D.D.C. 16-cv-01460 DCKT 000120 - 002 Filed 2019-03-15

Case 1:16-cv-01460-APM Document 120-2 Filed 03/15/19 Page 1 of 57
IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF COLUMBIA
EN FUEGO TOBACCO SHOP LLC, doing )

business as En Fuego Tobacco Shop; CUBA )
LIBRE ENTERPRISES LLC, doing business )
as El Cubano Cigars; TEXAS CIGAR )
MERCHANTS ASSOCIATION, )
)
Plaintiffs, )
)
v. )
)
UNITED STATES FOOD AND DRUG ) Civil Action No. 18-01797
ADMINISTRATION; UNITED STATES )
DEPARTMENT OF HEALTH AND )
HUMAN SERVICES; ALEX AZAR II, in )
his official capacity as Secretary of Health )
and Human Services; and SCOTT )
GOTTLIEB, M.D., in his official capacity as )
Commissioner of Food and Drugs, )
)
Defendants. )
MEMORANDUM OF LAW IN SUPPORT OF PLAINTIFFS’ MOTION

FOR SUMMARY JUDGMENT AND A PERMANENT INJUNCTION
Dated: March 15, 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
Clyde M. Siebman, Texas Bar No. 18341600

Elizabeth S. Forrest, Texas Bar No. 24086207
SIEBMAN FORREST BURG & SMITH, LLP
Federal Courthouse Square
300 N. Travis Street
Sherman, TX 75090
Telephone: (903) 870-0070
clydesiebman@siebman.com
elizabethforrest@siebman.com
Counsel for Plaintiffs

TABLE OF CONTENTS
Page
INTRODUCTION ......................................................................................................................... 1
BACKGROUND ........................................................................................................................... 3
I. THE PLAINTIFFS ARE FAMILY-OWNED SMALL BUSINESSES
THAT MAKE AND SELL PREMIUM CIGARS................................................. 3
II. THE FDA IMPOSES A COMPLICATED AND ONEROUS
REGULATORY FRAMEWORK ON PREMIUM CIGARS ............................... 5
III. THE FDA’S MASSIVE AND REPEATED NEW WARNING LABELS
FOR PREMIUM CIGARS .................................................................................... 6
IV. THE FDA OPENS A RULEMAKING DOCKET TO RECONSIDER
THE TREATMENT OF PREMIUM CIGARS IN LIGHT OF NEW
RESEARCH........................................................................................................... 8
ARGUMENT............................................................................................................................... 12
I. STANDARD OF REVIEW ................................................................................. 12
II. THE FDA’S NEW WARNING LABELS VIOLATE THE FIRST
AMENDMENT.................................................................................................... 14
A. The Disclosures Are Not “Purely Factual and Uncontroversial” as
Applied to Premium Cigars, and Thus Must Be Evaluated Under
Strict or Intermediate Scrutiny................................................................. 16
B. The FDA’s New Warnings Fail Either Central Hudson or Strict
Scrutiny.................................................................................................... 20
1. The FDA’s New Warnings Do Not Serve a “Substantial”
Interest.......................................................................................... 21
2. The FDA’s New Warnings Do Not Directly or Materially
Advance the Government’s Interest............................................. 22
3. The FDA’s New Warnings Are Not Narrowly Tailored ............. 23
C. When the Warnings Are Imposed on Premium Cigars, They Fail
the Zauderer Test for Certain Compelled Commercial Disclosures ....... 28
D. The FDA’s Warning Plan Preapproval System Violates the First
Amendment.............................................................................................. 32
III. THE FDA’S NEW WARNINGS REGIME IS ARBITRARY AND
CAPRICIOUS...................................................................................................... 33
A. The FDA’s Enforcement of the Warnings on Premium Cigars,
Despite the Agency’s Ongoing Rulemaking Proceedings, Is
Arbitrary and Capricious.......................................................................... 33
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B. The FDA’s Imposition of the Warnings on Premium Cigars Was

Arbitrary and Capricious.......................................................................... 37
C. The FDA’s Failure to Make the Requisite Statutory Findings
Specific to Premium Cigars Renders the Rule “Contrary to Law” in
Violation of the APA and the Family Smoking Prevention Act.............. 40
IV. THE ISSUANCE OF THE FINAL RULE BY A CAREER EMPLOYEE
OF THE FDA VIOLATES THE CONSTITUTION’S APPOINTMENTS
CLAUSE AND THE APA................................................................................... 42
CONCLUSION............................................................................................................................ 44
- ii -
TABLE OF AUTHORITIES
Page(s)
Cases
AFL-CIO v. FEC,
333 F.3d 168 (D.C. Cir. 2003) .................................................................................................12
*Airmark Corp. v. FAA,

758 F.2d 685 (D.C. Cir. 1985) ...........................................................................................34, 35
Alfa Int’l Seafood v. Ross,

Civ. No. 17-00031, 2017 WL 3738397 (D.D.C. June 22, 2017).............................................43
All. for Nat. Health U.S. v. Sebelius,

775 F. Supp. 2d 114 (D.D.C. 2011) ...................................................................................11, 20
Am. Acad. of Implant Dentistry v. Parker,

860 F.3d 300 (5th Cir. 2017) ...................................................................................................14
*Am. Beverage Ass’n v. City & Cty. of S.F,

Case No. 16-16072, slip op.,
916 F.3d 749 (9th Cir. Jan. 31, 2019) (en banc)........................................15, 16, 25, 29, 30, 31
Am. Meat Inst. v. U.S. Dep’t of Agriculture,

760 F.3d 18 (D.C. Cir. 2014) .......................................................................................18, 21, 31
Arizona v. Thompson,
281 F.3d 248 (D.C. Cir. 2002) .................................................................................................37
Brown v. Entm’t Merchants Ass’n,

564 U.S. 786 (2011).................................................................................................................21
Buckley v. Valeo,
424 U.S. 1 (1976).....................................................................................................................42
Burlington N. & Santa Fe Ry. Co. v. Surface Transp. Bd.,

403 F.3d 771 (D.C. Cir. 2005) .................................................................................................34
Central Hudson Gas & Electric Co. v. Pub. Serv. Comm’n of N.Y.,
447 U.S. 557 (1980).........................................................................2, 14, 20, 21, 22, 23, 26, 32
Cigar Ass’n v. FDA,

315 F. Supp. 3d 143 (D.D.C. 2018) ................................................................................. passim
Cigar Ass’n v. FDA,

317 F. Supp. 3d 555 (D.D.C. 2018) .........................................................................................35
*CTIA—The Wireless Ass’n v. City & Cty. of S.F.,

827 F. Supp. 2d 1054 (N.D. Cal. 2011) ...................................................................................18
- iii -
Del. Dep’t of Natural Res. & Envtl. Control v. EPA,

785 F.3d 1 (D.C. Cir. 2015) .....................................................................................................26
Edmond v. United States,

520 U.S. 651 (1997).................................................................................................................42
Edward J. DeBartolo Corp. v. Fla. Gulf Coast Bldg. & Constr. Trades Council,
485 U.S. 568 (1988).................................................................................................................41
Entm’t Software Ass’n v. Blagojevich,

469 F.3d 641 (7th Cir. 2006) ...................................................................................................31
Freytag v. Comm’r,
501 U.S. 868 (1991).................................................................................................................42
FW/PBS, Inc. v. City of Dall.,

493 U.S. 215 (1990).................................................................................................................32
Gen. Chem. Corp. v. United States,

817 F.2d 844 (D.C. Cir. 1987) .................................................................................................34
*Gerber v. Norton,
294 F.3d 173 (D.C. Cir. 2002) .................................................................................................41
Green Country Mobilephone, Inc. v. FCC,

765 F.2d 235 (D.C. Cir. 1985) .................................................................................................35
Grill v. Quinn,
Civ. No. 10-0757, 2013 WL 3146803 (E.D. Cal. June 18, 2013) ...........................................13
Humane Soc’y of U.S. v. Zinke,

865 F.3d 585 (D.C. Cir. 2017) .................................................................................................37
Individual Reference Servs. Grp., Inc. v. FTC,

145 F. Supp. 2d 6 (D.D.C. 2001) .............................................................................................12
Landry v. FDIC,
204 F.3d 1125 (D.D.C. 2000) ..................................................................................................42
Lorillard Tobacco Co. v. Reilly,

533 U.S. 525 (2001).....................................................................................................23, 25, 32
Marbury v. Madison,
5 U.S. 137 (1803).....................................................................................................................13
McCullen v. Coakley,
134 S. Ct. 2518 (2014).............................................................................................................27
Milavetz, Gallop, & Milavetz, P.A. v. United States,

559 U.S. 229 (2010).................................................................................................................31
Minority Television Project, Inc. v. FCC,

736 F.3d 1192 (9th Cir. 2013) (en banc) .................................................................................14
- iv -
Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co.,
463 U.S. 29 (1983)...................................................................................................................12
*Nat’l Ass’n of Home Builders v. EPA,

682 F.3d 1032 (D.C. Cir. 2012) ...............................................................................................39
Nat’l Ass’n of Mfrs. v. SEC,

800 F.3d 518 (D.C. Cir. 2015) .....................................................................................13, 23, 26
*Nat’l Ass’n of Wheat Growers v. Zeise,

309 F. Supp. 3d 842 (E.D. Cal. 2018)................................................................................18, 19
*Nat’l Inst. of Family & Life Advocates v. Becerra,

138 S. Ct. 2361 (2018)..................................................................................................... passim
Nat’l Med. Enters., Inc. v. Shalala,

826 F. Supp. 558 (D.D.C. 1993) ..............................................................................................13
Nat’l Wildlife Fed’n v. Hodel,

839 F.2d 694 (D.C. Cir. 1988) .................................................................................................38
Nutritional Health All. v. Shalala,

144 F.3d 220 (2d Cir. 1998).....................................................................................................32
Poett v. United States,

657 F. Supp. 2d 230 (D.D.C. 2009) .........................................................................................12
Porter v. Califano,
592 F.2d 770 (5th Cir. 1979) ...................................................................................................13
*Portland Cement Ass’n v. EPA,

665 F.3d 177 (D.C. Cir. 2011) ...........................................................................................34, 36
*R.J. Reynolds Tobacco Co. v. FDA,

696 F.3d 1205 (D.C. Cir. 2012) .......................................................................20, 21, 22, 23, 41
Rubin v. Coors Brewing Co.,

514 U.S. 476 (1995)...........................................................................................................22, 26
Rydeen v. Quigg,
748 F. Supp. 900 (D.D.C. 1990) ..............................................................................................13
Sanjour v. EPA,
56 F.3d 85 (D.C. Cir. 1995) (en banc).....................................................................................24
Sorrell v. IMS Health, Inc.,

564 U.S. 552 (2011).................................................................................................................19
Tucker v. Comm’r,
676 F.3d 1129 (D.C. Cir. 2012) ...............................................................................................42
United Space All., LLC v. Solis,

824 F. Supp. 2d 68 (D.D.C. 2011) ...........................................................................................12
-v-
United States v. Wenger,

427 F.3d 840 (10th Cir. 2005) .................................................................................................31
Va. State Bd. of Pharmacy v. Va. Citizens Consumer Prot. Council,

425 U.S. 748 (1976).................................................................................................................32
Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio,

471 U.S. 626 (1985)...................................................................2, 14, 15, 16, 21, 26, 27, 30, 31
Statutes, Rules, and Regulations
5 U.S.C. § 500 et. seq.........................................................................................................12, 43, 44
Family Smoking Prevention and Tobacco Control Act of 2009,

Pub. L. No. 111–31, 123 Stat. 1776...........................................................................................5
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et. seq. .................5, 6, 19, 37, 40, 41, 43
21 C.F.R. § 1143 ............................................................................................6, 7, 17, 18, 26, 29, 31
Final Rule, Deeming Tobacco Products to Be Subject to the Federal Food, Drug,
and Cosmetic Act, 81 Fed. Reg. at 28,974 (May 10, 2016)............................................. passim
Proposed Rule, Deeming Tobacco Products to Be Subject to the Federal Food,

Drug, and Cosmetic Act, 79 Fed. Reg. 23,142 (Apr. 25, 2014) ..............7, 8, 20, 23, 24, 36, 40
Regulation of Flavors in Tobacco Products, 83 Fed. Reg. 12,294 (Mar. 21, 2018) ......................24
Regulation of Premium Cigars, 83 Fed. Reg. 12,901 (Mar. 26, 2018).................................. passim
Tobacco Product Standard for Nicotine Level of Combusted Cigarettes,

83 Fed. Reg. 11,818 (Mar. 16, 2018).......................................................................................24
U.S. Const. art. II, § 2, cl. 2 ...............................................................................................41, 42, 43
- vi -
Plaintiffs En Fuego Tobacco Shop LLC, Cuba Libre Enterprises LLC, and Texas Cigar
Merchants Association file this motion for summary judgment on all Counts of the Amended
Complaint for Declaratory and Injunctive Relief (the “Complaint”) and for a permanent
injunction. ECF No. 20.
INTRODUCTION
In its 2016 Rule, the FDA imposed a massive warnings labels scheme on premium cigars.
Those warning labels cover 30 percent of the two principal panels of each cigar box and 20
percent of every “advertisement,” or nearly anything that is said about a premium cigar.
What the FDA failed to recognize is that premium cigars are different than other cigars.
Premium cigars are made by the hands of artisan craftsman, wholly from natural tobacco leaf and
water. Premium cigars have dramatically different usage patterns than other cigars. Premium
cigars are almost never used by youth. Premium cigars are used by adults who are older, of
higher-income, and better educated than consumers of other cigars. The few adults who use
premium cigars do so very infrequently, in a manner that suggests an appreciation of the risks of
regular use.
The FDA itself is aware that premium cigars are different. It opened a rulemaking
proceeding to determine whether premium cigars should be regulated at all and, if so, how they
should be regulated differently. See Regulation of Premium Cigars, 83 Fed. Reg. 12,901
(Mar. 26, 2018). In that rulemaking, the FDA is expressly addressing whether and with what
content and in what form premium cigars should bear health warnings. Id. at 12,903-04. The
agency extended several deadlines under the Deeming Rule to accommodate this rulemaking, but
left the warnings deadline in place. This Court recognized that imposition of warning
requirements’ vast compliance costs, as the agency was rethinking those requirements, as “a
grossly unfair exercise of agency authority.” Cigar Ass’n v. FDA, 315 F. Supp. 3d 143, 175
(D.D.C. 2018). As applied to premium cigars, the warnings requirement violates the First
Amendment and the Administrative Procedures Act. The Rule is not a routine commercial
disclosure subject to the Supreme Court’s standard under Zauderer v. Office of Disciplinary
Counsel of Supreme Court of Ohio, 471 U.S. 626 (1985). That is because the content of the
warnings is not “purely factual and uncontroversial” as applied to premium cigars. The agency
is forcing premium cigar manufacturers and retailers to assert as settled science heath warning
content that it is currently reconsidering, the very definition of “controversial” compelled speech.
In any event, the evidence shows that as much as 97 percent of premium cigar consumers use the
product less frequently than daily, and the median premium cigar consumer uses the product 1.7
days per month. Studies by the FDA staff, in turn, show no statistically significant increase in
mortality for those who smoke cigars less frequently than daily. The warnings—blaring the
unqualified risk of cancer—provide an incomplete and thus misleading picture of the health
risks.
As explained below, the Rule fails the strict constitutional scrutiny that applies to
compelled disclosures that are not “purely factual and uncontroversial,” Nat’l Inst. of Family &
Life Advocates v. Becerra, 138 S. Ct. 2361 (2018), or the Supreme Court’s standard under
Central Hudson Gas & Electric Co. v. Pub. Serv. Commission of N.Y., 447 U.S. 557 (1980),
applicable to restrictions of commercial speech.
Even if the Zauderer standard were to apply, the warnings requirements as applied to
premium cigars fail that as well. Their size is “unjustified” and “unduly burdensome” when
applied to premium cigars. Premium cigars are not used by youth or other vulnerable
populations whose behavior large and blaring warnings might be argued to affect. And they are
used with a frequency that shows an appreciation of risk by their consumers. Also, the warnings
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will destroy the luxury, heirloom boxes that define the premium cigar industry and will
overwhelm the particular manner in which premium cigars are regularly sold—in corner tobacco
stores with walk-in humidors where the warning will be repeated hundreds of times. In any
event, the warnings are far more burdensome than those struck down by the Supreme Court and
the en banc Ninth Circuit in opinions subsequent to this Court’s ruling in Cigar Association.
The agency’s decision to enforce the warnings requirement, notwithstanding the
pendency of a rulemaking docket reconsidering the regulation of premium cigars, is arbitrary
and capricious in violation of the Administrative Procedure Act. There is no explanation for
extending other Rule deadlines while the agency’s reformatory rulemakings are pending, but not
the warning requirement deadline. And the agency did no work to explain why the warnings
requirement should extend to premium cigars in the first place. It imbedded in the Rule an
erroneous interpretation of the Family Smoking Prevention Act, claiming warnings on premium
cigars were statutorily required once the decision to regulate them at all was made.
The Court should vacate the warnings requirement as to premium cigars or otherwise
vacate the warnings requirement in its entirety and remand to the agency appropriately to deal
with the premium cigar. In the alternative, it should enjoin the enforcement of the warnings
requirement until one year after the final disposition of the agency’s pending premium cigar
rulemaking docket.
BACKGROUND
I. THE PLAINTIFFS ARE FAMILY-OWNED SMALL BUSINESSES THAT MAKE

AND SELL PREMIUM CIGARS
The Plaintiffs in this case are small, family-owned businesses that make premium cigars or
sell premium cigars in their local Texas communities. Premium cigars are made differently than
mass-produced cigars. They consist only of natural tobacco leaf, water, and a small dab of
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plant-based adhesive. They contain no artificial additives or flavors. Skilled artisans make
premium cigars by hand in a painstaking process that takes years to complete, and each
manufacturer has its own style. As a result of the laborious crafting process, premium cigars are
expensive. Their manufacturing process bears no relation to the machines churning identical,
mass-produced cigars off the assembly line.
All the Plaintiffs are dedicated to the sale of premium cigars and are concerned that those
very unique products have been lumped into an omnibus regulation of all tobacco products. Mark
Moore and his father, Larry, started En Fuego Tobacco Shop LLC (“En Fuego”) in 2006. They
opened their first premium cigar shop in Rockwall, Texas, and, with Mark’s brother, Lee, opened
two additional stores in Frisco and Murphy, Texas. There, they catered to an adult clientele they
knew by name, who would stop by on the weekends or the way home from work to pick up a
couple of cigars, to see the newest special editions, or to watch a baseball game with friends.
Manuel Lopez started El Cubano Cigars in 2006, together with his son, Manuel “Manny”
Lopez Jr. The company counts six generations in the tobacco industry, reaching back to a family
tobacco farm in Cuba at the turn of the 20th Century. Today, El Cubano makes its own brand of
premium cigars, with master artisans rolling each cigar carefully by hand in the Cuban tradition
at its factory in Texas City, Texas. El Cubano sells its cigars at a retail store and lounge just
adjacent to the factory, so its customers can come and see where and how the cigars are made.
El Cubano operates another retail store and lounge for its products in League City, Texas.
The Texas Cigar Merchants Association (“TxCMA”) is a not-for-profit association with
43 members that are local cigar retailers, manufacturers, and distributors. TxCMA’s members are
confronting the threat that warnings will be placed on all of their premium cigar products.
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II. THE FDA IMPOSES A COMPLICATED AND ONEROUS REGULATORY

FRAMEWORK ON PREMIUM CIGARS
In 2016, the FDA issued a rule that subjected the premium cigars made and sold by the
Plaintiffs to a massive regulatory regime. See Final Rule, Deeming Tobacco Products to Be
Subject to the Federal Food, Drug, and Cosmetic Act, 81 Fed. Reg. at 28,974 (May 10, 2016)
(the “Rule”). The Rule was issued by Leslie Kux, Associate Commissioner for Policy at the
FDA. 81 Fed. Reg. at 29,106. The FDA’s website confirms that Ms. Kux is a career employee
of the FDA. Ex. A. According to an FDA Staff Manual, the Associate Commissioner for Policy
is selected by the FDA Commissioner or Deputy Commissioner. 2005 FDA Staff Manual
§ 1431.23 (Ex. B).
The FDA’s Rule placed all cigars into the regulatory scheme Congress constructed for
cigarettes. That scheme stems from the Family Smoking Prevention and Tobacco Control Act of
2009 (the “Family Smoking Prevention Act” or the “Act”). See generally Pub. L. No. 111–31,
123 Stat. 1776. As the Act’s findings demonstrate, Congress passed this legislation to tackle the
problems posed by cigarettes and smokeless tobacco, particularly their widespread use by the
underaged and long-standing allegations that cigarettes had been chemically manipulated to
make them more addictive. See Family Smoking Prevention Act § 2, 123 Stat. at 1776–81.
Congress was not sure that any cigars, much less premium cigars, should be regulated at all; it
left that issue up to the agency to decide through careful rulemaking on a scientific record. See
Federal Food, Drug, and Cosmetic Act (“FD&C Act”) § 901(b), 21 U.S.C. § 387a(b).
The Rule lumped all cigars together, despite the many differences between premium and
mass-marketed cigars. See 81 Fed. Reg. at 29,020–27. Under the Rule, each separate premium
cigar product coming into being after 2007 would need to pass through a painstaking premarket
review process, akin to that for prescription drugs and medical devices. See id. at 29,020; see
-5-
also FD&C Act §§ 905(j), 910(a), 21 U.S.C. §§ 387e(j), 387j(a). Extensive chemical testing is
required for each separate product, even though the technology and methodology to test large
cigars does not even exist. See 81 Fed. Reg. at 29,020; see also FD&C Act § 904(e), 21 U.S.C.
§ 387d(e). Manufacturers would be required to register, to submit ingredient listings for each
product, and to await surprise FDA inspections. See 81 Fed. Reg. at 29,020; see also FD&C Act
§§ 904(a), 905(b)–(g), 21 U.S.C. §§ 387d(a), 387e(b)–(g). As described below, the Rule also
required massive warnings on cigar packages and advertisements.
III. THE FDA’S MASSIVE AND REPEATED NEW WARNING LABELS FOR
PREMIUM CIGARS
The Final Rule requires every cigar package and advertisement to bear one of six warning
statements:
(1) WARNING: Cigar smoking can cause cancers of the mouth and throat, even
if you do not inhale;
(2) WARNING: Cigar smoking can cause lung cancer and heart disease;
(3) WARNING: Cigars are not a safe alternative to cigarettes;
(4) WARNING: Tobacco smoke increases the risk of lung cancer and heart
disease, even in nonsmokers;
(5) WARNING: Cigar use while pregnant can harm you and your baby;
Or SURGEON GENERAL WARNING: Tobacco Use Increases the Risk
of Infertility, Stillbirth, and Low Birth Weight; and
(6) WARNING: This product contains nicotine. Nicotine is an addictive
chemical.
21 C.F.R. § 1143.5(a)(1). Package warnings must occupy at least 30 percent of the two principal
display panels—those “most likely to be displayed, presented, shown, or examined by the
consumer”—and must be printed in black text against a white background, in a font size large
enough that “the required warning statement occupies the greatest possible proportion of the
warning area.” Id. §§ 1143.1, 1143.5(a)(2). The warnings serve as an integrated whole, as each
of the six statements “must be randomly displayed in each 12-month period, in as equal number
of times as is possible on each brand of cigar sold in product packaging.” Id. § 1143.5(c)(1).
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On cigar advertisements, the warnings must cover at least 20 percent of the area of each
advertisement and must be printed in black text against a white background, again taking up as
much of the allocated space as possible. Id. § 1143.5(b)(2). As with the package warnings,
manufacturers and retailers cannot choose among the warnings as they wish; all six must be
rotated. See id. § 1143.5(c)(2). Importantly, a premium cigar retailer cannot just make a decision
to advertise and then include the warnings; rather it must submit a written rotation plan to the FDA
twelve months in advance of advertising. Id. § 1143.5(c)(3). Until the agency approves that
warning plan—an action constrained by no final deadline—a retailer or manufacturer cannot sell or
advertise its products. See id. § 1143.5(c); 81 Fed. Reg. at 29,072–73.
The FDA has defined “advertising” to cover just about every communication with
consumers about a cigar. If a local tobacconist like En Fuego sends a flyer or an e-mail,
maintains a website or a Facebook account, or posts a description of the qualities of a cigar in his
store, all must bear the warning. See 21 C.F.R. § 1143.5(b); see also 81 Fed. Reg. at 29,062
(“interpret[ing] broadly” the term “advertisement” to include “statements regarding the
availability of tobacco products”). During radio ads, one of the six warnings must be read aloud.
See 81 Fed. Reg. at 29,064. Every retail store must display all six cigar warning statements in at
least 17-point font on an 8.5 x 11 inch sign posted at each cash register. 21 C.F.R.
§ 1143.5(a)(3). These overlapping requirements ensure that the Government’s message will be
repeated hundreds of times in each store, in a glaring black-on-white format. Photographs of El
Cubano’s cigar boxes, with and without the new warnings, and photographs of the retail humidors
at El Cubano’s and En Fuego’s stores can be found in the Addendum at the end of this brief.
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IV. THE FDA OPENS A RULEMAKING DOCKET TO RECONSIDER THE

TREATMENT OF PREMIUM CIGARS IN LIGHT OF NEW RESEARCH
The agency was not sure that premium cigars should be regulated by the FDA, and it still
is not. When it started the process leading to the Rule, the FDA proposed so-called “Option 2,”
which would have entirely exempted from regulation a class of premium cigars. See Proposed
Rule, Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic Act, 79
Fed. Reg. 23,142, 23,150 (Apr. 25, 2014). The FDA defined “premium cigars” as those with a
100 percent tobacco leaf wrapper and binder, made by hand, lacking characterizing flavors, and
costing more than $10 for each cigar. Id.1 The agency observed that the demographics of
premium cigar customers and their usage patterns may not warrant regulation and that the
regulatory burden could cripple the many small businesses in the premium cigar industry. Id. at
23,150–52; Preliminary Regulatory Impact Analysis (“PRIA”) at 65–67. With little explanation,
the agency rejected Option 2 in the Final Rule. See 81 Fed. Reg. at 29,026.
The new Administration recognized the Rule’s many defects. On July 28, 2017, the
agency announced a comprehensive overhaul of its regulation of tobacco products. See FDA
Press Release (July 28, 2017) (Ex. C). The agency promised to take a new look through
1
In particular, the agency defined “premium cigar” to mean “a cigar that: (1) Is wrapped in
whole tobacco leaf; (2) contains a 100 percent leaf tobacco binder; (3) contains primarily long
filler tobacco; (4) is made by combining manually the wrapper, filler, and binder; (5) has no
filter, tip, or non-tobacco mouthpiece and is capped by hand; (6) has a retail price (after any
discounts or coupons) of no less than $10 per cigar (adjusted, as necessary, every 2 years,
effective July 1st, to account for any increases in the price of tobacco products since the last
price adjustment); (7) does not have a characterizing flavor other than tobacco; and (8) weighs
more than 6 pounds per 1000 units.” Id. at 23,150. Plaintiffs, as many commenters urged the
agency, believe the price requirement should be eliminated from the definition of premium cigar.
That position is consistent with the research conducted by Dr. Corey and the FDA staff, which
identified premium brands first on the basis of tobacco blends, components, and manufacturing
process, using a $2 per cigar minimum price threshold in those cases where a survey respondent
could not remember or did not specify the brand. Corey et al. at 3 (Ex. D). The definition’s
requirements of manufacture by hand and from whole leaf tobacco ensure that premium cigars
will remain considerably more expensive than machine-made, non-premium cigars.
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rulemaking at whether and how premium cigars should be regulated and to fix other aspects of
the Rule. Id. At the same time, the agency said the focus of its efforts should be in reducing use
of cigarettes, the most dangerous product on a continuum of risk. Id. And it declared a
regulatory focus on flavored tobacco products, including flavored cigars, out of concern that they
were more attractive to youth. Id. To accommodate this review, the agency extended most of
the Rule’s deadlines until 2020 at the earliest. But it left the August 10, 2018 compliance date
for cigar warnings in place, without explaining why.
The FDA followed through and opened a new rulemaking docket explicitly to reconsider
whether premium cigars should be regulated differently or at all. See 83 Fed. Reg. 12,901. The
agency placed the warnings squarely on the table, soliciting data on whether the “advertising,
labeling, and/or packaging requirements . . . should be applied differently to premium cigars.”
Id. at 12,903–04. The docket also sought information about the accuracy of the warnings
statements themselves as applied to premium cigars. Id. at 12,904.
The agency’s Advance Notice of Proposed Rulemaking highlighted a recent study
conducted by the FDA’s own staff and led by Dr. Catherine Corey. See id. at 12,902 (citing
Catherine G. Corey et al., U.S. Adult Cigar Smoking Patterns, Purchasing Behaviors, and
Reasons for Use According to Cigar Type: Findings from the Population Assessment of Tobacco
and Health (PATH) Study, 2013-14, Nicotine & Tobacco Res., Sept. 15, 2017 (Ex. D)). That
paper analyzed data collected in 2013-2014 (Wave 1) from the FDA Center for Tobacco
Products’ Population Assessment of Tobacco and Health (PATH) Study, which is an ongoing,
“nationally representative, longitudinal cohort study of 45,971 adults and youth in the United
States.” Corey et al. at 2. Dr. Corey’s work found “clear distinctions between premium and
non-premium smoker characteristics, use patterns and purchasing behaviors.” Id. at 1, 4 tbl.1.
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Among other findings, Dr. Corey showed that premium cigars are consumed far less frequently
than other cigar types or cigarettes. Id. at 5 tbl.2.
The comment period for the Advance Notice of Proposed Rulemaking closed on July 25,
2018. 83 Fed. Reg. at 12,901. Submissions answering the FDA’s call for additional studies and
information concerning premium cigars included a comprehensive review of the PATH data by
Dr. Faten Sabry and her colleagues at NERA Economic Consulting. Dr. Sabry’s study analyzed
newly available PATH data from Waves 2 and 3, covering 2014 to 2016. See Faten Sabry, et al.,
Report Regarding Consumption Patterns of Premium Cigars, July 25, 2018, at ¶¶ 4-6 (Ex. 1 to
Declaration of Faten Sabry (“Sabry Decl.”)). Dr. Sabry’s analysis showed a gulf between the
usage patterns of premium cigars and other cigars.
First, premium cigars are used much less frequently than mass-marketed cigars or
cigarettes. The median consumer of cigarettes smokes nearly every day. See Sabry et al. at
¶¶ 40-44, tbls.4a-c (Sabry Decl. Ex. 1); Corey et al. at 5 tbl.2 (Ex. D). The median consumer of
premium cigars uses them just 1.3 to 1.7 days per month. See id. Nearly all premium cigar
consumers—from 93.1% in PATH Study Wave 1 to 96.5% in Wave 3—use premium cigars less
frequently than daily, and generally much less. See Sabry et al. at ¶¶ 40-44, tbls.4a-c; Corey et
al. at 5 tbl.2 (93.3% at Wave 1).
Second, there is no evidence that premium cigar use leads to cigarette use. Only 2.3% of
adult premium cigar users who were not everyday cigarette smokers at the end of Wave 1 in
2014 had become everyday cigarette smokers by the end of Wave 3 in 2016; not statistically
different from the 1.1% of adult study participants who were not users of any combustible
tobacco product at the end of Wave 1 but who became everyday cigarette smokers by the end of
Wave 3. See Sabry et al. at ¶ 51, tbl.6.
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Third, premium cigars are used almost exclusively by adults. Overall youth premium
cigar use was almost imperceptible across all three PATH Study waves and declined over time
from 0.08% in Wave 1 to 0.02% in Wave 3. See Sabry et al. at ¶¶ 25-26, tbl.1. Indeed, in
Wave 3, there is only one current premium cigar user among 11,814 PATH Study participants
aged 12-17. See Sabry et al. at ¶¶ 7(i)(a), 26, tbl.1. By Wave 3, the median age of premium
cigar consumers at first regular use had increased to 29.8 years, or more than 13 years older than
the median age of first regular use among cigarette consumers, which held steady at 16.7 years
old. See id. at ¶ 49, tbls.5a-c.; see also Corey et al. at 5 tbl.2 (24.5 years for premium cigars in
Wave 1). And those adults who are users of premium cigars tend to be substantially older, of
higher-income, and better-educated than users of other cigar types or cigarettes. See Sabry et al.
at ¶¶ 29-38, tbls.3a-c; Corey et al. at 4 tbl.1, 6 tbl.3.
The comments received by the FDA also included other new studies from the growing
body of research that premium cigars present different public health considerations. For
example, an important peer-reviewed article by the FDA’s own staff concluded that those who
use cigars less than daily—as nearly all premium cigar consumers do—show no statistically
significant mortality increase. See Carol H. Christensen et al., Association of Cigarette, Cigar,
and Pipe Use With Mortality Risk in the US Population, JAMA Internal Med., Feb. 19, 2018, at
E1, E6 tbl.3 (Ex. E). Likewise, yet another paper by FDA staff determined that regular use of
premium cigars by youth was so rare it could not be reliably measured. See Karin A. Kasza et
al., Tobacco-Product Use by Adults and Youths in the United States in 2013 and 2014, 376 N.
Engl. J. Med. 342 (2017), at 349, supp. app. at 14 tbl.S4 (Ex. F).
The FDA’s premium cigars rulemaking docket remains open. Perhaps given the weight
of the evidence presented, it is unlikely to be resolved before this Court’s current stay of the
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warnings requirement pending appeal potentially expires. The premium cigar rulemaking docket
was designated as a “Long-Term Action” in the most recent Unified Agenda of Regulatory and
Deregulatory Actions, signaling no expected action within 12 months. Ex. G.
ARGUMENT
I. STANDARD OF REVIEW
Summary judgment under the Administrative Procedure Act “serves as the mechanism for
deciding, as a matter of law, whether [an] agency action is supported by the administrative record
and otherwise consistent with the APA standard of review.” All. for Nat. Health U.S. v. Sebelius,
775 F. Supp. 2d 114, 118 (D.D.C. 2011). The APA demands that a court “hold unlawful and set
aside agency action, findings, and conclusions found to be . . . arbitrary, capricious, an abuse of
discretion, or otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A). In assessing agency
action under the APA, “the Court must engage in a ‘thorough, probing, in-depth review’” to
determine “whether the agenc[y] ha[s] ‘examine[d] the relevant data and articulate[d] a satisfactory
explanation for its action.’” Individual Reference Servs. Grp., Inc. v. FTC, 145 F. Supp. 2d 6, 25
(D.D.C. 2001). The court “considers whether the agency acted within the scope of its legal
authority, whether the agency has explained its decision, whether the facts on which the agency
purports to have relied have some basis in the record, and whether the agency considered the
relevant factors.” Id. Counsel’s “post hoc rationalizations” will not do; “an agency’s action must
be upheld, if at all, on the basis articulated by the agency itself.” Motor Vehicle Mfrs. Ass’n of
U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 50 (1983).
When the constitutionality of an agency’s action is challenged, the court “must (like any
appellate tribunal) determine for itself whether the agency based its decision on the appropriate
constitutional standard.” United Space All., LLC v. Solis, 824 F. Supp. 2d 68, 78 (D.D.C. 2011).
“‘[A] reviewing court owes no deference to the agency’s pronouncement on a constitutional
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question,’ and must instead make ‘an independent assessment of a citizen’s claim of
constitutional right when reviewing agency decision-making.’” Poett v. United States, 657 F.
Supp. 2d 230, 241 (D.D.C. 2009). This sort of searching “‘[i]ndependent judicial judgment is
especially appropriate in the First Amendment area.’” Id. The Court “do[es] not accord [an
agency] deference when its regulations create ‘serious constitutional difficulties.’” AFL-CIO v.
FEC, 333 F.3d 168, 175 (D.C. Cir. 2003).
This Court may consider evidence outside of the administrative record for the Rule when
deciding Plaintiffs’ First Amendment claims. While review under the APA typically is limited to
the administrative record, here Plaintiffs bring direct claims under the United States Constitution.
ECF No. 20 at ¶¶ 64-107. Of course, a statute such as the APA cannot redefine constitutional
rights. See Marbury v. Madison, 5 U.S. 137, 180 (1803) (“[A] law repugnant to the constitution is
void . . . [and] courts, as well as other departments, are bound by that instrument.”). At least one
Circuit and multiple judges in this District have held that review is not limited to the administrative
record in these circumstances. See Porter v. Califano, 592 F.2d 770, 780–81 (5th Cir. 1979);
Nat’l Med. Enters., Inc. v. Shalala, 826 F. Supp. 558, 565 n.11 (D.D.C. 1993) (“Chief among
[circumstances where a court may consider extra-record evidence] is a court’s review of a
constitutional claim.”); Rydeen v. Quigg, 748 F. Supp. 900, 906 (D.D.C. 1990) (courts “may
consider the additional affidavits . . . not before the agency upon administrative review” when
“reviewing constitutional challenges to agency decisionmaking”). Indeed, the Fifth Circuit ruled
that even a “literal reading” of the APA compels courts to “make an independent assessment of a
citizen’s claim of constitutional right when reviewing agency decision-making.” Porter, 592
F.2d at 780-81; see also Grill v. Quinn, Civ. No. 10-0757, 2013 WL 3146803, at *6 n.8 (E.D.
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Cal. June 18, 2013) (“A direct constitutional challenge is reviewed independent of the APA. As
such the court is entitled to look beyond the administrative record in regard to this claim.”).
First Amendment freedoms do not turn on what evidence happened to exist at the time an
agency conducted a rulemaking; otherwise agencies could compel statements in perpetuity just
because the evidence proving them inaccurate or controversial arose later. See Nat’l Ass’n of
Mfrs. v. SEC, 800 F.3d 518, 528 (D.C. Cir. 2015) (“[P]ropositions once regarded as factual and
uncontroversial may turn out to be something quite different.”). This common sense rule is in
accord with courts’ reliance on post-decisional evidence in resolving constitutional challenges to
statutes and ordinances. See Am. Acad. of Implant Dentistry v. Parker, 860 F.3d 300, 307–11 (5th
Cir. 2017) (discussing post-decision evidence in First Amendment challenge to state regulation);
Minority Television Project, Inc. v. FCC, 736 F.3d 1192, 1199 (9th Cir. 2013) (en banc) (“As a
matter of course, in multiple First Amendment cases, the Court has looked beyond the record
before Congress at the time of enactment.”). Importantly, the evidence presented herein is on an
agency record, if that were somehow required in a constitutional case, as it either was cited by
the agency in opening or submitted in response to the agency’s pending premium cigar
rulemaking docket.
II. THE FDA’S NEW WARNING LABELS VIOLATE THE FIRST AMENDMENT
As applied to premium cigars, the FDA’s warning label requirement violates the First
Amendment.
This Court identified several levels of constitutional scrutiny that apply to compelled
speech, depending on the circumstances. See Cigar Ass’n, 315 F. Supp. 3d at 164. When
considering an undifferentiated group of cigars and setting aside arguments regarding premium
cigars in particular, this Court applied the Supreme Court’s Zauderer test for certain compelled
commercial disclosures. But when it comes to imposing the warning requirement on premium
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cigars, strict scrutiny, or at least the intermediate scrutiny governing restrictions of commercial
speech, governs. That is because the warnings, as applied to premium cigars, are not “purely
factual and uncontroversial.” Zauderer, 471 U.S. at 651. And strict scrutiny is appropriate where
a compelled disclosure does not fall within the narrow confines of Zauderer. See Becerra, 138
S. Ct. at 2372. The choice between the Central Hudson test and strict scrutiny does not affect the
outcome of this case, however, as the Rule plainly fails both tests.
Even if the Zauderer test were to govern, the application of the warnings requirement to
premium cigars would fail that test as well. Against the evidence of how frequently and by whom
premium cigars are used, 30 percent warnings on premium cigar products are complete overkill
and would plainly be “unjustified” or “unduly burdensome” under the Supreme Court’s Zauderer
test. The Zauderer standard is not a free pass; it is real constitutional scrutiny, as the Supreme
Court clarified in June 2018. Even the compelled commercial disclosures to which Zauderer
applies must “remedy a harm that is ‘potentially real not purely hypothetical,’ and . . . extend ‘no
broader than reasonably necessary.’” Becerra, 138 S. Ct. at 2377. Indeed, the en banc Ninth
Circuit followed Becerra to strike down a health warning that consumed 20% of certain beverage
advertisements. See Am. Beverage Ass’n v. City & Cty. of S.F, Case No. 16-16072, slip op.
at 15-16, 916 F.3d 749 (9th Cir. Jan. 31, 2019) (en banc).
Finally, the Rule’s warning plan preapproval requirement is an unconstitutional prior
restraint. The Rule requires retailers to seek FDA approval at least a year before speaking to
their customers, without imposing any deadline on the agency’s decision. There can be no
justification for this indefinite gag order; it violates the First Amendment.
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A. The Disclosures Are Not “Purely Factual and Uncontroversial” as Applied to

Premium Cigars, and Thus Must Be Evaluated Under Strict or Intermediate
Scrutiny
The FDA itself, in the Federal Register, acknowledged that the accuracy of the warning
statements as applied to premium cigars warranted further study. 83 Fed. Reg. at 12,903-04.
That was wise, because the current content of the mandated warnings is inconsistent with studies
and information gathered in connection with the agency’s pending rulemaking docket, which
include peer-reviewed research funded by the FDA and conducted by its own staff. The warnings
take a position contrary to scientific evidence, omit information without which the statements are
misleading, and, at the very least, force the Plaintiffs to take a position on a scientific issue that
requires additional study and about which there is a continuing debate. They are not the “purely
factual and uncontroversial” commercial disclosures that, in some circumstances not present
here, can qualify for Zauderer review.
The PATH Study is the Nation’s most comprehensive collection of data regarding usage
of tobacco products. Since 2011, the PATH Study has collected data that allow analysis of
premium cigars specifically. The first wave of data was studied by Dr. Catherine Corey along
with FDA staff in 2017; waves three and four by Dr. Faten Sabry in 2018. All confirm that
premium cigar consumers use them far less frequently than users of cigarettes or other cigar
types. The data show that the median consumer of premium cigars uses the product 1.3 to 1.7
days per month. See Sabry et al. at ¶¶ 40-44, tbls.4a-c (Sabry Decl. Ex. 1); Corey et al. at 5 tbl.2
(Ex. D). In stark comparison, the median consumer of cigarettes use the product 29.4 days per
month. See id. 93 to 97 percent of premium cigar consumers use the product less frequently
than daily. See id. By contrast, nearly 15.6-22.0% of cigarillo users, 37.3-40.9% of filtered cigar
users, and 76.0-79.5% of cigarette users smoke those products each and every day. See Sabry et
al. at ¶¶ 40-44, tbls.4a-c; see also Corey et al. at 5 tbl.2.
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These data are crucial in light of a study published by the FDA in 2017. That study
examined data from the Tobacco Use Supplement to the Current Population Survey linked to the
National Longitudinal Mortality Study (“NLMS”), “a nationally representative sample of the
civilian, noninstitutionalized US population” dating back to 1973. See Christensen et al. at E2
(Ex. E). A total of 640,726 NLMS participants from the surveys administered between 1985 and
2011 provided tobacco use information. Id. According to the FDA staff’s analysis, the data
show no greater risk of death that is statistically significant among persons who used cigars less
frequently than daily. See id. at E6 tbl.3.2 In other words, if consumers use premium cigars as 93
to 97 percent of them do, that is, less frequently than daily, the evidence shows no statistically
significant threat of premature death.
That is certainly not the message conveyed when the FDA’s mandated warnings are
affixed to the packages of premium cigars and communications about them. These mandated
messages include: “WARNING: Cigar smoking can cause lung cancer and heart disease”;
“WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not
inhale”; and “WARNING: Tobacco smoke increases the risk of lung cancer and heart disease,
even in nonsmokers.” 21 C.F.R. § 1143.5(a)(1). These dire predictions are not in a scientific
paper, surrounded by context. Instead, they take up 30 percent of the two principal panels of the
package; 20 percent of an advertisement; and come in glaring black text on a white background.
When combined with their formatting, the warnings’ message is unambiguous: “If you use the
premium cigars in this box as most people do, they will kill you.”
2
Under the method used by the paper, a hazard ratio of 1.0 denotes that the risk of death is the
same for both group identified and those that have never used tobacco.. See Ex. E at E6 tbl.3.
The value of 1.0 was included in the range for those who use cigars less frequently than daily.
Accordingly, the FDA’s staff cannot rule out the possibility that non-daily users of cigars have
the same risk of death as never tobacco users. See id.
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At the very least, the content of the warnings is “controversial” as applied to premium
cigars, by the FDA’s own admission. The FDA opened a rulemaking docket citing one of the
above studies and effectively acknowledging that the accuracy and completeness of each of the
warnings as applied to premium cigars requires further scientific study. See 83 Fed. Reg.
at 12,902-03 (citing Corey et al.); id. at 12,904. If the warnings required by the Rule were
allowed to stand, Plaintiffs would be forced to claim that scientific inquiry is settled and that
premium cigars used as nearly all premium cigar consumers do in fact increase the risk of cancer
and other diseases. That type of jumping to a conclusion, before the scientific work is complete,
is precisely what renders a mandated disclosure “controversial.” See, e.g., See Nat’l Ass’n of
Wheat Growers v. Zeise, 309 F. Supp. 3d 842, 854 (E.D. Cal. 2018) (striking down a compelled
disclosure that glyphosate is “known” to cause cancer where some studies were to the contrary),
reconsideration denied, 2018 WL 3000488 (E.D. Cal. June 12, 2018); CTIA—The Wireless
Ass’n v. City & Cty. of S.F., 827 F. Supp. 2d 1054, 1062–63 (N.D. Cal. 2011) (competing
authorities on cancer related to cell phone use rendered disclosure “neither factual nor
uncontroversial”), aff’d in relevant part, 494 F. App’x 752 (9th Cir. 2012).
The warnings do not become “purely factual and uncontroversial” simply because the
agency hedges its claims and uses the word “can,” as in “cigar smoking can cause lung cancer
and heart disease.” 21 C.F.R. § 1143.5(a)(1) (emphasis added). Of course, some of the
messages contain no hedging of any kind. One warning says “Tobacco smoke increases”—not
“may increase” or “can increase” or “in certain circumstances increases”—“the risk of lung
cancer and heart disease.” 21 C.F.R. § 1143.5(a)(1).
In any event, even using the word “can,” the warning is misleading because it omits
material information. See Am. Meat Inst. v. U.S. Dep’t of Agriculture, 760 F.3d 18, 27 (D.C. Cir.
- 18 -
2014) (recognizing that “some required factual disclosures could be so one-sided or incomplete
that they would not qualify as ‘factual and uncontroversial’”); CTIA—The Wireless Ass’n, 827 F.
Supp. 2d at 1062–63 (compelled disclosures violate the First Amendment where, “[a]lthough
each factoid in isolation may have an anchor in some article somewhere, the overall message . . .
is misleading by omission”). The warning does not say, for example, that “if used frequently or
in combination with other tobacco products,” premium cigars “can cause lung cancer and heart
disease.”
This omission of clarifying information is particularly problematic because the
combination of the Rule and the Family Smoking Prevention Act otherwise bans manufacturers
from making claims about the health effects of their products, especially on packages and
advertising. See FD&C Act § 911(a), (b)(2)(A), 21 U.S.C. § 387k(a), (b)(2)(A) (product’s “label,
labeling, or advertising” cannot, without FDA approval, “represent[] explicitly or implicitly” that it
“presents a lower risk of tobacco-related disease or is less harmful”); 81 Fed. Reg. at 28,987–88.
Courts have found disclosure requirements not “purely factual and uncontroversial” where the
same regulation effectively bans a manufacturer or retailer from providing clarifying information
about the risk of cancer. See Nat’l Ass’n of Wheat Growers, 309 F. Supp. 3d at 852 & n.12.
Against this record, the warnings do exactly what the Supreme Court has prohibited: They
“burden the speech of others in order to tilt public debate in a preferred direction.” Sorrell v. IMS
Health, Inc., 564 U.S. 552, 578–79 (2011).
Other warnings appear directed at problems plaguing different tobacco products. The
FDA presented no data, for example, showing that pregnant women use premium cigars, as
women who are addicted to cigarettes and become pregnant have been known to do. Indeed,
only 1.5-3.5% of all premium cigar consumers are women. See Sabry et al. at tbls.3a-c (Sabry
Decl. Ex. 1). Nor is there any evidence in the record of a practice of consumers migrating from
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cigarettes to premium cigars as a means of delivering nicotine, as there is with regard to small
cigars or cigarillos. That phenomenon is apparently the object of the warning, “Cigars are not a
safe alternative to cigarettes.” Id.; see 81 Fed. Reg. at 29,070. Presumably for those and other
reasons, the agency reopened its scientific inquiry as to each and every warning statement as
applied to premium cigars. See 83 Fed. Reg. at 12,903–04.
In any event, the FDA intended all the warnings together to be an integrated message to
premium cigar consumers. For that reason, it required equal rotation of the warnings, explicitly
to give consumers the full story of the health risks of, in this case, premium cigars. See 81 Fed.
Reg. at 29,072–73. If one of the warnings is not “purely factual and uncontroversial” as applied
to premium cigars, all must be evaluated under the intermediate or strict scrutiny applicable to
mandated disclosures of such information.
B. The FDA’s New Warnings Fail Either Central Hudson or Strict Scrutiny
The Supreme Court has now clarified that when the government mandates private parties
to carry a message that is not “purely factual and uncontroversial” on their products or
advertising, that requirement is subject to strict constitutional scrutiny. See Becerra, 138 S. Ct.
at 2372. Prior to Becerra, the D.C. Circuit had held that, when such a message is required to be
carried in a commercial setting, the Supreme Court’s Central Hudson test applies. See R.J.
Reynolds Tobacco Co. v. FDA, 696 F.3d 1205, 1217 (D.C. Cir. 2012), overruled in part on other
grounds by Am. Meat Inst., 760 F.3d at 18. As explained below, the Rule as applied to premium
cigars fails either standard.
To satisfy Central Hudson, the FDA must prove that (1) the asserted governmental
interest is substantial; (2) the regulation directly advances the governmental interest asserted; and
(3) the regulation is not more extensive than is necessary to serve that interest. Cent. Hudson, 447
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U.S. at 566. The FDA’s “burden is not light.” R.J. Reynolds, 696 F.3d at 1218. It fails on all
counts. This Central Hudson analysis shows that the Rule fails strict scrutiny as well.
1. The FDA’s New Warnings Do Not Serve a “Substantial” Interest
The FDA says that the Rule’s purpose is “to help current and potential tobacco users
understand and appreciate the serious adverse health consequences associated with tobacco use
and the addictive nature of tobacco products.” 79 Fed. Reg. at 23,163; see also, e.g., id. at
23,165, 23,166; 81 Fed. Reg. at 28,981, 29,063, 29,075; Final Regulatory Impact Analysis
(“FRIA”) at 64. It has disclaimed any other. The D.C. Circuit, applying the Central Hudson
test, has held that the communication of tobacco product health risks to consumers, standing
alone, is not a substantial interest. See R.J. Reynolds, 696 F.3d at 1221. The D.C. Circuit
explained that it would lead to an entirely circular inquiry, as any larger and more eye popping
warning would improve the communication of health risks. See id. at 1221 & n.16 (“[T]he
government’s stated interest in ‘effectively’ communicating information is illusory absent some
barometer for assessing that effectiveness.”). Central Hudson requires a showing that a
restriction of speech or compelled warning would actually address a public health problem, that
is, actually reduce use of a tobacco product. See id. at 1219-21. And an interest that is not even
“substantial” by definition cannot be “compelling,” as required to survive strict scrutiny. See
Brown v. Entm’t Merchants Ass’n, 564 U.S. 786, 799–803 (2011).
This Court in Cigar Association held that the FDA’s stated interest was sufficient as a
government objective under the Zauderer test. This Court’s reasoning included an exegesis of
the D.C. Circuit’s R.J. Reynolds decision, concluding that the D.C. Circuit was at least in part
concerned that the communication of health risks had not been offered in the cigarette warnings
rule under review, but instead in litigation. Cigar Ass’n, 315 F. Supp. 3d at 170. The Court also,
however, distinguished Central Hudson from Zauderer, and explained that the communication of
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health risks was at least as weighty as several interests considered by the D.C. Circuit applying
Zauderer in American Meat Institute. See id. at 169 (citing Am. Meat Inst., 760 F.3d at 23). Of
course, the D.C. Circuit’s holdings, if any, about what would suffice under Zauderer would not
necessarily guide this Court in applying Central Hudson.
2. The FDA’s New Warnings Do Not Directly or Materially Advance the

Government’s Interest
The FDA failed to identify any serious problem relating to premium cigars that the Rule
would directly and materially address. The agency’s burden “‘is not satisfied by mere speculation
or conjecture; rather, a government body seeking to sustain a restriction on commercial speech
must demonstrate that the harms it recites are real and that its restriction will in fact alleviate them
to a material degree.’” Rubin v. Coors Brewing Co., 514 U.S. 476, 487 (1995) (quoting Edenfield,
507 U.S. at 770–71). “Central Hudson requires FDA to find and present data supporting its claims
prior to imposing a burden on commercial speech.” R.J. Reynolds, 696 F.3d at 1221.
To begin, the FDA provided no evidence that youth use premium cigars in any
statistically significant way. Articles written by the FDA’s own staff show that underaged use of
premium cigars is so rare that it cannot be reliably measured. See Kasza et al. at 349, supp. app.
at 14 tbl.S4 (Ex. F); see also Sabry et al. at ¶¶ 25-26, tbl.1 (overall youth prevalence
0.08%-0.02%) (Sabry Decl. Ex. 1); Reynolds Decl. ¶¶ 29–56. The record before the agency
when issuing the Rule is not to the contrary. One study pressed by the FDA to show youth
premium cigar use indicated that 3.8% of past-30-day cigar smokers aged 12 to 17 reported using
a vaguely defined “premium” brand. 81 Fed. Reg. at 29,023 (citing Ref. 59). But past-30-day
cigar smokers comprised only 3.3% of this age group, meaning that less than 0.1% of youth aged
12 to 17 had used premium cigars. See Cristine D. Delnevo et al., Preference for Flavoured
Cigar Brands Among Youth, Young Adults and Adults in the USA, 24 Tobacco Control 389, 390–
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92 (2015) (Ex. H). The evidence leaves no doubt that the agency’s concerns about youth use of
premium cigars are not “real.” Edenfield, 507 U.S. at 771.
Nor did the agency show that adult consumers misunderstand the health risks of using
premium cigars. Their behavior would so indicate: Most premium cigar consumers use the
product sparingly. The median premium cigar consumer uses the product 1.3 to 1.7 days per
month. See Sabry et al. at ¶¶ 40-44, tbls.4a-c (Sabry Decl. Ex. 1); Corey et al. at 5 tbl.2 (Ex. D).
The distinctive demographics of premium cigar users—they tend to be substantially
better-educated, of higher income, and older than users of other tobacco products—confirm that
the consumers of these products are not an uninformed or vulnerable population. See Sabry et al.
at ¶¶ 29-38, tbls.3a-c; Corey et al. at 4 tbl.1, 6 tbl.3. The Rule itself cited no study focused on the
risk perceptions of premium cigar consumers.
All of this led to the agency’s own conclusion: “Reliable evidence on the impacts of
warning labels . . . on users of cigars . . . does not, to our knowledge, exist.” FRIA at 62. In
short, the FDA is aware of no evidence that its proposed restriction “will in fact alleviate” any
problem of misperception of health risks of premium cigars to “a material degree.” Edenfield,
507 U.S. at 770–71 (emphasis added). Without such evidence, the rule cannot stand, as “[a]
restriction that ‘provides only ineffective or remote support for the government’s purposes’ is not
sufficient.” R.J. Reynolds, 696 F.3d at 1218–19; see also Nat’l Ass’n of Mfrs., 800 F.3d at 527.
3. The FDA’s New Warnings Are Not Narrowly Tailored
Under Central Hudson, narrow tailoring “requires a reasonable fit between the means and
ends of the regulatory scheme.” Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 561 (2001). The
FDA’s warnings are not narrowly tailored for four reasons.
First, the FDA extended the warnings to premium cigars, despite that all the evidence in the
Rule and the problems it was attempting to solve concerned mass-produced cigars that, the FDA
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believes, are used like cigarettes. In opening its formal rulemaking docket, the agency
acknowledged (as it had in the past) that premium cigars are distinct from mass-produced and
flavored cigars and raise different questions of public health. See 83 Fed. Reg. at 12,902–04; see
also 79 Fed. Reg. at 23,150 (proposing an exemption of premium cigars from regulation). The
FDA is specifically revisiting whether it should regulate premium cigars at all and whether the
warnings makes sense as applied to premium cigars. 83 Fed. Reg. at 12,903–04. And the FDA
opened separate dockets seeking to tighten regulations on flavored tobacco products including
flavored cigars (which docket has progressed to the “pre rule stage”), and to reduce nicotine levels
in cigarettes. See Regulation of Flavors in Tobacco Products, 83 Fed. Reg. 12,294–301 (Mar. 21,
2018); Tobacco Product Standard for Nicotine Level of Combusted Cigarettes, 83 Fed. Reg.
11,818–43 (Mar. 16, 2018). Throughout the rulemaking process regarding cigars, the FDA
identified the key problems as the migration of cigarette-style products and cigarette users to mass-
produced cigars and youth initiation of tobacco use through cigars. See, e.g., 79 Fed. Reg. at
23,146–47; 81 Fed. Reg. at 29,024; 83 Fed. Reg. at 12,903; 83 Fed. Reg. at 12,295–97; 83 Fed.
Reg. at 11,819–20.
The evidence shows that these are not problems for premium cigars: There are no data
showing that cigarette smokers are turning to large, expensive premium cigars as a nicotine
delivery system. See Background Part IV, supra. After all, the median premium cigar consumer
smokes only 1.3 to 1.7 out of 30 days; this pattern of occasional use is not consistent with an
exodus of cigarette smokers—the median of which smokes 29.4 out of every 30 days—seeking
to feed an addiction to nicotine. See Sabry et al. at ¶¶ 40-44, tbls.4a-c (Sabry Decl. Ex. 1); Corey
et al. at 5 tbl.2 (Ex. D). And the percentage of premium cigar users who became everyday
cigarette smokers over the course of PATH Study Wave 1 through Wave 3 was tiny (2.3%) and
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not statistically different from the percentage of non-smokers who became everyday cigarette
smokers over the same time period (1.1%). See Sabry et al. at ¶ 51, tbl.6. The underaged use of
premium cigars is so small it is almost impossible to distinguish from zero. See Sabry et al. at
¶¶ 25-26, tbl.1; see also Kasza et al. at 349, supp. app. at 14 tbl.S4 (Ex. F); Reynolds Decl.
¶¶ 29–68.
The requirement of narrow tailoring bars the government from restricting the speech of a
category of products that it has identified as distinct and unmoored from the stated regulatory
problem. See Becerra, 138 S. Ct. at 2375, 2377 (striking down a compelled disclosure as both
overbroad and underinclusive); Sanjour v. EPA, 56 F.3d 85, 97 (D.C. Cir. 1995) (en banc) (“If the
government has a substantial interest with respect to only a subcategory of the restricted speech,
then its interest will not readily outweigh the burden imposed on the larger category of speech
subject to regulation.”). Whatever the case for imposing large warnings on mass-produced or
flavored cigars, the Constitution forbids lumping premium cigars into that restriction of speech.
Second, the warnings are just too big to constitute a “reasonable fit between the means
and ends of the regulatory scheme.” Lorillard, 533 U.S. at 561. The warnings confiscate giant
swaths of premium cigar packaging and advertising, taking up 30 percent of both of a product’s
two principal display panels and 20 percent of any advertising. Since this Court’s summary
judgment decision in Cigar Association, the en banc Ninth Circuit has invalidated health
warnings covering 20% of certain beverage advertisements. See Am. Beverage Ass’n, slip op.
at 15-16. There is no evidence in the record that consumers of premium cigars, in order to
understand the health risks of those products, need to confront a glaring warning, in large black
text on a white background, that inevitably becomes the predominant message on the box.
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Third, the rote repetition of the warnings in every communication by retailers is hardly a
reasonable fit. A premium cigar retailer like En Fuego must now display or recite the warnings
in virtually every communication with its customers, from print ads and radio spots to social
media pages and in-store signage, even though the warnings will already appear twice on each
package and once at each cash register. 81 Fed. Reg. at 29,064. For example, retail websites
that merely announce store hours and special offers must bear warnings covering at least 20
percent of the screen. Declaration of Mark Moore (“Moore Decl.”) ¶¶ 9–10 & Ex. B. The
warnings also will dominate the limited space available in Twitter, Facebook, and Instagram
posts. See id. Exs. C–E; Declaration of Manuel Lopez (“Lopez Decl.”) ¶ 10 & Ex. B.
This repetition problem is particularly severe for premium cigars, which are mostly sold
in retail stores with large humidors displaying the many varieties with signs describing them.
This is different than a convenience store selling a handful of mass-produced cigars behind the
counter. In En Fuego’s premium cigar retail humidor, the FDA warnings could be repeated
hundreds of times—two on every cigar box, one on each placard describing a cigar in the
humidor, one on every in-store display referencing a cigar, and again on the sign at each cash
register. See 21 C.F.R. § 1143.5(a), (b); see Addendum at 5 (pictures of the humidor). This
degree of repetition far exceeds that required by the warnings scheme recently struck down as
“unduly burdensome” by the Supreme Court in Becerra, where the “unlicensed disclosure” at
issue needed to appear just once or twice in the affected clinics. See Becerra, 138 S. Ct.
at 2370, 2378. Narrow tailoring requires some limit to the madness; once the Government takes
a third of each package for its message, requiring the warning over and over again is not a
“reasonable fit” with any legitimate end.
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Fourth, the FDA ignored obvious alternatives that would have restricted less of the
Plaintiffs’ speech. The FDA must show that there are no other options available that “could
advance [its] asserted interest in a manner less intrusive to [Plaintiffs’] First Amendment rights.”
Rubin, 514 U.S. at 491; see also Nat’l Ass’n of Mfrs., 800 F.3d at 555 (“The government cannot
satisfy [Central Hudson] if it presents no evidence that less restrictive means would fail.”). The
FDA could have imposed smaller warnings, but it declined even to examine a Federal Trade
Commission scheme of smaller warnings in place for seven cigar manufacturers. Whether or not
such a review could be bypassed under Zauderer, see Cigar Ass’n, 315 F. Supp. 3d at 171, it
could not be ignored under Central Hudson.3
Nor did the FDA consider whether a public information campaign of its own was “a
sufficient alternative” to “co-opting” a private business “to deliver its message for it.” See
Becerra, 138 S. Ct. at 2376. To reduce youth tobacco use, the Government also could raise the
minimum legal age to purchase tobacco products; increase penalties and enforcement measures
relating to sales of tobacco to youth; increase support for programs aimed at the social factors
underlying tobacco use by youth; and raise the prices of tobacco products. See Reynolds Decl.
¶¶ 69–80, 92-94. Premium cigars prove that last point. Premium cigars are more expensive than
other tobacco products, and there is no statistically significant youth use.
3
The agency’s failure to seriously consider the “[m]any comments” urging smaller warnings
consistent with the FTC scheme also violated the APA. See 81 Fed. Reg. at 29,066. The APA
demands that the FDA “must respond to serious objections” such as these, and that those
responses must be “sufficient[] to ‘enable [the Court] to see what major issues of policy were
ventilated . . . and why the agency reacted to them as it did.’” Del. Dep’t of Natural Res. &
Envtl. Control v. EPA, 785 F.3d 1, 15-16 (D.C. Cir. 2015). The FDA’s one-sentence treatment
of the FTC warnings’ format does not meet these clear standards. See 81 Fed. Reg. at 29,066.
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Of course, by extension, the warnings fail strict scrutiny, which requires the Government to
use “the least restrictive means of achieving a compelling state interest.” See McCullen v. Coakley,
134 S. Ct. 2518, 2530 (2014).
C. When the Warnings Are Imposed on Premium Cigars, They Fail

the Zauderer Test for Certain Compelled Commercial Disclosures
Even if this Court were to apply the Zauderer test, imposing the FDA’s warnings on
premium cigars is both “unjustified” and “unduly burdensome.” Zauderer, 471 U.S. at 651. In
its June 2018 National Institute of Family & Life Advocates v. Becerra decision, the Supreme
Court made clear that Zauderer requires an arduous review of commercial disclosures even when
they qualify for the test.
First, the warnings are “unjustified” when applied to premium cigars. The FDA cannot
show that its new warnings requirement is “no broader than reasonably necessary” to address a
“not purely hypothetical” harm. Becerra, 138 S. Ct. at 2377. As explained above, the FDA
cannot demonstrate a real problem with regard to premium cigars that the warnings would solve.
Premium cigars are used infrequently, in a manner showing their consumers understand the risks
of excessive use. Premium cigar consumers are not impressionable youth for whom the health
risks may arguably need underscoring through large warnings. They instead are older,
better-educated, and of higher income than users of other cigars. And there is no evidence that
large warnings will cause premium cigar users to reduce their already infrequent use of the
product.
For premium cigars, therefore, 30 percent warnings repeated twice on each box and
warnings covering 20 percent of every advertisement cannot be justified. Whatever the case that
can be made for mass-produced cigars that are being used by youth and with a frequency
arguably indicating potential abuse, none of that can be said about premium cigars. At the same
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time, the warnings’ effect on the luxury product that is premium cigars is more profound, as it
mars mahogany boxes that long have been collectors’ items. See Lopez Decl. ¶ 6; Moore Decl.
¶ 4. Any trip to the local premium cigar store will find the boxes for sale, on their own, with no
cigars. The FDA warnings will put an end to that.
Second, the extreme size and repetition of the warnings render them “unduly
burdensome.” The warnings are so large and glaring that they make the Government the most
prominent speaker on cigar packages and advertising. This repetition particularly strikes at
premium cigars, which are generally sold in retail humidors where the warning will be repeated
hundreds of times. This Court held that the warnings were not unduly burdensome, when its
application to all cigars was at issue. Cigar Ass’n, 315 F. Supp. 3d at 172-73. But the term is
“unduly burdensome,” and there is no evidence of the problems that the Government was
seeking to address with regard to premium cigars to which the burden can be compared.
There also have been intervening developments since this Court’s Cigar Association
decision. The Supreme Court struck down a compelled disclosure in Becerra as unduly
burdensome. See Becerra, 138 S. Ct. at 2378. And that disclosure was far less intrusive than the
FDA’s warnings, which must be repeated with much greater frequency in a larger and more
glaring format.
For comparison, the “unlicensed disclosure” in Becerra was a “29-word statement” to be
“provided on site and in all advertising materials” in pregnancy-related clinics in “English and
any additional languages specified in state law.” Id. at 2370, 2378. In its advertisements, a
clinic “must call attention to the notice, instead of its own message, by some method such as
larger text or contrasting type or color.” Id. at 2378. The notice also must be “posted
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‘conspicuously’ at the entrance of the facility and in at least one waiting area,” on a sign “at least
8.5 inches by 11 inches and written in no less than 48-point type.” Id. at 2370.
The FDA warnings must cover 30% of the two principal display panels of each cigar box
and 20% of every advertisement, in a stark black-on-white format set off by a thick rectangular
border. See 21 C.F.R. § 1143.5(a)(2), (b)(2). They will appear in a larger font than most of the
text on the package or advertisement and in a contrasting type and color. See id. While the
Becerra sign needed to appear just twice at a clinic, the FDA sign must appear at every single
cash register in the store, in addition to the repetitive warnings on multiple panels of each and
every cigar package, every descriptive note on retail shelves, and every other “advertisement”
inside the store. Id.; see 81 Fed. Reg. at 29,064.
The en banc Ninth Circuit has since applied the principles of Becerra to San Francisco’s
requirement that warnings cover 20% of certain beverage advertisements, but not the beverages
themselves or their packaging. Am. Beverage Ass’n, slip op. at 16. That disclosure was found
“unduly burdensome” because San Francisco had “not shown that the contrasting rectangular
border containing a warning that covers 20% of the advertisement does not ‘drown out’
Plaintiffs’ messages and ‘effectively rule out the possibility of having an advertisement in the
first place.’” Id. (quoting Becerra, 138 S. Ct. at 2378) (alterations in original). The Ninth
Circuit reached this conclusion notwithstanding that 80% of the physical real estate of every
advertisement remained at the advertiser’s disposal. The Ninth Circuit rejected efforts to justify
the size by claiming that “20% size requirements adhere to the best practices for health and
safety warnings.” Id. at 15. The FDA has leaned on the same claim to justify its warnings: That
they were “similar to those suggested by” the World Health Organization as best practices for
tobacco warnings. See 81 Fed. Reg. at 29,066.
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This Court took guidance from the en banc Ninth Circuit having granted review and
vacated the panel decision in American Beverage, also applying Zauderer and striking down the
same 20 percent warnings. See Cigar Ass’n, 315 F. Supp. 3d at 173 n.11. Now the en banc
Ninth Circuit, when it had to confront the Supreme Court’s holding in Becerra, should similarly
guide this Court. After Becerra, it is evident that compelled disclosures as intrusive as these
violate the First Amendment.
Third, this Court exonerated the FDA for not having considered less burdensome
alternatives, explaining that Zauderer did not require it. Cigar Ass’n, 315 F. Supp. 3d at 172-73.
Today, such a holding would be difficult to square with the Supreme Court’s Becerra decision
that a compelled disclosure must be “no broader than reasonably necessary.” See Becerra, 138
S. Ct. at 2377. And the en banc Ninth Circuit thereafter held that a compelled warning could not
survive Zauderer where a “smaller warning–half the size” might “accomplish [San Francisco’s]
stated goals.” Am. Beverage Ass’n, slip op. at 15-16.
Fourth, the Supreme Court’s decision in Becerra reopens a defect in the warnings
requirement that had been blocked by D.C. Circuit precedent. The D.C. Circuit had split with
other circuits by allowing Zauderer’s application outside the context of correcting consumer
deception. Compare Am. Meat, 760 F.3d at 22–23, with Entm’t Software Ass’n v. Blagojevich,
469 F.3d 641, 652 (7th Cir. 2006) (Zauderer applies only to disclosures “reasonably related to
. . . preventing deception of consumers”), and United States v. Wenger, 427 F.3d 840, 849 (10th
Cir. 2005) (same). The Supreme Court has explained that “Zauderer governs” when a statute “is
directed at misleading commercial speech.” Milavetz, Gallop, & Milavetz, P.A. v. United States,
559 U.S. 229, 249 (2010). Despite every opportunity to do so in Becerra, the Supreme Court
declined to clarify that Zauderer applies outside of that context. See Becerra, 138 S. Ct. at 2372,
- 31 -
2377-78 (announcing “reluctan[ce] to mark off new categories of speech for diminished
constitutional protection.”); Am. Beverage Ass’n, slip op. at 37-40 (Nguyen, J., concurring)
(Becerra requires overturning Ninth Circuit precedent expanding Zauderer beyond regulations
seeking to correct misleading speech). American Meat’s expansion of Zauderer cannot survive
intervening Supreme Court precedent. Here, there is no evidence that the mandated disclosures
are directed at correcting some premium cigar campaign of consumer deception.
D. The FDA’s Warning Plan Preapproval System Violates the First Amendment
The Rule also prohibits premium cigar retailers from speaking to consumers for twelve
months or more while the FDA considers their plans to comply with the mechanical task of
rotating the six required warning statements. The FDA requires that each plan be submitted one
year before communicating with consumers. See 21 C.F.R. § 1143.5(c)(3); 81 Fed. Reg. at
29,072–73. Even then, the Rule does not require the agency to make a decision in that one year
period. Id. Plaintiff En Fuego and many other members of TxCMA have not submitted warning
plans. That, in part, is due to the structure of the required plan, mandating that retailers
accurately predict about what and in what media a retailer intends to communicate a year in
advance. The warning plan requirement, thus, threatens to serve as a gag order preventing
Plaintiffs from speaking with consumers once they make the decision to do so.
Count IV of the Complaint challenges this scheme as a clearly unconstitutional prior
restraint of speech. ECF No. 20 at ¶¶ 97-107. A prohibition on speech absent advance approval
from the Government is a prior restraint that “bear[s] a heavy presumption against its
constitutional validity.” FW/PBS, Inc. v. City of Dall., 493 U.S. 215, 225 (1990). A prior
restraint is per se unconstitutional where there is no time limit on agency review. See id. at 226;
Nutritional Health All. v. Shalala, 144 F.3d 220, 228 (2d Cir. 1998) (“absence of final deadline
constituted a prior restraint of unlimited duration” that does “not pass constitutional muster”).
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Even putting aside this fatal prior restraint problem, the FDA’s warning plan is at least a
restriction on speech that must satisfy Central Hudson. The warning plan requirement makes
retailers wait before announcing the sale of a cigar at a particular price, or “who is producing and
selling what product, for what reason, and at what price.” Va. State Bd. of Pharmacy v. Va.
Citizens Consumer Prot. Council, 425 U.S. 748, 765 (1976).
In the Rule itself, the agency claims that the warning plan system is designed to ensure
that the different warnings “reach[] as many individuals as possible” and do not “grow stale from
overuse if repeated too many times for the same individual.” 81 Fed. Reg. at 29,072. But that is
an argument for warning rotation, which could be ensured by enforcement while speech is
occurring, not for halting speech pending government preapproval. The agency provides no
explanation in the Rule why contemporaneous enforcement of warning rotation would not be
adequate. As such, the FDA cannot demonstrate that this restriction is no broader than
reasonably necessary to achieve sufficient rotation of the Government’s messages. See Lorillard
Tobacco Co., 533 U.S. at 561-65.
III. THE FDA’S NEW WARNINGS REGIME IS ARBITRARY AND CAPRICIOUS
The FDA’s refusal to stay enforcement of the warnings as to premium cigars despite the
pendency of its new rulemaking docket and decision to reach premium cigars in the first place
are arbitrary and capricious agency action in violation of the Administrative Procedure Act.
A. The FDA’s Enforcement of the Warnings on Premium Cigars, Despite the

Agency’s Ongoing Rulemaking Proceedings, Is Arbitrary and Capricious
In its May 2018 ruling, this Court observed that the agency’s decision to enforce the
warnings requirement against premium cigars, even as it had opened a rulemaking docket to
reconsider whether premium cigars should bear those warnings, was a “a grossly unfair exercise
of agency authority.” Cigar Ass’n, 315 F. Supp. 3d at 175. The Court held that issue was not
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presented in that case. Id. at 176. It is squarely presented here. ECF No. 20 at ¶¶ 121, 124
(Count VI).
In July 2017, the FDA announced an overhaul of its regulatory scheme. (Ex. C) It would
turn its regulatory focus toward cigarettes, which it placed at the most dangerous end of a
continuum of risk regarding tobacco products. It pledged to target for enforcement flavored
tobacco products. At the same time, it promised to open a rulemaking docket to reconsider
whether premium cigars should be regulated and, if so, how. And, sensibly, the agency delayed
many of the most onerous compliance deadlines of the rule until 2020 or later, so its rulemakings
could be opened and concluded before regulatory requirements that may be changed went into
effect. Without explanation, the agency left in place an August 10, 2018 deadline for complying
with the warnings requirement.
The agency followed through on its July 2017 plan. It opened the premium cigar
rulemaking docket and specifically indicated its reconsideration of whether the warning
requirements should be applied to premium cigars. See 83 Fed. Reg. 12,901. It sought comment
on the size and the content of each of the six warnings. Id. at 12,903-904. And its action was
not from a standing start, as the agency cited studies showing the sharply different usage patterns
of premium cigars versus mass-produced cigars. Id. at 12,902-903 (citing Corey et al.).
The scope of the FDA’s decision to extend substantial equivalence and premarket
marketing application deadlines to 2020 and 2021, respectively, but not the warnings deadline
was unexplained and arbitrary. The apparent rationale for the extensions—to spare regulated
entities the costs of complying with regulations that may change in the rulemaking proceedings—
applies with equal force to the warnings. As the Court observed, “[r]equiring the premium cigar
industry to incur substantial compliance costs while the agency comprehensively reassesses the
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wisdom of regulation, before the warnings requirements go into effect, smacks of basic
unfairness.” Id. The actual premium cigar docket shows that applying the warnings requirement
to premium cigars is being reexamined just as much as the substantial equivalence and premarket
review requirements. See 83 Fed. Reg. at 12903-04. An unexplained deviation from an
enforcement rationale is arbitrary and capricious and violates the APA. See Airmark Corp. v. FAA,
758 F.2d 685, 691–92 (D.C. Cir. 1985); see also Burlington N. & Santa Fe Ry. Co. v. Surface
Transp. Bd., 403 F.3d 771, 777 (D.C. Cir. 2005) (invalidating application of “different standards to
similarly situated” circumstances without “a reasoned explanation and substantial evidence in the
record”); Gen. Chem. Corp. v. United States, 817 F.2d 844, 846 (D.C. Cir. 1987) (agency decision
was arbitrary and capricious because it was “internally inconsistent and inadequately explained”).
Moreover, no principle of law builds separate silos around the rulemaking leading to the
Rule and the new premium cigar rulemaking. An agency must take account of parallel
rulemakings that could modify the Rule it is seeking to enforce. See Portland Cement Ass’n v.
EPA, 665 F.3d 177, 187 (D.C. Cir. 2011) (it is arbitrary and capricious for an agency to “bas[e]
its decision on a premise the agency itself has already planned to disrupt”). In Portland Cement
Association, the Court held arbitrary and capricious an EPA rule issued amidst another
rulemaking, the timing and speed of which was entirely in the agency’s control, that could
subject the regulated industry to modified requirements and unnecessary compliance expense.
Id. While the parallel rulemaking in that case had been initiated just before the challenged rule
had become final, id., both a final rule and the manner in which it is enforced are subject to
review for arbitrariness and caprice. See Airmark, 758 F.2d at 691–92; Green Country
Mobilephone, Inc. v. FCC, 765 F.2d 235, 237 (D.C. Cir. 1985) (agency’s waiver of deadlines for
some applicants but not others was abuse of discretion because agency “invoked the rule
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inconsistently” and “has not treated similar cases similarly”). Here, too, the FDA has initiated a
process to reorder the regulatory landscape, yet it continues to enforce a burdensome requirement
that it may change.
Nor should the Court view the premium cigar rulemaking docket as a mere call for
updated information that is not oriented toward agency action. Cigar Ass’n, 315 F. Supp. 3d at
176. FDA Commissioner Gottlieb acknowledged in a televised interview last year, “It is true
that we are revisiting the rule that deemed premium cigars ‘tobacco products’ subject to all the
same regulation as, let’s say, cigarettes.” CNBC Squawk Box4 (May 15, 2018) (emphasis added).
Similarly, the FDA asked this Court to dismiss certain claims and stay judicial proceedings in the
Cigar Association case “because those announced regulatory actions may materially change the
regulatory scheme.” See Cigar Ass’n v. FDA, 317 F. Supp. 3d 555, 563–64 (D.D.C. 2018). In
any event, the D.C. Circuit has held that it is arbitrary to enforce a regulation that might be
changed by such proceedings, exposing regulated entities to waves of duplicative and changing
requirements. See Portland Cement Ass’n, 665 F.3d at 187.
This Court’s correct injunction of the warnings pending appeal in Cigar Association, see
Cigar Ass’n, 317 F. Supp. 3d at 563–64, has relieved the urgency of the question presented here,
but not the problem. The agency is not on schedule to conclude its premium cigar rulemaking
before the likely expiration of this Court’s stay, having designated it as a “Long-Term Action.”
(Ex. G.) The Court should enjoin the enforcement of the warnings with regard to premium
cigars, at least until the agency concludes its rulemaking proceedings and determines finally
whether premium cigars require new or different health warnings, or any warnings at all.
4
Available at https://archive.org/details/CNBC_20180515_100000_Squawk_Box/start/7860/end
/7920.
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B. The FDA’s Imposition of the Warnings on Premium Cigars Was Arbitrary

and Capricious
The FDA’s decision to mandate massive new warnings on premium cigars was arbitrary
and capricious in several respects.
First, the FDA imbedded a legal error at the base of its inclusion of premium cigars in the
warnings requirement. As the agency recognized in its rulemaking, the Family Smoking
Prevention Act authorizes the Secretary of HHS to “deem” all cigars, some cigars, or no cigars
subject to the Act. See, e.g., 79 Fed. Reg. at 23,143. The agency considered a so-called
“Option 2” that would have chosen not to deem a category of premium cigars subject to the Act,
but ultimately rejected it. See 81 Fed. Reg. at 29,020–27. Once it exercised its deeming
authority to reach premium cigars, it viewed the imposition of warnings on premium cigars as
statutorily required. As the agency explained, “FDA has selected Option 1, which requires all
cigars (rather than a subset) to include the textual health warnings.” 81 Fed. Reg. at 29,026.
That was legal error: The agency misconstrued its statutory discretion.
Sections 901 and 906 of FD&C Act are separate founts of Government authority.
Section 901 empowers the Secretary of HHS to “deem” tobacco products subject to the Act,
while Section 906 vests the Secretary with the power to issue “regulation[s] impos[ing]
restrictions on the advertising and promotion of a tobacco product.” Compare FD&C Act
§ 901(b), 21 U.S.C. § 387a(b), with FD&C Act § 906(d)(1), 21 U.S.C. § 387f(d)(1). Once the
FDA “deemed” all cigars subject to the Act, it had to separately invoke its authority under
Section 906 to mandate warning labels. And the agency had absolute discretion not to impose
warnings on any segment of the cigar industry. An agency acts arbitrarily and capriciously when
it assumes a regulatory step is mandated by statute, rather than explaining why a discretionary
step is warranted. See Arizona v. Thompson, 281 F.3d 248, 259 (D.C. Cir. 2002) (“As we have
- 37 -
said before, an agency regulation must be declared invalid, even though the agency might be able
to adopt the regulation in the exercise of its discretion, if it was not based on the [agency’s] own
judgment but rather on the unjustified assumption that it was Congress’ judgment that such [a
regulation is] desirable or required.”). And that is exactly what happened here.
Second, the agency provides no meaningful scientific explanation for why warning labels
should extend to premium cigars, despite commenters assertions that the labels were particularly
ill-suited for premium cigars. See Fed. Reg. at 29,062, 29,069-72; Humane Soc’y of U.S. v.
Zinke, 865 F.3d 585, 606 (D.C. Cir. 2017) (“[A] failure to address ‘an important aspect of the
problem’ that is factually substantiated in the record is unreasoned, arbitrary, and capricious
decisionmaking.”). Its casual and inadequate examination of the issue plainly was motivated by
the agency erroneously believing it had no legal discretion to exclude premium cigars from the
warning requirement, once the deeming decision was made. In the section of the Rule
addressing the warnings requirement, spanning 12 dense pages in the Federal Register, the FDA
mentioned premium cigars only four times. 81 Fed. Reg. at 29,062, 29,067–68, 29,069, 29,071.
None addresses the differences in the demographics of premium cigar consumers and the
frequency with which premium cigars are used. For example, in response to “several comments
[that] took issue with the proposed warnings for premium cigars, claiming that they lack a sound
scientific basis,” the agency offered a single sentence: “FDA finds there is a strong scientific
basis to require health warnings on cigar packages and in cigar advertisements.” That passage
summarily referred to cigars generally and never addressed the separate issues pertaining to
premium cigars. Id. at 29,062. And it never explained why premium cigars in particular, given
these differences, needed warnings that were so large, covering 30 percent of the two package
panels.
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Instead, the agency primarily relied on evidence and anecdotes of tobacco products other
than premium cigars. The FDA premised its new warnings on the asserted need to attack youth
tobacco use and to inform consumers about the health effects of cigar use. See 81 Fed. Reg. at
29,063, 29,064, 29,070. To that end, the agency cited studies of the usage patterns and
appreciation of health risks of materially different tobacco products—cigarettes and
mass-produced cigars. See, e.g., id. at 29,070 (citing Refs. 269, 270, 271). But the record
contained no credible evidence regarding premium cigars, other than studies showing that
premium cigars are used by youth in statistically insignificant numbers and do not serve as a
gateway to the initiation of tobacco use. See, e.g., id. at 29,023 (citing Ref. 59 (study finding that
less than 0.1% of youth aged 12 to 17 had used premium cigars)). It is the height of arbitrary and
capricious rulemaking to use evidence regarding one product segment—here, cigarettes or mass-
marketed cigars—as a justification to impose a tremendously burdensome regulatory scheme on
another—here, premium cigars. See Nat’l Wildlife Fed’n v. Hodel, 839 F.2d 694, 723 (D.C. Cir.
1988) (the APA requires an agency to explain why “basic differences” between regulatory
targets do not merit different treatment).
Third, the FDA bypassed any serious weighing of the costs and the benefits of extending
the warnings to premium cigars. The record before the agency was clear that the defining
features of premium cigars—their endless varieties and their ornate packaging—would make the
imposition of glaring warnings, sized by percent-based coverage of the display area,
extraordinarily costly. The FDA openly admitted in its Final Regulatory Impact Analysis that
each product label would undergo a “major change,” and the labeling requirements are “a large
contributor to the costs of this rule.” AR023952, AR024017, AR024019. Using the FDA’s own
estimates, one premium cigar manufacturer with 1,670 unique products would face costs ranging
- 39 -
from $2.5 million to $27.8 million. AR130285–86; AR024019. At the same time, the agency
conceded that it had no “[r]eliable evidence” that the warnings would have a tangible effect on
the use of any cigars, AR023973—to say nothing of the use of premium cigars, which skews
statistically toward older, wealthier, and better educated adults who smoke infrequently. But,
consistent with the requirement of reasoned decision-making at the heart of the APA, “when an
agency decides to rely on a cost–benefit analysis as part of its rulemaking, a serious flaw
undermining that analysis can render the rule unreasonable.” Nat’l Ass’n of Home Builders v.
EPA, 682 F.3d 1032, 1040 (D.C. Cir. 2012).
C. The FDA’s Failure to Make the Requisite Statutory Findings Specific to

Premium Cigars Renders the Rule “Contrary to Law” in Violation of the
APA and the Family Smoking Prevention Act
Section 906 of the Family Smoking Prevention Act requires the agency, before imposing a
warnings requirement, to make findings regarding whether it will reduce tobacco use. When this
Court was presented with a claim about all cigars—not differentiating premium cigars—it held that
the FDA made those findings. See Cigar Ass’n, 315 F. Supp. 3d at 160-62. This case is different:
It concerns whether the agency satisfied legal standards concerning premium cigars as its own
category of tobacco product. The agency did not make the findings as to premium cigars.
Section 906(d)(1) of the Act applies to “restrictions on the sale and distribution of a
tobacco product,” and provides that the mandated “finding . . . shall be determined with respect
to the risks and benefits to the population as a whole, including users and nonusers of the
tobacco product.” FD&C Act § 906(d)(1), 21 U.S.C § 387f(d)(1) (emphases added). And the
agency recognized when proposing the Rule, and reaffirmed when it opened a new premium cigars
rulemaking docket, that premium cigars are a distinct category of tobacco product that may present
different questions of public health. See 79 Fed. Reg. at 23,150; 83 Fed. Reg. at 12,902-04. Had
Congress intended to authorize the FDA to rely upon a single, generic finding when imposing
- 40 -
restrictions upon diverse categories of tobacco products, it would not have selected the careful
language “users and nonusers of the tobacco product.” See FD&C Act § 906(d)(1), 21 U.S.C
§ 387f(d)(1) (emphases added).
In holding that the agency had made the statutorily required findings as to cigars, this Court
relied upon a series of assertions by the agency regarding the “importance and efficacy of the
health warnings.” Cigar Ass’n, 315 F. Supp. 3d at 160. Elsewhere, other parties have disputed
the adequacy of those assertions to qualify as the findings required by the Act. See id. at 161-62;
Brief for Appellants, Cigar Ass’n, et al. v. FDA, et al., Case No. 18-5195, at 44-49 (D.C. Cir.
Feb. 19, 2019). Regardless, it is beyond dispute that none of the findings on which the Court
relied says anything about premium cigars in particular, let alone grapples with the distinctive
demographics and usage patterns unique to premium cigars. See 79 Fed. Reg. at 23,164–65. All
of those findings regarded cigars or tobacco products generally. See, e.g., 79 Fed. Reg. at 23,165
(stating that “[t]he content of the proposed messages also indicates that they should help
consumers understand and appreciate the health risks” and referencing “small and large cigars”).
That is not enough to extend the warnings to premium cigars, including because Section 906(d)
is expressly intended as a safeguard against violations of the First Amendment. See FD&C Act
§ 906(d)(1), 21 U.S.C. § 387f(d)(1) (any “restrictions on the advertising and promotion of a
tobacco product” must be “consistent with . . . the first amendment to the Constitution”). Any
conceivable ambiguity in the Family Smoking Prevention Act as to the nature of the FDA’s
findings therefore must be resolved in favor of avoiding violations of the First Amendment,
which prohibits using adverse evidence regarding one product to restrict speech regarding
another. See Edward J. DeBartolo Corp. v. Fla. Gulf Coast Bldg. & Constr. Trades Council,
485 U.S. 568, 575 (1988); Argument Part II.B.3, supra.
- 41 -
Also relevant is the agency’s admission that it possessed no “[r]eliable evidence on the
impacts of warning labels . . . on users of cigars,” and that it needed to study the issue in the
future. See AR023973; see also 81 Fed. Reg. at 29,065. This is not consistent with Congress’s
requirement of findings before warnings are imposed, not after. See Gerber v. Norton, 294 F.3d
173, 185-86 (D.C. Cir. 2002). That study of premium cigars was possible is underscored by
what has happened since, namely that the FDA opened a rulemaking docket gathering studies on
premium cigars, including by the FDA’s own staff. See Background Part IV, supra. That the
agency’s concession came in the Final Regulatory Impact Analysis should not matter. In R.J.
Reynolds, this Court found dispositive a materially indistinguishable admission by FDA. See
R.J. Reynolds, 696 F.3d at 1219–20 (“FDA’s Regulatory Impact Analysis . . . essentially
concedes the agency lacks any evidence showing that the graphic warnings are likely to reduce
smoking rates”).
IV. THE ISSUANCE OF THE FINAL RULE BY A CAREER EMPLOYEE OF

THE FDA VIOLATES THE CONSTITUTION’S APPOINTMENTS CLAUSE
AND THE APA
The Rule violates the Appointments Clause of the United States Constitution, which
reserves significant government actions to “Officers of the United States.” U.S. Const. art. II,
§ 2, cl. 2. “[T]he Appointments Clause of Article II is more than a matter of ‘etiquette or
protocol’; it is among the significant structural safeguards of the constitutional scheme.”
Edmond v. United States, 520 U.S. 651, 659 (1997). For that reason an Appointments Clause
violation warrants vacating the unauthorized agency action. See Landry v. FDIC, 204 F.3d 1125,
1131-32 (D.D.C. 2000).
The Rule imposed substantive regulations on an entire segment of the economy. It
therefore constituted the “exercis[e] [of] significant authority pursuant to the laws of the United
States” that the Constitution exclusively reserves to principal officers of the United States
- 42 -
appointed consistent with the Appointments Clause. Buckley v. Valeo, 424 U.S. 1, 126 (1976).
At minimum, the Rule is a “final decision” of a federal agency and an “exercise [of] independent
authority” for which the action of an inferior officer of the United States is required. See Freytag
v. Comm’r, 501 U.S. 868, 882 (1991); Tucker v. Comm’r, 676 F.3d 1129, 1133 (D.C. Cir. 2012).
Yet the FDA’s Rule was issued not by the Secretary of the Department of Health and
Human Services or by the Commissioner of Food and Drugs—both officers appointed by the
President and confirmed by the Senate—but by an Associate Commissioner for Policy, whose
putative authority is rooted in an unconstitutional delegation. See 81 Fed. Reg. at 29,106. The
career employee of the FDA who issued the rule held that title because she was selected by the
FDA Commissioner or Deputy Commissioner. See FDA Bio for Leslie Kux (Ex. A); FDA Staff
Manual § 1431.23 (Ex. B) Neither the Commissioner nor the Deputy Commissioner is a “Head
of Department” within the meaning of the Appointments Clause. See Freytag, 501 U.S. at 886
(“term ‘Heads of Departments’ does not embrace ‘inferior commissioners and bureau officers’”).
This career employee was never nominated by the President, confirmed by the Senate, and
appointed to her position by Presidential commission as a principal officer of the United States.
U.S. Const. art. II, § 2, cl. 2. Nor has Congress established the office of the Associate
Commissioner for Policy by statute or directed that she may be appointed by the Head of a
Department. Id. Therefore, the Rule was not issued by a principal officer or even an inferior
officer of the United States, as the Appointments Clause demands. The Rule, and any
enforcement of it, is invalid under the Appointments Clause.
Although this Court has on another occasion ruled that post-hoc ratification by an Officer
of the United States may cure an Appointments Clause violation in an appropriate case, Alfa Int’l
Seafood v. Ross, Civ. No. 17-00031, 2017 WL 3738397 (D.D.C. June 22, 2017), ratification
- 43 -
would not save the Rule here. Any subsequent ratification of the Rule by an Officer of the
United States would violate the APA. The APA allows agencies to issue regulations such as the
Rule only after notice to the public and consideration of comments received. 5 U.S.C. § 553.
An Officer of the United States must conduct that notice, consider the information submitted on
the administrative record, and then formally issue the Rule. A post-hoc ratification would not
satisfy that requirement.
Ms. Kux’s only claim to rulemaking authority is an unconstitutional delegation. Through
the Family Smoking Prevention Act, Congress delegated rulemaking authority to the Secretary of
HHS, a principal officer of the United States. See FD&C Act § 901(a), 21 U.S.C. § 387a(a).
Through an FDA staff manual, the Secretary of HHS sub-delegated this power to the
Commissioner of Food and Drugs. See 2 FDA Staff Manual Guide § 1410.10 (2016) (Ex. I).
The Commissioner, again through an FDA Staff Manual, sub-sub-delegated this power to the
Associate Commissioner for Policy. See 2 FDA Staff Manual Guide § 1410.21 (2016) (Ex. J).
These delegations were unconstitutional because they vested a career employee with authority
that was specifically reserved to the Secretary of HHS by the Family Smoking Prevention Act
and that cannot be exercised by persons other than Officers of the United States under the
Appointments Clause. The Final Rule therefore is contrary to constitutional right, power,
privilege, or immunity and in excess of statutory jurisdiction, authority, or limitations, or short of
statutory right. See 5 U.S.C. § 706(2)(B)–(C).
CONCLUSION
For the foregoing reasons, Plaintiffs respectfully request that the Court grant Plaintiffs’
motion for summary judgment on all Counts of the Complaint. In doing so, the Court should
vacate the Rule’s warnings requirements, set forth in 21 C.F.R. pt. 1143, with respect to and
permanently enjoin their enforcement against premium cigar products. The Court should define
- 44 -
premium cigars as the agency did, minus the requirement that the exceed a certain cost, which is
inconsistent with evidence cited by the agency. See Footnote 1, supra. As a first alternative to
this relief, the Court should vacate the Rule’s warnings requirement as to cigars generally and
remand the Rule to the agency. As a second alternative to this relief, the Court should enjoin
enforcement of the Rule until one year after the agency takes final agency action on its premium
cigar rulemaking docket, Regulation of Premium Cigars, Docket No. FDA-2017-N-6107 (2018).
Dated: March 15, 2019 Respectfully submitted,
/s/ Michael J. Edney

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

Clyde M. Siebman
Texas Bar No. 18341600
clydesiebman@siebman.com
Elizabeth S. Forrest
Texas Bar No. 24086207
elizabethforrest@siebman.com
Federal Courthouse Square
300 N. Travis Street
Sherman, TX 75090
Telephone: (903) 870-0070
Facsimile: (903) 870-0066
Counsel for Plaintiffs En Fuego Tobacco Shop

LLC, Cuba Libre Enterprises LLC, and Texas
Cigar Merchants Association
- 45 -
ADDENDUM
1. El Cubano Cigar Boxes

2. El Cubano Cigar Boxes with FDA Warnings

3. El Cubano Cigars, Texas City – Retail Humidor

4. El Cubano Cigars, League City – Retail Humidor

5. En Fuego Tobacco Shop, Frisco – Retail Humidor

D.D.C. 16-cv-01460 DCKT 000120 - 002 Filed 2019-03-15

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Case 1:16-cv-01460-APM Document 120-2 Filed 03/15/19 Page 1 of 57

IN THE UNITED STATES DISTRICT COURT

EN FUEGO TOBACCO SHOP LLC, doing )

MEMORANDUM OF LAW IN SUPPORT OF PLAINTIFFS’ MOTION

Dated: March 15, 2019 Michael J. Edney, DC Bar No. 492024

Clyde M. Siebman, Texas Bar No. 18341600

Counsel for Plaintiffs

B. The FDA’s Imposition of the Warnings on Premium Cigars Was

*Airmark Corp. v. FAA,

Alfa Int’l Seafood v. Ross,

All. for Nat. Health U.S. v. Sebelius,

Am. Acad. of Implant Dentistry v. Parker,

*Am. Beverage Ass’n v. City & Cty. of S.F,

Am. Meat Inst. v. U.S. Dep’t of Agriculture,

Brown v. Entm’t Merchants Ass’n,

Burlington N. & Santa Fe Ry. Co. v. Surface Transp. Bd.,

Cigar Ass’n v. FDA,

Cigar Ass’n v. FDA,

*CTIA—The Wireless Ass’n v. City & Cty. of S.F.,

Del. Dep’t of Natural Res. & Envtl. Control v. EPA,

Edmond v. United States,

Entm’t Software Ass’n v. Blagojevich,

FW/PBS, Inc. v. City of Dall.,

Gen. Chem. Corp. v. United States,

Green Country Mobilephone, Inc. v. FCC,

Humane Soc’y of U.S. v. Zinke,

Individual Reference Servs. Grp., Inc. v. FTC,

Lorillard Tobacco Co. v. Reilly,

Milavetz, Gallop, & Milavetz, P.A. v. United States,

Minority Television Project, Inc. v. FCC,

*Nat’l Ass’n of Home Builders v. EPA,

Nat’l Ass’n of Mfrs. v. SEC,

*Nat’l Ass’n of Wheat Growers v. Zeise,

*Nat’l Inst. of Family & Life Advocates v. Becerra,

Nat’l Med. Enters., Inc. v. Shalala,

Nat’l Wildlife Fed’n v. Hodel,

Nutritional Health All. v. Shalala,

Poett v. United States,

*Portland Cement Ass’n v. EPA,

*R.J. Reynolds Tobacco Co. v. FDA,

Rubin v. Coors Brewing Co.,

Sorrell v. IMS Health, Inc.,

United Space All., LLC v. Solis,

United States v. Wenger,

Va. State Bd. of Pharmacy v. Va. Citizens Consumer Prot. Council,

Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio,

Statutes, Rules, and Regulations

5 U.S.C. § 500 et. seq.........................................................................................................12, 43, 44

Family Smoking Prevention and Tobacco Control Act of 2009,

21 C.F.R. § 1143 ............................................................................................6, 7, 17, 18, 26, 29, 31

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

Tobacco Product Standard for Nicotine Level of Combusted Cigarettes,

U.S. Const. art. II, § 2, cl. 2 ...............................................................................................41, 42, 43

injunction. ECF No. 20.

applicable to restrictions of commercial speech.

The agency’s decision to enforce the warnings requirement, notwithstanding the

pendency of a rulemaking docket reconsidering the regulation of premium cigars, is arbitrary

I. THE PLAINTIFFS ARE FAMILY-OWNED SMALL BUSINESSES THAT MAKE

mass-produced cigars off the assembly line.

The Texas Cigar Merchants Association (“TxCMA”) is a not-for-profit association with

II. THE FDA IMPOSES A COMPLICATED AND ONEROUS REGULATORY

§ 1431.23 (Ex. B).

required massive warnings on cigar packages and advertisements.

display panels—those “most likely to be displayed, presented, shown, or examined by the

advertise its products. See id. § 1143.5(c); 81 Fed. Reg. at 29,072–73.

(“interpret[ing] broadly” the term “advertisement” to include “statements regarding the