FDA Reply Brief 5.23.2024

USCA Case #23-5220 Document #2056061 Filed: 05/23/2024 Page 1 of 39
[ORAL ARGUMENT NOT SCHEDULED]
No. 23-5220
IN THE UNITED STATES COURT OF APPEALS

FOR THE DISTRICT OF COLUMBIA CIRCUIT
CIGAR ASSOCIATION OF AMERICA, et al.,

Plaintiffs-Appellees,
v.
FOOD & DRUG ADMINISTRATION, et al.,
Defendants-Appellants.
ON APPEAL FROM THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF COLUMBIA
REPLY BRIEF
Of Counsel: BRIAN M. BOYNTON

Principal Deputy Assistant
SAMUEL R. BAGENSTOS
Attorney General
General Counsel
Department of Health & Human Services MARK B. STERN
LINDSEY POWELL
MARK RAZA
Attorneys, Appellate Staff
Chief Counsel
Civil Division, Room 7531
WENDY S. VICENTE U.S. Department of Justice
Deputy Chief Counsel for Litigation 950 Pennsylvania Ave., NW
Washington, DC 20530
PETER DICKOS
(202) 616-5372
Associate Chief Counsel
Office of the Chief Counsel
U.S. Food & Drug Administration
CERTIFICATE AS TO PARTIES,
RULINGS, AND RELATED CASES
Pursuant to Circuit Rule 28(a)(1), counsel certifies as follows:
A. Parties and Amici. Defendants-appellants are the U.S. Food and
Drug Administration (FDA); the U.S. Department of Health and Human
Services (HHS); Xavier Becerra, in his official capacity as HHS Secretary;
and Robert M. Califf, MD, in his official capacity as FDA Commissioner.
Plaintiffs-appellees are Cigar Association of America, Cigar Rights of
America, and Premium Cigar Association.
The following entities participated as amici at an earlier stage of
these proceedings:
 American Academy of Pediatrics

 American Cancer Society Cancer Action Network
 American Heart Association
 American Lung Association
 American Thoracic Society
 Campaign for Tobacco-Free Kids
 Cause of Action Institute
 Cynthia Fishman
 David Myles
 Leah Brasch
 Linda Goldstein
 Maryland Chapter – American Academy of Pediatrics
 Steven Hirsch
 The States of Arizona, Louisiana, Michigan, and Texas
 Tobacco Control Legal Consortium

 Truth Initiative
The following entities moved to intervene in district court at an
earlier stage of these proceedings but later withdrew their motion:
 A. Fuente & Co.

 Alec Bradley Cigar Distributors, Inc.
 Ashton Distributors, Inc.
 Crowned Heads, LLC
 Holt Cigar Co., Inc.
 Oliva Cigar Co., Inc.
 Piloto Cigars, Inc.
 Rocky Patel Premium Cigars
B. Rulings Under Review. The rulings under review are the
following orders of the United States District Court for the District of
Columbia (Mehta, J.) in case number 16-1460: (1) the July 5, 2022, opinion
and order granting in part and denying in part the parties’ cross-motions
for summary judgment (available at 2022 WL 2438512); (2) the August 9,
2023, opinion denying the government’s request for remand without
vacatur (available at 2023 WL 5094869); and (3) the August 9, 2023, order
vacating FDA’s final deeming rule insofar as it applies to premium cigars
(unpublished).
C. Related Cases. Unrelated issues in this case have previously been
on appeal and were decided by this Court in No. 18-5195 (published at 964
F.3d 56 (D.C. Cir. 2020)), and No. 20-5266 (published at 5 F.4th 68 (D.C. Cir.
2021)). Counsel is unaware of any related cases within the meaning of
Circuit Rule 28(a)(1)(C).
/s/ Lindsey Powell

LINDSEY POWELL
TABLE OF CONTENTS
Page
GLOSSARY
INTRODUCTION AND SUMMARY OF ARGUMENT ................................... 1
ARGUMENT ............................................................................................................ 5
I. FDA Reasonably Determined that Regulating Premium

Cigars Will Benefit the Public Health ................................................... 5
A. FDA thoroughly considered the public health implications

of exempting premium cigars from regulation ............................. 5
B. FDA reasonably considered the effects of regulation

on youth use of cigars ...................................................................... 19
II. The District Court Abused Its Discretion in Remanding

Without Vacatur .................................................................................... 21
CONCLUSION ...................................................................................................... 28
CERTIFICATE OF COMPLIANCE
CERTIFICATE OF SERVICE
TABLE OF AUTHORITIES
Cases: Page(s)
A.L. Pharma, Inc. v. Shalala,
62 F.3d 1484 (D.C. Cir. 1995) ........................................................................... 19
Allied-Signal, Inc. v. U.S. Nuclear Regulatory Comm’n,
988 F.2d 146 (D.C. Cir. 1993) ....................................................................... 3, 26
American Great Lakes Ports Ass’n v. Schultz,
962 F.3d 510 (D.C. Cir. 2020) ............................................................... 22, 25, 26
Big Time Vapes, Inc. v. FDA,
963 F.3d 436 (5th Cir. 2020) ..................................................................... 1, 5, 14
Cablevision Sys. Corp. v. FCC,
649 F.3d 695 (D.C. Cir. 2011) ..................................................................... 15, 19
CTS Corp. v. EPA,
759 F.3d 52 (D.C. Cir. 2014) ............................................................................. 16
Dickson v. Secretary of Def.,
68 F.3d 1396 (D.C. Cir. 1995) ............................................................................ 16
Fontem US, LLC v. FDA,
82 F.4th 1207 (D.C. Cir. 2023)....................................................................... 9-10
Heartland Reg’l Med. Ctr. v. Sebelius,
566 F.3d 193 (D.C. Cir. 2009) ........................................................................... 23
McKinney v. Wormuth,
5 F.4th 42 (D.C. Cir. 2021) ................................................................................ 16
Motor Vehicle Mfrs. Ass’n of the U.S. v. State Farm Mut. Auto. Ins. Co.,
463 U.S. 29 (1983) .........................................................................................15, 22
Nicopure Labs, LLC v. FDA,
944 F.3d 267 (D.C. Cir. 2019) ............................................................................. 1
Prohibition Juice Co. v. FDA,
45 F.4th 8 (D.C. Cir. 2022) ................................................................................ 19
ii
Rempfer v. Sharfstein,
583 F.3d 860 (D.C. Cir. 2009) ........................................................................... 19
R.J. Reynolds Co. v. FDA,
696 F.3d 1205 (D.C. Cir. 2012) .......................................................................... 21
SecurityPoint Holdings, Inc. v. Transportation Sec. Admin.,
867 F.3d 180 (D.C. Cir. 2017) ........................................................................... 22
Statutes:
Family Smoking Prevention and Tobacco Control Act,

Pub. L. No. 111-31, § 2(2), 123 Stat. 1776, 1777 (2009) .................................... 1
21 U.S.C. § 387a ............................................................................................... 5
21 U.S.C. § 387a(b) .......................................................................................... 5
21 U.S.C. § 387s ............................................................................................... 4
21 U.S.C. § 387s(b)(1)(K) .............................................................................. 28
21 U.S.C. § 387s(b)(2)(B)(ii) ......................................................................... 28
21 U.S.C. § 387s(b)(5).................................................................................... 24
21 U.S.C. § 321(rr)(1) .............................................................................................. 7
26 U.S.C. § 5701(a) ................................................................................................ 24
Regulations:
21 C.F.R. § 1150.5(b)(2) ........................................................................................ 24
21 C.F.R. § 1150.13(e) ........................................................................................... 24
21 C.F.R. § 1150.15 ................................................................................................ 24
iii
Other Authorities:
Cigar Ass’n of Am., Market Trends, https://perma.cc/RWM4-4ZSC .......... 28
Ctr. for Tobacco Prods., FDA, CTP Statement on Withdrawal of

the Unified Agenda Entry Pertaining to the Advance Notice of
Proposed Rulemaking for Premium Cigars and Related Request for
Information (June 11, 2021), https://perma.cc/F2AB-JCNG ................17, 18
Ctr. for Tobacco Prods., FDA, Enforcement Priorities for

Electronic Nicotine Delivery Systems (ENDS) and Other
Deemed Products on the Market Without Premarket
Authorization (Jan. 2020) (JA 156-208) ............................................................. 18
Ctr. for Tobacco Prods., FDA, FDA Deems Certain Tobacco

Products Subject to FDA Authority, Sales and Distribution
Restrictions, and Health Warning Requirements for Packages
and Advertisements (Revised): Guidance for Industry
(Oct. 2020), https://perma.cc/YJ46-VZ7A ............................................. 26-27
FDA, Tobacco User Fee Assessment Formulation by Product Class,

https://perma.cc/RWM4-4ZSC (last updated Nov. 21, 2023) .................. 28
Fed. Interagency Forum on Child & Family Statistics,

POP1 Child Population: Number of Children (in Millions)
Ages 0-17 in the U.S. by Age, 1950-2022 and Projected
2023-2050, https://perma.cc/HGL6-548C .................................................. 21
79 Fed. Reg. 23,142 (Apr. 25, 2014) ...................................................... 7, 8, 10, 11
81 Fed. Reg. 28,707 (May 10, 2016) .................................................................... 24
81 Fed. Reg. 28,974 (May 10, 2016) .................... 1, 2, 3, 5, 6, 8, 9, 10, 11, 12, 13,
14, 15, 16, 19, 20, 21, 22, 23
83 Fed. Reg. 12,901 (Mar. 26, 2018) .............................................................. 16, 17
iv
GLOSSARY
FDA U.S. Food and Drug Administration
JA Joint Appendix
TCA Family Smoking Prevention and Tobacco

Control Act
v
INTRODUCTION AND SUMMARY OF ARGUMENT
The Family Smoking Prevention and Tobacco Control Act (TCA)
“establishes a thorough framework for regulating tobacco products” for the
purpose of “protecting public health.” Big Time Vapes, Inc. v. FDA, 963 F.3d
436, 437, 444 (5th Cir. 2020). “A consensus exists within the scientific and
medical communities that tobacco products are inherently dangerous,”
Nicopure Labs, LLC v. FDA, 944 F.3d 267, 272 (D.C. Cir. 2019) (quoting TCA,
Pub. L. No. 111-31, § 2(2), 123 Stat. 1776, 1777 (2009)), and the U.S. Food
and Drug Administration (FDA) reasonably determined that “there will be
many public health benefits associated with deeming tobacco products
(including products referred to as premium cigars),” 81 Fed. Reg. 28,974,
29,020 (May 10, 2016). The agency explained that “deeming tobacco
products on a product or category basis would create regulatory loopholes,
substantial delay (at the risk to public health), and significantly impede
FDA’s ability to create a comprehensive regulatory scheme.” Id. at
28,982-83. And it found that, for a variety of reasons, “exempting premium
cigars” from all FDA regulation “would have a negative impact on the
public health.” Id. at 29,020.

Plaintiffs nevertheless urge that the district court properly exempted
these products from regulation on the ground that FDA did not adequately
address two studies in the course of discussing the public health basis for
regulating premium cigars. As explained in our opening brief, FDA
repeatedly cited the studies on which plaintiffs rely. See 81 Fed. Reg. at
29,020-25. And the agency expressly acknowledged the premises for which
plaintiffs cite them—i.e., that “some premium cigar smokers might smoke
such products infrequently,” id. at 29,020, and that mortality risks diminish
with decreased cigar use, id. at 29,021. FDA further explained that, as with
e-cigarettes and certain other products, see id. at 28,984, bringing premium
cigars within FDA’s regulatory authority will benefit the public health even
if the use of such products may entail less risk for some users, id. at 29,020,
29,027. Among other considerations, FDA cautioned that exempting
premium cigars would negatively affect the public health by “mislead[ing]
consumers to believe that premium cigars are safe” and “leading more
youth and young adults to initiate use” of such products. Id. at 29,021.
Disregarding the agency’s extensive analysis, plaintiffs cite
statements wholly removed from their context suggesting that “there were
2
no data provided to support the premise that there are different patterns of
use of premium cigars and that these patterns result in lower health risks.”
Br. 1-2, 8, 19, 22 (quoting 81 Fed. Reg. at 29,020). The broader discussion,
however, shows that FDA was plainly aware of the studies that plaintiffs
cite as relevant, and the agency reasonably explained why bringing
premium cigars under FDA’s regulatory authority would benefit the public
health even if many premium-cigar smokers use such products
infrequently. The fuller analysis in the final rule refutes any contention
that FDA misunderstood the record or failed to consider an important
aspect of the problem. See 81 Fed. Reg. at 29,020-27. Like plaintiffs, the
district court erred in failing to consider the full scope of the agency’s
analysis or credit its reasoned public health determination.
If the Court were nevertheless to conclude that FDA needed to
further explain its view of the two studies on which plaintiffs rely, the
appropriate remedy would be remand without vacatur. See Allied-Signal,
Inc. v. U.S. Nuclear Regulatory Comm’n, 988 F.2d 146, 150-51 (D.C. Cir. 1993).
Any explanatory error was minor within the broader scope of the agency’s
discussion of premium cigars, and FDA could readily provide further
detail on remand. Vacating the rule in the interim creates risks to the
3
public health by leaving a category of harmful and potentially addictive
products essentially unregulated, and it significantly disrupts the operation
of the statutory user fee scheme that Congress established to fund federal
tobacco regulation, see 21 U.S.C. § 387s. In contrast, maintaining the status
quo as it existed for the seven years prior to the district court’s vacatur
order while FDA further explains its decision would impose no significant
regulatory burden. Plaintiffs mistakenly urge that remand without vacatur
would require premium-cigar manufacturers to engage in costly testing of
cigar ingredients. Br. 53. But FDA has deferred enforcement of that
requirement pending issuance of further guidance—which is why plaintiffs
have not conducted such tests already. Similarly, the rulemaking plaintiffs
cite in urging that remand without vacatur would subject their members to
onerous manufacturing standards, Br. 53-54, has not resulted in a final rule,
making “its ultimate impact speculative,” as the district court
acknowledged. JA 14. The district court abused its discretion by vacating
the rule in these circumstances.
4
ARGUMENT
I. FDA Reasonably Determined that Regulating Premium

Cigars Will Benefit the Public Health.
A. FDA thoroughly considered the public health implications

of exempting premium cigars from regulation.
1. The TCA gives “FDA broad authority to address ‘the public health
and societal problems caused by the use of tobacco products.’” Big Time
Vapes, Inc. v. FDA, 963 F.3d 436, 438 (5th Cir. 2020). This regulatory scheme
encompasses all “tobacco products” deemed by FDA through rulemaking,
in addition to the four categories of tobacco products listed in the Act. 21
U.S.C. § 387a(b). The deeming rule is thus a “foundational rule” that is a
condition precedent to any FDA regulation of tobacco products not
enumerated in the Act. 81 Fed. Reg. at 29,003; see 21 U.S.C. § 387a.
While the degree of risk varies by product, “[t]here is inherent risk in
all tobacco-derived products,” 81 Fed. Reg. at 29,025, and FDA concluded
that it was appropriate to deem all such products, including nicotine gels,
dissolvables, e-cigarettes, pipe tobacco, hookahs, and cigars, id. at 28,982.1
As in our opening brief (at 9 n.2), references to FDA’s decision to

1
deem all “tobacco products” are subject to the caveat that the agency
excluded accessories of such products.
5
The agency determined that it is “critical to deem these noncigarette
tobacco products and place restrictions upon them that are appropriate for
the protection of the public health, including age and identification
restrictions to help prevent youth use.” Id. at 29,049. FDA explained that
this conclusion extends to products like e-cigarettes that “may eventually
be shown to have a net benefit” to public health at the population level, id.
at 28,984, and to those like pipe tobacco, hookahs, and premium cigars,
which users may smoke less frequently, see id. at 29,020, 29,049-50.
Plaintiffs fundamentally misunderstand the scope of the TCA in
describing it as a “regulatory scheme that Congress built for cigarettes” in
particular. Br. 1; see Br. 30, 35, 43. And they similarly err in urging that the
“crucial question” in determining whether a product should be subject to
the Act’s requirements is whether the product is “made and used in similar
ways to cigarettes.” Br. 35. The TCA provides no support for this
construction, and plaintiffs cite none. (Indeed, their interpretation would
seem to exclude smokeless tobacco, which Congress itself specifically
brought within the regulatory scheme.)
The TCA defines “tobacco product” in pertinent part as “any product
made or derived from tobacco . . . that is intended for human consumption,
6
including any component, part, or accessory of a tobacco product.” 21
U.S.C. § 321(rr)(1). In determining whether to deem a tobacco product
subject to FDA’s authority under the Act, the central consideration is
whether doing so would benefit the public health. 79 Fed. Reg. 23,142,
23,145, 23,150 (Apr. 25, 2014). Accordingly, when FDA issued a notice of
proposed rulemaking that would bring most “tobacco products” within the
regulatory framework, it asked for comments regarding the extent of the
public health risks posed by different products, id. at 23,143, including
different kinds of cigars, id. at 23,150-52.2
To that end, FDA sought comment “on the relative merits” of
deeming all tobacco products (Option 1) versus exempting premium cigars
(Option 2), “taking into account what is appropriate for the public health,
including possible benefits to the public health or possible negative public
health consequences of adopting one Option or the other.” 79 Fed. Reg. at
23,145. In outlining the preliminary basis for Option 1, FDA explained that
2 Plaintiffs elsewhere misstate the relevant inquiry in suggesting that

FDA was required to determine “whether the proposed regulatory
measures could meaningfully reduce” youth use, Br. 38-39, or that the TCA
required FDA to weigh the public health benefits of regulation against the
costs to business, Br. 40. The TCA requires no such inquiry.
7
“all cigars are harmful and potentially addictive,” id. at 23,150, and it noted
that some large cigars “may contain as much tobacco as a whole pack of
cigarettes” and may have nicotine levels “up to 8 times higher than levels
in cigarette smoke,” id. at 23,151. In setting forth Option 2, FDA cited
comments suggesting that premium-cigar users smoke only occasionally
and do not inhale, id., and that there might thus be “little public health
benefit if FDA were to regulate premium cigars,” id. at 23,152. FDA
accordingly solicited evidence “related to disease risk, nicotine addiction,
and how premium cigars are used,” id., in order to assess the “claim that
premium cigars are not a public health problem requiring FDA
regulation,” id. at 23,151.
In concluding that “there is no public health justification for
exempting premium cigars,” the final rule expanded upon the findings in
the proposed rule, emphasizing that “[a]ll cigars pose serious negative
health risks” to users, and “[a]ll cigars produce secondhand smoke, which
causes negative health effects such as heart disease and lung cancer in
bystanders.” 81 Fed. Reg. at 29,020. FDA considered the available
evidence regarding patterns of cigar use and acknowledged that “cigar
smokers generally smoke at a lower frequency and tend not to inhale the
8
smoke,” id., and that infrequent use or reduced inhalation may entail lower
risk, id. at 29,020-22, 29,024. While FDA noted that “most studies cited in
this section do not explicitly pertain to premium cigars,” it explained that
“the bulk of the established data on the health effects of cigar smoking is
based on smokers of traditional, large cigars and, therefore, is applicable to
the toxicity of premium cigars given that they share the same
characteristics and are generally smoked in similar ways.” Id. at 29,020.
While noting that patterns of infrequent use or non-inhalation may
entail less risk for some users, FDA determined that these use patterns do
not negate the risk of harm. 81 Fed. Reg.at 29,020, 29,024. To the contrary,
the available evidence—including one of the studies on which plaintiffs
principally rely—expressly rejects the idea that “cigar smokers who smoke
few cigars or do not inhale have no increased risk of disease,” JA 339
(Monograph 9), and confirms that “no amount of smoking is safe,” 81 Fed.
Reg. at 29,020. FDA also determined that a number of other public health
considerations—including youth use, the harms of secondhand smoke
exposure, and patterns of using cigars in combination with other tobacco
products—further weigh in favor of regulation. Id. at 29,023-24. Thus, far
from moving the “regulatory goalposts,” Br. 34 (quoting Fontem US, LLC v.
9
FDA, 82 F.4th 1207, 1222 (D.C. Cir. 2023)), FDA continued the public health
inquiry initiated in the proposed rule and found that the evidence did not
show that “premium cigars are not a public health problem requiring FDA
regulation,” 79 Fed. Reg. at 23,151; see 81 Fed. Reg. at 29,020 (finding “no
public health justification for exempting premium cigars”). The district
court failed to give appropriate deference to that determination.
2. The final rule’s eight-page discussion of the comments and
evidence regarding premium-cigar use patterns and other public health
considerations refutes plaintiffs’ assertion that, “[t]o read the Final Rule, it
was as if the Proposed Rule and the evidence submitted through the
comment process never happened.” Br. 8. In addition to discussing a large
volume of other evidence regarding patterns of cigar use, FDA repeatedly
acknowledged the two studies on which plaintiffs premise their challenge,
see Br. 22-23.3 And the agency directly addressed the central premises for
which plaintiffs cite them—noting, among other things, that “a majority of
cigar users are occasional smokers,” 81 Fed. Reg. at 29,024, and that less
frequent cigar use entails less risk, id. at 29,020-21.
3See 81 Fed. Reg. at 29,020-25 (citing Monograph 9 (Ref. 69) sixteen

times and the Corey study (Ref. 90) five times).
10
Indeed, in both the proposed and final rule, FDA expressly cited
Monograph 9 for the finding on which plaintiffs rely—i.e., that “data for
the lowest level of cigar users (one to two cigars per day) do not reveal
mortality rates that are significantly different from nonsmokers.” 81 Fed.
Reg. at 29,024 (citing Ref. 69); see 79 Fed. Reg. at 23,151 (same).4 Based on
the available evidence, however, the agency concluded that infrequent
premium-cigar use does not obviate the risk of adverse health effects that
result from exposure to the many toxic substances undisputedly found in
all cigar smoke. 81 Fed. Reg. at 29,020-21. Consistent with that conclusion,
Monograph 9 itself rejected the idea that “cigar smokers who smoke few
cigars or do not inhale have no increased risk of disease,” explaining that
“the risks experienced by cigar smokers are proportionate to their exposure
to tobacco smoke,” JA 339, and that “quitting is the only way to eliminate
the documented harm that can result from cigar smoking,” JA 330. FDA
reasonably determined that the evidence of “increased disease risk and
nicotine dependence among infrequent cigar users,” id. at 29,024, along
4Plaintiffs’ assertion that FDA did not “cite[] Monograph 9 for . . . the
health effects of using less than 2 cigars per day,” Br. 28 n.3, cannot be
reconciled with the clear statements in the record.
11
with the other public health considerations discussed below, supported
bringing premium cigars within FDA’s regulatory authority. To the extent
the district court discounted this evidence on the ground that it “is not
specific to premium cigars,” JA 26 (discussing a study finding that more
than 9,000 premature deaths annually are attributable to smoking cigars
regularly (i.e., at least every other day, on average)), the court erred in
failing to acknowledge that the same is true of Monograph 9.
In urging that the agency wholly failed to respond to comments
about premium-cigar use, see Br. 8, plaintiffs also fail to acknowledge that
many comments focused not on infrequent use but on whether patterns of
non-inhalation among premium-cigar smokers obviate the risk to users. As
part of its broader public health analysis, FDA addressed that evidence at
length. The agency explained that, “[w]hile inhaling cigar smoke poses
much higher morbidity and mortality rates than not inhaling, significant
risk still exists for those who do not inhale,” and such users “are still
subject to the addictive and other adverse health effects of the product.”
81 Fed. Reg. at 29,024-25. Plaintiffs do not challenge FDA’s analysis in this
respect or its conclusion that, even though non-inhalation may reduce the
risk to users, significant risk remains. See id. at 29,024.
12
Plaintiffs and the district court also improperly discount a number of
other considerations that expressly informed the agency’s public health
assessment. For example, rather than looking at premium-cigar use in a
vacuum, FDA appropriately considered concurrent use of other tobacco
products because it affects users’ overall risk of addiction and harm.
81 Fed. Reg. at 29,022. The Corey study shows that 35.1% of adult
premium-cigar smokers—or roughly 1.3 million people nationwide—also
smoke cigarettes. Id. FDA explained that such “multiple product use is
concerning because polytobacco users are more likely to report symptoms
of nicotine dependence,” and such use also increases exposure to toxic
constituents and the attendant health risks. Id. Given their heightened
health risks, dual use of combustible tobacco products—such as cigars and
cigarettes—is a particular concern. See id.
FDA also considered the harm cigars cause to bystanders who inhale
their toxic smoke secondhand. 81 Fed. Reg. at 29,020, 29,022. And the
agency explained that exempting premium cigars “could mislead
consumers to believe that premium cigars are safe, which contradicts the
available evidence that all cigars are harmful and potentially addictive”
and could “lead[] more youth and young adults to initiate use of premium
13
cigars.” Id. at 29,021. By contrast, “[d]eeming all tobacco products,
including premium cigars, . . . will help to alleviate mistaken beliefs that
certain tobacco products are safer alternatives to cigarettes by virtue of the
fact that they are not subject to FDA regulation.” Id. at 29,024. Together,
these considerations underscore the complexity of the public health inquiry
and the need for “FDA to attack those problems comprehensively.” Big Time
Vapes, 963 F.3d at 445. And they amply support the agency’s determination
that “exempting premium cigars would have a negative impact on the
public health.” 81 Fed. Reg. at 29,020.
3. Without fully addressing the agency’s analysis and extensive
response to comments, the district court focused on statements in the final
rule indicating that “there were no data provided to support the premise
that there are different patterns of use of premium cigars and that these
patterns result in lower health risks.” JA 19, 21, 23, 29 (quoting 81 Fed. Reg.
at 29,020); see JA 6, 21, 24 (stating that no evidence was submitted
addressing “how the potential different patterns of use for premium cigars
might result in different or decreased health impacts” (quoting 81 Fed. Reg.
at 29,022)). Plaintiffs repeat that focus. Br. 1-2, 8, 19, 22. As the preceding
discussion makes clear, however, FDA was aware of—and responded over
14
several pages of the Federal Register to—comments and evidence
addressing these issues. Three other “no data” statements in the final rule
more clearly indicate what FDA considered deficient about the available
evidence, emphasizing that “the comments did not include data indicating
that premium cigar smokers are not subject to disease risk and addiction,”
81 Fed. Reg. at 29,024, are precluded from “negative health effects,” id. at
29,027, or are not otherwise “susceptible to health risks,” id. at 29,020. The
agency thus found no evidence to support the conclusion that premium-
cigar use does not implicate the public health.
Review of the agency’s statements in context leaves no doubt that it
directly considered patterns of premium-cigar use as part of its broader
public health analysis. As discussed, FDA acknowledged patterns of
infrequent use and determined that the remaining risk, along with other
public health considerations, made it appropriate to bring premium cigars
within the agency’s regulatory authority. There can thus be no serious
contention that the agency “entirely failed to consider an important aspect
of the problem,” Cablevision Sys. Corp. v. FCC, 649 F.3d 695, 714 (D.C. Cir.
2011) (quoting Motor Vehicle Mfrs. Ass’n of the U.S. v. State Farm Mut. Auto.
Ins. Co., 463 U.S. 29, 43 (1983)), or provide “a rational connection between
15
the facts found and the choice made,” McKinney v. Wormuth, 5 F.4th 42, 47
(D.C. Cir. 2021) (per curiam) (quoting Dickson v. Secretary of Def., 68 F.3d
1396, 1404 (D.C. Cir. 1995)). Nor is there any merit to plaintiffs’ contention
that FDA “improperly shifted the burden of justifying the Final Rule,” Br.
20; see Br. 42-43, in determining that “deeming all cigars, rather than a
subset, more completely protects the public health,” 81 Fed. Reg. at 29,020.
4. Plaintiffs mistakenly suggest that FDA’s 2018 issuance of an
advance notice of proposed rulemaking, 83 Fed. Reg. 12,901 (Mar. 26, 2018),
and other subsequent statements undermine the agency’s basis for
deeming premium cigars. See Br. 10-12, 29, 37, 41, 42. As an initial matter,
it is “black-letter administrative law that in an [Administrative Procedure
Act] case, a reviewing court should have before it neither more nor less
information than did the agency when it made its decision.” CTS Corp. v.
EPA, 759 F.3d 52, 64 (D.C. Cir. 2014) (alteration in original) (quotation
marks omitted). Thus, the reasonableness of FDA’s decision must be
assessed on the record before the agency in 2016, when it promulgated the
deeming rule.
In any event, plaintiffs’ argument is without basis. Contrary to
plaintiffs’ suggestion that the advance notice indicates that FDA was not
16
aware of the frequency data from the Corey study, Br. 29, the notice simply
shows that—as with other tobacco products—FDA continues to monitor
developments that may inform regulatory decisions and enforcement
priorities. The advance notice solicited evidence that was “not submitted
in response to the proposed deeming rule, or that may have become
available since then, that could further inform FDA’s thinking about the
regulation of premium cigars,” and it cited a different Corey study
published after the deeming rule as an example of data that had “become
available since” the rule issued. 83 Fed. Reg. at 12,902. In response, FDA
received many comments, “including comments from public health groups
noting the known adverse health effects of all cigars, the rise of cigar use
among youth and youth use of premium cigars, the evolving tobacco
market, and the potential for market manipulation to avoid regulation if
FDA were to treat premium cigars more favorably than other tobacco
products.” Ctr. for Tobacco Prods., FDA, CTP Statement on Withdrawal of
the Unified Agenda Entry Pertaining to the Advance Notice of Proposed
Rulemaking for Premium Cigars and Related Request for Information (June 11,
2021), https://perma.cc/F2AB-JCNG.
17
In early 2021, FDA withdrew the advance notice’s entry from the
Unified Agenda, explaining that “current regulatory measures applicable
to premium cigars—such as the prohibition of sales to youth—are
supported by the existing evidence.” CTP Statement, supra. FDA further
explained that, “[e]ven if there is significant occasional use of premium
cigars, some premium cigar smokers have frequent use with significant
exposure to harmful constituents that are known to increase the risk of
oral, esophageal, laryngeal, and lung cancer (among other negative health
consequences) in cigar smokers compared to non-tobacco users.” Id.
“Dual use of premium cigars with other tobacco products is also a
significant concern.” Id. The agency’s subsequent statements thus align
with its findings in the deeming rule.5
5Plaintiffs misstate the facts in asserting that in “January 2020, the

FDA expressly concluded that premium cigars did not need to be regulated
with the same measures” as other tobacco products. Br. 11 (citing JA 187).
The guidance plaintiffs cite addresses the agency’s enforcement priorities
in connection with products marketed without authorization. Ctr. for
Tobacco Prods., FDA, Enforcement Priorities for Electronic Nicotine Delivery
Systems (ENDS) and Other Deemed Products on the Market Without Premarket
Authorization (Jan. 2020) (JA 156-208). The fact that, amidst a surge in youth
e-cigarette use, FDA chose to prioritize enforcement of flavored e-cigarettes
marketed without authorization hardly suggests that the agency thought
premium cigars should not be regulated at all.
18
B. FDA reasonably considered the effects of regulation

on youth use of cigars.
In determining that deeming premium cigars would benefit the
public health, FDA also considered current patterns of youth use and the
likely effect of nonregulation on future use. FDA noted that “youth cigar
use has not declined when compared to use of other tobacco products,”
and it cited several studies showing that “youth and young adults are
using premium cigars.” 81 Fed. Reg. at 29,023 (additionally finding that
youth cigar use is likely underreported). The agency also predicted that an
exemption for premium cigars would “lead[] more youth and young adults
to initiate use of premium cigars.” Id. at 29,021; cf. Prohibition Juice Co. v.
FDA, 45 F.4th 8, 26 (D.C. Cir. 2022) (noting the fluidity of youth tobacco-use
patterns). The Court gives such predictive and “scientific judgment[s]
within [the agency’s] ‘area of expertise[]’ . . . a ‘high level of deference.’”
Rempfer v. Sharfstein, 583 F.3d 860, 867 (D.C. Cir. 2009) (quoting A.L.
Pharma, Inc. v. Shalala, 62 F.3d 1484, 1490 (D.C. Cir. 1995)); see Cablevision
Sys., 649 F.3d at 714.
Plaintiffs take issue with FDA’s discussion of one of the studies cited
as evidence of youth premium-cigar use (the Delnevo study), suggesting
19
that it “could mislead the reasonable reader” to think that the study found
that 3.8% of all youth aged 12 to 17, and 12.1% of all young adults aged
18-25, use premium cigars. Br. 39-40. But FDA’s discussion accurately
represented the study, explaining that it used data from a “sample
consisting of 6,678 past 30-day cigar smokers who reported smoking a
usual brand of cigars.” 81 Fed. Reg. at 29,023. In the next sentence, FDA
described the use patterns of that sample of cigar smokers, stating that 3.8% of
youth and 12.1% of young adults “identified certain premium cigars to be
the brand they smoked most often.” Id. “Individuals in both cohorts
reported at least eight different premium cigar brands among the brands
they used most often, providing evidence that youth and young adults are
smoking premium cigars.” Id. Nothing in this discussion or the broader
context suggests that FDA was under the misimpression that nearly 4% of
all youth and 12% of all young adults smoke premium cigars. And there is
no merit to plaintiffs’ suggestion that use of premium cigars by the tens of
thousands of youth implicated by the study findings6 is not a matter of
6 See JA 323; Fed. Interagency Forum on Child & Family Statistics,

POP1 Child Population: Number of Children (in Millions) Ages 0-17 in the U.S.
by Age, 1950-2022 and Projected 2023-2050, https://perma.cc/HGL6-548C
(table) (estimating 25 million U.S. youth ages 12-to-17).
20
public health. See Br. 40 (also inaptly citing R.J. Reynolds Co. v. FDA, 696
F.3d 1205 (D.C. Cir. 2012)).
The Delnevo study is also consistent with other studies that FDA
reviewed before concluding that the data “clearly indicate that youth and
young adults are using premium cigars.” 81 Fed. Reg. at 29,023 (discussing
other studies). And the agency reasonably determined that this evidence of
youth use—coupled with the possibility that exempting premium cigars
from regulation could exacerbate that problem, id. at 29,021—supported
regulating premium cigars. Plaintiffs fail to acknowledge these findings in
asserting that “[t]he agency did not explain how the incidence of behavior
it wishes to curb was distinguishable from zero.” Br. 41.
II. The District Court Abused Its Discretion in Remanding

Without Vacatur.
If the Court were to find that FDA insufficiently addressed the
relevance of two study findings, the appropriate remedy would be to
remand to the agency without vacatur. Both the minor nature of “the
[action’s] deficiencies” and the “likely disruptive consequences of vacatur”
favor that result, American Great Lakes Ports Ass’n v. Schultz, 962 F.3d 510,
21
518-19 (D.C. Cir. 2020) (alteration in original) (quotation marks omitted),
and the district court abused its discretion in concluding otherwise.7
At the first step of this inquiry, the district court erred in concluding
that FDA “entirely failed to consider an important aspect of the problem,”
JA 9 (quoting SecurityPoint Holdings, Inc. v. Transportation Sec. Admin., 867
F.3d 180, 185 (D.C. Cir. 2017) (quoting State Farm, 463 U.S. at 43)), when the
record shows that FDA amply considered comments and evidence relating
to patterns of premium-cigar use in the context of its broader public health
determination, 81 Fed. Reg. at 29,020-27. The court also erred (at JA 11) in
discounting the other bases for FDA’s decision—including patterns of dual
use and polyuse, 81 Fed. Reg. at 29,022, the risks of secondhand smoke
exposure, id., and patterns of youth use, id. at 29,021, 29,023. Any failure to
explain more fully the agency’s view of two studies addressed in the
rulemaking is precisely the type of deficiency that the agency “may be able
7 There is no substance to plaintiffs’ suggestion (Br. 49) that the

government’s opening brief somehow waived this argument in explaining
that the district court’s vacatur decision is reviewed for abuse of discretion
and that all relevant considerations make remand without vacatur the
correct result in these circumstances. See Opening Br. 21, 37-45.
22
readily to cure” on remand. Heartland Reg’l Med. Ctr. v. Sebelius, 566 F.3d
193, 198 (D.C. Cir. 2009).
At the second step of the inquiry, the district court failed to
appreciate the disruptive effects of leaving premium cigars essentially
unregulated at the federal level. FDA found that “deeming tobacco
products on a product or category basis would create regulatory loopholes,
substantial delay (at the risk to public health), and significantly impede
FDA’s ability to create a comprehensive regulatory scheme.” 81 Fed. Reg.
at 28,982-83. In addition, creating a unique exception for premium cigars
may “mislead consumers to believe that premium cigars are safe” and
could potentially “lead[] more youth and young adults to initiate use” of
such products. Id. at 29,021. Plaintiffs seek to minimize the consequences
of leaving premium cigars free from federal minimum-age-of-sale and
other requirements by citing the enforcement guidance that FDA issued in
2020 amidst a surge in youth e-cigarette use, supra p. 18 n.5, which
identified premium cigars that are marketed without authorization as a
low enforcement priority relative to products like flavored e-cigarettes. Br.
50 (citing JA 187). But FDA has never identified any sales of tobacco
products to children as a low priority.
23
As explained in our opening brief (at 42-43), vacatur also upends
FDA’s administration of the user fee scheme that Congress established to
fund federal tobacco regulation because the statutory user fee calculation
methodology cannot distinguish between “premium” cigars and other
cigars. 21 U.S.C. § 387s(b)(5); 26 U.S.C. § 5701(a); 21 C.F.R. § 1150.5(b)(2);
see 81 Fed. Reg. 28,707, 28,713 (May 10, 2016). Plaintiffs’ sole response is to
state that vacatur has required the agency to administer a user fee carveout
for premium cigars, and that the agency has done so “successfully.” Br. 51.
But the statutory features that preclude the necessary calculation remain an
impediment to successful administration, and FDA is still evaluating how
to administer an exception that Congress never contemplated. Because the
agency lacks reliable and standardized information to distinguish between
premium and non-premium cigar activity, it is currently relying on
manufacturers to employ the agency’s user fee dispute process for each
assessment. See 21 C.F.R. §§ 1150.13(e), 1150.15. There are nearly 100 such
disputes currently pending before the agency, and that number is expected
to rise. As the agency continues to evaluate options for allocating to other
manufacturers and importers the fees that would otherwise have been
collected for premium cigars, FDA is not receiving that portion of the total
24
user fee amount provided by Congress. See Opening Br. 42-43. It is
unsurprising that such complications would result from the district court’s
erroneous decision to give legal dimension to a subclass of cigars that the
TCA does not acknowledge, under a definition that FDA has never
adopted for purposes of deeming. See id. at 44.
In discounting this significant disruption, plaintiffs contend that
there is “no precedent” for remanding a user-fee issue without vacatur
when the risk of harm constitutes the loss of fees otherwise paid to the
government. Br. 52. But here, vacatur may result in other private parties
not before the Court having to pay more in user fees due to the zero-sum
nature of the TCA’s user fee scheme. See Opening Br. 42. Moreover,
plaintiffs have indicated that their members may seek refunds of past user
fees, Dkt. No. 274, at 6, which could potentially affect what other users owe
for past years under the terms of the statute. The significant complexity
entailed in trying to administer—and potentially unravel—such fee
arrangements is precisely why there is substantial precedent for remand
without vacatur in cases involving agency fee collection. See American
Great Lakes, 962 F.3d at 519; Allied-Signal, Inc. v. U.S. Nuclear Regulatory
Comm’n, 988 F.2d 146, 151 (D.C. Cir. 1993). The disruption threatened in
25
this case is similar to disruption that supported remand without vacatur in
American Great Lakes and Allied-Signal, in which the Court noted the
difficulty that might result if agencies had to refund fees already paid or
recalculate the fees owed by other parties. See American Great Lakes, 962
F.3d at 519; Allied-Signal, 988 F.2d at 151.
In contrast to the substantial harms caused by vacatur, maintaining
the status quo as it existed for the seven years prior to the district court’s
vacatur order while FDA further explains its decision would impose no
significant regulatory burdens on premium-cigar manufacturers. Plaintiffs
contend that remand without vacatur would require manufacturers to
“test[] the constituents of each of the thousands of types of premium
cigars” at a cost of up to “$75,000 per cigar type.” Br. 53. But as the district
court acknowledged, JA 13, FDA has stated its intent to exercise discretion
not to enforce that requirement generally (not just for premium cigars)
until after the agency issues additional guidance. See Ctr. for Tobacco
Prods., FDA, FDA Deems Certain Tobacco Products Subject to FDA Authority,
Sales and Distribution Restrictions, and Health Warning Requirements for
Packages and Advertisements (Revised): Guidance for Industry 33-34 (Oct. 2020),
https://perma.cc/YJ46-VZ7A. Although the district court acknowledged
26
that these testing requirements are “not currently in effect,” it erred in
relying on plaintiffs’ speculation that the status quo might change. JA 13.
The district court likewise engaged in conjecture where it
acknowledged that a proposed rule prescribing manufacturing standards
for tobacco products “is not final, and thus its ultimate impact [is]
speculative,” but nevertheless concluded that “allowing the Final Deeming
Rule to remain in place could expose premium cigar manufacturers to more
costly and burdensome regulation.” JA 14 (emphasis added). On appeal,
plaintiffs refer to this rulemaking as if it had been finalized, asserting that
“FDA released a new manufacturing standard that (if the deeming decision
were allowed to stand) would have automatically applied to premium
cigar manufacturers.” Br. 53. But the proposed rule remains just that, and
the possible effect of a not-yet-issued final rule remains entirely conjectural.
The district court erred in relying on these concededly speculative claims of
harm. And it abused its discretion in concluding that the Allied-Signal
factors do not support remand without vacatur in these circumstances.8
8Contrary to plaintiffs’ suggestion, Br. 51, the government has amply

supported its assertion that the annual burden of user fees on premium
cigar manufacturers totals less than one cent per cigar, see Dkt. No. 270, at
27
CONCLUSION
For the foregoing reasons, the judgment of the district court should
be reversed.
Respectfully submitted,
Of Counsel: BRIAN M. BOYNTON

Principal Deputy Assistant
SAMUEL R. BAGENSTOS
Attorney General
General Counsel
Department of Health & Human Services MARK B. STERN
/s/ Lindsey Powell
MARK RAZA
LINDSEY POWELL
Chief Counsel
Attorneys, Appellate Staff
WENDY S. VICENTE Civil Division, Room 7531
Deputy Chief Counsel for Litigation U.S. Department of Justice
950 Pennsylvania Ave., NW
PETER DICKOS
Washington, DC 20530
Associate Chief Counsel
(202) 616-5372
Office of the Chief Counsel
[email protected]
U.S. Food & Drug Administration
MAY 2024
8 & n.6. As explained, the TCA sets the total annual user fees for all
tobacco products at $712 million. 21 U.S.C. § 387s(b)(1)(K). Of that total,
14.3198%, or about $102 million, is allocated to cigars as a class for fiscal
year 2024. FDA, Tobacco User Fee Assessment Formulation by Product Class,
https://perma.cc/RWM4-4ZSC (last updated Nov. 21, 2023); 21 U.S.C.
§ 387s(b)(2)(B)(ii). There are about 13.1 billion cigars sold in the U.S. each
year. Cigar Ass’n of Am., Market Trends, https://perma.cc/RWM4-4ZSC.
28
CERTIFICATE OF COMPLIANCE
I hereby certify that the foregoing brief uses a proportionately
spaced, 14-point font and contains 6,237 words according to the count of
this office’s word processing system, and thus complies with Rule
32(a)(7)(B)(ii) of the Federal Rules of Appellate Procedure.
/s/ Lindsey Powell

LINDSEY POWELL
CERTIFICATE OF SERVICE
I hereby certify that on May 23, 2024, I electronically filed the
foregoing brief with the Clerk of the Court for the United States Court of
Appeals for the D.C. Circuit by using the appellate CM/ECF system. All
participants in the case are registered CM/ECF users and will be served by
the appellate CM/ECF system.
/s/ Lindsey Powell

LINDSEY POWELL

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USCA Case #23-5220 Document #2056061 Filed: 05/23/2024 Page 1 of 39

[ORAL ARGUMENT NOT SCHEDULED]

IN THE UNITED STATES COURT OF APPEALS

CIGAR ASSOCIATION OF AMERICA, et al.,

ON APPEAL FROM THE UNITED STATES DISTRICT COURT

Of Counsel: BRIAN M. BOYNTON

Pursuant to Circuit Rule 28(a)(1), counsel certifies as follows:

A. Parties and Amici. Defendants-appellants are the U.S. Food and

Drug Administration (FDA); the U.S. Department of Health and Human

Services (HHS); Xavier Becerra, in his official capacity as HHS Secretary;

and Robert M. Califf, MD, in his official capacity as FDA Commissioner.

Plaintiffs-appellees are Cigar Association of America, Cigar Rights of

America, and Premium Cigar Association.

The following entities participated as amici at an earlier stage of

 American Academy of Pediatrics

 Tobacco Control Legal Consortium

The following entities moved to intervene in district court at an

earlier stage of these proceedings but later withdrew their motion:

 A. Fuente & Co.

B. Rulings Under Review. The rulings under review are the

for summary judgment (available at 2022 WL 2438512); (2) the August 9,

2023, opinion denying the government’s request for remand without

vacating FDA’s final deeming rule insofar as it applies to premium cigars

C. Related Cases. Unrelated issues in this case have previously been

2021)). Counsel is unaware of any related cases within the meaning of

Circuit Rule 28(a)(1)(C).

/s/ Lindsey Powell

INTRODUCTION AND SUMMARY OF ARGUMENT ................................... 1

I. FDA Reasonably Determined that Regulating Premium

A. FDA thoroughly considered the public health implications

B. FDA reasonably considered the effects of regulation

II. The District Court Abused Its Discretion in Remanding

Family Smoking Prevention and Tobacco Control Act,

21 U.S.C. § 321(rr)(1) .............................................................................................. 7

26 U.S.C. § 5701(a) ................................................................................................ 24

21 C.F.R. § 1150.5(b)(2) ........................................................................................ 24

21 C.F.R. § 1150.13(e) ........................................................................................... 24

21 C.F.R. § 1150.15 ................................................................................................ 24

Cigar Ass’n of Am., Market Trends, https://perma.cc/RWM4-4ZSC .......... 28

Ctr. for Tobacco Prods., FDA, CTP Statement on Withdrawal of

Ctr. for Tobacco Prods., FDA, Enforcement Priorities for

Ctr. for Tobacco Prods., FDA, FDA Deems Certain Tobacco

FDA, Tobacco User Fee Assessment Formulation by Product Class,

Fed. Interagency Forum on Child & Family Statistics,

79 Fed. Reg. 23,142 (Apr. 25, 2014) ...................................................... 7, 8, 10, 11

81 Fed. Reg. 28,707 (May 10, 2016) .................................................................... 24

FDA U.S. Food and Drug Administration

TCA Family Smoking Prevention and Tobacco

INTRODUCTION AND SUMMARY OF ARGUMENT

The Family Smoking Prevention and Tobacco Control Act (TCA)

“establishes a thorough framework for regulating tobacco products” for the

medical communities that tobacco products are inherently dangerous,”

and Drug Administration (FDA) reasonably determined that “there will be

many public health benefits associated with deeming tobacco products

(including products referred to as premium cigars),” 81 Fed. Reg. 28,974,

products on a product or category basis would create regulatory loopholes,

FDA’s ability to create a comprehensive regulatory scheme.” Id. at

28,982-83. And it found that, for a variety of reasons, “exempting premium

public health.” Id. at 29,020.