Court Opinion

ID: 9407629
Source: CourtListenerOpinion
Date Created: 2023-07-07 18:01:02.742169+00
Date Added: 2024-06-11T17:20:39.283608
License: Public Domain

FOR PUBLICATION

  UNITED STATES COURT OF APPEALS
       FOR THE NINTH CIRCUIT

LOTUS VAPING TECHNOLOGIES,             No. 21-71328
LLC,

               Petitioner,
                                         OPINION
 v.

U.S. FOOD & DRUG
ADMINISTRATION,

               Respondent.

NUDE NICOTINE INC.,                    No. 21-71321

               Petitioner,

 v.

U.S. FOOD & DRUG
ADMINISTRATION,

               Respondent.

      On Petition for Review of an Order of the
           Food & Drug Administration
2            LOTUS VAPING TECHNOLOGIES, LLC V. FDA

           Argued and Submitted August 11, 2022
                 San Francisco, California

                        Filed July 7, 2023

    Before: Johnnie B. Rawlinson, Bridget S. Bade, and
              Daniel A. Bress, Circuit Judges.

                     Opinion by Judge Bade

                          SUMMARY *

               Food and Drug Administration

    The panel denied petitions for review challenging the
denial of Petitioners’ premarket tobacco product
applications seeking Food and Drug Administration
(“FDA”) authorization to sell nicotine-containing e-liquids
in the United States.
    The FDA issued marketing denial orders for Petitioners’
flavored products, finding that Petitioners’ applications
lacked sufficient evidence showing that their flavored
products would provide a benefit to adult users that
outweighs the risks such products pose to youth.
   The panel held that the text of the Family Smoking
Prevention and Tobacco Control Act (the “Tobacco Control

*
  This summary constitutes no part of the opinion of the court. It has
been prepared by court staff for the convenience of the reader.
           LOTUS VAPING TECHNOLOGIES, LLC V. FDA            3

Act”) plainly authorizes the FDA to require that
manufacturers submit comparative health risk data, which
necessarily includes comparisons of flavored e-liquids to
tobacco-flavored e-liquids. The panel also held that the
FDA did not arbitrarily or capriciously deny Petitioners’
applications, and that any error the agency committed by
failing to consider Petitioners’ marketing plans was
harmless.
    First, Petitioners contended that the FDA exceeded its
statutory authority by requiring comparative efficacy studies
to demonstrate that their flavored products— electronic
nicotine delivery systems (“ENDS”)—better promote
smoking cessation than comparable tobacco-flavored
products. The panel joined the Second, Third, Fourth,
Seventh, and D.C. Circuits in holding that the FDA had
statutory authority to regulate as it did. The Tobacco
Control Act expressly authorized the FDA’s consideration
of comparative evidence.
     Second, Petitioners argued that that the FDA acted
arbitrarily and capriciously by denying their applications to
market flavored e-liquids. The panel rejected Petitioner’s
first argument that the FDA unfairly surprised them by
demanding that they compare their flavored e-liquids to
tobacco-flavored ones. Considering the Tobacco Control
Act’s purpose and the FDA’s concern regarding the
substantial increase in youth initiation prompted by flavored
ENDS products, Petitioners cannot plausibly contend that
the agency led them to believe a flavor-to-flavor comparison
would meet the Act’s requirements. The panel also rejected
Petitioner’s second argument—that the FDA purportedly
stated that it would accept single-point-in-time studies, like
consumer surveys, but ultimately required studies that
followed consumers over long time periods. The panel held
4          LOTUS VAPING TECHNOLOGIES, LLC V. FDA

that the FDA did not introduce a new evidentiary standard;
rather, it consistently required evidence that evaluated the
impacts of flavored versus non-flavored products on
initiation and cessation. The FDA acted in conformity with
its previous guidance and reasonably rejected Petitioners’
applications because their other proffered evidence was not
sufficiently reliable and robust. The panel held the agency
did not act arbitrarily or capriciously by concluding that
Petitioners’ evidence fell short.
    The panel next turned to Petitioners’ contentions that the
FDA’s failure to consider their marketing and sales-access-
restrictions plans was arbitrary and capricious. The panel
assumed, without deciding, that the FDA erred in ignoring
Petitioners’ marketing plans, but concluded that any error
was harmless. The Tobacco Control Act incorporates the
Administrative Procedures Act’s harmless error
rule. Petitioners do not identify how their marketing
measures were materially different from those the FDA had
already said are insufficient. At the time the FDA reviewed
Petitioners’ applications, it had already concluded that
eliminating marketing aimed at youth users and monitoring
retailers’ sales were ineffective in preventing youth use
because children maintained a steady stream of access to the
flavored products they desired through alternate means, like
their friends and social networks. Accordingly, the panel
concluded that, even if the agency erred by failing to
consider Petitioners’ marketing plans, any error was
harmless, and it would not remand on this basis.
   Finally, the panel addressed Petitioners’ post-argument
motions to supplement the administrative record and file
supplemental briefing, and seeking judicial notice of a
premarket tobacco product application deficiency letter,
FDA internal memoranda, and FDA press releases. The
           LOTUS VAPING TECHNOLOGIES, LLC V. FDA         5

panel denied the motions to supplement the administrative
record and file supplemental briefing and granted the
motions for judicial notice.

                       COUNSEL

Eric N. Heyer (argued), Joseph A. Smith, and Jessica
Tierney, Thompson Hine LLP, Washington, D.C., for
Petitioner Lotus Vaping Technologies LLC.
Kate Talmor (argued), Lindsey Powell, Antonia Konkoly,
and Joshua Koppel, Trial Attorneys, Civil Division; Eric B.
Beckenhauer, Assistant Branch Director; Brian M. Boynton,
Principal Deputy Assistant Attorney General; Julie Lovas,
Senior Counsel, Office of Chief Counsel, Food and Drug
Administration; Wendy S. Vicente, Acting Department
Chief Counsel for Litigation, Food and Drug
Administration; Daniel J. Barry, Acting General Counsel,
Department of Health and Human Services; United States
Department of Justice; Washington, D.C.; for Respondent.
J. Gregory Troutman, Troutman Law Office PLLC,
Louisville, Kentucky, for Amici Curiae 38 National and
State Electronic Nicotine Delivery System Product
Advocacy Associations.
Mary G. Bielaska, Zanicorn Legal PLLC, New York, New
York, for Amici Curiae Dr. David B. Abrams, Clive D.
Bates, and Professor David T. Sweanor.
Jordan Raphael, Byron Raphael LLP, Los Angeles,
California; Dennis A. Henigan and Connor Fuchs,
Campaign for Tobacco-Free Kids, Washington, D.C.; for
Amici Curiae Medical and Public Health Groups.
6           LOTUS VAPING TECHNOLOGIES, LLC V. FDA

                          OPINION

BADE, Circuit Judge:

    Congress has authorized the United States Food and
Drug Administration (“FDA”) to regulate the manufacture,
marketing, and distribution of tobacco products. 21 U.S.C.
§ 387a. Exercising that authority, the FDA promulgated a
final rule in 2016 that subjects e-cigarettes and their
component e-liquids to the requirements outlined in the
Family Smoking Prevention and Tobacco Control Act
(“Tobacco Control Act” or the “Act”). Id. §§ 387–387t. The
Act requires manufacturers to apply for authorization to sell
new tobacco products, which the FDA permits only if the
marketing of such products would be “appropriate for the
protection of the public health.” Id. § 387j(c)(2)(A).
    Petitioners Lotus Vaping Technologies, LLC, and Nude
Nicotine Inc. each submitted premarket tobacco product
applications seeking FDA authorization to sell nicotine-
containing e-liquids in the United States. The FDA issued
marketing denial orders for Petitioners’ flavored products,
finding that Petitioners’ applications lacked sufficient
evidence showing that their flavored products would provide
a benefit to adult users that outweighs the risks such products
pose to youth. Petitioners seek review of these denial
orders. 1
    We are asked to decide whether the FDA has statutory
authority to require manufacturers to demonstrate that their
flavored electronic nicotine delivery systems (“ENDS”)

1
  We consolidated these cases for oral argument, and we keep them
consolidated for disposition.
            LOTUS VAPING TECHNOLOGIES, LLC V. FDA             7

better promote smoking cessation than comparable tobacco-
flavored products, and whether the agency arbitrarily or
capriciously denied Petitioners’ applications. We hold that
the text of the Tobacco Control Act plainly authorizes the
FDA to require that manufacturers submit comparative
health risk data, which necessarily includes comparisons of
flavored e-liquids to tobacco-flavored e-liquids. We also
hold that the FDA did not arbitrarily or capriciously deny
Petitioners’ applications and that any error the agency
committed by failing to consider Petitioners’ marketing
plans is harmless. In so holding, we join the majority of our
sister circuits that have addressed the merits of the same
issues in materially identical cases. See Magellan Tech., Inc.
v. FDA, No. 21-2426, 2023 WL 4035722 (2d Cir. June 16,
2023); Liquid Labs LLC v. FDA, 52 F.4th 533 (3d Cir.
2022); Avail Vapor, LLC v. FDA, 55 F.4th 409 (4th Cir.
2022); Gripum, LLC v. FDA, 47 F.4th 553 (7th Cir. 2022);
Prohibition Juice Co. v. FDA, 45 F.4th 8 (D.C. Cir. 2022).
We deny the petitions for review.
                               I
                               A
    The Federal Food, Drug, and Cosmetic Act (“FDCA”),
21 U.S.C. §§ 301–399i, as amended by the Tobacco Control
Act, id. §§ 387–387t, authorizes the Secretary of Health and
Human Services to regulate the manufacture, marketing, and
distribution of “tobacco products” through the FDA. Id.
§ 387a(a), (e). Congress’s stated purpose in enacting the
Tobacco Control Act was to, among other things, “ensure
that the Food and Drug Administration has the authority to
address issues of particular concern to public health officials,
especially the use of tobacco by young people and
dependence on tobacco” and “to promote cessation to reduce
8            LOTUS VAPING TECHNOLOGIES, LLC V. FDA

disease risk and the social costs associated with tobacco-
related diseases.” Tobacco Regulation, Federal Retirement
Reform, Pub. L. No. 111-31, § 3, 123 Stat. 1776, 1781–82
(2009); see also Big Time Vapes, Inc. v. FDA, 963 F.3d 436,
444 (5th Cir. 2020) (“Obviously, the [Tobacco Control
Act’s] purpose sounds in (1) protecting public health and (2)
preventing young people from accessing (and becoming
addicted to) tobacco products.”). Congress immediately
subjected “cigarettes, cigarette tobacco, roll-your-own
tobacco,” “smokeless tobacco,” and “any tobacco product
containing nicotine that is not made or derived from
tobacco” to the FDA’s tobacco-product authorities. 21
U.S.C. § 387a(b). But Congress delegated to the Secretary
the power to determine whether “any other tobacco
products” should be covered by the Act. Id. § 387a(b); see
id. § 321(d).
    Exercising this authority, the FDA promulgated a final
rule in 2016 that extended the Tobacco Control Act to all
products meeting the FDCA’s definition of “tobacco
product” under 21 U.S.C. § 321(rr)(1). 2 See Deeming
Tobacco Products To Be Subject to the Federal Food, Drug,
and Cosmetic Act, as Amended by the Family Smoking
Prevention and Tobacco Control Act, 81 Fed. Reg. 28,973-
01 (May 10, 2016) (“Deeming Rule”). The parties agree that
ENDS generally, and Petitioners’ products specifically,
satisfy that statutory definition. Id. at 28,975–76.
   Thus, under the Deeming Rule, Petitioners must comply
with the Tobacco Control Act. This includes § 387j, which

2
  Under that definition, a “tobacco product” is “any product made or
derived from tobacco, or containing nicotine from any source, that is
intended for human consumption, including any component, part, or
accessory of a tobacco product.” 21 U.S.C. § 321(rr)(1).
           LOTUS VAPING TECHNOLOGIES, LLC V. FDA          9

requires that manufacturers obtain FDA authorization to
market “new tobacco product[s]” in interstate commerce. 21
U.S.C. § 387j(a)(1)–(2). Premarket authorization can be
obtained in three ways. Only one is relevant here: A
manufacturer may submit a premarket tobacco product
application (“PMTA”) showing that the “product to be
marketed would be appropriate for the protection of the
public health.” Id. § 387j(a)(2)(A), (c)(2)(A).
    “The PMTA process is onerous, requiring manufacturers
to gather significant amounts of information.” Big Time
Vapes, 963 F.3d at 439. Congress requires that applications
include “full reports . . . concerning investigations which
have been made to show the health risks of such tobacco
product and whether such tobacco product presents less risk
than other tobacco products,” a full statement of the
ingredients, and a full description of the manufacturing
process, among other information.          See 21 U.S.C.
§ 387j(b)(1).
    When evaluating an application, the FDA must examine
“the risks and benefits to the population as a whole,
including [to] users and nonusers of the tobacco product.”
Id. § 387j(c)(4). This includes “the increased or decreased
likelihood that existing users of tobacco products will stop
using such products,” and “the increased or decreased
likelihood that those who do not use tobacco products will
start using such products.” Id. The Tobacco Control Act
instructs that the FDA “shall deny” an application “if, upon
the basis of the information submitted . . . and any other
information before [the FDA],” the application does not
show that the marketing of the product “would be
10            LOTUS VAPING TECHNOLOGIES, LLC V. FDA

appropriate for the protection of the public health.” 3 Id.
§ 387j(c)(2)(A). Otherwise, and if all other statutory
requirements are met, the FDA must issue a marketing
granted order. Id. § 387j(c)(1)(A).
    When the Deeming Rule was promulgated, ENDS
products were widely available in the United States. See
Deeming Rule, 81 Fed. Reg. at 28,982. The FDA recognized
that manufacturers of these products would need time to
gather data and prepare the documents needed to receive
market authorization. 4 Id. at 29,010–11. Thus, the FDA
announced staggered compliance deadlines for newly
deemed products that were marketed in the United States as
of August 8, 2016. Id. at 28,974, 29,011.
    The Deeming Rule originally set the PMTA submission
deadline for August 8, 2018. Id. The FDA later extended
the deadline to August 8, 2022. FDA, Enforcement
Priorities for Electronic Nicotine Delivery Systems (ENDS)
and Other Deemed Products on the Market Without
Premarket Authorization (Revised): Guidance for Industry 5
(2020) (“2020 Guidance”). But, after a successful challenge

3
  In addition, the FDA must deny an application if: (1) “the methods used
in, or the facilities or controls used for, the manufacture, processing, or
packing of such tobacco product do not conform to the requirements of
section 387f(e) of [the Tobacco Control Act]”; (2) “based on a fair
evaluation of all material facts, the proposed labeling is false or
misleading in any particular”; or (3) “such tobacco product is not shown
to conform in all respects to a tobacco product standard in effect under
section 387g of [the Tobacco Control Act], and there is a lack of adequate
information to justify the deviation from such standard.” 21 U.S.C.
§ 387j(c)(2)(B)–(D).
4
 Tobacco products that were on the market on or before February 15,
2007 were “grandfathered” and did “not require premarket
authorization.” Deeming Rule, 81 Fed. Reg. at 29,009.
           LOTUS VAPING TECHNOLOGIES, LLC V. FDA           11

by the American Academy of Pediatrics and other interested
entities, a district court accelerated the deadline to May 11,
2020, Am. Acad. of Pediatrics v. FDA, 399 F. Supp. 3d 479,
480–81, 487 (D. Md. 2019), and then adjusted it to
September 9, 2020 in response to the COVID-19 pandemic,
see Order, Am. Acad. of Pediatrics v. FDA, No. 8:18-CV-
883, Dkt. 182 (D. Md. Apr. 22, 2020); id., Dkt. 201 at 1 (D.
Md. April 15, 2022).
    The FDA also implemented a twelve-month grace period
after the PMTA submission deadline to afford the agency
time to review the applications and issue appropriate orders.
Deeming Rule, 81 Fed. Reg. at 28,978. The agency did not
“intend to initiate enforcement action for failure to have
premarket authorization” until after the entire compliance
period expired on September 9, 2021. Id. at 29,011; Center
for Tobacco Products, Deemed Product Review: A
Conversation with the Office of Science 4 (June 11, 2021).
                              B
   In advance of the submission deadline, the FDA issued
nonbinding guidance and a proposed rule to assist ENDS-
product manufacturers with their applications.
                              1
    In June 2019, the FDA issued guidance outlining its
then-current “thinking on the types of information an
applicant should include in a PMTA to help show that
permitting the new tobacco product to be marketed would be
[appropriate for the protection of the public health].” FDA,
Premarket Tobacco Product Applications for Electronic
Nicotine Delivery Systems: Guidance for Industry 46 (2019)
(“2019 Guidance”). That information included “well-
controlled investigations”—i.e., investigations that “are
12           LOTUS VAPING TECHNOLOGIES, LLC V. FDA

designed and conducted in such a way that minimizes or
controls for bias, confounding variables, and other factors
that may render the results unreliable”—or “other ‘valid
scientific evidence’ if found sufficient to evaluate the
tobacco product.” Id. at 12 & n.21.
    For example, the FDA “intend[ed] to review”
“information on other products (e.g., published literature,
marketing information)” if applicants provided “appropriate
bridging studies.” Id. at 12. 5 But the FDA cautioned that
published literature reviews “are considered a less robust
form” of evidence, id. at 47, and that “[n]onclinical studies
alone are generally not sufficient to support” marketing
authorization, id. at 12 & n.22, 46. Nonetheless, given the
relative newness of the products, the FDA did “not expect
that applicants [would] need to conduct long-term studies to
support an application.” 6 Id. at 13.
    The 2019 Guidance also encouraged applicants to submit
“data that adequately characterizes the potential impact of
the new tobacco product on the health of both users and
nonusers.” Id. at 37. To that end, the FDA advised that

5
  The FDA further explained: “For clinical assessments, instead of
conducting clinical studies that span months or years to evaluate
potential clinical impact, applicants could demonstrate possible long-
term health impact by including existing longer duration studies in the
public literature with the appropriate bridging information (i.e., why the
data used are applicable to the new tobacco product) and extrapolating
from short-term studies.” 2019 Guidance at 13; see also id. at 50.
6
  The 2019 Guidance mirrored the assertions made by the FDA at a
public meeting in October 2018. See Center for Tobacco Products,
Premarket Tobacco Product Application Content Overview 26 (Oct. 23,
2018) (stating that “[n]o specific studies are required for a PMTA” and
that “it may be possible to support a marketing order for an ENDS
product without conducting new nonclinical or clinical studies”).
           LOTUS VAPING TECHNOLOGIES, LLC V. FDA            13

applicants include “[e]valuations of the likelihood of
initiation among never-users and former users of tobacco
products and cessation among current tobacco users.” Id. at
38. Those behaviors could be addressed in “randomized
clinical trials,” but the FDA “believe[d] this would also be
true of observational studies (perception, actual use, or both)
examining cessation behaviors.” Id.
    Relatedly, the 2019 Guidance conveyed the FDA’s
recommendation that applicants compare their products to
other tobacco products to demonstrate the risks and benefits
of marketing. Id. at 13–14, 23–24. The FDA explained that,
as part of its determination under § 387j(c)(4), it would
“review[] the health risks associated with changes in tobacco
product use behavior (e.g., initiation, switching, dual use,
cessation) that are likely to occur with the marketing of the
new tobacco product.” Id. at 13. Thus, the FDA urged
applicants to “compare the health risks of [their] product[s]
to both products within the same category and subcategory,
as well as products in different categories as appropriate.”
Id.
    For e-liquids, the FDA recommended that “the product’s
health risks be compared to those health risks presented by
other e-liquids used in a similar manner” and that
manufacturers “include those characteristics (materials,
ingredients, design, composition, heating source, or other
features) that contribute to the new product presenting the
same, less, or different health risks than other tobacco
products of similar category and subcategory.” Id. at 14.
“This comparative health risk data,” the FDA advised, would
be “an important part of the evaluation of the health effects
of product switching.” Id. at 13.
14         LOTUS VAPING TECHNOLOGIES, LLC V. FDA

                             2
    In September 2019, the FDA issued a proposed rule to
help “ensure that PMTAs contain sufficient information for
[the] FDA to determine whether a marketing order should be
issued.” Premarket Tobacco Product Applications and
Recordkeeping Requirements, 84 Fed. Reg. 50,566-01,
50,566 (Sept. 25, 2019) (“Proposed Rule”). The focus of the
Proposed Rule’s “content requirements [was] the threshold
amount of information necessary for application filing”
because the FDA was “still gaining experience in applying
the authorization standard to PMTAs” and it believed that
applicants had “some flexibility in the types of scientific
information they [could] submit.” Id. at 50,567.
    The threshold information included a marketing plan
“concerning at least the first year of marketing after an
applicant receives a marketing order.” Id. at 50,580. The
Proposed Rule advised that marketing plans would aid the
agency in assessing “whether permitting the marketing of the
new tobacco product would be [appropriate for the
protection of the public health] because they . . . provide
input that is critical to [the] FDA’s determination of the
likelihood of changes in tobacco product use behavior,
especially when considered in conjunction with other
information contained in the application.” Id. at 50,581.
    Like the 2019 Guidance, the Proposed Rule did “not set
requirements for specific studies that must be contained in
every single PMTA.” Id. at 50,599. The FDA similarly
recognized that “long-term data is not available for all
categories of products,” and thus, it did “not expect that
long-term clinical studies . . . [would] need to be conducted
for each PMTA.” Id. at 50,619. The Proposed Rule
reinforced, however, that the FDA would rely “upon only
           LOTUS VAPING TECHNOLOGIES, LLC V. FDA            15

valid scientific evidence to determine whether the marketing
of the new tobacco product would be [appropriate for the
protection of the public health].” Id.
    In addition, the Proposed Rule reiterated the FDA’s
“recommend[ation]” that an “applicant compare the health
risks of its product to both products within the same category
and subcategory, as well as products in different categories
as appropriate.” Id. at 50,600. And, echoing the 2019
Guidance, the Proposed Rule underscored that “comparative
health risk data is an important part of the evaluation.” Id.
                              3
    In April 2020, the FDA issued guidance conveying its
enforcement priorities for ENDS products. 2020 Guidance
at 9. Relevant here, the FDA announced that it would
prioritize enforcement against “flavored, cartridge-based
ENDS products” to counteract “an alarming increase in the
use of ENDS products by middle and high school students”
driven by the “extraordinary popularity” of flavored
products with minors and their “overwhelming[]
prefer[ence]” for cartridge-based devices. Id. at 3, 6, 13, 15,
19–22.
    Notably, the 2020 Guidance also compiled a list of
measures that manufacturers had proposed as safeguards to
limit youth access to ENDS products for both brick and
mortar and online stores. Id. at 7. The safeguards included
(1) age-verification requirements and technology; (2)
contractual penalties for retailers that sold tobacco products
to minors; and (3) restrictions on the quantity of ENDS
products that consumers could purchase. Id. But the FDA
reported that youth e-cigarette use continued to increase, id.
at 8–9, and that youth continued to have access to such
products even when those safeguards were in place, id. at 8–
16            LOTUS VAPING TECHNOLOGIES, LLC V. FDA

9, 21. Thus, the FDA concluded “that focusing on how the
product was sold would not appropriately address youth use
of . . . flavored, cartridge-based products,” id. at 21, and it
advised the industry that “age verification alone” would not
adequately address youth use of tobacco products “given the
many sources of products available for youth access,” id. at
44.
                                    C
    Lotus Vaping Technologies, LLC is an Idaho-based
manufacturer of tobacco products.         Lotus’s nicotine-
containing e-liquids are designed to be used in open-system
devices 7 and come in a variety of flavors. Although such
flavors include tobacco and menthol, Lotus’s other flavored
products 8—e.g., “apple,” “cinnamon candy,” “juicy fruit,”
and “rootbeer”—are the ones at issue here.
    Nude Nicotine Inc. is a California-based manufacturer of
nicotine-containing e-liquids. Like Lotus’s products, Nude
Nicotine’s e-liquids are also designed to be used in open-
system devices. But unlike Lotus’s products, Nude
Nicotine’s e-liquids are not sold with added flavors.
Nevertheless, Nude Nicotine’s products constitute “flavored

7
  E-cigarettes come in “open” and “closed” forms. Premarket Tobacco
Product Applications & Recordkeeping Requirements, 86 Fed. Reg.
55,300-01, 55,317 (Oct. 5, 2021). An open device “includes a reservoir
that a user can refill with an e-liquid of their choosing.” Id. A closed
device, by contrast, “includes an e-liquid reservoir that is not refillable
. . . or that uses e-liquid contained in replaceable cartridges or pods that
are not intended to be refillable.” Id.
8
  We use the term “flavored products” to refer to products other than
tobacco- or menthol-flavored products, which includes nonflavored
products that are designed to have flavor added to them. Our definition
is consistent with the nomenclature used by the FDA.
           LOTUS VAPING TECHNOLOGIES, LLC V. FDA          17

products” because they are designed to be suitable for flavor
addition.
                             1
    In September 2020, Lotus and Nude Nicotine submitted
applications seeking marketing authorization for their
flavored products. Lotus supported its application with a
scientific literature review, a customer survey, and a
coalition survey of thousands of participants. Nude Nicotine
submitted product testing, an e-liquid stability study, and
scientific literature.
    Each Petitioner also submitted a marketing plan to
describe the steps it would take to minimize unauthorized
use of their products. Both Petitioners proposed age
verification for sales of their products and age gating to
restrict youth access to advertisements on outlets such as
social media. Lotus also proposed individual purchase limits
for online sales and maintained that product demonstrations
or sampling would occur only at age-gated industry trade
shows. Nude Nicotine outlined a program that would
purportedly bind its retailers to comply with age gating
requirements, certain marketing procedures, and other post-
market monitoring practices. Petitioners also emphasized
their commitment to post-market surveillance to ensure
appropriate marketing of their products.
                             2
    In July 2021, a few months before the FDA issued
decisions on Petitioners’ applications, the FDA circulated an
internal memorandum that announced “a new plan to
effectively manage” a subset of applications for flavored
ENDS products and to “take final action on as many
18           LOTUS VAPING TECHNOLOGIES, LLC V. FDA

applications as possible by September 10, 2021.” 9 Under
this new plan, the agency would conduct a “simple” fatal
flaw review to identify whether the application contained
“either a randomized controlled trial (RCT) or a longitudinal
cohort study.” If those studies were lacking, the application
would “likely receive a marketing denial order.”
     One month later, the FDA circulated another internal
memorandum that explained that the agency would broaden
its inquiry to consider evidence from other types of studies
if such studies “reliably and robustly assess behavior
change.” The memorandum cautioned that cross-sectional
surveys, consumer perception studies, and general scientific
literature would “not likely be sufficiently robust or direct in
providing evidence as to the impact of the new ENDS on
adult switching or cigarette reduction.” The memorandum
also advised that the FDA would not evaluate marketing
plans “for the sake of efficiency.” The FDA rescinded this
memorandum within days of its circulation.

9
  The FDA initially believed that it would receive applications for a few
thousand ENDS products. See FDA, Final Regulatory Impact Analysis
Final Regulatory Flexibility Analysis Unfunded Mandate Reform Act
Analysis 48 (May 2016). The agency ultimately received applications
for more than 6.5 million newly deemed tobacco products, and the
majority of those applications were for ENDS. See News Release, FDA,
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); Center for Tobacco Products,
Deemed Product Review: A Conversation with the Office of Science 17
(June 11, 2021); Statement, FDA, FDA Makes Significant Progress in
Science-Based Public Health Application Review, Taking Action on
Over 90% of More Than 6.5 Million ‘Deemed’ New Tobacco Products
Submitted (Sept. 9, 2021).
           LOTUS VAPING TECHNOLOGIES, LLC V. FDA           19

    In late August 2021, the FDA announced that it had
issued the first marketing denial orders for ENDS products
“after determining the applications for about 55,000 flavored
ENDS products . . . lacked sufficient evidence that they have
a benefit to adult smokers sufficient to overcome the public
health threat posed by the well-documented, alarming levels
of youth use of such products.” News Release, FDA, 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).
Within a matter of weeks, then-Acting Commissioner of the
FDA, Janet Woodcock, issued a statement conveying that
the agency had acted on applications for over 6 million
ENDS products. Statement, FDA, FDA Makes Significant
Progress in Science-Based Public Health Application
Review, Taking Action on Over 90% of More Than 6.5
Million ‘Deemed’ New Tobacco Products Submitted (Sept.
9, 2021). This action included the issuance of marketing
denial orders “for more than 946,000 flavored ENDS
products.” Id.
                              3
    In September 2021, the FDA issued marketing denial
orders to Lotus and Nude Nicotine for their flavored e-
liquids. The “key basis” for both orders was that Petitioners’
applications did not include “a randomized controlled trial
and/or longitudinal cohort study that demonstrated the
benefit of [Petitioners’] flavored ENDS products over an
appropriate comparator[:] tobacco-flavored ENDS,” and
that the applications otherwise lacked “reliabl[e] and
robust[]” forms of “other evidence . . . evaluat[ing] the
impact of the new flavored [versus] tobacco-flavored
20         LOTUS VAPING TECHNOLOGIES, LLC V. FDA

products on adult smokers’ switching or cigarette reduction
over time.”
      Along with the orders, the FDA provided each Petitioner
with a Technical Project Lead review (“TPL”) that described
the agency’s reasoning in greater detail. The TPLs, which
are materially identical, stressed the “exponential growth in
youth ENDS use” and the “enduring prevalence of youth
ENDS use in the U.S.” The FDA found that “[t]he role of
flavors in increasing the appeal of tobacco products to youth
. . . is well-established in the literature.” And although the
agency acknowledged that “there is variability in the
popularity of device types among youth,” it determined that
“the role of flavor is consistent.” For example, the FDA
pointed to a “substantial rise in use of disposable flavored
ENDS” after it “changed its enforcement policy to prioritize
pod-based flavored ENDS.” Thus, in the FDA’s view, the
data established “that the removal of one flavored product
option prompted youth to migrate to another ENDS type that
offered the desired flavor options, underscoring the
fundamental role of flavor in driving appeal.”
    In addition, the TPLs described the types of evidence
capable of showing that flavored products are appropriate for
the protection of the public health. For flavored products,
“the magnitude of the likely benefit [to adult smokers] would
have to be substantial enough to overcome the significant
risk of youth uptake and use posed by [those] products.”
Thus, “strong direct evidence” demonstrating the potential
benefit was required. Randomized controlled trials and
longitudinal cohort studies were “most[] likely to
demonstrate such a benefit,” but “other types of evidence
could be adequate if sufficiently reliable and robust.” The
FDA explained that evidence must be product specific, and
the agency concluded that cross-sectional surveys (entailing
            LOTUS VAPING TECHNOLOGIES, LLC V. FDA              21

“a one-time assessment of self-reported outcomes”),
consumer perception studies (evaluating intentions but not
actual product use or behavior), and general scientific
literature would not suffice.
    The TPLs advised that the FDA had reviewed
Petitioners’ applications to assess whether they contained “a
randomized controlled trial, longitudinal cohort study, or
other evidence regarding the impact of the ENDS on
switching or cigarette reduction that could potentially
demonstrate the benefit of their flavored ENDS over
tobacco-flavored ENDS” and concluded they did not.
Because that “key evidence” was missing, the FDA did not
“assess other aspects of the applications,” including
Petitioners’ marketing plans.
   Petitioners timely sought review in this court. See 21
U.S.C. § 387l(a).
                                II
    “Under the Tobacco Control Act’s judicial review
provision, a party subject to a marketing denial order may
petition for review either in [the D.C. Circuit] or in the circuit
in which its principal place of business is located.”
Prohibition Juice, 45 F.4th at 17 (citing 21 U.S.C. §
387l(a)(1)(B)). We review such orders in accordance with
the Administrative Procedure Act (“APA”), which requires
us to “hold unlawful and set aside agency action, findings,
and conclusions” that are “arbitrary, capricious, an abuse of
discretion, or otherwise not in accordance with law.”
5 U.S.C. § 706(2)(A).
   Under this “narrow standard of review,” we do not
substitute our own judgment for that of the agency. DHS v.
Regents of the Univ. of Cal., 140 S. Ct. 1891, 1905 (2020).
22           LOTUS VAPING TECHNOLOGIES, LLC V. FDA

Instead, we assess only “whether the decision was based on
a consideration of the relevant factors and whether there has
been a clear error of judgment.” Marsh v. Or. Nat. Res.
Council, 490 U.S. 360, 378 (1989) (quotation omitted).
Agency action must “be reasonable and reasonably
explained.” FCC v. Prometheus Radio Project, 141 S. Ct.
1150, 1158 (2021). And an agency “must defend its actions
based on the reasons it gave when it acted,” not with post
hoc rationalizations. Regents, 140 S. Ct. at 1909.
                                 III
    Petitioners primarily assert two arguments on appeal.
First, they contend that the FDA exceeded its statutory
authority by requiring comparative efficacy studies. Second,
Petitioners argue that the FDA’s denial of their PMTAs was
arbitrary, capricious, or otherwise unlawful. We begin with
the FDA’s statutory authority.
                                 A
     Petitioners maintain that the FDA exceeded the scope of
its statutory authority by requiring applicants to demonstrate
that their flavored products better promote smoking
cessation than comparable tobacco-flavored products. We
disagree and join the Second, Third, Fourth, Seventh, and
D.C. Circuits in holding that the FDA had statutory authority
to regulate as it did. 10 See, e.g., Magellan Tech., Inc., 2023
WL 4035722 at *7 (“The TCA expressly contemplates a
comparative analysis among tobacco products in the context
of evaluating whether the products are Appropriate.”);
Liquid Labs, 52 F.4th at 542 (explaining that the Act

10
   Because the Tobacco Control Act “is best read to support the FDA’s
action, we need not consider whether or how much deference to accord
its interpretation.” Prohibition Juice, 45 F.4th at 18.
           LOTUS VAPING TECHNOLOGIES, LLC V. FDA         23

“expressly asks for evidence concerning whether an
applicant’s tobacco product presents less risk than other
tobacco products” (internal quotation marks and citations
omitted)); Avail Vapor, 55 F.4th at 427 (“The [Act]
explicitly contemplates that [the] FDA must embark on a
comparative inquiry before allowing any marketing of a new
tobacco product.”); Gripum, 47 F.4th at 555 (explaining that
the FDA is required under the Act to “weigh a product’s
risks of hooking new users (typically youth) into the world
of tobacco, broadly defined, against its potential to help
existing users (typically adults) wean themselves from
tobacco’s unhealthier forms (namely, combustible
cigarettes)”); Prohibition Juice, 45 F.4th at 19 (concluding
that the Act “not only allows but expressly instructs the
FDA” to compare a flavored ENDS product’s effectiveness
at promoting cessation of combustible cigarette use).
    We start with the text of the Tobacco Control Act. See
Van Buren v. United States, 141 S. Ct. 1648, 1654 (2021).
The Act permits the FDA to authorize the marketing of a
new tobacco product only if the manufacturer has
established that it “would be appropriate for the protection
of the public health.” 21 U.S.C. § 387j(c)(2)(A). In making
that determination, the FDA must consider “the increased or
decreased likelihood that existing users of tobacco products
will stop using such products,” as well as “the increased or
decreased likelihood that those who do not use tobacco
products will start using such products.” Id. § 387j(c)(4)
(emphases added). These considerations are inherently
comparative. See Avail Vapor, 55 F.4th at 428.
    The textual support for the FDA’s authority does not end
there. Congress also directed applicants seeking to market a
new tobacco product to include in their applications “full
reports of all information . . . concerning investigations
24            LOTUS VAPING TECHNOLOGIES, LLC V. FDA

which have been made to show the health risks of such
tobacco product and whether such tobacco product presents
less risk than other tobacco products.”            21 U.S.C.
§ 387j(b)(1)(A) (emphasis added). Section 387j(c) provides,
in turn, that the FDA “shall deny an application . . . if, upon
the basis of the information submitted”—which would
necessarily include any comparative reports submitted in
accordance with § 387j(b)(1)(A)—“and any other
information before the [FDA],” the agency finds that the
applicant did not show “that permitting [the] tobacco product
to be marketed would be appropriate for the protection of the
public health.” Id. § 387j(c)(2)(A). Put differently, the FDA
must weigh the risk of hooking new users on tobacco
products against a product’s potential to help existing users
switch from unhealthier forms of tobacco—i.e., combustible
cigarettes. See Gripum, 47 F.4th at 555.
    Perhaps realizing that the Tobacco Control Act expressly
authorizes the FDA’s consideration of comparative
evidence, 11 Petitioners contend that the term “risk,” as used
in § 387j(b)(1)(A), refers only to “physiological health
risks” and “not some broader concept of risk that
encompasses initiation and cessation behaviors.” We find
this contention wholly unpersuasive. As the D.C. Circuit
aptly explained: “The degree to which a harmful product
entices and addicts new users is inarguably a component of
the ‘health risk’ it poses.” Prohibition Juice, 45 F.4th at 19–
20.

11
   Indeed, Nude Nicotine “acknowledged fully” at oral argument that “it
is a fair application of the statutory standard” for the FDA to require that
manufacturers of flavored ENDS compare their products to tobacco-
flavored products to obtain marketing authorization.
             LOTUS VAPING TECHNOLOGIES, LLC V. FDA                    25

    We therefore conclude that the Tobacco Control Act
expressly authorizes the FDA to consider comparative
evidence, and we agree with our sister circuits that “[t]he
FDA acted well within [Congress’s] statutory directive when
it compared the claimed cessation benefits of flavored and
non-flavored products.” 12 Id. at 19; Gripum, 47 F.4th at 558
(“Th[e] [statutory] language expressly orders the agency to
conduct the described balancing process and to consider both
the risks and benefits attendant to each application that it
adjudicates.”); Liquid Labs, 52 F.4th at 543 (finding that “the
statute and June 2019 Guidance are clear about comparative
analysis”); Avail Vapor, 55 F.4th at 427–28 (same);
Magellan Tech., Inc., 2023 WL 4035722 at *7 (same).
                                   B
   We turn now to Petitioners’ remaining challenge: that the
FDA acted arbitrarily and capriciously by denying their
applications to market flavored e-liquids.
    In their opening briefs, Petitioners advance virtually
identical arguments to those asserted by the ENDS
manufacturers in Prohibition Juice, Gripum, Liquid Labs,
Avail Vapor, and Magellan. Petitioners insist that the FDA
pulled a “surprise switcheroo” by requiring manufacturers to
submit evidence of comparative efficacy through a
randomized controlled trial, longitudinal cohort study, or
other long-term study, while also rejecting evidence that the
agency had previously recommended manufacturers submit,
including published scientific literature and observational

12
   We reject Petitioners’ arguments premised on 21 U.S.C. §§ 355 and
387k for the same reasons articulated by the D.C. Circuit in Prohibition
Juice, 45 F.4th at 20. Similarly, we need not evaluate whether injunctive
relief is appropriate because we deny the petitions for review.
26           LOTUS VAPING TECHNOLOGIES, LLC V. FDA

studies. Petitioners also maintain that the FDA acted
arbitrarily and capriciously by ignoring their marketing
plans, rejecting the evidence they submitted in support of
their applications, “imposing an evidentiary double
standard,” failing to consider allegedly material distinctions
between different kinds of ENDS products, and failing to
offer less drastic alternatives to marketing denial orders.
Nude Nicotine additionally contends that the FDA’s review
resulted in disparate outcomes for similarly situated
applicants. The D.C. Circuit rejected each of these
arguments days before we held oral argument in these
consolidated cases. See Prohibition Juice, 45 F.4th at 20–
24.
    Ostensibly in response to our sister circuit’s decision,
Petitioners refocused their arbitrary and capricious challenge
at oral argument, advocating primarily that the FDA did not
provide sufficient notice of the “substantive evidentiary
standard” governing PMTAs. 13            We therefore take
Petitioners to raise two principal arguments in support of
their arbitrary and capricious claim. We find neither
persuasive.
                                    1
    The first argument proceeds as follows: Although the
2019 Guidance informed ENDS manufacturers to “compare
the health risks of [their] product[s] to both products within
the same category and subcategory, as well as products in

13
  Petitioners were likely also influenced by the Fifth Circuit’s rejection
of these arguments, also shortly before argument in these cases. See
Wages & White Lion Invs., LLC v. FDA (Triton II), 41 F.4th 427 (5th
Cir. 2022), reh’g en banc granted, vacated by 58 F.4th 233 (5th Cir.
2023).
            LOTUS VAPING TECHNOLOGIES, LLC V. FDA            27

different categories,” 2019 Guidance at 13, Petitioners
believed that they had unfettered discretion to choose a
relevant comparator. Under Petitioners’ theory, it would
have been adequate for a manufacturer of flavored ENDS to,
for example, compare its flavored e-liquids to other flavored
e-liquids. Petitioners thus contend that the FDA unfairly
surprised them by demanding that they compare their
flavored e-liquids to tobacco-flavored ones.
    We, like the D.C. Circuit, find this argument to be “far
off base.” Prohibition Juice, 45 F.4th at 23. As discussed,
the FDA may authorize the marketing of a new tobacco
product only if an applicant demonstrates that it “would be
appropriate for the protection of the public health.” 21
U.S.C. § 387j(c)(2)(A). To facilitate that inquiry, Congress
directed manufacturers to include in their applications
reports concerning “whether [the] tobacco product presents
less risk than other tobacco products.” Id. § 387j(b)(1)(A).
And, as Petitioners admitted at oral argument, the FDA told
ENDS manufacturers to compare the health risks of their
products to “products within the same category and
subcategory, as well as products in different categories.”
2019 Guidance at 13.
    Moreover, as the D.C. Circuit explained, “[a] core
objective of the Tobacco Control Act is to ‘ensure’ tobacco
products will not be ‘sold or accessible to underage
purchasers,’” Prohibition Juice, 45 F.4th at 12 (quoting P.L.
No. 111-31, § 3(7)), and at the time Petitioners were
preparing their PMTAs, they knew the FDA was focusing on
the desirability of flavored products to youth users. See, e.g.,
2019 Guidance at 42; 2020 Guidance at 11–17. Considering
the Act’s purpose and the FDA’s concern regarding the
substantial increase in youth initiation prompted by flavored
ENDS products, Petitioners cannot plausibly contend that
28           LOTUS VAPING TECHNOLOGIES, LLC V. FDA

the agency led them to believe a flavor-to-flavor comparison
would meet the Act’s requirements.
    Indeed, Petitioners do not explain how a flavor-to-flavor
comparison would provide any meaningful information to
the FDA. For example, demonstrating that “apple” flavored
ENDS products are less risky than “cinnamon candy”
flavored products would not provide the FDA with useful
information about whether Petitioners’ flavored tobacco
products on the whole are less harmful to existing users than
their tobacco-flavored counterparts, or whether flavored
products draw existing users away from combustible
cigarettes or help them otherwise quit smoking—benefits
that could counterbalance the risk of youth use. We
therefore conclude that the FDA did not act arbitrarily or
capriciously in requiring a comparison between flavored
products and tobacco-flavored products. See Prohibition
Juice, 45 F.4th at 23 (because the FDA had identified flavor
as a driver of youth use, “Petitioners’ own unflavored or
tobacco-flavored e-liquids were an obvious, otherwise-
similar comparator against which to gauge whether the
added risks of their flavored e-liquids are overcome by those
products’ added benefits to adult smokers”). 14

14
    After oral argument and in subsequent motions to this court,
Petitioners have seemingly attempted to renew their contention that the
FDA failed to meaningfully consider the distinction between cartridge-
based or disposable ENDS products and bottled e-liquids. We join our
sister circuits in rejecting this argument. First, the FDA acknowledged
that “there is variability in the popularity of device types among youth,
suggesting there may be differential appeal of certain product styles,”
but “reasonably explained that it nonetheless found the scientific
literature about public health risks to youth applicable to petitioners’
products, because ‘across these different device types, the role of flavor
             LOTUS VAPING TECHNOLOGIES, LLC V. FDA                     29

                                    2
    Petitioner’s second argument—that the FDA purportedly
stated that it would accept single-point-in-time studies, like
consumer surveys, but ultimately required studies that
followed consumers over long time periods—fares no better.
     Again, we agree with our sister circuits who have held
that the FDA did not introduce a new evidentiary standard;
rather, it consistently required evidence that evaluated the
impacts of flavored versus non-flavored products on
initiation and cessation.       The FDA repeatedly used
conditional language indicating that it might accept evidence
other than long term studies if such evidence was sufficiently
reliable and robust. See, e.g., Gripum, 47 F.4th at 559–60
(explaining that the FDA stated that “‘in some cases, it may
be possible to support a marketing order for an [e-cigarette]
product without conducting new nonclinical or clinical
studies,’ though that depends on whether ‘an established
body of evidence . . . can be adequately bridged to [the]
product such as data from the published literature or
government-sponsored databases’” (quoting 2019 Guidance
at 46) (alterations in original)); Prohibition Juice, 45 F.4th
at 21 (explaining that the FDA provided that “randomized

is consistent.’” Prohibition Juice, 45 F.4th at 26 (citation omitted). The
“FDA’s original focus on enforcement against cartridge-based ENDS
products did not foreclose it from denying a marketing order for
[Petitioners’] e-liquids, especially in light of the growing evidence that
the role of flavors in driving youth initiation was consistent across
products.” Avail Vapor, 55 F.4th at 427; see also Liquid Labs, 52 F.4th
at 544–45 (same). The FDA supported its determination with evidence
including “large, national surveys and longitudinal cohort studies” that
“consistently demonstrated” the “preference for use of flavored ENDS
among youth.” Thus, the FDA did not arbitrarily disregard distinctions
between open and closed ENDS products.
30         LOTUS VAPING TECHNOLOGIES, LLC V. FDA

controlled trials or longitudinal studies would not be
necessary if applicants submitted similarly rigorous ‘valid
scientific evidence’” and “[t]he FDA nowhere guaranteed
that unspecified other forms of evidence would necessarily
be sufficient—only that they might be” (quoting 2019
Guidance at 12–13)); Magellan Tech., Inc., 2023 WL
4035722 at *5 (same).
    As the Fourth Circuit explained: the “FDA never
guaranteed that manufacturers could carry their evidentiary
burden under the [Act] without providing long-term data.”
Avail Vapor, 55 F.4th at 422. And by focusing on isolated
statements in the 2019 Guidance that the FDA did not expect
applicants would need to conduct long-term studies,
Petitioners “failed to look at the 2019 guidance in any
depth,” as “[t]he agency made quite clear that it was
interested in receiving information about long-term impact,
even if that information did not necessarily come from a
long-term study.” Id. at 422–23.
    Here, the FDA acted in conformity with its previous
guidance and reasonably rejected Petitioners’ applications
because their other proffered evidence was not sufficiently
reliable and robust. See id. at 422 (concluding that the FDA
“did not reject Avail’s application because it failed to
include certain long-term studies, but rather due to a lack of
any ‘valid scientific evidence’ substantial enough to
outweigh the known risks to youth of flavored products”).
Specifically, Petitioners stumbled at the initial hurdle of
providing useful comparative evidence demonstrating the
risks and benefits of initiation and cessation. Lotus failed to
even include product-specific evidence. And, although
Nude Nicotine offered some product-specific evidence—for
example, in the form of a Harmful and Potentially Harmful
Constituents analysis—the FDA adequately explained that
            LOTUS VAPING TECHNOLOGIES, LLC V. FDA             31

such evidence did not, standing alone, “demonstrate that
current smokers are likely to start using the new product
exclusively or predominantly.” Therefore, Petitioners could
not show a sufficient benefit to adult users relative to the risk
to youth users.
    Lotus points to cross-sectional surveys, literature
reviews, and a coalition survey, and Nude Nicotine contends
that its PMTA contained abuse liability studies, a cross-
sectional actual use survey, and a consumer perception
studies review. But the FDA reasonably explained in the
Marketing Denial Orders and TPLs that cross-sectional
surveys are not sufficiently robust for flavored products
because they “entail a one-time assessment of self-reported
outcomes” and that “single data collection does not enable
reliable evaluation of behavior change over time.”
Similarly, consumer perception studies, like surveys or
experiments, are not sufficiently rigorous because they “are
not designed to directly assess actual product use behavior.”
Petitioners do not contend that they offered any other forms
of robust evidence that could overcome a lack of randomized
controlled trials or longitudinal cohort studies.
    Thus, the FDA did not act arbitrarily or capriciously in
finding Petitioners’ “other evidence” insufficient. See, e.g.,
Liquid Labs, 52 F.4th at 539–43 (explaining that “the FDA
did not newly require those specific types of [long-term]
studies but instead found that Liquid Labs’ other evidence
was inadequate”); Avail Vapor, 55 F.4th at 422 (explaining
that “Avail failed to include” “the type and quality of
evidence” the FDA required, and “this failure, rather than the
absence of certain [long-term] studies in its PMTAs, resulted
in FDA issuing a marketing denial order”); Gripum, 47 F.4th
at 558–61 (explaining that because Gripum did not
(1) provide robust, product specific evidence that “the
32          LOTUS VAPING TECHNOLOGIES, LLC V. FDA

benefits to adult users . . . outweigh[ed] the risk of fomenting
youth use,” or (2) offer sufficient explanations to bridge the
data between long-term studies of other products and its own
products, the FDA did not act arbitrarily and capriciously
when it denied Gripum’s application); see also Magellan
Tech., Inc., 2023 WL 4035722 at *5 (“Consistent with its
position, the FDA considered Magellan’s weak scientific
evidence and found it insufficient to support an Appropriate
finding.”); Prohibition Juice, 45 F.4th at 22 (explaining that
the FDA reasonably drew differing conclusions from
evidence of differing strength). But see R.J. Reynolds Vapor
Company v. FDA, 65 F.4th 182, 190 (5th Cir. 2023)
(concluding that the FDA acted arbitrarily and capriciously
when it previously “represented that long-term studies were
likely unnecessary” and never told applicants that switching
evidence would be required for menthol-flavored products).
    We are not tasked with determining whether we agree
with the FDA’s decision, made within its area of expertise,
that Petitioners’ proffered evidence was insufficient.
Instead, we join the Second, Third, Fourth, Seventh, and
D.C. Circuits in determining that the agency consistently
advised that, in the absence of long-term data, it might rely
upon sufficiently robust and reliable other evidence. The
agency did not act arbitrarily or capriciously by concluding
that Petitioners’ evidence fell short of that standard.
                               3
    We now turn to Petitioners’ contentions that the FDA’s
failure to consider their marketing and sales-access-
restrictions plans was arbitrary and capricious. We assume,
without deciding, that the FDA erred in ignoring Petitioners’
marketing plans, but we conclude that any error was
harmless.
           LOTUS VAPING TECHNOLOGIES, LLC V. FDA          33

    The Tobacco Control Act incorporates the APA’s
harmless error rule. See 21 U.S.C. § 387l(b); 5 U.S.C. § 706
(“[D]ue account shall be taken of the rule of prejudicial
error.”). An error is harmless if it “had no bearing on the
procedure used or the substance of [the] decision reached.”
Cal. Wilderness Coal. v. U.S. Dep’t of Energy, 631 F.3d
1072, 1092 (9th Cir. 2011) (alteration in original) (quoting
Paulsen v. Daniels, 413 F.3d 999, 1006 (9th Cir. 2005)).
“[T]he burden of showing an agency’s deviation from the
APA was not harmless rests with the petitioner.” Id.
Generally, this court “must judge the propriety of [agency]
action solely by the grounds invoked by the agency.” SEC
v. Chenery Corp., 332 U.S. 194, 196 (1947). But “Chenery
does not require that [courts] convert judicial review of
agency action into a ping-pong game.” N.L.R.B. v. Wyman-
Gordon Co., 394 U.S. 759, 766 n.6 (1969) (plurality
opinion).
    In the 2020 Guidance, the FDA identified the measures
that manufacturers had proposed to restrict minors’ access to
ENDS products sold online and at brick-and-mortar stores.
These measures included: (1) age-verification technology
for online sales; (2) enhanced monitoring for retailer
compliance       with     age-verification     requirements;
(3) contractual penalties for retailers selling tobacco
products to minors; and (4) restrictions on the quantity of
ENDS products customers can purchase within a period of
time. Despite those efforts, youth e-cigarette use continued
to increase. Consequently, the 2020 Guidance reported the
FDA’s conclusion that “age verification alone is not
sufficient” and that “focusing on how the product was sold
would not be sufficient to address youth use of these
products given the many sources of products available for
youth access.”
34         LOTUS VAPING TECHNOLOGIES, LLC V. FDA

    We are persuaded by the Second, Third, Fourth, and D.C.
Circuits’ analysis on this issue. In each of the cases decided
by these courts, “the manufacturers were unable to identify
any prejudice they suffered from the FDA’s lack of
individualized review of their plans to prevent youth access
to their flavored e-liquids,” because the proffered marketing
plans contained materially identical measures to those that
the FDA had already described as insufficient. Prohibition
Juice, 45 F.4th at 24; see also Liquid Labs, 52 F.4th at 544
(concluding that Liquid Labs did not show that its marketing
plans would have changed the result because its “age
verification measures,” “mystery shopper program,” and
“prohibition on marketing material” targeting youth were
“similar, if not identical, to the kinds of approaches the FDA
found did not address this serious problem,” and such plans
could not, in any case, have rectified the other scientific
deficiencies in its applications); Avail Vapor, 55 F.4th at
425–26 (same); Magellan Tech., Inc., 2023 WL 4035722 at
*6 (same). Here, Petitioners’ marketing plan arguments fail
for the same reason.
    Petitioners do not identify how their marketing measures
are materially different from those the FDA has already said
are insufficient. For example, Lotus’ marketing plan
provides that its products “will continue to be strictly
marketed and sold to adults in adult-only retailers and
through age-verified online websites,” and that the products
“will not be promoted by Lotus partners, sponsors,
influencers, bloggers, or brand ambassadors on non-age-
gated social media, radio or television.” Nude Nicotine’s
marketing plan similarly provides for “using and requiring
age-gating and age verification for sales of all Nude Nicotine
products,” requiring distributors and retailers to register as
licensed or authorized resellers, contractually binding its
           LOTUS VAPING TECHNOLOGIES, LLC V. FDA           35

authorized retailers to use age-gating marketing procedures,
and engaging in post-marketing surveillance.
    At oral argument, Lotus was asked to identify how its
marketing plan differed from the marketing plans in
Prohibition Juice.       Counsel identified the following
differences: limiting consumer engagement to trade shows,
age-gated social media, no use of social media influencers,
quantity restrictions for online sales, and contractual
penalties. But these measures track those that the FDA
found were ineffective to counterbalance the risk of youth
use, see 2020 Guidance at 6–8, 21–22, 44–45, and
Petitioners did not otherwise argue that any of their
marketing tactics were novel. Cf. Prohibition Juice, 45 F.4th
at 16 (recognizing that some “e-cigarette companies are
developing novel technologies, such as requiring age
verification assisted by facial recognition software to unlock
their products, which they assert could prevent underage
use” (emphasis added)); Bidi Vapor LLC v. FDA, 47 F.4th
1191, 1205 (11th Cir. 2022) (finding the FDA acted
arbitrarily and capriciously by not reviewing the tobacco
companies’ marketing plans, which “included measures not
specifically mentioned in the 2020 Guidance,” such as
“Trace/Verify technology” and counterfeit prevention
systems); Avail Vapor, 55 F.4th at 418, 425–26 (explaining
that “[w]hile some other ENDS manufacturers were
exploring innovative ‘access restriction’ technology,
whereby, for example, an ENDS product is tied to the thumb
print of the purchaser, Avail’s marketing plan included only
garden variety restrictions,” including non-descriptive
product names and age-verification services). We therefore
join the Second, Third, Fourth, and D.C. Circuits in
concluding that the FDA’s failure to consider Petitioners’
marketing plans, if erroneous, was harmless error.
36         LOTUS VAPING TECHNOLOGIES, LLC V. FDA

    We acknowledge that in Bidi Vapor, the Eleventh Circuit
reached a different conclusion, see 47 F.4th at 1205, but we
do not understand our decision to conflict with that case.
There, the Eleventh Circuit noted that the petitioners had
submitted marketing plans containing novel restrictions
designed to limit youth access. See id. at 1205 (discussing
marketing      plans     that    “conformed        with   the
recommendations . . . , directly addressed the concerns of
youth access . . . , and included measures not specifically
mentioned in the [FDA’s] 2020 Guidance”); see also id. at
1206 (describing “novel marketing and sales-access-
restriction plans”). So, although the Eleventh Circuit
concluded that the FDA’s error was not harmless in Bidi
Vapor, it did so on a materially different record.
    In sum, at the time the FDA reviewed Petitioners’
applications, it had already concluded that eliminating
marketing aimed at youth users and monitoring retailers’
sales were ineffective in preventing youth use because
children maintained a steady stream of access to the flavored
products they desired through alternate means, like their
friends and social networks. See 2020 Guidance at 44–45;
Prohibition Juice, 45 F.4th at 24–25 (“When an agency’s
mistake plainly had no bearing on the substance of its
decision, we do not grant a petition for review based on that
mistake” and “[w]here a petitioner had ample opportunity
yet failed to show that an agency error harmed it, vacatur and
remand to give the agency an opportunity to fix the error is
unwarranted.” (internal quotation marks and citation
omitted)). Therefore, even if the agency erred by failing to
consider Petitioners’ marketing plans, any error was
harmless, and we will not remand on this basis.
             LOTUS VAPING TECHNOLOGIES, LLC V. FDA                     37

                                   IV
    Finally, we address Petitioners’ post-argument motions
to supplement the administrative record and file
supplemental briefing and seeking judicial notice of PMTA
deficiency letters, FDA internal memoranda, and FDA press
releases.    We deny the motions to supplement the
administrative record and file supplemental briefing and
grant the motions for judicial notice.
    First, Petitioners filed motions to supplement the
administrative record with an internal FDA Memorandum,
dated August 19, 2020, and for leave to file supplemental
briefing. 15 The memorandum describes a “bundling and
bracketing” procedure to expedite review of PMTAs.
Petitioners argue that the August 2020 Memorandum
demonstrates that the FDA was using a “holistic review
approach” at the time Petitioners submitted their PMTAs
that “made no reference whatsoever to requiring randomized
controlled trials, longitudinal cohort studies, or ‘other
evidence’ comparing flavored bottled e-liquids to tobacco-

15
   The general rule is “that courts reviewing an agency decision are
limited to the administrative record.” Lands Council v. Powell, 395 F.3d
1019, 1029 (9th Cir. 2005) (citing Fla. Power & Light Co. v. Lorion, 470
U.S. 729, 743–44 (1985)). Although “[r]eview may . . . be expanded
beyond the record if necessary to explain agency decisions,” we have
only allowed extra-record materials in limited circumstances that do not
apply here. See Sw. Ctr. for Biological Diversity v. U.S. Forest Serv.,
100 F.3d 1443, 1450 (9th Cir. 1996) (explaining that the administrative
record may be supplemented “(1) if necessary to determine whether the
agency has considered all relevant factors and has explained its decision,
(2) when the agency has relied on documents not in the record, . . . (3)
when supplementing the record is necessary to explain technical terms
or complex subject matter,” or (4) when “plaintiffs make a showing of
agency bad faith” (internal quotation marks and citations omitted)).
38         LOTUS VAPING TECHNOLOGIES, LLC V. FDA

flavored bottled e-liquids in terms of their ability to promote
reduction or cessation of use of combustible cigarettes.”
Petitioners then argue that this “holistic” approach was
subsequently, and without notice, replaced by a different and
more demanding evidentiary requirement. Petitioners argue
from a negative—that is, because the memorandum does not
state that comparative studies are required, the FDA must
have been using an approach that did not require such studies
and shifted the review criteria only after Petitioners
submitted their PMTAs.
    The FDA responds that there is no reason to supplement
the record because the memorandum prescribes procedures
for a stage of review that Petitioners’ PMTAs never reached
and therefore is “inapplicable in these circumstances.”
Additionally, the FDA contends that this “wholly internal
memo” could not have created reliance interests, and that it
is merely “a procedural document discussing an approach for
streamlining a narrow aspect of the review of certain
products in further scientific review.”
    The agency’s final argument is sufficient to demonstrate
that the motion to supplement is not well taken: the August
2020 Memorandum is procedural in nature—it does not
describe the standards that would apply to the review of the
data; rather, it offers procedural instructions to increase the
efficiency of reviewing thousands of PMTAs at the outset—
and therefore it is irrelevant to the substantive issues
presented here. See Gripum, 47 F.4th at 560–61 (finding the
same memorandum “of dubious relevance”). “Bundling and
bracketing,” as procedural tools, say nothing about how the
agency substantively reviews the applications. Even
assuming that Petitioners’ PMTAs were bundled and
bracketed, that does not mean that their applications would
have been granted. Indeed, simply using bundling and
             LOTUS VAPING TECHNOLOGIES, LLC V. FDA                   39

bracketing procedures cannot change the results of the
review process if the PMTAs failed to include the necessary
comparative studies contemplated in the Tobacco Control
Act. Because a memorandum describing a procedure to
streamline the review of data (either before or during
scientific review) is irrelevant to the issues presented in this
appeal, Petitioners’ motions to supplement and for leave to
file supplemental briefs are denied. 16
    Second, Lotus filed three motions asking the court to
take judicial notice of various documents. In one motion,
Lotus seeks judicial notice of two PMTA deficiency letters
issued by the FDA in other matters: Logic Technology
Development LLC v. FDA, No. 22-3030, (June 26, 2020),
and R.J. Reynolds Vapor Company v. FDA, No. 23-60037.
In a second motion, Lotus seeks judicial notice of two FDA
internal memoranda: Development of the Approach to
Evaluating Menthol-Flavored ENDS PMTAs (Oct. 25,
2022); and Process for Evaluating Menthol-Flavored ENDS
PMTAs (Oct. 25, 2022). In a third motion, Lotus seeks
judicial notice of an October 26, 2022 FDA press release:
FDA Denies Marketing of Logic’s Menthol E-Cigarette
Products Following Determination They Do Not Meet
Public Health Standard, FDA (Oct. 26, 2022) (“October
Press Release”).
    Rule 201(b) of the Federal Rules of Evidence provides
that we may take judicial notice of “a fact that is not subject
to reasonable dispute because it . . . can be accurately and
readily determined from sources whose accuracy cannot

16
  In any event, for the reasons we have already given, supplementing the
record to include this memorandum would not change the result in this
case, and the parties effectively briefed the memorandum through their
submissions on Petitioners’ motions to supplement.
40         LOTUS VAPING TECHNOLOGIES, LLC V. FDA

reasonably be questioned.” These are published materials
representing the considered views of the FDA, and the FDA
does not contest their accuracy here. Therefore, we take
judicial notice of the FDA’s deficiency letters, internal
memoranda, and press release. But, as we explain next, they
do not alter our analysis.
    Based on the additional PMTA deficiency letters, Lotus
raises the same “surprise switcheroo” argument we rejected
in Section IV.B., supra. Specifically, Lotus argues that the
FDA indicated that scientific evidence was needed to
demonstrate whether flavored ENDS products facilitate
adult smokers switching from combustible cigarette use at a
rate exceeding that of tobacco-flavored or menthol-flavored
products after Lotus submitted its own PMTA. This
argument fails for the reasons we have previously discussed.
The FDA has consistently required sufficiently robust,
product-specific evidence demonstrating that flavored
ENDS products are appropriate for protection of the public
health, which necessarily requires evidence of their effects
on switching product use.
    Lotus similarly argues that the agency’s internal
memoranda establish that the FDA’s Office of Science
preliminarily recommended that the FDA grant marketing
authorization of menthol-flavored products, and that
recommendation was later overruled. In Lotus’s view, these
memoranda demonstrate that the FDA “adopted the
evidentiary standard it would ultimately apply to grant
marketing authorization well after the applications were
submitted.” We disagree.
    As an initial matter, the October 2022 memoranda
address menthol-flavored ENDS products (which are not at
issue here) and address the status of the review process long
           LOTUS VAPING TECHNOLOGIES, LLC V. FDA           41

after Petitioners’ PMTAs were denied in September 2021.
Moreover, the internal memoranda simply reflect the process
by which the FDA considered the available evidence and
concluded that menthol-flavored ENDS products should be
treated the same as other flavored ENDS products (e.g., fruit,
sweets, and mint)—that is, “the products could be found to
be [appropriate for the protection of the public health] only
if the evidence showed that the benefits of the menthol-
flavored ENDS were greater than tobacco-flavored ENDS,
which pose lower risk to youth.” See Development of the
Approach to Evaluating Menthol-Flavored ENDS PMTAs at
2–3. These memoranda do not demonstrate that the FDA
engaged in a “surprise switcheroo.”
    Finally, Lotus argues that the FDA press release
discusses the first menthol-flavored ENDS products to
receive a full scientific review, and the FDA issued
marketing denial orders because the applications did not
demonstrate that these products are “more effective at
promoting complete switching or significant cigarette use
reduction relative to tobacco-flavored [ENDS] among adult
smokers.” Lotus argues that this statement is relevant to
evaluating FDA’s claims that its analysis of Lotus’
application focused on “benefits,” not “efficacy,” and that it
has never “required” smoking cessation studies.
     But the FDA’s statements in the press release simply
bolster the position that it has maintained throughout this
litigation: the FDA “evaluat[es] new tobacco products based
on a public health standard that considers the risks and
benefits of the tobacco product to the population as a whole”
by assessing whether the flavored ENDS product is likely to
reduce combustible cigarette use among adults as compared
to tobacco-flavored ENDs products, so as to justify the risk
flavored products pose to youth. October Press Release; see
42         LOTUS VAPING TECHNOLOGIES, LLC V. FDA

also, e.g., Gripum, 47 F.4th at 559 (explaining, in response
to the argument that the FDA’s approach amounted to a
“product-efficacy assessment,” that “all the FDA required
Gripum to do [was] to show that its flavored e-cigarette
products were relatively better at reducing rates of tobacco
use than products already on the market” and concluding the
FDA “properly applied the comparative standard mandated
by the statute; Gripum simply failed to meet it”). Therefore,
while we grant Lotus’s motions seeking judicial notice, these
documents do not change our analysis.
                             V
    The FDA acted within its statutory authority under the
Tobacco Control Act to require Petitioners to demonstrate
that their flavored ENDS products are comparatively better
at promoting smoking cessation than tobacco-flavored
products. Moreover, the agency’s denial of Petitioners’
PMTAs was not arbitrary and capricious. The FDA did not
impose a new evidentiary standard or unfairly surprise
Petitioners in requiring comparative evidence and, even
assuming the FDA erred in failing to assess Petitioners’
marketing plans, any error was harmless.
     PETITIONS FOR REVIEW DENIED.