Case 1:16-cv-01460-APM Document 136-1 Filed 07/02/19 Page 1 of 22

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF COLUMBIA
CIGAR ASSOCIATION OF AMERICA, et )
al., )
)
Plaintiffs, )
v. )
Civil Action No. 16-1460 (APM)
)
UNITED STATES FOOD AND DRUG )
ADMINISTRATION, et al., )
)
Defendants. )
EN FUEGO TOBACCO SHOP LLC, doing )
business as En Fuego Tobacco Shop, et al., )
)
Plaintiffs, )
v. )
Civil Action No. 18-01797 (APM)
)
UNITED STATES FOOD AND DRUG )
ADMINISTRATION, et al., )
)
Defendants. )

MEMORANDUM IN SUPPORT OF PLAINTIFFS’ MOTION FOR PARTIAL

SUMMARY JUDGMENT ON COUNT X OF THE AMENDED COMPLAINT AND FOR
A DECLARATION PURSUANT TO SECTION 705 OF THE APA
Dated: July 2, 2019 Michael J. Edney, DC Bar No. 492024
NORTON ROSE FULBRIGHT US LLP
799 9th Street, NW, Suite 1000
Washington, DC 20001-4501
Telephone: (202) 662-0200
michael.edney@nortonrosefulbright.com

Attorneys for Plaintiffs International Premium

Cigar and Pipe Retailers Association and
Cigar Rights of America

Mark S. Raffman, DC Bar No. 414578

GOODWIN PROCTER LLP
901 New York Avenue NW
Washington, DC 20001
Telephone: (202) 346-4000
mraffman@goodwinlaw.com

Attorneys for Plaintiff Cigar Association of

America
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TABLE OF CONTENTS
PAGE
I. INTRODUCTION ............................................................................................................. 1
II. FACTUAL BACKGROUND ............................................................................................ 4
A. The Plaintiffs Broadly Challenge the Deeming Rule’s Regulation of
Cigars and Pipe Tobacco, and the Court Stayed Several Claims Based on
the Agency’s Extension of Compliance Deadlines and Opening of
Rulemakings to Alter Aspects of the Rule ............................................................. 4
B. The Public Health Advocacy Groups Filed Suit in Maryland Focusing on
E-Cigarettes After This Court Denied Them Standing .......................................... 8
III. ARGUMENT ................................................................................................................... 10
A. The Requested Declaration Would Preserve this Court’s Framework for
Managing this Case .............................................................................................. 10
B. The Equities Strongly Favor a Declaration That the Compliance
Extensions Are Valid for the Products or the Parties Subject to this Case .......... 12
C. The Court Has Ample Legal Authority to Declare the FDA’s Compliance
Extensions Valid for the Products or the Parties Subject to this Case ................. 13
IV. CONCLUSION ................................................................................................................ 17

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TABLE OF AUTHORITIES

Page(s)

Cases

Abbott Labs. v. Gardner,

387 U.S. 136 (1967) ...........................................................................................................15, 16

Am. Acad. of Pediatrics, et al. v. FDA, et al.,

-- F. Supp. 3d --, 2019 WL 2123397 (D. Md. May 15, 2019) .............................................9, 10

Am. Acad. of Pediatrics, et al. v. FDA, et al.,

8:18-cv-00883 (D. Md.) .........................................................................................2, 3, 9, 10, 17

Arizona v. California,
460 U.S. 605 (1983) .................................................................................................................16

Burlington Ins. Co. v. Okie Dokie, Inc.,

439 F. Supp. 2d 124 (D.D.C. 2006) .........................................................................................16

Cigar Assoc. of Am. v. U.S. Food and Drug Admin.,

315 F. Supp. 3d 143 (D.D.C. 2018) .....................................................................................3, 13

Cigar Assoc. of Am. v. U.S. Food and Drug Admin.,

317 F. Supp. 3d 555 (D.D.C. 2018) .....................................................................................3, 12

FBME Bank Ltd. v. Lew,

209 F. Supp. 3d 299 (D.D.C. 2016) .........................................................................................15

Florida v. U.S.,
820 F. Supp. 2d 85 (D.D.C. 2011) ...........................................................................................15

In re GTE Serv. Corp.,

762 F.2d 1024 (D.C. Cir. 1985) ...............................................................................................15

Heckler v. Chaney,
470 U.S. 821 (1985) .................................................................................................................14
Jerome Stevens Pharm., Inc. v. FDA,
319 F. Supp. 2d 45 (D.D.C. 2004) ...........................................................................................14

Missouri Coalition for the Environment v. U.S. Army Corps of Engineers,

369 F. Supp. 3d 151 (D.D.C. 2019) .........................................................................................15

Safety – Kleen Corp. v. EPA,

1996 U.S. App. LEXIS (D.C. Cir. Jan. 19, 1996)....................................................................16

Tierney v. Schweiker,
718 F.2d 449 (D.C. Cir. 1983) .................................................................................................15

UtahAmerican Energy, Inc. v. Dep’t of Labor,

685 F.3d 1118 (D.C. Cir. 2012) ...............................................................................................17

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Rules and Statutes

5 U.S.C. § 705 ......................................................................................................................1, 15, 16

21 U.S.C. §§ 387–387u ....................................................................................................................4

Other Authorities

Content and Format of Substantial Equivalence Reports 84 Fed. Reg. 12,740

(April 2, 2019) .................................................................................................................4, 7, 13

Final Rule, Deeming Tobacco Products to Be subject to the Federal Food, Drug,
and Cosmetic Act, 81 Fed. Reg. 28,974 (May 10, 2016) ..........................................................5

Proposed Rule, Deeming Tobacco Products to Be Subject to the Federal Food,

Drug, and Cosmetic Act, 79 Fed. Reg. 23,142 (Apr. 25, 2014) ......................................1, 5, 12

Regulation of Premium Cigars, 83 Fed. Reg. 12,901 (Mar. 26, 2018) ............................................7

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This brief concerns the continuing judicial challenges to FDA regulation of cigars and

pipe tobacco through its so-called Deeming Rule. 79 Fed. Reg. 23,142. Plaintiffs move for

summary judgment with respect to their proposed amended claim, seeking a declaration

clarifying that the FDA’s enforcement policy extending compliance deadlines for premarket

approval applications and substantial equivalence reports remains valid and in effect for the cigar

and pipe tobacco products that are the subject of this case or, alternatively, for the association

parties in this case and their members. Plaintiffs also move for the same declaration pursuant to

the Court’s authority under Section 705 of the Administrative Procedure Act to preserve the

status quo pending the resolution of judicial challenges to the FDA’s rule. This declaration is

necessary because of a recent opinion from the United States District Court in Maryland,

involving plaintiffs different from the plaintiffs here, which may result in a remedy that threatens

this Court’s case management orders.

I. INTRODUCTION

From the inception of this case, this Court has been the tribunal addressing legal issues

regarding the application of the FDA’s Deeming Rule to cigars and pipe tobacco. Plaintiffs in

this action are trade associations that represent cigar and pipe tobacco manufacturers, retailers,

and consumers. They brought this case in July 2016 to challenge the FDA’s Deeming Rule to

the extent it regulated cigars and pipe tobacco.

Since then, this Court has managed this case through the “serious, substantial [and]

difficult” legal questions raised by the FDA’s treatment of cigars and pipe tobacco in connection

with the Deeming Rule. See ECF No. 106 at 7-8. The Court’s case management efforts have

been based on the FDA’s successive decisions to extend enforcement of compliance deadlines

for certain aspects of the Rule challenged in this litigation. This process culminated in FDA’s

issuance of the August 2017 Guidance extending key compliance deadlines that had not yet

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arrived to allow for rulemakings that may address issues raised in this case. The agency

extended, until August 8, 2021, the deadline for submitting premarket approval applications and

substantial equivalence reports for cigars and pipe tobacco that were on the market as of August

8, 2016. The FDA allowed manufacturers to continue selling such products until August 8, 2021

without a premarket application or substantial equivalence report and thereafter if a premarket

application or substantial equivalence report had been submitted. See U.S. FOOD & DRUG

ADMINISTRATION, EXTENSION OF CERTAIN TOBACCO PRODUCT COMPLIANCE DEADLINES

RELATED TO THE FINAL DEEMING RULE: GUIDANCE FOR INDUSTRY (REVISED) (Aug. 2017).

These extensions allowed the parties to present and the Court to adjudicate claims pertaining to

important aspects of the Rule before they go into effect.

This Court’s intervention is needed to preserve its case management framework. That is

because of an action brought by several public health advocacy groups in the United States

District Court for the District of Maryland. 1 These same public health advocacy groups had

sought to intervene in this case. But, on October 16, 2017, the Court issued a 22-page opinion

concluding that they lacked standing to do so. See ECF No. 68. Instead of asking this Court to

invalidate the Guidance or to reconsider its denial of their intervention motion, the Public Health

Advocacy Groups filed a new lawsuit in the District of Maryland. That suit focused almost

exclusively on e-cigarettes and asked that court to overturn the extensions of compliance dates

provided in the August 2017 Guidance. American Academy of Pediatrics v. Food and Drug

Administration, Case No. 8:18-cv-00883-PWG (D. Md.). In an opinion that, in turn, focuses

almost entirely on e-cigarettes, the District of Maryland (Grimm, J.) granted the Public Health

1
Those groups were the American Academy of Pediatrics, the American Cancer Society Cancer
Action Network, the American Heart Association, the American Lung Association, the
Campaign for Tobacco-Free Kids, and the Truth Initiative (hereinafter, the “Public Health
Advocacy Groups”).

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Advocacy Groups summary judgment and concluded that it would “vacate the FDA’s August

2017 Guidance.” See American Academy of Pediatrics v. Food & Drug Admin., -- F. Supp. 3d --

, 2019 WL 2123397 (D. Md. May 15, 2019) (the “Maryland Opinion”). Because that Guidance

also affects cigars and pipe tobacco, albeit with different extended compliance dates, Judge

Grimm’s opinion threatens this Court’s management of the instant case absent clarification from

this Court about the regime that governs the parties and products in this case.

Plaintiffs respectfully request that this Court enter a declaration that the extensions are

valid for the cigar and pipe tobacco products that are the subject of this case or, alternatively, for

the association plaintiffs and their members. Such a declaration is warranted for at least three

reasons.

First, it would preserve the Court’s case management framework, which allows judicial

testing of each challenged provision of the Rule before it goes into effect. The alternative may

force the Court into a “fire drill” situation to accelerate review, this summer, of the aspects of the

Rule for which compliance dates have been extended by the agency.

Second, it is consistent with this Court’s prior review of the agency’s extensions of

compliance deadlines. The Court characterized as “grossly unfair” imposing the “substantial

compliance costs” of the FDA’s health warning requirements on premium cigar manufacturers,

while the FDA had opened a rulemaking proceeding to reevaluate the regulation. See Cigar

Assoc. of Am. v. U.S. Food and Drug Admin., 315 F. Supp. 3d 143, 175; 317 F. Supp. 3d 555,

562-63 (D.D.C. 2018) (Mehta, J.). The logical converse of the Court’s view is that the agency’s

voluntary extension of other deadlines, while rulemaking proceedings would alter or clarify

aspects of the Rule and judicial challenges were pending, was not an abuse of agency discretion.

That converse amply applies here, given that the agency has announced or opened rulemaking

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proceedings to adjust and to clarify the premarket approval and substantial equivalence process

for cigars and pipe tobacco. See FDA News Release, July 28, 2017; Content and Format of

Substantial Equivalence Reports, 84 Fed. Reg. 12,740 (April 2, 2019).

Third, the requested declaration is well founded in the law. The agency voluntarily has

declined to enforce aspects of the Deeming Rule. Plaintiffs are not asking the Court to force the

agency to act or not to act or to enter a declaration that bars the agency from changing its mind in

the future. An agency’s decision to enforce a rule or regulation is subject to judicial review and

may not be arbitrary or inconsistent with its other reasoning and decisions. But an agency’s

decision to delay enforcement of aspects of a regulation, especially those with which compliance

was not already required, is within an agency’s discretion and not subject to judicial override.

The declaration requested herein would be implementing that well established legal principle.

II. FACTUAL BACKGROUND

A. The Plaintiffs Broadly Challenge the Deeming Rule’s Regulation of Cigars

and Pipe Tobacco, and the Court Stayed Several Claims Based on the
Agency’s Extension of Compliance Deadlines and Opening of Rulemakings
to Alter Aspects of the Rule

Plaintiffs are non-profit associations that represent cigar and pipe tobacco manufacturers,

importers, distributors, suppliers and consumers, as well as premium cigar and pipe tobacco

retail shops. Traditional cigars and pipe tobacco have been sold in this country for hundreds of

years. Despite this long history, Congress declined to regulate these products immediately when

it enacted the Family Smoking Prevention and Tobacco Control Act (“FSPTCA” or the “Act”) in

2009. The Act subjected only cigarettes, roll-your-own tobacco, and smokeless tobacco to

immediate regulation. See generally Pub. L. No. 111–31, 123 Stat. 1776, 1776—1852 (2009)

(codified at 21 U.S.C. §§ 387–387u).

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In passing the Act, Congress left whether and how to regulate cigars and pipe tobacco to

the FDA. On April 25, 2014, the FDA issued a proposed rule that would regulate cigars, pipe

tobacco, and e-cigarettes. See generally Deeming Tobacco Products to Be Subject to the Federal

Food, Drug, and Cosmetic Act, 79 Fed. Reg. 23,142 (Apr. 25, 2014). Among the regulatory

schemes imposed on cigars and pipe tobacco was the requirement for products not on the market

in 2007 to submit premarket approval applications or substantial equivalence reports. Though

the FDA admitted it had misgivings about whether manufacturers could feasibly “identify a

viable predicate” product to show substantial equivalence, id. at 23,176, the agency nonetheless

adopted the Rule on May 10, 2016.

The FDA itself recognized the substantial time that would be required for the industry to

prepare for compliance. So the agency did not require compliance with requirements for various

provisions for many months. Cigar and pipe tobacco warnings were not slated to go into effect

until May 10, 2018. 81 Fed. Reg. 28,974 at 29,006. Deadlines for premarket review

submissions for cigars and pipe tobacco were staggered by application type, with substantial

equivalence reports not due for 18 months and premarket tobacco applications not due for 24

months. 81 Fed. Reg. at 28,978.

Plaintiffs filed this suit in July 2016. The litigation concerns no tobacco product other

than cigars and pipe tobacco. Plaintiffs’ arguments are unique to these products and take direct

aim at the premarket review and substantial equivalence aspects of the Rule, among many others.

Plaintiffs filed a comprehensive motion for summary judgment in February 2017. See

ECF No. 22. At that stage, Plaintiffs were prepared to litigate all aspects of their complaint,

including their challenges to the marketing review and approval scheme. See id. Because of the

contemporaneous change in administration, the agency requested a 30-day extension of its

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deadline to respond to the motion for summary judgment on March 21, 2017. See ECF No. 27 at

2. Plaintiffs consented but noted that further extensions would require corresponding extensions

of compliance deadlines, given the Court’s objective of allowing for a sensible adjudication of

claims challenging major aspects of the Rule before compliance was necessary. See id.

On May 1, 2017, the Government again sought an extension of its deadline to respond to

the motion for summary judgment, this time by three months. See ECF No. 34 at 2. The parties

reported to the Court that “[t]he FDA has represented that it will extend and defer enforcement of

all future compliance deadlines under the Rule for cigar and pipe tobacco products for 3 months,

and that it plans to issue guidance to that effect. Accordingly, Plaintiffs join in this motion.” See

id. The Court thereafter entered an order approving the extension based specifically “[u]pon

consideration of . . . Defendants’ representation that the FDA will extend and defer enforcement

of all future compliance deadlines under the Rule for cigar and pipe tobacco products for 3

months.” ECF No. 35 at 1-2.

Notably, at the time of this order, one of the Public Health Advocacy Groups, Campaign

for Tobacco-Free Kids, already had requested leave of Court to file an amicus curiae brief. See

ECF No. 29. This organization voiced no objection to the extension. All six Public Health

Advocacy Groups thereafter filed their motion to intervene on July 24, 2017. ECF No. 36.

On August 1, 2017, which was the due date for the FDA’s summary judgment response,

the Government sought another briefing extension. See ECF No. 40. This time, the FDA

reported to the Court that it was undertaking a “new comprehensive plan” for regulating tobacco

products, and that it would shortly announce a “new enforcement policy” – i.e., the August 2017

Guidance. See id. at 2-3. The Guidance extended until August 8, 2021 (from November 8, 2018

and May 8, 2018 respectively) the requirement to submit premarket applications and substantial

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equivalence reports for cigars and pipe tobacco that were on the market as of August 8, 2016,

and allowed manufacturers to continue selling such products until August 8, 2021 and thereafter

if an application or report were timely submitted. See ECF No. 51 ¶ 3; Ex. A. (Guidance).

Importantly, this compliance deadline for cigars and pipe tobacco is different from the

corresponding compliance date for e-cigarettes: August 8, 2022. The agency was extending

these deadlines because it was opening new rulemaking dockets that would adjust and clarify the

premarket review and substantial equivalence processes, including the information specific to

cigars and pipe tobacco that would be expected in applications or reports, and that would

reconsider whether premium cigars would be exempt from the Rule and have to go through this

process at all. Importantly, FDA now staggered the compliance deadlines for premarket review

by product category, as opposed to the original compliance deadlines that were staggered based

on whether a product was submitting a substantial equivalence report or a premarket application.

See FDA News Release, July 28, 2017; Content and Format of Substantial Equivalence Reports

84 Fed. Reg. 12,740 (April 2, 2019); Regulation of Premium Cigars, 83 Fed. Reg. 12,901 (Mar.

26, 2018). These dockets remain open.

The parties asked the Court to stay claims relating to the portions of the Deeming Rule

affected by the compliance extensions, which included Plaintiffs’ claims relating to the

premarket review and substantial equivalence process, the inclusion of premium cigars in the

Deeming Rule, and the FDA’s cost-benefit analysis. See ECF No. 53. The explicit premise of

those stays was that the compliance extensions would allow the parties to brief and the Court to

adjudicate these aspects of the Rule, as modified by the announced rulemakings, before

compliance was necessary. And the Court successively entered orders staying these claims. See,

e.g., ECF No. 35 at 1-2 (May 2, 2017 order extending scheduling order “[u]pon consideration of

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. . . Defendants’ representation that the FDA will extend and defer enforcement of all future

compliance deadlines under the Rule for cigar and pipe tobacco products for 3 months”); ECF

No. 40 at 2-3 (Aug. 1, 2017 joint motion to extend briefing deadlines based on July 28

announcement regarding August 2017 Guidance; motion was granted by minute order on August

7, 2017); ECF No. 51 at 2-3 (Sept. 5, 2017 Joint Status Report advising that resolution of claims

relating to premarket review process, inclusion of premium cigars in Deeming Rule and the

FDA’s cost-benefit analysis should be deferred based on August 2021 Extension); ECF Nos. 53,

110, 112, 115 and 119 (numerous joint submissions regarding continued stay of claims regarding

premarket review and substantial equivalence because of August 2017 Guidance and orders

continuing the stay of those claims).

B. The Public Health Advocacy Groups Filed Suit in Maryland Focusing on E-

Cigarettes After This Court Denied Them Standing

On July 24, 2017, the Public Health Advocacy Groups sought to intervene in this Court’s

adjudication of the cigar and pipe tobacco challenges to the Deeming Rule. In doing so, the

groups cited the FDA’s announced compliance extensions as reason for doubt that the FDA and

the Department of Justice would adequately defend the Rule. See ECF Nos. 36 at 7-8, 46 at 11-

12. Though the Public Health Advocacy Groups had endeavored to demonstrate that their

activities would be “perceptibly impaired” absent intervention, the Court rejected their

arguments, holding that the “generalized harm” of the Public Health Advocacy Groups wanting

maximum and most prompt regulation was not enough for standing. See ECF No. 68 at 13-14.

The Public Health Advocacy Groups did not attempt to seek reconsideration or other review of

the Court’s thorough opinion of October 16, 2017 barring them from intervening in the cigar and

pipe tobacco case. See ECF No. 68. Nor did they seek to appeal it on the merits, when aspects

of this Court’s rulings on the merits became final. ECF No. 94.

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On March 27, 2018, however, the Public Health Advocacy Groups filed an independent

lawsuit in the United States District Court for the District of Maryland, this time focusing their

attention on e-cigarettes. The suit challenged the compliance extensions that those Groups had

cited as evidence in this Court that the Government would not adequately defend the Rule. The

Groups’ filings in Maryland highlighted the reportedly soaring popularity of e-cigarettes among

young users as grounds for emergency judicial action.

After the Maryland District Court initially deferred ruling on the Public Health Advocacy

Groups’ motion for summary judgment pending further regulatory action (Am. Acad. of

Pediatrics, et al. v. FDA, et al., 8:18-cv-00883 (D. Md. Mar. 26, 2019), ECF 62), the Groups

sought reconsideration. Two months after its initial ruling, the Maryland District Court reversed

course, granted the motion for reconsideration, and held that the Guidance extending compliance

deadlines under the Deeming Rule was invalid. At the core of the court’s reasoning was that e-

cigarettes presented a novel public health crisis of youth usage that could not await the extended

2022 premarket review deadline. See Maryland Opinion, , -- F. Supp. 3d --, 2019 WL 2123397,

at *1 (D. Md. May 15, 2019) (“As it turns out, even addiction has become electronic”; noting

75% increase in e-cigarette use by high schoolers); id. at *5 (“As noted, youth use of e-cigarettes

has reached epidemic proportions”; also citing FDA statement about “how quickly teenage use

of these products has accelerated” and how “[r]ising e-cigarette use by children makes the

marketing of this product especially deserving of close attention”); id. at *9 (noting how “JUUL,

currently one of the most popular e-cigarettes among school-aged youth, has not gone through

the premarket review process”); id. at n.5, *21 (discussing marketing of “‘Apple Juice’ e-

cigarette” product and similar e-cigarette products that “target a youth market . . . at a time when

minors’ use of tobacco products like e-cigarettes is at an epidemic level and rising”).

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Although Judge Grimm barely mentioned cigars or pipe tobacco in his opinion, he

concluded by stating that he would “vacate the FDA’s August 2017 Guidance” based on the

concerns raised in the opinion, without distinguishing between the e-cigarettes on which his

opinion focused and cigars and pipe tobacco. Judge Grimm ordered supplemental briefing as to

appropriate remedies, which has just been completed. See id. at *26. Proposals include setting

court-ordered enforcement deadlines just months away for the premarket review and substantial

equivalence processes. See Am. Acad. Of Pediatrics v. FDA, Civ. Action No. 8:18-cv-00883,

ECF No. 78 at 9. These deadlines are virtually certain to arrive before the aforementioned open

dockets are closed and any resulting rules are published.

III. ARGUMENT

This Court should declare valid the FDA’s extension of certain deadlines as applied to

cigar and pipe tobacco products or, alternatively, to the association parties in this case and their

members. The declaration would preserve this Court’s framework for managing judicial review

of the FDA’s regulation of cigars and pipe tobacco. It would prevent a “grossly unfair” result of

requiring compliance with aspects of the Deeming Rule that the agency is considering changing

through pending rulemakings. And it would be wholly consistent with applicable law, which

permits the agency to defer enforcement of regulatory requirements, especially when that delay

occurs before the compliance is required.

A. The Requested Declaration Would Preserve this Court’s Framework for

Managing this Case

As an initial matter, the requested declaration would preserve this Court’s framework for

managing litigation challenging the FDA’s regulation of cigars and pipe tobacco. This Court has

deferred adjudication of claims attacking the system of premarket review and substantial

equivalence submissions as applied to cigars and pipe tobacco. ECF No. 35. This system was

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designed to ensure that the parties could fully argue and the Court could fully consider those

challenges before compliance with the underlying regulatory provisions was required. Absent

the declaration and the ambiguity that would ensue regarding whether the extensions for cigars

and pipe tobacco remained in place, the Court would be faced with an entirely unnecessary and

unwarranted judicial emergency, requiring expedited consideration of the merits of these

challenges. This is not what the parties or the Court contemplated when managing this case

based on the extension of compliance deadlines.

The ability of litigants and the Court to rely on scheduling orders and on representations

by parties to craft those orders also strongly supports granting declaratory relief. The FDA’s

extensions, including the Guidance, have been an indispensable feature of the Court’s case

management efforts. Plaintiffs were ready in February 2017 to litigate their summary judgment

motion in full. See ECF No. 22. After agreeing to the FDA’s initial request for a 30-day

extension, Plaintiffs advised the Court that they could not agree to further extensions unless the

FDA agreed to corresponding extensions of the Deeming Rule regulations at issue here, given

the looming FDA deadlines. See ECF No. 27 at 2. All of the subsequent briefing extensions

referenced in this motion were approved based on the FDA’s representations that it was

extending enforcement of the compliance deadlines pursuant to the Guidance and the initial 30-

day extension, so that Plaintiffs and the Court would not be thrown into a fire-drill situation.

That the potential rescission of the Guidance has been prompted by outside entities that

had no standing to be in this lawsuit reinforces the appropriateness of the requested declaration

for the products and/or parties in this case. If a government regulator represents to the Court that

the regulator extended an enforcement deadline on which key litigation deadlines are based, the

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Court should be entitled to presume that the regulator had the authority to extend its deadline and

properly exercised such authority, especially absent a direct challenge in this Court.

B. The Equities Strongly Favor a Declaration That the Compliance Extensions

Are Valid for the Products or the Parties Subject to this Case

Second, the equities tilt strongly in favor of issuing the declaration. The Court previously

recognized in the warning-label context that cigar makers would be irreparably harmed if forced

to undertake “millions of dollars” in new compliance costs that may ultimately be unnecessary

given the possibility of meaningful changes to the Rule. See Cigar Ass’n. of Am., 317 F. Supp.

3d at 562-63. The Court also recognized that it was “grossly unfair” to force premium cigar

makers into immediate compliance with the warning rules when the FDA had sought “additional

information that bears on the need for health warnings on premium cigars.” See id. at 563.

Notably, the Court decided that those considerations were severe enough to warrant injunctive

relief pending appeal, which is a significantly more difficult standard for Plaintiffs to meet than

the standards for simple declaratory relief here. See ECF 106. Again, no party is asking the

Court to force the agency do to anything, but instead to declare that its voluntary course is valid

for the products or, alternatively, the parties in this case.

The compliance burdens arising from immediate enforcement of the premarket review

and substantial equivalence regime are significant, on par with those arising from the health

warnings rules. Although the utility and legality of those processes as applied to cigars and pipe

tobacco are contested by the parties, the dramatic costs are not. The premarket review and

substantial equivalence process is highly costly and burdensome: the FDA observed it had doubt

about whether cigar and pipe tobacco “manufacturers would be able to use the [substantial

equivalence] pathway” to approval. See 79 Fed. Reg. at 23,176. The proposition here, though, is

very limited: That the agency’s voluntary action to delay compliance while it uses rulemaking to

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calibrate what exactly it wants from cigar and pipe tobacco manufacturers in their submissions is

valid.

Put another way, if the FDA’s uncertainty about “the need for health warnings” for

premium cigars were sufficient to make immediate enforcement of the warnings requirement

“grossly unfair” and an “abuse of agency discretion,” it would be a sound and just exercise of

agency discretion to delay enforcement of the premarket review and substantial equivalence

requirements on cigar manufacturers as the agency is seeking to clarify and streamline those

requirements. Cigar Ass’n, 315 F. Supp. 3d at 175. With regard to the premarket review

applications and substantial equivalence reports, the agency has opened rulemakings and

promised guidance that will tell industry participants what must be included in the submissions

and procedures for how the agency will decide them. 84 Fed. Reg. 12,740. This is just the sort

of sensible progression that the parties and the Court contemplated, under which much-needed

“rules of the road” would be proposed, commented upon, and finalized before the issues raised

by these regulatory schemes would be adjudicated in this proceeding. Whether the imposition of

this scheme on cigars and pipe tobacco can be justified will turn, in part, on the content of these

new regulations. And the premarket review and substantial equivalence process is designed to

provide the Food and Drug Administration with information to make a decision about whether

they remain on the market.

C. The Court Has Ample Legal Authority to Declare the FDA’s Compliance
Extensions Valid for the Products or the Parties Subject to this Case

Third, the declaration is fully consistent with applicable law. As an initial matter, the

agency’s decision to extend deadlines for compliance with regulatory provisions, especially

before compliance had been required, is valid. A decision to enforce a provision of a regulation

against private parties is judicially reviewable and must be consistent with the agency’s

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reasoning and justifications in enforcing or declining to enforce other aspects of the regulation.

But the FDA’s decision not to enforce a regulatory provision is presumptively unreviewable.

Heckler v. Chaney, 470 U.S. 821, 835 (1985). The Guidance’s extensions of the premarket

review and substantial equivalence deadlines are thus within the agency’s discretion. That is so,

even as the agency’s decision to enforce and not delay compliance deadlines for other aspects of

the regulation are subject to challenge and must not be arbitrarily inconsistent with the reasoning

underlying the substantial equivalence and premarket review extensions.

It was entirely appropriate for the FDA to accommodate the pending rulemaking

proceedings by extending the Deeming Rule’s premarket review and substantial equivalence

compliance deadlines. Absent such extensions, cigar and pipe tobacco manufacturers would

have been compelled to prepare and submit, and agency staff to process, many thousands of

burdensome premarket applications and substantial equivalence reports. Those reports may not

have provided the agency with the information it desired, without the agency first having

released rules on the subject, and also may have proven unnecessary for premium cigar

manufacturers if the agency were to choose to narrow the category of cigars subject to this

process.

Particularly important here is that the delays in compliance dates are designed to

accommodate processes to modify and clarify the premarket review and substantial equivalence

requirements and were put in place before the compliance deadlines had arrived. This is hardly

an instance of the FDA “abdicating its statutory responsibilities.” Id. at 833 n.4; see Jerome

Stevens Pharm., Inc. v. FDA, 319 F. Supp. 2d 45, 57 (D.D.C. 2004) (determining that there is no

abdication where “deadline extensions do not constitute a permanent policy,” but “rather were

limited to non-approved manufacturers for a period of three years”). The Chaney doctrine is

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particularly applicable because, at the time the agency implemented the extensions, compliance

with the affected provisions was not yet required. As such, the agency was not changing the

status quo of regulatory provisions with which compliance already had been required.

In addition, this Court has broad authority to “enjoy broad discretion when deciding case

management and scheduling matters, . . . a discretion that extends to determining how and in

what order cases should be heard and determined.” Florida v. U.S., 820 F. Supp. 2d 85, 89

(D.D.C. 2011). Indeed, declaratory relief is appropriate when it will serve “a useful purpose in

clarifying the legal relations in issue . . . .” Tierney v. Schweiker, 718 F.2d 449, 456 (D.C. Cir.

1983); Missouri Coalition for the Environment v. U.S. Army Corps of Engineers, 369 F. Supp. 3d

151, 162 (D.D.C. 2019). Such relief is particularly well grounded when the court is managing

complex litigation challenging an agency action. Section 705 of the APA provides that, “[o]n

such conditions as may be required and to the extent necessary to prevent irreparable injury, the

reviewing court, including the court to which a case may be taken on appeal . . . , may issue all

necessary and appropriate process to postpone the effective date of an agency action or to

preserve status or rights pending conclusion of the review proceedings.” 5 U.S.C. § 705. The

declaration here would preserve the “status or rights” of persons affected by the Deeming Rule

while the Deeming Rule is under review. See id.; In re GTE Serv. Corp., 762 F.2d 1024, 1026

(D.C. Cir. 1985); FBME Bank Ltd. v. Lew, 209 F. Supp. 3d 299, 310 (D.D.C. 2016) (staying

implementation of rule under 5 U.S.C. § 705, which “‘authorizes courts to stay agency rules

pending judicial review without any time limit on the duration of the stay.’”) (internal citations

omitted); see also Abbott Labs. v. Gardner, 387 U.S. 136, 155–56 (1967) (discussing availability

of Section 705 to postpone enforcement of federal regulations).

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Here, Plaintiffs are seeking even a lesser judicial intervention than the injunctions

authorized by Section 705 of the APA. Plaintiffs are not asking the Court to force the agency to

do anything, but instead to allow the agency’s voluntary action, facilitating the adjudication of

this case, to remain in place for the products that are the subject of this case or, alternatively, the

parties in this case and their members. 2 The requested declaration would not restrict current or

future agency action in any way: The declaration itself would not prevent the agency from

changing its mind on the scope or timing of the compliance extensions reflected in the Guidance.

It would recognize, however, the validity of the agency’s voluntary extensions for the cigar and

pipe tobacco products or, alternatively, the parties that are the subject of this case.

Finally, the Court may rely on “law of the case” principles to issue the requested

declaration. This Court’s case management orders, relying on the compliance extensions as

applied to cigars and pipe tobacco memorialized in the Guidance, have made those extensions

the “law of the case.” See Burlington Ins. Co. v. Okie Dokie, Inc., 439 F. Supp. 2d 124, 132

(D.D.C. 2006) (holding that courts may permissively apply “law of the case” principles to

interlocutory orders); see also Arizona v. California, 460 U.S. 605, 618 (1983) (describing that

the law of the case doctrine was crafted to direct a court’s discretion). Having relied on the

extensions embodied in the Guidance as a foundation for the scheduling orders in this case, the

Court would be well within its discretion to declare the extensions valid as to the products or the

parties and their members in this suit, so that the integrity of this Court’s orders is preserved.

2
The federal Government has taken the view elsewhere that Section 705 of the APA may only
be invoked to delay a technical effective date of a rule, rather than its later internal compliance
deadlines. See Safety – Kleen Corp. v. EPA, 1996 U.S. App. LEXIS (D.C. Cir. Jan. 19, 1996).
Plaintiffs disagree with this position. The Supreme Court has broadly characterized Section 705
of the APA as a mechanism for courts to use to delay enforcement of an administrative
regulation to permit is judicial review, without focusing on what the agency chooses to describe
as “effective dates” and “compliance dates.” See Abbott Labs, 387 U.S. at 155–56. In this case,
the Court may rely on Section 705 as a font of authority to make the requested declaration.

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Such a declaration would be consistent with this case’s status as the “first filed” suit regarding

cigars and pipe tobacco, which has been the foundation for this Court’s orders accepting transfer

of cigar and pipe tobacco cases filed elsewhere. See En Fuego Tobacco Shop et al., v. FDA, 18-

cv-01797 (APM) (D.D.C. Jan. 11, 2019) ECF No. 78.

This suit was filed long before the Maryland Case by parties that actually have standing.

It focuses squarely on cigars and pipe tobacco, not e-cigarettes, which involve vastly different

policy concerns. First-filed cases typically have priority, and it makes far more sense for this

Court to continue to serve as the “cigar and pipe tobacco” venue after having invested so much

effort in wading through these issues. Cf. UtahAmerican Energy, Inc. v. Dep’t of Labor, 685

F.3d 1118, 1124 (D.C. Cir. 2012) (outlining the “first-filed” rule as applied by the D.C. Circuit).

Drawing a clear distinction between the “cigar litigation” and the “e-cigarette litigation” will also

reduce the risk of conflict between this case and the Maryland Case. The Court should not allow

its carefully crafted approach to this litigation be thrown into chaos just because the Public

Health Advocacy Groups went to another venue and obtained an order premised heavily on a

different type of product with starkly different policy concerns. The Court instead should grant

the declaration.

IV. CONCLUSION

For the reasons set forth above, the Court should grant partial summary judgment and

declare the deadline extensions as reflected in the Guidance to be valid for the products at issue

in this case (or, at the very least, for the parties in this case and their members). Plaintiffs are not

seeking an injunction or to limit the agency’s current or future exercises of discretion in any way.

They simply seek a declaration that the agency’s voluntary deadline extensions remain valid as

to cigars and pipe tobacco, so that this Court need not undertake emergency proceedings to

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evaluate challenges to the regulatory provisions for which compliance has been delayed.

Plaintiffs pray for all other relief to which they are entitled.

Dated: July 2, 2019 Respectfully submitted,

/s/ Michael J. Edney

Michael J. Edney, DC Bar No. 492024
NORTON ROSE FULBRIGHT US LLP
799 9th Street, NW, Suite 1000
Washington, DC 20001-4501
Telephone: (202) 662-0200
Fax: (202) 662-4643
michael.edney@nortonrosefulbright.com

Attorneys for Plaintiffs International Premium

Cigar and Pipe Retailers Association and
Cigar Rights of America

/s/ Mark S. Raffman

Mark S. Raffman, DC Bar No. 414578
GOODWIN PROCTER LLP
901 New York Avenue NW
Washington, DC 20001
Telephone: (202) 346-4000
Fax: (202) 346-4444
mraffman@goodwinlaw.com

Attorneys for Plaintiff Cigar Association of

America

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