Fontem Us, LLC v. United States Food and Drug Administration

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.

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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

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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.

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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.

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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

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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).

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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

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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

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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.

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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

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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.

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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.”

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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.

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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

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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

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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

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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

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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.

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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.

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