Logic Technology Development LLC v. FDA ( 2023 )

PRECEDENTIAL
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
__________
No. 22-3030
__________
LOGIC TECHNOLOGY DEVELOPMENT LLC,
Petitioner
v.
UNITED STATES FOOD AND DRUG
ADMINISTRATION
__________
On Petition from the United States Food & Drug
Administration
(FDA-1: PM0000528.PD1, PM0000534.PD1,
PM0000539.PD1)
__________
Argued May 9, 2023
Before: KRAUSE, PORTER, and AMBRO, Circuit Judges
(Filed: October 19, 2023)
Bryan M. Haynes
Troutman Pepper
1001 Haxall Point, 15th Floor
Richmond, VA 23219
Misha Tseytlin [ARGUED]
Troutman Pepper
227 W Monroe Street, Suite 3900
Chicago, IL 60606
Counsel for Petitioner
Alisa B. Klein
Catherine M. Padhi [ARGUED]
Lindsey Powell
United States Department of Justice
950 Pennsylvania Avenue NW
Washington, D.C. 20530
Counsel for Respondent
William B. Schultz
Zuckerman Spaeder
1800 M Street NW Suite 1000
Washington, DC 20036
Counsel for Amici-Respondents
__________
OPINION
__________
KRAUSE, Circuit Judge.
New information and changes in the marketplace can
alter consumers’ decisions about the products they buy, and the
same is true of the federal agencies that regulate the marketing
of those products. Here, starting in early 2020, the Food and
Drug Administration (FDA) began taking aggressive action to
2
remove fruit- and dessert-flavored e-cigarettes, also known as
electronic nicotine delivery systems (ENDS), from the stream
of commerce, leaving aside at that time tobacco- and menthol-
flavored ENDS. More recently, based on additional studies
and market data, the FDA has denied the applications of
importers and manufacturers like Petitioner Logic Technology
Development (Logic) to market menthol-flavored ENDS.
Logic now challenges that denial as a violation of the
Administrative Procedure Act (APA), claiming it was arbitrary
and capricious for the FDA (1) to apply the same regulatory
framework to menthol that it used to assess the appropriateness
of sweeter flavors, (2) to ultimately reject its applications for
its menthol-flavored ENDS to remain on the market, and (3) to
do so without granting Logic a transition period following that
decision. For the reasons explained below, however, we find
those arguments unpersuasive because the FDA applied a
regulatory framework consistent with its statutory mandate,
provided a reasoned explanation for its denial, and based its
decision on scientific judgments that we may not second-guess.
We will therefore deny Logic’s petition for review.
I. Background
Because our resolution of Logic’s petition requires an
understanding of the highly reticulated scheme that Congress
laid out in the Family Smoking Prevention and Tobacco
Control Act (Tobacco Control Act), we review that framework
before assessing its application to the menthol-flavored
products at issue here.
A. Statutory framework
3
The Tobacco Control Act requires any tobacco product
not on the market before February 15, 2007 to receive approval
from the FDA. See 21 U.S.C. § 387j(a)(1)–(2). Only if the
FDA concludes that “permitting such tobacco product to be
marketed would be appropriate for the protection of the public
health” (health-appropriate) can the product be approved. 1 Id.
§ 387j(c)(2). Manufacturers seeking advance permission to
market one of these newer products can submit a “premarket
tobacco product application” (PMTA or premarket
application) to the agency. See Liquid Labs LLC v. FDA, 52
F.4th 533, 537 (3d Cir. 2022) (citations omitted).
When considering such an application, the FDA is
statutorily required to conduct a balancing test to determine
whether an ENDS is health-appropriate and, thus, whether it
can remain on the market. The agency must assess:
[T]he risks and benefits to the population as a
whole, including users and nonusers of the
tobacco product, and taking into account—
1
The FDA first deemed ENDS and their flavor
cartridges “new tobacco products” and thus subject to the
Tobacco Control Act in 2016. 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, 81 Fed. Reg. 28,974, 28,976 (May 10,
2016). The D.C. Circuit upheld this rule in Nicopure Labs,
LLC v. FDA, 944 F.3d 267, 281–82 (D.C. Cir. 2019).
4
(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 tobacco
products.
21 U.S.C. § 387j(c)(4)(A)–(B). This mandate in effect creates
a sliding scale: the greater the risk of the new tobacco product
to non-smokers, especially children, the greater the benefit to
smokers that the manufacturer must demonstrate. See Bidi
Vapor LLC v. FDA, 47 F.4th 1191, 1211 (11th Cir. 2022)
(Rosenbaum, J., dissenting).
When applying that test, the FDA is to consult a wide
range of evidence. The agency must deny a premarket
application “if, upon the basis of the information submitted to
the Secretary as part of the application and any other
information . . . with respect to such tobacco product,” it
determines that the product is not health-appropriate. 21
U.S.C. § 387j(c)(2)(A) (emphasis added). And it “shall, when
appropriate” make that determination “on the basis of well-
controlled investigations, which may include 1 or more clinical
investigations by experts qualified by training and experience
to evaluate the tobacco product.” Id. § 387j(c)(5)(A). But if
the agency “determines that there exists valid scientific
evidence” beyond those studies that “is sufficient to evaluate
the tobacco product, the Secretary may authorize that the
[health-appropriateness] determination . . . be made on the
basis of such evidence. Id. § 387j(c)(5)(B).
5
B. The FDA’s previous regulation of vaping
Within the FDA, the Center for Tobacco Products (the
Center) manages the premarket application evaluation
process. 2 The Center, in turn, contains multiple divisions,
including the Director’s office, the Office of Science, and the
Office of Compliance and Enforcement. 3 A manufacturer’s
premarket application passes through several discipline-
specific reviews, including engineering, chemistry,
epidemiology, and social sciences. The Technical Project
Lead then synthesizes those teams’ findings and ultimately
determines whether the product is health-appropriate. Though
the FDA has delegated authority to review premarket
applications to the Office of Science, the Director retains
supervisory authority over the Center’s component offices.
Thus, there is room for deliberation among the Center’s teams,
but the buck stops with the Director.
The Center’s experts began to face a new challenge in
the late 2010s as youth tobacco product use suddenly
skyrocketed. Prior to 2017, high schoolers’ e-cigarette use had
been dropping. But from 2017 to 2019, “ENDS product use
more than doubled among middle school and high school
2
U.S. Food & Drug Admin., About the Center for
Tobacco Products (CTP) (July 21, 2023),
https://www.fda.gov/tobacco-products/about-center-tobacco-
products-ctp.
3
See U.S. Food & Drug Admin., Center for Tobacco
Products Organization Chart (Mar. 30, 2023),
https://www.fda.gov/about-fda/fda-organization-
charts/center-tobacco-products-organization-chart.
6
students.” JA 1118. From 2017 to 2018, the proportion of
twelfth graders who had smoked an e-cigarette in the past thirty
days went from 16.6% to 26.7%. For tenth graders, that figure
went from 13.1% to 21.7% in the same period. According to
the National Youth Tobacco Survey (the Youth Survey),
among high schoolers overall, e-cigarette use went from 11.7%
to 20.8%. By 2018, the Surgeon General had deemed youth
ENDS use an “epidemic.” Prohibition Juice Co. v. FDA, 45
F.4th 8, 10 (D.C. Cir. 2022).
Flavored e-cigarettes were the driving force behind this
epidemic. Youth Survey data showed that in 2014, 65.1% of
high schoolers and 55.1% of middle schoolers who were using
ENDS said they were using a non-tobacco flavor (including
menthol). By 2022, that figure had risen to 85.5% for high
schoolers and 81.5% for middle schoolers, meaning
approximately 2,110,000 of the 2,550,000 students using
ENDS. Manufacturers were marketing ENDS with names and
flavors that were more appropriate for a candy store than a
smoke shop, such as “Brain Freeze Caramel Cone, Buncha
Crunch . . . Crazy Bubble Grape, Giggle Juice,” id. at 15,
“Peanut Butter Milk Pie, Bad Monkey Giovanni, and Sunshine
Vape Dragon Berry Balls,” Gripum LLC v. FDA, 47 F.4th 553,
556 (7th Cir. 2022) (internal quotation marks omitted). The
results were predictable. Flavors that most resembled fruit,
candies, or desserts were more popular with kids than those
that resembled combustible cigarettes. In a 2019 survey of kids
who used JUUL e-cigarettes—then the most popular ENDS
brand—the vast majority of respondents listed mango, mint, or
fruit as the flavor they used most often. Tobacco and menthol
barely registered with respondents.
7
The FDA had to figure out how it would address this
crisis within the bounds of the Tobacco Control Act. The
agency promulgated multiple guidance documents for
manufacturers, the most relevant here being one published in
June 2019 (Premarket Application Guidance), 4 which set out
what the FDA was looking for in premarket applications for
ENDS, and another, published in April 2020 (Enforcement
Priorities), 5 which articulated the agency’s priorities for
enforcement actions against manufacturers whose products
were not considered health-appropriate.
In the Premarket Application Guidance, the FDA said
that “the finding of whether permitting the marketing of a
product would be [health-appropriate] will be determined,
when appropriate, on the basis of well-controlled
investigations.” JA 1027. “Nonclinical studies alone,” on the
other hand, “generally [would] not [be] sufficient to support
[such] a determination.” Id. The FDA also recommended that
manufacturers “compare the health risks of its product to both
products within the same category and subcategory” that “are
most likely to [be] considered interchangeable.” JA 1028. As
applied to fruit-flavored ENDS, the Premarket Application
Guidance meant that the FDA would not approve a product
without evidence that it offered benefits “over an appropriate
4
U.S. Food & Drug Admin., Premarket Tobacco
Product Applications for Electronic Nicotine Delivery
Systems: Guidance for Industry (June 2019).
5
U.S. Food & Drug Admin., Enforcement Priorities for
Electronic Nicotine Delivery Systems (ENDS) and Other
Deemed Products on the Market Without Premarket
Authorization (Revised): Guidance for Industry (Apr. 2020).
8
comparator tobacco-flavored ENDS” with randomized
controlled trials, longitudinal cohort studies, or other similar
evidence “that could potentially demonstrate the [relative
health] benefit[s] of . . . flavored ENDS.” Liquid Labs, 52
F.4th at 538 (citation omitted).
The Enforcement Priorities reflected recent trends in
youth ENDS vaping. Highest priority would be given to non-
tobacco, non-menthol flavors, along with other ENDS
manufacturers with insufficient marketing restrictions or
products marketed to kids. To support this approach, the
agency cited survey data like that above, showing both middle-
and high-school students using fruit flavors more often than
mint or menthol. While survey data disaggregating mint from
menthol ENDS was spotty at the time, the JUUL study had
found that mint was much more popular than menthol. The
FDA received, considered, and rejected comments arguing that
menthol should be included among the flavors selected for
aggressive enforcement. It noted that “[d]ata shows that
tobacco- and menthol-flavored ENDS products are not as
appealing to minors as other flavored ENDS products.” JA
1145.
ENDS manufacturers attacked the FDA’s application of
the Premarket Application Guidance and Enforcement
Priorities, with mixed results across the circuit courts. 6 We
6
The Second, Fourth, Sixth, Seventh, Ninth, and D.C.
Circuits all have denied petitions or stays. Magellan Tech.,
Inc. v. FDA, 70 F.4th 622, 625 (2d Cir. 2023); Avail Vapor,
LLC v. FDA, 55 F.4th 409, 413 (4th Cir. 2022), cert. denied,
No. 22-1112, 2023 WL 6558399 (Mem) (Oct. 10, 2023);
9
rebuffed that attack and upheld the FDA’s approach in Liquid
Labs. There, the company had received a marketing denial
order for eighteen ENDS with non-tobacco, non-menthol
“characterizing” flavors like “OG Summer Blue” and “Berry
Au Lait.” Liquid Labs, 54 F.4th at 537. To support its
premarket applications, the manufacturer submitted a
marketing plan, “an abuse liability study, a cross-sectional
perception and intention study, a population modeling analysis,
a clinical literature review, and well-controlled non-clinical
analyses.” Id. (internal quotation marks and citation omitted).
The FDA found this evidence insufficient because Liquid Labs
had failed to submit “randomized controlled trial[s] and/or
longitudinal stud[ies]” or any other evidence that “reliably and
robustly evaluated the impact of the new flavored vs. tobacco-
flavored products on adult smokers’ switching or cigarette
reduction over time.” Id. at 538 (internal quotation marks and
citation omitted). The manufacturer petitioned for review,
arguing that the FDA had “pull[ed] a surprise switcheroo” by
changing the evidentiary standard for premarket applications.
Id. at 539 (internal quotation marks and citation omitted).
Breeze Smoke, LLC v. FDA, 18 F.4th 499, 508 (6th Cir. 2021);
Gripum, 47 F.4th at 553; Lotus Vaping Techs., LLC v. FDA,
Nos. 21-71328, 21-71321, 2023 WL 4384447, at *2 (9th Cir.
July 7, 2023); Prohibition Juice, 48 F.4th at 8. The Fifth and
Eleventh Circuits have granted stays to manufacturers, albeit
for different reasons. R.J. Reynolds Vapor Co. v. FDA, 65
F.4th 182, 187 (5th Cir. 2023); Bidi Vapor, 47 F.4th at 1191.
The Fifth Circuit also has heard en banc argument to determine
the validity of the FDA’s comparative approach in Wages and
White Lion Invs., LLC v. FDA, Nos. 21-60766, 21-60800 (5th
Cir. May 16, 2023).
10
We sided with the FDA and sustained the marketing
denial order. The Premarket Application Guidance, we
determined, “nowhere guaranteed that unspecified other forms
of evidence would necessarily be sufficient,” id. at 540
(quoting Prohibition Juice, 45 F.4th at 21), and the text of the
Tobacco Control Act “necessarily implie[d] a comparative
analysis,” id. at 543 (quoting Wages and White Lion Invs., LLC
v. FDA, 41 F.4th 427, 434 (5th Cir. 2022), vacated and reh’g
en banc granted, 58 F.4th 233 (5th Cir. 2023). Thus, we
concluded that Liquid Labs had “fair notice of the analysis the
agency would perform and the purpose of those comparisons,”
id. (quoting Prohibition Juice, 45 F.4th at 24), and the FDA’s
comparative evidentiary standard for fruit and similar flavors
was not arbitrary or capricious.
C. Procedural background
While the courts were determining the legality of the
FDA’s approach to these flavors, the FDA made good on its
comments in the Enforcement Priorities and turned its attention
to menthol. Menthol posed an additional regulatory challenge
because it had a legal substitute in menthol-flavored
combustible cigarettes. With menthol making up about 37%
of the combustible cigarette market, it was thought that ENDS
offering a similar characterizing flavor might help millions of
smokers ditch tobacco, potentially dramatically altering the
health-appropriateness calculation and decreasing the showing
that a manufacturer would need to make in terms of menthol’s
appeal to children. Thus, manufacturers, Logic among them,
sought to make the case that the Tobacco Control Act’s
balancing test should produce a different result in the case of
menthol-flavored ENDS.
11
1. Logic’s Premarket Application
In August 2019, Logic submitted premarket
applications 7 for over a dozen of its ENDS, including its
menthol- and tobacco-flavored products. 8 To support its
applications, Logic submitted hundreds of thousands of pages
of data, including clinical studies to determine the products’
risk of abuse, two sixty-day randomized controlled studies to
determine the products’ effects on smokers, and a marketing
plan explaining how it would limit sales to children. As Logic
saw things, this data offered “overwhelming scientific
evidence” that its menthol-flavored ENDS were health-
appropriate, Opening Br. at 12, because, among other things,
the studies showed that its products helped adult menthol
cigarette smokers reduce their daily cigarette intake, lowering
their exposure to nicotine and helping them quit, and that these
smokers preferred its menthol-flavored ENDS to its tobacco-
flavored ones.
7
Manufacturers submit one premarket application per
new tobacco product for which they are seeking agency
approval. Logic submitted over a dozen premarket
applications for ENDS with various characterizing flavors,
three of them menthol-flavored. The Marketing Denial Order
covers only these products. For ease of reference, we refer to
Logic’s applications for the at-issue ENDS as its Premarket
Application.
8
The history concerning some of Logic’s other
applications is recounted below, but only the FDA’s rejection
of its menthol-flavored ENDS is at issue in this appeal.
12
And on the other side of the health-appropriateness
ledger, Logic provided survey data that it contended showed
(1) that children do not use its products, 9 and (2) that menthol
as a flavor was not nearly as popular among children as fruit or
similar sweet flavors. In the same vein, Logic adopted many
of the traditional marketing restrictions that other applicants
have employed to keep its products out of children’s hands,
age-gating its website, quitting social media, and avoiding
designs, flavors, and advertising campaigns directed at kids.
With this combination, Logic believed it had made a strong
case for its menthol-flavored ENDS to remain on the market.
2. The Center’s deliberations about
menthol
Logic’s Premarket Application for menthol-flavored
ENDS became something of a test case “because . . . it was one
of the applications” for such a product “furthest along in
review” when the Center began to assess how the same health-
appropriateness balance should apply to that flavor. JA 908.
Because it believed there was a “potential benefit” to
adults who smoked menthol-flavored cigarettes, the Office of
Science’s “preliminary” recommendation was to approve
Logic’s Premarket Application. Id. Menthol cigarette
smokers’ potential switch to a menthol-flavored ENDS like
Logic’s could alter the health-appropriateness balance by
making the benefit to current smokers greater than in fruit-
9
According to the 2019 Youth Survey, just 0.8% of
high-school-aged respondents said that they used Logic’s
products. At the time, most high schoolers used JUUL or did
not have a usual e-cigarette brand.
13
flavored ENDS. At the same time, the risk to non-smoking
youth, while higher than for tobacco-flavored ENDS, appeared
lower than for fruit-flavored ones.
But the Office of the Center Director was not so sure,
and raised questions about the Office of Science’s
recommendation that “continued over the course of several
months into 2022.” JA 908. Director Brian King, who arrived
at the Center in July 2022, shared this concern and continued
to question whether Logic’s menthol-flavored ENDS were
appropriate for the protection of public health. JA 904, 909.
According to a memorandum by Dr. Todd Cecil, then Acting
Director of the Office of Science (the Cecil Memo), Dr. King
“raised questions about the [Office of Science’s]
recommendation, including questions about the role and
sufficiency of the general scientific literature on adult menthol
smokers’ differential preference for menthol ENDS in
demonstrating likely behavioral change, and underscored [his]
concerns about the substantial appeal of menthol to youth.” JA
908. The Director ultimately concluded that “the approach to
menthol-flavored ENDS should be the same as with other
flavored ENDS with respect to the evidence of adult benefit.”
JA 904. Under that approach, as with fruit and similar
characterizing flavors, the Center could only approve a
menthol-flavored ENDS “if the evidence showed that the
benefits . . . were greater than tobacco-flavored ENDS.” JA
909.
The Director did not arrive at this conclusion in a
vacuum. According to his memorandum (the King Memo), he
solicited feedback from Office of Science staffers who may
have disagreed with him “in a voluntary, confidential, and non-
pressured environment” through the Center’s Ombuds Team.
14
JA 905. King’s team considered several competing approaches
to these products, including:
whether [the Center’s] evaluation of ENDS
products places too much emphasis on the risks
to youth from ENDS use, is not adequately
bearing in mind the dangers from conventional
smoking, and is pursuing the elimination of
youth ENDS use without adequate regard to the
impact on potential benefits to adult smokers.
[The Center’s] review process [took] into
account the magnitude and rigor of the data
related to youth ENDS use, how [the Center]
should consider these data . . ., and the critical
need to weigh evidence among both youth and
adults in deciding whether to grant or deny
marketing authorization.
JA 904. Notably, as part of this process, the Center also
considered whether its “approach to evaluating ENDS
applications will result in the removal of all ENDS from the
U.S. market except for tobacco-flavored ENDS . . . based on
an assumption that no applicant would ever submit evidence
sufficient to support authorization.” Id. n.3.
Having completed that review, Director King concluded
that “nationally representative data have not demonstrated that
menthol combustible cigarette smokers are more likely to
actually use menthol-flavored ENDS over tobacco-flavored
ENDS to completely quit combustible cigarettes or
significantly reduce their cigarette use.” JA 905. On the other
hand, “scientific evidence on the role of flavors in youth use of
ENDS is significantly more rigorous and robust than the
15
preference data concerning menthol combustible cigarette
smokers.” Id. Drawing on this scientific literature, King
concluded that the primary additional benefit that menthol-
flavored ENDS could have brought relative to fruit-flavored
ones was illusory, and the risks were higher than the Office of
Science had thought.
The Office of Science “on its own initiative” ultimately
agreed, concluding that “the literature did not demonstrate that
menthol-flavored ENDS were differentially effective, relative
to tobacco-flavored ENDS, in terms of promoting significant
cigarette reduction or complete switching among adult
smokers.” JA 909.
3. The FDA’s review of Logic’s Premarket
Application
The appropriate framework in hand and in agreement on
the risks and benefits of menthol, Center staff assessed Logic’s
Premarket Applications, approving those for tobacco-flavored
ENDS, but finding those for menthol-flavored ENDS lacking.
On the benefits to current smokers, the agency looked for two
things: (1) evidence that menthol cigarette smokers did not just
prefer menthol-flavored ENDS to other flavors but in fact
would switch to using them, and (2) statistically significant
evidence that those benefits were greater than the ones that
tobacco offered.
The FDA agreed with Logic that its studies showed that
menthol cigarette smokers “show a preference for menthol-
flavored ENDS, relative to non-menthol-flavored ENDS.” JA
914. It cautioned, however, that “evidence of preference is not
evidence of behavior change, and these studies showing
16
preference for menthol-flavored ENDS were not designed to
directly address the outcomes of complete switching or
cigarette reduction. Actual product use is critical in the
evaluation of product switching.” Id. And when it came to
evidence of switching, Logic came up short. The types of
surveys Logic used were designed to “assess outcomes
believed to be precursors to behavior, such as preferences or
intentions . . . but [were] not designed to directly assess actual
product use behavior.” JA 951. This was consistent with the
FDA’s view of the broader scientific literature, which only
showed that menthol smokers “prefer menthol-flavored
ENDS,” not that they actually promoted “complete switching
or cigarette reduction.” Id. As the FDA explained:
[T]he ability of a product to promote switching
among smokers arises from a combination of its
product features . . . as well as the sensory and
subjective experience of use (taste, throat hit,
nicotine delivery), and can also be influenced by
how the device itself looks and feels to the user.
Moreover, uptake and transition to ENDS use is
a behavioral pattern that requires assessment at
more than one time point.
Id.
Logic’s evidence that menthol offered any benefit
beyond what tobacco presented was similarly lacking. Its
randomized controlled studies did not demonstrate that its
menthol-flavored ENDS generated a statistically greater
reduction in cigarette smoking than its tobacco-flavored
ENDS. This again tracked the more general literature, which
did not show “that menthol-flavored ENDS differentially
17
facilitate switching or cigarette reduction.” JA 944 (emphasis
added). Thus, the potential benefit of menthol-flavored ENDS
to current cigarette smokers remained just that—potential.
Turning to the flavor’s appeal to non-smokers, menthol
was not meaningfully less popular than fruit or dessert flavors
such that it could escape comparison to tobacco. True, it
remained less popular than fruit or sweets, but the gap was
shrinking. By 2022, Youth Survey data showed that, among
high schoolers who had used e-cigarettes in the previous thirty
days, almost 27% had tried menthol, not far behind mint (about
30%) and sweets (about 38%). The National Institutes of
Health (NIH) Population Assessment of Tobacco and Health
longitudinal study had tracked long-term trends in youth
vaping with stark results: across waves of this study, the vast
majority of youth (12-17 year-olds) and young adults (18-24
year-olds) who started vaping did so with a flavor other than
tobacco. A staggering 93.2% of youth in the NIH study’s
2016-17 cohort said that their first ENDS product was not
tobacco-flavored, while a relatively paltry 54.9% of adults
twenty-five or older said the same. This was crucial because
even a relatively small gap between tobacco and menthol can
have important public health consequences for children.
Studies have shown that “non-tobacco flavoring . . . make[s]
them more palatable for novice users . . . which can lead to
initiation, more frequent and repeated use, and eventually
established regular use.” JA 945. The key takeaway from the
data, per the FDA, was not that menthol was less popular than
fruit, but that it was more popular than tobacco.
In addition, the FDA had reason to believe that flavor
preference data would trend in menthol’s favor in the future.
As enforcement actions had taken many cartridge-based
18
flavored ENDS devices off the market, high schoolers in one
survey increased their use of disposable flavored ENDS over
tenfold (2.4% to 26.5%) in just a year. As the FDA saw it,
“[t]his trend underscores the fundamental role of flavor in
driving appeal. . . . [T]he removal of one flavored product
option prompted youth to migrate to another ENDS type that
offered flavor options, even though it exhibited lower youth
use prevalence historically.” JA 935. For the time being, the
FDA had turned its attention to fruit and dessert flavors that
had especially strong appeal to kids. But as enforcement
actions removed those flavors from the market, the FDA
reasoned, other flavors like menthol could become yet more
popular as kids turned to the remaining islands of flavor in the
e-cigarette market.
Nor could Logic’s marketing restrictions bridge the gap.
The FDA already had assessed the efficacy of the types of
restrictions that Logic had implemented in previous cases and
concluded that they were “insufficient to mitigate the
substantial risk to youth from flavored ENDS.” JA 966.
Indeed, evidence had consistently shown that these marketing
restrictions were not responsive to children’s actual purchasing
patterns because “the majority of youth do not purchase e-
cigarettes themselves from retail locations, but rather they
obtain them from social sources, including from friends or
family members, steal them, or use someone else’s product.”
JA 940. While some new technologies, such as biometrics or
geo-fencing, seemed promising to the Center, Logic did not
offer them.
The FDA thus issued a Marketing Denial Order for
Logic’s menthol-flavored ENDS on October 26, 2022. Logic
19
successfully obtained a stay of that order and timely filed this
petition for review.
II. Jurisdiction and Standard of Review
We have jurisdiction over Logic’s petition under 28
U.S.C. § 1331 and 21 U.S.C. § 387l(a)(1)(B). The Tobacco
Control Act directs petitioners to file in the D.C. Circuit or in
the circuit encompassing their principal place of business. 21
U.S.C. § 387l(a)(1)(B). Logic’s principal place of business is
in Teaneck, New Jersey, so we may hear its petition.
The APA governs our review of the FDA’s Marketing
Denial Order. We must vacate the agency’s decision if it was
“arbitrary, capricious, an abuse of discretion, or otherwise not
in accordance with law.” Sanofi Aventis U.S. LLC v. HHS, 58
F.4th 696, 702–03 (3d Cir. 2023) (quoting 5 U.S.C.
§ 706(2)(A)).
III. Discussion
Logic raises four principal challenges to the Marketing
Denial Order. First, it contends that the FDA changed course
and rejected its Premarket Application “pursuant to an
undisclosed, illegal policy against all menthol ENDS.”
Opening Br. at 36. Second, and relatedly, it characterizes the
Technical Project Lead Review as the product of a new
evidentiary standard that unfairly surprised the company.
Next, it characterizes the Marketing Denial Order as the
product of the FDA’s failure to examine important aspects of
the regulatory problem and inconsistent with the evidence in
its Premarket Application. Finally, it attacks as allegedly
inconsistent with agency practice the FDA’s decision to
20
require the immediate withdrawal of its menthol-flavored
ENDS from the market rather than allow a transition period.
In each instance, Logic’s arguments are unavailing, so we will
deny its petition for review.
A. Arbitrary and capricious review
When an agency acts, it “must examine the relevant data
and articulate a satisfactory explanation for its action including
a ‘rational connection between the facts found and the choice
made.’” Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm
Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983) (citation omitted)
(State Farm); see Encino Motorcars, LLC v. Navarro, 579 U.S.
211, 221 (2016). If it does not, the agency has failed to “engage
in reasoned decisionmaking,” and the APA requires the agency
action be set aside. Michigan v. EPA, 576 U.S. 743, 750 (2015)
(internal quotation marks and citation omitted).
In addition, while the APA requires no “more detailed
justification than what would suffice for a new policy created
on a blank slate,” when an agency revises or updates existing
policies, it must at least “display awareness that it is changing
position” and explain “that [it] believes [the new action] to be
better.” FCC v. Fox Television Stations, Inc., 556 U.S. 502,
515 (2009). And when the new approach “rests upon factual
findings that contradict those which underlay its prior policy;
or when its policy has engendered serious reliance interests that
must be taken to account,” that extra explanation is necessary.
Id.; see also Encino Motorcars, 579 U.S. at 222. Relatedly, an
agency cannot say that it is going to approach a regulatory or
licensing issue using one framework only to pull a “surprise
switcheroo” on private parties and use a different framework
instead. Prohibition Juice, 45 F.4th at 20; see also Christopher
21
v. SmithKline Beecham Corp., 567 U.S. 142, 156 (2012)
(citation omitted) (noting that “agencies should provide
regulated parties ‘fair warning of the conduct [a regulation]
prohibits or requires’”).
We also are not free to sustain agency action based only
on any post hoc reasoning that the parties offer up in litigation.
Instead, we are limited to the justifications that were available
to and relied upon by the agency at the time. See DHS v.
Regents of the Univ. of Cal., 140 S. Ct. 1891, 1907 (2020)
(citation omitted); Citizens to Preserve Overton Park, Inc. v.
Volpe, 401 U.S. 402, 419 (1971) (citation omitted); SEC v.
Chenery Corp., 318 U.S. 80, 94 (1943).
That said, arbitrary and capricious review is not meant
to be an exacting standard. Because “a court is not to substitute
its judgment for that of the agency,” Fox Television, 556 U.S.
at 513 (quoting State Farm, 463 U.S. at 43), we will uphold
agency action even if its reasoning is “of less than ideal clarity”
as long as “the agency’s path may reasonably be discerned,”
Garland v. Ming Dai, 141 S. Ct. 1669, 1679 (2021) (quotation
omitted). This is especially true in highly technical areas like
public health, as “[w]e are ‘particularly reluctant to second-
guess agency choices involving scientific disputes that are in
the agency’s province of expertise.’” N.J. Env’t Fed’n v. U.S.
Nuclear Regul. Comm’n, 645 F.3d 220, 230 (3d Cir. 2011)
(quotation omitted); see also Fertilizer Inst. v. Browner, 163
F.3d 774, 777 (3d Cir. 1998) (“[T]he court should not
substitute its own judgment for the scientific expertise
possessed by the agency.”).
B. The alleged blanket anti-menthol policy
22
Logic paints the debate memorialized in the King and
Cecil Memos as proof that Director King effectively imposed
a blanket anti-menthol policy and overrode the Office of
Science’s determination that Logic’s menthol-flavored ENDS
were health-appropriate, violating both the APA and the
Tobacco Control Act. Absent a more explicit explanation of
why the agency viewed menthol as less dangerous to public
health in the Enforcement Priorities and then considered the
flavor to be essentially indistinguishable from fruit and sweets
in the Technical Project Lead Review, Logic contends that the
FDA’s change in course was necessarily arbitrary and
capricious.
Logic’s view aligns in this respect with that recently
articulated by the Fifth Circuit in R.J. Reynolds Vapor. There,
the panel granted a stay to a much larger menthol ENDS
manufacturer that had received a marketing denial order,
reasoning that these memoranda showed that Director King
“told” the Office of Science what the framework for menthol
premarket applications would be and “are strong evidence that
[the Center] developed and internally circulated new criteria
for evaluating [premarket applications] for menthol-flavored
ENDS.” 65 F.4th at 192. As the Fifth Circuit saw it, the FDA’s
marketing denial order “rest[ed] upon factual findings that
contradict those which underlay its prior policy,” so the FDA
was required to offer “a more detailed justification” of its
decision. Id. (quoting Fox Television, 556 U.S. at 515).
We do not share the Fifth Circuit’s view of what
happened within the Center or its legal impact. First, the pat
story about Director King overriding the Office of Science’s
recommendation both oversimplifies and obscures. True, at
first, the Office of Science thought that the health-
23
appropriateness balance might favor menthol and was
therefore preliminarily inclined to recommend approval of
Logic’s Premarket Application. But at this early juncture, the
Office of Science only considered the benefit of Logic’s
menthol-flavored ENDS to menthol cigarette smokers
“potential,” JA 908, and “did not find that the current literature
support[ed] that use of menthol-flavored ENDS by adult
smokers [was] associated with greater likelihood of complete
switching or significant cigarette reduction relative to tobacco-
flavored ENDS,” 10 JA 907–08. So even before any discussions
with Director King, the Office of Science was at most
lukewarm about treating menthol differently from other non-
tobacco characterizing flavors.
And crucially, after discussions with Director King, the
Office of Science “on its own initiative” went back to the
evidence and “decided it was reasonable and consistent to treat
menthol-flavored ENDS [premarket applications] in the same
way as other non-tobacco-flavored ENDS [premarket
applications].” JA 909 (emphasis added). It did so, moreover,
after multiple opportunities for rigorous discussions about
menthol with both the Director and the Center’s Ombuds
Team. Thus, the record does not support Logic’s rendition of
a political appointee parachuting in and dictating a new
framework for the Office of Science to adopt. 11 R.J. Reynolds
10
Of course, the agency eventually adopted this same
view in Logic’s Technical Project Lead review.
11
Even if the Director were bringing political
considerations to bear, that would not render the agency’s
action here arbitrary or capricious. As the Supreme Court has
made clear, “a court may not set aside an agency’s
24
Vapor, 65 F.4th at 192. Nor does it evince a blanket policy
against menthol promulgated from on high. Instead, it reflects
that the Office of Science’s tenuous preliminary support for
Logic’s Premarket Application withered in the face of its own
evolving understanding of the scientific evidence.
Second, and more fundamentally, the internal debates
that the memoranda describe do not reflect a pre-existing
agency policy or final agency action. The APA limits our
jurisdiction to (1) “[a]gency action made reviewable by
statute,” and (2) “final agency action for which there is no other
adequate remedy in a court.” 5 U.S.C. § 704 (emphasis added).
Agency action counts as “final” only if (1) it “mark[s] the
‘consummation’ of the agency’s decisionmaking process,” and
(2) it is “one by which ‘rights or obligations have been
determined’ or from which ‘legal consequences will flow.’”
Bennett v. Spear, 520 U.S. 154, 177–78 (1997) (citations
omitted); see also 5 U.S.C. § 551(13) (defining “agency
action” for purposes of the APA). The consummation of the
process here was the FDA’s issuance of the Marketing Denial
Order. 12
policymaking decision solely because it might have been
influenced by political considerations or prompted by an
Administration’s priorities. . . . Such decisions are routinely
informed by unstated considerations of politics, the legislative
process, public relations, interest group relations, foreign
relations, and national security concerns (among others).”
Dep’t of Com. v. New York, 139 S. Ct. 2573, 2575 (2019).
12
The Marketing Denial Order is reviewable pursuant
to 21 U.S.C. § 387l(a)(1)(B).
25
In contrast to the Marketing Denial Order, however, the
King and Cecil Memos are not—and therefore cannot be
reviewed as—“final agency action” because they flunk the first
finality requirement. 13 They show only that, to the extent that
one component of the Center had developed a view of menthol
at all by the second half of 2021, parts of it had arrived at a
“preliminary recommendation” to approve Logic’s Premarket
Application. JA 908. This was nowhere close to a final
decision—that would not come for almost a year while it
determined what the right framework would be for menthol-
flavored ENDS. As it internalized new information about
menthol, the Center’s understanding of the characterizing
13
We may, of course, consider agency memos and other
documents in the administrative record in determining whether
an agency’s change in existing policy was arbitrary and
capricious, and whether its “sole stated reason” for its action is
pretextual. Dep’t of Com., 139 S. Ct. at 2575 (considering
agency documents in determining that the Secretary of
Commerce’s stated rationale for reversing prior policy and
reinstating a citizenship question on the 2020 census
questionnaire was “contrived”). Here, the King Memo and the
Deficiency Letter do not reflect any prior agency policy, but
merely its evolving understanding of the scientific evidence
and the exchange of views among its different components.
And the FDA’s explanation for its final agency action in the
Marketing Denial Order is entirely consistent with that
evidence and exchange of views, i.e., “with what the record
reveals about the agency’s priorities and decisionmaking
process.” Id.
26
flavor crystallized into something more formal. 14 This is not
the sort of “change[d] course” that can trigger a heightened
burden for the FDA, Regents, 140 S. Ct. at 1913, nor does it
expose some “secret” and nefarious anti-menthol policy, as
Logic contends. 15 Crediting that argument would penalize the
14
Our dissenting colleague characterizes the FDA’s
preliminary discussions differently, insisting that the FDA’s
statements suggesting that menthol-flavored ENDS could be
less harmful to public health reflected a “policy position,”
Dissent at 12, and that the FDA then “changed the agency’s
menthol policy ‘out of Logic’s sight,’” id. at 8. But the very
portions of the record that the dissent has quoted contradict this
characterization. See id. at 10 (citing agency’s language in the
Deficiency Letter indicating that menthol products “may have
lower youth appeal”); id. at 11 (citing an internal FDA memo
explaining that menthol-flavored ENDS offered a “potential
means by which some adult smokers might seek to transition
completely away from combusted tobacco products to
potentially less harmful tobacco products”). These portions of
the record underscore the tentative and preliminary nature of
the agency’s inconclusive inclinations before it issued the
Marketing Denial Order.
15
To be clear, Logic’s advocacy is the lone source for
the dissent’s assertion that the FDA rejected Logic’s
applications as “a matter of policy, not science.” Dissent at 6.
The dissent cites a report outside the record for that
proposition. See id. (citing Lauren Silvis et al., Reagan-Udall
Found., Operational Evaluation of Certain Components of
FDA’s Tobacco Program (“Reagan-Udall Report”) 15 (2022),
https://perma.cc/NP3A-3QNJ). But that report does not
27
Center for engaging in the “ongoing dialogue” and deliberation
that is supposed to be the hallmark of reasoned agency
decision-making. 16 See Avail Vapor, 55 F.4th at 424.
It is also notable that these debates took place within the
FDA, out of Logic’s sight, and therefore could not have
“engendered serious reliance interests that must be taken into
account.” Regents, 140 S. Ct. at 1913 (quoting Encino
Motorcars, 579 U.S. at 222). The Fourth Circuit ably
explained why deliberations like these cannot fall within the
concern Logic’s application. See Lauren Silvis et al., Reagan-
Udall Found., Operational Evaluation of Certain Components
of FDA’s Tobacco Program (“Reagan-Udall Report”) 15
(2022), https://perma.cc/NP3A-3QNJ. Instead, the report
generally acknowledges that weighing an ENDS application’s
public health benefits to adult smokers (who may use the
product to quit combustible tobacco products) against the risks
to youth non-smokers (whom the product may appeal to)
implicates policy questions as well as scientific ones. But that
assertion is clearly irrelevant here, where the FDA determined,
as a scientific matter, both that Logic’s menthol-flavored
ENDS posed a risk to youth non-smokers and that there was
insufficient evidence of any benefits to adult smokers. JA 914,
945, 951. The FDA therefore did not need to engage in the
weighing analysis that the Reagan-Udall Report characterizes
as a policy decision.
16
Nor was there anything untoward about the Center
considering the possibility that the standard it was adopting
amounted to a per se anti-flavoring rule. The Center is to be
commended, not disparaged, for considering this possibility
and taking pains to rule it out.
28
APA’s reach in Avail Vapor, another case denying an ENDS
manufacturer’s petition. There, the petitioner raised concerns
about internal FDA memoranda discussing the weight that the
agency was going to accord certain evidence in premarket
applications. See Avail Vapor, 55 F.4th at 423–24. Judge
Wilkinson forcefully rejected the petitioner’s assertions that
these memoranda exposed a turnabout in FDA policy: “What
Avail fails to recognize . . . is that these internal documents
were just that: internal,” and agencies merit “latitude in their
internal discussions and debates” that “needs to be broad in the
case of a statutory charge as general as this one, where internal
discussions involve complex predictions within the [FDA’s]
area of special expertise.” Id. at 424 (internal quotation marks
and citations omitted); see also Regents, 140 S. Ct. at 1913–15.
A contrary rule, he observed, would lead to “gridlock, an
agency decisional process robbed of the value of ongoing
dialogue.” Avail Vapor, 55 F.4th at 424.
Echoing the Fourth Circuit, we will not “locate a point
where agency deliberations become frozen in time.” Id. We
also will not acquiesce in binding the FDA to what were, by
their own terms, the preliminary recommendations of one
section of one of its divisions or require it to offer an additional
explanation under Regents and Fox Television as a penalty for
engaging in an iterative, deliberative discussion. Id.; cf.
Fertilizer Inst., 163 F.3d at 778 (holding that the EPA did not
need to justify updating its definition of “chronic health
effects” from the one it had put in an unpromulgated draft
guideline); but see R.J. Reynolds Vapor, 65 F.4th at 192.
Reasoned disagreement among civil servants is the stuff of
good government, not APA violations.
C. Change in evidentiary standard for menthol
29
Stripped of the hyperbole that the FDA laid down a
blanket anti-menthol policy, the record reflects nothing more
than the application to menthol-flavored ENDS of the same
regulatory framework and evidentiary standard that the agency
had applied previously to other non-tobacco flavored ENDS
and that we upheld in Liquid Labs. See 52 F.4th at 542–43.
Analyzing new information under the same framework is no
change at all as far as the APA is concerned. 17
Here, too, we part ways with the Fifth Circuit, which
accepted the argument that the FDA had changed course with
respect to (1) the types of evidence that would be required for
a premarket application to win approval, and (2) the
appropriate comparator for menthol-flavored ENDS. R.J.
Reynolds Vapor, 65 F.4th at 190. We already tread this ground
in Liquid Labs, where we held that the FDA’s evidentiary
requirements did not constitute a “surprise switcheroo.” 52
F.4th at 540. Even if Liquid Labs had not paved the way,
however, we would reach the same conclusion here about the
FDA’s guidance for menthol premarket applications
specifically.
17
The record does not support the proposition, espoused
by the dissent, that the framework the FDA applied to Logic’s
application was “previously reserved for non-menthol flavored
ENDS.” Dissent at 1. What it does reflect is that the agency
established a framework that it determined was appropriate to
assess whether the marketing of ENDS was health-appropriate,
and it proceeded to apply that framework to ENDS products in
descending order of enforcement priority, starting with fruit-
flavored ENDS and eventually turning to menthol- and mint-
flavored ENDS.
30
To review, the Premarket Application Guidance advised
ENDS manufacturers in 2019 that “well-controlled
investigations” would be necessary for their products to remain
on the market, and that “[n]onclinical studies alone” probably
would not be enough to win approval. JA 1027. The FDA
made clear what it was looking for, recommending that
applicants “compare the health risks of its product to . . .
products within the same category and subcategory” that “are
most likely to [be] considered interchangeable.” JA 1028. For
Logic’s products, that meant menthol combustible cigarettes
and tobacco-flavored ENDS.
Those expectations were not lost on Logic. Our
dissenting colleague asserts that “Logic had no reason to
compare menthol products to tobacco products.” Dissent at
16. But the Premarket Application speaks for itself, as Logic
made a point of providing those comparisons in the
application. They included randomized controlled studies that
juxtaposed the observed change in cigarette consumption for
subjects who received Logic’s menthol-flavored ENDS with
the same effect for subjects who received Logic’s tobacco-
flavored ENDS. And at argument, Logic sought to persuade
us that this comparison should have resulted in a favorable
decision because its studies allegedly proved the decreases
were attributable to the ENDS’ menthol flavor alone. 18
18
Indeed, counsel argued that the FDA “overlooked”
the aspects of Logic’s submission that “do exactly what they
claim to want to do, which is the comparison between the
actual efficacy of switching between the menthol flavored ends
and the tobacco flavored ends.” Oral Arg. Tr. 18:10-14.
31
But that is not quite right. Logic included a
comparison, but not one that was statistically significant. As
the Technical Project Lead Review pointed out, these studies
“were not designed to address direct comparisons between
Logic’s menthol-flavored ENDS and tobacco-flavored ENDS
(or any other flavor combinations).” JA 949. So the problem
was not that Logic had no reason to compare menthol products
to tobacco products, but that it failed its statutory responsibility
to present “well-controlled investigations.” 21 U.S.C.
§ 387j(c)(5)(A).
No matter, Logic retorts, because the APA violation
here was the FDA’s “egregious” “bait-and-switch” in telling
Logic in a Deficiency Letter that Logic should compare its
menthol-flavored ENDS to other flavored ENDS, and then
insisting that it compare those products to tobacco-flavored
products instead. Opening Br. at 40. This argument might
have traction if the FDA indeed had tacked on “an additional,
previously undisclosed evidentiary requirement” for the
approval of Logic’s menthol-flavored ENDS, id. at 40–41, and
failed to communicate it to the company. See SmithKline
Beecham, 567 U.S. at 156–57. But that is not what happened
here.
The part of the Deficiency Letter to which Logic refers
concerned only its Premarket Applications for certain fruit
flavors, not the menthol-flavored ENDS at issue in this case.
Cf. Fontem US, LLC v. FDA, __F.4th__, 2023 WL 5536194, at
According to counsel, the comparison between menthol-
flavored ENDS and tobacco-flavored ENDS “was there in
plain black and white in the submission.” Id. at 20:19-20.
32
*9 (D.C. Cir. Aug. 29, 2023) (determining that the FDA
“pull[ed] a surprise switcheroo” by representing in a deficiency
letter that the information being requested “would be sufficient
for the agency to approve Fontem’s products” but later denying
Fontem’s application because Fontem failed to provide
additional information). The FDA had made clear already both
the appropriate comparators, including tobacco, and the types
of data that would show their relative efficacy. See Liquid
Labs, 52 F.4th at 539–40. Nothing in the Deficiency Letter
changed those standards. 19
19
The Enforcement Priorities do not compel a different
conclusion. That document did not modify the FDA’s
guidance about the evidentiary standards to which the agency
would subject premarket applications for menthol-flavored
ENDS. It only set the order in which the FDA would launch
enforcement actions against “certain deemed tobacco products
that do not have premarket authorization.” JA 1108. Our
dissenting colleague characterizes the Enforcement Priorities
differently, suggesting that statements in that document are
probative of a prior agency policy. But this characterization
contradicts the FDA’s own description of the document, which
explained that it merely delineated the agency’s enforcement
priorities and was “not binding on FDA or the public.” JA
1108. The dissent may disagree with the agency’s description
of its document or, like Logic, may disagree with the agency’s
scientific determination. But agree or disagree, on matters of
science we may not “substitute [our] judgment for that of the
agency.” See Sierra Club v. U.S. Env’t Prot. Agency, 972 F.3d
290, 298 (3d Cir. 2020) (quoting Motor Vehicle Mfrs. Ass’n v.
State Farm Mut. Auto Ins. Co., 463 U.S. 29, 43 (1983)).
33
In sum, because the FDA’s Marketing Denial Order
applied the same standard it had been applying since 2019 to
other non-tobacco flavors, Logic cannot rest its APA claim on
any unfair surprise.
D. Conformity with the evidence before the
agency
Logic next asserts that the Marketing Denial Order and
Technical Project Lead Review “fall[] short of the ‘reasoned
decisionmaking’ standard mandated by the APA,” Opening Br.
at 50 (quoting Michigan, 576 U.S. at 750), because the FDA
incorrectly weighed the evidence it submitted, and improperly
discounted its “product-specific” evidence, relying instead on
“general claims concerning other menthol- and candy and fruit
flavored ENDS products,” id. at 49. The record tells a different
story.
1. Benefits to adults
Logic challenges the FDA’s conclusion that the
potential benefit of menthol-flavored ENDS—their ability to
serve as a substitute for menthol cigarette smokers—was
largely illusory. Its menthol-flavored ENDS, it maintains, “are
both preferred to and likely more effective than its tobacco-
flavored ENDS in helping adult smokers reduce their
combustible cigarette use or quit smoking altogether.”
Opening Br. at 48.
The Tobacco Control Act, however, requires the agency
to assess whether “existing users of tobacco products will stop
using such products.” 21 U.S.C. § 387j(c)(4) (emphasis
added). The lodestar is not what products smokers may prefer,
34
but what products they actually use. Yet Logic’s data proved
the former, not the latter. As the FDA explained at length in
the Technical Project Lead Review, its Premarket Application
“assess[ed] precursors to . . . product use behavior” like
quitting, JA 951, and did not show a differential benefit for the
menthol-flavored ENDS over and above its tobacco-flavored
ones. While Logic may quarrel with the appropriateness of that
standard, we already crossed that bridge in Liquid Labs. 52
F.4th at 542–43. That precedent controls.
So does the FDA’s scientific judgment about the
validity of Logic’s studies. As Article III judges, “[w]e are
‘particularly reluctant to second-guess agency choices
involving scientific disputes that are in the agency’s province
of expertise.’” N.J. Env’t Fed’n, 645 F.3d at 230 (quotation
omitted); Fertilizer Inst., 163 F.3d at 777. When asked to
determine whether agency action was arbitrary or capricious,
our job is only to (1) assess the sufficiency of the agency’s
review of the record, (2) ensure the agency offered a reasoned
explanation for its decision, and (3) confirm the explanation
accords with that record. See State Farm, 463 U.S. at 43. We
overstep when we purport to substitute our judgment for the
agency’s as to the statistical validity or ultimate findings of
clinical studies. N.J. Env’t Fed’n, 645 F.3d at 230.
Yet that is precisely what Logic asks us to do. And
Logic does not argue that the FDA ignored the evidence.
Instead, it contends that the FDA did not weigh the evidence to
Logic’s liking. It objects that, after looking at the evidence that
Logic’s menthol-flavored ENDS would get smokers to stop
smoking, the FDA found that evidence lacking and discounted
the company’s studies accordingly. So this is not a situation
where the FDA failed to “address the potential benefits of [the
35
applicant’s] products for the public at large” or to “consider the
possibility that existing users of combustible tobacco products
such as cigarettes would reap health benefits by transitioning
to [Logic’s] products.” Fontem US, LLC, 2023 WL 5536194,
at *7. This is instead a scientific debate, so the “fundamental
principle of judicial restraint” dictates that we avoid it.
Washington State Grange v. Washington State Republican
Party, 552 U.S. 442, 450 (2008).
It is enough for our purposes that the FDA’s decision to
deny Logic’s Premarket Application was not “without
substantial basis in fact” and was “within [the FDA’s] area of
competence.” N.J. Env’t Fed’n, 645 F.3d at 230 (quotation
omitted).
2. Risks to children
Logic’s arguments on the other side of the health-
appropriateness scale fail for similar reasons. Logic contends
it was arbitrary and capricious to issue a Marketing Denial
Order to a company whose products were so unpopular with
kids, taking particular exception to the FDA’s reliance on
“general statistics [that] do not account for Logic’s particular
products.” Opening Br. at 51, 53. In Logic’s view, the only
way the agency could reject its Premarket Application was by
“resort[ing] to improper speculation . . . further demonstrating
that the FDA did not care at all about the evidence concerning
Logic’s particular product.” Id. at 53.
Under the Tobacco Control Act, however, the FDA was
well within its rights to rely on both Logic’s product-specific
evidence and broader scientific literature about the appeal of
menthol. The Act permits the agency to look at “any . . .
36
information before the Secretary with respect to such tobacco
product,” 21 U.S.C. § 387j(c)(2)(A), including, “when
appropriate, . . . well-controlled investigations, which may
include . . . clinical investigations by experts,” id.
§ 387j(c)(5)(A), or other “valid scientific evidence” that “is
sufficient to evaluate the tobacco product,” id. § 387j(c)(5)(B).
Taken together, Congress set limitations on the quality of the
evidence consulted by the agency— i.e., whether the studies
are “well-controlled,” or whether the other evidence is
“valid”—but not on the subject matter or scope of that
evidence—i.e., whether it only analyzed a specific applicant’s
ENDS. Of course, scientific evidence may be more persuasive
when it evaluates the particular ENDS at issue, but that does
not render otherwise “valid” general evidence irrelevant or
incompetent.
Nor was the Center’s conclusion about menthol’s
appeal to children improperly “speculative.” Opening Br. at
49. The agency was acting pursuant to Congress’s express
directive in the Tobacco Control Act. When making the
health-appropriateness determination, the FDA must look at
“the risks and benefits to the population as a whole.” 21 U.S.C.
§ 387j(c)(4). “Risk” encompasses far more than facts currently
known to an agency beyond a reasonable doubt—assessing
risk requires looking to the future, i.e., examining “the chance
of injury, damage, or loss[, especially] the existence and extent
of the possibility of harm.” Risk, Black’s Law Dictionary (11th
ed. 2019). There is nothing improper under the APA about the
Center prognosticating what will happen to children’s menthol
use as other flavored ENDS exit the market. It made reasoned
projections based on market responses to previous enforcement
actions, and it did so pursuant to a statute that not only permits
it to forecast, but requires it to do so. See Avail Vapor, 55 F.4th
37at 424. The conclusions the FDA reached as a result thus
comport with its statutory mandate.
Logic seeks to change the calculus, touting its efforts to
avoid marketing to children, but the FDA’s skepticism on this
score also had a reasoned basis. In Liquid Labs, we upheld the
FDA’s marketing denial order even though the agency had
ignored the manufacturer’s marketing plan because “there
[was] no indication the plan would have made up for the
deficiencies the FDA identified in Liquid Labs’ applications.”
52 F.4th at 543 (citations omitted). Here, the FDA did analyze
Logic’s marketing plan and found it lacking, clearing the low
bar we set in Liquid Labs. The statute is not preoccupied with
whether children are deterred from buying Logic’s products; it
focuses instead on the much broader question of whether they
are deterred from using them. See 21 U.S.C. § 387j(c)(4). And
the evidence has shown for years that marketing restrictions
like Logic’s do not cut down on youth use sufficiently to
change the health-appropriateness balance.
E. Transition period
Finally, Logic complains that, in its treatment of its
menthol-flavored ENDS, the FDA modified its purported
“policy when removing marketing authorization for drugs,
tobacco, or other products already on the market to give
manufacturers a reasonable transition period before requiring
that they remove their products completely from the market.”
Opening Br. at 57. But the products it identifies that received
transition periods share little in common with Logic’s menthol-
38
flavored ENDS. 20 See, e.g., 85 Fed. Reg. 13,312, 13,349 (Mar.
6, 2020) (electrical stimulation devices “for self-injurious or
aggressive behavior”); 83 Fed. Reg. 50,490, 50,502 (Oct. 9,
2018) (styrene for food flavoring); 81 Fed. Reg. 91,722, 91,728
(Dec. 19, 2016) (powdered surgeon’s gloves). Nor do the few
instances in which the FDA has issued ENDS manufacturers
an administrative stay add up to an established agency policy.
See Bennett, 520 U.S. at 177–78. And with approximately
2,110,000 students using flavored ends in 2022 and youth
continuing to migrate to menthol-flavored ENDS in the
absence of fruit-flavored ENDS, the FDA could reasonably
conclude that immediate removal of these products from the
marketplace was “appropriate for the protection of the public
health.” 21 U.S.C. § 387j(c)(2)(A).
IV. Conclusion
The FDA here fulfilled its statutory mandate in all
respects. It saw a public health crisis—youth vaping—
20
In its Reply Brief, Logic suggests that the dearth of
tobacco-related transition periods supports its argument
because the “FDA is admitting that it has treated tobacco
products, including even some ENDS products, worse than
non-tobacco products,” which “itself violates the APA”
because the FDA “provides no reasoned explanation as to why
ENDS products should be treated more harshly than other
types of products.” Reply Br. at 27. Because this argument
was not pressed in Logic’s Opening Brief, it is forfeited. See
Barna v. Bd. of Sch. Dirs. of Panther Valley Sch. Dist., 877
F.3d 136, 146 (3d Cir. 2017) (citing In re Grand Jury, 635 F.3d
101, 105 n.4 (3d Cir. 2011)).
39
unfolding at the sweet spot of its expertise and the core of the
jurisdiction it was given in the Tobacco Control Act. It
reasonably prioritized among the products at issue, and when
it reached menthol-flavored ENDS and Logic’s Premarket
Application, the scientific studies and market changes in the
interim led it to conclude the marketing of that product was not
“appropriate for the protection of the public health.” 21 U.S.C.
§ 387j(c)(2)(A). That was a reasoned decision, with
substantial basis in fact, and thus did not run afoul of the APA
or the Tobacco Control Act.
For the foregoing reasons, we will deny Logic’s petition
for review.
40
PORTER, Circuit Judge, dissenting.
The majority concludes that the FDA’s secret, unex-
plained policy decision to treat menthol electronic delivery
systems (ENDS) like fruit-and-dessert-flavored ENDS was not
arbitrary and capricious but an example of “good government.”
Maj. Op. at 29. Logic Tech (Logic) was therefore foolish to
rely on the agency’s previous representations that (1) menthol
and tobacco ENDS were different than flavored ENDS and (2)
Logic needn’t demonstrate that its menthol products are more
likely to promote cigarette reduction compared to tobacco-
flavored products. The majority says Logic has no ground to
complain that the agency disregarded its own scientific conclu-
sions and denied Logic’s menthol ENDS applications using an
evidentiary standard previously reserved for non-menthol fla-
vored ENDS.
I view the FDA’s actions differently. Before July 2022,
it treated menthol ENDS like tobacco ENDS and told Logic
that was its policy. According to the agency, menthol offered
benefits to smokers wanting to transition from combustible
cigarettes and posed less risk to youth, who prefer sweet and
fruity flavors. But that month, unbeknownst to Logic, the
agency abruptly changed its policy and lumped menthol
together with fruit, candy, and dessert flavors. The FDA never
informed Logic of the policy shift until after it denied Logic’s
menthol-product applications. Because the agency failed to
give a reasoned analysis or detailed justification for the policy
change, I respectfully dissent.
1
I
In July and August 2019, Logic submitted Premarket
Tobacco Product Applications (PMTA) for fifteen ENDS.
Three of the PMTAs were for menthol products.
While the applications were pending, the FDA twice
communicated to Logic that it viewed menthol ENDS more
like tobacco ENDS and not like flavored ENDS. In April 2020,
the agency published guidance describing its ENDS enforce-
ment priorities: It would target unlawfully marketed “flavored,
cartridge-based ENDS products (other than tobacco- and
menthol-flavored).” J.A. 1109. By targeting fruit and other fla-
vored products but not tobacco or menthol products, the FDA
said it sought to “strike[] an appropriate balance between
restricting youth access to [fruit and mint products], while
maintaining availability of potentially less harmful options for
current and former adult smokers who have transitioned or
wish to transition completely away from combusted tobacco
products.” J.A. 1126.
In June 2020, the FDA issued a deficiency notice to
Logic requesting additional information that was “needed for a
marketing granted order determination.” J.A. 3010. The FDA
requested, among other things, additional data comparing the
use of “products with fruit- or fruit-combination flavors,”
which “pose particular risks for youth initiation and progres-
sion to regular ENDS use,” to “tobacco- or menthol-flavored
products, which may have lower youth appeal.” J.A. 3016.
Pointedly, the notice did not request such data comparing men-
thol to tobacco products. This was the final correspondence
that Logic received from the FDA until the MDO was issued.
2
By March 2022, every discipline within the Office of
Science (OS) concluded that Logic’s menthol products should
be approved for marketing. At a PMTA Preliminary
Assessment Meeting in May 2021, the Engineering,
Chemistry, Microbiology, Behavioral and Clinical
Pharmacology, and Medical Disciplines and the Office of
Compliance and Enforcement identified no deficiencies with
any Logic PMTA. The Toxicology and Environmental Science
Disciplines joined their cohorts after a second review of
Logic’s PMTAs in March 2022. And that same month, the
Social Science and Epidemiology Disciplines advised that
Logic’s menthol and tobacco products be approved for market-
ing but recommended that Logic’s fruit and fruit-combination
applications be denied. Social Science noted that the “menthol
flavored new products . . . have lower youth appeal,” J.A.
3097, and “may offer menthol cigarette smokers an appealing
option to transition away from combusted cigarette smoking,
an option particularly important given some menthol smokers’
lower rates of combusted cigarette cessation,” J.A. 3101.
Epidemiology, similarly, distinguished menthol from other fla-
vored ENDS by expressing its “concerns regarding the lack of
evidence on the new products’ with non-tobacco/non-menthol
characterizing flavors ability to facilitate switching or cigarette
reduction among adult combusted cigarette smokers.” J.A.
3067.
Given these recommendations, the OS decided that
Logic’s menthol products merited approval. It found that that
the “potential benefit” of adult menthol smokers switching
from combustible cigarettes to menthol ENDS “amounted to a
likelihood of greater cessation or significant reduction in
smoking that would outweigh the known risks to youth from
the marketing of the products, sufficient to meet the legal
3
standard for authorization.” J.A. 908 (Cecil Memo). On March
24, 2022, FDA approved PMTAs for Logic’s e-cigarette
devices and tobacco-flavored products and denied the applica-
tions for fruit- and fruit-combination-flavored products, but it
did not announce a decision on Logic’s menthol products.
In July 2022, after each of the OS disciplines had
cleared Logic’s menthol applications, Brian King was
appointed Office of the Center Director (OCD) of the Center
for Tobacco Products (CTP). King immediately changed the
FDA’s approach to menthol ENDS, communicating to the OS,
through his Senior Science Advisor, that for the first time, “the
approach to menthol-flavored ENDS should be the same as
for” fruit, candy, and dessert flavored ENDS. J.A. 909 (Cecil
Memo).
Chastened by the new directive, OS leadership acqui-
esced to King’s policy decision “to treat menthol-flavored
ENDS PMTAs in the same way as other non-tobacco-flavored
ENDS PMTAs regarding the evidence needed to show a
potential benefit to adult smokers.” J.A. 909.
King explained the agency’s new menthol policy in an
internal memo dated October 25, 2022. Without citing any sci-
entific studies or published articles, he asserted that “scientific
evidence on the role of flavors in youth use of ENDS is signif-
icantly more rigorous and robust than the preference data con-
cerning menthol combustible cigarette smokers.” J.A. 905
(King Memo). Therefore, “robust evidence of benefit is
required to overcome the risk to youth and show that authoriz-
ing the marketing of a menthol-flavored ENDS would be
appropriate for the protection of the public health.” Id.
4
The majority insists that this decision was made, not “in
a vacuum,” but with “feedback from Office of Science staff-
ers.” Maj. Op. at 14. I read the Cecil and King memoranda very
differently.
The decision to change the agency’s menthol policy was
made unilaterally by the new OCD after the OS divisions
approved Logic’s menthol applications and before consultation
with OS. After the policy change was a fait accompli, OS lead-
ership complied based on its “new awareness and understand-
ing of the OCD position,” as Cecil delicately wrote in his after-
the-fact memo. J.A. 909. Still later, OS staff who had under-
taken the menthol-flavored ENDS reviews—and whose scien-
tific conclusions were overridden by the new policy—were
given the opportunity to speak with the CTP Ombuds regarding
the new approach. J.A. 905.
No one at the FDA informed Logic of the policy change.
Nor did the agency give Logic an opportunity to amend the
menthol-product PMTAs in response to the new policy. The
agency simply relied on the new policy to deny Logic’s appli-
cations on October 26, 2022—one day after King wrote his
internal memo justifying the shift.
In the Marketing Denial Order (MDO), the FDA
explained for the first time that under the new policy it required
“a randomized controlled trial, longitudinal cohort study, or
other evidence demonstrating the benefit of the new products
to adult smokers relative to tobacco-flavored ENDS products.”
J.A. 2. Logic’s PMTAs were deemed insufficient because—of
course—they lacked the now-required evidence.
5
II
As the majority properly observes, “[w]e are particu-
larly reluctant to second-guess agency choices involving sci-
entific disputes that are in the agency’s province of expertise.”
Maj. Op. at 22 (quoting N.J. Env’t Fed’n v. NRC, 645 F.3d 220,
230 (3d Cir. 2011) (quotation marks omitted)). But the FDA’s
choice was a matter of policy, not science. See Lauren Silvis et
al., Operational Evaluation of Certain Components of FDA’s
Tobacco Program, Reagan-Udall Found. 15 (2022),
https://perma.cc/NP3A-3QNJ. 1 Indeed, OCD’s policy change
overrode the unanimous OS divisions’ careful scientific anal-
yses. Id. at 15 (observing that “a lack of clarity about the dis-
tinction between, and the intersection between, policy and sci-
ence has created controversy within CTP and may lead to a
perception that the Center’s scientific integrity is being chal-
lenged when, in fact, policy decisions that transcended the sci-
ence are being made”) (emphasis added).
Because the FDA’s decision to treat menthol ENDS like
other flavored ENDS rather than tobacco was a policy change,
the FDA was required to “supply a reasoned analysis.” 2 Motor
1
The Reagan-Udall Foundation is an independent organization
created by Congress to support the FDA. Silvis et al., supra, at
5. In 2022, the Foundation performed an independent evalua-
tion of the CTP and PMTA review process upon the request of
FDA Commissioner Robert Califf. Id.
2
The majority emphasizes that the policy change was wholly
internal. See Maj. Op. at 28 (“It is also notable that these
debates took place within the FDA, out of Logic’s sight.”). But
that’s precisely the problem. As far as Logic knew, the FDA’s
previously communicated policy was that menthol ENDS
offered benefits to menthol smokers and were less appealing to
6
Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins.
Co., 463 U.S. 29, 57 (1983) (quoting Greater Boston
Television Corp. v. FCC, 444 F.2d 841, 852 (D.C. Cir. 1970));
see also CBS Corp. v. FCC, 663 F.3d 122, 138 (3d Cir. 2011)
(“[An agency] cannot change a well-established course of
action without supplying notice of and a reasoned explanation
for its policy departure.”). Although an agency “is not pre-
cluded from announcing new principles in an adjudicative pro-
ceeding,” NLRB v. Bell Aerospace Co., 416 U.S. 267, 294
(1974), it “acts arbitrarily if it departs from its established prec-
edents without ‘announcing a principled reason’ for the depar-
ture,” Johnson v. Ashcroft, 286 F.3d 696, 700 (3d Cir. 2002)
(quoting Fertilizer Inst. v. Browner, 163 F.3d 774, 778 (3d Cir.
1998).
At a minimum, the agency must “display awareness that
it is changing position.” FCC v. Fox TV Stations, Inc., 556 U.S.
502, 515 (2009). It cannot “depart from a prior policy sub
silentio[.]” Id. An agency “fail[ing] to acknowledge that it has
changed its policy . . . is unable to comply with the requirement
under State Farm that an agency supply a reasoned explanation
for its departure from prior policy.” CBS Corp., 663 F.3d at
151–52.
When a “new policy rests upon factual findings that
contradict those which underlay its prior policy; or when its
prior policy has engendered serious reliance interests that must
be taken into account,” the agency must “provide a more
detailed justification than what would suffice for a new policy
created on a blank slate.” Fox TV Stations, Inc., 556 U.S. at
515. As part of that “more detailed justification” the agency
youth, so menthol, like tobacco, would be treated differently
than other flavors.
7
“must consider the alternatives that are within the ambit of the
existing policy” and the reliance interests at stake, their signif-
icance, and their weight against competing policy concerns.
DHS v. Regents of the Univ. of Cal., 140 S. Ct. 1891, 1913,
1915 (2020) (quotation marks, citation, and brackets omitted);
see also Prohibition Juice Co. v. FDA, 45 F.4th 8, 20 (D.C.
Cir. 2022) (“Agencies must explain changes in position, par-
ticularly once a prior position has engendered regulated par-
ties’ reliance.”).
To survive the arbitrary and capricious standard of
review, the FDA must first have acknowledged that it changed
its menthol policy and then provided a reasoned analysis for
the change that addressed Logic’s reliance interests and con-
sidered available alternatives. It did not do so. Instead, King
overruled the OS divisions, changed the agency’s menthol pol-
icy “out of Logic’s sight,” and then the agency denied Logic’s
menthol PMTAs because they failed to meet an undisclosed
evidentiary standard. That is not “good government.” Maj. Op.
at 29.
The majority asserts that these “internal” debates do not
reflect a policy change because, “fundamentally,” they do not
constitute “final agency action” under the APA. Maj. Op. at 25
(quoting 5 U.S.C. § 704). That is, the majority argues that the
debates reflected in documents like the King Memo do not
“trigger a heightened burden for the FDA” under Regents
because they were “nowhere close to a final decision.” Maj.
Op. at 26, 27. Thus, it concludes that these portions of the rec-
ord “cannot fall within the APA’s reach” and should not con-
trol our arbitrary-and-capricious review. Maj. Op. at 29.
I disagree with the majority’s description of judicial
review under the APA. It’s true that our review is limited to a
8
“final” agency action—the FDA’s denial of Logic’s PMTAs.
We must determine whether that denial was “reasonable and
reasonably explained.” Dep’t of Com. v. New York, 139 S. Ct.
2551, 2571 (2019). But under the APA and the Tobacco
Control Act, our review is not limited to the FDA’s proffered
explanations for the denial, located in the MDO and the
Technical Project Lead Review (TPL Review). We are
required to “review the whole [administrative] record” in
determining whether the FDA’s denial was reasonably
explained. 5 U.S.C. § 706. The FDA submitted the administra-
tive record, as defined for PMTA proceedings in 21 U.S.C.
§ 387l(a)(2)(C), on December 6, 2022. See Opening Br. at 28.
And the Cecil and King Memoranda were included in this sub-
mission. See Oral Arg. Tr. at 12:8–10 (noting that the “Cecil
and King memos . . . were part of the administrative record”).
Because these documents are a part of “the whole rec-
ord,” we must review them in determining whether the FDA’s
denial was reasonably explained. And because they show that
the FDA “change[d] course,” we must determine whether the
FDA’s explanation satisfied the requirements outlined in
Regents. 140 S. Ct. at 1913. Neither the APA nor the Tobacco
Control Act requires that these documents reflect any final
agency actions to serve this purpose.
The Supreme Court’s decision in Dep’t of Com. v. New
York supports this understanding of judicial review under the
APA. There, the Court found that the Secretary of Commerce’s
decision to include a citizenship question on the decennial cen-
sus failed the “reasoned explanation requirement of adminis-
trative law” under § 706. 139 S. Ct. at 2575. In reaching this
conclusion, the Court did not limit its review to the Secretary’s
proffered “explanation for agency action.” Id. It broadly con-
sidered “what the record reveal[ed] about the agency’s priori-
9
ties and decisionmaking process.” Id. This included several
communications that were not “final” agency actions under
§ 704, including letters that the Secretary exchanged with the
Department of Justice. Id. Accordingly, we may—indeed, we
should—consider documents like the King Memo in determin-
ing whether the FDA’s denial was reasonably explained. And
because those documents reveal a policy change, the FDA’s
explanation must satisfy Regents’ special requirements.
III
“Deciding whether agency action was adequately
explained requires, first, knowing where to look for the
agency’s explanation.” Regents of the Univ. of Cal., 140 S. Ct.
at 1907. For that we have the MDO and the TPL Review, which
provides in-depth explanation of the FDA’s reasons for denial.
See Liquid Labs LLC v. FDA, 52 F.4th 533, 537–38 (3d Cir.
2022) (relying on the same).
The FDA did not provide a principled reason for the
policy change in the MDO. The agency wrote, “There is sub-
stantial evidence that the use of menthol flavors in tobacco
products, like the menthol flavors in the new products, has sig-
nificant appeal to youth and is associated with youth initiation
of such products.” J.A. 2. But it did not explain why it adopted
this position despite telling Logic in the deficiency notice that
menthol products “may have lower youth appeal,” J.A. 3016,
or what had changed in the weeks following the Social Science
discipline’s March 18 conclusion that the “menthol flavored
new products . . . have lower youth appeal,” J.A. 3097.
The FDA also reported that it was “unable to determine
whether or to what extent [Logic’s] menthol-flavored new
products facilitate complete switching or significant cigarette
10
reduction as compared to tobacco-flavored ENDS products.”
J.A. 2–3. Again, the FDA did not explain why it abandoned its
earlier position that menthol ENDS offered a “potential means
by which some adult smokers might seek to transition com-
pletely away from combusted tobacco products to potentially
less harmful tobacco products.” J.A. 1125.
Nor did the FDA explain why it never requested a com-
parison between menthol and tobacco products in the defi-
ciency letter despite specifically asking Logic to compare its
fruit and fruit-combination flavored ENDS to tobacco-flavored
ENDS.
So we must look for a principled reason for the policy
change in the TPL Review. The FDA acknowledged that it was
applying a novel approach to menthol ENDS. J.A. 3174 (“The
clear evidence of substantial use of menthol-flavored ENDS
products among youth also reflects evidence beyond what was
available at the time that FDA issued [the 2019 enforcement]
guidance.”), 3179 (“This grouping of tobacco and menthol
together . . . reflected the perspective, at that time, that the
menthol ENDS products might not necessitate the same
strength of product-specific evidence of benefit that other fla-
vored ENDS require relative to tobacco flavored ENDS.”). But
it failed to provide sufficient reasons for the departure.
The project leader wrote in the TPL Review, “I disagree
with the social science reviewer’s conclusion” that menthol
ENDS are less appealing to youth than other flavors. J.A. 3180.
An unsubstantiated personal opinion is an insufficient reason
for a departure from agency policy.
The FDA cited several studies purporting to show that
the use of flavored ENDS, including menthol, was rising
11
among student populations as cause to abandon its previous
conclusion that menthol was less appealing to youth. These
studies are unavailing for several reasons.
First, the studies predated the earlier policy position.
See J.A. 3157 (studies from 2015 to 2020); 3171–72 (studies
from 2004 to 2022). OS was still adhering to that policy as late
as March 2022. See J.A. 3052–3156 (March 2022 OS Review
of PMTAs, treating flavored ENDS differently than menthol
and tobacco ENDS). So the July 2022 policy change was not
based on fresh scientific data that OS hadn’t already consid-
ered.
The National Youth Tobacco Surveys (NYTS), which
the majority cites as evidence that “[f]lavored e-cigarettes were
the driving force behind [the youth ENDS] epidemic,” Maj.
Op. at 7, show that ENDS use was relatively unchanged
between 2014 and 2022. In 2014, NYTS published that “65.1%
of high schoolers and 55.1% of middle schoolers who were
using ENDS said they were using non-tobacco flavor (includ-
ing menthol).” Id. In total, the NYTS estimated that 1,580,000
students used flavored ENDS in 2014. Corey et al., Flavored
Tobacco Use Among Middle and High School Students –
United States, 2014, Morbidity and Mortality Weekly Report
(Oct. 2, 2015), https://perma.cc/99KK-MHUN. Because
63.3% of ENDS users reported flavored use, this means that
roughly 2,496,000 students used ENDS of any kind in 2014.
See id.By 2022, the number of flavored ENDS users “had risen
to 85.5% for high schoolers and 81.5% for middle schoolers”
who were using ENDS of any kind. Maj. Op. at 7. But the data
showed only that the number of flavored ENDS users
increased, not the total number of ENDS users. NYTS esti-
12
mated that 2,110,000 students used flavored ENDS and that
2,550,000 students used ENDS of any kind in 2022. J.A. 1159.
Compared with the 2,496,000 student ENDS users in 2014,
there were only fifty thousand more in 2022.
These fifty thousand individuals may have been stu-
dents who would not have used any tobacco products but for
the availability of flavored ENDS. Or they may have been
individuals who would have otherwise consumed a different
tobacco product if not for the option of using ENDS—the
NYTS estimated that, in 2014, 2,950,000 students used a
tobacco product other than ENDS. Corey et al., supra. Because
the 2022 NYTS only surveyed ENDS use, the majority doesn’t
know how the use of other tobacco products might have
changed. See 21 U.S.C. § 387j(c)(4) (instructing the FDA to
consider “the increased or decreased likelihood that existing
users of tobacco products will stop using such products”).
And because neither the NYTS nor any other survey
independently assessed menthol ENDS use until 2022, the
majority’s confident assertion that the “gap [between menthol
and flavored ENDS use] was shrinking” is baseless. Maj. Op.
at 18. The 2014 NYTS grouped all flavors together and the
2019 NYTS grouped menthol and mint together. J.A. 3174;
Corey et al., supra. Without any data comparing menthol use
to other flavors, the majority cannot possibly know whether
“the gap was shrinking.” Maj. Op. at 18.
The majority seeks to bolster its assertion by reference
to the TPL Review, dated October 26, 2022 (the same day that
FDA sent Logic the MDO). Id. In particular, the majority
focuses on the TPL Review’s treatment of 2022 NYTS data.
But the majority’s discussion is misleading because it indulges
the post hoc ergo propter hoc fallacy. The 2022 NYTS results
13
first appeared in the CDC’s Morbidity and Mortality Weekly
Report dated October 7, 2022. J.A. 1158. There is no evidence
that King had or relied on them when he changed the policy
three months earlier, but the majority inexplicably assumes that
the October data informed the July decision.
In this and other instances, the majority omits too many
inconvenient facts in its comforting narrative of apolitical,
science-driven “good government,” so I must demur. My skep-
ticism is shared by a unanimous Fifth Circuit panel that con-
sidered a different manufacturer’s challenge to FDA’s rejec-
tion of its menthol-product PMTAs. See R.J. Reynolds Vapor
Co. v. FDA, 65 F.4th 182, 189 (5th Cir. 2023).
Oddly, the majority says the R.J. Reynolds decision
rejects “Logic’s rendition of a political appointee parachuting
in and dictating a new framework for the Office of Science to
adopt.” Maj. Op. at 24 (citing R.J. Reynolds, 65 F.4th at 192).
But that is precisely what the Fifth Circuit did find. Like me,
our sister circuit perceives that shortly after OS recommended
that the menthol-flavored PMTAs be granted “a new CTP
director appeared on the scene and told OS that ‘the approach
to menthol-flavored ENDS should be the same as for other fla-
vored ENDS . . . .’ OS then changed its position.” Id. at 192.
The R.J. Reynolds court characterized this as “strong evidence
that CTP developed and internally circulated new criteria for
evaluating PMTAs for menthol-flavored ENDS in Summer
2022 . . . .” Id. The Fifth Circuit’s analysis in R.J. Reynolds is
clear-eyed and correct, but the majority barely engages it. 3
3
The majority brusquely dismisses the Fifth Circuit’s decision,
asserting that “we already tread this ground in Liquid Labs,
where we held that the FDA’s evidentiary requirements did not
14
Importantly, the majority fails to consider what the FDA
did not say: The agency never discussed Logic’s reliance inter-
ests or “the alternatives that are within the ambit of the existing
policy.” See Regents of the Univ. of Cal., 140 S. Ct at 1913,
1915.
Neither the FDA nor the majority consider how Logic
may have reasonably relied on the previous policy of grouping
menthol and tobacco ENDS together. “Dealing with adminis-
trative agencies is all too often a complicated and expensive
game, and players like [Logic] are entitled to know the rules.”
R.J. Reynolds v. FDA, 65 F.4th at 189 (citation and quotation
marks omitted). “To keep things fair, agencies must give notice
of conduct the agency ‘prohibits or requires’ and cannot ‘sur-
constitute a ‘surprise switcheroo.’” Maj. Op. at 30. That is
plainly wrong. Unlike this case and R.J. Reynolds, our decision
in Liquid Labs addressed only fruit-and-dessert flavored ENDS
and not menthol-flavored or tobacco-flavored ENDS. Liquid
Labs, 65 F.4th at 537. The manufacturer’s “surprise switch-
eroo” argument in Liquid Labs was different from Logic’s
argument here. In Liquid Labs, the petitioner challenged the
FDA’s requirement that it perform randomized control trials or
longitudinal cohort studies after the agency had said in an
industry guidance document that such studies would not be
necessary. Id. at 540. Here, Logic is challenging the FDA’s
decision to treat menthol products like fruit, dessert, and candy
flavored ENDS despite previously treating menthol like
tobacco given its lower youth appeal and benefit as a combus-
tible cigarette alternative for adult smokers. The analogous
Fifth Circuit decision to Liquid Labs is not R.J. Reynolds but
Wages & White Lion Invs., LLC v. FDA, 41 F.4th 427 (5th Cir.
2022), reh’g granted, 58 F.4th 233 (5th Cir. 2023), which the
majority does not cite.
15
prise’ a party by penalizing it for ‘good-faith reliance’ on the
agency’s prior positions.” Id. (citing Christopher v. Smithkline
Beecham Corp., 567 U.S. 142, 156–57 (2012)).
The FDA dismissed Logic’s randomized clinical trials
as insufficient evidence that menthol encouraged switching
from combustible cigarettes. But, as Logic explained, the goal
of these studies was not to explore the benefits of menthol but
“to assess biomarkers of tobacco exposure and effect during a
60-day controlled switch to [a Logic ENDS] compared with
the continued use of combustible cigarettes or tobacco cessa-
tion.” J.A. 1946, 2312. Logic had no reason to compare men-
thol products to tobacco products because FDA never said it
required such information. The agency specifically instructed
Logic to compare its fruit and fruit-combination flavored
ENDS to tobacco ENDS in the deficiency notice, but “never
told [Logic] that similar evidence would be required for its
menthol . . . PMTA[s].” R.J. Reynolds, 65 F.4th at 190.
The FDA also failed to indicate that it considered alter-
natives to denying Logic’s applications. See Regents of the
Univ. of Cal., 140 S. Ct at 1913. For one, the agency could have
issued another deficiency notice asking Logic for data compar-
ing menthol products to tobacco products. In the TPL Review,
the FDA explained,
One approach to evaluate whether the menthol-
flavored varieties are more effective than
tobacco-flavored varieties at increasing com-
plete switching or significant reductions in [cig-
arettes per day], would have been to conduct a
study that randomized smokers of menthol ciga-
rettes to receive either the menthol- or tobacco-
flavored variety.
16
J.A. 3177. But this was the first time that FDA made that rec-
ommendation to Logic, and it only came by way of explaining
why the PMTAs were denied. FDA could have issued a second
deficiency notice asking for more information regarding the
benefits of menthol in light of its new menthol policy. 4 See,
e.g., R.J. Reynolds, 65 F.4th at 191 (noting that the FDA
accepted thirteen amendments to R.J. Reynolds’ non-menthol
and non-tobacco PMTAs). That’s not to say that the FDA had
to issue a second deficiency notice, but it was at least required
to take Logic’s reliance interest into account.
IV
The FDA “cannot change a well-established course of
action without supplying notice of and a reasoned explanation
for its policy departure.” CBS Corp., 663 F.3d at 138. That is
exactly what happened here. Without such explanation, the
agency’s action was arbitrary and capricious, so I respectfully
dissent.
4
The FDA is required to act on an application in 180 days. 21
U.S.C. § 387j(c)(1)(A). But that deadline had long since
elapsed. Logic’s PMTAs had been pending for three years.
There would have been no harm in delaying a decision to per-
mit Logic to perform a “long-term (i.e. six months or longer)”
study on the benefits of menthol. J.A. 3175 n.15.
17