Case 1:16-cv-01460-APM Document 293 Filed 08/07/25 Page 1 of 14

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF COLUMBIA

CIGAR ASSOCIATION OF AMERICA, et al.,

Plaintiffs,
v. No. 1:16-cv-1460 (APM)

UNITED STATES FOOD AND DRUG

ADMINISTRATION, et al.,

Defendants.

DEFENDANTS’ SUPPLEMENTAL BRIEF REGARDING

THE DEFINITION OF “PREMIUM CIGARS”

ROBERT FOX FOSTER BRETT A. SHUMATE

Acting General Counsel Assistant Attorney General
Chief Counsel for Food, Research, and Drugs Civil Division
U.S. Department of Health and Human
Services ERIC B. BECKENHAUER
Assistant Branch Director
SEAN R. KEVENEY Federal Programs Branch
Chief Counsel
Food and Drug Administration STEPHEN M. PEZZI
Senior Trial Counsel
WENDY S. VICENTE United States Department of Justice
Deputy Chief Counsel for Litigation Civil Division, Federal Programs Branch

DANLI SONG Counsel for Defendants

Associate Chief Counsel
Office of the Chief Counsel
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Bldg. 32, Room 4397
Silver Spring, MD 20993
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TABLE OF CONTENTS
INTRODUCTION ........................................................................................................................................... 1

BACKGROUND .............................................................................................................................................. 1

ARGUMENT..................................................................................................................................................... 4

I. ALTHOUGH FDA RESERVES THE RIGHT TO DEFINE “PREMIUM

CIGARS” IN A FUTURE RULEMAKING, THE D.C. CIRCUIT HAS
DIRECTED THIS COURT TO DEFINE “PREMIUM CIGARS” IN THE
INTERIM. ............................................................................................................................................ 4

II. THE CURRENT DEFINITION SHOULD BE LEFT UNDISTURBED. ............................ 5

A. Any changes to the definition now would create significant practical problems. ................ 5

B. Plaintiff CAA’s proposed changes raise significant questions of science and public-
health policy that would be better addressed by FDA in rulemaking. .................................. 8

CONCLUSION ...............................................................................................................................................11

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INTRODUCTION

All agree that the Food and Drug Administration (FDA) has the authority to define the

category of “premium cigars” under the Tobacco Control Act. FDA reserves the right to address that

subject in a future rulemaking. In the interim, however, the D.C. Circuit has directed this Court to

issue an order that defines the category of “premium cigars,” for purposes of this Court’s prior order

of vacatur, which the D.C. Circuit otherwise affirmed in all respects. Cigar Ass’n of Am. v. FDA, 132

F.4th 535, 543 (D.C. Cir. 2025). After all, some definition must be in place, unless and until FDA

revisits the subject in a future rulemaking.

This Court should not disturb the eight-point definition of “premium cigars” that is currently

in effect, and that FDA and regulated parties have been operating under since at least August of 2020.

Any changes to that definition now—large or small—risk creating significant practical problems for

both FDA and regulated parties, as this Court’s prior orders have already (by necessity) been

incorporated into the regulatory regime for tobacco products.

Even setting aside the practical problems with making and implementing changes now,

Plaintiff Cigar Association of America (CAA)’s proposals to broaden the definition—including, most

ambitiously, to include flavored cigars—also raise significant public-policy and public-health concerns

that would be better addressed by FDA in a future rulemaking. So in the interim, for the reasons

below, and for the reasons stated in the attached Declaration of Michele Mital (Deputy Director of

FDA’s Center for Tobacco Products (CTP)) (“Mital Decl.”), the Court should maintain the status

quo, and reject CAA’s proposed changes to the current eight-point definition of “premium cigars”—

a definition that this Court has already adopted twice, and that has been in place for at least five years.

BACKGROUND

This litigation began in July of 2016. See Compl., ECF No. 1. As relevant here, 1 Plaintiffs

alleged, in their first of many complaints, that FDA’s deeming rule was arbitrary and capricious “with

1
This brief will generally assume the Court’s familiarity with this well-aged litigation, and will
only briefly recount the relevant background, as it relates to the definition of “premium cigars.”

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respect to premium cigars,” and thus asked this Court to “vacate and set aside enforcement of the

Final Rule as to premium cigars.” Compl. ¶ 133. Despite that request, Plaintiffs did not offer any

definition of “premium cigars” in their complaint.

In August of 2020, the Court enjoined FDA’s enforcement of premarket-review requirements

with respect to “premium cigars.” See Cigar Ass’n of Am. v. FDA, 480 F. Supp. 3d 256, 281-82 (D.D.C.

2020), aff’d, 5 F.4th 68 (D.C. Cir. 2021). Drawing from an August 2020 filing in another case describing

then-forthcoming FDA guidance about premarket review, ECF No. 209, the Court used the following

eight-point definition of “premium cigars”:

a cigar that: (1) is wrapped in whole tobacco leaf; (2) contains a 100
percent leaf tobacco binder; (3) contains at least 50 percent (of the filler
by weight) long filler tobacco (i.e., whole tobacco leaves that run the
length of the cigar); (4) is handmade or hand rolled (i.e., no machinery
was used apart from simple tools, such as scissors to cut the tobacco
prior to rolling); (5) has no filter, nontobacco tip, or nontobacco
mouthpiece; (6) does not have a characterizing flavor other than
tobacco; (7) contains only tobacco, water, and vegetable gum with no
other ingredients or additives; and (8) weighs more than 6 pounds per
1,000 units.
Cigar Ass’n, 480 F. Supp. 3d at 281. Because this definition originated with FDA, the Court did not

have to “devise a definition of premium cigars out of whole cloth.” Id. In any event, this definition

was “similar to the definition that commenters”—including some of the Plaintiffs in this case—had

previously “urged the FDA to adopt during the rulemaking for the Final Deeming Rule.” Id. (citing

comments from Plaintiff CAA).

On July 5, 2022, the Court concluded that the deeming rule violated the Administrative

Procedure Act (APA) insofar as it applied to “premium cigars.” Cigar Ass’n of Am. v. FDA, 2022 WL

2438512 (D.D.C. July 5, 2022). The Court did not vacate any part of the rule at that time, however,

and thus did not need to (and did not) discuss the definition of “premium cigars”—instead, the Court

invited further briefing on “the appropriate remedy” for the APA violation that the Court had

identified. Id. at *9. Plaintiffs’ remedy brief, on behalf of all Plaintiffs (including CAA), appeared

largely content with the eight-point definition, arguing only that “the Court’s order should vacate the

Rule as to at least those cigars the FDA and the Court defined as ‘premium’ in 2020 for purposes of

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providing relief from the premarket review process,” ECF No. 271 at 1—with the possible exception

of one conclusory footnote in one of the appendices to that brief, in which CAA stated without

elaboration that it “maintains its position regarding the scope of premium cigars set forth in prior

briefing.” Appendix A to Pls.’ Remedy Br. at 1 n.1, ECF No. 271-3 (citing one prior footnote from

one prior brief, which itself cites only CAA’s comments to the deeming rule and does not include any

actual proposed definition). FDA argued for remand without vacatur; like Plaintiffs, FDA did not

argue for any new definition. See Defs.’ Remedy Br., ECF No. 270.

On August 9, 2023, the Court rejected FDA’s arguments for remand without vacatur, and
vacated the deeming rule insofar as it applied to “premium cigars.” ECF Nos. 276, 277; Cigar Ass’n of

Am. v. FDA, 2023 WL 5094869, at *5 (D.D.C. Aug. 9, 2023). Presumably at least in part due to the

absence of any real argument from any party in favor of a different definition, the Court retained the

same definition of “premium cigars” that had appeared in its August 2020 opinion. See Order at 1

n.1, ECF No. 277; see also Cigar Ass’n, 2023 WL 5094869, at *6 n.7 (same). FDA appealed.

The D.C. Circuit affirmed in part, reversed in part, and remanded. Cigar Ass’n of Am. v. FDA,

132 F.4th 535 (D.C. Cir. 2025). On the substance of the APA issues in the case, the D.C. Circuit

affirmed this Court’s opinion “in full.” Id. at 543. On the remedy, however, the D.C. Circuit noted

that this Court’s order of vacatur “incorporated a definition of ‘premium cigar’ that FDA never

formally adopted.” Id. To address this issue, the D.C. Circuit closed its opinion with specific

instructions for the parties and the Court:

Given the centrality of this issue, we think the parties should have the
opportunity to express their views before the district court
determines—in effect—the permissible scope of the FDA’s existing
rule. Accordingly, we affirm in part, reverse in part, and remand only
so that the district court can invite briefing on the appropriate
definition of “premium cigars” before entering a final order. Of
course, the FDA may separately begin a new rulemaking to redefine
the “premium cigars” carve-out or it may seek to regulate these
products once again. But until then, and with the understanding that
vacatur will not permit revisiting past user fee payments, we otherwise
affirm the district court’s well-reasoned opinion in full.

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Id. As required by the D.C. Circuit, this Court then set a schedule for “briefing on the appropriate

definition of ‘premium cigars.’” Id. Because Plaintiff CAA is the only party proposing a change to

the currently operative definition, CAA filed its brief first. ECF No. 286. Defendants now respond.

ARGUMENT

The eight-point definition of “premium cigars” that is currently in effect—which was adopted

by this Court in each of its prior orders in this case—should be left undisturbed. Making changes

now could create significant practical problems for FDA and regulated parties, given the myriad ways

in which this Court’s prior orders have, by necessity, been incorporated into FDA’s regulatory regime.

Even setting aside those practicalities, Plaintiff CAA’s proposals raise significant concerns of public-

health policy that would be better addressed (if at all) by FDA, in a future rulemaking. The Court

should thus maintain the status quo, in its entirety, unless and until FDA revisits this issue.
I. ALTHOUGH FDA RESERVES THE RIGHT TO DEFINE “PREMIUM CIGARS”
IN A FUTURE RULEMAKING, THE D.C. CIRCUIT HAS DIRECTED THIS
COURT TO DEFINE “PREMIUM CIGARS” IN THE INTERIM.
Under the Tobacco Control Act, 21 U.S.C. §§ 387 et seq., FDA has the authority to regulate

tobacco products. That includes the power to define the category of “premium cigars” for the

purposes of FDA’s “deeming” authority. FDA has not yet issued a regulation that would establish

such a definition—after all, such a regulation would not have been necessary had FDA prevailed in

this litigation. Of course, at least as relevant here, FDA did not prevail in this litigation. As a result,

the definition of “premium cigars” now has legal significance. See Cigar Ass’n, 132 F.4th at 543 (“[T]he

district court’s determination that the FDA acted irrationally made it necessary to define ‘premium

cigars’ with some precision.”).

FDA reserves the right to exercise its own discretion to define “premium cigars” in a future

rulemaking—after all, ultimately, the appropriate definition is a matter of science and public-health

policy that FDA, rather than a court, is the most appropriate entity to decide. So, as the D.C. Circuit

stated expressly, at some later date, “the FDA may separately begin a new rulemaking to redefine the

‘premium cigars’ carve-out or it may seek to regulate these products once again.” Id.

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In the interim, however, some definition must control. And the D.C. Circuit expressly directed

this Court to “invite briefing on the appropriate definition of ‘premium cigars’ before entering a final

order” defining that term. Id. Through this process, according to the D.C. Circuit, “the district court”

will “determine[]—in effect—the permissible scope of the FDA’s existing rule.” Id. Accordingly,

unless and until FDA conducts a rulemaking on the subject, this Court can—indeed, under the

mandate rule, it must, see, e.g., Am. Council of Blind v. Mnuchin, 977 F.3d 1, 5 (D.C. Cir. 2020)—issue an

order defining the term “premium cigars.” That definition will then delineate the scope of this Court’s

order of vacatur, which has otherwise now been affirmed by the D.C. Circuit in relevant part. See
Cigar Ass’n, 132 F.4th at 543.

II. THE CURRENT DEFINITION SHOULD BE LEFT UNDISTURBED.

The Court should retain the current definition of “premium cigars” in its entirety, for two

primary reasons. First, any changes to the definition now, large or small, risk creating significant

practical problems for both FDA and regulated parties, as this Court’s prior orders have already been

incorporated into FDA’s regulatory regime for cigars. Second, even setting aside those practical issues,

Plaintiff CAA’s proposed changes raise significant concerns of public-health policy that would be

better addressed by FDA in a future rulemaking, rather than in litigation briefing by a handful of

interested parties. The Court should thus maintain the status quo, unless and until FDA revisits this

subject in a future rulemaking.

A. Any changes to the definition now would create significant practical problems.

The current definition “has been the agency’s operative ‘premium cigar’ definition for several

years, used by both the agency and regulated parties in multiple contexts.” Mital Decl. ¶ 5.

Accordingly, making any changes to “the definition at this juncture would disrupt agency processes,

including, among other things,” the Center for Tobacco Product’s “user fee program and review of

applications for tobacco products seeking premarket authorization.” Id. That is reason enough to

reject all of CAA’s proposed changes.

1. FDA has used the current definition of “premium cigars” since as early as August of 2020,

when this Court first issued an order enjoining FDA from enforcing premarket-review requirements

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against “premium cigars.” See id. ¶ 7 (citing Cigar Ass’n, 480 F. Supp. 3d at 281). Since that time, the

agency has used that definition “to communicate with regulated entities, enforce restrictions on the

sale of tobacco products to youth, and review applications for tobacco products seeking market

authorization.” Id. That includes, since August of 2020, using the definition in “determining whether

thousands of applications for premarket authorization of cigar products are subject to premarket

review.” Id. ¶ 14.

Now, “under Plaintiff CAA’s proposed definition, the ‘premium cigar’ category would

encompass many more products than the agency has understood the category to contain for years.”
Id. ¶ 15. That is because, for the past five years, “CTP has used the eight-point definition as it reviewed

and sometimes denied applications for marketing authorization.” Id. “Broadening the category of

products that are excluded from CTP’s jurisdiction now would thus render moot many of those

marketing denials (if those products fall under Plaintiff CAA’s broader definition and thus did not

have to seek premarket authorization in the first instance) and cause others to be questioned (as CTP

would need to determine which denials may have been for products that fall under a broader definition

and applicants would likely question that determination).” Id. Taken together, “[t]hese complications

would substantially undermine CTP’s efforts to implement and enforce TCA requirements.” Id.

2. FDA has also used the current definition in several agency regulations and other rulemaking

documents. First, in October 2021, FDA used the current definition to define “premium cigars” in

the final Premarket Tobacco Applications (PMTA) rule. See 21 C.F.R. § 1114.3 (“For purposes of this

part . . . ‘Premium’ cigar means a type of cigar that . . .”); see also FDA, Final Rule, Premarket Tobacco

Product Applications and Recordkeeping Requirements, 86 Fed. Reg. 55,300, 55,308 (Oct. 5, 2021) (“[T]he

codified language has been revised to exclude ‘premium’ cigars from the scope of this final rule, and

the Cigar Ass’n of Am. court’s definition of ‘premium’ cigars has been added to section § 1114.3.”).

Similarly, FDA also used that definition in the final Substantial Equivalence (SE) rule. See 21 C.F.R.

§ 1107.12 (same). Accordingly, changing the definition now would presumably “require CTP to

change how these regulations are applied during the review of tobacco product marketing

authorization applications.” Mital Decl. ¶ 18.

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Similarly, both the agency and public commenters have used the current definition in several

different agency rulemaking proceedings, some of which remain pending. See, e.g., FDA, Tobacco Product

Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products, 90 Fed. Reg. 5,032,

5,043 n.13 (Jan. 16, 2025) (citing the definition in a proposed rule that would establish a maximum

nicotine level in cigarettes and certain other tobacco products); FDA, Tobacco Product Standard for

Characterizing Flavors in Cigars, 87 Fed. Reg. 26,396, 26,434 (May 4, 2022) (citing the definition in a

proposed rule that would prohibit characterizing flavors other than tobacco in all cigars, and

explaining that the current definition of “premium cigars” excludes flavored cigars); Cigar Rts. of Am.,
Comment on Requirements for Tobacco Product Manufacturing Practice, Docket No. FDA-2013-N-0227, at 2

(Oct. 6, 2023) (citing the definition to argue that “premium cigars” should be exempt from the final

rule), available at https://www.regulations.gov/comment/FDA-2013-N-0227-0406. Changing the

definition now could upend some of these ongoing rulemaking processes.

3. Most recently, since this Court’s August 2023 Order, ECF No. 277, “CTP has been using

the eight-point definition in its efforts to administer a program that assesses user fees for domestic

manufacturers and importers of cigars while,” because of this Court’s order, “exempting ‘premium

cigars’ from user fee payment.” Mital Decl. ¶ 9. In particular, to comply with this Court’s order, each

quarter, the agency has been sending notices to regulated parties that “use the Court’s eight-point

definition in explaining the process for disputing fees and request evidentiary documentation that

demonstrates the products for which the disputed fees are assessed meet this definition.” Id. ¶ 10.

Accordingly, as part of that process, “[s]ince the first quarterly notices were issued in September 2023,

cigar manufacturers and importers have been disputing user fees and submitting evidence based on

the eight-point definition.” Id. ¶ 11. “CTP is currently reviewing these disputes, including soliciting

documentation based on this definition.” Id. “Changing the definition now would disrupt the review

of disputes already underway, likely requiring industry to resubmit disputes under the new definition

and the agency to request additional documentation establishing whether products meet the new

definition.” Id. ¶ 12. “This would burden both the agency and industry.” Id.

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B. Plaintiff CAA’s proposed changes raise significant questions of science and

public-health policy that would be better addressed by FDA in rulemaking.
For the reasons above, making any change to the existing definition of “premium cigars” risks

significant practical problems, both for FDA and for regulated parties. CAA’s proposal, however, is

not problematic for that reason alone; it also has several more specific flaws. At a minimum, CAA’s

ambitious request to include flavored cigars in the category of “premium cigars” raises acute public-

health concerns, given the well-documented connection between characterizing flavors and youth use

of tobacco products. CAA’s two other proposed changes—that is, (1) allowing unlimited “ingredients

or additives,” rather than only “tobacco, water, and vegetable gum,” and (2) eliminating the
requirement of “at least 50 percent (of the filler by weight) long filler tobacco”—likewise raise complex

questions of science and public-health policy that would be more appropriately addressed by FDA in

a future rulemaking, with the benefit of public input and scientific analysis by agency experts.

1. Most boldly, CAA proposes to eliminate the aspect of the definition that “premium cigars”

cannot “have a characterizing flavor other than tobacco.” As explained in the Mital Declaration and

in prior FDA rulemaking documents, that proposal “implicates long-stated agency concerns about the

role of characterizing flavors in how users, especially youth, initiate and continue using tobacco

products.” Mital Decl. ¶ 25.

“Researchers have found that characterizing flavors in cigars and other tobacco products play

a key role in how users and nonusers, particularly youth, initiate, progress, and continue using tobacco

products.” Id. ¶ 26(a) (quoting 87 Fed. Reg. at 26,397). As FDA has explained, “[t]he process of

becoming a regular cigar smoker includes stages of experimentation, development of nicotine

dependence, and progression to regular use.” Id. ¶ 26(f) (quoting 87 Fed. Reg. at 26,406). And FDA

has found that “flavors are frequently added to cigars for the express purpose of making harsh

products more palatable to new users.” Id. ¶ 26(d) (quoting 87 Fed. Reg. at 26,401). That is because

“[c]haracterizing flavors in cigars and other tobacco products reduce the harshness, bitterness, and

astringency of tobacco during inhalation and soothe irritation during use.” Id. ¶ 26(b) (quoting 87

Fed. Reg. at 26,399). Flavors thus “increase the youth appeal of those tobacco products and promote

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youth initiation, resulting in an increased likelihood that youth and young adults experimenting with

flavored cigars will become addicted and progress to regular smoking.” Id. (quoting 87 Fed. Reg. at

26,399).

FDA has also explained that flavors “can activate the brain’s reward circuit, producing

rewarding effects that, when added to tobacco products, can reinforce the effects of nicotine” in

creating or sustaining addiction. Id. ¶ 26(e) (quoting 87 Fed. Reg. at 26,418). CAA itself has

acknowledged that “flavors have universal appeal to both adults and minors.” See Cigar Ass’n of Am.,

Comment on Regulation of Flavors in Tobacco Products, Docket No. FDA-2017-N-6565, at 8 (July 19, 2018),
available at https://www.regulations.gov/comment/FDA-2017-N-6565-22346).

Accordingly, FDA previously explained in a notice of proposed rulemaking that entirely

“eliminating flavored cigar varieties would decrease the number of youth experimenting and the

likelihood that youth will progress to regular, sustained use of tobacco products, and, thus, would

reduce the risk of tobacco-related death and disease.” Mital Decl. ¶ 26(f) (quoting 87 Fed. Reg. at

26,406) (emphasis added). Although no such rule has been finalized, similar concerns counsel against

defining “premium cigars” to include flavored cigars—lest they be subject to significantly less

regulatory oversight than virtually any other tobacco product.

At the very least, these substantial policy concerns underscore why it should—if anyone—be

FDA, rather than this Court, that makes such a significant change to the currently operative definition

of “premium cigars,” and to the regulatory treatment (or lack thereof) of flavored cigars. In the

context of a rulemaking, and with the benefit of scientific analysis and public comments from a wide

variety of stakeholders, FDA can weigh the policy and public-health trade-offs between possible

increases in youth usage, on one hand, and the purported benefits of flavors identified by CAA, on

the other. In the interim, however, CAA offers this Court no basis to reject the concerns previously

raised by FDA (and many others) about characterizing flavors in tobacco products, including cigars.

2. In addition, CAA proposes two other changes to the definition of “premium cigars,”

namely: (1) to allow for unlimited “ingredients or additives,” rather than only “tobacco, water, and

vegetable gum,” and (2) to eliminate the requirement that a premium cigar “contain at least 50 percent

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(of the filler by weight) long filler tobacco.” These changes should also be rejected at this time, and

reserved for possible future consideration by FDA in the context of rulemaking. In short,

“[d]etermining the potential effects of removing each of these provisions is a complex endeavor best

done through rulemaking,” rather than litigation briefing. Mital Decl. ¶ 28.

For example, when it comes to ingredients and additives, “CTP’s subject-matter experts may

wish to review and solicit public comments on the kinds of additives and ingredients that could be

added by cigar manufacturers if the criterion was completely removed from the definition.” Id. ¶ 29.

After all, CAA does not propose to amend that requirement, but rather to delete it altogether—such
that there would be no limitation at all on the sorts of “ingredients or additives” that may be included

in “premium cigars.” Future rulemaking would “allow the agency to consider, as an alternative to

wholesale deletion, whether that criterion should be amended to provide at least some guardrails on

the kinds of additives and ingredients that could be added to premium cigars.” Id.

Similarly, on the issue of the percentage of long-filler tobacco, the agency’s “subject-matter

experts may wish in a rulemaking to examine the effect of the length of the filler on exposure to

tobacco,” which is not addressed in CAA’s filing. Id. ¶ 31. And “CAA’s claims about industry

confusion over the meaning of ‘long filler’ and the impracticality of post-manufacturing verification

of long filler use would” likewise “benefit from public comment.” Id. After all, “[f]inding a consensus

on industry norms of understanding is a task ill-suited to this litigation, where a single litigant is

claiming to represent the views of the industry even where the other industry plaintiffs in the same

litigation are not in agreement.” Id. ¶ 32.

3. Finally, setting aside the specifics, the Court should consider how CAA’s late-breaking

proposal fits within the original theory behind this litigation. All Plaintiffs in this case have always

argued that “premium cigars” were somehow special, and thus worthy of different regulatory

treatment—indeed, worthy of no federal regulatory oversight at all. That narrative was built around

cigars “constructed by the hands of artisans,” used infrequently, by customers who “are generally

older, better-educated, and have higher incomes than consumers of other tobacco products.” 4th

Am. Compl. ¶¶ 168, 171, ECF No. 236. The Court was told that a “premium cigar” was “a special

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occasion product,” “made by the hands of artisans pulling the tobacco from a particular harvest,”

composed of “all natural, expensive long-filler tobacco,” using methods passed down from “fathers

or grandfathers from Cuba, the Dominican Republic or Honduras.” Decl. of Rocky Patel Decl. ¶¶ 2,

4, 8, ECF No. 271-2. In other words, these cigars were not the sort of thing that every 18-year-old can

find behind the counter at every gas station or convenience store.

But now, Plaintiff CAA’s proposed changes risk broadening the category of “premium cigars”

such that the exception swallows more and more of the rule, allowing an ever-larger swath of cigar

sales to entirely escape FDA oversight. And manufacturers will surely respond to powerful economic
incentives to try to fit more and more of their products within a new, broader definition of “premium

cigars.” The result of that public-policy experiment is difficult to predict in advance—but that is all

the more reason for FDA to be the entity to take on that burden, in a future rulemaking, with this

Court preserving the status quo in the interim. Otherwise, the Court may be dismayed to go to a gas

station one day and see that the tobacco industry has found clever ways to ensure that nearly all cigars

have conveniently become “premium cigars,” at least for legal purposes—even those that bear little

resemblance to the sort of artisanal product upon which Plaintiffs built and won this case.

CONCLUSION

For these reasons, the Court should retain the current definition of “premium cigars,” in its

entirety, unless and until FDA revisits that definition in a future rulemaking.

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Date: August 7, 2025 Respectfully submitted,

ROBERT FOX FOSTER BRETT A. SHUMATE

Acting General Counsel Assistant Attorney General
Chief Counsel for Food, Research, and Drugs Civil Division
U.S. Department of Health and Human
Services ERIC B. BECKENHAUER
Assistant Branch Director
SEAN R. KEVENEY Federal Programs Branch
Chief Counsel
Food and Drug Administration /s/ Stephen M. Pezzi
STEPHEN M. PEZZI (D.C. Bar No. 995500)
WENDY S. VICENTE Senior Trial Counsel
Deputy Chief Counsel for Litigation United States Department of Justice
Civil Division, Federal Programs Branch
DANLI SONG 1100 L Street NW
Associate Chief Counsel Washington, DC 20005
Office of the Chief Counsel (202) 305-8576
U.S. Food and Drug Administration [email protected]
10903 New Hampshire Avenue
Bldg. 32, Room 4397 Counsel for Defendants
Silver Spring, MD 20993

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