Fontem US, LLC v. FDA

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued January 25, 2023 Decided August 29, 2023

No. 22-1076

FONTEM US, LLC,

PETITIONER

v.

UNITED STATES FOOD AND DRUG ADMINISTRATION,

RESPONDENT

Consolidated with 23-1021

On Petitions for Review of an Order

of the Food and Drug Administration

Andrew D. Prins argued the cause for petitioner. With him

on the briefs were Philip J. Perry and Jacob Rush.

Garrett Coyle, Trial Attorney, U.S. Department of Justice,

argued the cause for respondent. With him on the brief were

Brian M. Boynton, Principal Deputy Assistant Attorney

General, and Samuel R. Bagenstos, General Counsel, U.S.

Department of Health and Human Services.

2

Before: RAO and WALKER, Circuit Judges, and GINSBURG,

Senior Circuit Judge.

Opinion for the Court filed by Circuit Judge RAO.

RAO, Circuit Judge: This case concerns the scope of the

Food and Drug Administration’s authority to regulate the

marketing of new tobacco products under the Tobacco Control

Act. After the FDA promulgated regulations applying the Act

to vaping products, Fontem US, LLC, submitted numerous

applications to market its flavored and unflavored vaping

products. The FDA denied all of them, concluding Fontem had

not shown its products were “appropriate for the protection of

the public health.” 21 U.S.C. § 387j(c)(2)(A). Fontem petitions

for review, arguing the denial was unlawful.

We agree with Fontem in part. As to Fontem’s flavored

products, the FDA reasonably found a lack of evidence that the

benefits of such products to adult smokers sufficiently

outweighed the potential risks to young non-smokers. As to

Fontem’s unflavored products, however, the FDA acted

unlawfully by failing to engage in the holistic public health

analysis required by the statute. The agency did not take into

account the potential benefits of unflavored products or weigh

those benefits against risks to the public health.

Accordingly, we deny the petition for review as to

Fontem’s flavored products and grant the petition for review

with respect to the unflavored products.

I.

A.

In 2009, Congress authorized the FDA to regulate new

tobacco products. Family Smoking Prevention and Tobacco

3

Control Act (“Tobacco Control Act”), Pub. L. No. 111-31, 123

Stat. 1776 (codified at 21 U.S.C. § 387 et seq.). The Tobacco

Control Act sets out a highly detailed framework governing the

FDA’s regulatory authority. For instance, the agency may

impose “tobacco product standards” that govern the ingredients

or properties of tobacco products, see 21 U.S.C. § 387g; it may

restrict the sale and distribution of tobacco products, see id.

§ 387f(d)(1); and it may prescribe regulations governing the

manufacturing of these products, see id. § 387f(e). Each of

these regulatory avenues is governed by distinct and detailed

procedural requirements, which are discussed below.

The Act also provides that all new tobacco products—

those not commercially marketed in the United States prior to

February 2007—must be approved by the FDA before being

marketed to the public. See id. § 387j. The agency must deny

an application to market a new tobacco product if it makes one

of four findings: (1) “there is a lack of a showing” that

marketing the product is “appropriate for the protection of the

public health”; (2) the manufacturing of the product does not

conform to manufacturing regulations promulgated by the

agency; (3) the proposed labeling of the product is “false or

misleading”; or (4) the product does not conform to a “tobacco

product standard” promulgated by the agency. Id. § 387j(c)(2).

The Act further details the necessary factors for determining a

product is not shown to be “appropriate for the protection of

the public health” and the type of investigations and evidence

the FDA must consider before making such a finding. Id.

§ 387j(c)(4).

The Act initially did not apply to “electronic nicotine

delivery systems,” colloquially known as vaping products. See

id. § 387a(b) (providing the statute applies to “cigarettes,

cigarette tobacco, roll-your-own tobacco, and smokeless

tobacco”). These devices utilize solutions containing nicotine.

4

When activated, the device heats the solution, vaporizing it and

allowing the user to inhale the aerosolized liquid. Some vaping

products have the same flavor as more traditional tobacco

products—menthol or tobacco—and are referred to as

“unflavored.” Other “flavored” vaping products have a taste

reminiscent of fruits or desserts.

Under the Tobacco Control Act, the FDA may by

regulation subject “any product made or derived from

tobacco … intended for human consumption” to the provisions

of the statute.1 21 U.S.C. §§ 321(rr)(1), 387a(b). In 2016, the

agency invoked this authority to deem vaping products subject

to the Act. See 81 Fed. Reg. 28,974, 28,975 (May 10, 2016)

(“Deeming Rule”). As a result of this Deeming Rule,

manufacturers of vaping products were required to secure

premarketing approval from the FDA unless the product in

question had been marketed prior to 2007.

After issuing the Deeming Rule and following litigation,

the FDA required applications for approval of vaping products

to be submitted by September 2020. See Enforcement Priorities

for Electronic Nicotine Delivery Systems and Other Deemed

Products on the Market Without Premarket Authorization

(Revised); Guidance for Industry; Availability, 85 Fed. Reg.

23,973, 23,974 (Apr. 30, 2020); Am. Acad. of Pediatrics v.

FDA, 379 F. Supp. 3d 461, 472 (D. Md. 2019). At no point,

however, did the FDA use its regulatory authority to

promulgate tobacco product standards or manufacturing

regulations. And while the agency issued preliminary guidance

in 2019, that guidance did not crystallize into a final rule until

1

Last year, the Act was amended to make explicit that products

“containing nicotine from any source” may qualify as tobacco

products. Consolidated Appropriations Act, 2022, Pub. L. No. 117-

103, div. P., § 111(a)(1), 136 Stat. 49, 789.

5

well after manufacturers were required to submit applications.

See Premarket Tobacco Product Applications and

Recordkeeping Requirements, 86 Fed. Reg. 55,300 (Oct. 5,

2021).

B.

Fontem began marketing vaping products in 2009 and

therefore had to secure premarketing approval for these

products. Fontem applied to the agency in April 2020 to market

a variety of its vaping products, both flavored and unflavored.

The FDA responded with a deficiency letter, making

twenty-two requests for additional information. Although

Fontem responded to each of these requests, the agency denied

all of Fontem’s applications on April 8, 2022. The agency’s

denial decision rested entirely on the finding that Fontem had

not sufficiently demonstrated that permitting its products to be

marketed would be “appropriate for the protection of the public

health.” 21 U.S.C. § 387j(c)(2)(A).

In support of this conclusion, the agency identified six

deficiencies in Fontem’s applications:

• Fontem failed to provide sufficient information about

the safety of its products, such as the quantities of

various compounds “at the maximum allowable coil

temperature” (Deficiency 1);

• Fontem failed to provide sufficient information about

the “puffing regimens” used to determine “toxicant

yields” and about “aerosol temperature measurements”

(Deficiency 2);

• Fontem failed to provide the agency with certain

information relating to the manufacturing and stability

of its products, including details about the laboratories

6

Fontem employed (Deficiency 3) and about the

“microbiological stability” of Fontem’s vaping devices

(Deficiency 4);

• As to its flavored products, Fontem failed to show such

products would be sufficiently beneficial to adults to

offset their attractiveness to youth (Deficiency 5);

• Certain files relied upon by Fontem did not include

adequate information (Deficiency 6).

On May 6, 2022, Fontem filed a petition for review of the

marketing denial order. See 21 U.S.C. § 387l(a)(1). On June 6,

2022, Fontem also submitted an administrative appeal, seeking

supervisory review of the order. Following the agency’s denial

of that appeal, Fontem filed a second petition for review on

January 23, 2023.

II.

At the outset, the government maintains we lack

jurisdiction over Fontem’s first petition because, once Fontem

filed an administrative appeal, the FDA’s denial order was not

final and therefore not reviewable. By contrast, the government

views Fontem’s second petition as properly before this court.

We disagree with both propositions.2

The Tobacco Control Act permits “any person adversely

affected” by the “denial of an application under section

387j(c)” to petition for judicial review within 30 days of the

denial. 21 U.S.C. § 387l(a)(1). The FDA’s order, issued on

April 8, 2022, denied Fontem’s section 387j(c) application, and

2

Circuit Judge GINSBURG would hold that, because, as Fontem

points out, one of its petitions for review is necessarily timely, we

need not decide which one. See Collins v. Nat’l Transp. Safety Bd.,

351 F.3d 1246, 1250 (D.C. Cir. 2003).

7

Fontem filed its initial petition for review within 30 days of that

order, on May 6, 2022. We have jurisdiction over that petition

for review. Conversely, Fontem’s second petition for review

was filed long after the 30-day time period had ended, on

January 23, 2023. The petition was therefore untimely and we

cannot review it.

Fontem’s administrative “appeal” does not affect our

jurisdiction. To begin with, the “denial of an application” is a

sufficient basis for this court’s jurisdiction. Id. § 387l(a)(1)(B).

The Act includes no requirement of finality. Nor is such a

finality requirement imposed by the APA, which provides that

“[a]gency action made reviewable by statute and final agency

action for which there is no other adequate remedy in a court

are subject to judicial review.” 5 U.S.C. § 704. A denial order

is “made reviewable” by the Tobacco Control Act, and

therefore the APA imposes no additional finality requirement.

Furthermore, Congress did not explicitly provide for

agency rehearing of marketing denial orders in the Tobacco

Control Act. Instead, administrative review of orders is set

forth in FDA regulations that specify an informal and

unstructured process by which “[a] decision of an FDA

employee … is subject to review by the employee’s

supervisor” at “the request of an interested person outside the

agency.” 21 C.F.R. § 10.75(a). Nothing in the Act or the

regulations suggests this informal process for reviewing

employee “decisions” limits applicants’ ability to petition for

review of marketing denial orders. In order to secure judicial

review, Fontem simply had to file within 30 days of the order.

The government argues this court has previously held in

other contexts that administrative rehearing requests render an

underlying order unreviewable. The cases cited by the

government, however, involve statutes with jurisdictional

8

finality requirements. For instance, this court has held that we

lack jurisdiction over petitions filed under the Hobbs Act when

the petitioner has concurrently requested agency rehearing

because the Hobbs Act grants this court jurisdiction only over

“final orders.” 28 U.S.C. § 2342(1); see also, e.g., Flat

Wireless, LLC v. FCC, 944 F.3d 927, 933 (D.C. Cir. 2019).

Similarly, we have held that finality concerns preclude our

review of petitions brought under the Federal Power Act that

coincide with requests for rehearing before the Federal Energy

Regulatory Commission. See Clifton Power Corp. v. FERC,

294 F.3d 108, 110 (D.C. Cir. 2002) (explaining that this court

may review only final orders under the Federal Power Act).

Unlike these other statutes, the Tobacco Control Act does not

contain a finality requirement; rather, it provides for judicial

review over a defined class of orders, including the denial order

at issue here.

In this statutory and regulatory context, the government’s

position—that judicial review of a denial order is available

only after the FDA also denies a supervisory appeal—would

create uncertainty for litigants and pose serious challenges for

judicial administration. Under the government’s theory, a

supervisory appeal would toll the Act’s 30-day timeline to file

a petition for judicial review until the appeal is denied. But in

the absence of any governing time limits, parties could

circumvent the 30-day statutory limit for judicial review by

filing a belated supervisory appeal. Alternatively, as

government counsel conceded at oral argument, the FDA could

delay judicial review by failing to act on an appeal. Nothing in

the Tobacco Control Act suggests the availability of judicial

review turns on such informal and open-ended regulatory

appeals controlled exclusively by the agency.

Under the Tobacco Control Act, when a party files for

review within 30 days of a marketing denial order, that order is

9

immediately reviewable regardless of any administrative

appeals the party may file. We thus have jurisdiction over

Fontem’s initial petition. Fontem’s second petition, however,

is untimely because it was filed over eight months after the 30-

day time period expired.3

III.

Fontem argues the FDA’s denial of its vaping product

applications was unlawful. We first consider the denial of

Fontem’s flavored products and conclude the FDA reasonably

found Fontem failed to show marketing these products would

be appropriate for the protection of public health.

A.

The Tobacco Control Act structures the FDA’s review of

premarketing applications by providing four distinct grounds

under which the agency may deny such applications. In

denying Fontem’s flavored products, the FDA invoked only the

first ground: whether “there is a lack of a showing that

permitting such tobacco product to be marketed would be

appropriate for the protection of the public health.” 21 U.S.C.

§ 387j(c)(2)(A). While public health standing alone may be a

capacious concept, the Act specifies the basis for such a

finding. The FDA must determine:

3

Because Fontem’s initial petition is properly before this court, and

the second petition raises the same substantive arguments, the

untimeliness of the second petition does not alter the scope of our

review.

10

the risks and benefits to the population as a

whole, including users and nonusers of the

tobacco product, and taking into account—(A)

the increased or decreased likelihood that

existing users of tobacco products will stop

using such products; and (B) the increased or

decreased likelihood that those who do not use

tobacco products will start using such products.

Id. § 387j(c)(4). In addition, when determining whether an

applicant has demonstrated that marketing of a tobacco product

is appropriate for the protection of public health, the FDA

“shall, when appropriate” rely on “well-controlled

investigations,” which may include expert “clinical

investigations.” Id. § 387j(c)(5)(A). The Secretary may also

authorize the use of other types of evidence. Id.

§ 387j(c)(5)(B).

To deny an application on public health grounds, the FDA

must make a single predictive judgment whether a given

tobacco product, on balance, will benefit the public as a whole.

The Act explicitly requires the FDA to consider both “the risks

and benefits” of the product. Id. § 387j(c)(4). Moreover, the

public health inquiry looks to the overall effect of a product for

the “population as a whole,” id., which means the agency

should generally be concerned with the most epidemiologically

significant factors associated with approving the marketing of

a new product. As part of this determination, the agency must

balance the benefits of transitioning existing smokers to the

product against the costs of inducing non-smokers to take up

smoking. Id. § 387j(c)(4)(A), (B). This requirement is

bolstered by the information applicants must provide, which

includes “full reports of all information … concerning

investigations which have been made to show the health risks

of such tobacco product and whether such tobacco product

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presents less risk than other tobacco products.” Id.

§ 387j(b)(1)(A). Weighing the relative risks of new tobacco

products will often be central to the public health analysis given

the reality that there are both many smokers who wish to stop

smoking and many individuals who do not presently consume

tobacco products at all. The Act requires the FDA to undertake

a holistic analysis directed at the overall effect a product will

have on the public health.

B.

The FDA lawfully concluded Fontem had not shown its

flavored products were appropriate for the protection of the

public health. In Deficiency 5, the agency explained that

because flavored products “have significant appeal to youth

and are associated with youth initiation of such products,”

Fontem would have to provide “robust and reliable

evidence … regarding the magnitude of the potential benefit to

adult smokers.” Such benefits may come from switching to

vaping or cigarette reduction over time. In the agency’s

judgment, the primary study Fontem conducted did not show

flavored products had any added benefit for adult smokers

relative to unflavored products. The FDA concluded that

Fontem failed to show the benefits of its flavored products to

adult smokers outweighed the substantial risks of flavored

products to youth.

We recently found it reasonable for the FDA to determine

that “flavored products present greater risks than other tobacco

products, based on a robust array of literature showing the

dangers those products pose of hooking new users, especially

youth.” Prohibition Juice Co. v. FDA, 45 F.4th 8, 19 (D.C. Cir.

2022). The FDA applied the same determination when denying

Fontem’s applications for flavored products. The FDA

considered the extent to which flavored products might help

12

adult smokers quit or reduce smoking, compared with the

possibility that such products may encourage young non-

smokers to take up smoking. By weighing the public health

benefits against the public health risks based on the record

before it, the agency’s analysis was consistent with the

statutory requirements and with the balance we approved in

Prohibition Juice.

Fontem raises three arguments in response. First, Fontem

argues the FDA impermissibly altered its standards between

the initial deficiency letter and the denial order. Fontem

suggests the deficiency letter merely required Fontem to show

a “likelihood” that flavored products increase switching by

adult smokers, while the subsequent denial order required

Fontem to show the benefits of its flavored products “outweigh

the risk to youth” by some unspecified magnitude.

Fontem’s distinction amounts to splitting hairs. In the

deficiency letter, the FDA required Fontem to show its flavored

products “increase[] the likelihood of complete switching

among adult smokers … while minimizing initiation,

particularly by youth.” In its denial order, the agency explained

Fontem failed to show its products “have a potential to benefit

adult smokers … that would outweigh the risk to youth.” These

statements simply recast the statutory tradeoff required by the

Act—whether “the increased or decreased likelihood that

existing users of tobacco products will stop using such

products” outweighs “the increased or decreased likelihood

that those who do not use tobacco products will start using such

products.” 21 U.S.C. § 387j(c)(4)(A)–(B). While the FDA may

have used different words in the deficiency letter and the denial

order, the underlying public health analysis was the same.

13

Next, Fontem argues the FDA’s denial unlawfully

imposed “device access restrictions”4 for flavored products,

and that such restrictions may be imposed only pursuant to a

tobacco product standard. Fontem maintains any access

restrictions must comply with the procedural requirements for

promulgating tobacco product standards, and the agency

cannot use a public health finding as a backdoor to circumvent

those requirements. Fontem’s argument relies on a footnote in

which the FDA indicated that measures short of device access

restrictions “cannot mitigate the substantial risk to youth” from

flavored products. But in context, this footnote does not

categorically mandate device access restrictions; it merely

suggests that certain mitigation measures cannot substitute for

evidence demonstrating that flavored products benefit adult

smokers. Indeed, in that same paragraph the FDA indicated that

high-quality evidence such as randomized trials could justify

approval of Fontem’s flavored products. The agency simply

concluded Fontem had not produced the necessary evidence.

Finally, Fontem contends that even if the findings in

Deficiency 5 were lawful, that deficiency was not an

independent basis for the FDA’s denial decision, and therefore

the denial can be upheld only if every other deficiency is also

lawful. We disagree. “When an agency relies on multiple

grounds for its decision, some of which are invalid, we may

nonetheless sustain the decision as long as one is valid and the

agency would clearly have acted on that ground even if the

other were unavailable.” Casino Airlines, Inc. v. Nat’l Transp.

Safety Bd., 439 F.3d 715, 717 (D.C. Cir. 2006) (cleaned up).

4

As explained in the FDA’s technical review of Fontem’s

applications, device access restrictions are “technologies that require

adult user identification by fingerprint or other biometric parameters

in order to unlock and use a tobacco product.”

14

The reasoning provided in Deficiency 5 is sufficient to support

the denial of Fontem’s flavored products. The FDA concluded

Fontem had failed to provide “sufficient evidence

demonstrating that” the flavored products “have a potential to

benefit adult smokers, who switch completely or significantly

reduce their cigarette use, that would outweigh the risk to

youth.” The explanation makes clear the agency understood

Deficiency 5 to be a sufficient basis for denying approval of

Fontem’s flavored products. The FDA focused on the question

central to the public health inquiry—whether Fontem had

shown the “increased or decreased likelihood that existing

users of tobacco products will stop using such products”

outweighs the “increased or decreased likelihood that those

who do not use tobacco products will start using such

products.” 21 U.S.C. § 387j(c)(4)(A)–(B). Having answered

that critical question in the negative, the agency had a sufficient

basis for denying Fontem’s products.

The FDA adequately explained its finding that Fontem had

failed to show that marketing its flavored products would be

appropriate for the protection of the public health. Accordingly,

we deny Fontem’s petition as to these products.

IV.

With respect to Fontem’s unflavored products, the FDA

also denied Fontem’s applications on the public health ground.

While the FDA identified multiple “deficiencies,” it failed to

analyze the tradeoffs necessary to make a public health finding.

Nor did the agency explain how the specific deficiencies relate

to its overall conclusion that Fontem failed to demonstrate its

unflavored products were appropriate for the protection of

public health. The agency’s denial therefore failed to comport

with the requirements of the Tobacco Control Act.

15

In denying Fontem’s unflavored products, the FDA relies

solely on the public health ground. The FDA could have

promulgated regulations imposing consistent requirements on

the composition and manufacturing of tobacco products. Had

the agency done so, Fontem’s failure to meet those standards

would be an independent and sufficient ground for denying the

applications, regardless of the overall public health

consequences of Fontem’s products. But the agency has not

exercised its regulatory authority. Because the FDA has chosen

to proceed application by application under the public health

ground, it must undertake the holistic inquiry required by the

statute. We hold that the agency failed to engage in the

necessary analysis with respect to Fontem’s unflavored

products.

A.

As described above, to deny a product on the basis of

public health, the FDA must make an all-things-considered

judgment that a given tobacco product has not been shown to

be appropriate for the protection of the public health. By its

nature, such a judgment may validly incorporate a range of

factors but, at the same time, it is not unlimited in scope. The

agency’s review is limited to the public health consequences of

the tobacco product, which “shall be determined with respect

to the risks and benefits to the population as a whole, including

users and nonusers of the tobacco product.” 21 U.S.C.

§ 387j(c)(4).

Other provisions of the Tobacco Control Act confirm that

the public health inquiry requires the FDA to engage in a high-

level balancing test as to the overall public health consequences

of the product at issue. The Act provides specific grants of

regulatory authority to the agency to promulgate tobacco

product standards and manufacturing regulations. These

16

regulatory authorities permit the FDA to set forth requirements

for tobacco products, providing notice and predictability for

manufacturers.

First, the FDA has authority to “prescribe regulations”

governing the “methods used in, and the facilities and controls

used for, the manufacture, preproduction design

validation …, packing, and storage of a tobacco product.” Id.

§ 387f(e)(1)(A). The failure to comply with a manufacturing

regulation is an independent ground for denying an application.

Id. § 387j(c)(2)(B). Before promulgating a manufacturing

regulation, the FDA must comply with numerous and detailed

procedural requirements. The agency must first receive

recommendations from the Tobacco Products Scientific

Advisory Committee (the “Scientific Advisory Committee”)

and afford “opportunity for an oral hearing.” Id.

§ 387f(e)(1)(B)(i)–(iii). Parties may petition for exemptions

from the regulation, and such petitions may be reviewed by the

Scientific Advisory Committee. Id. § 387f(e)(2). In

establishing the effective date of a regulation, the FDA must

provide a “reasonable period of time” for manufacturers to

conform to the regulation at issue, and, in determining that

period of time, the agency must consider a variety of factors,

including historical differences in manufacturing practices, the

“financial resources” of manufacturers, and the “state

of … existing manufacturing facilities.” Id.

§ 387f(e)(1)(B)(iv). Finally, the agency must exempt small

manufacturers from such regulations for at least four years after

the regulation’s effective date. Id. § 387f(e)(1)(B)(v).

Similarly, the FDA has authority to promulgate tobacco

product standards, which are uniform rules governing the

composition of tobacco products or restricting their sale and

distribution. See id. § 387g(a)(4). The failure to conform to

such a standard is another independent ground for denying an

17

application. Id. § 387j(c)(2)(D). As with manufacturing

regulations, tobacco product standards are subject to detailed

substantive and procedural requirements. Tobacco product

standards may address a range of different issues, regulating,

for example, nicotine yields, the reduction of harmful

components, or the testing of products. Id. § 387g(a)(4). With

respect to procedure, the agency must employ notice-and-

comment rulemaking, must review reports from the Scientific

Advisory Committee, and must consider the “technical

achievability of compliance” with the standard at issue, as well

as the possibility that imposition of the standard will shift

demand to contraband products not regulated by the FDA. Id.

§ 387g(b)–(c), (d)(1). Tobacco product standards generally

may not take effect for at least a year. Id. § 387g(d)(2). And the

Act requires the FDA to balance the concerns of manufacturers

by considering information from interested parties as to

whether compliance within the timeframe of the effective date

is feasible; and by establishing an effective date “so as to

minimize, consistent with the public health, economic loss to,

and disruption or dislocation of, domestic and international

trade.” Id.

Furthermore, the FDA must consider the protection of

public health when promulgating manufacturing regulations

and tobacco product standards. See id. § 387f(e)(1)(A)

(manufacturing regulations shall “assure that the public health

is protected”); id. § 387g(a)(4) (tobacco product standards

must include provisions as “appropriate for the protection of

the public health”). Congress thus specified different avenues

for the FDA to protect public health, and the FDA cannot

impose regulatory requirements through its authority to make

public health findings.

If the FDA had established regulatory standards, it could

deny applications that fall short of the standards without

18

undertaking an individualized public health balancing for each

product. Because the FDA made the choice to proceed through

ad hoc adjudication, the Tobacco Control Act requires the

agency to undertake a holistic analysis of whether the benefits

and risks of the individual products have been shown to be

appropriate for the protection of the public health.

B.

With respect to Fontem’s unflavored products, the FDA

failed to undertake the analysis required for a denial on public

health grounds. Instead of making an overall assessment that

Fontem had not shown its products were beneficial to the

public, the agency identified five highly technical deficiencies.

But nothing in the denial order explains how the deficiencies

relate to the overall public health consequences of Fontem’s

unflavored products. And despite the express statutory

requirement that the agency consider the “risks and benefits to

the population as a whole,” including the “increased or

decreased likelihood that existing users of tobacco products

will stop using such products,” 21 U.S.C. § 387j(c)(4),

nowhere in the denial order did the FDA address the potential

benefits of Fontem’s products for the public at large. Nor did it

consider the possibility that existing users of combustible

tobacco products such as cigarettes would reap health benefits

by transitioning to Fontem’s vaping products.

We hold that none of the five deficiencies supports the

FDA’s finding that Fontem’s unflavored products were not

appropriate for the protection of public health.

1.

In Deficiencies 1 and 2, the FDA faults Fontem for failing

to provide very specific information about the physical

19

properties of Fontem’s products, but fails to explain how the

identified problems relate to the “risks and benefits to the

population as a whole, including users and nonusers of the

tobacco product.” 21 U.S.C. § 387j(c)(4).

In Deficiency 1, the agency faulted Fontem for failing to

provide the quantities of certain compounds at the “maximum

allowable … temperature” of the heating coil used in Fontem’s

products. The agency stated that high coil temperatures could

lead to the emission of harmful chemicals, and it suggested

more information about “aerosol constituent testing” would be

necessary for Fontem’s devices to be approved. But the FDA

did not explain why this deficiency was sufficiently serious to

outweigh any benefits associated with Fontem’s products

across the population as a whole. Fontem provided evidence

that even under highly conservative assumptions the

concentration of harmful compounds in Fontem’s vaping

products was “substantially lower” than in combustible

cigarettes. The FDA did not acknowledge, much less analyze,

these benefits, nor did it suggest how the harms of a high coil

temperature were so risky as to outweigh these benefits.

Similarly, in Deficiency 2, the FDA concluded Fontem

had failed to provide sufficient information about the “puffing

regimens” used to determine “toxicant yields” or about

“aerosol temperature measurements.” The agency expressed

concern that higher puff counts could increase the heater coil

temperature, thus “resulting in higher toxicant yields.” But

Fontem had already provided extensive information about its

puffing regimens, which were chosen to reflect more risky

behavior than would be likely for actual users. Nothing in the

marketing denial order explains why any negative

consequences associated with toxicant yields or aerosol

temperature were so serious as to outweigh the asserted

benefits of Fontem’s products.

20

If the FDA wishes to prescribe uniform rules requiring

“aerosol constituent testing,” mandating specific tests to

determine puff counts, or imposing limits on heating coil

temperatures, it may do so by promulgating a tobacco product

standard. Under its statutory authority, the FDA may impose

requirements to eliminate or reduce “harmful components of

the product”; to govern the “construction, components,

ingredients, additives, constituents, … and properties” of a

tobacco product; to require the “testing” of tobacco products;

and to require the results of such tests to meet certain standards.

Id. § 387g(a)(4)(A)(ii), (B)(i), (ii), (iv). The failure to meet

such a standard would be a ground for denying an application,

and no public health balancing would be necessary. But

because the FDA has not promulgated such regulations and

instead has chosen to evaluate Fontem’s application on public

health grounds, it must consider all the relevant public health

considerations, including the benefits of the product.

2.

Next, Deficiencies 3 and 4 pertain to concerns about

Fontem’s manufacturing process or about the stability of its

products. In Deficiency 3, the agency concluded Fontem had

failed to provide sufficient information about its “e-liquid

[quality control] testing” and its “liquidpod filling process.” In

particular, the agency sought the names, accreditation, and

specifications of certain laboratories used by Fontem. And in

Deficiency 4, the FDA determined Fontem had failed to

provide “post-manufacturing microbiological stability

information” for its finished products to show those products

remain stable “over the defined shelf life.” These may or may

not be legitimate concerns, but they do not reflect the required

statutory balancing for denying an application on public health

grounds. The agency did not balance its concerns against the

potential benefits of Fontem’s products. Nor did it explain why

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these deficiencies were so serious as to justify a finding that

Fontem had not shown its products would be appropriate for

the protection of the public health.

Deficiencies 3 and 4, like Deficiencies 1 and 2, could be

sufficient grounds for the FDA to deny Fontem’s products if

the agency had promulgated valid manufacturing regulations

or tobacco product standards. For instance, if the agency had

used its regulatory authority to specify the “methods used in,

and the facilities and controls used for” the manufacture of

tobacco products, see 21 U.S.C. § 387f(e)(1)(A), Fontem

would be bound to follow such methods and use such controls.

And if Fontem had failed to observe such regulations, the FDA

could lawfully deny approval of Fontem’s products without

engaging in any overall balancing analysis. Instead, however,

the agency chose to proceed through ad hoc adjudication under

the public health provision. The FDA has a certain amount of

flexibility to deny a product after making a public health

finding, but “however inclusive may be the general language

of a statute, it will not be held to apply to a matter specifically

dealt with in another part of the same enactment.” Genus Med.

Techs. LLC v. FDA, 994 F.3d 631, 639 (D.C. Cir. 2021)

(quoting Fourco Glass Co. v. Transmirra Prods. Corp., 353

U.S. 222, 228 (1957)). Having opted not to issue

manufacturing regulations or tobacco product standards, the

FDA had to evaluate Fontem’s application under the all-things-

considered, holistic analysis required to deny a product on

public health grounds. Neither Deficiency 3 nor Deficiency 4

includes the necessary analysis to support the FDA’s finding.

3.

Finally, nothing in the denial order explains why

Deficiency 6 justifies denying approval of Fontem’s

unflavored products. The FDA stated simply there were

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“issues” in certain master files relied upon by Fontem, and that

the agency required “additional information … to perform a

complete review.” But the FDA does not explain why these

issues are so serious as to make impossible an informed

judgment as to the overall public health consequences of

Fontem’s products. Nor does the agency even suggest the

issues with the master files have caused uncertainty about any

specific aspect of Fontem’s unflavored products related to

public health. Deficiency 6 makes no public health finding and

therefore cannot justify the FDA’s denial on public health

grounds.

C.

The FDA’s failure to correctly apply the public health

inquiry to Fontem’s unflavored products led it to make another

serious error. In its initial deficiency letter, the FDA requested

certain information from Fontem, thereby indicating such

information would be sufficient for the agency to approve

Fontem’s products. Cf. 21 U.S.C. § 387j(c)(3) (providing an

application denial “be accompanied by a statement informing

the applicant of the measures required to remove such

application from deniable form”). But in several instances, the

FDA changed its tune in the denial order, reproaching Fontem

for failing to provide information the agency had never

explicitly sought. With respect to Deficiency 2, for instance,

the FDA initially requested a “scientific justification for why

consecutive puffing does not cause an increased risk of user

injury” and “[t]he target value, upper and lower range limits,

and test data” for the studies employed by Fontem. But after

Fontem provided that information, the FDA faulted Fontem for

failing to provide “scientific justifications” for its puff counts

or the “maximum values” of “aerosol temperature

measurements.” Similarly, with respect to Deficiency 3, the

FDA’s letter requested information about the quality control

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processes at one facility. Yet the denial order faulted Fontem

for failing to provide information about the processes at a

different facility.

Shifting the regulatory goalposts without explanation is

arbitrary and capricious. By indicating in its deficiency letter

that Fontem could resolve issues with its applications by

providing specific information, the FDA represented such

information would be sufficient to secure approval. By later

requiring different information, the agency “pull[ed] a surprise

switcheroo.” Env’t Integrity Project v. EPA, 425 F.3d 992, 996

(D.C. Cir. 2005). The lack of consistency and notice to

regulated entities is another unlawful consequence of the

agency’s departure from the holistic public health inquiry.

***

The FDA denied Fontem’s applications solely on the

ground that Fontem had not shown its flavored and unflavored

products were “appropriate for the protection of the public

health.” 21 U.S.C. § 387j(c)(2)(A). In order to make such a

finding, the agency must weigh the potential benefits of the

product to the public at large against the potential risks. The

agency properly engaged in that analysis as to Fontem’s

flavored products, and we deny the petition as to those

products.

As to Fontem’s unflavored products, however, the FDA

failed to undertake the necessary “public health” analysis.

Instead, the agency identified highly granular deficiencies but

failed to evaluate the potential effects of such deficiencies on

the public health or to weigh these deficiencies against the

potential benefits of Fontem’s products. If the FDA wishes to

require fine-grained requirements of all tobacco products, it

must do so by promulgating tobacco product standards or

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manufacturing regulations. Otherwise, the agency must

consider the overall public health consequences of the product.

Congress established a comprehensive and interlocking

scheme for the regulation and approval of tobacco products,

defining the considerations the FDA must use to evaluate

whether a product is appropriate for the protection of the public

health and providing for a regulatory process that accounts for

the competing interests regarding the production, marketing,

and safety of tobacco products. Cf. FDA v. Brown &

Williamson Tobacco Corp., 529 U.S. 120, 159–60 (2000)

(emphasizing Congress had for decades “creat[ed] a distinct

regulatory scheme for tobacco products”). The FDA cannot

simply ignore Congress’s detailed directives when denying

tobacco marketing applications.

Because the FDA failed to justify its “public health” denial

of Fontem’s unflavored products, we grant the petition and

vacate the FDA’s marketing denial order as to those products.

So ordered.