FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

LOTUS VAPING TECHNOLOGIES, 

LLC, 

Petitioner, 

 v. 

U.S. FOOD & DRUG 

ADMINISTRATION, 

Respondent.

No. 21-71328 

OPINION

NUDE NICOTINE INC., 

Petitioner, 

 v. 

U.S. FOOD & DRUG 

ADMINISTRATION, 

Respondent.

No. 21-71321 

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-accessrestrictions 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 nicotinecontaining 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 tobaccoflavored 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 tobaccorelated 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-CV883, 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 ENDSproduct 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 “wellcontrolled 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 longterm 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 nicotinecontaining e-liquids are designed to be used in open-system 

devices7 and come in a variety of flavors. Although such 

flavors include tobacco and menthol, Lotus’s other flavored

products8—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 opensystem 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 postmarket 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 ECigarette 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 eliquids. 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 tobaccoflavored 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, otherwisesimilar 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 cartridgebased 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 crosssectional 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-accessrestrictions 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. WymanGordon 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-agegated 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-accessrestriction 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 tobacco15 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 mentholflavored 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 motionsseeking 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.