E.D. Tex. 18-cv-00028 DCKT 000022 - 000 Filed 2018-03-27

Case 4:18-cv-00028-ALM-KPJ Document 22 Filed 03/27/18 Page 1 of 57 PageID #: 637
IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF TEXAS
SHERMAN DIVISION
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. 4:18-cv-00028
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. )
)
PLAINTIFFS’ MOTION FOR PARTIAL SUMMARY JUDGMENT OR, IN THE

ALTERNATIVE, FOR A PRELIMINARY INJUNCTION AND MEMORANDUM OF
LAW IN SUPPORT
TABLE OF CONTENTS
Page
INTRODUCTION........................................................................................................................ 1
BACKGROUND .......................................................................................................................... 4
I. The Plaintiffs Are Texas-Based, Family-Owned Small Businesses that
Make and Sell Premium Cigars ............................................................................. 4
II. Premium Cigars Are Different than Mass-Produced Cigars and Other
Tobacco Products ................................................................................................... 5
III. The FDA Imposes a Massive and Complicated Regulatory Framework on
Premium Cigars and Then Opens a Rulemaking Docket to Reconsider
That Decision ......................................................................................................... 7
IV. The FDA’s New Warning Labels for Cigars and Pipe Tobacco ......................... 10
ARGUMENT .............................................................................................................................. 12
I. Legal Standard ..................................................................................................... 12
II. The FDA’s New Warning Labels Violate the First Amendment ........................ 13
A. The Rule Mandates Disclosures That Are Not “Purely Factual and
Uncontroversial,” as Applied to Premium Cigars, and Thus Must
Be Evaluated Under Strict or Intermediate Scrutiny ............................... 14
B. The Rule Restricts Commercial Speech as Applied to Premium
Cigars and Pipe Tobacco, Requiring Intermediate Scrutiny Under
Central Hudson ........................................................................................ 19
C. The FDA’s New Warnings Fail Central Hudson 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 Reduction of Premium Cigar or Pipe Tobacco
Use ............................................................................................... 22
3. The FDA’s New Warnings Are Not Narrowly Tailored ............. 24
A. The FDA’s Warnings Are Unjustified and Unduly Burdensome ............ 29
B. The FDA’s Warning Plan System Violates the First Amendment .......... 33
1. The Warning Plan Scheme Is an Unconstitutional Prior
Restraint ....................................................................................... 33
2. The Warning Plan Scheme Is an Unconstitutional
Restriction of Commercial Speech .............................................. 34
III. The FDA’s New Warning Labels Violate the FSPTCA and The APA ............... 35
-i-
TABLE OF CONTENTS
(continued)
Page
A. The Rule Violates the APA Because the FDA Arbitrarily and
Capriciously Mandated Warnings Before Completing its Scientific
Review of Premium Cigars and Inverted Its Own Risk Assessment ....... 35
B. The Rule Violates the APA Because the FDA Failed to Make
Mandatory Findings ................................................................................. 38
IV. Plaintiffs Are Entitled to a Preliminary Injunction Against Enforcement of
the FDA’s New Warnings .................................................................................... 39
CONCLUSION .......................................................................................................................... 41
-ii-
TABLE OF AUTHORITIES
Page(s)
Cases
44 Liquormart, Inc. v. Rhode Island,

517 U.S. 484 (1996) ...........................................................................................................19, 34
Allstate Ins. Co. v. Abbott,

495 F.3d 151 (5th Cir. 2007) .............................................................................................20, 27
Am. Acad. of Implant Dentistry v. Parker,

860 F.3d 300 (5th Cir. 2017) .......................................................................................22, 24, 28
Am. Beverage Ass’n v. City & Cty. of S.F.,

871 F.3d 884 (9th Cir. 2017) .............................................................................................26, 32
Am. Meat Inst. v. U.S. Dep’t of Agric.,

760 F.3d 18 (D.C. Cir. 2014) (en banc) ...................................................................................17
Associated Builders & Contractors of Se. Tex. v. Rung,

No. 1:16-CV-425, 2016 WL 8188655 (E.D. Tex. Oct. 24, 2016) .....................................40, 41
Brock v. Merrell Dow Pharm., Inc.,

874 F.2d 307 (5th Cir. 1989) ...................................................................................................15
Brown v. Entm’t Merchants Ass’n,

564 U.S. 786 (2011) .................................................................................................................22
Burk v. Augusta-Richmond Cty.,

365 F.3d 1247 (11th Cir. 2004) ...............................................................................................34
Cano v. Everest Minerals Corp.,

362 F. Supp. 2d 814 (W.D. Tex. 2005)....................................................................................15
Central Hudson Gas & Electric Co. v. Public Service Commission of New York,
447 U.S. 557 (1980) ......................................................................................................... passim
Chamber of Commerce of U.S.A. v. U.S. Dep’t of Labor,

--- F.3d ----, 2018 WL 1325019 (5th Cir. 2018) ................................................................35, 37
Christian Legal Soc’y v. Walker,

453 F.3d 853 (7th Cir. 2006) ...................................................................................................41
CTIA—The Wireless Ass’n v. City & Cty. of S.F.,

827 F. Supp. 2d 1054 (N.D. Cal. 2011) .............................................................................17, 20
CTIA—The Wireless Ass’n v. City of Berkeley, Cal.,

854 F.3d 1105 (9th Cir. 2017) .....................................................................................17, 30, 31
De Leon v. Perry,
975 F. Supp. 2d 632 (W.D. Tex. 2014)....................................................................................41
-i-
Deerfield Med. Ctr. v. City of Deerfield Beach,

661 F.2d 328 (5th Cir. 1981) ...................................................................................................40
Discount Tobacco City & Lottery, Inc. v. United States,

674 F.3d 509 (6th Cir. 2012) ...................................................................................................26
Dwyer v. Cappell,
762 F.3d 275 (3d Cir. 2014)...............................................................................................20, 32
Edenfield v. Fane,
507 U.S. 761 (1993) .....................................................................................................22, 23, 24
Edward J. DeBartolo Corp. v. Fla. Gulf Coast Bldg. & Constr. Trades Council,
485 U.S. 568 (1988) .................................................................................................................39
Entm’t Software Ass’n v. Blagojevich,

469 F.3d 641 (7th Cir. 2006) .............................................................................................19, 26
FW/PBS, Inc. v. City of Dall.,

493 U.S. 215 (1990) ...........................................................................................................33, 34
Pursuing Am.’s Greatness v. FEC,

831 F.3d 500 (D.C. Cir. 2016) .................................................................................................20
Grill v. Quinn,
No. 2:10-cv-0757, 2013 WL 3146803 (E.D. Cal. June 18, 2013) ...........................................13
Grinin v. Johnson,
224 F. Supp. 3d 525 (S.D. Tex. 2015) .....................................................................................13
Hornbeck Offshore Servs., L.L.C. v. Salazar,

696 F. Supp. 2d 627 (E.D. La. 2010) .......................................................................................38
Int’l Dairy Foods Ass’n v. Amestoy,

92 F.3d 67 (2d Cir. 1996)...................................................................................................22, 31
Int’l Women’s Day March Planning Comm. v. City of San Antonio,

619 F.3d 346 (5th Cir. 2010) ...................................................................................................33
Kornman & Assocs., Inc. v. United States,

527 F.3d 443 (5th Cir. 2008) ...................................................................................................12
McCullen v. Coakley,
134 S. Ct. 2518 (2014) .............................................................................................................29
Milavetz, Gallop & Milavetz, P.A. v. United States,

559 U.S. 229 (2010) .................................................................................................................29
Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co.,
463 U.S. 29 (1983) .............................................................................................................36, 37
Nat’l Ass’n of Wheat Growers v. Zeise,

No. 2:17-cv-2401, 2018 WL 1071168 (E.D. Cal. Feb. 26, 2018) .....................................16, 18
- ii -
Nat’l Shooting Sports Found. v. Jones,

716 F.3d 200 (5th Cir. 2013) ...................................................................................................38
Nat’l Wildlife Fed’n v. Hodel,

839 F.2d 694 (D.C. Cir. 1988) .................................................................................................37
Nevada v. U.S. Dep’t of Labor,

218 F. Supp. 3d 520 (E.D. Tex. 2016) ...............................................................................12, 40
Nichols v. Alcatel USA, Inc.,

532 F.3d 364 (5th Cir. 2008) ...................................................................................................12
Porter v. Califano,
592 F.2d 770 (5th Cir. 1979) ...................................................................................................13
Pub. Citizen, Inc. v. La. Attorney Disciplinary Bd.,

632 F.3d 212 (5th Cir. 2011) ........................................................................................... passim
Pub. Citizen v. FMCSA,

374 F.3d 1209 (D.C. Cir. 2004) ...............................................................................................39
R.J. Reynolds Tobacco Co. v. FDA,

696 F.3d 1205 (D.C. Cir. 2012) .......................................................................19, 22, 26, 31, 37
R.J. Reynolds Tobacco Co. v. FDA,

845 F. Supp. 2d 266 (D.D.C. 2012) ...................................................................................26, 28
Riley v. Nat’l Fed’n of the Blind of N.C., Inc.,

487 U.S. 781 (1988) .................................................................................................................34
Rosen v. Port of Portland,

641 F.2d 1243 (9th Cir. 1981) .................................................................................................34
Rubin v. Coors Brewing Co.,

514 U.S. 476 (1995) ...........................................................................................................19, 27
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) .....................................................................................25
Shays v. FEC,
528 F.3d 914 (D.C. Cir. 2008) .................................................................................................37
Sorrell v. IMS Health, Inc.,

564 U.S. 552 (2011) .................................................................................................................18
Stuttering Found. of Am. v. Springer,

498 F. Supp. 2d 203 (D.D.C. 2007) .........................................................................................13
Teladoc, Inc. v. Tex. Med. Bd.,

112 F. Supp. 3d 529 (W.D. Tex. 2015)....................................................................................41
- iii -
Test Masters Educ. Servs., Inc. v. Robin Singh Educ. Servs., Inc.,
799 F.3d 437 (5th Cir. 2015) ...................................................................................................30
Tex. Office of Pub. Util. Counsel v. FCC,

183 F.3d 393 (5th Cir. 1999) ...................................................................................................13
Texans for Free Enter. v. Tex. Ethics Comm’n,

732 F.3d 535 (5th Cir. 2013) .............................................................................................40, 41
Thompson v. W. States Med. Ctr.,

535 U.S. 357 (2002) .................................................................................................................29
Tillman v. Miller,
133 F.3d 1402 (11th Cir. 1998) .........................................................................................27, 33
U.S. Postal Serv. v. Athena Prods.,

654 F.2d 362 (5th Cir. 1981) ...................................................................................................33
United States v. Playboy Entm’t Grp., Inc.,

529 U.S. 803 (2000) .................................................................................................................29
Va. State Bd. of Pharmacy v. Va. Citizens Consumer Prot. Council,

425 U.S. 748 (1976) .................................................................................................................34
Valle Del Sol, Inc. v. Whiting,

709 F.3d 808 (9th Cir. 2013) ...................................................................................................25
Wooley v. Maynard,
430 U.S. 705 (1977) .................................................................................................................19
Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio,

471 U.S. 626 (1985) ......................................................................................................... passim
Statutes and Regulations
5 U.S.C. § 706 ................................................................................................................................13
15 U.S.C. § 1333 ............................................................................................................................37
21 U.S.C. § 387a ..............................................................................................................................8
21 U.S.C. § 387d ..............................................................................................................................8
21 U.S.C. § 387e ..............................................................................................................................8
21 U.S.C § 387f .............................................................................................................................38
21 U.S.C. § 387j...............................................................................................................................8
21 U.S.C. § 387k ......................................................................................................................17, 30
- iv -
Regulations
Proposed Rule, Deeming Tobacco Products to Be Subject to the Federal Food,

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

Reg. 11,818 (Mar. 16, 2018).....................................................................................................25
21 C.F.R. § 1143.3 .........................................................................................................................12
21 C.F.R. § 1143.5 ................................................................................................................. passim
-v-
Plaintiffs En Fuego Tobacco Shop LLC, Cuba Libre Enterprises LLC, and Texas Cigar
Merchants Association file this motion for partial summary judgment or, in the alternative, for a
preliminary injunction. On the basis of the facts and arguments presented herein, Plaintiffs are
entitled to summary judgment on Counts I–VI of Plaintiffs’ Amended Complaint for Declaratory
and Injunctive Relief (Dkt. #20).
INTRODUCTION
In 2016, the FDA imposed a massive, blunderbuss regulation of all cigars, requiring
every cigar product to run a regulatory gauntlet that was previously designed for prescription
drugs and medical devices. As part of this regulatory maze, the FDA mandated that every cigar
product bear massive warnings, larger than even those currently required for cigarettes.
Underneath this scheme was a premise: All cigars are the same and should be regulated the same.
What the FDA failed to recognize then is that premium cigars are different. They are
manufactured, marketed, and used differently than other cigars, much less cigarettes and smokeless
tobacco. Instead of rolling off an assembly line, they are made by the hands of skilled artisans.
Rather than seeking uniformity, premium cigar manufacturers pursue variation, taking the best of
tobacco grown in a season and crafting unique products in each manufacturer’s own distinctive
style as winemakers create varietals. For their part, customers use premium cigars infrequently.
And study after study has shown there is no statistically significant youth use of premium cigars.
The new Administration recognized that premium cigars are different. The FDA just
opened a rulemaking proceeding to determine whether premium cigars should be entirely
exempted from FDA regulation. See Regulation of Premium Cigars, 83 Fed. Reg. 12,901–04
(Mar. 26, 2018) (Ex. A). Among the aspects of the Rule the FDA seeks to reconsider is the
warnings requirement. When it promised this rulemaking proceeding in July 2017, the agency
suspended most of the original regulation to allow time for this reconsideration to conclude. But
-1-
that suspension inexplicably left in place—to take effect on August 10, 2018—its mandate for
premium cigars to bear large health warnings. Hence this lawsuit, and its request for emergency
relief to prevent the violation of First Amendment rights through a Rule on which not even the
FDA is fully settled, is now before the Court.
The FDA’s warnings must cover 30 percent of the two principal panels of every cigar
box and 20 percent of virtually every communication with a consumer about cigars. They
consist of large black text against a white background that blares the FDA’s message. They will
drape the hand-crafted, artistic boxes that tell each manufacturer’s story, from its family history
to its intricate process for taking a cigar from leaf to product. Every e-mail, flyer, sign, and
social media post must bear the Government’s message. In the store, the warnings must be
repeated twice on each cigar box, on every sign describing a product, on every fixture bearing
the name of a cigar product, and at the cash register.
These warnings plainly violate the First Amendment, the Administrative Procedure Act,
and the statue authorizing FDA rulemaking in this area. They are not routine commercial
disclosure requirements and thus are subject to intermediate or strict constitutional scrutiny.
First, the warnings are not purely factual and uncontroversial as applied to premium cigars. This
is demonstrated by the recent opening of a rulemaking docket that seeks input on whether the
content of the warnings as applied to premium cigars should be revised. See Ex. A at 12,904.
This is also demonstrated by data analyzed by the FDA’s own staff, which show that the median
premium cigar consumer smokes 1.7 days per month and 93 to 97 percent of premium cigar
consumers smoke less frequently than daily. Studies by the FDA staff, in turn, show no
statistically significant increase in mortality for those who smoke cigars less frequently than
-2-
daily. The warnings—blaring the unqualified risk of cancer—provide an incomplete and thus
misleading picture of the health risks.
Second, the size of the warnings crowds out the speech of premium cigar manufacturers
and retailers, and thus restricts commercial speech. But the agency made absolutely no effort to
justify the warnings under the four-part test long required for commercial speech restrictions in
Central Hudson Gas & Electric Co. v. Public Service Commission of New York, 447 U.S. 557
(1980), which is the minimum standard of constitutional review in these circumstances. None of
the evidence in the record shows that youth use premium cigars, or that customers of premium
cigars do not understand their health risks, or that large warnings are needed. The agency also
blew right by obvious less restrictive alternatives, including a cigar warnings scheme long
required for several cigar manufacturers by the Federal Trade Commission (“FTC”), which
covers far less of each package and advertisement. Even if the standards for routine commercial
disclosures set forth in Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio,
471 U.S. 626 (1985), were to apply, the warnings are so big that they are “unduly burdensome.”
The agency’s contradictory pronouncements—that further study is required to determine
whether premium cigars should be regulated at all, while leaving the warnings in place for
premium cigars—also create a classic example of arbitrary and capricious rulemaking in
violation of the Administrative Procedure Act. The Court should vacate the arbitrary and
capricious warnings requirement, which also violates the First Amendment, or in the alternative
preliminarily enjoin its enforcement until the Court may fully resolve the merits.
-3-
BACKGROUND
I. THE PLAINTIFFS ARE TEXAS-BASED, 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 and pipe tobacco in local Texas communities. All the Plaintiffs are
exclusively dedicated to the sale of premium cigars and pipe tobacco 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 in 2006. They opened their first
premium cigar and pipe tobacco 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 Texas-based, local cigar retailers, manufacturers, and distributors. TxCMA’s
members in this State are confronting the imminent reality that, absent the Court’s intervention,
warnings will be placed on all of the premium cigar and pipe tobacco products they make and sell.
-4-
II. PREMIUM CIGARS ARE DIFFERENT THAN MASS-PRODUCED CIGARS

AND OTHER TOBACCO PRODUCTS
The FDA’s rulemaking record simply does not support treating premium cigars
identically to the mass-produced cigars that often are used like cigarettes. As explained below,
the FDA has identified a category of “premium cigars” that are distinct from other cigars and has
acknowledged that further study is needed to prove that their regulation is necessary.
Premium cigars are, in fact, different. First, premium cigars are made differently than
mass-produced cigars. By definition, premium cigars consist only of natural tobacco leaf, water,
and a small amount of 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. Manufacturers, every day, harness changes
in growing conditions and weather carefully to craft each cigar. Because of these changes, they
regularly offer special editions and new blends. As a result of the laborious crafting process,
premium cigars are expensive. Their manufacturing process bears no relation to the machines
robotically churning identical, mass-produced cigars off the assembly line.
Second, premium cigars are used differently than mass-marketed cigars. The median
consumer of cigarettes smokes nearly every day. The median consumer of premium cigars
smokes 1.7 days per month. See 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, at 1, 5 tbl.2 (Ex. B). 93 to 97 percent of premium cigar consumers smoke
less frequently than daily. Id. (calculating non-daily use rates of 93.3 percent); see also
Catherine G. Corey et al., Little Filtered Cigar, Cigarillo, and Premium Cigar Smoking Among
Adults—United States, 2012–2013, 63 Morbidity & Mortality Wkly. Rep. 650, 652 (Aug. 1,
-5-
2014) (Ex. C) (calculating non-daily use rates of 96.7 percent). The FDA’s own staff has
concluded, in a peer-reviewed article, that those who smoke cigars less than daily show no
statistically significant increase in mortality. 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. D). There has been no evidence or allegations that cigarette
smokers have migrated to premium cigars or that cigarette products have made modifications to
be classified as premium cigars, as allegedly has occurred with mass-produced cigars.
Third, premium cigars are used almost exclusively by adults. FDA staff analyzed the
results of the Population Assessment of Tobacco and Health (“PATH”) study, which has
amassed data on use of tobacco and other products by youth annually since 2011. 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, 343 (2017) (Ex. E). Those FDA staff members concluded that regular
use of premium cigars by youth was so rare that it could not be reliably measured. Id. at 349,
supp. app. at 14 tbl.S4. The typical premium cigar consumer is an older adult who smokes
infrequently. See Ex. B at 4 tbl.1; Ex. C at 651 tbl.
Fourth, premium cigars are marketed differently than cigarettes, mass-produced cigars, or
other tobacco products. Premium cigars generally are sold in ornate packages that communicate
a message of luxury and craftsmanship and often are viewed as collector’s items in their own
right. Those boxes provide consumers with information about the rare tobacco used and often
celebrate the anniversaries of the company; they inform consumers about the qualities of the
product. Because of the painstaking work by hand to craft premium cigars, they are more
expensive than mass-produced cigars and other tobacco products and thus more inaccessible to
the underaged, who are deterred by expense. See Declaration of Cecil R. Reynolds, Ph.D.
-6-
(“Reynolds Decl.”) ¶¶ 32, 92. Most premium cigars are sold in specialty tobacco stores, which
are themselves inaccessible to those under the legal smoking age. Id. ¶ 14; see also Ex. B at 6
tbl.3. This stands in stark contrast to mass-produced cigars and cigarettes, which are often
displayed behind the counters of convenience stores and other retailers.
Fifth, premium cigar manufacturers tend not to be large international conglomerates.
Plaintiff El Cubano is a prime example. El Cubano employs roughly 8 people total in both of its
east Texas locations. El Cubano is a distinctly local business that caters to a distinctly local
clientele and lacks the legal compliance department of a multi-national corporation necessary to
navigate the FDA’s regulations.
III. THE FDA IMPOSES A MASSIVE AND COMPLICATED REGULATORY

FRAMEWORK ON PREMIUM CIGARS AND THEN OPENS A RULEMAKING
DOCKET TO RECONSIDER THAT DECISION
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 FDA’s rule is commonly called the “Deeming Rule,” because it effectively “deemed” many
products indistinguishable from cigarettes and poured them into the regulatory scheme Congress
constructed for cigarettes. That scheme stems from the Family Smoking Prevention and
Tobacco Control Act of 2009 (the “FSPTCA” 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 FSPTCA § 2, 123 Stat. at 1776–81. Congress was not sure that
pipe tobacco and cigars, much less premium cigars, should be regulated at all; it left that issue up
-7-
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
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). The same requirements applied to
pipe tobacco products. See 81 Fed. Reg. at 29,048–49. As described in further detail below, the
Rule also required massive warnings on cigar and pipe tobacco packages and advertisements.
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 Deeming 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. Id. 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
-8-
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.
When the new Administration took office, compliance deadlines under the Rule were
imminent. The new Administration knew there was a problem and extended those compliance
deadlines several times. See Ctr. for Tobacco Prods., Food & Drug Admin., Extension of
Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule: Guidance
for Industry (Revised) 1–4 (Nov. 2017) (Ex. F). Then, on July 28, 2017, the agency made a
substantive announcement, conceding that the Rule regulating all cigars the same needed to
change. See Press Release, U.S. Food & Drug Admin., FDA Announces Comprehensive
Regulatory Plan to Shift Trajectory of Tobacco-Related Disease, Death (July 28, 2017) (Ex. G).
The agency delayed many aspects of the Rule for three-and-a-half years to give it time to open
and conclude a rulemaking docket to reconsider the regulation of premium cigars. Id.
This week, the FDA opened that rulemaking docket, which explicitly seeks to reconsider
whether premium cigars should be regulated differently or at all. Ex. A at 12,902–04. The
warnings requirement is not excluded from this reconsideration. The docket specifically seeks
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 seeks information about the
accuracy of the warnings statements themselves as applied to premium cigars, acknowledging
that “alternative” warning statements may be more appropriate. Id. at 12,904. Despite its public
determination that the warnings requirements as applied to premium cigars require further
scientific study, the agency still has not modified the August 10, 2018, deadline for affixing
warnings to premium cigar packages and advertising. See Cigar Labeling and Warning
Statement Requirements, U.S. Food & Drug Admin., https://www.fda.gov/Tobacco
-9-
Products/Labeling/Labeling/ucm524442.htm (last updated Jan. 8, 2018) (Ex. H). These
contradictory decisions mean that the First Amendment rights of the Plaintiffs, who manufacture,
speak with consumers about, and sell premium cigars, will be restricted before the agency has
determined whether regulation of premium cigars, or even the content of the required warnings,
is scientifically warranted.
IV. THE FDA’S NEW WARNING LABELS FOR CIGARS AND PIPE TOBACCO
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). The 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 set aside for the required text.” Id. §§ 1143.1, 1143.5(a)(2). Further,
manufacturers lack the liberty to choose among the six warnings. Rather, they serve as an
integrated whole, as each of the six warning 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 and be randomly distributed in all areas of the United States in which the product is
marketed.” Id. § 1143.5(c)(1).
- 10 -
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).
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 a sign no smaller than 8.5 x 11 inches 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 retail 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 stores and at En Fuego’s Frisco store can be found in the
Addendum at the end of this brief.
Importantly, a retailer cannot just choose to advertise and 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 Rule appears to require a retailer’s warning plan to name the brands it
- 11 -
intends to advertise; if a retailer takes on a new brand, it must supplement its warning plan and wait
another 12 months before speaking about it. Ctr. for Tobacco Prods., Food & Drug Admin.,
Submission of Warning Plans for Cigars: Guidance for Industry 7 (Dec. 2016) (Ex. I).
The new warnings on pipe tobacco packages and advertisements are subject to the same
formatting requirements. See 21 C.F.R. § 1143.3(a)–(b). Only one warning applies to pipe
tobacco, however: “WARNING: This product contains nicotine. Nicotine is an addictive
chemical.” Id. § 1143.3(a)(1).
ARGUMENT
I. LEGAL STANDARD
The decision to preliminarily enjoin agency action “lies within the sound discretion of the
district court.” Nevada v. U.S. Dep’t of Labor, 218 F. Supp. 3d 520, 526 (E.D. Tex. 2016). To
establish their entitlement to a preliminary injunction, Plaintiffs must show (1) “a substantial
likelihood of success on the merits,” (2) “a substantial threat that [they] will suffer irreparable
harm if the injunction is not granted,” (3) “that the threatened injury outweighs any damage that
the injunction might cause the defendant,” and (4) “that the injunction will not disserve the
public interest.” Nichols v. Alcatel USA, Inc., 532 F.3d 364, 372 (5th Cir. 2008). Plaintiffs need
not “prove [their] case in full at a preliminary injunction hearing.” Nevada, 218 F. Supp. 3d at
526. A prima facie showing will suffice to demonstrate the requisite likelihood of success. Id.
Summary judgment “should be rendered ‘if the pleadings, the discovery and disclosure
materials on file, and any affidavits show that there is no genuine issue as to any material fact
and that the movant is entitled to judgment as a matter of law.’” Kornman & Assocs., Inc. v.
United States, 527 F.3d 443, 450 (5th Cir. 2008). Summary judgment under the Administrative
Procedure Act (the “APA”) “serves as the mechanism for deciding, as a matter of law, whether
the agency action is supported by the administrative record and otherwise consistent with the
- 12 -
APA standard of review.” Grinin v. Johnson, 224 F. Supp. 3d 525, 530 (S.D. Tex. 2015)
(quoting Stuttering Found. of Am. v. Springer, 498 F. Supp. 2d 203, 207 (D.D.C. 2007)). The
APA directs the Court to “hold unlawful and set aside agency action, findings, and conclusions
found to be” (A) “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance
with law,” (B) “contrary to constitutional right, power, privilege, or immunity,” or (C) “in excess
of statutory jurisdiction, authority, or limitations, or short of statutory right.” 5 U.S.C.
§ 706(2)(A)–(C). The Court does not give an agency’s actions “deference when reviewing a
potential violation of a constitutional right.” Tex. Office of Pub. Util. Counsel v. FCC, 183 F.3d
393, 410 (5th Cir. 1999). Rather, the Court must “make an independent assessment of a citizen’s
claim of constitutional right when reviewing agency decision-making.” Id. And it may consider
evidence outside the administrative record to that end. See Porter v. Califano, 592 F.2d 770,
780–81 (5th Cir. 1979); see also Grill v. Quinn, No. 2:10-cv-0757, 2013 WL 3146803, at *6 n.8
(E.D. Cal. June 18, 2013); Rydeen v. Quigg, 748 F. Supp. 900, 906 (D.D.C. 1990). Indeed,
“[i]ndependent judicial judgment is especially appropriate in the First Amendment area” because
“courts, not agencies, are expert on the First Amendment.” Porter, 592 F.2d at 780 n.15.
II. THE FDA’S NEW WARNING LABELS VIOLATE THE FIRST AMENDMENT
As applied to the premium cigars and pipe tobacco sold by the Plaintiffs, the FDA’s
warning label requirement violates the First Amendment. The Supreme Court has established a
series of tests for evaluating regulations of speech. The warnings requirement is subject to at least
the intermediate scrutiny governing restrictions of commercial speech, or to even strict
constitutional scrutiny, for two reasons. First, the warnings requirement does not compel the
disclosure of “purely factual and uncontroversial information.” Zauderer, 471 U.S. at 651. In such
circumstances, many courts apply strict scrutiny; at a minimum, the intermediate scrutiny of
Central Hudson applies. Second, the warnings requirement restricts commercial speech, because
- 13 -
the warnings are so large and stark that they crowd out the speech of the Plaintiffs on packages and
advertising and become the predominant message. The choice between the Central Hudson test
and strict scrutiny does not affect the outcome of this case, as the Rule plainly fails both tests.
Even if only the standard for relatively unobtrusive, purely factual and uncontroversial
commercial disclosures under Zauderer were to apply, the Rule fails that test as well. The
warnings are both “unjustified” and “unduly burdensome,” and therefore unconstitutional.
Zauderer, 471 U.S. at 651; see also Pub. Citizen, Inc. v. La. Attorney Disciplinary Bd., 632 F.3d
212, 228–29 (5th Cir. 2011).
Finally, the Rule’s warning plan requirement is an unconstitutional prior restraint.
Plaintiff En Fuego, for example, does not know today what cigar brands it will carry or about
which it will want to communicate with consumers a year from now. The Rule, though, requires
retailers to seek FDA approval at least a year before speaking about each brand. There is no
justification for this 12-month gag order; it violates the First Amendment.
A. The Rule Mandates Disclosures That 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, has acknowledged that the accuracy of the
warning statements as applied to premium cigars requires further study. Ex. A at 12,904. That
was wise, because the current content of the mandated warnings is inconsistent with peer-
reviewed research funded by the FDA and conducted by its own staff. As such, 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 more flexible constitutional review.
- 14 -
FDA staff, in collaboration with other researchers, recently conducted an extensive
review of the PATH Study, which has collected data regarding the use of premium cigars since
2011. See Ex. B at 2–3. According to the FDA staff, the data showed that the median consumer
of premium cigars uses the product 1.7 days per 30 days. Id. at 5 tbl.2. And 93 to 97 percent of
premium cigar consumers use the product less frequently than daily. See id.; see also Ex. C at
652. By contrast, the median consumer of cigarettes smokes 29.4 days per month, and the
median consumers of non-premium cigars, cigarillos, and filtered cigars smoke 9.2, 7.5, and 14
days per month, respectively. Ex. B at 5 tbl.2.
These data are crucial in light of a study published by FDA staff in February of this year.
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. Ex. D at E2. 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. 1 In other words, if consumers use premium cigars as 93
1
The researchers estimated mortality risks using “Cox proportional hazards models with age as
the underlying time variable,” and made multivariable adjustments for sex, race/ethnicity, and
other factors. Ex. D at E3. Specifically, the confidence intervals for the multivariable analyses
of the hazard ratios for each mortality outcome include the baseline of 1.0 for never tobacco
users. Id. at E6 tbl.3. A hazard ratio of 1.0 denotes that the risk of death is the same for both
groups. See id. 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. The Fifth Circuit has long
recognized that, “[i]f the confidence interval [in an epidemiological study] is so great that it
includes the number 1.0, then the study will be said to show no statistically significant
association between the factor and the disease.” Brock v. Merrell Dow Pharm., Inc., 874 F.2d
307, 312 (5th Cir. 1989); see also Cano v. Everest Minerals Corp., 362 F. Supp. 2d 814, 821
(W.D. Tex. 2005) (“[T]o support causation, an epidemiological study must be statistically
significant at the 95% confidence level and the confidence interval may not include 1.0.”).
- 15 -
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.”
At the very least, the content of the warnings is “controversial” as applied to premium
cigars, by the FDA’s own admission. The FDA on March 26, 2018, 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 Ex. A at 12,902–03 (citing Ex. B); 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 most 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, No. 2:17-cv-2401, 2018 WL 1071168, at *7 (E.D. Cal. Feb. 26, 2018)
(striking down a compelled disclosure that glyphosate is “known” to cause cancer because some
- 16 -
studies were to the contrary); 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). First, even using the word “can,”
the warning is misleading because it omits material information. See, e.g., CTIA—The Wireless
Ass’n v. City of Berkeley, Cal., 854 F.3d 1105, 1119 (9th Cir. 2017) (in determining whether a
disclosure qualifies for relaxed constitutional scrutiny, “a statement may be literally true but
nonetheless misleading and, in that sense, untrue”); Am. Meat Inst. v. U.S. Dep’t of Agric., 760
F.3d 18, 27 (D.C. Cir. 2014) (en banc) (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, “if done frequently” or “if done daily,” cigar smoking “can
cause lung cancer and heart disease.” This omission of clarifying information is particularly
problematic because the combination of the Rule and the FSPTCA otherwise bans manufacturers
from making claims about the health effects of their products, especially on packages and
advertising. See FD&C Act § 911(a), 21 U.S.C. § 387k(a); 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
- 17 -
the risk of cancer. See Nat’l Ass’n of Wheat Growers, 2018 WL 1071168, at *6 & 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).
Second, when the warnings’ content is combined with their size, the message clearly is
that this product should not be used and poses a serious risk of harm if used as frequently as 93
to 97 percent of consumers do. That simply cannot be squared with the scientific conclusions of
the FDA’s own staff. In any event, 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).
The other warnings appear directed at problems plaguing other 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. Nor is there
any evidence in the record of a practice of consumers migrating from cigarettes to premium
cigars as 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
is seeking information on premium cigar usage patterns and reopening its scientific inquiry as to
each and every warning statement as applied to premium cigars. See Ex. A 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
- 18 -
to premium cigars, all must be evaluated under the intermediate or strict scrutiny applicable to
mandated disclosures of such information.
When the government mandates private parties to carry a message that is not “purely
factual and uncontroversial” on their products and advertising, that requirement is subject to
strict constitutional scrutiny. See Wooley v. Maynard, 430 U.S. 705, 714 (1977) (“[T]he right of
freedom of thought protected by the First Amendment against state action includes both the right
to speak freely and the right to refrain from speaking at all.”); Entm’t Software Ass’n v.
Blagojevich, 469 F.3d 641, 651–52 (7th Cir. 2006) (commercial disclosures that are not “purely
factual and uncontroversial” are subject to strict scrutiny). Some courts have held that, when
such a message is required to be carried in a commercial setting, the Supreme Court’s Central
Hudson test, its form of intermediate scrutiny for regulations of commercial speech, applies.
See, e.g., R.J. Reynolds Tobacco Co. v. FDA, 696 F.3d 1205, 1217 (D.C. Cir. 2012), overruled
on other grounds by Am. Meat Inst., 760 F.3d 18. As explained below, the Rule as applied to
premium cigars fails either standard.
B. The Rule Restricts Commercial Speech as Applied to Premium Cigars and

Pipe Tobacco, Requiring Intermediate Scrutiny Under Central Hudson
The Supreme Court’s Central Hudson test applies for another reason: The massive size
of the warnings restricts commercial speech and crowds out communications that Plaintiffs make
to consumers. This flows from two premises. First, the trademarks and trade dress of the boxes
made and sold by the Plaintiffs communicate important qualities of the products and constitute
protected commercial speech. See 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 504–08
(1996) (striking an advertising ban “prohibit[ing] truthful, nonmisleading speech about a lawful
product” as contrary to the First Amendment); Rubin v. Coors Brewing Co., 514 U.S. 476, 480–
83 (1995) (information on a product’s label constitutes commercial speech). Plaintiffs sell
- 19 -
premium cigars in distinctive boxes, the designs, symbols, and trademarks of which send a
message to consumers about the qualities of the products and the craftsmanship with which they
were made. Pipe tobacco, too, often is sold in similar packages.
Second, the new warning labels will confiscate a significant amount of space on premium
cigar and pipe tobacco packaging and advertising. This is space retailers and manufacturers use
to speak with consumers and may no longer once the warnings requirements go into effect.
Taking 30 percent of two panels of each package, 20 percent of each communication with
consumers, and requiring a retailer such as En Fuego to display the warnings hundreds of times
in its humidor will ensure that the Government’s message dominates over the Plaintiffs’
message. It is so obtrusive that it effectively crowds out and restricts the Plaintiffs’ speech and
thus must satisfy the Central Hudson test. See Pursuing Am.’s Greatness v. FEC, 831 F.3d 500,
507 & n.3 (D.C. Cir. 2016) (recognizing that a compelled disclosure can be so obtrusive as to
effectively restrict speech); Dwyer v. Cappell, 762 F.3d 275, 284 (3d Cir. 2014) (a disclosure
requirement intended to “make [speech] so burdensome” that speakers cease communicating in a
particular medium amounts to “an outright ban . . . properly . . . analyzed under the heightened
Central Hudson standard of scrutiny”); CTIA—The Wireless Ass’n, 827 F. Supp. 2d at 1064
(disclaimers that “unduly intrude upon . . . retailers’ own message” violate the First Amendment
because the Government “cannot paste its municipal message over the message of the retailers”).
C. The FDA’s New Warnings Fail Central Hudson Scrutiny
To satisfy Central Hudson, the FDA must prove that the Rule (1) serves a “substantial
governmental interest” (2) “directly advances” that interest, and (3) “is not more extensive than
necessary to serve that interest.” Allstate Ins. Co. v. Abbott, 495 F.3d 151, 165 (5th Cir. 2007).
The FDA fails on all counts. The Government’s “burden is a ‘heavy’ one that cannot be satisfied
‘by mere speculation or conjecture.’” Pub. Citizen, 632 F.3d at 218. To the extent that strict
- 20 -
scrutiny applies due to the mandating of other than purely factual and uncontroversial disclosures,
the following analysis under Central Hudson shows the Rule fails strict scrutiny as well.
1. The FDA’s New Warnings Do Not Serve a “Substantial” Interest
The FDA says 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. That is a means, not an end. When it comes to tobacco use generally, courts
have held that a restriction of speech has to be directed realistically at reducing the use of
tobacco. And the FDA disclaimed any effort to show that the Rule would reduce tobacco use.
See FRIA at 62 (“Reliable evidence on the impacts of warnings labels . . . on users of cigars . . .
[and] pipe tobacco . . . does not, to our knowledge, exist.”); 81 Fed. Reg. at 28,981 (announcing
that the agency “cannot predict” any quantifiable benefits directly resulting from the Rule).
The Supreme Court has recognized only one substantial interest that can justify restrictions
on speech regarding tobacco products: The reduction of underage tobacco use. As the Court
explained in Lorillard Tobacco Co. v. Reilly:
The State’s interest in preventing underage tobacco use is substantial, and even
compelling, but it is no less true that the sale and use of tobacco products by
adults is a legal activity. We must consider that tobacco retailers and
manufacturers have an interest in conveying truthful information about their
products to adults, and adults have a corresponding interest in receiving truthful
information about tobacco products. . . . As the State protects children from
tobacco advertisements, tobacco manufacturers and retailers and their adult
consumers still have a protected interest in communication.
533 U.S. 525, 564 (2001). “[A] speech regulation,” the Court wrote, “cannot unduly impinge on
the speaker’s ability to propose a commercial transaction and the adult listener’s opportunity to
obtain information about products.” Id. at 565.
- 21 -
The D.C. Circuit then rejected the FDA’s effort to ground its mandated cigarette
warnings in “an interest in ‘effectively communicating health information’ regarding the
negative effects of cigarettes,” holding that such an interest “is too vague to stand on its own”
and is “not an independent interest capable of sustaining the Rule.” R.J. Reynolds, 696 F.3d at
1209–10, 1221; see also, e.g., Int’l Dairy Foods Ass’n v. Amestoy, 92 F.3d 67, 73 (2d Cir. 1996)
(asserted interests in “strong consumer interest and the public’s ‘right to know’” were
“insufficient to justify compromising protected constitutional rights”). Rather, the Government
must seek to show that the mandated warnings will reduce use of the tobacco product in
question. See R.J. Reynolds, 696 F.3d at 1209–10, 1221. The FDA disclaimed this interest and
cannot change course now, as the Court is “confined to reviewing the government interests that
[the FDA] has actually put forward.” Pub. Citizen, 632 F.3d at 220. The FDA’s exclusive
reliance on an interest that does not qualify as substantial, on its own, invalidates the Rule. 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).
2. The FDA’s New Warnings Do Not Directly or Materially Advance the

Reduction of Premium Cigar or Pipe Tobacco Use
The FDA failed to identify any serious problem with regard to underaged use of premium
cigars and pipe tobacco, much less one that the Rule would directly and materially address. “The
FDA’s burden is “significant,” and “is not satisfied by mere speculation or conjecture; rather, a
governmental 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.” Am. Acad. of Implant Dentistry v. Parker, 860 F.3d 300, 309 (5th Cir. 2017) (quoting
Edenfield v. Fane, 507 U.S. 761, 770–71 (1993)).
- 22 -
To begin, the FDA provided no evidence that underaged use of premium cigars and pipe
tobacco occurs 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 Ex. E at
348–49; Reynolds Decl. ¶¶ 29–56. One such study reported virtually no use of pipe tobacco by
the underaged. Ex. E supp. app. at 3, 11 tbl.S3, 14 tbl.S4. The record before the agency is not
to the contrary. One study pressed by the FDA to show that youth use premium cigars showed
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, 390–92 (2015)
(Ex. J). The evidence in the record leaves no doubt that “the harms [the FDA] recites” 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 1.7 days per 30 days.
Ex. B at 5 tbl.2.
The Rule itself cited no study focused on the risk perceptions of premium cigar consumers.
Even the few studies that evaluated cigars generally, including small cigars with very different
patterns of use and demographics among consumers, did not establish a deficiency in consumer
understanding of health risks requiring correction. See 79 Fed. Reg. at 23,158 (citing Refs. 35,
116, 117, 119); id. at 23,166 (citing Ref. 158); 81 Fed. Reg. at 29,070 (citing Refs. 268, 269, 270,
and 271, and 79 Fed. Reg. at 23,158). Dr. Cecil Reynolds, an expert in such studies, thoroughly
- 23 -
explains in his attached declaration how those studies cannot be used to draw conclusions about
current understandings of health risks among premium cigar users. Reynolds Decl. ¶¶ 62–68.
All of this led to the agency’s own conclusion, which may begin and end the Court’s
inquiry: “Reliable evidence on the impacts of warning labels . . . on users of cigars . . . [and]
pipe tobacco . . . does not, to our knowledge, exist.” FRIA at 62. In short, the FDA openly has
admitted that it is aware of no evidence that its proposed restriction “will in fact alleviate” any
underage or even adult use of any cigars, much less premium cigars, and pipe tobacco to “a
material degree.” Edenfield, 507 U.S. at 770–71 (emphasis added).
Because the agency has “fail[ed] to point to any specific harms or to how they will be
alleviated,” the Rule cannot stand. Pub. Citizen, 632 F.3d at 222; see also Am. Acad. of Implant
Dentistry, 860 F.3d at 310–11.
3. The FDA’s New Warnings Are Not Narrowly Tailored
The FDA’s massive warnings, recklessly cast over all categories of cigars no matter the
evidence, represent an abject failure of narrow tailoring. Under Central Hudson, narrow
tailoring “requires a reasonable fit between the means and ends of the regulatory scheme.”
Lorillard, 533 U.S. at 561.
The FDA’s warnings are not narrowly tailored for four reasons. First, the FDA extended
the warnings to premium cigars, despite the fact that all the evidence in the Rule and the problems
it was attempting to solve concerned mass-produced cigars that, the FDA believes, are used like
cigarettes. In opening its formal rulemaking docket on March 26, 2018, 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 Ex. A 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 content (and presumably the
- 24 -
format) of the warnings makes sense as applied to premium cigars. Ex. A at 12,903–04. And the
FDA has opened separate dockets seeking to tighten regulations on flavored tobacco products,
including flavored cigars, and to reduce nicotine levels in cigarettes. See Regulation of Flavors in
Tobacco Products, 83 Fed. Reg. 12,294–301 (Mar. 21, 2018) (Ex. K); Tobacco Product Standard
for Nicotine Level of Combusted Cigarettes, 83 Fed. Reg. 11,818–43 (Mar. 16, 2018) (Ex. L).
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; Ex. A at 12,903; Ex. K at 12,295–97; Ex. L at 11,819–20.
The evidence shows that these are not problems for premium cigars: There is no
evidence that cigarette smokers are turning to large, expensive premium cigars as a nicotine
delivery system. After all, the median premium cigar consumer smokes only 1.7 days per 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 Ex. B at 5 tbl.2. And underaged use of premium cigars is so rare that it cannot be reliably
measured. Ex. E at 348–49, supp. app. at 14 tbl.S4; 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, e.g., Valle Del
Sol, Inc. v. Whiting, 709 F.3d 808, 825 (9th Cir. 2013) (“[A] restriction on commercial speech
‘must not be more extensive than is necessary to serve’ a substantial government interest—i.e., it
should not be overinclusive.”); 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
- 25 -
subject to regulation.”). Whatever the case for imposing large warnings on mass-produced or
flavored cigars, the Constitution forbids lumping premium cigars into a 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 and pipe tobacco packaging and advertising, taking up 30 percent of
both of a product’s two principal display panels and 20 percent of any advertising. Federal
courts applying the First Amendment to fully constructed warnings this large consistently have
struck them down. See, e.g., Am. Beverage Ass’n v. City & Cty. of S.F., 871 F.3d 884, 894, 897
(9th Cir. 2017) (invalidating health warnings covering 20% of soda advertisements), reh’g en
banc granted, 880 F.3d 1019 (9th Cir. 2018), and proceedings stayed pending decision in Nat’l
Inst. of Family & Life Advocates v. Becerra, No. 16-1140 (U.S. 2018); cf. Entm’t Software Ass’n,
469 F.3d at 652 (holding that a 4-square-inch warning label on a 7.5-by-5.5-inch DVD box—
covering 39 percent of just one display panel—“literally fails to be narrowly tailored [because]
the sticker covers a substantial portion of the box”). 2 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.
Third, the required 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
2
The Sixth Circuit upheld the FSPTCA’s requirement of large warning labels for cigarettes
against a facial challenge to the statute. Discount Tobacco City & Lottery, Inc. v. United States,
674 F.3d 509, 552–53, 562–63 (6th Cir. 2012). The FDA had not yet issued the implementing
regulations, id. at 552–53, 558–59; once it did, the D.C. district and circuit courts reviewed the
actual warnings and struck them down. R.J. Reynolds Tobacco Co. v. FDA, 845 F. Supp. 2d 266,
274–77 (D.D.C. 2012); see also R.J. Reynolds, 696 F.3d at 1217–22.
- 26 -
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 first screen, if not more. Declaration of Mark Moore (“Moore Decl.”)
¶¶ 9–10 & Ex. B. Likewise, while the FDA has offered no guidance on how the warnings must
be displayed on social media, it is evident that they 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. The same is true of radio advertisements, which retailers often
purchase in 15-second increments during peak hours: Up to 7 seconds (nearly 50 percent) will
be devoted to reciting a warning. See Tillman v. Miller, 133 F.3d 1402, 1404 & n.4 (11th Cir.
1998) (requirement that five seconds of a 30-second television ad be dedicated to a disclaimer
violated the First Amendment). 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.
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. The FDA cannot make that showing if its interest “could be equally well
served by a more limited restriction on commercial speech.” Allstate, 495 F.3d at 166–67. Chief
among the less intrusive alternatives is the FTC warnings scheme, in place for the preceding
sixteen years on the packages of the seven largest cigar manufacturers. On average, the FTC
warnings cover 13–15 percent of one panel of a cigar package and 7–16 percent of cigar
advertising by the manufacturers covered by the consent decree. See, e.g., Decision and Order at
- 27 -
3–9, In the Matter of Consol. Cigar Corp., Docket No. C-3966 (F.T.C. Aug. 25, 2000) (Ex. M).
The FDA warnings are several times larger than their FTC counterparts—roughly double the size
on any one panel of cigar packages, covering up to five times more total package surface area
(because the warnings must be placed on two panels, rather than one), and triple the size on
advertisements. Yet the FDA neglected to consider the size and scope of the FTC warnings. The
FDA had a decade-and-a-half laboratory to study the effectiveness of the FTC-sized warnings on
a large segment of the cigar industry, but the Rule does not have a word of analysis regarding
their effectiveness. This violates the First Amendment. See Am. Acad. of Implant Dentistry, 860
F.3d at 311–12 (advertising restriction failed Central Hudson where Government “has not
suggested it considered less-burdensome alternatives”).
As the Fifth Circuit has held, “numerous and obvious less burdensome alternatives”
strongly suggest that a commercial speech restriction is not narrowly tailored. Id. at 311. And
they abound here. The Government “could disseminate its anti-smoking message itself” through
government advertising and public information campaigns. R.J. Reynolds, 845 F. Supp. 2d at
276. The Government could raise the minimum legal age to purchase tobacco products; increase
penalties and enforcement measures relating to sales of tobacco to, or possession or use of
tobacco by, youth; increase support for programs aimed at the social factors underlying tobacco
use by youth; and raise the prices of tobacco products. See, e.g., Reynolds Decl. ¶¶ 69–80, 92–
94. Premium cigars are a case study in preventing youth use. Premium cigars are more
expensive than other tobacco products, and there is no statistically significant youth use. All of
these measures are directed at the root causes of youth tobacco use and involve no restriction of
speech. See Reynolds Decl. ¶¶ 92–94. None was analyzed by the FDA and shown to be
- 28 -
inadequate. After all, “regulating speech must be a last—not first—resort.” Thompson v. W.
States Med. Ctr., 535 U.S. 357, 373 (2002).
Because the warnings are not narrowly tailored under Central Hudson, they necessarily fail
strict scrutiny, which requires the Government to use “the least restrictive means of achieving a
compelling state interest.” McCullen v. Coakley, 134 S. Ct. 2518, 2530 (2014). Where, as here,
less restrictive means exist, the First Amendment requires the Government to use those means or to
demonstrate why they would be ineffective. See, e.g., United States v. Playboy Entm’t Grp., Inc.,
529 U.S. 803, 813–17 (2000). The FDA has not made, and cannot make, this showing.
A. The FDA’s Warnings Are Unjustified and Unduly Burdensome
Because the content of the warnings is not “purely factual and uncontroversial” and
because the warnings are so large that they crowd out the Plaintiffs’ speech on packages and
advertising, the Rule should be evaluated under at least the intermediate scrutiny of Central
Hudson. The FDA warnings also fail the Zauderer standard for compelled commercial
disclosures. Under Zauderer, even “purely factual and uncontroversial” disclosures violate the
First Amendment if they are not directed at correcting consumer deception or if they are
“unjustified” or “unduly burdensome.” 471 U.S. at 651.
First, there is no evidence that the mandated disclosures are directed at correcting the
deception of premium cigar consumers, as they must be for the Zauderer standard to apply. The
Supreme Court in Zauderer crafted a more flexible standard of constitutional review for
disclosures addressing situations where assertions on a package or in an advertisement might
otherwise deceive consumers. Id. (allowing relaxed scrutiny when “the disclosure requirements
are reasonably related to the State’s interest in preventing deception of consumers”). In 2010,
the Supreme Court drew a line under this requirement, explaining that Zauderer “intended to
combat the problem of inherently misleading commercial advertisements.” Milavetz, Gallop &
- 29 -
Milavetz, P.A. v. United States, 559 U.S. 229, 250 (2010). No Supreme Court case has applied
relaxed Zauderer scrutiny where preventing consumer deception was not the claimed interest.
Although some circuit courts have allowed government agencies to reach Zauderer
scrutiny without seeking to correct consumer deception, e.g., CTIA—The Wireless Ass’n, 854 F.3d
at 1117, the Fifth Circuit has not so ruled. To the contrary, the Fifth Circuit has held that, to come
under Zauderer, “the State’s interest in preventing deception of consumers” must be implicated.
Pub. Citizen, 632 F.3d at 227; see also Test Masters Educ. Servs., Inc. v. Robin Singh Educ. Servs.,
Inc., 799 F.3d 437, 453 (5th Cir. 2015) (“When regulations are directed at deceptive or misleading
commercial speech and require a disclosure rather than a ‘flat prohibition[]’ on speech, the
Supreme Court has created [the Zauderer] standard to gauge the regulation.” (emphasis added)).
The FDA made absolutely no effort to ground this Rule in preventing consumer deception,
nor could it. Congress, in passing the Family Smoking Prevention and Tobacco Control Act, made
extensive findings regarding a history of cigarette manufacturers deceiving consumers as to their
health risks and chemically manipulating their products to make them more addictive. See
FSPTCA § 2, 123 Stat. at 1776–81. Congress made no such findings with regard to premium
cigars. Nor is there any evidence in the agency’s record that premium cigar manufacturers have
engaged in some campaign to mislead consumers about the health effects of their products.
Just as important, there is no health claim on premium cigar boxes or advertising that is
necessary to put in context. Indeed, such health claims by manufacturers are effectively banned
by the combination of the Rule and the FSPTCA. See See FD&C Act § 911(a), 21 U.S.C.
§ 387k(a); 81 Fed. Reg. at 28,987–88. This stands in stark contrast to cases in which the Fifth
Circuit has applied the Zauderer test. In Public Citizen, for example, disclaimers were required
with attorney advertisements containing portrayals of clients by non-clients or of courtroom
- 30 -
scenes. 632 F.3d at 227–28. Those disclaimers sought to correct the impression the
advertisements might otherwise have left: That the attorney’s clients are all pleased or that the
attorney can obtain great results in every case, regardless of the facts. Id. Here, the FDA’s is the
only message about the health effects of smoking premium cigars and, given its size, it becomes
the predominant message on a box or advertisement.
In any event, even if the correction of consumer deception were not required, the FDA has
disclaimed pursuit of any interest that would qualify as “substantial” under Central Hudson. Those
courts outside the Fifth Circuit that countenance justifications other than correcting consumer
deception still require the interest to be “substantial” within the meaning of Central Hudson. See
CTIA—The Wireless Ass’n, 854 F.3d at 1117 (“Central Hudson explicitly requires that a
substantial interest be furthered by a challenged regulation prohibiting or restricting commercial
speech, and we see nothing in Zauderer that would allow a lesser interest to justify compelled
commercial speech.”). The FDA’s circular interest in increasing the quality of health information
conveyed to consumers plainly does not qualify. See supra Sections II.C.1–2; see also R.J.
Reynolds, 696 F.3d at 1221 (holding that “an interest in ‘effective’ communication is too vague to
stand on its own” and “is not an independent interest capable of sustaining” a compelled warning);
Int’l Dairy Foods, 92 F.3d at 74 (“[C]onsumer curiosity alone is not a strong enough state interest
to sustain the compulsion of even an accurate, factual statement in a commercial context.”).
Second, the labels are “unduly burdensome” because they are too large. See Zauderer,
471 U.S. at 651. The warning labels confiscate 30 percent of two sides of packages, 20 percent
of visual advertisements, and a significant share of audio advertisements, where manufacturers
and retailers would otherwise communicate the qualities of their products. While the size of the
labels alone violates Zauderer, the burdens are only magnified for premium cigars and pipe
- 31 -
tobacco, given the importance of the artistic and expressive qualities of the product packaging to
both manufacturers and consumers. See Lopez Decl. ¶ 6; Moore Decl. ¶ 4.
The Fifth Circuit unequivocally has held that compelled disclosures this disruptive violate
Zauderer, even when the Government presents evidence that existing disclosures are ineffective.
In Public Citizen, the Court confronted a Louisiana rule increasing the size and length of attorney
advertising disclosures. 632 F.3d at 228. There, Louisiana required font sizes just as large as
anything else in the advertisement, id.; here, the size of the FDA’s message is likely to be larger
than anything else, see 21 C.F.R. § 1143.5(b)(2). The Court struck down the rule even though the
Government provided evidence that consumers were not recalling the disclaimers in their existing
form. Pub. Citizen, 632 F.3d at 229. According to the Court, government agencies need to do
more than show that existing warnings are not working; they must show that bigger and more
cumbersome warnings are needed to correct the problem: “This is evidence that Louisiana’s
previous disclaimer requirements were ineffective, but is not evidence that the specific
requirements of [the rule] will effectively prevent consumer deception.” Id. Even with the
evidence lacking here—surveys indicating a problem with the existing scheme—the increased size
of the disclosures violated the First Amendment under Zauderer. Id.
The Fifth Circuit’s searching review of the justification for larger and more burdensome
warnings complements circuit court after circuit court that has struck down mandated disclosures
that take up too much space. See Am. Beverage Ass’n, 871 F.3d at 896–97 (health warnings
covering 20 percent of all advertisements for added-sugar beverages unduly burdensome under
Zauderer because the warning “overwhelms other visual elements in the advertisement”);
Dwyer, 762 F.3d at 284 (attorney-advertising rule “is so cumbersome that it effectively nullifies
- 32 -
the advertisement”); Tillman, 133 F.3d at 1404 & n.4 (requirement that one-sixth of a television
ad be reserved for a disclaimer was unduly burdensome).
B. The FDA’s Warning Plan System Violates the First Amendment
The Rule also prevents premium cigar retailers and manufacturers 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. Each plan must be submitted
one year before communicating with consumers through a package or advertising about a cigar
brand, and the FDA makes no promise to complete its review in that time. See 21 C.F.R.
§ 1143.5(c)(3); 81 Fed. Reg. at 29,072–73. Plaintiff En Fuego and many other members of
TxCMA have not submitted warning plans, in part because they do not know the brands about
which they will want to communicate with consumers a year in advance. The warning plan
requirement, thus, threatens to serve as a year-or-longer gag order preventing Plaintiffs from
speaking with consumers about a premium cigar brand once they make the decision to do so.
1. The Warning Plan Scheme Is an Unconstitutional Prior Restraint
Regulations requiring advance government approval of speech amount to prior restraints
and bear a heavy presumption of unconstitutionality. FW/PBS, Inc. v. City of Dall., 493 U.S.
215, 225 (1990). The Fifth Circuit has held that this rule applies to commercial speech. See U.S.
Postal Serv. v. Athena Prods., 654 F.2d 362, 367 (5th Cir. 1981) (“[T]he first amendment
protects against erroneously imposed prior restraints of excessive duration even in the area of
commercial speech.”).
The FDA’s pre-approval system fails every requirement for prior restraints of commercial
speech. First, there is no reason—much less a compelling one—why speech to the marketplace
should be frozen for twelve months or longer while the FDA considers a plan for the rotation of the
six mandated messages. See Int’l Women’s Day March Planning Comm. v. City of San Antonio,
- 33 -
619 F.3d 346, 354 (5th Cir. 2010) (prior restraints generally “must satisfy strict scrutiny”); Burk v.
Augusta-Richmond Cty., 365 F.3d 1247, 1251 (11th Cir. 2004) (same); Rosen v. Port of Portland,
641 F.2d 1243, 1250 (9th Cir. 1981) (prior restraints “are permitted only when the infringement is
minimal and there is a compelling governmental interest which cannot be protected by any other
means”). This is not an issue of stopping packaging or advertisements of cigars without any health
warning; the only issue the pre-approval process addresses is whether the warnings are rotated with
the frequency the FDA desires. But there is no serious public health reason why the agency cannot
address deficiencies in warning rotation while the speech is occurring.
Second, there is no time limit for FDA review. See 21 C.F.R. § 1143.5(c); 81 Fed. Reg. at
29,072–73. The waiting period to speak is thus indefinite, rendering the prior restraint
unconstitutional per se. See FW/PBS, 493 U.S. at 226 (“[A] prior restraint that fails to place limits
on the time within which the decisionmaker must [act] is impermissible.”); Riley v. Nat’l Fed’n of
the Blind of N.C., Inc., 487 U.S. 781, 802 (1988) (licensing scheme was unconstitutional because
“[t]he statute on its face does not purport to require when a determination must be made, nor is
there an administrative regulation or interpretation doing so”).
2. The Warning Plan Scheme Is an Unconstitutional Restriction of

Commercial Speech
Under the Rule, a small business like En Fuego or El Cubano that one day wishes to
announce to the public that it has a particular cigar for sale at a particular price cannot just speak;
it must wait twelve months. The warning plan requirement restricts the essence of commercial
speech—“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); see
also 44 Liquormart, 517 U.S. at 495–504. As such, the FDA at least must show that the warning
plan gag order satisfies Central Hudson. It fails on all fronts.
- 34 -
First, the warning plan system does not advance any “substantial” governmental interest,
much less directly and materially. In this context, the FDA would need to demonstrate that not
just warnings, but the FDA’s ability to fine tune their rotation twelve months in advance, will
reduce youth premium cigar use. As demonstrated above, youth use of premium cigars is so rare
that it cannot be reliably measured. See supra Section II.C.2. And the FDA has not even
attempted to show that the warning plan scheme will reduce premium cigar use. See Pub.
Citizen, 632 F.3d at 222 (regulation fails Central Hudson where Government “fail[s] to point to
any specific harms or to how they will be alleviated” by regulation).
Second, the FDA cannot demonstrate any “reasonable fit” between means and ends.
Lorillard, 533 U.S. at 561. The FDA 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, not for halting speech pending government preapproval.
In sum, the warning plan requirement offends the First Amendment under any standard.
III. THE FDA’S NEW WARNING LABELS VIOLATE THE FSPTCA AND THE APA
Although the record establishes the unconstitutionality of the FDA’s new warnings, the
Court may resolve the case and strike down the Rule on statutory grounds: The Rule violates the
FSPTCA and the APA.
A. The Rule Violates the APA Because the FDA Arbitrarily and Capriciously
Mandated Warnings Before Completing its Scientific Review of Premium
Cigars and Inverted Its Own Risk Assessment
First and foremost, the imposition of massive warnings on premium cigars cannot be
squared with the agency’s new rulemaking docket. See Chamber of Commerce of U.S.A. v. U.S.
Dep’t of Labor, --- F.3d ----, 2018 WL 1325019, at *17 (5th Cir. 2018) (“Illogic and internal
inconsistency are characteristic of arbitrary and unreasonable agency action.”). That docket
- 35 -
acknowledges that more scientific work needs to be done regarding the patterns of use and health
effects of premium cigars before the agency can reach a final conclusion regarding whether
premium cigars should be regulated at all or whether they should bear the warnings in their
current form. See Ex. A at 12,903–04. Mandating massive warnings on premium cigars now,
before work is completed on whether the regulation is warranted, is arbitrary and capricious. See
Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983)
(an agency decision that is incomplete because the agency has “failed to consider an important
aspect of the problem” violates the APA).
Second, the FDA acted contrary to its own observations about the differences between
premium cigars and other tobacco products. The FDA repeatedly has acknowledged that premium
cigars are a separate category of tobacco products, with different patterns of use. See Ex. A at
12,902–03; 79 Fed. Reg. at 23,150–52. To impose the Rule on premium cigars, the FDA relied on
studies of the usage patterns and appreciation of health risks of cigarettes and, to some extent,
mass-produced cigars. See, e.g., 81 Fed. Reg. at 29,070 (citing Refs. 269, 270, 271). But the
record contained absolutely no evidence regarding premium cigars, other than studies showing that
premium cigars and pipe tobacco 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); id. at
29,048 (citing Ref. 9); Reynolds Decl. ¶¶ 14–18, 29–56, 62–68, 81–91.
Nonetheless, the agency imposed on all cigars, including premium cigars, a warning
requirement designed to attack youth tobacco use and to inform consumers about their health
effects. From an expert agency, one would expect evidence that youth are using premium cigars or
that premium cigar consumers are not getting the message regarding their health effects. The latter
proposition, of course, cannot be squared with the uncontroverted evidence that premium cigar
- 36 -
consumers use those products sparingly, with the median consumer smoking 1.7 days per month.
Ex. B at 5 tbl.2. 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
massively burdensome regulatory scheme on another—here, premium cigars. See Shays v. FEC,
528 F.3d 914, 926 (D.C. Cir. 2008) (the APA requires an agency to “show that its rule rationally
separates” regulable and non-regulable conduct consistently with legislative intent); 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).
Nor can the Rule be squared with agency’s own observations about the “risk continuum
of tobacco products.” In its July 28, 2017, announcement, the FDA found that tobacco products
fall along a risk continuum, with cigarettes being the most dangerous. See Ex. G (nicotine “is
most harmful when delivered through . . . cigarettes”). In the same announcement, the agency
explained that it needed to study premium cigars further to determine whether they merited any
federal regulation, id., and it has now opened a docket to do so, Ex. A. But the warnings on
premium cigars are larger and more glaring than the federal warnings currently required of
cigarettes. They cover a considerably greater portion of packages and advertisements, and they
apply to nearly everything said about cigars by retailers, whereas cigarette warnings are not
required of retailers at all. See 15 U.S.C. § 1333 (2008). 3 For the FDA to act consistently with
its own conclusions and avoid arbitrary reasoning, it should have tackled cigarette warnings first.
See State Farm, 463 U.S. at 43; Chamber of Commerce, 2018 WL 1325019, at *17.
3
Under the current cigarette warning regime, one warning label appears on one side panel of a
cigarette package, covering only around 4.8 percent of the package. See 15 U.S.C. § 1333(a)(1)
(2008). The FSPTCA amended this statute but made the amendment contingent on the issuance
of regulations mandating graphic warnings for cigarettes—the same regulations that the D.C.
Circuit invalidated in R.J. Reynolds. See TCA § 201(a), (b), 123 Stat. at 1842–45.
- 37 -
Third, as explained above, the agency neglected to consider an obvious, less costly
alternative: Adopting the size of the FTC warnings that had been in place for the seven largest
cigar manufacturers for nearly two decades. The failure to consider less burdensome alternatives
is a problem under nearly any applicable First Amendment standard, but it also violates the APA.
See Nat’l Shooting Sports Found. v. Jones, 716 F.3d 200, 215 (5th Cir. 2013) (an agency “must
consider and explain its rejection of ‘reasonably obvious alternative[s],’” including “significant
and viable” alternatives); Hornbeck Offshore Servs., L.L.C. v. Salazar, 696 F. Supp. 2d 627,
636–38 (E.D. La. 2010) (Government’s failure to consider alternatives violated the APA).
B. The Rule Violates the APA Because the FDA Failed to Make Mandatory
Findings
Before mandating warnings, the Secretary of the Department of Health and Human
Services was statutorily required to make express findings on “the increased or decreased
likelihood that existing users of tobacco products will stop using such products” and “the
increased or decreased likelihood that those who do not use tobacco products will start using
such products.” FD&C Act § 906(d)(1), 21 U.S.C § 387f(d)(1).
Yet the agency openly admitted that it could not make the findings the Act requires:
“Reliable evidence on the impacts of warning labels . . . on users of cigars . . . [and] pipe tobacco
. . . does not, to our knowledge, exist.” FRIA at 62. As if to highlight its error, the agency said it
needed to study the issue in the future, e.g., 81 Fed. Reg. at 29,065, but the statute demands
findings on the “increased or decreased likelihood” of smoking initiation and cessation before
warnings are imposed, not after, FD&C Act § 906(d)(1), 21 U.S.C. § 387f(d)(1). Moreover, the
agency made no effort to analyze the effects of the warnings on initiation and continuing use of
premium cigars as a separate category, despite possessing evidence that premium cigars are used
very differently and by a demographically distinct set of consumers than mass-marketed cigars.
- 38 -
Congress clearly did not envision that the agency could amass evidence regarding one category of
tobacco products and then use that evidence as the basis for findings regarding another.
Congress sensibly wrote the FSPTCA to require explicit agency findings that warning
labels would reduce tobacco use. That is because the Constitution requires the same evidence
before the government restricts speech about tobacco products. See supra Section II.C.2. If
there were any ambiguity about the required findings, the Court should demand that the agency
find specifically and with evidence that the warnings would reduce premium cigar and pipe
tobacco use, so as to avoid the serious constitutional problems that otherwise would result. See
Edward J. DeBartolo Corp. v. Fla. Gulf Coast Bldg. & Constr. Trades Council, 485 U.S. 568,
575 (1988) (courts generally construe statutes to avoid “serious constitutional problems”).
Moreover, the FDA’s noncompliance with the FSPTCA’s statutory directive to expressly
determine whether and how warnings would reduce tobacco use renders the rule per se arbitrary
and capricious. See Pub. Citizen v. FMCSA, 374 F.3d 1209, 1216 (D.C. Cir. 2004) (“[W]e have
held that ‘the complete absen[c]e of any discussion’ of a statutorily mandated factor . . . mak[es]
the agency’s reasoning arbitrary and capricious.”).
IV. PLAINTIFFS ARE ENTITLED TO A PRELIMINARY INJUNCTION AGAINST

ENFORCEMENT OF THE FDA’S NEW WARNINGS
Plaintiffs believe this matter can be resolved in streamlined summary judgment
proceedings concluding in a hearing before Memorial Day. But to the extent the Court believes
that resolution of this matter will extend into the summer, with an imminent compliance date on
August 10, or will require an evidentiary hearing, the Court should grant Plaintiffs a preliminary
injunction until final judgment. All four factors the Court weighs in considering injunctive
relief—the likelihood of success, the risk of irreparable harm, the balance of equities, and the
- 39 -
public interest—strongly favor Plaintiffs, and the Court should exercise its “sound discretion” to
preliminarily enjoin enforcement of the new warnings. Nevada, 218 F. Supp. 3d at 526.
First, the foregoing discussion establishes, at the very least, a prima facie showing that the
new warnings violate the Constitution, the FSPTCA, and the APA. Id.; see supra Sections II–III.
Second, Plaintiffs already have begun to incur significant compliance costs, which will
only mount as the effective date of the rule approaches. En Fuego and El Cubano are working to
redesign their websites, their advertisements, their goods, and their stores to accommodate the new
warnings. See Lopez Decl. ¶ 15; Moore Decl. ¶ 15. For example, El Cubano offers various unique
product and package configurations, and makes signage and branded merchandise that appear to
qualify as “advertising” under the FDA’s expansive interpretation. See Lopez Decl. ¶¶ 6–8, 11–12
& Exs. A, C–D. El Cubano’s redesign and replacement efforts are expected to cost significant
sums of money—on top of the expenses of printing the new labels, discarding unusable inventory,
and preparing a distribution system for warning rotation. See Lopez Decl. ¶ 15.
En Fuego, El Cubano, and TxCMA’s members unquestionably are suffering irreparable
harm. The threatened deprivation of First Amendment rights is irreparable. See Texans for Free
Enter. v. Tex. Ethics Comm’n, 732 F.3d 535, 539 (5th Cir. 2013); (“[T]he loss of First Amendment
freedoms for even minimal periods of time constitutes irreparable injury justifying the grant of a
preliminary injunction.”); Deerfield Med. Ctr. v. City of Deerfield Beach, 661 F.2d 328, 338 (5th
Cir. 1981) (when a constitutional right “is ‘either threatened or in fact being impaired,’” this
“mandates a finding of irreparable injury”); Associated Builders & Contractors of Se. Tex. v. Rung,
No. 1:16-CV-425, 2016 WL 8188655, at *14 (E.D. Tex. Oct. 24, 2016) (“Once First Amendment
rights have been chilled, there is no effective remedy, and it is well established in the Fifth Circuit
that infringement of First Amendment rights, standing alone, constitutes irreparable harm.”). The
- 40 -
costs of preparing to comply with an illegal rule likewise are irreparable because of the difficulty
of recovering them from the Government. See Teladoc, Inc. v. Tex. Med. Bd., 112 F. Supp. 3d 529,
543 (W.D. Tex. 2015) (possibility of Government asserting immunity from damages “weighs in
favor” of irreparable harm); see also Associated Builders, 2016 WL 8188655, at *14 (an injury
“not readily compensable through monetary damages” is irreparable).
Third, an injunction will harm neither the FDA nor the public. The FDA cannot
simultaneously admit that the necessity and content of warnings for premium cigars requires
further study and insist the public will be harmed if the warnings do not go into effect in months.
Fourth, an injunction is in the public interest. “[I]njunctions protecting First Amendment
freedoms are always in the public interest.” Texans for Free Enter., 732 F.3d at 539 (quoting
Christian Legal Soc’y v. Walker, 453 F.3d 853, 859 (7th Cir. 2006)); Associated Builders, 2016
WL 8188655, at *15 (“Public policy demands that governmental agencies be enjoined from acting
in a manner contrary to the law.”); De Leon v. Perry, 975 F. Supp. 2d 632, 665 (W.D. Tex. 2014)
(“[A] preliminary injunction preventing the enforcement of an unconstitutional law serves, rather
than contradicts, the public interest.”).
“To preserve the status quo, federal courts in the Fifth Circuit have regularly enjoined
federal agencies from implementing and enforcing new regulations pending litigation
challenging them.” Associated Builders, 2016 WL 8188655, at *5. Given the Rule’s
constitutional and statutory defects and the extraordinarily high stakes for the small businesses
that populate the premium cigar and pipe tobacco industries, this case should be no different.
CONCLUSION
Plaintiffs’ motion for partial summary judgment or, in the alternative, a preliminary
injunction should be granted.
- 41 -
Dated: March 27, 2018 Respectfully submitted,
/s/ Clyde M. Siebman

SIEBMAN, BURG, PHILLIPS & SMITH, LLP
Clyde M. Siebman
Texas Bar No. 18341600
clydesiebman@siebman.com
Elizabeth S. Forrest
elizabethforrest@siebman.com
Federal Courthouse Square
300 N. Travis Street
Sherman, TX 75090
Telephone: (903) 870-0070
Facsimile: (903) 870-0066
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
Ryan Meltzer
ryan.meltzer@nortonrosefulbright.com
98 San Jacinto Boulevard, Suite 1100
Austin, TX 78701-4255
Telephone: (512) 536-5234
Facsimile: (512) 536-4598
Counsel for Plaintiffs En Fuego Tobacco Shop

LLC, Cuba Libre Enterprises LLC, and Texas
Cigar Merchants Association
ADDENDUM
El Cubano Cigar Boxes
- A-1 -
El Cubano Cigar Boxes with FDA Warnings
- A-2 -
El Cubano Cigars, Texas City – Retail Humidor
- A-3 -
El Cubano Cigars, League City – Retail Humidor
- A-4 -
En Fuego Tobacco Shop, Frisco – Retail Humidor
- A-5 -
CERTIFICATE OF SERVICE
The undersigned certifies that on this 27th day of March, 2018, all counsel of record who
are deemed to have consented to electronic service are being served with a copy of this document
through the Court’s CM/ECF system under Local Rule CV-5(a)(3).
SIEBMAN, BURG, PHILLIPS & SMITH, LLP
By: /s/ Clyde M. Siebman

CERTIFICATE OF CONFERENCE
Counsel has complied with the meet-and-confer requirement in Local Rule CV-7(h). I
certify that on March 19, 2018, counsel for Plaintiffs, Michael J. Edney, conferred with counsel
for Defendants, Eric B. Beckenhauer, via email and telephone regarding the relief requested in
this motion. Counsel for Defendants indicated that Defendants oppose the relief sought herein.
Therefore, discussions have conclusively ended in an impasse, leaving an open issue for the
Court to resolve.
NORTON ROSE FULBRIGHT US LLP
By: /s/ Michael J. Edney

E.D. Tex. 18-cv-00028 DCKT 000022 - 000 Filed 2018-03-27

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

E.D. Tex. 18-cv-00028 DCKT 000022 - 000 Filed 2018-03-27

Uploaded by

Copyright:

Available Formats

Case 4:18-cv-00028-ALM-KPJ Document 22 Filed 03/27/18 Page 1 of 57 PageID #: 637

IN THE UNITED STATES DISTRICT COURT

EN FUEGO TOBACCO SHOP LLC, doing )

PLAINTIFFS’ MOTION FOR PARTIAL SUMMARY JUDGMENT OR, IN THE

44 Liquormart, Inc. v. Rhode Island,

Allstate Ins. Co. v. Abbott,

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 Agric.,

Associated Builders & Contractors of Se. Tex. v. Rung,

Brock v. Merrell Dow Pharm., Inc.,

Brown v. Entm’t Merchants Ass’n,

Burk v. Augusta-Richmond Cty.,

Cano v. Everest Minerals Corp.,

Chamber of Commerce of U.S.A. v. U.S. Dep’t of Labor,

Christian Legal Soc’y v. Walker,

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

CTIA—The Wireless Ass’n v. City of Berkeley, Cal.,

Deerfield Med. Ctr. v. City of Deerfield Beach,

Discount Tobacco City & Lottery, Inc. v. United States,

Entm’t Software Ass’n v. Blagojevich,

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

Pursuing Am.’s Greatness v. FEC,

Hornbeck Offshore Servs., L.L.C. v. Salazar,

Int’l Dairy Foods Ass’n v. Amestoy,

Int’l Women’s Day March Planning Comm. v. City of San Antonio,

Kornman & Assocs., Inc. v. United States,

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

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

Nat’l Shooting Sports Found. v. Jones,

Nat’l Wildlife Fed’n v. Hodel,

Nevada v. U.S. Dep’t of Labor,

Nichols v. Alcatel USA, Inc.,

Pub. Citizen, Inc. v. La. Attorney Disciplinary Bd.,

Pub. Citizen v. FMCSA,

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

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

Riley v. Nat’l Fed’n of the Blind of N.C., Inc.,

Rosen v. Port of Portland,

Rubin v. Coors Brewing Co.,

Sorrell v. IMS Health, Inc.,

Stuttering Found. of Am. v. Springer,

Teladoc, Inc. v. Tex. Med. Bd.,

Tex. Office of Pub. Util. Counsel v. FCC,

Texans for Free Enter. v. Tex. Ethics Comm’n,

Thompson v. W. States Med. Ctr.,

U.S. Postal Serv. v. Athena Prods.,

United States v. Playboy Entm’t Grp., Inc.,

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

Valle Del Sol, Inc. v. Whiting,

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

Statutes and Regulations

5 U.S.C. § 706 ................................................................................................................................13

15 U.S.C. § 1333 ............................................................................................................................37

21 U.S.C. § 387a ..............................................................................................................................8

21 U.S.C. § 387d ..............................................................................................................................8

21 U.S.C. § 387e ..............................................................................................................................8

21 U.S.C § 387f .............................................................................................................................38

21 U.S.C. § 387k ......................................................................................................................17, 30

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

Tobacco Product Standard for Nicotine Level of Combusted Cigarettes, 83 Fed.

21 C.F.R. § 1143.3 .........................................................................................................................12

21 C.F.R. § 1143.5 ................................................................................................................. passim