PUBLISH

UNITED STATES COURT OF APPEALS

FOR THE TENTH CIRCUIT

_______________________________________

ELECTRIC CLOUDS, INC. and

CLOUD 9 VAPOR PRODUCTS, 

L.L.C., 

 Petitioners, 

v.

UNITED STATES FOOD AND 

DRUG ADMINISTRATION, 

 Respondent.

---------------------------------------- 

AMERICAN ACADEMY OF 

FAMILY PHYSICIANS; 

AMERICAN ACADEMY OF 

PEDIATRICS; AMERICAN 

CANCER SOCIETY CANCER 

ACTION NETWORK; AMERICAN 

HEART ASSOCIATION; 

AMERICAN LUNG ASSOCIATION 

OF OKLAHOMA; AMERICAN 

MEDICAL ASSOCIATION; 

CAMPAIGN FOR TOBACCO-FREE 

KIDS; COLORADO MEDICAL 

SOCIETY; PARENTS AGAINST 

VAPING E-CIGARETTES; TRUTH 

INITIATIVE,

 Amici Curiae.

Nos. 21-9577 & 21-9578

FILED

United States Court of Appeals

Tenth Circuit

February 27, 2024

Christopher M. Wolpert

Clerk of Court

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___________________________________________

PETITION FOR REVIEW FROM AN ORDER OF THE 

U.S. FOOD AND DRUG ADMINISTRATION

(FDA Nos. PM0002382 & PM002523)

_________________________________________

Jerad Wayne Najvar, Najvar Law Firm, PLLC, Houston, Texas, for 

Petitioners.

Joshua M. Koppel, Appellate Staff Attorney, U.S. Department of Justice, 

Washington D.C. (Bryan M. Boynton, Principal Deputy Assistant Attorney 

General, and Alisa B. Klein, Appellate Staff Attorney, with him on the 

briefs), for Respondent.

William B. Schultz, Andrew N. Goldfarb, and Trillium Chang of 

Zuckerman Spaeder LLP, Washington D.C., and Dennis A. Henigan and 

Connor Fuchs, Campaign for Tobacco-Free Kids, Washington, D.C., filed 

an amicus curiae brief in support of Respondent.

__________________________________________

Before BACHARACH, BALDOCK, and MURPHY, Circuit Judges.

___________________________________________

BACHARACH, Circuit Judge.

___________________________________________

This case arose from concern over the spread of nicotine. 

Traditionally, nicotine had come mainly from cigarettes. But nicotine now 

comes from other sources, such as e-cigarettes. With e-cigarettes, users 

inhale vaporized liquid rather than smoke; the vapor comes from heated

liquids called e-liquids.

E-liquids contain nicotine, which harms human health. So the Food 

and Drug Administration began requiring manufacturers to apply for 

approval before they could continue selling e-liquids. Because the 

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application process would be new, the FDA issued guidance for 

manufacturers. 

With this guidance, manufacturers blitzed the FDA with applications 

to market e-liquids bearing attractive flavors. Our petitions for review 

involve applications from two of these manufacturers: Electric Clouds, Inc. 

and Cloud 9 Vapor Products, L.L.C. With their applications, Electric 

Clouds and Cloud 9 submitted scientific data and marketing proposals to 

restrict access for children. The FDA rejected the applications without 

reviewing the proposed restrictions on access, and Electric Clouds and 

Cloud 9 seek judicial review on two main issues:

1. Notice: Because the application process was new, the FDA 

provided manufacturers with guidance. For example, the FDA 

suggested to manufacturers that they would need to show 

enough benefits to adult users to offset the risk of attracting 

children to e-liquids. Did this suggestion mislead 

manufacturers to believe that they wouldn’t need long-term 

clinical studies or comparisons involving flavored and nonflavored e-liquids? We answer no.

2. Harmless error: The FDA studied existing access restrictions 

based on age and found that they had generally proved 

ineffective. Electric Clouds and Cloud 9 proposed age 

restrictions like those that the FDA had regarded as ineffective. 

Did the FDA prejudice Electric Clouds or Cloud 9 by rejecting 

their applications without reviewing their proposed agerestrictions? We again answer no.

1. FDA approval is required to manufacture e-liquids.

The FDA considered the applications against the backdrop of federal 

law, which permits approval only if the availability of the e-liquid “would 

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be appropriate” to protect public health. 21 U.S.C. § 387j(c)(2)(A). To 

apply this standard, the FDA must balance

• the chance that more adult users will transition away from 

tobacco use and

• the risk that more children will start using e-liquids.

21 U.S.C. § 387j(c)(4)(A)–(B). 

In balancing these factors, the FDA has considered the advantages 

and disadvantages of e-liquids. The disadvantages mainly involve the 

presence of nicotine. See Family Smoking Prevention and Tobacco Control 

Act, Pub. L. 111-31, § 2(3), 123 Stat. 1776, 1777 (2009); Avail Vapor, LLC

v. FDA, 55 F.4th 409, 414–15 (4th Cir. 2022). So the FDA has set out to 

encourage adult users to transition to e-liquids without making them 

attractive to children. Breeze Smoke, LLC v. FDA, 18 F.4th 499, 504–05

(6th Cir. 2021). This task was complicated by the growing use of flavors in 

e-liquids. These flavors attract children by making the e-liquids taste like 

fruit, mint, candy, desserts, and other sweets. See Avail Vapor, 55 F.4th at 

415. 

2. The FDA denied the applications by Electric Clouds and Cloud 9 

to market flavored e-liquids.

With this regulatory framework in place, Electric Clouds and Cloud 9

applied for approval to manufacture flavored e-liquids bearing names like 

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Ice Cream Dream, Berries Gone Wild, Cap’n Berry Crack, Banana Colada, 

Apple Pie, and Candy Man. ER6–10, 306–23.

The FDA denied the applications, finding that Electric Clouds and 

Cloud 9 hadn’t shown that their flavored e-liquids would help adult 

smokers enough to offset the risk to youth. ER14–15, ER325–26. The FDA 

considered the manufacturers’ scientific evidence, but regarded it as 

deficient based on the absence of 

• long-term, product-specific studies of cigarette reduction or 

comparisons to tobacco-flavored e-liquids (such as a 

randomized controlled trial or longitudinal cohort study) or

• other evidence that had reliably evaluated the effect of 

flavoring on adults reducing their use of cigarettes or 

transitioning to e-liquids.

ER14–15, 325–26.

Given these deficiencies, the FDA rejected the applications without 

reviewing the proposed marketing plans. ER15, 325. The FDA 

acknowledged that marketing plans might theoretically reduce the risk to 

youth. ER35 n.xix, 352 n.xix. But the FDA pointed out that it hadn’t yet 

seen any marketing plans that would sufficiently offset the risk of 

attracting young consumers. Id.

3. The FDA didn’t mislead Electric Clouds or Cloud 9 by ambushing 

them with a new, undisclosed evidentiary standard.

Electric Clouds and Cloud 9 argue in part that the FDA misled them 

by imposing rigid requirements after suggesting a more flexible approach. 

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The changes, according to Electric Clouds and Cloud 9, involved 

requirements for long-term clinical studies and comparisons between eliquids based on the presence of flavoring.

An agency must explain changes in its position, particularly when a 

regulated party has relied on the earlier position. FCC v. Fox Television 

Stations, Inc., 556 U.S. 502, 515–16 (2009). Electric Clouds and Cloud 9 

argue that the FDA changed its position after fostering reliance on its 

written guidance, proposed rule, and statements in a public meeting. We 

disagree, concluding that the FDA didn’t deviate from its earlier 

statements. See Prohibition Juice Co. v. FDA, 45 F.4th 8, 20–21 (D.C. Cir. 

2022) (rejecting a similar challenge because the FDA’s final 

determinations were consistent with the FDA’s 2019 Guidance).

3.1 The FDA’s statements didn’t mislead Electric Clouds or Cloud 9

on the need for long-term clinical studies or the equivalent. 

Electric Clouds and Cloud 9 argue that three of the FDA’s statements 

had suggested to manufacturers that they could forgo long-term clinical 

studies:

1. the Guidance in 2019 for e-liquid manufacturers, FDA, 

Guidance for Industry, Premarket Tobacco Applications for 

Electronic Nicotine Delivery Systems (June 2019),

2. a 2019 proposed rule, Premarket Tobacco Product Applications 

and Recordkeeping Requirements, 84 Fed. Reg. 50,566 (Sept. 

25, 2019), and 

3. an FDA public meeting on October 22–23, 2018.

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3.1.1 The 2019 Guidance didn’t mislead the manufacturers.

Electric Clouds and Cloud 9 argue that they were misled by the 

FDA’s guidance. Granted, “[t]he fair-notice requirement extends to 

informal guidance.” Breeze Smoke, LLC v. FDA, 18 F.4th 499, 504 (6th 

Cir. 2021). But the guidance itself stressed that 

• it was not binding, 

• the FDA would continue to adapt to new information, and

• manufacturers would need to show empirical data at multiple 

points in time.

In both 2019 and 2020, the FDA issued guidance, beginning both 

times with warnings that they “represent[] the current thinking of the 

[FDA] on this topic” and are “not binding on the FDA or the public.” 

ER47, ER115 (emphasis added). The 2019 Guidance added that “guidances 

. . . should be viewed only as recommendations, unless specific regulatory 

or statutory requirements are cited.” ER117. To emphasize the nonbinding 

nature of the guidance, the FDA included a bolded disclaimer on every 

page saying that it “[c]ontains nonbinding recommendations.” See Wages & 

White Lion Invs., LLC v. FDA, 90 F.4th 357, slip op. at 65 n.6 (5th Cir. 

2024) (en banc) (Haynes, J., dissenting) (“The conditional language used 

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by the FDA in its nonbinding guidance documents indicates that it never 

guaranteed that a certain type of evidence would be sufficient.”). 1

With these disclaimers, the FDA emphasized in the 2020 Guidance 

that the requirements would change based on new information: 

“Manufacturers cannot have settled expectations to market unlawful 

products, especially in the face of evolving public health concerns.” ER72,

Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) 

and Other Deemed Products on the Market Without Premarket 

Authorization (Revised): Guidance for Industry (Apr. 2020). Given the 

development of new information, the FDA reminded manufacturers that 

they

• would need to adapt their compliance policies based on 

“changed circumstances” and 

1 The Fifth Circuit disagreed, reasoning that the D.C. Circuit had 

declined to consider cautionary language in two opinions: Southwest

Airlines Co. v. FERC, 926 F.3d 851 (D.C. Cir. 2019), and Physicians for 

Social Responsibility v. Wheeler, 956 F.3d 634 (D.C. Cir. 2020). Wages & 

White Lion Invs., LLC v. FDA, 90 F.4th 357, slip op. at 27–40 (5th Cir. 

2024) (en banc). But in these opinions, the D.C. Circuit hadn’t addressed 

the impact of an agency’s cautionary language. For example, in Southwest

Airlines Co., the D.C. Circuit had examined an agency’s sudden departure 

from longstanding procedures for making determinations. See Sw. Airlines 

Co., 926 F.3d at 856–58. The case hadn’t involved guidance or a 

suggestion that the agency’s statements weren’t binding. See id. The same 

is true of Physicians for Social Responsibility. This case had involved an 

agency directive departing from a policy established by a handbook and a 

report. Physicians for Soc. Respon., 956 F.3d at 645. There the court again 

had no occasion to discuss administrative guidance or a suggestion that the 

agency’s statements weren’t binding. See id. 

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• couldn’t reasonably rely “on a . . . policy subject to change at 

any time.” 

ER79–80. 2

Regardless of these reminders, the 2019 Guidance shouldn’t have 

induced Electric Clouds or Cloud 9 to omit long-term clinical studies or 

the equivalent. In the guidance, the FDA regarded long-term clinical 

studies as the strongest type of evidence; however, the FDA also 

acknowledged that existing data might suffice. For example, the FDA said 

that it would consider “established bod[ies] of evidence,” such as “existing 

2 In their reply brief, Electric Clouds and Cloud 9 urge judicial 

estoppel for the first time, arguing that the FDA made contrary arguments 

in other federal cases. Petitioners’ Reply Br. at 12–13. We generally 

decline to address issues raised for the first time in a reply brief. See, e.g., 

Belnap v. Iasis Healthcare, 844 F.3d 1272, 1293 n.16 (10th Cir. 2017). 

But we would reject this argument even if it had come earlier

because the FDA hadn’t taken a different position in the prior cases. In 

those cases, the FDA emphasized that 

• “the guidance [was] ‘not binding on FDA or the public’” and 

• manufacturers could submit alternative forms of evidence, but 

only “if [the evidence] satisfie[d] the requirements of the 

applicable statutes and regulations.” 

Defendants’ Response to Industry Amicus Br. at 4, Am. Acad. of Pediatrics 

v. FDA, No. 18-883 (D. Md. June 26, 2019) (quoting the 2019 Guidance); 

see also Final Br. for Appellees at 26, Nicopure Labs, LLC v. FDA, No. 17-

5196 (D.C. Cir. June 5, 2018) (“FDA has stated in draft guidance that 

scientific-literature reviews may be acceptable in some circumstances, and 

has discussed alternatives to randomized, controlled trials.” (emphasis 

added)). The FDA took the same position here. See pp. 10–11, below.

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longer duration studies in the public literature.” ER160, ER127. But the 

manufacturer would still need to “bridg[e]” its own e-liquid to the existing 

data by showing why the existing data would apply to the new product. 

ER127; see ER160.

The 2019 Guidance also clarified that 

• the FDA would review “‘other valid scientific evidence’” to 

determine whether it was “sufficient to evaluate the tobacco 

product,” ER126 (quoting 21 U.S.C. § 387j(c)(5)(B)), 

• “[n]onclinical studies alone [were] generally not sufficient,” 

ER126, and 

• “[p]ublished literature reviews . . . [were] considered a less 

robust form of support.” ER161.

Given these qualifications, seven federal appellate courts have 

rejected similar challenges, reasoning that the 2019 Guidance had not 

guaranteed approval without long-term clinical studies. Magellan Tech., 

Inc. v. FDA, 70 F.4th 622, 629 (2d Cir. 2023); Liquid Labs, LLC v. FDA, 

52 F.4th 533, 541 (3d Cir. 2022); Avail Vapor, LLC v. FDA, 55 F.4th 409, 

422–23 (4th Cir. 2022); Breeze Smoke, LLC v. FDA, 18 F.4th 499, 505–07 

(6th Cir. 2021); Gripum, LLC v. FDA, 47 F.4th 553, 559–60 (7th Cir. 

2022); Lotus Vaping Techs., LLC v. FDA, 73 F.4th 657, 672 (9th Cir. 

2022); Prohibition Juice Co. v. FDA, 45 F.4th 8, 23 (D.C. Cir. 2022).

For example, the D.C. and Seventh Circuits addressed similar 

reliance on the 2019 Guidance. In these cases, manufacturers of e-liquids 

argued that they had skipped long-term studies because of the 2019 

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Guidance. See Prohibition Juice Co., 45 F.4th at 23–24; Gripum, 47 F.4th 

at 559. The D.C. Circuit rejected this argument, explaining that the FDA 

hadn’t “guaranteed that unspecified other forms of evidence would 

necessarily be sufficient—only that they might be, so the FDA would 

consider them.” Prohibition Juice Co., 45 F.4th at 21 (citing the 2019 

Guidance at 12–13). The Seventh Circuit also rejected the argument, 

pointing out that the 2019 Guidance had “consistently reflected” the need 

for “product-specific long-term data . . . only if existing studies [had been] 

inadequately related to the proposed product.” Gripum, 47 F.4th at 559.

These opinions are persuasive. 3 Unlike Electric Clouds and Cloud 9, 

the D.C. and Seventh Circuits relied on the entirety of the FDA’s guidance. 

Even if that guidance could have fostered reliable expectations, the

entirety of the documents would have informed manufacturers of the need 

to 

• tie their own e-liquids to the existing data or

• present new studies.

3 One circuit disagrees, pointing out that “law is not a nose-counting 

exercise.” Wages & White Lion Invs., LLC v. FDA, 90 F.4th 357, slip op. at

20, 28–30 (5th Cir. 2024) (en banc). We agree, but we’re persuaded by the 

reasoning of the seven other circuit courts.

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3.1.2 The proposed rule didn’t mislead the manufacturers.

The manufacturers rely not only on the 2019 Guidance, but also on a 

proposed rule. There the FDA said that it didn’t expect each applicant to 

include a new long-term clinical study. But the FDA explained that with or 

without such a study, applicants would need to provide “both clinical and 

nonclinical investigations” offering “comprehensive information about the 

product’s likely health effects in the U.S. market.” 84 Fed. Reg. 50,566;

50,619 (Sept. 25, 2019). The FDA added that an applicant might be able to 

forgo new studies by “bridging” its own e-liquid to existing studies. Id. 

And even then, the FDA cautioned, “information from nonclinical studies 

alone” would generally not suffice. Id.

Given the whole of the proposed rule, it shouldn’t have misled 

Electric Clouds or Cloud 9 to think that it could forgo a new long-term 

clinical study or an effort to bridge the new e-liquids to an existing study. 

3.1.3 The 2018 public meeting didn’t mislead the manufacturers.

Electric Clouds and Cloud 9 also argue that the FDA misled them at a 

public meeting in 2018. At that meeting, an FDA representative stated: 

“[I]t may be possible to support a marketing order for an [electronic 

nicotine delivery system], as an example, without conducting new nonclinical or clinical studies, given other data sources can support the 

[marketing application].” Transcript, Tobacco Product Application Review 

Public Meeting at 133–34 (Oct. 23, 2018).

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This statement shouldn’t have misled Electric Clouds or Cloud 9. The 

representative said only that “it may be possible” to rely on existing 

studies. From that statement, Electric Clouds and Cloud 9 shouldn’t have 

assumed that they could forgo either a new long-term clinical study or any 

effort to bridge the new e-liquids to an existing study. 4

* * *

The FDA didn’t mislead Electric Clouds or Cloud 9 about the need to 

present either a new long-term clinical study or to bridge the new e-liquid

to an existing study. 5

4 The Fifth Circuit concluded that the public meetings had misled 

tobacco manufacturers. There the Fifth Circuit relied on the FDA’s slides

that 

• included this statement and 

• disclaimed a requirement for “specific studies.”

Wages & White Lion Invs., LLC v. FDA, 90 F.4th 357, slip op. at 5–7 (5th 

Cir. 2024) (en banc). It’s unclear whether Electric Clouds and Cloud 9 are 

relying on the FDA’s statement at the public meeting or the slides. 

The slides themselves are not in our record. From the petitioners’ 

description, however, the slides shouldn’t have misled anyone. Just 

because the FDA didn’t require a specific type of study doesn’t mean that 

Electric Clouds and Cloud 9 could omit any new studies or bridging 

efforts. After all, the FDA had repeatedly stressed that applicants would 

need to bridge their own products to valid scientific evidence. See Parts 

3.1.1–3.1.2, above.

5 Electric Clouds and Cloud 9 also cite the final rule, arguing that the 

FDA never said that it would require long-term studies. Premarket Tobacco 

Product Applications and Recordkeeping Requirements, Final Rule, 86 

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3.2 The FDA didn’t mislead manufacturers about the need to 

compare e-liquids with and without flavoring.

Electric Clouds and Cloud 9 also argue that the FDA misled them 

about the need to compare flavored and unflavored e-liquids. But the FDA 

repeatedly explained that manufacturers would need to present comparative 

data on the impact of flavors.

3.2.1 The Tobacco Control Act should have flagged the need for 

comparative evidence.

The Tobacco Control Act itself would have informed manufacturers 

that they needed to compare flavored e-liquids with other e-liquids. See 

Abhe & Swoboda, Inc. v. Chao, 508 F.3d 1052, 1060–61 (D.C. Cir. 2007) 

(stating that the underlying statute provided fair notice of regulatory 

requirements). For example, the Act requires manufacturers to show 

whether the new e-liquid “presents less risk than other tobacco products.” 

Fed. Reg. 55,300 (Oct. 5, 2021). But the final rule came after the 

application deadline, so the petitioners could not have relied on it.

The final rule was consistent with the FDA’s prior statements, saying 

only that the FDA would consider evidence besides long-term studies: 

While this [Final Rule] does not necessarily require applicants 

to conduct new studies . . . FDA expects that it could not issue a

marketing granted order unless an application contains data from 

a variety of sources, including both clinical and nonclinical 

investigations that give FDA comprehensive information about 

the product’s likely health effects.

Id. at 55,387. With this language, the FDA warned that “information from 

nonclinical studies alone [was] generally not sufficient” for approval. Id.

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21 U.S.C. § 387j(b)(1)(A) (emphasis added). To evaluate that showing, the 

FDA must consider “the increased or decreased likelihood that existing 

users of tobacco will stop using such products.” 21 U.S.C. § 387j(c)(4)(A) 

(emphasis added). 

Given the statutory language, five federal appellate courts have 

concluded that the Act supplied adequate notice of the need to compare 

flavored and unflavored e-liquids. Magellan Tech., Inc. v. FDA, 70 F.4th 

622, 632 (2d Cir. 2023); Liquid Labs, LLC v. FDA, 52 F.4th 533, 542–43, 

543 n.12 (3d Cir. 2022); Avail Vapor, LLC v. FDA, 55 F.4th 409, 427–28

(4th Cir. 2022); Lotus Vaping Techs., LLC v. FDA, 73 F.4th 657, 670–71 

(9th Cir. 2023); Prohibition Juice Co. v. FDA, 45 F.4th 8, 23 (D.C. Cir. 

2022). 6 For example, the Second and Fourth Circuits addressed similar 

challenges based on the FDA’s guidance. In these cases, the courts rejected 

the challenges, reasoning in part that the Tobacco Control Act “explicitly 

contemplates that FDA must embark on a comparative inquiry.” Avail 

Vapor, LLC v. FDA, 55 F.4th 409, 427 (4th Cir. 2022); see Magellan Tech., 

Inc. v. FDA, 70 F.4th 622, 632 (2d Cir. 2023) (following the Fourth 

Circuit’s analysis involving the Act).

6 Only one circuit court has found inadequate notice of the FDA’s 

scientific requirements. Wages & White Lion Invs., LLC v. FDA, 90 F.4th 

357, slip op. at 22–42 (5th Cir. 2024) (en banc). But that court did not 

discuss notice from the statute itself. See id. 

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This reasoning is persuasive. The Tobacco Control Act uses clear 

comparative language and should have expressly alerted manufacturers to 

the need to compare e-liquids based on flavoring. 

3.2.2 The FDA flagged the need for comparative evidence.

Before the application process unfolded, the FDA had told 

manufacturers that they would need to compare products within the same 

category. For example, the 2019 Guidance recommended comparisons to 

“other . . . tobacco products within the same product category.” ER138

(emphasis added). And in the proposed rule, the FDA encouraged 

manufacturers to “compare the health risks of [their] products to both 

products within the same category and subcategory, as well as [other] 

products.” 84 Fed. Reg. 50,566, 50,600 (Sept. 25, 2019) (emphasis added). 

Electric Clouds and Cloud 9 argue that the term category was too 

vague. But the FDA had repeatedly explained the youthful appeal of 

flavoring. For example, the 2019 Guidance stressed the importance of 

“scientific reviews of flavors” because of “the potential impact of flavors 

on . . . appeal to youth and young adults.” ER155. Given the potential 

effect on youthful consumers, the 2019 Guidance urged applicants to 

compare the risks from new products with the risks from “other tobacco 

products.” ER156. 

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The FDA repeated these recommendations in guidance published in 

2020. ER45. There the FDA again interpreted the data to “show that 

flavors are a strong driver for youth use.” ER65.

The public meetings contained similar admonitions. In these 

meetings, the FDA encouraged manufacturers to show how

• “appeal of a specific product might be generalized to other 

products within the same brand family, or to similar products 

of other brands” and

• “consumers perceive the product and its flavor, as well as [the 

flavor’s] impact on intention to use the product, as well as 

actual use.” 

Transcript, Tobacco Product Application Review Public Meeting at 123–24 

(Oct. 23, 2018).

The FDA thus repeatedly notified manufacturers of the need to 

compare the risks of e-liquids with and without flavoring. Without these 

comparisons, the FDA explained that it couldn’t adequately assess the 

increased risk of attracting children from the presence of flavoring. Given 

these explanations, the FDA didn’t mislead Electric Clouds and Cloud 9; 

they had adequate notice of the need to compare their flavored e-liquids 

with unflavored e-liquids. See Prohibition Juice Co. v. FDA, 45 F.4th 8, 23 

(D.C. Cir. 2023) (“Petitioners’ own unflavored or tobacco-flavored eliquids were an obvious, otherwise-similar comparator against which to 

gauge whether the added risk of their flavored e-liquids are overcome by 

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those products’ added benefits to adult smokers.”); Lotus Vaping Techs., 

LLC v. FDA, 73 F.4th 657, 671 (9th Cir. 2023) (same).

4. The FDA’s internal documents don’t show reliance on a new 

evidentiary standard.

Electric Clouds and Cloud 9 argue not only that they were misled, 

but also that the FDA secretly planned to deny any application omitting 

long-term clinical studies (even if the application contained the equivalent 

information). For this argument, Electric Clouds and Cloud 9 rely on 

• a July 2021 internal memorandum, which the FDA later 

superseded, 

• an August 2021 internal memorandum, which the FDA later 

rescinded, and

• the review forms attached to each denial letter.

These documents don’t suggest a plan to automatically reject applications 

lacking long-term clinical studies, and the internal memoranda had lapsed 

before Electric Clouds and Cloud 9 applied. 7

In July 2021, the FDA internally circulated a memorandum on how to 

assess applications lacking long-term clinical studies. ER167–68. In the 

memorandum, an employee suggested that the FDA should deny any 

7 Electric Clouds and Cloud 9 wouldn’t have seen these documents 

until after they had applied. So Electric Clouds and Cloud 9 couldn’t have 

relied on these documents. See Avail Vapor, LLC v. FDA, 55 F.4th 409, 

424 (4th Cir. 2022) (reasoning that the memoranda were “internal 

documents unlikely to create reliance interests”).

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application lacking either a randomized controlled trial or long-term 

clinical studies. Id. The FDA superseded this memorandum a month later, 

and there’s no evidence that the FDA ever applied the earlier 

memorandum. 

Electric Clouds and Cloud 9 also rely on another FDA memorandum

from August 2021, which suggested that applications for flavored e-liquids 

show “that the flavored products have an added benefit relative to that of 

tobacco-flavored” e-liquids. ER180. But the FDA rescinded this 

memorandum before accepting applications.

Even if the memoranda hadn’t become obsolete, they didn’t suggest a 

plan to require long-term clinical studies. The first memorandum didn’t 

foreclose “reliance on other forms of rigorous evidence,” and the second 

memoranda “expressly required the agency to consider other forms of 

evidence if sufficiently robust.” Prohibition Juice Co. v. FDA, 45 F.4th at

22; Liquid Labs v. LLC v. FDA, 52 F.4th 533, 541 (3d Cir. 2022) (quoting 

Prohibition Juice, 45 F.4th at 22).

No matter what the memoranda had said, they were superseded or 

rescinded before the FDA opened the application process. So four federal 

appellate courts have concluded that the memoranda in July and August 

2021 couldn’t have supported the existence of an internal plan. Magellan

Tech., Inc. v. FDA, 70 F.4th 622, 630 (2d Cir. 2023); Liquid Labs, 52 F.4th 

at 540 n.7, 541 (3d Cir. 2022); Avail Vapor, LLC v. FDA, 55 F.4th 409, 424 

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(4th Cir. 2022); Prohibition Juice Co., 45 F.4th at 22. For example, the 

Fourth Circuit explained that “these internal documents were just that: 

internal.” Avail Vapor, 55 F.4th at 424. 

We agree with these courts: the memoranda don’t reveal a secret 

plan, and they weren’t even in effect when Electric Clouds and Cloud 9 

applied. 

Electric Clouds and Cloud 9 rely not only on the internal memoranda, 

but also on the FDA’s review forms. These forms tell the reviewer to 

consider not only long-term clinical studies, but also other evidence. 

Reviewers had to note “whether the [applications] contain evidence from a 

randomized controlled trial, longitudinal cohort study, and/or other 

evidence.” ER20, 333 (emphasis added). So the review forms didn’t 

suggest a secret plan to nix any application omitting a long-term clinical 

study.

* * *

The FDA’s documents don’t show a secret change in position after 

the FDA’s issuance of informal guidance to manufacturers because

• the FDA superseded the July 2021 memorandum,

• the FDA rescinded the August 2021 memorandum, and

• the review forms showed the opportunity for manufacturers to 

rely on evidence besides long-term clinical studies.

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21

5. The FDA didn’t act arbitrarily and capriciously by finding 

insufficient scientific evidence for approval.

Electric Clouds and Cloud 9 also argue that the denials were 

arbitrary and capricious based on the administrative record. See 5 U.S.C. 

§ 706(2)(A) (arbitrary-and-capricious standard). We disagree.

Congress designated the FDA as the agency with scientific expertise. 

Family Smoking Prevention and Tobacco Control Act, Pub. L. 111-31, 

§ 2(44)–(45), § 3(1), (7), 123 Stat. 1776, 1780, 1782 (2009). So we 

conduct a “narrow” review and can’t substitute our judgment for the 

FDA’s. Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. 

Ins. Co., 463 U.S. 29, 43 (1983).

In our view, the denials weren’t arbitrary and capricious. The FDA 

considered the evidence and acted reasonably in concluding that the 

applications didn’t merit approval under the statutory standard. 

Under that standard, Electric Clouds and Cloud 9 needed to show that 

the benefit to adult smokers would outweigh the risk of attracting children 

to tobacco. 21 U.S.C. § 387j(c)(4)(A)–(B). In trying to satisfy this 

standard, Electric Clouds and Cloud 9 submitted two kinds of evidence: 

1. Literature reviews summarizing existing scientific studies and

2. surveys of current customers. 

The FDA acted reasonably when it regarded the literature reviews as 

insufficient for approval. The literature reviews acknowledged 

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22

• the need for more long-term studies comparing the harms from 

e-cigarettes and traditional cigarettes and 

• the presence of mixed results involving the impact of e-liquids 

on young individuals’ use of cigarettes. 8

And in the literature reviews submitted by Electric Clouds and Cloud 9, 

there was no discussion about the impact of flavoring on underage use. See 

ER278–84. So the FDA had no evidence to compare the risks of 

• flavored e-liquids and 

• unflavored or tobacco-flavored e-liquids.

When faced with similar literature reviews, six federal appellate 

courts have concluded that the FDA didn’t act arbitrarily and capriciously 

by rejecting applications based on insufficient evidence arising from the 

8 The literature reviews stated:

The evolving nature of [electronic nicotine delivery systems] 

presents challenges for the gathering of recent relevant studies 

of current methods of use. Current studies find that [electronic 

nicotine delivery systems] are much less harmful to the user than 

traditional combustible cigarettes, but more long term studies are 

needed.

* * * *

Some studies have found that for youth and young adults, 

[electronic nicotine delivery systems] may increase the use of 

ever using combustible cigarettes; however, other studies found 

that the reverse is true—that e-cigarette use in youth is limited 

primarily to individuals who already smoke combustible 

cigarettes. 

ER207.

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23

presence of mixed results or the absence of studies addressing the impact 

of flavors on youth. Magellan Tech., Inc. v. FDA, 70 F.4th 622, 629 (2d 

Cir. 2023); Liquid Labs, LLC v. FDA, 52 F.4th 533, 541 (3d Cir. 2022); 

Avail Vapor, LLC v. FDA, 55 F.4th 409, 420–21 (4th Cir. 2022); Breeze 

Smoke, LLC v. FDA, 18 F.4th 499, 506 (6th Cir. 2022); Lotus Vaping

Techs., LLC v. FDA, 73 F.4th 657, 672–73 (9th Cir. 2022); Prohibition 

Juice Co. v. FDA, 45 F.4th 8, 21–22 (D.C. Cir. 2022). 9

For example, the D.C. Circuit said that a literature review was 

“insufficiently rigorous” because of the dearth of “evidence from welldesigned studies to determine whether e-cigarette flavors aid in smoking 

cessation.” Prohibition Juice Co., 45 F.4th at 21 (quoting the petitioners’ 

literature review). Similarly, the Third Circuit concluded that the FDA had 

acted properly in denying an application based on uncertainty in the 

literature on the value of flavors in helping smokers to quit. Liquid Labs, 

52 F.4th at 541. This reasoning is persuasive here because Electric Clouds 

and Cloud 9 submitted literature reviews with equally mixed results.

9 The Fifth Circuit disagreed, concluding that the agency should have 

credited the tobacco manufacturers’ literature review. Wages & White Lion 

Invs., LLC v. FDA, 90 F.4th 357, slip op. at 33–34 (5th Cir. 2024) (en 

banc). But the Fifth Circuit did not discuss the mixed nature of the 

literature reviews. Cf. id., slip op. at 68, 75 n.12 (en banc) (Haynes, J., 

dissenting) (noting that the majority didn’t address statements in the 

literature reviews that there was “not enough evidence . . . to determine 

whether e-cigarette flavors aid in smoking cessation” (quoting the 

petitioners’ literature reviews)). 

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24

Electric Clouds and Cloud 9 also presented surveys, but the FDA 

identified four defects: 

1. The surveys hadn’t compared flavored and unflavored ecigarettes. 

2. The surveys had captured only a single point in time, so they 

couldn’t help to assess product switching or cigarette reduction 

from the “use of these [flavored] products over time.” ER326.

3. The customer surveys had been online and voluntary, which 

restricted participation to existing customers. 

4. One survey had included only 314 participants, and another

survey had included only 30 participants. 

We’re not the first court to address similar survey results: Six federal 

appellate courts have already concluded that similar surveys weren’t 

rigorous enough to support approval. Magellan Tech., Inc. v. FDA, 70 

F.4th 622, 628 (2d Cir. 2023); Liquid Labs, LLC v. FDA, 52 F.4th 533, 541 

(3d Cir. 2022); Avail Vapor, LLC v. FDA, 55 F.4th 409, 421, 425 (4th Cir. 

2022); Breeze Smoke, LLC v. FDA, 18 F.4th 499, 506 (6th Cir. 2021);

Gripum, LLC v. FDA, 47 F.4th 553, 557 (7th Cir. 2022); Lotus Vaping

Techs., LLC v. FDA, 73 F.4th 657, 673 (9th Cir. 2023).

For example, the Ninth Circuit considered customer surveys

measuring a single point in time. Lotus Vaping Techs., 75 F.4th at 666. 

Measurement of a single point in time posed a problem, the Ninth Circuit 

explained, because the surveys hadn’t enabled “reliable evaluation of 

behavior change over time.” Id. at 673 (quoting the FDA’s denial order). 

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25

The Third Circuit also considered a survey that hadn’t compared all the 

manufacturer’s flavored e-cigarettes with unflavored e-cigarettes, 

concluding that the results hadn’t shown “a benefit to flavoring” or 

provided “meaningful information regarding actual switching or 

reduction.” Liquid Labs, 52 F.4th at 541. The same is true of the customer 

surveys submitted by Electric Clouds and Cloud 9.

The FDA also rejected the literature reviews and surveys because 

they didn’t relate to the e-liquids made by Electric Clouds and Cloud 9. In 

response, Electric Clouds and Cloud 9 argue that the FDA

• used a double-standard by relying on a scientific consensus to 

regard flavors as dangerous to children, 

• failed to consider whether these dangers had applied to the eliquids that Electric Clouds and Cloud 9 were making, and

• relied on a consensus involving closed systems even though 

Electric Clouds and Cloud 9 used open systems.

We reject these arguments and conclude that the FDA acted 

reasonably in relying on a scientific consensus. The Tobacco Control Act 

requires the FDA to consider all available information. See 21 U.S.C. 

§ 387j(c)(2)(A); see also Avail Vapor, LLC v. FDA, 55 F.4th 409, 419 (4th 

Cir. 2022) (recognizing the “FDA’s broad statutory mandate to determine 

from the totality of the evidence”). In considering such information, the 

FDA legitimately found a consensus showing the dangers from flavoring 

regardless of the type of device. ER31.

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26

The FDA found no such consensus on the value of flavoring on adults 

trying to quit. See ER35 (“Although . . . bridged data from the literature 

may still be appropriate for many new products, including tobacco-flavored 

[electronic nicotine delivery systems], robust and direct evidence . . . has 

been needed when the known risks are high as with all flavored [electronic 

nicotine delivery systems].”). The difference led the Fourth Circuit to 

reject a similar challenge: 

Whereas the evidence on the role of flavors in promoting youth 

use of [electronic nicotine delivery systems] was established as 

a matter of scientific consensus, there was no comparable 

showing of the benefits that flavored [electronic nicotine 

delivery systems] have for adult smokers in promoting switching

or cessation. Moreover, evidence showed that tobacco-flavored 

[electronic nicotine delivery systems] may offer the same type 

of public health benefits as flavored [electronic nicotine delivery 

systems], in encouraging adult cigarette smokers to switch to 

[electronic nicotine delivery systems] and decreasing the use of 

combustible cigarettes. Such tobacco-flavored products, 

however, do not pose the same degree of risk of youth uptake as 

fruit or dessert-flavored products. As such, FDA required [the 

manufacturer] to provide strong, product-specific evidence 

demonstrating its products would provide an extra benefit to 

current smokers over that of other lower-risk products.

Avail Vapor, LLC v. FDA, 55 F.4th 409, 421 (4th Cir. 2022) (cleaned up); 

see also Prohibition Juice Co. v. FDA, 45 F.4th 8, 22 (D.C. Cir. 2022) 

(rejecting a similar challenge based on the consensus as to the risks from 

flavored products and inconclusive information as to the benefits).

Electric Clouds and Cloud 9 disagree with the FDA, arguing that the 

existing information involves systems that were closed rather than open. 

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27

But the FDA could reasonably regard the role of flavor as consistent 

between closed systems and open systems. See Avail Vapor, LLC, 55 F.4th 

at 427 (rejecting a similar challenge based on the FDA’s conclusion that 

the risks of flavoring were consistent between open and closed systems); 

Prohibition Juice Co., 45 F.4th at 26 (rejecting a similar challenge based 

on the FDA’s assessment that the risks from flavoring were consistent and 

equally applicable to open and closed systems). 

Electric Clouds and Cloud 9 point to a 2021 study, which they 

characterize as proof that few children use open-system devices. But the 

administrative record doesn’t include this study, and it didn’t exist when 

the FDA decided the applications submitted by Electric Clouds and Cloud 

9. 10 See note 11, below (discussing our inability to stray beyond the 

administrative record).

At that time, the FDA could reasonably conclude that children 

preferred flavored e-liquids regardless of device type. The FDA thus 

10 Electric Clouds and Cloud 9 also cite an article, which quoted a 

former FDA commissioner. Petitioners’ Opening Br. at 44. When the 

individual made the quoted statement, he had left the FDA and was serving 

as a resident fellow at the American Enterprise Institute and as a special 

partner at a venture capital firm. Nicholas Florko, Former FDA 

Commissioner Calls for a Full Ban on Pod-Based E-Cigarettes, Stat News 

(Nov. 12, 2019) https://tinyurl.com/mdrjpyhw, quoted in Petitioners’ 

Opening Br. at 44. So his comments didn’t represent the FDA’s position, 

and Electric Clouds and Cloud 9 do not point to evidence supporting his 

statement.

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explained that it had learned that “the removal of one flavored product 

option prompted youth to migrate to another [electronic nicotine delivery 

system] type that offered the desired flavor options, underscoring the 

fundamental role of flavor in driving appeal.” ER32. 

This explanation doesn’t suggest that the FDA ignored the 

distinctions between products. To the contrary, the FDA relied on new 

evidence showing that children care more about flavors than the devices. 

See, e.g., ER31–32 (explaining the data showing the consistent role of 

flavor in youth use of all tobacco products). 11

The FDA used the new information to carry out the statutory mandate 

to balance 

• the known risks that flavored e-liquids posed to children and 

• the potential benefit to adults wanting to quit. 

The FDA didn’t act arbitrarily or capriciously by regarding flavors as 

attractive to children even when using open systems. See Prohibition Juice

11 The petitioners argue that open-system devices are big and clunky, 

making them unappealing to youth. The Fifth Circuit credited this 

argument, pointing to photographs of large open-system devices. Wages & 

White Lion Invs., LLC v. FDA, 90 F.4th 357, slip op. at 12 (5th Cir. 2024) 

(en banc). In our case, the FDA said that new open-system devices are 

often small, pointing to pictures submitted by the amici. Brief of Amici 

Curiae Medical, Public Health, and Community Groups in Support of 

Respondent at 11. But none of these photographs or pictures are in our 

record. So we don’t rely on them. See, e.g., Atteberry v. Finch, 424 F.2d 

36, 39 (10th Cir. 1970) (stating that judicial review is limited to evidence 

in the administrative record).

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29

Co. v. FDA, 45 F.4th 8, 22, 26 (D.C. Cir. 2022) (rejecting the doublestandard argument and upholding the FDA’s denial of approval to market 

an open-system e-liquid); Liquid Labs, LLC v. FDA, 52 F.4th 533, 544–45

(3d Cir. 2022) (upholding the FDA’s denial of approval to market an opensystem e-liquid because flavors appealed to children regardless of the 

device type); Breeze Smoke, LLC v. FDA, 18 F.4th 499, 506, 508 (6th Cir. 

2021) (upholding the FDA’s determination that generalized evidence

included in an open-system e-liquid application could not overcome the

clear preference of children for flavored e-cigarettes); Gripum, LLC v. 

FDA, 47 F.4th 553, 559–60 (7th Cir. 2022) (concluding that without 

product-specific evidence, the manufacturer of an open-system e-liquid 

hadn’t satisfied its burden of proof); Lotus Vaping Techs., LLC v. FDA, 73

F.4th 657, 671 n.14 (9th Cir. 2023) (concluding that the FDA didn’t 

arbitrarily disregard device types because the scientific consensus had 

shown that children preferred flavored e-liquids). 12

12 In their reply brief, Electric Clouds and Cloud 9 argue that the 

FDA’s studies show that open systems are less popular with youth than 

tobacco-flavored e-cigarettes. Petitioners’ Reply Br. at 19. For this 

argument, Electric Clouds and Cloud 9 cite a statement by the FDA; but 

this statement doesn’t discuss open systems. Id. (citing ER30). To the 

contrary, the cited page suggests that youthful consumers prefer fruit 

flavors over tobacco flavors without any mention of the devices being 

used. ER30 (stating that “66.8% of youth [electronic nicotine delivery 

system] users aged 13 to 17 reported using fruit, followed by . . . 13.3% 

for tobacco flavor”). When open systems were incorporated, the FDA 

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30

According to Electric Clouds and Cloud 9, the FDA reached different 

results for similarly situated manufacturers. But Electric Clouds and Cloud 

9 present no support for this claim, and we see no evidence of different 

standards for manufacturers of similar e-liquids. See Prohibition Juice Co., 

45 F.4th at 26 (rejecting this argument). To the contrary, the FDA 

consistently rejected evidence involving literature reviews and surveys:

Circuit Case Affirming FDA 

Denial

Manufacturers’ Scientific Evidence

Prohibition Juice Co. v. FDA, 45 

F.4th 8, 21–22 (D.C. Cir. 2022)

Online, one-time voluntary studies; 

mixed literature review.

Magellan Tech., Inc. v. FDA, 70 

F.4th 622, 627–29 (2d Cir. 2023)

Focus group of only 24 participants; 2-

week online study of 18 existing 

customers; a study of 15 participants; an 

online survey of 400 smokers and over 

1,000 non-smokers; insufficient literature 

review.

Liquid Labs, LLC v. FDA, 52 

F.4th 533, 537, 541 (3d Cir. 

2022)

Study lacking a comparison between 

flavored e-liquids with unflavored eliquids; survey that failed to discuss 

switching or reduction; mixed literature 

review.

Avail Vapor, LLC v. FDA, 55 

F.4th 409, 417, 420 (4th Cir. 

2022)

Online study for 2 weeks; focus group of 

39 participants; national attitude survey; 

study of 18 participants; mixed literature 

review.

Breeze Smoke, LLC v. FDA, 18 

F.4th 499, 506 (6th Cir. 2021)

Online survey of existing retail-store 

customers; mixed literature review.

Gripum, LLC v. FDA, 47 F.4th 

553, 557 (7th Cir. 2022)

Consumer surveys; insufficient literature 

review (no “bridge”).

Lotus Vaping Techs., LLC v. 

FDA, 73 F.4th 657, 666, 672–73 

(9th Cir. 2023)

Survey of existing customers; survey of 

thousands of participants; insufficient 

literature review (no “bridge”). 

found that 76% of high-school and middle-school students preferred 

flavors for the open systems. ER31, 348.

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The FDA thus did not act arbitrarily and capriciously by regarding the 

scientific evidence as inadequate to approve the petitioners’ applications. 

6. Even if the FDA should have reviewed the marketing plans, the

error would have been harmless.

Electric Clouds and Cloud 9 also argue that the FDA erred by failing 

to review their marketing plans. But even if an error had taken place, it 

would have been harmless because the FDA would have regarded the 

marketing plans as deficient for reasons already stated.

The Tobacco Control Act incorporates the harmlessness standard 

from the Administrative Procedure Act. See 21 U.S.C. § 387l(b) 

(instructing courts to apply 5 U.S.C. § 706); see also All Indian Pueblo 

Council v. United States, 975 F.2d 1437, 1443 (10th Cir. 1992) 

(considering harmlessness in the review of agency decisions). Under this 

standard, the petitioners must show that the FDA’s alleged error was 

harmful. See St. Anthony Hosp. v. U.S. Dep’t of Health & Hum. Servs., 309 

F.3d 680, 691 (10th Cir. 2002).

Generally, we cannot affirm an agency’s decision on grounds that the 

agency didn’t supply. SEC v. Chenery Corp., 332 U.S. 194, 196 (1947). 

But an exception exists if the error clearly didn’t affect the outcome. See 

Allen v. Barnhart, 357 F.3d 1140, 1145 (10th Cir. 2004) (explaining that 

we apply the harmless-error standard when “no reasonable administrative 

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32

factfinder, following the correct analysis, could have resolved the factual 

matter in any other way”).

This exception applies here. The FDA had warned before that similar 

marketing plans had proven ineffective. So the petitioners’ marketing plans 

couldn’t have overcome the other deficiencies in the applications. 

These marketing plans focused on restrictions designed to prevent

children from getting the e-liquids. Cloud 9’s plan consisted of a single 

paragraph, promising only warnings and a 21+ age-verification system. 13

ER365. Electric Clouds submitted a more detailed plan, which proposed 

requirements for identifying customers at retail stores, age verification for 

online sales, child-resistant packaging, and prohibitions on marketing or 

packaging that targeted minors. 

But the FDA had already rejected these types of restrictions. For 

example, in the 2020 Guidance, the FDA had addressed similar measures, 

which included

• technology to verify the customer’s age when making online 

purchases,

13 In its opening brief, Cloud 9 cited a more detailed marketing plan. 

But this marketing plan was not part of the administrative record or 

included with Cloud 9’s application. And Cloud 9 concedes that the more 

detailed marketing plan isn’t material to the issue. Petitioners’ Reply Br. at 

24 n.6, 24–25. So we need not consider the more detailed marketing plan

cited in Cloud 9’s opening brief. See note 11, above (stating that we 

consider evidence only if it was in the administrative record).

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33

• enhanced monitoring to ensure that retailers complied with the 

age requirements, 

• contractual penalties for retailers that sell tobacco to minors, 

and

• restrictions on the amount of e-liquids that customers can buy 

within a given time-period.

The FDA concluded that these measures hadn’t stopped children from 

using e-cigarettes: “The reality is that youth have continued access to these 

products in the face of legal prohibitions and even after voluntary actions 

by some manufacturers.” ER66 (emphasis added). The FDA thus warned 

manufacturers that marketing plans wouldn’t suffice if they focused only 

on “how the product was sold.” Id.

Electric Clouds and Cloud 9 don’t assert that their proposed 

marketing restrictions differ from the marketing restrictions that the FDA 

had already found ineffective. Because Electric Clouds and Cloud 9 had 

already failed to present adequate scientific evidence, their marketing

plans couldn’t have salvaged their applications. 

In similar circumstances, six federal appellate courts have found 

similar errors harmless for marketing plans like those submitted by

Electric Clouds and Cloud 9. Prohibition Juice Co. v. FDA, 45 F.4th 8, 16, 

24–25 (D.C. Cir. 2022); Magellan Tech., Inc. v. FDA, 70 F.4th 662, 630–

31 (2d Cir. 2023); Liquid Labs, LLC v. FDA, 52 F.4th 533, 543–44 (3d Cir. 

2022); Avail Vapor, LLC v. FDA, 55 F.4th 409, 417, 425–27 (4th Cir. 

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34

2022); Breeze Smoke, LLC v. FDA, 18 F.4th 499, 508 (6th Cir. 2021); 

Lotus Vaping Techs., LLC v. FDA, 73 F.4th 657, 666, 674–75 (9th Cir. 

2023).

For example, the Ninth Circuit considered a marketing plan that

• relied on age verification and 

• required that the product be “strictly marketed and sold to 

adults in adult-only retailers and through age-verified online 

websites.”

Lotus Vaping Techs., 73 F.4th at 674 (quoting the manufacturer’s 

marketing plan). But the Ninth Circuit concluded that any error would have 

been harmless because 

• those measures “track those that the FDA found were 

ineffective to counterbalance the risk of youth use” and 

• the manufacturer had not “otherwise argue[d] that any of 

marketing tactics were novel.”

Id. at 675. 

The Fourth Circuit similarly addressed harmlessness when the 

marketing plans “focused solely on age verification and avoiding 

marketing that would make its products attractive to youth.” Avail Vapor, 

LLC v. FDA, 55 F.4th 409, 426 (4th Cir. 2022). The court regarded these 

measures as “insufficient,” but suggested that the manufacturer could have 

supported its application with “novel access restrictions beyond those that 

the FDA previously determined were not working.” Id.

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35

The Third Circuit agreed that “marketing plans would not change the 

result” when the manufacturers had “not explained how the [proposed] 

approaches . . . differ from ones previously found insufficient or how [the 

proposed] marketing plans would have cured other noted deficiencies in its 

applications.” Liquid Labs, LCC v. FDA, 52 F.4th 533, 544 (3d Cir. 2022).

We are persuaded by the reasoning of the Third, Fourth, and Ninth 

Circuits. Electric Clouds and Cloud 9 presented marketing plans focused 

on age verification; these plans involved only the kinds of measures that 

the FDA had already rejected.

Two circuits have concluded that similar errors weren’t harmless,

basing these conclusions on two different reasons. The Fifth Circuit has 

rejected harmlessness based on its interpretation of Calcutt v. FDIC, 598 

U.S. 623 (2023). Wages & White Lion Invs., LLC v. FDA, 90 F.4th 357, 

slip op. at 3, 49–52 (5th Cir. 2024) (en banc). The Eleventh Circuit has 

rejected harmlessness because the marketing plans included novel 

marketing restrictions that the FDA hadn’t previously discussed. Bidi 

Vapor v. FDA, 47 F.4th 1191, 1205 (11th Cir. 2022). Neither of these 

rationales apply here.

Calcutt does not bar consideration of harmlessness. To the contrary,

Calcutt prohibits courts from basing harmlessness on a rationale that the 

agency didn’t invoke. Calcutt, 598 U.S. at 624, 628. This prohibition 

doesn’t apply here because we’re basing harmlessness on the FDA’s 

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36

existing approach to marketing restrictions, not a reason that we’ve 

detected on our own. And Calcutt acknowledged that the court may not 

need to remand when the agency’s prior actions make the outcome clear. 

Id. at 629–30. 

The Eleventh Circuit rejected harmlessness because there the 

manufacturers had used marketing plans unlike those that the FDA had 

addressed. Bidi Vapor, 47 F.4th at 1205 (discussing proposed 

“Trace/Verify technology” and an authentication system for preventing 

counterfeit products); see also Avail Vapor, LLC v. FDA, 55 F.4th 409, 

417–18, 427 (4th Cir. 2022) (distinguishing the novel measures in Bidi 

Vapor from “garden variety restrictions” like age-verification services); 

Lotus Vaping Techs., LLC v. FDA, 73 F.4th at 675 (distinguishing age 

verification and restrictions on retailers from the novel measures addressed 

in Bidi Vapor).

Electric Clouds and Cloud 9 don’t contend that their marketing plans 

contained any novel measures, but argue that the FDA

• ignored the importance of device types and

• could have required extra measures to overcome deficiencies in 

the proposed plans.

These arguments are unconvincing for two reasons.

First, Electric Cloud and Cloud 9 say that because they manufacture 

e-liquids for open-system devices, the FDA shouldn’t have assumed that 

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37

age restrictions would be ineffective. But the FDA warned manufacturers 

that flavored e-liquids had become increasingly popular among children

regardless of device type. See pp. 25–27, above. Given that warning, other 

circuits have rejected arguments about prejudice based on the FDA’s 

failure to review similar marketing plans for open-system e-liquids. 

Prohibition Juice Co. v. FDA, 45 F.4th 8, 26 (D.C. Cir. 2022); Liquid 

Labs, LLC v. FDA, 52 F.4th 533, 545 (3d Cir. 2022); Lotus Vaping Techs., 

LLC v. FDA, 73 F.4th 657, 671 n.14 (9th Cir. 2023). That reasoning is 

persuasive here.

Second, Electric Clouds and Cloud 9 agree that the FDA should have 

considered the possibility of imposing measures to reduce the risk to 

children. But the manufacturers bore the burden to show that their eliquids weren’t too risky for children. See 21 U.S.C. § 387j(c)(2)(A) 

(stating that the FDA “shall deny” applications that fail to make the 

required showing). Electric Clouds and Cloud 9 failed to carry that burden.

We thus agree with other circuits that found no prejudice when the 

FDA had failed to review similar marketing plans:

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38

Circuit Case Affirming 

FDA Denial

Manufacturers’ Proposed Marketing Plans

Prohibition Juice Co. v. 

FDA, 

45 F.4th 8, 15–16 (D.C. Cir. 

2022)

Age-verification measures on websites; 

marketing and packaging not directed and 

minors.

Magellan Tech., Inc. v. 

FDA, 70 F.4th 662, 631 (2d 

Cir. 2023)

Age-verification measures.

Liquid Labs, LLC v. FDA, 

52 F.4th 533, 544 (3d Cir. 

2022)

Age-verification measures; mystery-shopper 

program; marketing not directed at minors.

Avail Vapor, LLC v. FDA, 

55 F.4th 409, 417–18 (4th 

Cir. 2022)

Non-descriptive names; age verification in 

stores; program to bind distributors.

Lotus Vaping Techs., LLC v. 

FDA, 73 F.4th 657, 666 (9th 

Cir. 2023)

Age verification in stores; age-verification 

measures on websites; individual purchase 

limits for online sales; age-gated industry 

trade shows; program to bind retailers.

7. Conclusion

The FDA didn’t mislead Electric Clouds or Cloud 9 about what to put 

in their applications, and the FDA could reasonably regard the literature 

reviews and customer surveys as inadequate.

Along with the literature reviews and customer surveys, Electric 

Clouds and Cloud 9 submitted marketing plans. Though the FDA didn’t 

review these marketing plans, any possible error would have been 

harmless. These plans relied on youth-prevention measures that the FDA 

had previously rejected as ineffective. 

We thus deny the petitions for judicial review of the denial of the

applications to market flavored e-liquids.

Appellate Case: 21-9577 Document: 010111006058 Date Filed: 02/27/2024 Page: 38