Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca4-19-02132/USCOURTS-ca4-19-02132-0/pdf.json

Nature of Suit Code: 899
Nature of Suit: Other Statutes - Administrative Procedure Act/Review or Appeal of Agency Decision
Cause of Action: 

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UNPUBLISHED

UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

No. 19-2130

In re: CIGAR ASSOCIATION OF AMERICA; CIGAR RIGHTS OF AMERICA; 

PREMIUM CIGAR ASSOCIATION, f/k/a International Premium Cigar and Pipe 

Retailers Association,

 Appellants.

------------------------------

AMERICAN ACADEMY OF PEDIATRICS; MARYLAND CHAPTERAMERICAN 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.

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,

 Defendants.

------------------------------

STATE OF MARYLAND; MARYLAND ASSOCIATION OF COUNTY 

HEALTH OFFICERS,

 Amicus Supporting Appellees.

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No. 19-2132

AMERICAN ACADEMY OF PEDIATRICS; MARYLAND CHAPTERAMERICAN 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 ASSOCIATIONCONNECTICUT; 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,

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 Defendants,

------------------------------

WASHINGTON LEGAL FOUNDATION; CONSUMER ADVOCATES FOR 

SMOKE-FREE ALTERNATIVES ASSOCIATION; MICHAEL SIEGEL,

 Amici Supporting Appellants.

STATE OF MARYLAND,

 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,

 Defendants - Appellants.

------------------------------

STATE OF MARYLAND; MARYLAND ASSOCIATION OF COUNTY 

HEALTH OFFICERS,

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 Amici Supporting Appellees.

No. 19-2242

In re: AMERICAN E-LIQUID MANUFACTURING STANDARDS 

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,

 Appellants.

------------------------------

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,

 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 

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SERVICES; ALEX M. AZAR, II, in his Official capacity as Secretary of Health 

and Human Services; AMERICAN ASSOCIATION FOR RESPIRATORY CARE,

 Defendants.

------------------------------

WASHINGTON LEGAL FOUNDATION; CONSUMER ADVOCATES FOR 

SMOKE-FREE ALTERNATIVES; MICHAEL SIEGEL,

 Amici Supporting Appellants.

STATE OF MARYLAND; MARYLAND ASSOCIATION OF COUNTY 

HEALTH OFFICERS,

 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 Decided: May 4, 2020

Before AGEE, THACKER, and RUSHING, Circuit Judges.

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, 

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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.

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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 

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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.”

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that the FDA would continue to exercise “enforcement discretion” for an additional oneyear 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 

appeal.

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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 

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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.”).

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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.,

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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 

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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

argue that the 2020 Guidance was enacted without proper APA notice and comment, in 

violation of the district court’s order. Because, in their view, the 2020 Guidance repeats 

the same notice and comment error as the August 2017 Guidance, the Vapor Appellants 

argue it does not moot this appeal. The FDA counters, arguing that the 2020 Guidance is 

procedurally sound and that, in any event, a challenge to the 2020 Guidance must be made 

in a separate action. 

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B.

We hold that the 2020 Guidance moots the Vapor Appellants’ appeal because it 

supersedes the August 2017 Guidance, leaving no possible meaningful relief that this court 

could grant. In other words, any ruling by this court as to the procedural or substantive 

reasonableness of the August 2017 Guidance would amount to nothing more than an 

advisory opinion. 

“Under any conceivable disposition of the [Vapor Appellants’ appeal], it is clear 

that an ultimate determination of the rights and obligations of the parties concerning” the 

2020 Guidance’s procedural adequacy “can emerge only upon consideration of the validity 

of” that policy. CSPI, 727 F.2d at 1164. “That is unquestionably a matter for the district 

court initially, because a determination of the validity of [the 2020 Guidance] necessarily 

requires review of the new administrative record.” Id. As the FDA has represented, the 

August 2017 Guidance “is a dead letter, and cannot be revived in favor of intervenors. Any 

appellate pronouncement on the validity of that rule would be meaningless.” Id. at 1165.

Because this court can offer no relief to the Vapor Appellants in the context of this 

litigation, their appeal has become moot. See Lamprecht v. F.C.C., 958 F.2d 382, 389 

(D.C. Cir. 1992).

Accordingly, we hold the Vapor Appellants’ appeal is moot and dismiss it.5

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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IV.

Motion to Intervene

A.

Next, we consider whether the district court abused its discretion when it denied the

Cigar Appellants’ motion to intervene. We hold it did not. 

Pursuant to Federal Rule of Civil Procedure 24(a)(2), intervention as of right is only 

appropriate when “[o]n timely motion” an intervenor “claims an interest relating to the 

property or transaction that is the subject of the action, and is so situated that disposing of 

the action may as a practical matter impair or impede the movant’s ability to protect its 

interest unless existing parties adequately represent that interest.” Fed. R. Civ. P. 24(a)(2). 

“Thus, in addition to timeliness, intervention of right is dependent on the moving party’s 

fulfillment of three requirements: interest, impairment of interest and inadequate 

representation.” Gould v. Alleco, Inc., 883 F.2d 281, 284 (4th Cir. 1989) (emphasis 

supplied).

“[T]imeliness is a ‘cardinal consideration’ of whether to permit intervention.” 

Houston Gen. Ins. Co. v. Moore, 193 F.3d 838, 839 (4th Cir. 1999); see also id. (“The 

determination of timeliness is committed to the discretion of the district court and will not 

be disturbed on appeal except for an abuse of that discretion.”). The purpose of the 

timeliness exception is to “prevent a tardy intervenor from derailing a lawsuit within sight 

of the terminal.” Alt v. U.S. EPA, 758 F.3d 588, 591 (4th Cir. 2014) (citation omitted).

Thus, a movant’s failure to seek intervention in a timely manner is sufficient to 

justify denial of a motion to intervene. See Gould v. Alleco, Inc., 883 F.2d 281, 286 (4th 

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Cir. 1989). When assessing the timeliness of a motion to intervene in a civil action, “a trial 

court in this Circuit is obliged to assess three factors: first, how far the underlying suit has 

progressed; second, the prejudice any resulting delay might cause the other parties; and 

third, why the movant was tardy in filing its motion.” Alt, 758 F.3d at 591. And in

considering these three Alt factors, we have stressed that courts should be reluctant to stall 

“the momentum of [a] lawsuit” that is in the advanced stages of litigation. Id.

B.

The district court recognized that the Cigar Appellants sought to intervene because 

this case “potentially could disrupt the long-settled course of proceedings” in Cigar 

Association of America v. FDA, No. 16-1460, in the United States District Court for the 

District of Columbia, “an ongoing case in which they filed a challenge to the Deeming 

Rule in 2016.” J.A. 122. The district court determined the motion was untimely: 

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 

interested groups, the Cigar Appellants did not move to intervene at any point during the 

pendency of the district court litigation. Instead, their motion was not filed until September 

4, 2019 -- nearly 18 months after the complaint was filed, four months after the district 

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court granted summary judgment on May 15, 2019, and two months after the district court 

entered its remedy order on July 12, 2019. 

As to the first Alt factor, the underlying suit had progressed literally to its end. See, 

e.g., Houston Gen. Ins. Co., 193 F.3d at 840 (affirming denial of motion to intervene filed 

more than two months after the district court entered its final order of judgment). Though 

a party may intervene for purposes of appeal, Marino v. Ortiz, 484 U.S. 301, 304 (1988), 

none of the parties here raised the Cigar Appellants’ idiosyncratic interest in preserving the 

deadlines in the D.C. case during the course of the underlying litigation. That further 

undercuts the appropriateness of intervention at such a late stage of the present litigation. 

See Alt, 758 F.3d at 591 (“In such circumstances, the court was reasonably reluctant to 

arrest the momentum of the lawsuit so near its final resolution.”).

As to the second factor, the district court noted that the parties had not argued or 

briefed any of the issues raised by the Cigar Appellants throughout the course of the 

litigation and “the delay that litigating new issues theoretically would cause after the 

issuance of a final judgment is not outweighed by the Cigar Associations’ potential success 

on appeal.” J.A. 123. The district court did not abuse its discretion in reaching this 

conclusion. Indeed, we have previously found that the expenditure of “extra effort[s]” on 

the part of the parties could amount to prejudice on which a district court may base its 

denial of a motion to intervene. See Alt, 758 F.3d at 591 (“Affording the court its proper 

deference, we are in no position to disagree.”). The same is true here.

And as to the third Alt factor, the district court held “[t]he Cigar Associations have 

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 

because the district court had already denied the Vapor Appellants’ motion to intervene, 

this argument fails to recognize that the Cigar Appellants were seeking to intervene for 

different reasons. Indeed, the Cigar Appellants were on notice that the FDA was seeking 

to alter the PMTA compliance deadlines at least as early as March 2019, when the FDA 

published its draft superseding guidance. J.A. 182 (noting that the FDA was “reconsidering 

the compliance policy with respect to other deemed tobacco products,” including “flavored 

cigars”). Yet, the Cigar Appellants did not move to intervene for another six months. 

Instead, they filed a motion in the pending District of Columbia case seeking a declaration 

from that court that the deadlines put in place by the district court here did not apply to 

cigar products. See Cigar Ass’n of Am. v. FDA, Mem. in Supp. of Pls.’ Motion for a Decl., 

No. 16-1460, ECF No. 136-1. The District of Columbia court rightly rejected the Cigar 

Appellants’ attempted maneuvering. See Cig Ass’n of Am. v. FDA, 411 F. Supp. 3d 1, 4 

(D.D.C. 2019). Therefore, against this backdrop, it appears the Cigar Appellants “gambled 

and lost in the execution of [their] litigation strategy,” which “engenders little sympathy.” 

Alt, 758 F.3d at 591. We thus decline to disturb the district court’s ruling, which was well 

within its discretion.

Accordingly, we affirm the district court and hold that that it did not abuse its 

discretion when it denied the motion to intervene. 

V.

For the foregoing reasons, the district court’s denial of the Cigar Appellants’ Motion 

to Intervene is affirmed. And because the 2020 Guidance moots the merits of the Vapor 

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Appellants’ appeal, it is dismissed. The FDA has requested its appeal be dismissed if we 

reach the foregoing conclusions about the Appellants’ arguments; therefore, we dismiss 

the remainder of this appeal. 

AFFIRMED IN PART, DISMISSED IN PART

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