIATION; MARYLAND VAPOR ALLIANCE; NEW
`YORK STATE VAPOR ASSOCIATION; OHIO VAPOR TRADE
`ASSOCIATION; RIGHT TO BE SMOKE-FREE COALITION; SMOKE FREE
`ALTERNATIVES TRADE ASSOCIATION; SMOKE-FREE ALTERNATIVES
`TRADE ASSOCIATION- CALIFORNIA; SMOKE-FREE ALTERNATIVES
`TRADE ASSOCIATION- CONNECTICUT; SMOKE-FREE ALTERNATIVES
`TRADE ASSOCIATION- HAWAII; SMOKE-FREE ALTERNATIVES TRADE
`ASSOCIATION- LOUISIANA; SMOKE-FREE ALTERNATIVES TRADE
`ASSOCIATION- RHODE ISLAND; SMOKE-FREE ALTERNATIVES TRADE
`ASSOCIATION- TEXAS;
`SMOKE-FREE ALTERNATIVES TRADE
`ASSOCIATION- WISCONSIN; TENNESSEE SMOKE FREE ASSOCIATION;
`TEXAS VAPOR COALITION,
`
`
`
`------------------------------
`
`AMERICAN ACADEMY OF PEDIATRICS; AMERICAN CANCER SOCIETY
`CANCER ACTION NETWORK; AMERICAN HEART ASSOCIATION;
`AMERICAN LUNG ASSOCIATION; LEAH BRASCH; CAMPAIGN FOR
`TOBACCO-FREE KIDS; CYNTHIA FISHMAN; LINDA GOLDSTEIN;
`STEVEN HIRSCH; DAVID MYLES; MARYLAND CHAPTER- AMERICAN
`ACADEMY OF PEDIATRICS; TRUTH INITIATIVE,
`
`
`
`
`Appellants.
`
`Plaintiffs - Appellees,
`
`v.
`
`
`UNITED STATES FOOD AND DRUG ADMINISTRATION; SCOTT
`GOTTLIEB, in his Official capacity as Commissioner of Food and Drugs;
`NORMAN E. SHARPLESS, in his Official capacity as Commissioner of Food and
`Drugs; UNITED STATES DEPARTMENT OF HEALTH AND HUMAN
`
`
`
`4
`
`

`

`USCA4 Appeal: 19-2130 Doc: 165 Filed: 05/04/2020 Pg: 5 of 20
`
` Defendants.
`
`SERVICES; ALEX M. AZAR, II, in his Official capacity as Secretary of Health
`and Human Services; AMERICAN ASSOCIATION FOR RESPIRATORY CARE,
`
`
`
`------------------------------
`
`WASHINGTON LEGAL FOUNDATION; CONSUMER ADVOCATES FOR
`SMOKE-FREE ALTERNATIVES; MICHAEL SIEGEL,
`
`
`
`STATE OF MARYLAND; MARYLAND ASSOCIATION OF COUNTY
`HEALTH OFFICERS,
`
`
`
`Amici Supporting Appellants.
`
`Amici Supporting Appellees.
`
`
`Appeals from the United States District Court for the District of Maryland, at Greenbelt.
`Paul W. Grimm, District Judge. (8:18-cv-00883-PWG)
`
`
`
`
`Argued: March 18, 2020
`
`
`Before AGEE, THACKER, and RUSHING, Circuit Judges.
`
`
`
`Decided: May 4, 2020
`
`
`
`Affirmed in part, dismissed in part by unpublished per curiam opinion.
`
`
`
`
`
`
`ARGUED: Eric P. Gotting, KELLER AND HECKMAN LLP, Washington, D.C., for
`Intervenor-Appellants. Mark S. Raffman, GOODWIN PROCTER LLP, Washington, D.C,
`for Appellants. Joshua Revesz, UNITED STATES DEPARTMENT OF JUSTICE,
`Washington, D.C., for Appellant United States Food and Drug Administration. Jeffrey B.
`Dubner, DEMOCRACY FORWARD FOUNDATION, Washington, D.C., for Appellees.
`ON BRIEF: Joseph H. Hunt, Assistant Attorney General, Mark B. Stern, Lindsey Powell,
`Civil Division, UNITED STATES DEPARTMENT OF JUSTICE, Washington, D.C.;
`Robert P. Charrow, General Counsel, UNITED STATES DEPARTMENT OF HEALTH
`AND HUMAN SERVICES, Washington, D.C.; Stacy Cline Amin, Chief Counsel,
`Annamarie Kempic, Deputy Chief Counsel for Litigation, Wendy S. Vicente, Senior
`Counsel, Peter G. Dickos, Associate Chief Counsel, UNITED STATES FOOD AND
`DRUG ADMINISTRATION, Rockville, Maryland, for Appellants. Andrew Kim,
`
`
`
`5
`
`

`

`USCA4 Appeal: 19-2130 Doc: 165 Filed: 05/04/2020 Pg: 6 of 20
`
`Benjamin Hayes, GOODWIN PROCTER LLP, Washington, D.C., for Appellant Cigar
`Association of America. Azim Chowdhury, KELLER AND HECKMAN LLP,
`Washington, D.C., for Intervenor-Appellants. Michael J. Edney, STEPTOE & JOHNSON
`LLP, Washington, D.C., for Appellants Premium Cigar Association and Cigar Rights of
`America. Dennis A. Henigan, Swati Rawani, CAMPAIGN FOR TOBACCO-FREE
`KIDS, Washington, D.C.; Mark E. Greenwold, Washington, D.C.; Sean A. Lev, Nitin
`Shah, DEMOCRACY FORWARD FOUNDATION, Washington, D.C.; Eve L. Hill,
`BROWN GOLDSTEIN & LEVY, LLP, Baltimore, Maryland, for Appellees. Corbin K.
`Barthold, Cory L. Andrews, WASHINGTON LEGAL FOUNDATION, Washington,
`D.C., for Amicus Washington Legal Foundation. Keith D. Price, Andrew D. Ryan,
`Timothy C. Sansone, Zachary S. Merkle, SANDBERG PHOENIX & VON GONTARD,
`P.C., St. Louis, Missouri, for Amici Consumer Advocates for Smoke-Free Alternatives
`Association and Michael Siegel, M.D., M.P.H. Kathleen Hoke, UNIVERSITY OF
`MARYLAND SCHOOL OF LAW, Baltimore, Maryland, for Amicus Maryland
`Association of County Health Officers. Brian E. Frosh, Attorney General, Steven M.
`Sullivan, Solicitor General, John M. Leovy, Assistant Attorney General, Sarah W. Rice,
`Assistant Attorney General, OFFICE OF THE ATTORNEY GENERAL OF
`MARYLAND, Baltimore, Maryland, for Amicus State of Maryland. Rachel S.
`Bloomekatz, Columbus, Ohio, for Amici Public Health Law Center; Action on Smoking
`and Health; American Academy of Allergy, Asthma and Immunology; American College
`of Chest Physicians; American College of Occupational and Environmental Medicine;
`Americans for Nonsmokers’ Rights; American Medical Association; American Public
`Health Association; American Thoracic Society; NAATPN, Inc.; National Association for
`the Medical Direction of Respiratory Care; and National Medical Association.
`
`
`Unpublished opinions are not binding precedent in this circuit.
`
`
`
`
`
`6
`
`

`

`USCA4 Appeal: 19-2130 Doc: 165 Filed: 05/04/2020 Pg: 7 of 20
`
`PER CURIAM:
`
`
`
`This case involves a challenge to an August 2017 Guidance issued by the Food and
`
`Drug Administration (“FDA”) which set a compliance deadline for certain newly deemed
`
`tobacco products. That Guidance was superseded by another Guidance issued by the FDA
`
`in January 2020. Industry groups representing e-cigarettes and other vapor products (the
`
`“Vapor Appellants”) and cigars (the “Cigar Appellants”), along with the FDA, challenge
`
`the district court’s determination that the August 2017 Guidance was unlawful, as well as
`
`the district court’s decision to set its own replacement compliance deadline for the August
`
`2017 Guidance rather than remand for the FDA to issue a new Guidance.
`
`As to the Cigar Appellants, we affirm the district court’s denial of their motion to
`
`intervene. As to the Vapor Appellants, the 2020 Guidance moots the merits of their appeal.
`
`And, because the FDA asks us to dismiss its appeal if we reach the foregoing conclusions,
`
`we dismiss the remainder of the appeal.
`
`
`
`I.
`
`A.
`
`Relevant Background
`
`In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control
`
`Act (the “TCA”), which aims, in part, to reduce the use of tobacco products by children
`
`and adolescents. See 21 U.S.C. § 387 note. The TCA authorizes the FDA to regulate
`
`tobacco products, including “cigarettes, cigarette tobacco, roll-your-own tobacco, and
`
`smokeless tobacco,” as well as “any other tobacco products that the Secretary by regulation
`
`deems to be subject” to the TCA. Id. § 387a(b). Relevant here, the TCA requires
`
`
`
`7
`
`

`

`USCA4 Appeal: 19-2130 Doc: 165 Filed: 05/04/2020 Pg: 8 of 20
`
`manufacturers of new tobacco products1 to submit a Premarket Tobacco Application
`
`(“PMTA”) and receive authorization from the FDA prior to marketing these products.
`
`The PMTA must contain information about the product’s health risks, a statement
`
`of the product’s ingredients, specified manufacturing information, samples of the product,
`
`and the product’s proposed labeling. Id. § 387j(b)(1). A manufacturer of a new tobacco
`
`product may only avoid filing a PMTA if the product “is substantially equivalent to a
`
`tobacco product commercially marketed (other than for test marketing) in the United States
`
`as of February 15, 2007.” Id. § 382j(a)(2)(A)(i)(I).
`
`In accordance with its authority to “deem” new products subject to the TCA, the
`
`FDA issued a final “Deeming Rule” in May 2016 which deemed products such as cigars,
`
`pipe tobacco, and electronic nicotine delivery systems2 (“vapor products”) to be subject to
`
`the TCA. 81 Fed. Reg. 28974, 28982. Recognizing that the Deeming Rule meant that the
`
`newly deemed products may already be on the market without having submitted a PMTA,
`
`the Deeming Rule included a provision giving manufacturers of the newly deemed
`
`products time to come into compliance. Relevant here, the Deeming Rule included
`
`“staggered” twelve to twenty-four month compliance periods for manufacturers of newly
`
`deemed products already on the market. Id. at 29010. The Deeming Rule also specified
`
`
`1“New tobacco products” are “product[s] (including those products in test markets)
`that w[ere] not commercially marketed in the United States as of February 15, 2007,” or
`tobacco products that were modified after that date. 21 U.S.C. § 387j(a)(1).
`
`2 Electronic nicotine delivery systems are often referred to as “vaping” devices,
`including e-cigars, e-hookah, vape pens, personal vaporizers, and electronic pipes. See 81
`Fed. Reg. at 29028. We refer to these products collectively as “vapor products.”
`
`
`
`8
`
`

`

`USCA4 Appeal: 19-2130 Doc: 165 Filed: 05/04/2020 Pg: 9 of 20
`
`that the FDA would continue to exercise “enforcement discretion” for an additional one-
`
`year period while it processed PMTAs. Id. at 29014. The FDA explained that, during that
`
`time, it did not intend to seek to administratively or judicially enforce the statutory
`
`premarket review requirements for products with submitted PMTAs during the initial
`
`compliance period. Id. Together, these two periods, that is, the initial staggered
`
`compliance periods combined with the additional one year of enforcement discretion,
`
`meant that the FDA did not intend to enforce the TCA’s PMTA requirements for most
`
`deemed tobacco products until 2018.
`
`However, in May 2017, the FDA issued guidance that it would not prioritize
`
`enforcement of PMTA requirements for an additional three months beyond the initial
`
`staggered compliance dates set forth in the Deeming Rule. Then, in August 2017, the FDA
`
`again switched course. It issued a new Guidance (the August 2017 Guidance) extending
`
`the compliance period for combustible products like cigars until August 2021, and until
`
`August 2022 for noncombustible products, including most vapor products. Further, the
`
`August 2017 Guidance indicated that the FDA did not intend to prioritize enforcement of
`
`the PMTA requirements “until the agency renders a decision on [the manufacturer’s]
`
`application . . . or the application is withdrawn.” J.A. 143.3
`
`This case arises out of a challenge to the FDA’s August 2017 Guidance, which the
`
`FDA issued without any notice and comment period or other opportunity for public input.
`
`
`3 Citations to the “J.A.” refer to the Joint Appendix filed by the parties in this
`
`9
`
`appeal.
`
`
`
`

`

`USCA4 Appeal: 19-2130 Doc: 165 Filed: 05/04/2020 Pg: 10 of 20
`
`B.
`
`Procedural History
`
`On March 27, 2018, Appellees, six public-health organizations and five
`
`pediatricians, filed their complaint in the district court alleging the August 2017 Guidance
`
`violated the TCA and the Take Care Clause, U.S. Const. art. II, § 3, should have been
`
`issued through the Administrative Procedure Act’s (“APA”) notice and comment
`
`procedures, and was, therefore, arbitrary and capricious. In September 2018, during the
`
`course of litigation, the FDA announced it was considering whether to revisit the
`
`enforcement priorities set forth in the August 2017 Guidance. And in March 2019, the
`
`FDA published a draft superseding guidance in the Federal Register and initiated a notice
`
`and comment period. See 84 FR 9345.
`
`In May 2019, the district court granted summary judgment in favor of Appellees,
`
`holding the August 2017 Guidance was unlawful because it was inconsistent with the
`
`TCA’s mandatory language, and because it was “a legislative, rather than interpretive, rule”
`
`that required notice and comment. J.A. 86–97. However, because the original Deeming
`
`Rule compliance deadline of 2018 had passed during the pendency of litigation, the district
`
`court asked the parties to separately brief the question of an appropriate remedy. While
`
`the supplemental briefs were pending, numerous interest groups, including the Vapor
`
`
`
`10
`
`

`

`USCA4 Appeal: 19-2130 Doc: 165 Filed: 05/04/2020 Pg: 11 of 20
`
`Appellants (but not the Cigar Appellants) moved to intervene. Those motions were
`
`denied.4
`
`In July 2019, the district court entered its “Remedy Order” which directed the FDA
`
`to require all PMTAs to be filed by May 12, 2020, consistent with one of the FDA’s
`
`requests in its briefing. Less than one month later, the Vapor Appellants again moved to
`
`intervene -- this time, for purposes of appeal. Two months after the Remedy Order issued,
`
`the Cigar Appellants filed a motion to intervene. The district granted the Vapor Appellants’
`
`motion but denied the Cigar Appellants’ motion as untimely.
`
`The FDA and the Vapor Appellants appealed from the district court’s Summary
`
`Judgment and Remedy Orders. Appellees and the FDA argue that the Vapor Appellants’
`
`appeal is moot. The Cigar Appellants appeal the district court’s denial of their motion to
`
`intervene and, should they be successful, raise merits issues for consideration on appeal.
`
`On January 2, 2020, while these appeals were pending, the FDA finalized its new
`
`Guidance after receiving over 15,000 comments during the comment period (the “2020
`
`Guidance”). The 2020 Guidance replaced the August 2017 Guidance and set the PMTA
`
`compliance deadline as May 12, 2020.
`
`
`4 The Vapor Appellants appealed the district court’s denial of their first motion to
`intervene in Case No. 19-2242. However, they did not include any argument for reversing
`that decision in their opening brief. Therefore, we affirm the district court’s denial. See,
`e.g., IGEN Int’l, Inc. v. Roche Diagnostics GmbH, 335 F.3d 303, 308 (4th Cir. 2003)
`(“Failure to present or argue assignments of error in opening appellate briefs constitutes a
`waiver of those issues.”).
`
`
`
`11
`
`

`

`USCA4 Appeal: 19-2130 Doc: 165 Filed: 05/04/2020 Pg: 12 of 20
`
`II.
`
`
`
`This Court considers questions of jurisdiction de novo. Lee Graham Shopping Ctr.,
`
`LLC v. Estate of Kirsch, 777 F.3d 678, 680 (4th Cir. 2015). We review the denial of a
`
`motion to intervene for abuse of discretion. Stuart v. Huff, 706 F.3d 345, 349 (4th Cir.
`
`2013).
`
`III.
`
`
`
`Mootness
`
`A.
`
`Before considering the merits of this appeal, we must first consider whether the
`
`Vapor Appellants’ appeal is moot now that the FDA has replaced the challenged August
`
`2017 Guidance.
`
`
`
`“[T]he parties’ stake in the outcome of the case must exist not only at the case’s
`
`inception, but for the entire duration of the proceedings.” CVLR Performance Horses, Inc.
`
`v. Wynne, 792 F.3d 469, 474 (4th Cir. 2015). Thus, “[l]itigation may become moot during
`
`the pendency of an appeal when an intervening event makes it impossible for the court to
`
`grant effective relief to the prevailing party.” Id. And “‘[i]f an event occurs while a case
`
`is pending on appeal that makes it impossible for the court to grant any effectual relief
`
`whatever to a prevailing party, the appeal must be dismissed.’” Incumaa v. Ozmint, 507
`
`F.3d 281, 286 (4th Cir. 2007) (quoting Church of Scientology of Cal. v. United States, 506
`
`U.S. 9, 12 (1992)) (alteration omitted).
`
`
`
`In similar cases, when statutes or regulatory rules have changed during the course
`
`of litigation, courts have found the changes may render the initial suit moot. See, e.g.,
`
`
`
`12
`
`

`

`USCA4 Appeal: 19-2130 Doc: 165 Filed: 05/04/2020 Pg: 13 of 20
`
`Valero Terrestrial Corp. v. Paige, 211 F.3d 112, 116 (4th Cir. 2000); Esposito v. S.C.
`
`Coastal Council, 939 F.2d 165, 171 (4th Cir. 1991); Disabled in Action of Baltimore v.
`
`Bridwell, 820 F.2d 1219, at *4 (4th Cir. 1987) (unpublished); see also Ctr. for Sci. in the
`
`Pub. Interest v. Regan (“CSPI”), 727 F.2d 1161, 1167 (D.C. Cir. 1984). In Valero, the
`
`appellants initially sued in the district court challenging the constitutionality of several
`
`provisions of West Virginia law related to waste disposal. See Valero, 211 F.3d at 115.
`
`The district court initially agreed that the provisions were unconstitutional and entered an
`
`injunction prohibiting their enforcement. See id. While the case was still pending in the
`
`district court on several motions to reconsider, the West Virginia legislature revised the
`
`implicated provisions of West Virginia law. See id. The appellees moved the district court
`
`to dismiss the complaint as moot in light of the revisions, and the district court did so. See
`
`id. We affirmed on appeal because “[t]he amendments repealed the former requirement[s]”
`
`that were the subject of the lawsuit. Id. at 116. Further, we determined that the revisions
`
`did not preclude a mootness finding on the grounds of voluntary cessation by the State.
`
`See id. That doctrine, we held, “is generally limited to the circumstance . . . in which a
`
`defendant openly announces its intention to reenact ‘precisely the same provision’ held
`
`unconstitutional below.” Id. (citing City of Mesquite v. Aladdin’s Castle, Inc., 455 U.S.
`
`283, 289 & n.11 (1982)).
`
`
`
`Considering a similar case involving a change in an agency rule, the D.C. Circuit
`
`held that an intervening change moots a challenge to the prior rule. See CSPI, 727 F.2d at
`
`1167. Importantly, the D.C. Circuit recognized that the agency in that case “was
`
`legitimately empowered to initiate further rulemaking to correct the deficiencies that the
`13
`
`
`
`

`

`USCA4 Appeal: 19-2130 Doc: 165 Filed: 05/04/2020 Pg: 14 of 20
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`district court found in [the prior rule].” Id. at 1164–65. Because the prior rule, which was
`
`the alleged source of the plaintiffs’ harm, had been superseded, the D.C. Circuit determined
`
`“[a]ny appellate pronouncement on the validity of that rule would be meaningless” and
`
`dismissed the appeal. Id. at 1165. Relevant here, the D.C. Circuit also explained that any
`
`challenges to the amended rule “present[ed] a new case” and that any attacks on the new
`
`rule should be “by a separate action.” Id. at 1166.
`
`
`
`The FDA and Appellees argue the 2020 Guidance issued by the FDA moots the
`
`Vapor Appellants’ appeal because it expressly replaces the August 2017 Guidance. As
`
`they see it, any relief this court might grant in relation to the August 2017 Guidance would
`
`be useless as that Guidance no longer exists. Specifically, in the 2020 Guidance, the FDA
`
`explains that it is “prioritizing enforcement of premarket review requirements for [vapor]
`
`products, as described in this section, and is doing so independently of the [district] court
`
`order” regarding the August 2017 Guidance. J.A. 215. Interestingly, the Vapor Appellants
`
`do not dispute that the 2020 Guidance supersedes the August 2017 Guidance. Instead, they
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`argue that the 2020 Guidance was enacted without proper APA notice and comment, in
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`violation of the district court’s order. Because, in their view, the 2020 Guidance repeats
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`the same notice and comment error as the August 2017 Guidance, the Vapor Appellants
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`argue it does not moot this appeal. The FDA counters, arguing that the 2020 Guidance is
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`procedurally sound and that, in any event, a challenge to the 2020 Guidance must be made
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`in a separate action.
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`B.
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`
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`We hold that the 2020 Guidance moots the Vapor Appellants’ appeal because it
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`supersedes the August 2017 Guidance, leaving no possible meaningful relief that this court
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`could grant. In other words, any ruling by this court as to the procedural or substantive
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`reasonableness of the August 2017 Guidance would amount to nothing more than an
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`advisory opinion.
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`“Under any conceivable disposition of the [Vapor Appellants’ appeal], it is clear
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`that an ultimate determination of the rights and obligations of the parties concerning” the
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`2020 Guidance’s procedural adequacy “can emerge only upon consideration of the validity
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`of” that policy. CSPI, 727 F.2d at 1164. “That is unquestionably a matter for the district
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`court initially, because a determination of the validity of [the 2020 Guidance] necessarily
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`requires review of the new administrative record.” Id. As the FDA has represented, the
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`August 2017 Guidance “is a dead letter, and cannot be revived in favor of intervenors. Any
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`appellate pronouncement on the validity of that rule would be meaningless.” Id. at 1165.
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`Because this court can offer no relief to the Vapor Appellants in the context of this
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`litigation, their appeal has become moot. See Lamprecht v. F.C.C., 958 F.2d 382, 389
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`(D.C. Cir. 1992).
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`Accordingly, we hold the Vapor Appellants’ appeal is moot and dismiss it.5
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`5 Of course, the Vapor Appellants may challenge the 2020 Guidance, if they so
`choose, in a separate action brought in the appropriate district court.
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`
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`IV.
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`
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`Motion to Intervene
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`A.
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`
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`Next, we consider whether the district court abused its discretion when it denied the
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`Cigar Appellants’ motion to intervene. We hold it did not.
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`Pursuant to Federal Rule of Civil Procedure 24(a)(2), intervention as of right is only
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`appropriate when “[o]n timely motion” an intervenor “claims an interest relating to the
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`property or transaction that is the subject of the action, and is so situated that disposing of
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`the action may as a practical matter impair or impede the movant’s ability to protect its
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`interest unless existing parties adequately represent that interest.” Fed. R. Civ. P. 24(a)(2).
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`“Thus, in addition to timeliness, intervention of right is dependent on the moving party’s
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`fulfillment of three requirements: interest, impairment of interest and inadequate
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`representation.” Gould v. Alleco, Inc., 883 F.2d 281, 284 (4th Cir. 1989) (emphasis
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`supplied).
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`“[T]imeliness is a ‘cardinal consideration’ of whether to permit intervention.”
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`Houston Gen. Ins. Co. v. Moore, 193 F.3d 838, 839 (4th Cir. 1999); see also id. (“The
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`determination of timeliness is committed to the discretion of the district court and will not
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`be disturbed on appeal except for an abuse of that discretion.”). The purpose of the
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`timeliness exception is to “prevent a tardy intervenor from derailing a lawsuit within sight
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`of the terminal.” Alt v. U.S. EPA, 758 F.3d 588, 591 (4th Cir. 2014) (citation omitted).
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`Thus, a movant’s failure to seek intervention in a timely manner is sufficient to
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`justify denial of a motion to intervene. See Gould v. Alleco, Inc., 883 F.2d 281, 286 (4th
`16
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`Cir. 1989). When assessing the timeliness of a motion to intervene in a civil action, “a trial
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`court in this Circuit is obliged to assess three factors: first, how far the underlying suit has
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`progressed; second, the prejudice any resulting delay might cause the other parties; and
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`third, why the movant was tardy in filing its motion.” Alt, 758 F.3d at 591. And in
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`considering these three Alt factors, we have stressed that courts should be reluctant to stall
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`“the momentum of [a] lawsuit” that is in the advanced stages of litigation. Id.
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`B.
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`
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`The district court recognized that the Cigar Appellants sought to intervene because
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`this case “potentially could disrupt the long-settled course of proceedings” in Cigar
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`Association of America v. FDA, No. 16-1460, in the United States District Court for the
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`District of Columbia, “an ongoing case in which they filed a challenge to the Deeming
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`Rule in 2016.” J.A. 122. The district court determined the motion was untimely:
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`The litigation in the District of Columbia preceded this case
`and they could have sought to intervene months earlier. And,
`unlike the Vapor Associations that could not previously show
`harm to their interests, the Cigar Associations have been aware
`for months that this litigation challenged the deadlines that they
`believed they had negotiated to extend. Yet they chose not to
`seek leave to intervene previously, waiting instead to see if the
`case would survive Defendants’ motion to dismiss and, when
`it did, to see what the remedy would be. “Such deliberate
`forbearance understandably engenders little sympathy.”
`
`
`Id. at 123 (quoting Alt, 758 F.3d at 591). Indeed, unlike the Vapor Appellants and other
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`interested groups, the Cigar Appellants did not move to intervene at any point during the
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`pendency of the district court litigation. Instead, their motion was not filed until September
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`4, 2019 -- nearly 18 months after the complaint was filed, four months after the district
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`
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`court granted summary judgment on May 15, 2019, and two months after the district court
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`entered its remedy order on July 12, 2019.
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`As to the first Alt factor, the underlying suit had progressed literally to its end. See,
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`e.g., Houston Gen. Ins. Co., 193 F.3d at 840 (affirming denial of motion to intervene filed
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`more than two months after the district court entered its final order of judgment). Though
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`a party may intervene for purposes of appeal, Marino v. Ortiz, 484 U.S. 301, 304 (1988),
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`none of the parties here raised the Cigar Appellants’ idiosyncratic interest in preserving the
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`deadlines in the D.C. case during the course of the underlying litigation. That further
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`undercuts the appropriateness of intervention at such a late stage of the present litigation.
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`See Alt, 758 F.3d at 591 (“In such circumstances, the court was reasonably reluctant to
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`arrest the momentum of the lawsuit so near its final resolution.”).
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`As to the second factor, the district court noted that the parties had not argued or
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`briefed any of the issues raised by the Cigar Appellants throughout the course of the
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`litigation and “the delay that litigating new issues theoretically would cause after the
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`issuance of a final judgment is not outweighed by the Cigar Associations’ potential success
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`on appeal.” J.A. 123. The district court did not abuse its discretion in reaching this
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`conclusion. Indeed, we have previously found that the expenditure of “extra effort[s]” on
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`the part of the parties could amount to prejudice on which a district court may base its
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`denial of a motion to intervene. See Alt, 758 F.3d at 591 (“Affording the court its proper
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`deference, we are in no position to disagree.”). The same is true here.
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`And as to the third Alt factor, the district court held “[t]he Cigar Associations have
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`not provided any justification for their delay in raising their issues in this litigation.” Id.
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`Though the Cigar Appellants argue they had no opportunity to move to intervene earlier
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`because the district court had already denied the Vapor Appellants’ motion to intervene,
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`this argument fails to recognize that the Cigar Appellants were seeking to intervene for
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`different reasons. Indeed, the Cigar Appellants were on notice that the FDA was seeking
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`to alter the PMTA compliance deadlines at least as early as March 2019, when the FDA
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`published its draft superseding guidance. J.A. 182 (noting that the FDA was “reconsidering
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`the compliance policy with respect to other deemed tobacco products,” including “flavored
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`cigars”). Yet, the Cigar Appellants did not move to intervene for another six months.
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`Instead, they filed a motion in the pending District of Columbia case seeking a declaration
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`from that court that the deadlines put in place by the district court here did not apply to
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`cigar products. See Ciga