Cigar Association of America v. FDA

United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued May 7, 2021 Decided July 20, 2021
No. 20-5266
CIGAR ASSOCIATION OF AMERICA, ET AL.,
APPELLANTS
v.
UNITED STATES FOOD AND DRUG ADMINISTRATION, ET AL.,
APPELLEES
Appeal from the United States District Court
for the District of Columbia
(No. 1:16-cv-01460)
Michael J. Edney argued the cause for appellants. With
him on the briefs were Shannen W. Coffin, Mark S. Raffman,
and Andrew Kim.
Lindsey Powell, Attorney, U.S. Department of Justice,
argued the cause for appellees. With her on the brief were
Brian M. Boynton, Acting Assistant Attorney General, Mark B.
Stern and Alisa B. Klein, Attorneys, and Annamarie Kempic,
Deputy Chief Counsel for Litigation Food and Drug Division,
Department of Health and Human Services.
2
Andrew N. Goldfarb and William B. Schultz were on the
brief for amici curiae Public Health Groups in support of
appellees.
Before: ROGERS, TATEL and WALKER, Circuit Judges.
Opinion for the Court by Circuit Judge ROGERS.
Concurring Opinion by Circuit Judge WALKER.
ROGERS, Circuit Judge: This is a continuing challenge by
three non-profit trade associations to the Food and Drug
Administration (“FDA”) rule deeming cigars and pipe tobacco,
among other tobacco products, to be subject to regulation under
the Tobacco Control Act. Last year, this court held that the
rule’s warning requirements for cigars and pipe tobacco
violated the Tobacco Control Act and the Administrative
Procedure Act. Cigar Ass’n of Am. v. FDA, 964 F.3d 56, 61–
64 (D.C. Cir. 2020). Now the trade associations challenge
other unrelated aspects of the rule as well as an accompanying
rule assessing user fees for manufacturers and importers of
cigars and pipe tobacco but not of other newly deemed products
like e-cigarettes. For the following reasons, we affirm the grant
of summary judgment to FDA.
I.
The Family Smoking Prevention and Tobacco Control
Act, Pub. L. No. 111-31, 123 Stat. 1776 (2009) (“Tobacco
Control Act”), amended the Federal Food, Drug, and Cosmetic
Act “to establish a comprehensive regulatory scheme for
tobacco products.” Cigar Ass’n of Am., 964 F.3d at 59. The
Tobacco Control Act defines “tobacco product” as “any
product made or derived from tobacco that is intended for
human consumption, including any component, part, or
3
accessory of a tobacco product.” 21 U.S.C. § 321(rr)(1). It
regulates “all cigarettes, cigarette tobacco, roll-your-own
tobacco, and smokeless tobacco,” as well as “any other tobacco
products” that FDA “by regulation deems to be subject to” the
Tobacco Control Act. Id. § 387a(b); Office of the
Commissioner Reorganization, 74 Fed. Reg. 41,713, 41,732
(Aug. 18, 2009).
In May 2016, FDA promulgated a rule deeming all
products that meet the Tobacco Control Act’s definition of
“tobacco product,” including any “component” and “part” but
excluding any “accessory” of those products, to be subject to
the Tobacco Control Act. Deeming Tobacco Products To Be
Subject to the Federal Food, Drug, and Cosmetic Act, as
Amended by the Family Smoking Prevention and Tobacco
Control Act; Restrictions on the Sale and Distribution of
Tobacco Products and Required Warning Statements for
Tobacco Products, 81 Fed. Reg. 28,974, 28,975 (May 10,
2016) (codified at 21 C.F.R. §§ 1100, 1140 & 1143) (“Deeming
Rule”). Noting that it was “using the terms ‘component’ and
‘part’ interchangeably and without emphasizing the distinction
between the terms,” FDA defined “component or part” to mean
“any software or assembly of materials intended or reasonably
expected: (1) To alter or affect the tobacco product’s
performance, composition, constituents or characteristics; or
(2) to be used with or for the human consumption of a tobacco
product.” Id. In the preamble, it stated that a pipe used to
consume pipe tobacco was such a “component or part.” Id. at
29,042.
“The Deeming Rule subjects newly regulated tobacco
products, including cigars and pipe tobacco, to requirements
akin to those previously imposed by statute on cigarettes,
cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco.” Cigar Ass’n of Am., 964 F.3d at 60. One such
4
requirement is premarket review by FDA before the
introduction into interstate commerce of any “new tobacco
product,” defined as a tobacco product that “was not
commercially marketed in the United States as of February 15,
2007” or that was modified after that date. 21 U.S.C.
§§ 387j(a)(1)–(2). This lookback date is called the
“grandfather date.” Under the Tobacco Control Act,
manufacturers may obtain premarket authorization by showing
that “the tobacco product is substantially equivalent . . . to a
tobacco product commercially marketed (other than for test
marketing) in the United States as of February 15, 2007, or to
a tobacco product that [FDA] has previously determined . . . is
substantially equivalent.” Id. § 387e(j)(1)(A)(i). To do so,
they must submit a “report to [FDA] (in such form and manner
as [FDA] shall prescribe).” Id. § 387e(j)(1).
To allow manufacturers time to prepare premarket review
applications, in the preamble to the Deeming Rule, FDA
adopted “staggered compliance periods” during which it would
defer enforcement of the Tobacco Control Act’s premarket
review requirements for newly deemed products that were
being marketed as of the Rule’s effective date. 81 Fed. Reg. at
29,010. Pertinently, it stated that it did not intend to enforce
the requirements for 18 months from the Rule’s effective date
while manufacturers submitted substantial equivalence reports
and for an additional 12 months while it reviewed those reports.
See id. at 29,011.
On the same day that it issued the Deeming Rule, FDA
promulgated a separate rule addressing the assessment of user
fees for manufacturers and importers of cigars and pipe
tobacco. See Requirements for the Submission of Data Needed
to Calculate User Fees for Domestic Manufacturers and
Importers of Cigars and Pipe Tobacco, 81 Fed. Reg. 28,707(May 10, 2016) (codified at 21 C.F.R. § 1150) (“User Fees
5
Rule”). In the preamble, FDA stated that it was precluded by
the Tobacco Control Act from assessing user fees for
manufacturers and importers of tobacco products, such as e-
cigarettes, beyond six enumerated classes of tobacco products.
See id. at 28,709–11.
Appellants, three non-profit trade associations
representing cigar and pipe tobacco manufacturers, importers,
distributors, suppliers, and consumers, filed a lawsuit
challenging the Deeming Rule and the User Fees Rule in the
district court in July 2016. FDA announced in July 2017 that
it intended to make regulatory changes that might affect certain
of appellants’ claims. See Cigar Ass’n of Am. v. FDA, 315 F.
Supp. 3d 143, 158 (D.D.C. 2018). Appellants have since
“sought resolution of their claims piecemeal.” Cigar Ass’n of
Am. v. FDA, 480 F. Supp. 3d 256, 265 (D.D.C. 2020). The
present appeal concerns only the district court’s grant of
summary judgment to FDA on five of appellants’
Administrative Procedure Act (“APA”) challenges to the
Deeming Rule concerning its implementation of the Tobacco
Control Act’s premarket review requirements, underlying cost-
benefit analysis, and classification of a pipe as a “component
or part” of a tobacco product subject to regulation under the
Tobacco Control Act, as well as appellants’ APA challenge to
the User Fees Rule. See Cigar Ass’n of Am. v. FDA, 480 F.
Supp. 3d at 266–77; Cigar Ass’n of Am., 315 F. Supp. 3d at
177–82, 185–88.
II.
The court must uphold agency action under the APA
unless it is “arbitrary, capricious, an abuse of discretion, or
otherwise not in accordance with law.” 5 U.S.C. § 706(2).
Further, the “court is not to substitute its judgment for that of
the agency, but instead to assess only whether the decision was
6
based on a consideration of the relevant factors and whether
there has been a clear error of judgment.” Dep’t of Homeland
Sec. v. Regents of the Univ. of California, 140 S. Ct. 1891, 1905
(2020) (internal citations and quotation marks omitted). When
the district court reviews agency action under the APA, the
court reviews the district court’s decision de novo. Cigar Ass’n
of Am., 964 F.3d at 61. Applying that standard, appellants’
APA challenges to the Deeming Rule and the User Fees Rule
in the instant case are unpersuasive.
A. The Deeming Rule
1. Appellants first challenge FDA’s failure to provide
instructions about the form and manner of substantial
equivalence reports specific to cigars and pipe tobacco. They
emphasize that the Tobacco Control Act provides that
manufacturers shall “at least 90 days prior to making such
introduction or delivery, report to the Secretary (in such form
and manner as the Secretary shall prescribe).” 21 U.S.C.
§ 387e(j)(1) (emphasis added).
The court need not decide whether § 387e(j)(1) required
FDA to supply product-specific instructions before the due date
for substantial equivalence reports. In the preamble to the
Deeming Rule, FDA stated that it did not intend to enforce the
Act’s premarket review requirements for 18 months from the
Rule’s effective date while manufacturers submitted
substantial equivalence reports. See 81 Fed. Reg. at 29,011.
Appellants acknowledge that FDA did not need to include any
form and manner instructions in the Deeming Rule itself and
could have provided such instructions after the Rule’s
promulgation. See Appellants Br. 18–19; Oral Arg. Rec. 2:02.
Therefore, even assuming FDA’s failure to provide such
instructions violated § 387e(j)(1), that failure is not an error
stemming from the Deeming Rule.
7
Furthermore, the court need not consider appellants’
contention that FDA acted arbitrarily and capriciously by
inadequately considering “whether instructions needed to be in
place before substantial equivalence reports were due,”
Appellants Br. 20–21, because appellants “forfeited” it by
failing to raise it before the district court, Cigar Ass’n of Am.,
480 F. Supp. 3d at 274; see District of Columbia v. Air Florida,
Inc., 750 F.2d 1077, 1084 (D.C. Cir. 1984).
2. Appellants next contend that the Deeming Rule is
arbitrary and capricious because FDA premised the Rule’s
effective date and due date for substantial equivalence reports
on the faulty assumption that it “could set an initial due date for
substantial equivalence reports and defer evaluation of the
instructions provided for those reports, as it could always adjust
the due date later.” Appellants Br. 28. They highlight that in
the preamble to the Deeming Rule, FDA repeatedly stated that
“[a]gency compliance/enforcement policies are not subject to
the requirements that govern notice-and-comment
rulemaking.” Id. at 27 (quoting 81 Fed. Reg. at 28,977,
29,010). Yet appellants note that, contrary to FDA’s
statements, the district court for the District of Maryland held
in litigation relating to the Deeming Rule that “any change in
the due date had to go through notice-and-comment
rulemaking” and that “FDA’s selection of an effective date
anchored whatever discretion FDA might have to set a later
due date for substantial equivalence reports.” Id. at 28–29
(citing Am. Academy of Pediatrics v. FDA, 379 F. Supp. 3d
461, 470, 492 (D. Md. 2019)).
This contention fails on its own terms. Even assuming
FDA misconceived the law, appellants fail to show that FDA
set the Rule’s effective date and due date for substantial
equivalence reports “based on” those misconceptions. Phillips
Petroleum Co. v. FERC, 792 F.2d 1165, 1171 (D.C. Cir. 1986).
8
They point to nothing in the Deeming Rule itself or the
rulemaking record showing that those misconceptions “drove
the FDA’s approach to addressing its obligations under
[§ 387e(j)(1)] and whether it had provided adequate
instructions for cigar and pipe tobacco substantial equivalence
reports.” Appellants Br. 28.
3. Also meritless is appellants’ contention that FDA
arbitrarily concluded that it lacked authority under the Tobacco
Control Act to alter the statutory grandfather date for cigars and
pipe tobacco. See id. at 31–40. None of the provisions
identified by appellants grant FDA authority to alter that date.
Section 387a(b), which authorizes FDA to “deem” tobacco
products to be subject to the Tobacco Control Act’s
requirements, does not give FDA authority to modify those
requirements. See Nicopure Labs, LLC v. FDA, 944 F.3d 267,
281 (D.C. Cir. 2019). Even assuming § 387f(a) is an
authorizing provision, it plainly does not authorize revisions to
§ 387j(a), which sets the grandfather date for substantial
equivalence reports. Likewise, § 387e(j)(3) is inapposite
because it authorizes FDA to exempt from premarket review
requirements only “tobacco products that are modified by
adding or deleting a tobacco additive, or increasing or
decreasing the quantity of an existing tobacco additive.” And
neither § 387f(d) nor § 387g(a)(3)(A) authorizes FDA to
design a regulatory scheme for cigars and pipe tobacco
excluding the substantial equivalence process and its
grandfather date. See Appellants Br. 37–38. Those provisions
authorize FDA to issue regulations about “restrictions on the
sale and distribution of a tobacco product” and “tobacco
product standards . . . appropriate for the protection of the
public health” respectively. 21 U.S.C. §§ 387f(d)(1),
387g(a)(3)(A). They do not grant FDA authority to eliminate
any of the Tobacco Control Act’s premarket review
requirements, including the grandfather date.
9
4. Further, there is no merit to appellants’ contention that
FDA’s cost-benefit analysis in its Final Regulatory Impact
Analysis was arbitrary or capricious. See FDA, Final
Regulatory Impact Analysis, Final Regulatory Flexibility
Analysis, Unfunded Mandates Reform Act Analysis, Docket
No. FDA-2014-N-0189 (May 10, 2016) (“Reg. Impact”).
Notwithstanding the absence of a statutory duty, “when an
agency decides to rely on a cost-benefit analysis as part of its
rulemaking,” that analysis may be reviewable under the APA.
Nat’l Ass’n of Home Builders v. EPA, 682 F.3d 1032, 1040
(D.C. Cir. 2012). Nevertheless, because the court reviews cost-
benefit analyses “deferentially,” appellants’ “burden to show
error is high.” Id. (internal citations omitted).
The court need not decide the non-jurisdictional issue of
whether FDA’s cost-benefit analysis was reviewable. See
Friends of Animals v. Bernhardt, 961 F.3d 1197, 1207 (D.C.
Cir. 2020). Assuming the analysis was reviewable, appellants
fail to meet their burden. Appellants’ principal contention is
that FDA failed to analyze the specific costs and benefits of
subjecting cigars and pipe tobacco to the Tobacco Control
Act’s premarket review requirements. See Appellants Br. 41–
42. According to appellants, in contrast to its detailed analysis
of the benefits of subjecting e-cigarettes to premarket review,
FDA “never even tried to describe in any detail, much less put
a number on, the benefits of premarket review for cigars and
pipe tobacco.” Id. at 42. But appellants cite no authority for
the proposition that FDA needed to consider the benefits of
premarket review specifically for each industry or product
affected by the Deeming Rule. Nor, contrary to appellants’
suggestion, does the purpose of the Deeming Rule compel that
FDA’s cost-benefit analysis take a particular form. See id.
Further, although appellants do not dispute that FDA separately
quantified the costs of subjecting cigars and pipe tobacco to
10
substantial equivalence review, see, e.g., Reg. Impact at 95–96,
they complain in passing about “FDA’s arbitrary treatment of
the costs of the [premarket review] process,” Appellants Br.
43. Their conclusory objections to FDA’s approach to
calculating costs do not overcome our deferential review of
such agency calculations. See Nat’l Ass’n of Home Builders,
682 F.3d at 1040.
5. Challenging a different aspect of the Deeming Rule,
appellants object to FDA’s classification of a pipe as a
“component or part” of a tobacco product subject to the
Tobacco Control Act, rather than an “accessory” not subject to
the Act. To determine whether FDA’s interpretation accords
with the Tobacco Control Act, the court applies the familiar
Chevron two-step framework. See Genus Med. Techs. LLC v.
FDA, 994 F.3d 631, 636 (D.C. Cir. 2021). At Chevron step
one, “employing traditional tools of statutory construction,” the
court considers “whether Congress has directly spoken to the
precise question at issue.” Chevron, U.S.A., Inc. v. NRDC, Inc.,
467 U.S. 837, 842, 843 n.9 (1984). “If the intent of Congress
is clear, that is the end of the matter; for the court, as well as
the agency, must give effect to the unambiguously expressed
intent of Congress.” Id. at 842–43. If the statute is ambiguous,
then, at Chevron step two, “the question for the court is whether
the agency’s answer is based on a permissible construction of
the statute.” Id. at 843.
Therefore, the court “begin[s] with the language employed
by Congress and the assumption that the ordinary meaning of
that language accurately expresses the legislative purpose.”
Engine Mfrs. Ass’n v. S. Coast Air Quality Mgmt. Dist., 541
U.S. 246, 252 (2004) (internal citation omitted). The Tobacco
Control Act defines “tobacco product” as “any product made
or derived from tobacco that is intended for human
consumption, including any component, part, or accessory of a
11
tobacco product.” 21 U.S.C. § 321(rr)(1). Appellants do not
dispute that by leaving the term “component, part, or
accessory” undefined, Congress “explicitly left a gap for the
agency to fill.” Chevron, 467 U.S. at 843. Instead, they
maintain that the Deeming Rule’s definition of the term
“component or part” contradicts § 321(rr)(1)’s definition of the
term “tobacco product.”
In appellants’ view, a “‘component’ must be ‘of a tobacco
product’ in the sense of being integrated into such a product.”
Appellants Br. 45. Because a pipe “exist[s] separate from the
tobacco product being consumed” and is not “integrated into a
single product,” appellants maintain that a pipe cannot be a
“component.” Id. The Tobacco Control Act’s text does not,
however, unambiguously support appellants’ interpretation.
Neither § 321(rr)(1)’s phrase “of a tobacco product” nor
dictionary definitions of “component” compel appellants’
interpretation that a “component” must be integrated into a
tobacco product. See Appellants Br. 44–45. Nor, as
appellants’ suggest, does § 321(rr)(1) “command that all
tobacco products, including components, be ‘made or derived
from tobacco.’” Id. at 45 (quoting 21 U.S.C. § 321(rr)(1)). To
interpret § 321(rr)(1) as imposing such a limitation would
render superfluous the phrase “including any component, part,
or accessory of a tobacco product.” See Marx v. Gen. Revenue
Corp., 568 U.S. 371, 386 (2013). That the Tobacco Control
Act elsewhere uses the term “component parts” to include the
“filter” or “paper” of a cigarette further indicates that a
“component or part” need not itself be made or derived from
tobacco. 21 U.S.C. § 387g(a)(1)(A). Because the Tobacco
Control Act does not unambiguously foreclose FDA’s
interpretation of the term “component or part,” the court
proceeds to Chevron step two. See Catawba Cty. v. EPA, 571
F.3d 20, 35 (D.C. Cir. 2009).
12
At Chevron step two, the court defers to the agency’s
permissible interpretation “only if the agency has offered a
reasoned explanation for why it chose that interpretation.” Vill.
of Barrington, Ill. v. Surface Transp. Bd., 636 F.3d 650, 660
(D.C. Cir. 2011). “The analysis of disputed agency action
under Chevron Step Two and arbitrary and capricious review
is often ‘the same, because under Chevron step two, [the court
asks] whether an agency interpretation is arbitrary or capricious
in substance.’” Agape Church, Inc. v. FCC, 738 F.3d 397, 410
(D.C. Cir. 2013) (quoting Judulang v. Holder, 565 U.S. 42, 52
n.7 (2011)).
Appellants do not contest that a pipe meets the Deeming
Rule’s definition of “component or part.” Nor do they offer
any additional arguments at Chevron step two as to why that
definition is impermissible under the Tobacco Control Act or
lacks a reasonable explanation by FDA. Rather, appellants
contend that FDA arbitrarily and capriciously failed to explain
how “pipes themselves have any direct effect on public health”
and how “a mere container would meaningfully affect any
health consequences associated with the tobacco placed in it.”
Appellants Br. 46. This contention is unavailing. The
Deeming Rule’s definition of “component or part” does not
require FDA to identify a product’s health effects in order to
classify it as a “component or part,” see 81 Fed. Reg. at 28,975,
and appellants cite no authority for imposing that requirement.
Therefore, FDA’s classification of a pipe as a “component or
part” is not arbitrary or capricious and survives Chevron step
two.
B. The User Fees Rule
Appellants contend that FDA arbitrarily assessed user fees
for manufacturers and importers of cigars and pipe tobacco but
not of other newly deemed tobacco products like e-cigarettes.
13
See Appellants Br. 47–53. They maintain that FDA incorrectly
concluded that the Tobacco Control Act precluded it from
imposing user fees on e-cigarettes. See id. at 47. As before,
the court reviews FDA’s interpretation under the Chevron two-
step framework. See Chevron, 467 U.S. at 842–43.
Here, the Tobacco Control Act provides that FDA “shall
in accordance with this section assess user fees on, and collect
such fees from, each manufacturer and importer of tobacco
products subject to this subchapter.” 21 U.S.C. § 387s(a)
(emphasis added). It sets the “total amount of user fees
authorized to be assessed and collected” for each fiscal year.
Id. § 387s(b)(1). It then provides a two-stage process by which
FDA is to determine the assessment of user fees. At the first
stage, the total user fees to be assessed with respect to each
class of tobacco products is the total amount of user fees for
that fiscal year multiplied by the “applicable percentage” for
each class for the fiscal year. Id. § 387s(b)(2)(A). The
“applicable percentage” for six enumerated classes of tobacco
products — cigarettes, cigars, snuff, chewing tobacco, pipe
tobacco, and roll-your-own tobacco — is the percentage set
pursuant to 7 U.S.C. § 518d(c) of the Fair and Equitable
Tobacco Reform Act (“FETRA”). Id. §§ 387s(b)(2)(B)(i)–(ii).
FETRA lists initial percentages for each of the six enumerated
classes of tobacco products, totaling 100 percent, and describes
how percentages for those six classes should be adjusted for
subsequent fiscal years to reflect changes in shares of gross
domestic volume. 7 U.S.C. §§ 518d(c)(1)–(2). At the second
stage, the “percentage share” of each manufacturer and
importer within a particular class of tobacco products is the
percentage set in §§ 518d(e)–(h) of FETRA. 21 U.S.C.
§§ 387s(b)(3)–(4).
Notwithstanding Congress’ detailed user fee scheme,
appellants maintain that nothing in the Tobacco Control Act’s
14
text precludes the assessment of user fees on non-enumerated
classes of tobacco products, like e-cigarettes. See Appellants
Br. 48. In their view, by addressing the assessment of user fees
for only six enumerated classes of tobacco products, Congress
left a gap for FDA to determine how to assess user fees for non-
enumerated classes of tobacco products. See id. at 49–50. Yet
by mandating that FDA look to FETRA to determine the
“applicable percentage” of user fees for the six enumerated
classes of tobacco products and the “percentage share” of each
manufacturer and importer within those classes, Congress has
limited the assessment of user fees to manufacturers and
importers of the six enumerated classes of tobacco products.
Thus, “Congress has directly spoken to the precise question” of
against which classes of tobacco products FDA can assess user
fees. Chevron, 467 U.S. at 842. Appellants offer no
satisfactory explanation as to how FDA could, consistent with
the Tobacco Control Act and the cross-referenced FETRA
provisions, define an applicable percentage for a non-
enumerated class of tobacco products when Congress has
allocated 100 percent of the total user fees to six enumerated
classes of tobacco products. Adding an applicable percentage
for a non-enumerated class would increase the total to over 100
percent and require FDA to assess user fees beyond the total
amount for the fiscal year set in § 387s(b)(1). See 81 Fed. Reg.
at 28,709. Even assuming FDA could define an applicable
percentage for a non-enumerated class of tobacco products,
appellants do not dispute that the information needed for
calculating the “percentage share” of each manufacturer and
importer under FETRA is unavailable for non-enumerated
classes of tobacco products like e-cigarettes. See id. at 28,710–
12.
To the extent appellants contend that the Tobacco Control
Act’s text is ambiguous because it directs FDA to assess user
fees on “each manufacturer and importer of tobacco products
15
subject to this subchapter,” including e-cigarettes, they appear
to ignore the statutory limitation imposed by Congress.
Appellants Br. 48 (quoting 21 U.S.C. § 387s(a) and adding
emphasis). Section 387s(a) provides that FDA’s user-fees
assessment authority on “each manufacturer and importer of
tobacco products subject to this subchapter” “shall [be] in
accordance with this section.” (emphasis added). As
described, “this section” limits the assessment of fees to six
enumerated classes. In view of the limiting phrase “in
accordance with this section,” § 387s(a) introduces no
ambiguity at Chevron step one.
Nor does appellants’ invocation of the structure and
purpose of the statutory scheme. User fees “are the only funds
authorized to be made available for tobacco regulation
activities.” 21 U.S.C. § 387s(c)(2)(B)(i). Appellants assert that
as the market for e-cigarettes grows, “e-cigarettes threaten to
swamp the agency’s tobacco regulation budget and to compel
the manufacturers of six classes of tobacco products to spend
hundreds of millions to regulate an entirely different product.”
Appellants Br. 51. But appellants proffer no evidence in
support of their bald assertion, much less a basis for connecting
the increased e-cigarette use among high school students and
the anticipated number of e-cigarette premarket review
applications to FDA. See id. (citing 81 Fed. Reg. at 28,984 and
Reg. Impact at 84). Even when ambiguity may be found by
reference to the “broader context of the statute as a whole,”
United States v. Wilson, 290 F.3d 347, 353 (D.C. Cir. 2002)
(internal citation omitted), “there must be evidence that
Congress meant something other than what it literally said
before a court can depart from plain meaning,” Eagle Pharms.,
Inc. v. Azar, 952 F.3d 323, 332–33 (D.C. Cir. 2020) (quoting
Engine Mfrs. Ass’n v. EPA, 88 F.3d 1075, 1088 (D.C. Cir.
1996)). Appellants cannot dispute that Congress chose to rely
on FETRA’s methodology to determine the assessment of user
16
fees under the Tobacco Control Act and that FETRA’s
methodology cannot be used for non-enumerated classes of
tobacco products like e-cigarettes. Their invocation of the
general purpose of user fees is unsupported by evidence that
would allow FDA to depart from Congress’ specific scheme
for determining the assessment of user fees.
Even if the Tobacco Control Act were ambiguous about
whether FDA may impose user fees on non-enumerated classes
of tobacco products, FDA reasonably explained, in the
alternative, that it “would adopt the same interpretation of the
statute in an exercise of its discretion.” 81 Fed. Reg. at 28,711.
Agencies may “employ bright-line rules for reasons of
administrative convenience, so long as those rules . . . are
reasonably explained.” Emily’s List v. FEC, 581 F.3d 1, 22
n.20 (D.C. Cir. 2009). Here, FDA explained why imposing
user fees on non-enumerated classes of tobacco products would
require “fashion[ing] an entirely novel framework for
determining class percentage allocations and allocations within
each class of tobacco product.” 81 Fed. Reg. at 28,712. This
explanation survives our “highly deferential” review at
Chevron step two. Vill. of Barrington, Ill., 636 F.3d at 667.
Accordingly, we affirm the grant of summary judgment to
FDA on appellants’ current challenges to the Deeming Rule
and the User Fees Rule.
WALKER, Circuit Judge, concurring: I agree with the
Court that the Food and Drug Administration had the statutory
authority to classify a smoking pipe as a “component” or “part”
of a tobacco product. 21 U.S.C. § 321(rr)(1). Without a pipe,
pipe tobacco cannot be smoked in the manner its ordinary
purchaser expects when he buys it. In addition, nothing in the
text requires a component or part to be, as the Plaintiffs argue,
fully “integrated into a single product.” Appellants’ Br. 45.
Finally, although a pipe is not made from tobacco, neither are
a cigarette’s filter and paper, which are “component parts” of a
tobacco product under the express terms of the Tobacco
Control Act. 21 U.S.C. § 387g(a)(1)(A). Because in my view
“the intent of Congress is clear,” I would not proceed on that
question past Chevron step one. Chevron, U.S.A., Inc. v.
Natural Resources Defense Council, Inc., 467 U.S. 837, 842-
43 (1984) (“If the intent of Congress is clear, that is the end of
the matter; for the court, as well as the agency, must give effect
to the unambiguously expressed intent of Congress.”); cf.
Natural Resources Defense Council v. EPA, 489 F.3d 1364,
1373 (D.C. Cir. 2007) (“the absence of a statutory definition
does not render a word ambiguous”). Except as to that point, I
join the Court’s opinion in full.