Prohibition Juice Co. v. FDA ( 2022 )

United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued April 21, 2022 Decided July 26, 2022
No. 21-1201
PROHIBITION JUICE CO.,
PETITIONER
v.
UNITED STATES FOOD AND DRUG ADMINISTRATION,
RESPONDENT
Consolidated with 21-1203, 21-1205, 21-1207
On Petitions for Review of an Order
of the Food & Drug Administration
Jerad Wayne Najvar argued the cause and filed the briefs
for petitioners.
J. Gregory Troutman was on the brief for amici curiae 36
National and State Electronic Nicotine Delivery System
Product Advocacy Associations in support of petitioners.
Scott P. Kennedy, Trial Attorney, U.S. Department of
Justice, argued the cause for respondent. With him on the brief
were Brian M. Boynton, Principal Deputy Assistant Attorney
2
General, and Hilary K. Perkins, Assistant Director. Courtney
Dixon, Kathleen Gilchrist, Alisa B. Klein, Joshua M. Koppel,
and Lindsey Powell, Attorneys, entered appearances.
William B. Schultz and Andrew N. Goldfarb were on the
brief for amici curiae Medical and Public Health Groups in
support of respondent.
Before: HENDERSON, PILLARD, and KATSAS, Circuit
Judges.
Opinion for the Court filed by Circuit Judge PILLARD.
Concurring opinion filed by Circuit Judge KATSAS.
PILLARD, Circuit Judge: More than 3.6 million young
people in the United States reported using e-cigarettes in 2020,
including nearly one in five high school students. That makes
e-cigarettes “the most widely used tobacco product among
youth by far.” FDA, Technical Project Lead (TPL) Review of
PMTAs (2021) (FDA Technical Review), at 6. The public
health consequences are dire: Tobacco is quickly and
powerfully addicting, and e-cigarettes can permanently
damage developing adolescent brains, cause chronic lung
diseases, and hook young users for life. Given the scale and
severity of the problem, by 2018 the Surgeon General had
already decried an “epidemic” of youth e-cigarette use. 1 And
1
Surgeon General of the United States Public Health Service,
Surgeon General’s Advisory on E-cigarette Use Among Youth (Dec.
2018), https://www.cdc.gov/tobacco/basic_information/e-cigarettes/
surgeon-general-advisory/pdfs/surgeon-generals-advisory-on-e-
cigarette-use-among-youth-2018-h.pdf [https://perma.cc/3FPK-
7MRL]; see also Scott Gottlieb, Statement from FDA Commissioner
Scott Gottlieb, M.D., on New Steps to Address Epidemic of Youth E-
3
the FDA declared in 2021 that “preventing tobacco use
initiation in young people is a central priority for protecting
population health.” FDA Technical Review at 6.
Flavored tobacco products lie at the heart of the problem.
A vast body of scientific evidence shows that flavors encourage
youth to try e-cigarettes and, together with the nicotine, keep
them coming back. With names like Brain Freeze Caramel
Cone, Crazy Bubble Grape, and Green Apple Gummy Guts,
flavors play a “fundamental role” in driving youth interest in e-
cigarette use. FDA Technical Review at 8. The FDA has
concluded that the availability of flavored products “is one of
the primary reasons for the popularity of [e-cigarettes] among
youth.” Id. at 6.
Congress has called on the FDA to regulate e-cigarette
products pursuant to the Family Smoking Prevention and
Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776(2009) (Tobacco Control Act or Act). Under the Act,
manufacturers must apply for FDA authorization to sell new
tobacco products, which the FDA grants only if it determines
that doing so would be “appropriate for the protection of the
public health.” 21 U.S.C. § 387j(c)(2)(A). The agency makes
that determination by weighing, on a population-wide basis,
any benefits of such products against their harms. Id.
§ 387j(c)(4).
Prohibition Juice makes flavored liquids containing
nicotine derived from tobacco, which it sells for use in e-
cigarettes, or Electronic Nicotine Delivery Systems (ENDS).
cigarette Use (Sept. 11, 2018), https://www.fda.gov/news-
events/press-announcements/statement-fda-commissioner-scott-
gottlieb-md-new-steps-address-epidemic-youth-e-cigarette-use
[https://perma.cc/RL2A-4Y8F].
4
Along with the three other e-liquid manufacturer petitioners,
Prohibition applied in September 2020 for FDA authorization
to market several flavors in a range of sizes. The FDA denied
those applications a year later. 2 In view of flavored tobacco
products’ serious, well-documented, and lasting risks to youth,
the FDA requires applicants to present reliable evidence of
robust public health benefits exceeding known risks. The
manufacturers describe their products as a beneficial
alternative to combustible cigarettes that offer comparative
health benefits to existing smokers. Finding the manufacturers
had presented insufficient evidence that their flavored products
are more effective than unflavored products in helping adult
cigarette smokers decrease or quit harmful tobacco uses, the
FDA denied the applications.
The manufacturers petition for review of those denials.
They first argue that the FDA lacked statutory authority to
require that parties establish that their flavored liquids carry
greater public health benefits than unflavored liquids. They
also challenge the application denials as arbitrary and
capricious, asserting that the FDA (1) departed from an earlier
guidance document, changing both the types of evidence the
agency would accept and the substantive showing it expected
parties to make; (2) underscored the potential importance of
marketing plans including measures to limit youth access to
their products but then failed to consider the plans petitioners
submitted; and (3) overlooked various other aspects of the
problem.
2
The FDA applied a common Technical Project Lead memorandum
to the four manufacturers’ applications, and the record includes four
copies, as sent to each of four petitioners. See J.A. 34-53, 819-38,
1016-34, 1223-42.
5
We deny the petitions for review. The FDA plainly had
statutory authority under the Tobacco Control Act to regulate
as it did. As to the arbitrary and capricious challenges, we hold
that the FDA did not change the evidentiary or substantive
standard from its 2019 Guidance. We also hold that any error
in the FDA’s failure to consider the marketing plans was
harmless because the manufacturers failed to identify how
individualized review of the plans they submitted could have
made any difference. Finally, the FDA did not otherwise fail
to consider important aspects of the problem. We accordingly
deny the petitions for review.
I. BACKGROUND
A. Statutory Background
In 2009, Congress enacted the Tobacco Control Act to
regulate the sale of tobacco products. Pub. L. No. 111-31, 123
Stat. 1776. Congress concluded that the “use of tobacco
products by the Nation’s children is a pediatric disease of
considerable proportions that results in new generations of
tobacco-dependent children and adults.” Id. § 2, 123 Stat. at
1777. We canvassed the history of the Tobacco Control Act in
Nicopure Labs, LLC v. FDA, 944 F.3d 267 (D.C. Cir. 2019),
where we recounted that Congress acted based on extensive
evidence that tobacco is widely used, highly addictive, and
destructive of human health. See id. at 270-79. The enacting
Congress knew that kids are key: The FDA had already shown
that the vast majority of adults who smoke have their first
cigarette before the age of 18, and that “[v]irtually all new users
of tobacco products are under the minimum legal age to
purchase such products.” Id. at 272 (quoting the Tobacco
Control Act, Pub. L. No. 111-31, §§ 2(3), (4), 123 Stat. at 1777
(alteration in original)). Businesses seeking to make a profit
selling tobacco products know that, too, and face powerful
6
economic incentives to reach younger customers. A core
objective of the Tobacco Control Act is to “ensure” tobacco
products will not be “sold or accessible to underage
purchasers.” Pub. L. No. 111-31, § 3(7), 123 Stat. at 1782.
Under the Act, a “new tobacco product” may not be
marketed in interstate commerce unless the manufacturer
obtains premarket authorization from the FDA. 21 U.S.C.
§ 387j(a)(1)-(2). The FDA in turn “shall deny” an application
to market a new tobacco product unless the agency finds “that
permitting such tobacco product to be marketed would be
appropriate for the protection of the public health.” Id.
§ 387j(c)(2). The statute explains how the FDA is to determine
whether approving a product is, on balance, appropriate for the
protection of public health:
For purposes of this section, the finding as to whether
the marketing of a tobacco product for which an
application has been submitted is appropriate for the
protection of the public health shall be determined
with respect to the risks and benefits to the
population as a whole, including users and nonusers
of the tobacco product, and taking into account—
(A) the increased or decreased likelihood that
existing users of tobacco products will stop
using such products; and
(B) the increased or decreased likelihood that those
who do not use tobacco products will start
using such products.
Id. § 387j(c)(4)(A)-(B).
7
That statutory directive reflects the fact that tobacco is
highly addictive and generally harmful to human health. Proof
that a new tobacco product has public health benefit thus
depends on favorable substitution effects, such as evidence that
the new product is less harmful to existing users than current
products, and that it either draws existing users away from the
more harmful tobacco products or helps them to quit altogether.
Any such benefit must be shown to offset the product’s public
health harms to new users, including youth.
The statute also directs manufacturers to include in their
applications “full reports of all information . . . concerning
investigations which have been made to show the health risks
of such tobacco product and whether such tobacco product
presents less risk than other tobacco products.” Id.
§ 387j(b)(1)(A). The Act grandfathered tobacco products on
the market as of February 15, 2007, excusing them from the
premarket authorization requirement. Id. § 387j(a)(1). But no
product brought to market after that date may lawfully be sold
unless and until it receives FDA premarket authorization.
B. Regulatory Background
Electronic cigarettes subject to the Tobacco Control Act
deliver nicotine to their users by vaporizing a liquid derived
from tobacco. See Nicopure Labs, 944 F.3d at 270, 272. These
devices are either disposable (closed) or refillable (open).
Open systems are refilled either by inserting a pod or cartridge
containing the liquid into the device or by manually pouring in
the liquid. For current purposes, the liquids inside those
devices are treated as either non-flavored, meaning they taste
like tobacco, or as flavored because they carry a distinctive,
often sweet, flavoring. Flavored liquids are the subject of this
challenge. The FDA is separately addressing applications for
menthol-flavored devices, see FDA Technical Review at 3 n.ii,
8
and is re-evaluating whether it mistakenly included some
tobacco- and menthol-flavored products in the denial order
challenged here, see FDA Br. 16 n.6. (This opinion does not
address those products.)
A hallmark of flavored liquids is their disproportionate
appeal to children. The FDA cited clear scientific consensus
that such products hold “extraordinary popularity” among
youth. FDA, Enforcement Priorities for Electronic Nicotine
Delivery Systems (ENDS) and Other Deemed Products on the
Market Without Premarket Authorization (Revised) (2020)
(2020 Guidance). One study found that 93.2% of youth e-
cigarette users and 83.7% of young adult users (ages 18-24)
reported their first e-cigarette was flavored, and 84.7% of high
school e-cigarette users reported using a flavored product in
2020. FDA Technical Review at 6. The agency also surveyed
compelling evidence that youth are more likely than adults to
use flavored products. Id. It accordingly concluded that, for
flavored products, “the risk of youth initiation and use is
substantial.” Id. at 10.
In view of flavored tobacco products’ appeal to young
people, it is especially challenging for marketers to make a case
that those products are appropriate for the protection of public
health. Applicants seeking to market e-cigarettes have
generally sought to show that their products cause users of
existing, less safe tobacco products to transition to safer use
patterns without enticing new users, especially children. That
is, again, because the FDA may approve a new product only if
the applicant succeeds in showing that its benefits to the
population as a whole outweigh its risks.
In 2016, the FDA promulgated a “deeming rule”
designating e-cigarettes and their component e-liquids as “new
9
tobacco products” under the Act. 3 That means Prohibition
Juice and other e-liquid manufacturers may not lawfully market
their products without FDA approval. We rejected a challenge
to that deeming rule in Nicopure Labs, sustaining both the
Tobacco Control Act and its application to e-cigarettes. 944
F.3d at 272.
As a matter of enforcement discretion, however, the FDA
announced it would not enforce the Act against new (post-
2007) products for staggered two-to-three-year periods. See
Deeming Rule, 81 Fed. Reg. at 28,977-78. Following a further
FDA extension in 2017 of up to six years, a suit by the
American Academy of Pediatrics garnered a court-ordered
deadline, which in turn was adjusted due to the COVID-19
pandemic. See Am. Acad. of Pediatrics v. FDA, 399 F. Supp.
3d 479, 487 (D. Md. 2019), appeal dismissed sub nom. In re
Cigar Ass’n of Am., 812 F. App’x 128 (4th Cir. 2020). The
deadline for manufacturers to submit their marketing
applications ultimately settled on September 9, 2020. See
Breeze Smoke, LLC v. FDA, 18 F.4th 499, 504 (6th Cir. 2021).
Meanwhile, a wave of new e-cigarette products flooded the
market without scientific review or premarket authorization,
causing e-cigarette use to hit the highest levels ever seen. See
2020 Guidance at 6-9.
Central to the manufacturers’ claims is a nonbinding
guidance document the FDA issued in 2019 to help
manufacturers prepare applications ahead of the deadline.
FDA, Premarket Tobacco Product Applications for Electronic
3
See 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 (Deeming Rule), 81 Fed. Reg. 28,974 (May
10, 2016).
10
Nicotine Delivery Systems: Guidance for Industry (June 2019)
(2019 Guidance). Prohibition Juice highlights two pieces of
that guidance. First, it points to the FDA’s discussion of the
types of evidence that applicants should consider submitting.
2019 Guidance at 12-13. In relevant part, the agency wrote:
Given the relatively new entrance of [e-cigarettes] on
the U.S. market, FDA understands that limited data
may exist from scientific studies and analyses. If an
application includes, for example, information on
other products (e.g., published literature, marketing
information) with appropriate bridging studies, FDA
intends to review that information to determine
whether it is valid scientific evidence sufficient to
demonstrate that the marketing of a product would
be [appropriate for the protection of public health].
Nonclinical studies alone are generally not sufficient
to support a determination that permitting the
marketing of a tobacco product would be appropriate
for the protection of the public health. Nonetheless,
in general, FDA does not expect that applicants will
need to conduct long-term studies to support an
application.
2019 Guidance at 12-13 (footnote omitted).
Second, the manufacturers focus on how the agency
recommended that applicants compare their products to other
tobacco products to help identify and account for their own
product’s relative health risks. In a section titled “Comparison
Products,” the agency wrote:
As part of FDA’s consideration under 910(c)(4) of
the FD&C Act of the risks and benefits of the
marketing of the new tobacco product to the
11
population as a whole, including users and nonusers
of tobacco products, FDA reviews the health risks
associated with changes in tobacco product use
behavior (e.g., initiation, switching, dual use,
cessation) that are likely to occur with the marketing
of the new tobacco product. We recommend an
applicant compare the health risks of its product to
both products within the same category and
subcategory, as well as products in different
categories as appropriate. . . . This comparative
health risk data is an important part of the evaluation
of the health effects of product switching. . . . For
example, for [an application] for an e-liquid, FDA
recommends the product’s health risks be compared
to those health risks presented by other e-liquids used
in a similar manner.
2019 Guidance at 13-14.
The FDA followed up with a 2020 guidance document
setting out the agency’s enforcement priorities. FDA,
Enforcement Priorities for Electronic Nicotine Delivery
Systems (ENDS) and Other Deemed Products on the Market
Without Premarket Authorization (Revised) (2020) (2020
Guidance). The FDA issued that guidance after industry
manufacturers, at FDA’s urging, had identified a variety of
measures, including age verification, they said they would use
to try to restrict minors’ access to their products. See 2020
Guidance at 7. The 2020 Guidance emphasized that,
notwithstanding such measures, youth e-cigarette use “has hit
the highest levels ever recorded.” Id. at 8. With the rising wave
of youth vaping, the “extraordinary popularity” of flavored
products driving that rise, and industry’s measures proving
insufficient to stem it, the FDA announced that flavored
products would be an enforcement priority. Id. at 13, 18-21.
12
As a result, by the September 9, 2020, deadline for
submitting applications, the FDA had publicly highlighted the
particular dangers of flavored products and noted the types of
rigorous scientific evidence it would accept in support of
applications to market such products. The FDA received
applications from more than five hundred companies, many
submitted shortly in advance of that deadline, including those
of the four petitioners here. Enforcement was suspended for an
additional year following the deadline to allow the FDA time
to review and act on the applications. See Deeming Rule, 81
Fed. Reg. at 28,9778.
C. Procedural History
Prohibition Juice, ECig Charleston L.L.C., Cool Breeze
L.L.C., and Jay Shore Liquids L.L.C. manufacture flavored e-
liquid products. In September 2020, the manufacturers applied
for approval to market a large set of variously flavored e-liquid
products. A small sampling of the flavors the manufacturers
seek to sell includes Prohibition Juice’s Boozehound, Sweet
Thang, White Lightning, and Black Market (J.A. 3-24); Cool
Breeze’s Awesome Sauce (Peach, Raspberry, Strawberry),
Brain Freeze Caramel Cone, Buncha Crunch (Crunch Fruit
Cereal), Crazy Bubble Grape, Giggle Juice, Jolly Apple, and
Sugar Rush Peach Ring Candy (J.A. 472-807); ECig’s
Cinnamon Pear, Banana Strawberry, Cloud Chaser, and
Fireball Cinnamon (J.A. 986-1006); and Jay Shore’s Blueberry
Dream Cake, Green Apple Gummy Guts, Pink-Burst, and
Rootbeer Float (J.A. 1197-213).
Each manufacturer submitted a marketing plan as part of
its application. See J.A. 268-76 (Prohibition); J.A. 861-64
(Cool Breeze); J.A. 1036-41 (ECig); J.A. 1264-77 (Jay Shore).
The marketing plans described measures each manufacturer
13
was taking to limit youth access to their products. See Pet’rs
Br. at 39. As examples, the manufacturers highlighted their use
of age-verification “gating” on their websites (accepting any
qualifying birthdate) and “dull, less vibrant colors” without
“mascots and similar characters” on their labeling to avoid
appealing to youth. Id. (internal quotation omitted). Other e-
cigarette companies are developing novel technologies, such as
requiring age verification assisted by facial recognition
software to unlock their products, which they assert could
prevent underage use. The FDA noted those developments and
explained that it communicates with tobacco companies to
keep abreast of measures that might better control youth access
to their products. See Oral Argument Tr. at 31-32. Petitioners
acknowledge that their marketing plans proposed no such novel
controls. See Oral Argument Tr. at 12.
In September 2021, the FDA denied petitioners’
applications. It did so based on a common memorandum it
issued to all four manufacturers setting out the analytic
framework under which the agency assessed their applications.
It also issued each manufacturer a separate denial letter and
review memorandum.
The FDA’s common memorandum began by surveying the
well-known risks of flavored electronic nicotine delivery
systems to youth. FDA Technical Review at 4-9. It noted the
data showing dramatic and accelerating rates of youth use of e-
cigarette products, notwithstanding the decrease in cigarette
smoking by youth. Id. at 4-7. The memorandum also
referenced evidence that flavors drive youth uptake, intensity
of use, and addiction, and that flavored products appeal more
to youth than they do to adults. Id. The FDA surveyed the
substantial damage nicotine causes to the adolescent brain. Id.
at 8-9. It emphasized that the youth preference for flavor
remained “consistent” across different types of devices. Id. at
14
7. While there may be “variability” in the popularity of
different device types among youth, young people consistently
use whichever products will allow them to enjoy flavors that
appeal to them—evidence the FDA described as “underscoring
the fundamental role of flavor in driving appeal.” Id. at 7-8.
Based on this evidence, the FDA concluded that flavored e-
liquids “pose a significant risk to youth.” Id. at 9.
The FDA then considered how best to weigh that known
risk against potential benefits to adult smokers. It concluded
that “any risks posed by a new product to youth would need to
be overcome by a sufficient benefit to adult users, and as the
known risks increase, so too does the burden of demonstrating
a substantial enough benefit.” FDA Technical Review at 10.
And because flavored products carry a “substantial” risk of
youth initiation, the FDA determined that such products would
be approved only if a manufacturer could show “that the
significant risk to youth could be overcome by likely benefits
substantial enough such that the net impact to public health
would be positive.” Id. In sum, the FDA required that
manufacturers produce evidence that is scientifically rigorous;
compares flavored liquids to non-flavored liquids; and
establishes that flavored products have substantial benefits
over non-flavored ones to fully overcome flavored products’
known risks.
In separate denial orders to each manufacturer, the FDA
explained how each had failed to make that showing. The FDA
concluded that the manufacturers had not submitted rigorous
evidence demonstrating benefits of their flavored products as
compared to unflavored products—be that evidence from
randomized controlled trials, longitudinal studies, or some
other form of analysis. Without reliable, probative evidence of
benefits outweighing the products’ known risks, the FDA
denied the applications.
15
The FDA also declined to review the manufacturers’
marketing plans, stating its rationale in a footnote:
Limiting youth access and exposure to marketing is
a critical aspect of product regulation. It is
theoretically possible that significant mitigation
efforts could adequately reduce youth access and
appeal such that the risk for youth initiation would be
reduced. However, to date, none of the [applications]
that FDA has evaluated have proposed advertising
and promotion restrictions that would decrease
appeal to youth to a degree significant enough to
address and counter-balance the substantial
concerns, and supporting evidence, discussed above
regarding youth use. Similarly, we are not aware of
access restrictions that, to date, have been successful
in sufficiently decreasing the ability of youth to
obtain and use [e-cigarettes]. Accordingly, for the
sake of efficiency, the evaluation of the marketing
plans in applications will not occur at this stage of
review, and we have not evaluated any marketing
plans submitted with these applications.
FDA Technical Review at 11 n.xix.
The manufacturers timely petitioned this court for review,
and we consolidated the cases.
D. Decisions in Parallel Cases
Under the Tobacco Control Act’s judicial review
provision, a party subject to a marketing denial order may
petition for review either in this court or in the circuit in which
its principal place of business is located. See 21 U.S.C.
16
§ 387l(a)(1)(B). Other manufacturers have sought review in
other circuits of orders denying approval to market flavored
ENDS, with some courts denying and others granting stays of
enforcement pending review. See Breeze Smoke, LLC v. FDA,
18 F.4th 499 (6th Cir. 2021) (opinion denying stay), cert.
denied, 142 S. Ct. 638 (2021) (mem.); My Vape Order v. FDA,
No. 21-71302, ECF No. 18 (9th Cir. 2021) (order denying stay
of enforcement); Gripum LLC v. FDA, No. 21-2840, 2021 WL
8874972 (7th Cir. Nov. 4, 2021) (order granting stay), Bidi
Vapor LLC v. FDA, No. 21-13340-DD (11th Cir. Feb. 1, 2022)
(order granting stay).
To date, only the Fifth Circuit has reached the merits of
FDA denial orders like those challenged here. On the eve of
issuance of this opinion, that court in Wages & White Lion
Investments, LLC d/b/a Triton v. FDA (Triton), No. 21-60766,
2022 WL 2799797 (July 18, 2022), denied two e-liquid
manufacturers’ petitions for review. Id. at *1. The court
rejected as “blatantly wrong” the manufacturers’ contention
that the Tobacco Control Act does not authorize the FDA to
consider comparative cessation benefits of flavored over
unflavored or tobacco-flavored products. Id. at *4. And the
court denied the manufacturers’ various arbitrary and
capricious challenges. See id. at *5-11. It held that the FDA
adequately explained the shortcomings of the manufacturers’
study, considered relevant differences between “open” and
“closed” e-cigarette device types, did not assess applications
under evidentiary or substantive requirements different from
those communicated to the regulated parties, and adequately
justified its decision not to review the manufacturers’
marketing plans (or, alternatively, committed only harmless
error). Id. The court accordingly denied the manufacturers’
petitions for review. Id. at *11.
17
Judge Jones dissented on the ground that, in her view, the
orders are arbitrary and capricious. Id. at *12-19; see 16 F.4th
1130 (5th Cir. 2021) (motions panel granting stay on similar
reasoning). She would have held the FDA’s decision to not
review the manufacturers’ marketing plans “obviously illogical
and unreasonable,” 2022 WL 2799797 at *16, and rejected the
majority’s view that any error was harmless, id. at *17. She
also would have held that the FDA took a “meandering
administrative course” that, without notice, altered the
substantive and evidentiary requirements manufacturers were
expected to meet. Id. at *18. Her analysis tracked that of the
earlier motions panel in the same case, which had stayed the
FDA’s order and held the manufacturers were likely to succeed
on their arbitrary and capricious claims. See id. at *16 (quoting
and citing 16 F.4th at 1137).
The only other published opinion to date on flavored
ENDS product marketing orders is the Sixth Circuit’s opinion
in Breeze Smoke, LLC v. FDA, denying an e-liquid
manufacturer’s petition for a stay based on its failure to show a
likelihood of success. 18 F.4th at 503. For reasons later
adopted by the Fifth Circuit merits panel in Triton, the court
sustained the FDA’s determination that Breeze failed to meet
its evidentiary requirements, explaining that the FDA’s
statement in its 2019 Guidance that it was willing to “consider”
additional forms of evidence did not require it to accept such
evidence as sufficient to meet the statute’s requirement. Id. at
507. Relatedly, the court was unpersuaded that the FDA’s
Guidance had changed applicants’ evidentiary burden without
notice. The agency, the court observed, has consistently
required applicants to submit randomized controlled trials,
longitudinal studies, or other similarly rigorous evidence. Id.
at 506-07. Commenting that the FDA probably should have
more thoroughly considered applicants’ marketing and youth
prevention plans or better explained why it did not, the court
18
held that potential shortcoming did not in any event establish a
likelihood of success to justify a stay. Id. at 507-08.
II. DISCUSSION
A. Jurisdiction, Standing, and Standard of Review
The Tobacco Control Act confirms our jurisdiction to
review the FDA’s denial orders. See 21 U.S.C.
§ 387l(a)(1)(B). And the manufacturers have standing to
challenge the FDA’s marketing denial orders, which deny them
the authorization the Tobacco Control Act requires before they
may lawfully sell their products.
The manufacturers assert that the FDA exceeded its
statutory authority under the Tobacco Control Act by requiring
applicants to show their flavored e-liquids carry sufficiently
greater benefits than non-flavored e-liquids to outweigh their
relatively greater risks. Because we conclude the statute is best
read to support the FDA’s action, we need not consider whether
or how much deference to accord its interpretation. The
manufacturers also argue that the FDA’s denial order was
arbitrary and capricious in several respects. We review such
challenges to the FDA’s exercise of its Tobacco Control Act
authority under the ordinary APA standard of review. 21
U.S.C. § 387l(b) (citing 5 U.S.C. § 706(2)(A)). Under section
706 we assess whether the agency offered a “satisfactory
explanation for its action” and hold arbitrary and capricious
explanations that “entirely fail[] to consider an important
aspect of the problem.” Motor Vehicle Mfrs. Ass’n v. State
Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983). In so doing,
we must “judge the propriety of [an agency’s] action solely by
the grounds invoked by the agency.” SEC v. Chenery Corp.,
332 U.S. 194, 196 (1947). Our review incorporates the APA’s
prejudicial error rule, under which the “burden of showing that
19
an error is harmful normally falls upon the party attacking the
agency’s determination.” Shinseki v. Sanders, 556 U.S. 396,
409 (2009) (citing 5 U.S.C. § 706).
B. Challenge to FDA’s Statutory Authority
Congress directed the FDA to authorize the marketing of
only those new tobacco products that an applicant has shown
“would be appropriate for the protection of the public health.”
21 U.S.C. § 387j(c)(2)(A). The distinct public health hazards
of flavored tobacco products, especially to young people, are
extensively documented. Given those risks, purveyors of
flavored products cannot show they are appropriate in public
health terms without establishing that they have substantial
public health benefits that overcome their risks. The FDA
accordingly requires applicants seeking to market flavored
tobacco products to show their products are more beneficial to
the public health than non-flavored products.
Petitioners challenge that requirement as contrary to the
Act. They assert that the FDA lacks statutory authority to
consider a product’s “relative effectiveness at promoting
cessation of combustible cigarette use versus another product
with an otherwise similar health risk profile and labeling.”
Pet’rs Br. at 50. But the Tobacco Control Act itself instructs
that, in seeking an FDA determination that their product is
appropriate for the protection of the public health, an applicant
must supply “full reports of all information . . . concerning
investigations which have been made to show the health risks
of such tobacco product and whether such tobacco product
presents less risk than other tobacco products.” 21 U.S.C.
§ 387j(b)(1)(A) (emphasis added). The Act then provides that
the FDA “shall deny an application . . . if, upon the basis of the
information submitted . . . and any other information before the
[FDA],” it concludes that the applicant has failed to “show[]
20
that permitting [the] product to be marketed would be
appropriate for the protection of the public health.” Id.
§ 387j(c)(2). In other words, the statute not only allows but
expressly instructs the FDA to consider evidence regarding just
the comparison that the manufacturers say the FDA lacks
statutory authority to make.
The FDA acted well within that statutory directive when it
compared the claimed cessation benefits of flavored and non-
flavored products. The FDA has found that flavored products
present greater risks than other tobacco products, based on a
robust array of literature showing the dangers those products
pose of hooking new users, especially youth. See FDA
Technical Review at 5-9. Instead of stopping there and
denying the applications for flavored products as
comparatively risky, it addressed their asserted upsides,
reasoning that a product could still be net beneficial if its large
risks were overcome by larger benefits to current users. See id.
at 10-14. By contrast, if the new product carried greater risks
but no overmatching greater benefits, authorizing it would not
on balance serve public health. That is precisely the type of
analysis the statute calls for.
The manufacturers contend that the statutory phrase “the
health risks of such tobacco product” limits the FDA to
comparing only the “physiological health risks” of individual
tobacco products without taking account of a “broader concept
of risk that encompasses initiation and cessation behaviors.”
Pet’rs Reply Br. at 12-13. The statutory text is to the contrary.
The degree to which a harmful product entices and addicts new
users is inarguably a component of the “health risk” it poses.
That is plain from Congress’s express directive that the FDA
determine whether a product is “appropriate for the protection
of the public health,” a population-wide inquiry. 21 U.S.C.
§ 387j(c)(2)(A) (emphasis added); see also Health, BLACK’S
21
LAW DICTIONARY (11th ed. 2019) (defining “public health” as
“[t]he health of the community at large” or “the general body
of people or the community en masse”).
The manufacturers are wrong that the FDA applied a
standard akin to or more stringent than the “safe and effective”
standard to which new drugs are subject or conflated its
statutory inquiry with the “modified risk tobacco products”
inquiry. See Pet’rs Br. at 50-54 (citing 21 U.S.C.
§§ 355(b)(1)(A), 387k). Those distinct standards apply to
other kinds of approvals contingent on evidentiary showings
that do not apply here and that the FDA did not demand. See
21 U.S.C. § 355(b)(1)(A) (requiring evidence that new drug is
effective for therapeutic use, which the manufacturers do not
claim of e-cigarette liquids); id. § 387k (requiring evidence
substantiating specific modified risk claims, which the
manufacturers do not seek to make here). Moreover, the fact
that the FDA has other authorities through which it can approve
other products, like those designed and approved specifically
as smoking cessation products, does not release the FDA from
following its statutory mandate here to approve only tobacco
products the sale of which it determines “would be appropriate
for the protection of the public health.” 21 U.S.C. § 387j(c)(2).
The manufacturers give us no persuasive reason to think that
those other authorities somehow limit the inquiry the FDA may
make in reaching a § 387j determination.
C. Arbitrary and Capricious Challenges
The manufacturers also contend that the FDA’s denial of
their marketing applications was arbitrary and capricious.
They raise two principal arguments. First, they argue the FDA
misdirected applicants by altering both the types of evidence it
would accept and the comparison it required applicants to
make. Second, they argue the FDA failed to reasonably explain
22
its decision not to review the manufacturers’ individual
marketing plans. They more briefly make a handful of other
arguments, also addressed below.
We hold that the FDA did not misdirect applicants. And,
assuming the FDA insufficiently explained its non-review of
applicants’ marketing plans, we hold that error was harmless.
The manufacturers’ other arbitrary and capricious challenges
fail as well. We accordingly deny the petitions for review.
1. The “Surprise Switcheroo” Challenge Fails
The manufacturers argue that the FDA’s 2019 Guidance
rendered its denial orders arbitrary and capricious because the
guidance steered them astray. Agencies must explain changes
in position, particularly once a prior position has engendered
regulated parties’ reliance. See FCC v. Fox Television Stations,
Inc., 556 U.S. 502, 514-16 (2009); PHH Corp. v. CFPB, 839
F.3d 1, 44-49 (D.C. Cir. 2016), vacated and reinstated in
relevant part, 881 F.3d 75, 83 (D.C. Cir 2018) (en banc). The
manufacturers assail the FDA’s denial orders as departing from
its 2019 Guidance in two ways: They argue the FDA (1)
changed the types of evidence it expected applicants to
produce, and (2) changed the substantive comparison it
expected applicants to make. Because those changes conflicted
with the 2019 Guidance, the manufacturers say, the FDA acted
without fair notice of the requirements their applications had to
meet to gain approval. See Pet’rs Reply Br. at 3 (citing SNR
Wireless LicenseCo., LLC v. FCC, 868 F.3d 1021, 1043 (D.C.
Cir. 2017)).
The manufacturers’ notice claim effectively boils down to
an assertion that the FDA’s 2019 Guidance affirmatively
misdirected them. They do not claim insufficient notice based
on the statutory standard or the FDA’s deeming rule. Indeed,
23
they seem to acknowledge that, had the agency not issued its
2019 Guidance, they would have no claim of inadequate notice.
See Oral Argument Tr. at 5-6. The manufacturers instead argue
that the FDA’s 2019 Guidance suggested the agency would
approve the type of application they filed, making its rejections
unexpected and arbitrary. But the FDA’s final determinations
were consistent with the 2019 Guidance, undercutting their
claim.
a. No change to requisite types of evidence
The manufacturers argue that the FDA without warning
altered the types of evidence it would accept. Specifically, they
claim that the 2019 Guidance suggested that applicants need
not produce data from randomized controlled trials or
longitudinal studies, and that the FDA here suddenly reversed
course by effectively requiring those forms of evidence.
We disagree. The FDA did not reverse course. The 2019
Guidance said that randomized controlled trials or longitudinal
studies would not be necessary if applicants submitted
similarly rigorous “valid scientific evidence.” 2019 Guidance
at 12. In the orders under review, the agency found that these
applicants’ evidence was not similarly rigorous. As the Sixth
Circuit reasoned in Breeze Smoke, the FDA said only that “it
might accept evidence other than long-term studies, if that
evidence had sufficient scientific underpinnings” to meet the
statutory standard. 18 F.4th at 506-07. The FDA nowhere
guaranteed that unspecified other forms of evidence would
necessarily be sufficient—only that they might be, so the FDA
would consider them. 2019 Guidance at 12-13.
The text of the FDA’s 2019 Guidance makes that clear.
The agency stated that it “intends to review” evidence in forms
other than randomized controlled trials or longitudinal studies
24
“to determine whether it is valid scientific evidence sufficient
to demonstrate that” the statutory standard is met. 2019
Guidance at 12. The FDA thereby broadened the types of
evidence it would consider: Instead of limiting applicants to
the two types of evidence it usually requires, the agency
allowed manufacturers to submit evidence in other forms. But
at the same time the agency made clear it would not relax the
scientific rigor of the requisite public health demonstration.
The agency’s finding that the evidence was insufficiently
rigorous does not reflect a changed standard, but the
manufacturers’ failure to meet the standard the agency
consistently applied.
Nor did the FDA act arbitrarily and capriciously by finding
the manufacturers’ evidence insufficiently rigorous.
Prohibition Juice’s own literature review concluded that “there
is not enough evidence from well-designed studies to
determine whether e-cigarette flavors aid in smoking
cessation.” J.A. 469. The manufacturers argue that the FDA
failed to credit data they collected through online voluntary
surveys. But the FDA explained that one-time assessments and
consumer perception surveys “do[] not enable reliable
evaluation of behavior change over time” and that their lack of
product-specific comparisons deprive them of probative
weight. FDA Technical Review at 12-13. The FDA
accordingly concluded that, “in contrast to the evidence related
to youth initiation—which shows clear and consistent patterns
of real-world use that support strong conclusions—the
evidence regarding the role of flavors in promoting switching
among adult smokers is far from conclusive.” Id. at 11.
Considered in light of the evidence before the agency, that
conclusion was entirely reasonable.
The manufacturers argue that, even if the FDA nominally
claimed it would accept other evidence, the agency effectively
25
engaged in an arbitrary “fatal flaw” analysis to reject
applications lacking either of the two leading types of evidence.
Pet’rs Br. at 16. As they see it, the FDA in practice considered
only whether applicants had submitted data from randomized
controlled trials or longitudinal cohort studies. Id. But the
material the manufacturers rely on itself directly refutes that
characterization.
First, they point to the check-box forms the FDA used to
assess applications. But they omit that those forms looked
beyond randomized trials and longitudinal studies to list a third
category of potential support: “Other evidence in the
[application] related to potential benefit to adults.” See J.A.
32-33, FDA Br. at 43. The manufacturers’ problem, per that
document, was not their failure to include longitudinal or
randomized controlled studies. It was their failure to include,
as the FDA consistently required, studies sufficiently rigorous
to show a benefit of flavored e-cigarette products sufficient to
overcome their risks.
Second, the manufacturers point to an internal agency
guidance memorandum dated July 9, 2021, as evidence of this
fatal flaw approach. See J.A. 159-60. The July memorandum’s
prediction that applications lacking evidence from randomized
controlled trials or longitudinal studies would “likely” be
denied did not necessarily foreclose reliance on other forms of
rigorous evidence. Id. at 160. In any event, the FDA replaced
that memorandum the next month, on August 17, 2021, with
superseding guidance that expressly required the agency to
consider other forms of evidence if sufficiently robust. See J.A.
161-62; see also J.A. 162 n.ix. That August memorandum
preceded the FDA’s rejection of petitioners’ applications.
The manufacturers also contend the FDA imposed an
evidentiary “double standard” by using literature reviews as
26
evidence for flavored products’ risks but eschewing literature
reviews as evidence of their benefits. The FDA explained that
its treatment of various materials depended on the nature and
conclusiveness of the findings they reported. From its study of
reviews of the scientific evidence on the risks of flavored
products, the agency concluded that those risks “are understood
as a matter of scientific consensus.” Breeze Smoke, 18 F.4th at
508; see FDA Technical Memorandum at 11 (noting that risks
to youth are “clear and consistent”). But the reports of
evidence of flavored products’ benefits, the agency found, were
“far from conclusive” and “quite mixed,” particularly due to
relevant differences from product to product. FDA Technical
Memorandum at 11. The agency reasonably drew differing
conclusions from evidence of differing strength.
Finally, the manufacturers urge us to adopt the reasoning
of the Fifth Circuit panel in its decision to grant a stay in Triton.
That stay was in place as this case was briefed and argued, but
has been superseded by the decision on the merits.
Nonetheless, we consider on its own terms and are unpersuaded
by the stay panel’s analysis. See 2022 WL 2799797 at *5-11;
18 F.4th at 506-07. The stay panel, and merits dissent in
accord, over-read the FDA’s statement that it would consider
evidence other than long-term studies as announcing that
“long-term studies were likely unnecessary.” 16 F.4th 1140-
41. Against that asserted baseline, the stay opinion concluded
that the FDA’s rejection of Triton’s application showed the
agency “changed its mind and required the very thing it said it
would not—namely, long-term studies of e-cigarettes.” Id. at
1135. But again, the FDA has all along required “valid
scientific evidence,” and its denial orders explained how the
survey data petitioners submitted fell short of the mark.
27
b. No change to substantive standard
The manufacturers also argue that the FDA pulled a bait-
and-switch of the substantive standard it applied in reviewing
their applications. See Pet’rs Reply Br. at 4-8. The
manufacturers argue they relied on the FDA’s 2019 Guidance,
which included a section describing the types of “comparison
products” applicants should reference to show their products’
benefits. See 2019 Guidance at 13-14. There, the FDA
emphasized that applicants should compare their products to
“tobacco products in the same category or subcategory.” Id. at
13. But the manufacturers claim they were unfairly surprised
to see the FDA explain in its denial order that it looked for
evidence “that could potentially demonstrate [an] added benefit
to adult users of flavored ENDS [electronic nicotine delivery
system] over an appropriate comparator tobacco-flavored
ENDS.” Pet’rs Reply Br. at 5 (citing J.A. 47, 823, 1029, 1236).
The manufacturers contend that “nobody reading [the 2019
Guidance] would believe that it was necessary to compare a
particular e-liquid to a tobacco-flavored e-liquid,” id. at 6-7,
and that accordingly “FDA flunked Petitioners for failing to
answer a question that it never even asked,” id. at 8. They
claim that doing so both worked a change to the substantive
standard of review and upset their interest in reliance on the old
standard.
This argument is far off base. The governing statute
expressly asks for evidence concerning whether an applicant’s
“tobacco product presents less risk than other tobacco
products,” 21 U.S.C. § 387j(b)(1)(A), and the FDA’s 2019
Guidance told manufacturers that the agency would look for
comparisons between the proposed product and “tobacco
products in the same category or subcategory,” 2019 Guidance
at 13. Petitioners knew they needed to show that their flavored
e-liquids were sufficiently beneficial to adult smokers to offset
28
the risks from flavored products’ particular attractiveness to
youth. It was widely known when petitioners prepared and
submitted their applications that the FDA had identified e-
cigarette flavors as a driver of soaring youth rates of tobacco
uptake, use, and addiction. Petitioners’ own unflavored or
tobacco-flavored e-liquids were an obvious, otherwise-similar
comparator against which to gauge whether the added risks of
their flavored e-liquids are overcome by those products’ added
benefits to adult smokers. The manufacturers’ own insistence
that device type is the primary feature driving ENDS popularity
among youth does not render arbitrary or surprising the FDA’s
attention to the relative risks and benefits of flavored versus
unflavored products of the same type.
The manufacturers cannot identify any misdirection in the
2019 Guidance. The FDA’s product-specific analysis in the
denial orders is fully consistent with its Guidance. The 2019
Guidance identified what types of comparisons the FDA would
be looking for. The denial orders applied that guidance to
examine whether the added risk of these manufacturers’
flavored e-liquids over otherwise-comparable products without
flavoring is outweighed by greater added benefit to adult
smokers of the flavored over unflavored versions. That is a
straightforward application of the FDA’s stated standard.
There was nothing new about the FDA’s review of the
manufacturers’ applications that deprived them of fair warning.
See Breeze Smoke, 18 F.4th at 507. Because the 2019 Guidance
gave fair notice of the analysis the agency would perform and
the purpose of those comparisons, we hold the agency did not
create unfair surprise by focusing on comparisons between
otherwise similar flavored and nonflavored products.
29
2. The FDA’s Decision Not to Review Each Youth Access
Plan Was Immaterial
The manufacturers also argue that the FDA acted
arbitrarily and capriciously by failing to reasonably explain
why it did not review their individual marketing plans. They
make plausible arguments that the agency erred in acting as it
did without a more persuasive explanation. But the
manufacturers did not show that that error prejudiced them in
any way. We accordingly hold that, even assuming the FDA’s
explanation was error, that error was harmless.
In their briefing, and even when specifically pressed on the
point at argument, the manufacturers were unable to identify
any prejudice they suffered from the FDA’s lack of
individualized review of their plans to prevent youth access to
their flavored e-liquids. The Tobacco Control Act applies the
APA’s standard of review, see 21 U.S.C. § 387l(b), which
instructs courts to take “due account . . . of the rule of
prejudicial error” and thereby incorporates a harmless error
rule, 5 U.S.C. § 706; see Nat’l Assn. of Home Builders v.
Defenders of Wildlife, 551 U.S. 644, 659-60 (2007). Under that
rule, “the burden of showing that an error is harmful normally
falls upon the party attacking the agency’s determination.”
Shinseki v. Sanders, 556 U.S. 396, 409 (2009); see Air Canada
v. Dep’t of Transp., 148 F.3d 1142, 1156 (D.C. Cir. 1998).
When an agency’s mistake plainly “had no bearing” on the
substance of its decision, we do not grant a petition for review
based on that mistake. See Mass. Trs. of E. Gas & Fuel Assocs.
v. United States, 377 U.S. 235, 248 (1964).
We apply that harmless error rule consistent with SEC v.
Chenery Corp., which requires courts to refrain from assessing
agency action on bases the agency itself did not supply. 332
U.S. at 196. “[W]ith limited exception,” our circuit has noted,
30
Chenery “does not allow us to affirm an agency decision on a
ground other than that relied upon by the agency.” Manin v.
NTSB, 627 F.3d 1239, 1243 (D.C. Cir. 2011). But “when there
is not the slightest uncertainty as to the outcome of a
proceeding on remand, courts can affirm an agency decision on
grounds other than those provided in the agency decision.” Id.at 1243 n.1 (quoting Envirocare of Utah, Inc. v. Nuclear Regul.
Comm’n, 194 F.3d 72, 79 (D.C. Cir. 1999)) (formatting
modified); accord Grossmont Hosp. Corp. v. Burwell, 797 F.3d
1079, 1086 (D.C. Cir. 2015). Chenery, the Supreme Court has
elaborated, was designed to “assur[e] that initial administrative
determinations are made with relevant criteria in mind.” Mass.
Trs. of E. Gas & Fuel, 377 U.S. at 248. When an asserted error
clearly did not affect the outcome, applying Chenery and its
progeny “would not advance the purpose they were intended to
serve.” Id. In short, “Chenery does not require that we convert
judicial review of agency action into a ping-pong game,”
lobbing the matter from agency to court and back. NLRB v.
Wyman-Gordon Co., 394 U.S. 759, 766 n.6 (1969). Where a
petitioner had ample opportunity yet failed to show that an
agency error harmed it, vacatur and remand to give the agency
an opportunity to fix the error is unwarranted.
The manufacturers raise serious arguments that the FDA
erred in deciding not to review their marketing plans on the
ground that they presented nothing new, and that its
explanation for the non-review fell short insofar as the FDA
assumed the contents of plans without reading them. But those
plans are in the record for all to read, and they vindicate the
FDA’s assumption. Even the manufacturers do not claim that
FDA’s consideration of their marketing plans could have
changed the agency’s decision on their applications. The
measures they highlight in their marketing plans are not
materially different from those the FDA had previously found
insufficient to stem the surge in youth e-cigarette use. In their
31
briefing and at argument petitioners identified examples of the
youth access limitations they proposed and that they assert the
FDA erred in not specifically reviewing. See Pet’rs Br. at 39;
Oral Argument Tr. at 12. Yet their plans—to require
customers’ self-verification of age at the point of sale and to
use what they characterize as less vibrant marketing
unappealing to youth—track measures the FDA in its 2020
guidance deemed inadequate to prevent or otherwise materially
limit youth access to flavored ENDS. Compare Pet’rs Br. at
39, with 2020 Guidance at 42-44. The manufacturers fail to
explain why their proposals will prevent youth access where
other, similar measures did not.
Petitioners thus cannot identify how they were harmed
from the FDA’s failure to consider essentially the same
measures it had previously rejected. Indeed, they offered no
refutation whatsoever to the FDA’s pointed assertions that the
manufacturers “do not claim to have proposed access measures
different from those that FDA previously found inadequate,”
and accordingly that “there is no basis to conclude that any
harm flowed from the asserted failure-to-consider error.”
Compare FDA Br. at 38-39, with Pet’rs Reply Br. at 8-9. In
response to questioning on the point at oral argument, the
manufacturers again did not identify any harm they
experienced from FDA’s failure to have reviewed their
marketing plans, instead simply referring to the familiar and
demonstrably inadequate measures listed in their opening brief.
See Oral Argument Tr. at 12 (responding “well, no” to the
question whether manufacturers’ plans had proposed “anything
qualitatively different” from measures the FDA had previously
examined and deemed lacking); id. at 15 (responding “no” to
the question whether manufacturers’ marketing plans would
alone have altered the FDA’s analysis enough to warrant
granting the petition, absent their other challenges to purported
changing FDA guidance). In light of that failure, the
32
petitioners have also forfeited any argument that the alleged
error prejudiced them.
We accordingly assume without deciding that the FDA
erred in not individually reviewing the manufacturers’
marketing plans and offering an apparently circular
explanation for that approach. The manufacturers’ inability to
identify how the FDA’s denial orders could have come out
differently if only it had known the contents of their plans
defeats their request for vacatur and remand to the FDA for
further consideration.
3. The Other Arbitrary and Capricious Challenges Fail
None of the manufacturers’ other arbitrary and capricious
challenges has merit. See Pet’rs Br. at 34-49; Reply Br. at 8-11.
The manufacturers contend the FDA ignored a material
distinction between open and closed systems. These
manufacturers seek to market e-liquids used to refill open
systems, and they say the FDA erred in treating public health
data regarding the risks of youth access to flavored closed-
system e-cigarettes as applicable to flavored products used with
open systems. But the FDA did acknowledge the distinct
products, noting in its denial orders that “there may be
differential appeal of certain product styles.” FDA Technical
Memorandum at 7. The FDA then reasonably explained that it
nonetheless found the scientific literature about public health
risks to youth applicable to petitioners’ products, because
“across these different device types, the role of flavor is
consistent.” Id. The FDA cited data from the 2020 National
Youth Tobacco Survey, among other sources, to support its
conclusion that youth preference for flavor “is consistently
demonstrated across large, national surveys and longitudinal
cohort studies.” Id.
33
By contrast, the FDA noted that youth preferences for
different device types are “fluid,” and that youth readily shift
among devices. Id. at 8. For example, the FDA cited data
showing that “the removal of one flavored product option
prompted youth to migrate to another [device type] that offered
their desired flavor options.” Id. This fact “underscore[d] the
fundamental role of flavor in driving appeal.” Id. The FDA
supported its conclusion with substantial evidence, and we
have no basis to second-guess it.
The FDA also did not impermissibly treat like products
differently, as the manufacturers contend. The FDA concedes
that it inadvertently denied approval to some manufacturers
who had submitted results from randomized controlled trials
comparing their flavored products to non-flavored cigarettes;
the agency reports that it is reconsidering those applications
separately. See FDA Br. at 47-48; see also FDA 28(j) Letter
(dated Apr. 13, 2022) at 2. But the manufacturers here do not
contend that they submitted similar studies for their products.
Accordingly, there is no inconsistency between the FDA’s
distinct treatment of these different applications.
Finally, the FDA was not required to consider alternative
regulatory approaches before denying the manufacturers’
applications for premarket approval. The statute requires that
applicants make a certain showing before their products can be
approved for sale and provides that, where an applicant fails to
make that showing, the FDA “shall deny” the application. See
21 U.S.C. § 387j(c)(2)(A). After reviewing their applications,
the FDA here found that these manufacturers had failed to
make the requisite showing. The statute requires no more.
34
III. CONCLUSION
For all of the above reasons, we deny the petitions for
review.
So ordered.
KATSAS, Circuit Judge, concurring: This case arises from
the Food and Drug Administration’s denial en masse of
thousands of applications for permission to sell flavored e-
cigarettes or liquid cartridges for use in flavored e-cigarettes.
The FDA denied the applications primarily because flavored e-
cigarettes appeal to children. Yet the agency refused even to
consider any of the proposed marketing plans for these
products, which bear critically on the risk that they pose to
children. The FDA reasoned that because marketing plans it
had previously reviewed were inadequate, the agency could
simply stop reviewing the plans for other products, “for the
sake of efficiency.” FDA, Technical Project Lead (TPL)
Review of PMTAs (2021), at 11 n.xix (J.A. 44). The FDA earns
points for candor, but the Administrative Procedure Act
requires more. As the Fifth Circuit has explained, “it’s
unreasonable for the FDA to stop looking at proposed
[marketing] plans because past ones have been
unpersuasive.” Wages & White Lion Invs., LLC v. FDA, 16
F.4th 1130, 1137 (5th Cir. 2021); see also Breeze Smoke, LLC
v. FDA, 18 F.4th 499, 507 (6th Cir. 2021) (“The FDA likely
should have more thoroughly considered Breeze Smoke’s
marketing plan.”). 1
Despite the FDA’s obvious error, I join the Court’s
opinion in full. As Judge Pillard persuasively demonstrates,
the petitioners here made no serious argument that the FDA’s
failure to consider their marketing plans was prejudicial, as
required for them to obtain relief under the APA. See 5 U.S.C.
§ 706 (“due account shall be taken of the rule of prejudicial
1
The Fifth Circuit later held that the FDA’s failure to consider
the full marketing plans at issue in Wages & White Lion Investments
was not arbitrary. Wages & White Lion Invs., LLC v. FDA, No. 21-
60766, slip op. at 19–23 (5th Cir. 2022); but see id. at 32–35 (Jones,
J., dissenting). In that case, however, the FDA claimed to have
reviewed at least “a summary of the marketing plans.” Id. at 22
(majority). Here, the FDA did not claim to have done even that.
2
error”). Moreover, I agree that the petitioners’ other arguments
lack merit. In joining the Court’s opinion, I do not understand
it to foreclose the possibility of our finding prejudicial error in
other cases where manufacturers press the prejudice point more
forcefully.