FDA v. Wages and White Lion Investments, LLC

P R E L I M I N A R Y P R I N T
Volume 604 U. S. Part 2
Pages 542–592
OFFICIAL REPORTS
OF
T H E S U P R E M E C O U R T
April 2, 2025
REBECCA A. WOMELDORF
reporter of decisions
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N O T I C E : This preliminary print is subject to formal revision before
the bound volume is published. Users are requested to notify the Reporter
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pio@supremecourt.gov, of any typographical or other formal errors.

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542 OCTOBER
TERM, 2024
Syllabus
FOOD AND DRUG ADMINISTRATION v. WAGES AND
WHITE
LION INVESTMENTS, L. L. C., dba TRITON
DISTRIBUTION, et al.
certiorari to the united states court of appeals for
the fth circuit
No. 23–1038. Argued December 2, 2024—Decided April 2, 2025
This case concerns whether the Food and Drug Administration (FDA) law-
fully denied respondents authorization to market certain electronic nico-
tine delivery system products—known as electronic cigarettes, e-
cigarettes, or vapes. These products have rapidly gained popularity
during the past 20 years, offering existing smokers a potentially safer
alternative to traditional combustible cigarettes. But e-cigarettes
carry their own health risks, and the panoply of available favors—which
include not only traditional cigarette favors (like tobacco and menthol)
but also fruit, candy, and dessert favors—appeals to non-smokers, par-
ticularly younger Americans.
The FDA has long had the responsibility to determine whether manu-
facturers may market new drugs, but it was the passage of the Family
Smoking Prevention and Tobacco Control Act of 2009 (TCA) that frst
gave the FDA broad jurisdiction to regulate tobacco products. Al-
though the Act barred the FDA from banning all regulated tobacco
products outright, see 21 U. S. C. § 387g(d)(3), it prohibited a manufac-
turer from marketing any “new tobacco product” without FDA authori-
zation, see § 387j(a)(2)(A). One pathway to authorization of a “new
tobacco product” is the submission of a premarket tobacco product appli-
cation. See § 387j(c)(1)(A)(i). The TCA requires the FDA to deny such
an application unless an applicant shows that its product “would be ap-
propriate for the protection of the public health.” § 387j(c)(2)(A). To
determine this, the FDA must consider, among other things, “the risks
and benefts to the population as a whole” and “tak[e] into account” the
likelihood that users of existing tobacco products will stop using those
products and that non-users will start using them. § 387j(c)(4).
In 2016, in response to the surging youth demand for favored prod-
ucts, the FDA deemed e-cigarettes “tobacco products.” Given that
most e-cigarette products were not marketed in the United States be-
fore February 15, 2007, the vast majority of these products qualifed
as “new tobacco products” under the TCA. Most manufacturers of e-
cigarette products would thus need to comply with the TCA's
premarket-authorization regime to sell their products. This made the

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543
Syllabus
continued sale of most e-cigarette products illegal absent authorization.
So
to give these manufacturers adequate time to submit premarket to-
bacco product applications, the FDA delayed enforcement for two to
three years. See 81 Fed. Reg. 28977– 28978. Th is per mitted e-
cigarette products to remain on the market while manufacturers fled
their applications. A Federal District Court ultimately imposed a
deadline of September 9, 2020, for applications.
In the lead up to the application deadline, the FDA issued numerous
forms of guidance concerning premarket tobacco product applications
that orbited around four central themes: (1) the types of scientifc evi-
dence that would be required; (2) the importance of cross-product com-
parisons and investigations; (3) the FDA's enforcement priorities with
respect to device type; and (4) manufacturers' marketing plans, which
were described as “specifc restrictions on sale and distribution” meant
to deter new smokers from taking up e-cigarette products. App. 27.
In 2019, the FDA proposed a rule related to the submission of premar-
ket tobacco product applications, and the proposed rule distilled the four
topics discussed in the predecisional guidance. See 84 Fed. Reg. 50566,
50580, 50581, 50585, 50603.
Respondents submitted applications seeking approval to market and
sell favored e-liquids for open-system e-cigarettes. The FDA denied
respondents' applications, concluding they had not provided suffcient
scientifc evidence to demonstrate that the marketing of their products
would be appropriate for the protection of public health. Specifcally,
the FDA held respondents had not provided evidence from a randomized
controlled trial, longitudinal cohort study, or other “robust and reliable”
evidence that their dessert-, candy-, and fruit-favored products had
benefts over tobacco-favored products. Despite previously describing
marketing plans as “critical,” the FDA decided “for the sake of eff-
ciency” not to evaluate respondents' marketing plans. To each denial
order, the FDA appended a “Technical Project Lead (TPL) Review.”
See App. to Pet. for Cert. 177a, 285a. These lengthy documents, which
canvass the scientifc literature on youth e-cigarette use, refect the
FDA's evolving understanding of how favor, regardless of e-cigarette
device type, drives youth smoking initiation and nicotine addiction.
Respondents petitioned for judicial review of the FDA's denial orders
under the Administrative Procedure Act (APA). See § 387l(b) (citing 5
U. S. C. § 706(2)(A)). The Fifth Circuit, sitting en banc, granted re-
spondents' petitions for review and remanded to the FDA. The en banc
majority held that the FDA had acted arbitrarily and capriciously by
applying application standards different from those articulated in its
predecisional guidance documents regarding scientifc evidence, cross-
favor comparisons, and device type. The court expressed particular

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concern about the FDA's failure to review marketing plans it previously
deemed
critical. It also rejected the FDA's argument that any errors
were harmless.
Held:
1. As a preliminary matter, the Court declines to reach and thus ex-
presses no view on respondents' argument that the FDA erred in evalu-
ating respondents' applications under standards developed in adjudica-
tion rather than standards promulgated in notice-and-comment
rulemaking. This complicated question sweeps beyond the question
presented and lacks adequate briefng. P. 565.
2. The Fifth Circuit's conclusion that the FDA acted arbitrarily and
capriciously in its adjudication of manufacturers' premarket tobacco
product applications is vacated because the FDA's denial orders were
suffciently consistent with its predecisional guidance—as to scientifc
evidence, comparative effcacy, and device type—and thus did not run
afoul of the change-in-position doctrine. Pp. 566–586.
(a) The Court analyzes the Fifth Circuit's conclusion that the FDA
acted arbitrarily and capriciously under the change-in-position doctrine,
which provides that “[a]gencies are free to change their existing policies
as long as they provide a reasoned explanation for the change,” “ `display
awareness that [they are] changing position,' ” and consider “ `serious
reliance interests.' ” Encino Motorcars, LLC v. Navarro, 579 U. S. 211,
221–222 (quoting FCC v. Fox Television Stations, Inc., 556 U. S. 502,
515). This doctrine asks two questions: frst, whether an agency
changed existing policy, and second, whether the agency displayed
awareness of the change and offered good reasons for the new policy.
Pp. 566–571.
(b) The FDA's denial orders were suffciently consistent with its
predecisional guidance regarding scientifc evidence. The TCA states
that either “well-controlled investigations” or other “valid scientifc evi-
dence” if found “suffcient” may support a fnding that a new tobacco
produc t is “appropr iate for the protec ti on of the public hea lth. ”
§§ 387j(c)(5)(A)–(B). The TCA thus left the FDA broad discretion to de-
cide what sort of scientifc evidence an applicant was required to submit.
Across its various guidance documents, the FDA's main point was that
manufacturers who failed to submit evidence based on “well-controlled
investigations” would need to provide rigorous scientifc evidence that
the sale of their particular products would be appropriate for the protec-
tion of the public health. The applicants did not submit randomized
controlled trials or longitudinal cohort studies, so the fate of their appli-
cations turned on whether they submitted “other evidence” that met
the FDA's standard of scientifc rigor and relevance to their product.

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The FDA rejected respondents' applications because that test was not
met.
As evidence of a change in position, respondents point to the
FDA's July 9, 2021, internal memorandum, which stated that the failure
to submit evidence from a randomized controlled trial or longitudinal
cohort study would constitute a “fatal faw” that would “likely” result
in denial of an application. But the FDA issued a superseding memo-
randum, which recognized that “other evidence” may demonstrate a
product is “appropriate for the protection of the public health,” and the
FDA represents that it did not rely on the July 9, 2021, internal memo-
randum when adjudicating applications—a representation afforded a
presumption of regularity. Pp. 571–578.
(c) The FDA's comparative-effcacy requirement was not inconsist-
ent with its predecisional guidance. The TCA expressly contemplates
comparisons of different tobacco products, and the FDA's guidance elab-
orated on the types of comparisons that would be helpful. The FDA's
2019 guidance recommended that a manufacturer “compare the health
risks of its product to both products within the same category and
subcategory, as well as products in different categories as appropri-
ate,” and its 2020 enforcement guidance telegraphed the FDA's view
that dessert-, candy-, and fruit-favored products were more likely
than tobacco- and menthol-favored products to appeal to the young.
Thus, when the FDA denied respondents' applications for failing to dem-
onstrate the beneft of their favored products over tobacco-favored
products, it was following a natural consequence of its predecisional
guidance. Pp. 578–582.
(d) The FDA's treatment of device type did not violate the change-
in-position doctrine. The FDA's 2020 guidance did not establish a “safe
harbor” for non-cartridge-based products. Although the 2020 guidance
emphasized the FDA would prioritize enforcement against cartridge-
based products, it stated the FDA would also prioritize enforcement
against manufacturers “whose [products'] marketing is likely to promote
use by . . . minors.” That latter category seemingly covers respond-
ents' products. Even if the FDA had changed its position in this re-
spect, it offered “good reasons,” namely, evidence showing that youth
demand had moved from favored cartridge-based products to favored
disposable products. Fox Television, 556 U. S., at 515. From that evi-
dence, the FDA drew the reasonable inference that youth were most
strongly drawn by favor rather than device type. Pp. 582–586.
3. The Fifth Circuit relied on an overly broad reading of Calcutt v.
FDIC, 598 U. S. 623 (per curiam), to reject the FDA's claim of harmless
error regarding the agency's change of position on marketing plans.
The FDA does not contest that despite assuring manufacturers that
marketing plans would be “critical” to their applications, the FDA ulti-

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Syllabus
mately did not consider respondents' marketing plans. The FDA ar-
g
ued below that any error in this respect was harmless error because it
issued denial orders to other manufacturers after reviewing marketing
plans that were materially indistinguishable from respondents'. The
Fifth Circuit rejected the FDA's harmless-error argument, relying on
this Court's decision in Calcutt for the proposition that “APA errors are
only harmless where the agency would be required to take the same
action no matter what. In all other cases, an agency cannot avoid re-
mand.” 90 F. 4th 357, 390.
The Court agrees with the FDA that the Fifth Circuit read Calcutt
too broadly. That said, the proper standard presents a diffcult prob-
lem, requiring reconciliation of the so-called remand rule developed in
SEC v. Chenery Corp., 318 U. S. 80, 88, 93–95, with the APA's instruc-
tion that reviewing courts must take “ `due account' ” of “ `the rule of
prejudicial error' ” that “ordinarily appl[ies] in civil cases,” Shinseki v.
Sanders, 556 U. S. 396, 406 (quoting 5 U. S. C. § 706). The most natural
interpretation of the APA's language is that reviewing courts should
adapt the “rule of prejudicial error” applicable in ordinary civil litigation
(also known as the harmless-error rule) to the administrative-law con-
text, which, of course, includes the remand rule. In Calcutt, after recit-
ing the remand rule in strong terms, the Court acknowledged that a
“remand may be unwarranted . . . [w]here the agency `was required' to
take a particular action.” 598 U. S., at 630 (quoting Morgan Stanley
Capital Group Inc. v. Public Util. Dist. No. 1 of Snohomish Cty., 554
U. S. 527, 544). Although the Fifth Circuit interpreted Calcutt's discus-
sion to mean that there is only one exception to the remand rule, it has
long been accepted that a remand may not be necessary when an
agency's decision is supported by a plethora of factual fndings, only one
of which is unsound, because a remand would be pointless. See, e. g.,
Massachusetts Trustees of Eastern Gas & Fuel Associates v. United
States, 377 U. S. 235, 248. The existence of this exception is suffcient
to show that the Fifth Circuit's reading of Calcutt went too far. That
said, the FDA's reading of Sanders may also be excessive. The FDA
has not asked the Court to decide the harmless-error question at this
juncture, and the Court vacates and remands so the Fifth Circuit can
decide the question afresh without relying on its overly expansive read-
ing of Calcutt. Pp. 586–592.
90 F. 4th 357, vacated and remanded.
Alito, J., delivered the opinion for a unanimous Court. Sotomayor, J.,
fled a concurring opinion, post, p. 592.

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547
Counsel
Deputy Solicitor General Gannon argued the cause for
petiti
oner. With him on the briefs were Solicitor General
Prelogar, Principal Deputy Assistant Attorney General
Boynton, Vivek Suri, Joshua M. Koppel, Catherine Padhi,
Samuel R. Bagenstos, and Wendy S. Vicente.
Eric N. Heyer argued the cause for respondents. With
him on the brief were Joseph A. Smith and James C. Fraser.*
*Briefs of amici curiae urging reversal were fled for the Common-
wealth of Massachusetts et al. by Andrea Joy Campbell, Attorney General
of Massachusetts, David C. Kravitz, State Solicitor, and Alda Chan and
Matthew Lashof-Sullivan, Assistant Attorneys General, and by the Attor-
neys General for their respective jurisdictions as follows: Kris Mayes of
Arizona, Rob Bonta of California, Philip J. Weiser of Colorado, William
Tong of Connecticut, Brian L. Schwalb of the District of Columbia, Anne
E. Lopez of Hawaii, Kwame Raoul of Illinois, Aaron M. Frey of Maine,
Anthony G. Brown of Maryland, Dana Nessel of Michigan, Keith Ellison
of Minnesota, Matthew J. Platkin of New Jersey, Letitia James of New
York, Joshua H. Stein of North Carolina, Ellen F. Rosenblum of Oregon,
Michelle A. Henry of Pennsylvania, Peter F. Neronha of Rhode Island,
Charity R. Clark of Vermont, and Robert W. Ferguson of Washington; for
Public Health, Medical and Community Groups by William B. Schultz,
Andrew N. Goldfarb, and Dennis A. Henigan; and for Sixteen Members
of Congress by Mark B. Samburg and Victoria S. Nugent.
Briefs of amici curiae urging affrmance were fled for the Coalition of
Manufacturers of Smoking Alternatives by Erik S. Jaffe; for Electronic
Nicotine Delivery System Trade Associations et al. by Eric P. Gotting and
Azim Chowdhury; for the Goldwater Institute by Timothy Sandefur; for
Logic Technology Development LLC by Misha Tseytlin and Bryan M.
Haynes; for R. J. Reynolds Vapor Company et al. by Noel J. Francisco,
Donald F. McGahn II, Christian G. Vergonis, Ryan J. Watson, Andrew J.
M. Bentz, Charles E. T. Roberts, and Charles R. A. Morse; for the Taxpay-
ers Protection Alliance by Donald M. Falk and Erik S. Jaffe; for Thirteen
Members of Congress et al. by Jordan Sekulow, Donn Parsons, and Ben-
jamin P. Sisney; for Vaping Industry Stakeholders by J. Gregory Trout-
man; for the Vapor Technology Association by Anthony L. Abboud; and
for the Washington Legal Foundation by John M. Masslon II and Cory
L. Andrews.
Carter G. Phillips and Peter A. Bruland fled a brief for the Global
Action To End Smoking, Inc., as amicus curiae.
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548 FD
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Opinion of the Court
Justice Alito delivered the opinion of the Court.
Th
is case concerns the efforts of the Food and Drug Ad-
ministration (FDA) to regulate the sale of “e-cigarettes,” a
product that rapidly gained popularity during the past 20
years. The governing federal law, the Family Smoking Pre-
vention and Tobacco Control Act of 2009 (TCA), restricts the
sale of all “tobacco products” that were not commercially
marketed in the United States before February 15, 2007.
Unless otherwise authorized, a manufacturer may not in-
troduce such a product to the market until the FDA deter-
mines that it is “appropriate for the protection of the public
health.” 21 U. S. C. § 387j(c)(2)(A). In this case, we con-
sider whether the FDA lawfully denied authorization to
market certain favored e-cigarette products.
I
One of the FDA's longstanding responsibilities, dating
back nearly a century, is to determine whether manufactur-
ers may market new drugs. For much of that history, the
FDA lacked jurisdiction to regulate tobacco products. By
the time Congress conferred that authority in 2009, a new
product was ascendant on the market: the e-cigarette. This
product offers existing smokers a potentially safer alterna-
tive to traditional combustible cigarettes. But e-cigarettes
carry their own health risks, and they come in a dizzying
array of favors, many of which, such as dessert, candy, and
fruit favors, are particularly appealing to the young. The
surging youth demand for favored products—and the pros-
pect of a new generation of smokers—caught the FDA on its
back foot. In 2016, the agency declared that manufacturers
of e-cigarette products would need to obtain the same mar-
keting authorization that is required for other “tobacco prod-
ucts.” The FDA's regulatory efforts culminated in the 2021
denial of over a million applications for favored e-cigarette
products. The dispute before us ar ises from that mass
denial.
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A
The
Pure Food and Drugs Act of 1906 was Congress's frst
foray into the comprehensive regulation of food and drugs.
The Act prohibited the interstate transportation of “any arti-
cle of food or drugs which is adulterated or misbranded.”
Ch. 3915, § 2, 34 Stat. 768. That Act also vested important
responsibility in the precursor to the FDA, the Bureau of
Chemistry in the U. S. Department of Agriculture. § 4, id.,
at 769. But early in its tenure, the Bureau disclaimed any
authority to regulate tobacco products “labeled in such a
manner as to indicate their use for” nonmedicinal purposes
like “smoking or chewing or as snuff.” Dept. of Agriculture,
Bureau of Chemistry, 13 Service and Regulatory Announce-
ments 24 (Apr. 1914) (Feb. 1914 Announcements ¶13, Opinion
of Chief of Bureau C. Alsberg). Congress later renamed the
Bureau of Chemistry, frst as the Food, Drug, and Insecticide
Administration and then as the FDA, the name by which we
know it today. A Historical Guide to the U. S. Government
249 (G. Kurian ed. 1998).
In 1938, Congress enacted the Federal Food, Drug, and
Cosmetic Act (FDCA), which vastly expanded the FDA's
regulatory authority over “drugs and devices.” 52 Stat.
1049. One of the FDCA's major innovations was the estab-
lishment of a system for premarket authorization under
which manufacturers are prohibited from marketing “any
new drug ” in interstate commerce without the FDA's ap-
proval. §§ 505(a)–(b), (d), id., at 1052; Historical Guide, at
251. To receive such authorization, manufacturers must
prove to the FDA that their new products are safe for use.
And if the FDA has “insuffcient information” to make that
determination, it must “issue an order refusing ” marketing
authorization. § 505(d), 52 Stat. 1052.
By the middle of the 20th century, nearly one in two
Americans regularly smoked. See R. Rabin, A Sociolegal
History of the Tobacco Tort Litigation, 44 Stan. L. Rev. 853,
855 (1992). Toward the latter half of the century, however,
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Opinion of the Court
the public became increasingly aware of the “great” “poten-
tia
l hazard” of tobacco, Dept. of Health, Education, and Wel-
fare, Surgeon General's Advisory Committee, Smoking and
Health 25 (1964), and the addictive properties of nicotine, see
L. Goitein, G. Chernack, G. Liu, & M. Davis, Developments
in Policy: The FDA's Tobacco Regulations, 15 Yale L. & Pol'y
Rev. 399, 402 (1996).
The FDCA was enacted long before public awareness of
the dangers of smoking became widespread, and neither its
text nor its legislative history provided any indication that
tobacco products fell within the FDA's jurisdiction. See A.
Boeckman, An Exercise in Administrative Creativity: The
FDA's Assertion of Jurisdiction Over Tobacco, 45 Cath. U.
L. Rev. 991, 1015 (1996). Thus, during the frst 60 years
after the FDCA's enactment, the FDA (like the Chemistry
Bureau) repeatedly stated that it “lacked authority under
the FDCA to regulate tobacco absent claims of therapeutic
beneft by the manufacturer.” FDA v. Brown & William-
son Tobacco Corp., 529 U. S. 120, 144 (2000); see R. Kluger,
Ashes to Ashes: America's Hundred-Year Cigarette War, the
Public Health, and the Unabashed Triumph of Philip Morris
757–759 (1997) (Kluger).
Tobacco regulation was largely left to Congress, which
enacted various statutes between 1965 and the turn of the
century to address the harms of tobacco use, including the
imposition of warning requirements (15 U. S. C. §§ 1331, 1333,
4402(a)(1) (2000 ed.)); restrictions on the advertisement of
certain tobacco products (15 U. S. C. §§ 1335, 4402(a)(2), (f )
(2000 ed.)); requirements that the Secretary of Health and
Human Services report on scientifc fndings about, among
other things, “the addictive property of tobacco” (42 U. S. C.
§ 290aa–2(b)(2) (1994 ed.)); and age restrictions on the sale or
distribution of tobacco products (42 U. S. C. § 300x–26(a)(1)
(2000 ed.)). See Brown & Williamson Tobacco Corp., 529
U. S., at 137–139, 143–144. At no point during that period
did Congress grant the FDA jurisdiction to regulate tobacco
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Opinion of the Court
or tobacco products under the FDCA. And when the FDA
tr
ied via regulation to assert such jurisdiction in 1996, see
61 Fed. Reg. 44619–45318, this Court rejected that effort as
beyond the FDA's statutory authority, see Brown & Wil-
liamson Tobacco Corp., 529 U. S., at 126.
Against that backdrop, Congress enacted the Family
Smoking Prevention and Tobacco Control Act of 2009, 123
Stat. 1776. The TCA vests the Secretary of Health and
Human Services, acting through the FDA, with the authority
that this Court previously found lacking: namely, the power
to regulate the manufacturing, marketing, sale, and distribu-
tion of tobacco products. See § 901, id., at 1786. The TCA
explicitly granted the FDA regulatory authority over “ciga-
rettes, cigarette tobacco, roll-your-own tobacco, and smoke-
less tobacco.” 21 U. S. C. § 387a(b). It also granted author-
ity to regulate “any other tobacco products” that the FDA
“by regulation deems” to meet the defnition of a tobacco
product. Ibid.
The TCA's reach was broad. While the Act barred the
FDA from banning all regulated tobacco products outright
or requiring manufacturers to reduce nicotine yields to zero,
see § 387g(d)(3), it prohibited a manufacturer from marketing
any “new tobacco product” without FDA authorization, see
§ 387j(a)(2)(A). A “new tobacco product” is one that was not
marketed in the United States before February 15, 2007, and
the TCA subjected such products to a premarket authoriza-
tion process. See §§ 387j(a)(1)(A), (a)(2).
One pathway to authorization of the sale of a new tobacco
product is the submission of a premarket tobacco product
application.
1
§ 387j(c)(1)(A)(i). These applications require,
1
The TCA establishes a handful of other authorization pathways for new
tobacco products. For example, manufacturers may ask the FDA to make
a determination that a new tobacco product is substantially equivalent to
a product commercially marketed as of February 15, 2007. See 21 U. S. C.
§§ 387j(a)(2)–(3). And a showing of substantial equivalence may be un-
necessary for new tobacco products that make only minor modifcations
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among other things, information about a product's compo-
nents
and additives, the method by which it is manufactured,
any proposed labeling, and an assessment of its health risks.
See § 387j(b)(1). There are many reasons why the FDA may
deny marketing authorization to a “new tobacco product,”
but of main importance here, the agency must deny an ap-
plication unless it is shown that the product “would be
appropr iate for the protec ti on of the publ ic hea lth. ”
§ 387j(c)(2)(A).
To determine whether a product meets this standard, the
FDA must consider “the risks and benefts to the population
as a whole” and “tak[e] into account” the “increased or de-
creased likelihood” of two outcomes: frst, that the new prod-
uct will induce users of existing tobacco products such as
conventional cigarettes to stop using those products and,
second, that “those who do not use tobacco products will
start using ” them. § 387j(c)(4). The FDA's determination
regarding the likely effects of a new product must, “when
appropriate,” be based on “well-controlled investigations” or
other “valid scientifc evidence” that is “suffcient to evaluate
the tobacco product.” § 387j(c)(5).
The FDA must act “[a]s promptly as possible” on a pre-
market tobacco product application and “in no event later
than 180 days af ter the receipt of an appl icati on. ”
§ 387j(c)(1)(A). If the FDA denies an application for pre-
market authorization, “any person adversely affected” by the
denial has 30 days to seek judicial review in a court of ap-
peals. § 387l(a)(1). The reviewing courts must in turn
apply the provisions of the Administrative Procedure Act
(APA). § 387l(b) (citing 5 U. S. C. § 706(2)(A)).
to produc ts commercia l ly marketed as of Febr uary 15, 2007. See
§ 387e( j)(3)(A). Moreover, manufacturers may seek authorization for
“modifed risk tobacco products,” that is, products used “to reduce harm or
the risk of tobacco-related disease associated with commercially marketed
tobacco products.” §§ 387k(b)(1), (g)(1).
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Opinion of the Court
B
A
t the end of the 20th century, tobacco manufacturers
tried without much luck to market safer alternatives to tra-
ditional cigarettes, such as “smokeless” cigarettes. See
Kluger 599–604; Dept. of Health & Human Servs., E-
Cigarette Use Among Youth and Young Adults: A Report of
the Surgeon General 9 (2016) (2016 Surgeon General's Re-
port). But in 2007 a new product hit the American market:
electronic nicotine delivery systems, which are popularly
known as electronic cigarettes, e-cigarettes, or vapes. See
id., at 10; K. Lichtenberg, E-Cigarettes: Current Evidence
and Policy, 114 Mo. Med. 335 (2017). Practically overnight,
e-cigarettes became ubiquitous. Sales for e-cigarette prod-
ucts “surged exponentially” after 2010, 2016 Surgeon Gener-
al's Report 152, and according to one estimate, 11.2 million
American adults used e-cigarettes by 2016, see O. Obisesan
et al., Trends in E-Cigarette Use in Adults in the United
States, 2016–2018, 180 JAMA Internal Med. 1394 (2020).
The impetus for the invention of e-cigarettes was the de-
sire to create a product that would reduce the health risks
of smoking. A traditional combustible cigarette contains
shredded tobacco wrapped in paper, and when lit, the tobacco
“catches fre” and “produces smoke, which contains nicotine”
and “tar”—a “complex chemical mixture of more than 7,000
compounds that cause a wide range of diseases.” Brief for
Global Action To End Smoking, Inc., as Amicus Curiae 14
( inter na l quotati on marks omitted). In contrast, an e-
cigarette contains a battery, a heating element or atomizer,
a liquid nicotine reservoir, and a mouthpiece. See 2016 Sur-
geon General's Report 11. When an e-cigarette user inhales
through the device's mouthpiece, the heating coil engages,
and the liquid (called e-liquid or e-juice) turns into a nicotine-
infused vapor. See ibid. Unlike a traditional cigarette, an
e-cigarette does not release tar or other “byproducts of com-
bustion,” but it does “emit potentially toxic substances,” in-
cluding “fne particulate matter,” “metals,” and, of course,
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nicotine. Brief for Global Action To End Smoking, Inc., as
Ami
cus Curiae 15–16 (internal quotation marks omitted).
E-cigarettes typically come in either a “closed” or “open”
system. See 2016 Surgeon General's Report 151–152.
Closed-system e-cigarettes contain a set amount of e-liquid
that is deter mined by the manufacturer. Some closed-
system products are designed to be discarded after the e-
liquid supply runs out, while others can be reused by insert-
ing a cartridge or pod that contains e-liquid. By contrast,
an open-system e-cigarette contains a “tank” that users can
manually refll with the desired amount of e-liquid. Users
of open-system products may mix their own e-liquids and
adjust the amount of e-liquid in the tank.
There is ferce public debate about the potential benefts
and har ms of e-cigarettes. On one hand, many view e-
cigarettes as a harm-reduction tool. They enable current
smokers who are addicted to nicotine to reduce exposure to
some of the more harmful byproducts of traditional combus-
tible cigarettes. See id., at 10–11; National Academies of
Sciences, Engineering, and Medicine, Committee on the Re-
view of the Health Effects of Electronic Nicotine Delivery
Systems, Public Health Consequences of E-Cigarettes 18
(2018). On the other hand, e-cigarettes, as noted, pose their
own health risks, and there is concern that the use of e-
cigarettes by non-smokers—and especia lly young non-
smokers—may eventually lead them to smoke conventional
cigarettes. See id., at 532–535.
Early on, evidence began to mount that young Americans
are particularly drawn to e-cigarette products. By the mid-
2010s, approximately 2.4 million high-school students and
620,000 middle-school students reported using an e-cigarette
at least once in the last 30 days. 2016 Surgeon General's
Report 5, 10. And a more recent estimate suggests that
approximately 3.6 million American middle- and high-school
students used an e-cigarette within a 30-day period. See
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Congressional Research Service, H. Sheikh & V. Green, FDA
Reg
ulation of Tobacco Products 1 (2021).
One particular feature of e-cigarette products appears to
drive this youth demand: the panoply of e-liquid favors.
One nearly decade-old estimate found that there were 7,700
unique e-liquid favors, including not only favors that were
familiar to cigarette smokers (tobacco and menthol) but also
fruit, candy, and dessert favors that were appealing to non-
smokers. See 2016 Surgeon General's Report 11. The ka-
leidoscope of favor options adds to the allure of e-cigarettes
and has thus contributed to the booming demand for such
products among young Americans. See ibid.
Because the popularity of e-cigarettes is a relatively recent
phenomenon, these products initially escaped the FDA's reg-
ulatory reach. But in 2016, the FDA issued a rule deeming
e-cigarettes and e-liquids to be “tobacco products.” 81 Fed.
Reg. 29028 (2016). Since most e-cigarette products were
“not commercially marketed in the United States as of Feb-
ruary 15, 2007,” the deeming rule retroactively rendered
such products “new tobacco products” subject to the TCA's
premarket-authorization regime. 21 U. S. C. § 387j(a)(1)(A).
And because those products had not received premarket au-
thorization, the effect of the rule was to make their contin-
ued sale illegal. Companies that proceeded to sell their
products without such authorization would be subject to stiff
penalties. See §§ 331(a), 333(a)(1), and (f )(9).
To give these manufacturers adequate time to apply for
“premarket” authorization, the FDA delayed enforcement for
two to three years. See 81 Fed. Reg. 28977–28978. This per-
mitted e-cigarette products to remain on the market while
manufacturers fled their applications. Initially, applications
were due by August 8, 2018. See Vapor Tech. Assn. v. FDA,
977 F. 3d 496, 498 (CA6 2020) (per curiam) (citing 81 Fed. Reg.
29010–29011). The FDA later tried via guidance to extend
the compliance deadline through 2022, but a Federal District
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Court ultimately imposed a deadline of September 9, 2020,
addi
ng to the time crunch for compliance. See American
Academy of Pediatrics v. FDA, 399 F. Supp. 3d 479, 487 (Md.
2019) (imposing a May 12, 2020, deadline); Order in Ameri-
can Academy of Pediatrics v. FDA, No. 18–cv–883 (D Md.,
Apr. 22, 2020), ECF Doc. 182, p. 1 (extending the deadline to
September 9, 2020, due to the COVID–19 pandemic); see also
Vapor Tech. Assn., 977 F. 3d, at 498–500 (detailing the shift-
ing compliance deadline).
C
At the center of this case are the FDA's actions leading
up to its adjudication of manufacturers' premarket tobacco
product applications. The agency proposed a rule outlining
appl icati on requirements, issued g uidance to assist e-
cigarette manufacturers, and crafted internal memoranda
discussing how applications were to be reviewed. These vo-
luminous and discursive documents paint a picture of an
agency that was feeling its way toward a fnal stance and
was unable or unwilling to say in clear and specifc terms
precisely what applicants would have to provide. Pervading
these documents are four overarching topics that animate
the dispute before us.
1
The frst topic was the types of scientifc evidence needed
to show that an e-cigarette product is “appropriate for the
protection of the public health. ” § 387j(c)(2)(A). Recall
that the TCA states that “well-controlled investigations”
may suppor t such a show i ng “when appropr iate, ”
§ 387j(c)(5)(A), as can “other `valid scientifc evidence' if
found suffcient to evaluate the tobacco product,” App. 28
(quoting § 387j(c)(5)(B)). At an October 23, 2018, public
meeting, an FDA offcial opined that “[i]n most situations,”
the FDA would expect “some analytical testing specifc to [a
manufacturer's] product.” FDA /Center for Tobacco Prod-
ucts, Tobacco Product Application Review, A Public Meet-
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ing October 22–23, 2018—Day 2, Sess. 7, Part 2, at 2:12:35–
2:12:43,
https://www.fda.gov/tobacco-products/ctp-newsroom/
tobacco-product-application-review-public-meeting#Video2
(2018 Presentation Video). But the FDA also assured man-
ufacturers that no “specifc studies,” “[y]outh behavioral
data,” or “new nonclinical or clinical studies” would be re-
quired. FDA, Premarket Tobacco Product Application Con-
tent Overview 18, 26 (Oct. 23, 2018), https://www.fda.gov/
media /117507/download (2018 Presentation). The FDA said
much the same thing in a lengthy 2019 guidance document,
noting that the “relatively new entrance” of e-cigarette prod-
ucts meant that “limited data may exist from scientifc stud-
ies and analyses.” App. 28. So, according to this docu-
ment, the FDA would not require “long-term studies,” and
manufacturers could instead rely on various alternatives,
like observational studies, literature reviews, or evidence
bridging their new tobacco product to “a studied tobacco
product.” Id., at 28, 99–105.
After manufacturers submitted millions of applications for
favored e-cigarette products, the FDA “develop[ed] a new
plan to effectively manage” the scientifc evidence underly-
ing the onslaught of applications. Id., at 242. In a July 9,
2021, internal memorandum, the FDA took a far less capa-
cious view of the scientifc evidence it would consider. Spe-
cifcally, the FDA said that it would consider it a “fatal faw”
if an application lacked scientifc evidence about a product
based on either a randomized controlled trial or a longitu-
dinal cohort study. Id., at 243. A “fatal faw” would lead
to a manufacturer's “likely receiv[ing] a marketing denial
order” for that product. Ibid.
Over a month later on August 17, 2021, the FDA issued
another internal memorandum that differed in some respects
from the July memorandum. It stated that, in addition to
randomized controlled trials and longitudinal cohort studies,
the FDA “would also consider evidence from another study
design, provided that it could reliably and robustly assess
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behavior change” and “compar[e] users of favored products
w
ith those of tobacco-favored products.” Id., at 247, n. ix.
Then, on August 25, 2021, just before denying respondents'
applications, the FDA rescinded the August 17, 2021, memo-
randum and stated it would “not consider or rely” on it when
evaluating premarket tobacco product applications. Id., at
282.
2
The second topic was the need for manufacturers to com-
pare their proposed products to other products. The TCA
requires premarket tobacco product applications to provide
“full reports of all information . . . concerning investigations
which have been made to show” that a new product “pre-
sents less risk than other tobacco products.” 21 U. S. C.
§ 387j(b)(1)(A). Elaborating on that standard at a presenta-
tion on October 23, 2018, an FDA offcial encouraged appli-
cants to provide comparisons between their products and a
“representative sample of tobacco products on the market.”
2018 Presentation 11. And a 2019 guidance document simi-
larly recommended comparisons of “the health risks of [a
manufacturer's] product to both products within the same
category and subcategory, as well as products in different
categories as appropriate.” App. 30. The 2019 guidance
also gave manufacturers discretion to choose comparator
products as long as the FDA could “understand [an] appli-
cant's rationale and justifcation for [the] comparators chosen.”
Ibid. Later that year at a public meeting, an FDA offcial of-
fered the same general advice that a successful premarket to-
bacco product application “may include comparisons to other
tobacco products in the same category or in other categories
or subcategories.” FDA /CTP, Deemed Tobacco Product
Applications, Video Presentation of Premarket Tobacco
Product Applications (PMTAs) Review Process and Re-
sources (Oct. 28, 2019), at 31:10–31:16, https://collaboration
.fda.gov/ptf 21jryjxyk/?OWASP_CSRFTOKEN=7a8d148
ac776ca8f 3aec38aff 7dee12ea4988c1caed05010cded06ab7496
714f.
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3
In
a lengthy April 2020 guidance document,
2
the FDA
elaborated on a third theme: its enforcement priorities based
on device type. The agency said it would “prioritize en-
forcement of favored, cartridge-based” e-cigarette products
“other than tobacco- and menthol-favored products.” App.
160. It clai med that “ youth over whelmi ng ly prefer
cartridge-based” products, which are “easy to conceal, can
be used discreetly, may have a high nicotine content, and
are manufactured on a large scale.” Id., at 163. And the
document asserted that certain favors, such as candy and
fruit favors, “are a strong driver for youth use.” Id., at 164;
see also id., at 190 (discussing the increased use of “fruit-
and candy-favored” products). Although the FDA sug-
gested that its focus on favored, cartridge-based products
“should have minimal impact on small manufacturers (e. g.,
vape shops) that primarily sell non-cartridge-based” prod-
ucts, it noted that it would also prioritize enforcement
against “[a]ll other [e-cigarette] products for which the manu-
facturer has failed to take (or is failing to take) adequate
measures to prevent minors' access,” as well as “[a]ny [e-
cigarette] product that is targeted to minors or whose mar-
keting is likely to promote use of [e-cigarettes] by minors.”
Id., at 160–161.
4
The fnal theme cutting across these documents is the
FDA's unfinching advice that manufacturers should submit
“marketing plans” as part of their applications. “Marketing
plans” broadly refer to a manufacturer's “specifc restrictions
on sale and distribution” that could, for example, “decreas[e]
2
The Fifth Circuit suggested that the FDA's 2020 guidance does not
apply here because respondents manufacture “bottles of favored nicotine
liquids,” not e-cigarette products themselves. 90 F. 4th 357, 369 (2024)
(en banc). But the 2020 guidance concerned the FDA's enforcement prior-
ities with respect to “[e]lectronic nicotine delivery systems” or “ENDS,”
and, as the guidance document explains, “[e]-liquids are a type of ENDS
product.” App. 143 (emphasis deleted).
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the likelihood that those who do not use tobacco products
w
ill start using tobacco products.” Id., at 27. In its 2019
guidance, the FDA urged manufacturers to “shar[e]” their
“marketing plan[s] to enable FDA to better understand the
potential consumer demographic” of their products. Id., at
83. The 2020 enforcement guidance hit the same note, sug-
gesting the FDA “intend[ed] to consider” marketing plans
and that such plans would be relevant to the agency's en-
forcement “prioritization.” Id., at 167, 169. The FDA even
offered examples of what marketing restrictions manufac-
turers might consider, including screening retailers, age-
verifcation technology, mystery-shopper programs, controls
over distributors, and quantity limits. Id., at 167–169, 223.
It also cautioned that, based on its experience, “focusing on
how the product was sold” and “age verifcation” “would not
be suffcient to address youth use.” Id., at 215, 220–221.
D
In 2019, the FDA proposed a rule setting out the require-
ments for premarket tobacco product applications. See 84
Fed. Reg. 50566 (2019). That proposed rule, in signifcant
part, crystallized the four themes discussed above. It of-
fered specifcs on the “types of [scientifc] investigations”
that applications “would be required to contain.” Id., at
50603; see, e. g., ibid. (listing “[c]ross sectional and longitudi-
nal surveys,” “epidemiologic studies,” and “analytic studies”
like “randomized controlled clinical trials, cohort studies, and
case control studies”); id., at 50599 (proposing “health risk
investigations” besides new clinical studies). The proposed
rule also required certain cross-product comparisons. See
id., at 50603 (requiring that applicants “submit investigations
that have been made to show whether the tobacco product
has the same or different potential health risks . . . than other
tobacco products”). And it underscored the importance of
device type with respect to product testing. See id., at
50585 (proposing requirements for constituent testing spe-
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cifc to open-system products). In addition, the proposed
r
ule obligated manufacturers to submit marketing plans,
which were described as “provid[ing] input that is critical”
to the agency's review. Id., at 50580, 50581.
Notice-and-comment rulemaking takes time, and with a
court-imposed deadline fast approaching, the FDA pro-
ceeded to adjudicate the frst major wave of premarket to-
bacco product applications in August and September 2021
without a fnal rule and the standards it included. It was
not until October 5, 2021, that the FDA adopted the fnal
rule. See 86 Fed. Reg. 55300 (2021).
1
Respondents Wages and White Lion Investments, LLC,
doing business as Triton Distribution, and Vapetasia, LLC,
manufacture favored e-liquids for open-system e-cigarettes.
Their e-liquid favor offerings include “Killer Kustard Blue-
berry, ” “Rainbow Road, ” “Iced Blackberry Lemonade, ”
“Pineapple Express,” “Suicide Bunny Mother's Milk and
Cookies,” and “Blueberry Parfait.” See App. 396, 546, 587,
593, 605, 608.
Respondents submitted premarket tobacco product appli-
cations on September 9, 2020, the fnal court-ordered dead-
line. As the FDA recommended in its guidance, their appli-
cations included marketing plans, which touted respondents'
use of third-party age-verifcation technology, quantity lim-
its, and requirements for retailers to develop compliance
checks. See id., at 431–436, 441. To show the safety of
their products, respondents “pool[ed] resources” with “other,
similarly situated e-liquid companies” to “fund the develop-
ment of certain, required non-product specifc data,” includ-
ing what they characterized as a “comprehensive review of
the scientifc literature.” Id., at 311. One of the respond-
ents, Vapet asia, a lso submitted the resu lts of a cross-
sectional survey of current and former adult e-cigarette
smokers. See App. to Pet. for Cert. 280a.
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The FDA received applications from more than 500 compa-
nies
in total, covering more than 6.5 million e-cigarette prod-
ucts. See FDA Denies Marketing Applications for About
55,000 Flavored E-Cigarette Products for Failing To Provide
Evidence They Appropriately Protect Public Health (Aug.
26, 2021), https://fda.gov/news-events/press-announcements/
fda-denies-marketing-applications-about-55000-flavored-e-
cigarette-products-failing-provide-evidence. Almost a year
after the court-ordered deadline, the FDA adjudicated its
frst slate of premarket tobacco product applications and is-
sued marketing denial orders to three manufacturers whose
applications covered 55,000 favored e-cigarette products.
See ibid. The FDA concluded that the manufacturers failed
to provide “suffcient product-specifc scientifc evidence to
demonstrate enough of a beneft to adult smokers that would
overcome the risk posed to youth.” Ibid. Such “scientifc
evidence,” the agency said, “would likely be in the form of a
randomized controlled trial or longitudinal cohort study,” but
the FDA promised that it remained open to “other types of
evidence” that are “suffciently robust and reliable.” Ibid.
Shortly thereafter, the FDA denied respondents' applica-
tions. See App. to Pet. for Cert. 166a, 278a. It concluded
that respondents had not provided suffcient scientifc evi-
dence to demonstrate that the marketing of their products
would be appropriate for the protection of public health.
See id., at 166a–167a. Specifcally, the FDA held respond-
ents had not provided evidence from a randomized controlled
trial, longitudinal cohort study, or another “reliabl[e] and ro-
bus[t]” method showing that their dessert-, candy-, and fruit-
favored products had benefts “over an appropriate compa-
rator tobacco-favored” product. Id., at 167a. With such
evidence lacking, the FDA deemed respondents' products
“misbranded” and “adulterated” under the FDCA. Id., at
168a.
To each denial order, the FDA appended a “Technical Proj-
ect Lead (TPL) Review.” See id., at 177a, 285a. These
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lengthy documents have several noteworthy features. To
st
art, they offer a window into the FDA's evolving under-
standing of how favor, regardless of e-cigarette device type,
drives youth smoking initiation and nicotine addiction. The
reviews canvass the scientifc literature on youth e-cigarette
use and explain that this literature had led the agency to
conclude that favors make e-cigarette smoking “more palat-
able for novice youth and young adults” and may “increase
nicotine exposure by potentially infuencing the rate of nico-
tine absorption.” Id., at 190a, 298a. What is more, the FDA
stated, young people are drawn to particular favors, and the
FDA anticipated that its crackdown on one type of e-cigarette
device would lead youth to fock to a different type of device
to continue using a desired favor. See id., at 192a, 300a.
Despite the FDA's prior representations about the impor-
tance of marketing plans, the reviews stated that, “for the
sake of effciency,” the FDA had decided not to evaluate
respondents' marketing plans. Id., at 200a–201a, n. xix,
308a–309a, n. xix. The FDA acknowledged that it “is theo-
retically possible that signifcant mitigation efforts” could
decrease the appeal of favored e-cigarettes to a suffcient
degree to counterbalance the documented risks of such
products, but it found that none of the marketing plans the
FDA had seen had managed to do that. Ibid.
The FDA estimates that in its frst wave of marketing or-
ders, it issued denials to 320 applicants, who sought approval
for approximately 1.2 million products. See Tr. of Oral
Arg. 33.
2
Respondents petitioned for review in the Fifth Circuit. A
motions panel initially granted a stay of their marketing de-
nial orders pending review, see 16 F. 4th 1130, 1134 (2021),
but a divided merits panel ultimately denied the petitions,
see 41 F. 4th 427, 430 (2022).
The court then reheard the case en banc, granted respond-
ents' petitions for review, and remanded to the FDA. The
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en banc majority held that the FDA had acted arbitrarily
and
capriciously in denying respondents' applications. In
its view, the FDA performed a surprise switch from the re-
quirements articulated in the various predecisional docu-
ments. 90 F. 4th 357, 362 (2024). The court pointed to sev-
eral main examples of this phenomenon, including the FDA's
positions on scientifc evidence, cross-favor comparisons, and
device type. See, e. g., id., at 376, 377, 384. The court ex-
pressed particular concern that the FDA pulled the rug out
from under manufacturers by “not even read[ing] the mar-
keting plans it previously said were critical.” Id., at 372.
Although the FDA's attorneys represented that the agency
had reviewed “ `summar[ies]' ” of respondents' marketing
plans, the court deemed that representation an illicit post
hoc rationalization. Id., at 373.
In a footnote, the en banc majority also suggested that
the FDA had violated a provision of the TCA's notice-and-
comment requirements, see 21 U. S. C. §§ 387g(c)–(d), by im-
posing a “de facto ban on favored e-cigarettes” through mass
adjudicatory denials, 90 F. 4th, at 384, n. 5.
Having found that the FDA had erred in these ways, the
court rejected the FDA's suggestion that any errors were
harmless. Relying heavily on our decision in Calcutt v.
FDIC, 598 U. S. 623 (2023) (per curiam), the court suggested
that “APA errors are only harmless where the agency would
be required to take the same action no matter what. In all
other cases,” the court concluded, “an agency cannot avoid
remand.” 90 F. 4th, at 390. And, in a brief alternative
analysis, the court found that each of the FDA's errors
“plainly affected the procedure used” and was prejudicial.
Ibid. (internal quotation marks omitted).
Judge Haynes, joined by four other judges, dissented.
See ibid. Judge Graves joined the dissent in part. See id.,
at 405.
The en banc Fifth Circuit's decision conficted with those
of other Circuits, and we granted the FDA's petition for a
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writ of certiorari. 603 U. S. 904 (2024). We now vacate
and
remand.
II
The question we agreed to decide is whether the FDA
acted arbitrarily and capriciously in denying respondents'
applications for premarket approval of their tobacco prod-
ucts. See Pet. for Cert. I. But before tackling that ques-
tion, we briefy address as a preliminary matter an argument
that is touched on in respondents' brief: namely, that either
the APA or the TCA required the FDA to use notice-and-
comment rulemaking to set out the requirements that must
be met in a premarket tobacco product application.
Unless Congress has specifed otherwise, agencies are gen-
erally free to develop regulatory standards “either by gen-
eral [legislative] rule or by individual order” in an adjudica-
tion. SEC v. Chenery Corp., 332 U. S. 194, 202–203 (1947)
(Chenery II). Of course, if a statute requires rulemaking,
the affected agency must comply. Ibid. And that is what
respondents claim in passing here. Respondents' defense of
the decision below is based almost entirely on 5 U. S. C.
§ 706(2)(A) and related case law. But their brief also sug-
gests that the FDA's decision to issue denials based on stand-
ards developed in adjudication violated other provisions of
the APA and TCA that, they claim, required notice-and-
comment rulemaking. See Brief for Respondents 47–49,
and n. 33. This echoes an argument the Court of Appeals
made in a short footnote. See 90 F. 4th, at 384, n. 5 (citing
21 U. S. C. §§ 387g(a)(1)(A), (a)(2), (c)–(d)).
We did not grant certiorari on that question, and without
adequate briefng, it would not be prudent to decide it here.
See Anza v. Ideal Steel Supply Corp., 547 U. S. 451, 461
(2006). Accordingly, we do not reach that question and ex-
press no view on its merits.
3
3
Respondents' amici offer numerous alternative grounds for affrmance.
Three of these arguments are based on the Constitution: (1) that the TCA
unconstitutionally delegated lawmaking power to the FDA with respect
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III
W
e now turn to the Court of Appeals' holding that the
FDA acted arbitrarily and capriciously. That decision was
multifaceted, but its analysis boils down to a central concern:
it faulted the FDA for allegedly changing the requirements
for premarket tobacco product applications between the time
of its guidance and the denials of respondents' applications.
The feature of our current case law on arbitrary-and-
capricious review that addresses that issue is our change-in-
position doctrine. Under that doctrine, we must ask
whether the FDA changed course and, if it did, whether it
offered satisfactory reasons for the change. Analysis of the
FDA's position prior to the denials at issue requires a close
reading of nuanced statements in a body of guidance docu-
ments that evidence the agency's evolving assessment of the
relevant issues. Affected parties may have come away with
the impression that the agency would apply a less demanding
standard of proof than is evident in the denial orders the
FDA ultimately issued, but in the end, we cannot say that
to, among other things, the necessary contents of a premarket tobacco
product application, see Brief for Taxpayers Protection Alliance as Ami-
cus Curiae 7–8; (2) that the relevant provisions of the TCA are unconstitu-
tionally vague, see id., at 6–8; and (3) that respondents were denied due
process, see Brief for Washington Legal Foundation as Amicus Curiae 8–
11; Brief for Thirteen Members of Congress et al. as Amici Curiae 13–
16. Some amici also argue that the FDA violated our “major questions”
doctrine. See, e. g., Brief for Vaping Industry Stakeholders as Amici Cu-
riae 30–34; Brief for Thirteen Members of Congress et al. as Amici Cu-
riae 6–13.
Although these issues have a bearing on what appears to have been the
Court of Appeals' animating concern—i. e., that the FDA did not give
respondents and other applicants fair and accurate notice regarding what
it would insist that an application contain—these arguments fall outside
the scope of the question presented, were not passed on below, and were
not pressed in respondents' brief. We therefore decline to reach them.
See, e. g., Atlantic Marine Constr. Co. v. United States Dist. Court for
Western Dist. of Tex., 571 U. S. 49, 61 (2013). And our opinion should not
be read to suggest any view on their merits.
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the FDA improperly changed its position with respect to sci-
enti
fc evidence, comparative effcacy, or device type. With
respect to the FDA's guidance on marketing plans, we clarify
the appropriate legal standard governing claims of harmless
error, and we remand to the Fifth Circuit to apply that
standard in the frst instance.
A
We begin with our change-in-position doctrine. The APA
requires a reviewing court to “hold unlawful and set aside
agency action” found to be “arbitrary, capricious, an abuse of
discretion, or otherwise not in accordance with law.” 5
U. S. C. § 706(2)(A). Our well-worn arbitrary-and-capricious
standard ensures that an administrative agency “examine[d]
the relevant data and articulate[d] a satisfactory explanation
for its action including a rational connection between the
facts found and the choice made.” Motor Vehicle Mfrs.
Assn. of United States, Inc. v. State Farm Mut. Automobile
Ins. Co., 463 U. S. 29, 43 (1983) (internal quotation marks
omitted). The scope of this review “is narrow,” and review-
ing courts must exercise appropriate deference to agency de-
cisionmaking and not substitute their own judgment for that
of the agency. Ibid.
Our case law identifes numerous ways in which an agency
may act arbitrarily and capriciously. The Fifth Circuit con-
cluded that the FDA overstepped this standard in four such
ways. In its view, the FDA (1) “invent[ed] post hoc justif-
cations” for its failure to consider applicants' marketing
plans; (2) failed to give “fair notice” of the evidentiary and
comparative requirements that would be imposed at the ap-
plication stage; (3) changed its position regarding scientifc
evidence and device type; and (4) faulted respondent “for re-
lying in good faith on [its] previous” guidance. 90 F. 4th, at
371–386.
All four of these principles orbit around the same basic
concern: an agency should not mislead regulated entities.
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The essence of respondents' argument is that the FDA told
them
in guidance documents that it would do one thing and
then turned around and did something different when it re-
viewed their applications.
The change-in-position doctrine is administrative law's an-
swer to that problem. Under that doctrine, “[a]gencies are
free to change their existing policies as long as they provide
a reasoned explanation for the change,” “ `display awareness
that [they are] changing position,' ” and consider “ `serious
reliance interests.' ” Encino Motorcars, LLC v. Navarro,
579 U. S. 211, 221–222 (2016) (quoting FCC v. Fox Television
Stations, Inc., 556 U. S. 502, 515 (2009)). For reasons we
explain, the change-in-position doctrine provides the govern-
ing framework here.
Respondents appear to recognize as much, although they
suggest at times that the applicable requirements are not
just part of arbitrary-and-capricious review but are rooted
in part on the constitutional right to due process. See Brief
for Respondents 28–29, 35, 44. In substance, however, there
is little difference in the standard they ask us to apply.
4
They do not rely on four distinct administrative-law princi-
ples; rather, their arguments before this Court rest primar-
ily on the FDA's supposed change in position regarding appli-
cation requirements. See id., at 29–42, 45–47; Tr. of Oral
Arg. 88. To the extent respondents raise a freestanding
“fair notice” argument, see id., at 90, the exact contours of
that contention are somewhat unclear. By asking us to af-
frm the decision below, respondents do not now suggest that
4
At one point, however, respondents seem to suggest that the FDA
violated their due-process rights simply because it failed to provide clear
notice before it denied their applications and thus effectively put them out
of business. See Brief for Respondents 44. But the freestanding due-
process question to which the respondents feetingly refer lies outside the
question on which we granted review and is not well developed in their
brief. We therefore decline to decide it. See Anza v. Ideal Steel Supply
Corp., 547 U. S. 451, 461 (2006).
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under the TCA the FDA “had an affrmative obligation to
issue
specifc guidance” as to how it would evaluate favored
products. Brief for Respondents 33 (internal quotation
marks omitted). Instead, respondents merely support the
Fifth Circuit's conclusion that when an agency issues guid-
ance, it cannot “change the requirements set forth therein
without consideration of applicants' reasonable reliance in-
terests, proper notice to applicants, and a reasonable oppor-
tunity for applicants to conform to the changed require-
ments.” Ibid. It is unclear what, if any, daylight exists
between that conception of “fair notice” and our change-in-
position doctrine. See, e. g., Encino Motorcars, 579 U. S., at
221–222 (“In explaining its changed position, an agency must
also be cognizant that longstanding policies may have engen-
dered serious reliance interests that must be taken into
account. . . . [A] reasoned explanation is needed for disre-
garding facts and circumstances that underlay or were
engendered by the prior policy” (internal quotation marks
omitted)).
B
The change-in-position doctrine asks two questions. The
frst is whether an agency changed existing policy.
5
And we
have suggested that this occurs when an agency acts “incon-
5
The parties assume that the change-in-position doctrine applies when
an agency abandons a position it frst articulated in a nonbinding guidance
document. We have traditionally applied the change-in-position doctrine
when an agency shifts from a position expressed in a more formal setting.
See, e. g., FCC v. Fox Television Stations, Inc., 556 U. S. 502, 517 (2009).
True, we have on at least one occasion applied the doctrine when an
agency altered a position frst stated in a policy statement. See Depart-
ment of Homeland Security v. Regents of Univ. of Cal., 591 U. S. 1, 30
(2020). But as we explained in that case, the policy statement instituted
“a standardized review process” that “effectively” resembled adjudication.
Id., at 18. Given neither party has pressed this argument here, we as-
sume, without deciding, that the change-in-position doctrine applies to an
agency's divergence from a position articulated in nonbinding guidance
documents.
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sistent[ly]” with an “earlier position,” id., at 224, performs
“a
reversal of [its] former views as to the proper course,”
State Farm, 463 U. S., at 41, or “disavow[s]” prior “inconsist-
ent” agency action as “no longer good law,” Fox Television,
556 U. S., at 517 (internal quotation marks omitted). For
example, we have held that an agency changed its position
when it rescinded a prior regulation, see State Farm, 463
U. S., at 41–42, “expand[ed] the scope of its enforcement ac-
tivity,” Fox Television, 556 U. S., at 517, and “abandon[ed a]
decades-old practice” applied in enforcement actions, Encino
Motorcars, 579 U. S., at 218.
Once a change in agency position is identifed, the doctrine
poses a second question: Did the agency “display awareness
that it is changing position” and offer “good reasons for the
new policy”? Fox Television, 556 U. S., at 515. At this sec-
ond step, the agency does not need to show “that the reasons
for the new policy are better than the reasons for the old
one.” Ibid. Nor must it “provide a more detailed justif-
cation than what would suffce for a new policy created on a
blank slate.” Ibid. But the agency must “be cognizant
that longstanding policies may have `engendered serious reli-
ance interests that must be taken into account.' ” Encino
Motorcars, 579 U. S., at 221–222 (quoting Fox Television, 556
U. S., at 515).
Echoing the Fifth Circuit, respondents claim that the FDA
violated the change-in-position doctrine with respect to the
four principal themes discussed above. See supra, at 556–
560. First, according to respondents, the FDA, after initially
telling applicants that no specifc kinds of scientifc evidence
were required, turned around and rejected all applications
lacking evidence from a randomized controlled trial or longi-
tudinal cohort study. See Brief for Respondents 37, 40–42.
Second, respondents claim, the FDA told applicants they had
discretion to choose appropriate comparator products, but it
ultimately denied applications on the ground that they failed
to make specifc comparisons between dessert-, candy-, and

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fr uit-flavored produc ts, on the one hand, and tobacco-
favored
products on the other. See id., at 27–36. Third,
respondents claim that the FDA abandoned earlier guidance
about the importance of device type and instead denied au-
thorization to all dessert-, candy-, and fruit-favored e-
cigarette products regardless of device type. See id., at 45–
47. And fourth, according to respondents, the FDA went
back on its word by failing even to consider their marketing
plans. See id., at 49–50.
As to the frst three issues, we conclude that the FDA's
denial orders were suffciently consistent with its predeci-
sional guidance and thus did not run afoul of the change-in-
position doctrine. As to the failure to consider marketing
plans, the FDA does not seek review of the Fifth Circuit's
fnding of error. See Brief for Petitioner 31. Rather, it
asks us to clarify the harmless-error rule and remand for
application of the proper standard. See id., at 38. We
agree with the FDA that that is the appropriate course of
action.
1
We frst address the FDA's position on scientifc evidence.
In respondents' view, the FDA initially stated that manufac-
turers would not need to provide specifc kinds of studies
like randomized controlled trials or longitudinal cohort stud-
ies but then treated such evidence as essential.
a
Respondents express frustration about the lack of clear
prior notice regarding the type of scientifc evidence that
was essential for approval of an application, but we cannot
agree with their argument that the FDA went back on any
commitments made in the guidance it provided before ruling
on respondents' applications.
Both the TCA itself and the FDA's guidance left the
agency broad discretion to decide what sort of scientifc evi-
dence an applicant was required to submit. The TCA itself
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imposes only basic requirements on this matter. It says
that
the agency's determination of what “would be appro-
priate for the protection of the public health” must be made
based on either “well-controlled investigations, which may
include 1 or more clinical investigations by experts qualifed
by training and experience to evaluate the tobacco product,”
21 U. S. C. § 387j(c)(5)(A) (emphasis added), or—and this is
the point that is critical here—other “valid scientifc evi-
dence” that “is suffcient to evaluate the tobacco product,”
§ 387j(c)(5)(B). The TCA leaves it to the FDA to decide
what constitutes a “well-controlled investigatio[n]” or other
“valid scientifc evidence” that is “suffcient.”
Before ruling on respondents' and other manufacturers'
applications, the FDA addressed the issue of scientifc evi-
dence in a series of lengthy documents and oral presenta-
tions by agency offcials, but it is hard to fnd in all this ver-
biage any specifc commitments about exactly what sorts of
scientifc evidence an applicant would have to provide. As
we will detail below when we discuss the particulars of re-
spondents' applications, the FDA commented on the strength
of various types of evidence and how particular types of evi-
dence would likely be evaluated, but at no point did it lay
down any clear test.
For example, during an October 23, 2018, public meeting,
an agency offcial said that “[i]n most situations it is likely
that at least some [new] analytical testing specifc to the
product would be conducted to support” an application.
2018 Presentation Video, at 2:12:35–2:12:44 (emphasis added).
The offcial then offered examples such as “randomized con-
trolled clinical trials”; “alternatives” like “pharmacokinetic,”
“pharmacodynamic,” “biomarker,” “topography,” or “focus
group studies”; published peer-reviewed literature; and liter-
ature reviews more generally. Id., at 2:13:07–2:14:44. But
the offcial never stated that any particular type of study was
necessary. On the contrary, the FDA acknowledged that it
was open to evidence besides “new nonclinical or clinical
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studies.” 2018 Presentation 26. And the FDA promised
that
it would consider evidence “bridging ” new tobacco prod-
ucts to already marketed products whose safety was backed
by “existing clinical, nonclinical, or product information.”
Id., at 18, 27. None of this amounted to anything like a
hard-and-fast commitment as to the minimum evidence the
agency would require for marketing authorization.
6
A June 2019 guidance document was similarly noncommit-
tal. After reiterating the statutory requirement of “well-
controlled investigations,” the document recognized that the
“relatively new entrance” of e-cigarettes “on the U. S. mar-
ket” meant that “limited data may exist from scientifc stud-
ies and analyses.” App. 28 (citing 21 U. S. C. § 387j(c)(5)(A)).
As a result, the document stated, the FDA would consider
“other `valid scientifc evidence' if found suffcient.” App.
28. But it cautioned that “[n]onclinical studies alone are
generally not suffcient.” Ibid.
The guidance document went on to give examples of “other
evidence” that might suffce, but in doing so, it cautioned
about the need for scientifc rigor. For example, while stat-
ing that applicants could cite “data from the published litera-
ture or government-sponsored databases,” it warned that
such data must be “adequately bridged to your product” with
“a scientifc rationale.” Id., at 98. The document told man-
ufacturers that they could also cite “[p]ublished literature
reviews (including meta-analysis),” but that such evidence is
“considered a less robust form of support.” Id., at 100.
And applicants were advised that they could “conduc[t] inde-
pendent analyses of published studies,” but that “if critical
6
It is true that the FDA's accompanying slideshow represented that
“[n]o specifc studies” would be required for a premarket tobacco product
application. 2018 Presentation 26. But in light of what the TCA itself
demanded (i. e., “well-controlled investigations” or other “suffcient” “sci-
entifc evidence”) and the FDA offcial's numerous examples throughout
the presentation, the obvious import of the “[n]o specifc studies” state-
ment was that many different types of studies could potentially suffce.
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study details are not submitted, the studies may not be use-
fu
l in FDA's review.” Id., at 102.
A fair summary of the main point made in all this guidance
is that (a) it was not essential for manufacturers to submit
evidence based on “well-controlled investigations,” such as
randomized controlled trials or longitudinal cohort studies,
but (b) if they did not do so, they would have to provide
rigorous scientifc evidence that the sale of their particular
products would be appropriate for the protection of the pub-
lic health. In this case, the applicants did not submit ran-
domized controlled trials or longitudinal cohort studies, so
the fate of their applications turned on whether they submit-
ted “other evidence” that met the FDA's standard of scien-
tifc rigor and relevance to their product. The FDA re-
jected respondents' applications because it concluded that its
“other evidence” test was not met, and the explanation in its
denial orders echoed statements made at various points in
its earlier guidance.
Both respondents relied on a “comprehensive review of the
scientifc literature.” Id., at 303, 392. But respondents had
notice from the 2019 guidance that the FDA considered liter-
ature reviews “a less robust form of support.” Id., at 100.
The 2019 guidance also instructed that applicants submitting
literature reviews should, among other things, “[i]nclude
comparative assessments of the health risks associated with
use of [a manufacturer's] new tobacco product compared to
the risks associated with quitting tobacco product use, using
other tobacco products, and never using tobacco products.”
Id., at 101. Respondents' literature review did the opposite.
It concluded that “there is not enough evidence . . . to deter-
mine whether e-cigarette favors aid in smoking cessation.”
Id., at 475.
One of the respondents, Vapetasia, submitted results from
a cross-sectional survey fnding that “82.99% of survey re-
spondents indicated that e-cigarettes helped them quit smok-
ing combustible tobacco.” 41 F. 4th, at 436. But the FDA
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concluded the survey was not adequately tied to Vapetasia's
favored
products. App. to Pet. for Cert. 280a. That re-
quirement echoed the 2019 guidance's advice that manufac-
turers submitting evidence from “new nonclinical . . . stud-
ies” should “explain why [a] study is relevant to use for the
[manufacturer's] product (e. g., the similarities between the
product, product use, or product market).” App. 98–99.
Based on the FDA's largely noncommittal guidance on sci-
entifc evidence and its specifc reasons for rejecting respond-
ents' applications, we cannot say that the agency deviated
“from a prior policy sub silentio or simply disregard[ed]”
what it had previously said. Fox Television, 556 U. S., at
515. In line with the agency's prior guidance, each denial
order was based on the applicant's failure to provide either
evidence from well-controlled investigations, such as “a ran-
domized controlled trial and/or longitudinal cohort study,”
see App. to Pet. for Cert. 167a, or other evidence that was
found to be “reliabl[e] and robus[t],” id., at 167a–168a. No
change in position occurred in this respect.
b
Contrary to respondents' contention, this conclusion is not
undermined by the FDA's scientifc-review form, which con-
tained checkboxes to indicate whether an applicant submit-
ted a randomized controlled study (Criterion A), a longitudi-
nal cohort study (Criterion B), or other evidence “related to
potential beneft to adults” (Criterion C). App. 615–638; see
Brief for Respondents 32. Criterion C appears to defeat re-
spondents' argument, but they contend that the FDA made
it clear that this criterion demanded a study of the effect of
favored products on adult smokers “ ` “over time” ' ” and that
this requirement duplicated Criterion B, which looked for a
“longitudinal cohort study.” Id., at 37.
This argument fails because a “longitudinal cohort study”
and evidence of a product's effects “over time” are not the
same thing. The term “longitudinal study” is typically used
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to describe a particular kind of long-term study, namely,
one
that “employ[s] continuous or repeated measures to fol-
low particular individuals over prolonged periods of time—
of ten years or decades. ” E. Car uana, M. Roman, J.
Hernández-Sánchez, & P. Solli, Longitudinal Studies, 7 J.
Thoracic Disease E537 (2015). Not every study that consid-
ers a produc t's effec ts “over ti me” fa l ls w ith i n th is
understanding.
7
c
Based on the FDA's internal memoranda from the summer
of 2021, respondents argue that the agency secretly enforced
a new requirement that manufacturers must submit evidence
from either a randomized control trial or longitudinal cohort
study. See Brief for Respondents 31–32. Recall that the
FDA's July 9, 2021, memorandum stated that the failure to
submit such evidence would constitute a “fatal faw” that
would “likely” result in denial of an application. App. 243.
Even though this statement, like most of what the FDA said
in its guidance, was not categorical, it certainly suggested a
much harder stance than was implied by the FDA's public
statements, which told applicants that “other evidence”
might be capable of proving a new tobacco product's appro-
priateness for the protection of public health.
Respondents suggest that the FDA surreptitiously applied
the “fatal faw” memorandum, and as evidence, they note
that until well after their applications were denied, the FDA
7
In a related argument, respondents argue that the FDA “repeatedly
represented that it did not expect long-term clinical studies” in predeci-
sional guidance but later required such studies. Brief for Respondents
41. But a “long-term study” and evidence “over time” are not the same
thing. As the 2019 guidance explained, the FDA describes “long-term
studies” as “those studies that are conducted over six months or longer.”
App. 29. Nothing in the denial orders suggested that the FDA imposed
a rigid requirement that evidence come from such studies. And the 2019
guidance also underscored the FDA's expectation that applicants present
evidence about the “possible long-term health impact” of their new tobacco
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rejected all applications for favored products. But agencies
are
entitled to a presumption of regularity, Citizens to Pre-
serve Overton Park, Inc. v. Volpe, 401 U. S. 402, 415 (1971),
and the record offers enough support for us to conclude that
the FDA never enforced a rigid “fatal faw” standard.
To start, a later internal memorandum dated August 17,
2021, appeared to contradict the “fatal faw” memorandum.
The new memorandum represented that the FDA “would
also consider evidence from another study design” besides
randomized controlled trials and longitudinal cohort studies,
“provided that it could reliably and robustly assess behavior
change” and “compar[e] users of ” dessert-, candy-, and fruit-
favored “products with those of tobacco-favored products.”
App. 247, n. ix. The FDA also acknowledged that “indirect
evidence or bridged data from the literature might still be
appropriate for many new products” too. Id., at 266. Even
though the FDA predicted these “other types of evidence”
would “not likely be suffciently robust or direct,” the August
17, 2021, memorandum is unambiguous that the FDA would
nevertheless consider such evidence. Id., at 267.
This memo might be viewed as dooming any argument
based on the earlier “fatal faw” memorandum, but on Au-
gust 25, 2021, the FDA rescinded the August 17, 2021, memo-
randum and represented that it would “not consider or rely
on [it] as a supporting document.” Id., at 282.
Rescission of the August 17 memorandum raises the ques-
tion whether that action effectively reinstated the July 9,
2021, “fatal faw” memorandum or was a pretext to mask the
FDA's adherence to secret criteria. But the FDA repre-
sents that these internal memoranda played no role in its
review of applications, see Reply Brief 11–12, and for us to
peel back the curtain on that representation would have re-
quired respondents to make a “strong showing of bad faith
or improper behavior,” Overton Park, 401 U. S., at 420; see
also Department of Commerce v. New York, 588 U. S. 752,
781 (2019) (“[J]udicial inquiry into `executive motivation' rep-
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resents `a substantial intrusion' into the workings of another
branch
of Government and should normally be avoided”
(quoting Arlington Heights v. Metropolitan Housing Devel-
opment Corp., 429 U. S. 252, 268, n. 18 (1977))). Respond-
ents have not surmounted the high standard that must be
met to warrant such a “substantial intrusion” into the Execu-
tive's functioning. Id., at 268, n. 18 (internal quotation
marks omitted).
We thus conclude that respondents failed to show that the
FDA changed its position with respect to the scientifc evi-
dence supporting premarket tobacco product applications.
2
Next, we turn to the FDA's comparative-effcacy require-
ment, which called on manufacturers to compare the health
effects of their dessert-, candy-, and fruit-favored products
to those of tobacco-favored products. On respondents'
reading of the record, the FDA initially gave applicants
broad discretion to select appropriate comparators for their
products, but it later categorically rejected applications that
failed to show that “favored e-cigarettes promote more
switching than unfavored” or tobacco-favored e-cigarettes.
90 F. 4th, at 376–377; accord, Brief for Respondents 29–33.
a
The record does not suggest that the FDA contradicted
its predecisional guidance by requiring certain cross-favor
comparisons. To start, the TCA expressly contemplates
comparisons of different tobacco products. It requires an
applicant to provide “full reports of all information . . . con-
cerning investigations which have been made to show . . .
whether [its] tobacco product presents less risk than other
tobacco products. ” 21 U. S. C. § 387j(b)(1)(A) (emphasis
added). Moreover, the FDA's determination that a new to-
bacco product is “appropriate for the protection of the public
health” is an inherently comparative judgment. The FDA
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must account for the “increased or decreased likelihood that
existi
ng users of tobacco products will stop using such prod-
ucts” and the “increased or decreased likelihood that those
who do not use tobacco products will start using such prod-
ucts.” § 387j(c)(4). This balancing test calls out for various
types of comparisons, including comparisons between new
tobacco products and those that are already available, as well
as between different types of new tobacco products that may
attract new smokers.
Through its predecisional guidance, the FDA elaborated
on the types of comparisons that would be helpful. Echoing
the TCA, the June 2019 guidance document recommended
that a manufacturer “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.”
App. 30. The FDA went on to explain what it means for
manufacturers to make comparisons to “similar, marketed to-
bacco products in the same category.” Id., at 58. “For ex-
ample,” it advised, “if your [application] is for an e-liquid,
we recommend a comparison to other e-liquids with similar
nicotine content, favors, and other ingredients, used in the
same manner and under similar conditions.” Ibid. The
plain implication of this statement is that the FDA might
consider whether an application for a favored product in-
cluded a comparison with other products in the favored
category.
Other parts of the 2019 guidance also underlined the
FDA's concern about “the potential impact of favors on
product toxicity and appeal to youth and young adults.” Id.,
at 87. The FDA noted that it “considers the appeal and use
of [e-cigarette] product favors important in ascertaining the
health risks of these products” and thus recommended “sci-
entifc reviews of favors.” Id., at 87–88. Specifcally, it
called on manufacturers to “examine the impact of the favor-
ing on consumer perception . . . especially given the attrac-
tiveness of favors to youth and young adults.” Id., at 88.
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Further, in its 2020 enforcement guidance, the FDA tele-
graphed
its view that dessert-, candy-, and fruit-favored
e-cigarette products are more likely than tobacco- and
menthol-favored products to appeal to the young. The
FDA noted its intent to “prioritize enforcement of favored”
e-cigarette products “other than tobacco- and menthol-
favored products,” id., at 160, and observed that “youth use
of mint- and fruit-favored [e-cigarette] products is higher
than that of menthol- and tobacco-favored [e-cigarette] prod-
ucts.” Id., at 163. The FDA also relied on data that favors
like tobacco and menthol “were preferred more by adults
than youth.”
8
Id., at 162.
When it reviewed respondents' applications, the FDA did
not contradict any previously announced position with re-
spect to the comparative effects of differently favored prod-
ucts. As respondents' marketing denial orders stated, their
applications were unsuccessful because they failed to “dem-
onstrat[e] the beneft of ” their dessert-, candy-, and fruit-
favored e-cigarette “products over an appropriate compara-
tor tobacco-favored” e-cigarette product. App. to Pet. for
Cert. 167a. Admittedly, the FDA has not pointed us to any
portion of its predecisional guidance that said in so many
words that manufacturers must draw that precise compari-
son. And, in fact, the 2019 guidance gave manufacturers
some discretion in choosing appropriate comparators as long
as the “FDA [could] understand [an] applicant's rationale and
justifcation for comparators chosen.” App. 30. But the
FDA's comparative-effcacy standard was a natural conse-
quence of its predecisional guidance, which highlighted,
among other things, (1) the need for robust cross-product
8
An initial draft of the 2020 guidance exempted from enforcement prior-
ity mint-favored products, treating them similarly to tobacco- and
menthol-favored products. But in the revised 2020 guidance that we dis-
cuss here, the FDA no longer exempted mint-favored products based on
new evidence that youth are also drawn to mint favors. See App. 162–
164.
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comparisons (including on the dimension of favor) and (2)
the
FDA's heightened concern with dessert-, candy-, and
fruit-favored products compared to tobacco- and menthol-
favored products. Such a predictable outgrowth from pre-
vious guidance is not an “[u]nexplained inconsistency”
amounting to a “change” under the change-in-position doc-
trine. National Cable & Telecommunications Assn. v.
Brand X Internet Services, 545 U. S. 967, 981 (2005); cf. Long
Island Care at Home, Ltd. v. Coke, 551 U. S. 158, 174 (2007)
(“The Courts of Appeals have generally interpreted this to
mean that the fnal rule the agency adopts must be a logical
outgrowth of the rule proposed” (internal quotation marks
omitted)).
b
Respondents contend that the FDA “said nothing about
comparing ” dessert-, candy-, and fruit-favored “products to
tobacco-favored products,” Brief for Respondents 27, and
even suggested manufacturers could “freely select” compara-
tors as long as they provided adequate “justifcation or ra-
tionale” for their comparator choice, id., at 30–31.
As we noted, respondents are correct that the FDA did not
provide this precise instruction in its predecisional guidance.
But, as an FDA offcial noted at the 2018 public presentation,
manufacturers were encouraged throughout the application
process to think hard about “what is or are the most ap-
propriate comparators” to their products. 2018 Presenta-
tion Video, at 1:57:37–1:57:42. And the agency's subsequent
guidance emphasized the importance of cross-product compa-
rators and the FDA's specifc worry that dessert-, candy-,
and fruit-favored products would appeal to youth more than
tobacco- and menthol-favored products. The FDA is thus
better understood as having extended, not reversed, its pre-
vious guidance. See supra, at 580 and this page.
Quite tellingly, respondents appear to have received the
FDA's message on this front. Their applications are replete
with statements attempting (albeit unsuccessfully) to draw
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comparisons between dessert-, candy-, and fruit-favored and
tobacco-favored
products—the same sort of comparisons for
which the FDA allegedly provided no notice. See, e. g., App.
320 (“Another recent survey of more than 69,000 adult vapers
found that just 16% identifed tobacco, menthol, or mint as
favors they used most often; the vast majority preferred
fruit and sweet favors”); ibid. (“ `Fruity' favor was the num-
ber one favor preference by 49.98% of all respondents.
Only about 3% of all respondents stated that they preferred
no favor”); id., at 321 (noting that a third of surveyed smok-
ers “stated they started out using tobacco or menthol favors
but now always or almost always use other favors”). All
that is to say, respondents' applications are themselves
strong evidence that regulated entities had adequate notice
of the sort of comparative analysis the FDA anticipated.
Furthermore, even assuming the predecisional guidance
did not perfectly predict the comparative-effcacy standard
ultimately applied to applications, the FDA was not required
to issue such guidance in the frst place. Respondents do
not argue that the TCA imposed an affrmative obligation on
the FDA to spell out in detail how it expected applicants to
compare a new tobacco product to other tobacco products.
See Brief for Respondents 33. Rather, as we have ex-
plained, the FDA had discretion to work out the meaning of
the TCA's comparative standard when evaluating premarket
tobacco product applications. See 21 U. S. C. §§ 387j(b)
(1)(A), (c)(4). A contrary rule would be in tension with
Chenery II's teaching that, absent a statutory prohibition,
agencies may genera l ly develop reg u latory st andards
through either adjudication or rulemaking. 332 U. S., at
202–203.
3
Finally, we turn to the issue of device type. In respond-
ents' view, the FDA's 2020 guidance saw a material distinc-
tion between cartridge-based and other favored products,
but when it came to ruling on applications, the FDA effec-
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Opinion of the Court
tively imposed a fat ban on all favored products. Brief for
Respondents
45–47.
a
We cannot agree with respondents that the denial orders'
treatment of device type was “inconsistent” with any “ear-
lier position.” Encino Motorcars, 579 U. S., at 224. The
2020 guidance explained how the FDA “intend[ed] to priori-
tize [its] enforcement resources.” App. 129. Specifcally,
the agency planned to target three types of e-cigarette prod-
ucts: (1) “[f]lavored, cartridge-based” products; (2) “[a]ll
other [e-cigarette] products for which the manufacturer has
failed to take (or is failing to take) adequate measures to
prevent minors' access”; and (3) “[a]ny [e-cigarette] products
targeted to, or whose marketing is likely to promote use by,
minors.” Id., at 145. Admittedly, on any reading of this
guidance document, the FDA's central concern was the frst
category because data suggested “youth are more likely to
use certain favored, cartridge-based [e-cigarette] products.”
Id., at 147.
But nothing in the 2020 guidance suggested the FDA
would decline to take enforcement action against other prod-
ucts that might be appealing to the young. In fact, the
FDA's enumeration of the second and third enforcement pri-
orities, which are not limited to favored cartridge-based
products, supports the contrary conclusion. So when the
FDA ultimately denied authorization to respondents' fa-
vored (though non-cartridge) products, it did not reverse
course. Rather, it followed through on the 2020 guidance's
warning that the agency would also prioritize enforcement
against manufacturers “whose [products'] marketing is likely
to promote use by . . . minors.” Id., at 145. Indeed, the
FDA's marketing denial orders stated that respondents' ap-
plications were “insuffcient to demonstrate that the[ir] prod-
ucts would provide an added beneft that is adequate to out-
weigh the risks to youth.” App. to Pet. for Cert. 168a.
That is a consistent application of the 2020 guidance's en-
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forcement framework or, at the very least, an application
that
did not “revers[e the FDA's] former views as to the
proper course.” State Farm, 463 U. S., at 41.
This case is unlike Fox Television, in which we held that
an agency changed position by “expanding the scope of its
enforcement activity.” 556 U. S., at 517. That case con-
cerned the Federal Communications Commission's (FCC) en-
forcement of the federal indecency ban against the use of
offensive words on broadcast television. Initially, the FCC
distinguished between literal and nonliteral uses of offensive
words and determined that feeting uses of nonliteral offen-
sive words were not actionably indecent. See id., at 508.
But then, in a subsequent adjudication, the FCC eliminated
that safe harbor for nonliteral expletives and explained that
even a single use of an offensive word was actionably inde-
cent. See ibid. We deemed that shift in enforcement pol-
icy “a change” for purposes of the change-in-position doc-
trine. See id., at 517.
Here, in contrast, the FDA's 2020 guidance did not estab-
lish “a safe harbor” for non-cartridge-based products. Id.,
at 518. True, the 2020 guidance unmistakably emphasized
cartridge-based products, but it said nothing to suggest
dessert-, candy-, and fruit-favored products for open-system
e-cigarettes would escape regulatory scrutiny. And further
distinguishing Fox Television, the FDA's actions here did not
“br[eak] new ground.” Id., at 517. Indeed, there was no
new ground to break because respondents' denial orders
were part of the FDA's frst major exercise of its new author-
ity over tobacco products under the TCA. In other words,
the FDA could not “expan[d] the scope of ” previously nonex-
istent “enforcement activity.” Ibid.
Even if the FDA had changed its position, it offered “good
reasons” for looking beyond cartridge-based e-cigarette
products, id., at 515, namely, that there was evidence from
national surveillance data that youth demand had moved
from favored cartridge-based products to favored dispos-
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585
Opinion of the Court
able products, App. to Pet. for Cert. 191a–192a. From this,
the
FDA drew the conclusion that “across these different
device types, the role of favor is consistent.” Id., at 191a.
If one type of favored product were removed from the mar-
ket, the FDA concluded, youth would “migrate to another”
type of favored product. Id., at 192a. So the FDA decided
to focus on the “role of favors . . . across tobacco product
categories.” Id., at 191a. The FDA made this “conscious
change of course” because it “believe[d] it to be better,” and
the agency gave “good reasons” for the change. Fox Televi-
sion, 556 U. S., at 515.
Respondents cannot claim that the FDA's revised enforce-
ment priorities upset a “legitimate reliance” interest. Smi-
ley v. Citibank (South Dakota), N. A., 517 U. S. 735, 742
(1996). At most, the 2020 guidance may have led respond-
ents to believe that the FDA was more likely to authorize
their open-system products than other manufacturers'
cartridge-based products. But such a belief about how an
agency is likely to exercise its enforcement discretion is not
a “serious reliance interes[t].” Fox Television, 556 U. S., at
515. Our prior change-in-position cases have set a much
higher bar, requiring, for example, “decades of industry reli-
ance on [an agency's] prior policy.” Encino Motorcars, 579
U. S., at 222. Here, in contrast, respondents could not have
built up decades of reliance because they were part of the
very frst wave of marketing denials under the FDA's newly
minted jurisdiction over tobacco products.
We thus hold that the FDA's treatment of device type,
even if it evolved over time, did not violate the change-in-
position doctrine.
b
Respondents take issue with the FDA's explanation that it
changed enforcement priorities based on evidence that youth
demand shifted from cartridge-based products to disposable
products. In respondents' view, that evidence had nothing
to do with products such as theirs that are intended for open-
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system e-cigarette products. See Brief for Respondents 45–
46.
And respondents cite evidence from a study fnding that
between 2020 and 2021 high-school-student demand for de-
vices compatible with favored bottled e-liquids actually de-
creased. See id., at 46, and n. 32 (citing E. Park-Lee et al.,
Centers for Disease Control and Prevention, Notes From the
Field: E-Cigarette Use Among Middle and High School Stu-
dents—National Youth Tobacco Survey, United States, 2021,
70 Morbidity and Mortality Weekly Rep. 1387, 1387–1388
(2021)).
This counterargument is not persuasive. Even though
the FDA did not cite evidence that was specifcally about
increasing youth demand for open-system e-cigarette prod-
ucts, the FDA drew a reasonable inference based on the data
before it: namely, that the rapid shift in youth demand from
favored cartridge-based products to favored disposable
products strongly suggested that youth were most strongly
drawn by favor rather than device type. We see no reason
why the FDA could not extrapolate from that data and con-
clude that young people would be drawn to favored products
for open-system e-cigarettes. Regardless, we are not posi-
tioned in this arbitrary-and-capricious challenge to consider
respondents' evidence from a study that postdates the fling
of their applications and is, in any event, outside “the admin-
istrative record already in existence.” Camp v. Pitts, 411
U. S. 138, 142 (1973) (per curiam). Nor is respondents' evi-
dence of suffcient heft to call into question whether the
FDA's “factual determinations” about the powerful effect of
favor is supported by “substantial evidence” in the “existing
administrative record.” Biestek v. Berryhill, 587 U. S. 97,
102 (2019).
C
That brings us to the FDA's guidance concerning market-
ing plans. Recall that the FDA does not contest the Fifth
Circuit's fnding that it changed position regarding the sub-
mission of marketing plans, but it argues that this error was
harmless. This question presents a diffcult problem. It

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587
Opinion of the Court
requires us to reconcile the so-called remand rule developed
i
n SEC v. Chenery Corp., 318 U. S. 80, 88, 93–95 (1943)
(Chenery I), and Chenery II, 332 U. S., at 196–197, with the
APA's instruction that reviewing courts must take “ `due ac-
count' ” of “ `the rule of prejudicial error' ” that “ordinarily
appl[ies] in civil cases,” Shinseki v. Sanders, 556 U. S. 396,
406 (2009) (quoting 5 U. S. C. § 706).
1
In Chenery I, the Court announced the now-bedrock prin-
ciple that an agency action cannot stand “unless the grounds
upon which the agency acted in exercising its powers were
those upon which its action can be sustained.” 318 U. S., at
95. There, we rejected the Securities and Exchange Com-
mission's belated request to affrm its action on an alterna-
tive ground raised for the frst time in litigation. Id., at 92–
94. We reasoned that when Congress vests an agency with
authority to make “a determination of policy or judgment”
and the agency fails to exercise that authority, “a judicial
judgment cannot be made to do service for an administrative
judgment.” Id., at 88. Upholding agency action on an al-
ternative ground not considered by the agency, the Court
reasoned, would “intrude upon the domain which Congress
. . . exclusively entrusted to an administrative agency.”
Ibid. We reaffrmed this principle in Chenery II, see 332
U. S., at 196–197, and a necessary implication of that princi-
ple is that the better course when an agency error is identi-
fed is for the reviewing court, “except in rare circum-
st ances, ” “ to remand to the agency for additi ona l
investigation or explanation,” Florida Power & Light Co. v.
Lorion, 470 U. S. 729, 744 (1985). That implication of Chen-
ery is colloquially referred to as the “remand rule.” See
INS v. Orlando Ventura, 537 U. S. 12, 18 (2002) (per curiam)
(internal quotation marks omitted).
Three years after Chenery I was handed down, Congress
enacted the APA. Ch. 324, 60 Stat. 237. At that time, Rule
61 of the Federal Rules of Civil Procedure instructed courts
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not to disturb a judgment or order unless refusal to do so
wou
ld be “inconsistent with substantial justice.” Fed. Rule
Civ. Proc. 61 (1939). The APA picked up on this principle
and required courts reviewing agency action to take “due
account . . . of the rule of prejudicial error.” § 706. Taking
“due account” of a rule is not literally the same as applying
that rule lock, stock, and barrel. The most natural interpre-
tation of the APA's language is thus that reviewing courts
should adapt the “rule of prejudicial error” applicable in or-
dinary civil litigation (also known as the harmless-error rule)
to the administrative-law context, which, of course, includes
the remand rule.
2
The FDA's failure to consider marketing plans and its cho-
sen arguments in litigation have set the remand rule and the
APA's harmless-error principle in tension. Despite assuring
manufacturers in predecisional guidance that their market-
ing plans would be “critical,” the FDA refused to consider
respondents' marketing plans when it reviewed their pre-
market tobacco product applications. 84 Fed. Reg. 50581.
Based on its experience, the FDA opined that marketing and
access restrictions on favored e-cigarette products are, as a
practical matter, categorically insuffcient to sustain an oth-
erwise inadequate application. See App. to Pet. for Cert.
200a, n. xix. The Fifth Circuit held that this about-face was
arbitrary and capricious, see 90 F. 4th, at 372–373, and the
FDA has “not sought review of the Fifth Circuit's threshold
fnding of error,” Brief for Petitioner 31. Instead, it ex-
pands upon an argument it raised before the Fifth Circuit,
see En Banc Brief for Respondent in No. 21–60766, p. 29,
and contends that its failure to consider marketing plans was
harmless error because, subsequent to denying respondents'
applications, it issued denial orders to other manufacturers
after reviewing marketing plans that were materially indis-
tinguishable from respondents'. See Brief for Petitioner
34–36. That is proof, the FDA says, that reviewing re-
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Opinion of the Court
spondents' marketi ng plans wou ld not have made a
di
fference.
The Fifth Circuit rejected the FDA's harmless-error argu-
ment based on our most recent decision invoking the remand
rule, Calcutt v. FDIC, 598 U. S. 623 (2023) (per curiam).
See 90 F. 4th, at 389–390. In Calcutt, after reciting the re-
mand rule in strong terms, we acknowledged that a “remand
may be unwarranted . . . [w]here the agency `was required' to
take a particular action.” 598 U. S., at 630 (quoting Morgan
Stanley Capital Group Inc. v. Public Util. Dist. No. 1 of
Snohomish Cty., 554 U. S. 527, 544 (2008)). The Fifth Cir-
cuit interpreted Calcutt's discussion to mean that there is
only one exception to the remand rule. See 90 F. 4th, at 390
(“APA errors are only harmless where the agency would be
required to take the same action no matter what. In all
other cases, an agency cannot avoid remand”). That is cer-
tainly a plausible interpretation of Calcutt, but it would
imply a need to remand for all but the narrowest category of
agency errors, minimizing the role of harmless-error review.
The FDA disagrees with this broad reading of Calcutt and
cites, among other authorities, our decision in Sanders. In
that case, we opined that the APA incorporates “the same
kind of `harmless-error' rule that courts ordinarily apply in
civil cases.” 556 U. S., at 406. That principle, taken to its
logical extreme, could permit a reviewing court to sustain a
fawed agency decision whenever it fnds that the agency
would have reached the same result absent the initial error.
Understood in that way, harmless error might swallow the
remand rule.
There is thus obviously tension between Calcutt and
Sanders, and neither decision sought to harmonize the re-
mand and harmless-error rules. Calcutt made no reference
to the APA's prejudicial-error provision, and Sanders did not
discuss the remand rule or even cite Chenery.
Commentators have long puzzled over this tension and
proposed ways to bridge the divide. See H. Friendly, Chen-
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ery Revisited: Refections on Reversal and Remand of Ad-
mi
nistrative Orders, 1969 Duke L. J. 199, 222–225 (Friendly);
N. Bagley, Remedial Restraint in Administrative Law, 117
Colum. L. Rev. 253, 302–307 (2017) (Bagley); C. Walker,
Against Remedial Restraint in Administrative Law, 117
Colum. L. Rev. Online 106, 115–120 (2017). And the courts
of appeals have apparently developed their own practices to
reconcile the remand and harmless-error rules. See Bagley
302, n. 328 (citing cases). We will not attempt to provide a
complete answer to this vexing problem here.
For now, we agree with the FDA that the Fifth Circuit
read Calcutt too broadly. It has long been accepted, for ex-
ample, that a remand may not be necessary when an agency's
decision is supported by a plethora of factual fndings, only
one of which is unsound. When it is clear that the agency's
error “had no bearing on the procedure used or the sub-
stance of [the] decision reached,” a remand would be point-
less. Massachusetts Trustees of Eastern Gas & Fuel Asso-
ciates v. United States, 377 U. S. 235, 248 (1964); see Friendly
210–211 (“Massachusetts Trustees v. United States . . . might
be regarded as a true indentation of Chenery, [but] it is an
altogether sound one”).
9
We do not suggest that this excep-
tion and the one recognized in Calcutt exhaust the universe
of exceptions to the remand rule. But the existence of this
exception is suffcient to show that the Fifth Circuit's read-
ing of Calcutt went too far.
9
Despite its holding that Calcutt is the sole exception to the remand
rule, the Court of Appeals appears to have issued a brief alternative hold-
ing at the very end of its opinion. In that short discussion, the court cited
Circuit precedent echoing the rule of Massachusetts Trustees. See 90
F. 4th, at 390 (citing United States v. Johnson, 632 F. 3d 912, 930 (CA5
2011)). But the Court of Appeals applied Massachusetts Trustees at a
high level of generality, and absent any analysis applying Massachusetts
Trustees to the FDA's failure to consider respondents' marketing plans
specifcally, we are unable to affrm the decision on that alternative basis.
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That said, the FDA's reading of Sanders may also be ex-
cessive
. In an article that the FDA quotes with approval,
see Brief for Petitioner 41, Judge Friendly accurately cap-
tured the core of the remand rule when he wrote, “[w]here
the agency has rested decision on an unsustainable reason,
the court should generally reverse and remand even though
it discerns a possibility, even a strong one, that by another
course of reasoning the agency might come to the same
result,” Friendly 222 (emphasis added). There is an impor-
tant distinction, if only a subtle one, between this formula-
tion and the FDA's argument that a party attacking an
agency decision must prove that an error had a “substantial
bearing ” on the decision. Brief for Petitioner 36–37. And
the FDA has not identifed any prior case in which we have
held that the application of an erroneous understanding of
the governing law was harmless because a subsequent
agency decision shows that the agency would have reached
the same result if it had applied the correct understanding
of the law.
The FDA has not asked us to decide the harmless-error
question at this juncture. True, in its petition for certiorari,
it requested that we “review and reverse the Fifth Circuit's
holding that the error was not harmless.” Pet. for Cert. 18
(emphasis added). But the FDA unmistakably abandoned
that full-throated request after we granted certiorari. In
its opening brief, the FDA asked that we “only identify the
correct harmless-error rule and remand the case, allowing
the Fifth Circuit to determine whether respondents have
met their burden of showing prejudice.” Brief for Peti-
tioner 38. It reiterated that position in its reply. See
Reply Brief 18. And at argument, when asked, the FDA
was upfront that it seeks vacatur and remand so the Fifth
Circuit can decide the question afresh without relying on its
overly expansive reading of Calcutt. Tr. of Oral Arg. 55–
56. We follow that course.
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Sotomayor, J., concurring
***
F
or these reasons, we vacate the judgment of the United
States Court of Appeals for the Fifth Circuit and remand
the case for further proceedings consistent with this opinion.
It is so ordered.
Justice Sotomayor, concurring.
I join the Court's opinion, as it rightly rejects the conten-
tion that the FDA acted arbitrarily and capriciously in deny-
ing respondents' applications for premarket approval of their
tobacco products. I write separately, however, to clarify
one point.
I do not believe the FDA, in the lead up to denying re-
spondents' applications, “was feeling its way toward a fnal
stance and was unable or unwilling to say in clear and spe-
cifc terms precisely what applicants would have to provide.”
Ante, at 556. Instead, the record shows the agency reason-
ably gave manufacturers some fexibility as to the forms of
evidence that would suffce for premarket approval of their
products, while hewing to (and never suggesting it would
stray from) its statutory duty to approve only those products
that would be “appropriate for the protection of the public
health.” 21 U. S. C. § 387j(c)(2)(A). In light of the statu-
tory text and the well-documented and serious risks favored
e-cigarette products pose to youth, it should have come as
no surprise that applicants would need to submit rigorous
scientifc evidence showing that the benefts of their products
would outweigh those risks. See § 387j(c)(4).
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Reporter’s Note
The attached opinion has been revised to refect the usual publication
and citation style of the United States Reports. The revised pagination
makes available the offcial United States Reports citation in advance of
publication. The syllabus has been prepared by the Reporter of Decisions
for the convenience of the reader and constitutes no part of the opinion of
the Court. A list of counsel who argued or fled briefs in this case, and
who were members of the bar of this Court at the time this case was
argued, has been inserted following the syllabus. Other revisions may
include adjustments to formatting, captions, citation form, and any errant
punctuation. The following additional edits were made:
p. 579, line 3 from bottom: “the” is inserted before “favoring ”
p. 582, line 11: “that” is deleted