Fontem US, LLC et al v. United States Food and Drug Administration et al

UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF TEXAS
FORT WORTH DIVISION
F ONTEM US, LLC, ET AL .,
Plaintiffs,
v. 	No. 4:26-cv-00322-P
U NITED STATES F OOD AND D RUG
A DMINISTRATION , ET AL .,
Defendants.
OPINION & ORDER
Before the Court is Defendants’ Motion to Transfer. ECF No. 21.
Having considered the Parties’ briefs and applicable law, the Court finds
the Motion should be and hereby is GRANTED. Accordingly, the Court
TRANSFERS this case to the United States District Court for the
Middle District of North Carolina, Greensboro Division.
BACKGROUND
Plaintiff, Fontem, US, LLC filed suit—and now seeks an emergency
stay—challenging the Food and Drug Administration’s intermediate
decision to issue a “refuse to file” letter in response to Fontem’s
“Premarket Tobacco Product Applications.” In short, the letter simply
informs Plaintiff that its application needs more information prior to
review. Fontem seeks authorization to market synthetic nicotine pouch
products in the United States. While the FDA asserts that it needed
more information about the product’s ingredients in its application to
conduct a proper scientific review, Fontem counters that the FDA
needed 	to 	either 	approve 	or 	deny 	the 	applications 	under 	the
Administrative Procedure Act.
Filing alongside Fontem is Co-Plaintiff, OM Investment, LLC d/b/a
“Andy Food Store” gas station and convenience store in Fort Worth,
Texas. That single store is the nexus of any connection to Fort Worth in
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this 	case. 	Fontem, 	meanwhile, 	operates 	as 	a 	manufacturer 	and
marketer of nicotine pouch products primarily out of Greensboro, North
Carolina. In its relationship with “Andy Food Store,” Fontem maintains
some employees in this District to sell its products.
The government has now filed a motion to transfer the case to either
the Middle District of North Carolina, the District of Maryland, or the
District of Columbia. First, it argues that because Co-Plaintiff OM
Investment, LLC lacks standing—which would render venue in this
district improper—transfer is appropriate under 28 U.S.C. § 1406(a).
Alternatively, it argues that transfer under 28 U.S.C. § 1404(a) is
appropriate. With concerns regarding the propriety of venue in the Fort
Worth Division of the Northern District of Texas, the Court ordered
expedited briefing on the issue. Having received full briefing, the Motion
is now ripe for review.
LEGAL STANDARD
A district court may transfer any civil case “[f]or the convenience of
the parties and witnesses, in the interest of justice . . . to any other
district or division 	where 	it might have been 	brought.” 28 	U.S.C.
§ 1404(a). Such transfer is between venues, not forums. See In re
Volkswagen of Am., Inc., 545 F.3d 304, 308 n.2 (5th Cir. 2008) (en banc).
“It is well settled that the party moving for a change of venue bears the
burden” of demonstrating good cause for why the forum should be
changed. JTH 	Tax, 	LLC 	v. 	Yong, 	No. 	4:22-CV-01008-O, 	2023 	WL
5216496, at *2 	(N.D. 	Tex. 	Aug. 	11, 	2023) 	(O’Connor, 	J.) (internal
quotation marks omitted). To carry that burden, the defendant must
show that the transferee venue is “clearly more convenient than the
venue chosen by the party.” In re Volkswagen of Am., Inc., 545 F.3d at
315. If the defendant does not meet this burden, then “the plaintiff’s
choice should be respected.” Id.
When considering transfer of venue, the Fifth Circuit has identified
eight factors, four private and four public, to consider.
The private interest factors are: (1) the relative ease of access to
source of proof; (2) the availability of compulsory process to secure
the attendance of witnesses; (3) the cost of attendance for willing
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witnesses; and (4) all other practical problems that make trial of
a case easy, expeditious and inexpensive . . . .
The public interest factors are: (1) the administrative difficulties
flowing from court congestion; (2) the local interest in having
localized interests decided at home; (3) the familiarity of the
forum with 	the law 	that will govern 	the 	case; 	and (4) 	the
avoidance of unnecessary problems of conflict of laws or in the
application of foreign law.
In re Volkswagen of Am., Inc., 545 F.3d at 315.
The plaintiff’s choice of venue is “a factor to be considered but in and
of itself it is neither conclusive nor determinative.” In re Horseshoe Ent.,
337 F.3d 429, 434–35 (5th Cir. 2003). The weight accorded the Plaintiffs’
choice of venue “is diminished where the plaintiff brings suit outside his
home forum.” Santellano v. The City of Goldthwaite, 3:10-CV-2533-
D, 2011 WL 1429080, at *2 (N.D. Tex. Apr. 14, 2011) (Fitzwater,
C.J.) (citing Alexander & Alexander, Inc. v. Donald F. Muldoon & Co.,
685 F. Supp. 346, 349 (S.D.N.Y. 1988)); see also TransFirst Grp., Inc. v.
Magliarditi, 237 F. Supp. 3d 444, 459 (N.D. Tex. 2017) (Lindsay, J.).
Courts use a two-step inquiry to determine if transfer is proper. See In
re Volkswagen of Am., Inc., 545 F.3d at 312. First, they ask whether the
plaintiff could have originally sued in the transferee district. Id. Second,
they weigh the aforementioned private- and public-interest factors to
determine whether a venue transfer serves the convenience of parties
and witnesses and is in the interest of justice. Id. at 315.
ANALYSIS
As an initial matter, the Court assumes without deciding that this
action could have been brought in either the Northern District of Texas
or the Middle District of North Carolina.1 A civil action against a
government agency or officer in their official capacity may be brought in
1 To be sure, Defendants’ standing analysis appears meritorious to the
Court. Because the agency action at issue here effectively resulted in a mere
intermediate request for more information before meaningful review can be
conducted, the Co-Plaintiff’s harm appears to be far too attenuated from the
government’s action.
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a “judicial district in which any defendant resides,” “a judicial district in
which a substantial part of the events or omissions giving rise to the
claim occurred,” or where the plaintiff resides if no real property is
involved. 28 U.S.C. § 1391(e). Here, the Plaintiff seeking approval of its
application is Fontem, which operates in Greensboro, North Carolina.
Compare this with the analysis for Fort Worth, where venue is mainly
established through the operation of a single convenience store that
wants to sell these yet-to-be authorized products. Since the Court
assumes without deciding that this matter could have been brought in
either District, the Court must now determine whether private- and
public-interest factors weigh in favor of transfer under § 1404(a).
A. 	Private-Interest Factors
The private-interest factors to be considered are: (1) ease of access to
sources of proof; (2) availability of compulsory process for witnesses; (3)
the cost of witness attendance; and (4) all other practical factors that
might 	make 	a 	trial 	more 	expeditious 	and 	inexpensive. 	See 	In 	re
Volkswagen of Am., Inc., 545 F.3d at 315.
As to the first three factors, this case will chiefly focus on the
Administrative Procedure Act (“APA”), with little to no actual physical
records or evidence necessary for its resolution. Thus, the first three
factors are neutral with respect to transfer.
The fourth factor, however, is not neutral and heavily weighs in favor
of transfer. Defendants argue that the Middle District of North Carolina
is the more practical venue compared to the Northern District of Texas.
The Court agrees. Fontem’s personnel and materials are based in its
North Carolina headquarters—the same personnel that amassed the
materials at issue in the relevant application to the FDA. So it would
clearly be more convenient for any hearing or meetings in this case to be
held in North Carolina instead of Texas. While Fontem is the “master of
the complaint” and itself chose to file suit elsewhere and thus put this
inconvenience on itself, the ease with which it could appear in North
Carolina would make litigation there more convenient and logistically
more expeditious for all parties concerned. In re Clarke, 94 F.4th 502,
514–15 (5th Cir. 2024) (noting that it “abuses both logic and the court’s
discretion” to assume a “zero chance that the case would need any
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evidentiary hearing”) (cleaned up). And holding a trial in North Carolina
would for the same reasons be clearly more convenient as well.
Notably, Plaintiffs do not identify any substantial or practical issues
with this case being held in North Carolina. The Court concludes that,
because most of the private interest factors are neutral or weigh in favor
of transfer, the private interest factors as a whole favor transfer.
B. 	Public-Interest Factors
Next, the Court must consider whether public-interest factors weigh
in 	favor 	of 	transfer. 	These 	public-interest 	factors 	include: 	(1) 	the
administrative difficulties flowing from court congestion; (2) the local
interest in having localized interests decided at home; (3) the familiarity
of the forum with the law that will govern the case; and (4) the avoidance
of unnecessary problems of conflict of laws or in the application of
foreign law. See In re Volkswagen of Am., Inc., 545 F.3d at 315. The
latter two factors are neutral. But the remaining public factors move the
needle toward transfer.
First, it is well-documented that the Northern District of Texas has
a significantly busy docket. For one, this Court recently held a high-
profile trial regarding the shooting at ICE’s Prairieland detention center
last year, a trial that encompassed nearly four weeks of this Court’s
time. But that is just one case. The Northern District of Texas is
generally more congested than the Middle District of North Carolina.
See 	United 	States 	Courts, 	Federal 	court 	Management 	Statistics:
Judicial 	Caseload 	Profile 	(June 	30, 	2025),
https://www.uscourts.gov/sites/default/files/document/fcms_na_distprof
ile0630.2025.pdf. As of June 30, 2025, the Northern District of Texas,
had 522 pending cases per judgeship and 6,259 pending actions total,
while the Middle District of North Carolina had 374 pending cases per
judgeship and 1,497 pending actions total. So the judicial economy
favors transfer. Indeed, the Northern District of Texas has a docket
busier than some of the busiest courts in the country. See Chamber of
Com. of the U.S. v. CFPB, 735 F. Supp. 3d 731 (N.D. Tex. 2024) (Pittman,
J.) (mentioning that the Northern District of Texas has a busier docket
than the District Court for the District of Columbia); Perez v. Genoptix,
Inc., No. 4:19-cv-00309-O, 2018 WL 11435300, at *3 (N.D. Tex. Nov. 6,
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2018) (stating that to assess relative court congestion between districts,
courts may analyze federal judicial caseload statistics when determining
whether to transfer); see also Outsourcing Facilities Ass’n v. United
States Food & Drug Admin., No. 4:24-cv-00953, 2025 WL 1782574, at *1
(N.D. Tex. Mar. 26, 2025) (noting that the Fort Worth Division is up to
two 	to 	three 	times 	busier 	than 	the 	Dallas 	Division). 	Considering
Plaintiff seeks expedited relief, this factor especially favors transfer.
Second, there is a localized interest in having this dispute resolved
in the Middle District of North Carolina. The Court acknowledges that
this lawsuit ultimately seeks approval for nationwide marketing of a
product. But this factor still weighs towards transfer.
The success of a North Carolina company clearly pertains to North
Carolinians. As the Fifth Circuit has said, this factor concerns non-party
citizens. In re Chamber of Com. of the United States v. CFPB, 105 F.4th
297, 308 (5th Cir. 2024). 	Localized interests are present when “the
citizens of the forum have a sufficient interest in the controversy to
justify burdening them with jury duty.” Id. (cleaned up). “Jury duty is a
burden that ought not to be imposed upon the people of a community
which has no relation to the litigation.” Id. (cleaned up). It is hard to
think of a more concerned community than a community with neighbors
that work for Plaintiff’s headquarters.
While this case concerns an agency action—a category of actions that
often can be more fittingly characterized as having national interests
rather than localized interests—this action does not concern a general
rule applying to a wide array of companies. This concerns a very specific
application filed by one particular company in North Carolina seeking
approval 	of 	its 	product. 	Any 	remaining 	effects 	on 	retailers 	are
attenuated and miniscule in comparison. So the fact that an agency
conducted this action does not automatically shield it from any inquiry
into venue.
As this Court has consistently emphasized, venue is not a continental
breakfast; you cannot pick and choose on a Plaintiff’s whim where and
how a lawsuit is filed. Indeed, this is why § 1391(e)(1)(B) has the
“substantial” qualification as one of the factors in deciding venue.
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Federal courts have consistently cautioned against such behavior. See
Moreno v. City of N. Y., No. 14-cv-6062(NG), 2015 WL 403246 at *2
(E.D.N.Y. Jan. 28, 2015) (Gershon, J.) (holding that a court’s discretion
under 1404(a) is properly exercised to discourage venue shopping). Plus,
the Middle District of North Carolina clearly has the stronger interest
in resolving this dispute.
Here, there is no unique or particular impact felt in the Northern
District of Texas and little if any of the events surrounding the FDA’s
intermediate decision have occurred here. Importantly, while the third
and fourth factors are neutral, they (like all other private- and public-
interest factors) certainly do not favor this case remaining in the
Northern District of Texas and instead favor transfer to the Middle
District of North Carolina.
C. Local Rule 62.2
Lastly, the Court determines that a stay of transfer would disrupt a
just and expeditious resolution of this case. In September 2024, the
Northern District of Texas updated its Local Rules to require a 21-day
stay following any contested transfer order outside of the Fifth Circuit.
N.D. Tex. L.R. 62.2. But under Local Rule 83.1, and “[n]otwithstanding
the local civil rules, a presiding judge may direct the parties to proceed
in any manner that the judge deems just and expeditious.” N.D. Tex.
L.R. 	83.1. 	An 	additional 	21 	days—particularly 	in 	a 	case 	seeking
emergency relief—is not necessary, expeditious, or just.
The Court questions the legitimacy and practicality of Local Rule
62.2 (the “Rule”). In terms of legitimacy, the ostensible reason behind
the Rule is to allow the de facto appellate review of a district court’s
decision to transfer a case to another circuit. But jurisdiction of federal
courts to exercise appellate review is established by Congress and the
United States Supreme Court—not the district courts, or even learned
circuit courts, through local rules. The current venue statutes, 28 U.S.C.
§§ 1391, 1404(a), 1406, and 1631 say nothing related to a district court
needing to stay a case following a transfer order to another district, for
any amount of time. In fact, 1404(a) is so broad that it allows transfer to
“any other district or division where it might have been brought.” 28
U.S.C. 1404(a) (emphasis added). And courts have long enjoyed “broad
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discretion in deciding whether to order a transfer.” In re Volkswagen of
Am. Inc., 545 F.3d at 311. While the venue statutes have been enacted
for decades, and Congress has had ample opportunity to amend them,
the Rule seemingly circumvents that process with a substantive rather
than procedural revision. “That is wrong coming and going.” Evans v.
Garza, 161 F.4th 315, 325 (5th Cir. 2025) (Oldham, J., dissenting)
As for practicality, the Rule forces district court judges to prioritize
certain filings over others. For example, if a temporary restraining order
and motion to transfer are filed at the same time, a judge may be forced
to rule on the request for a restraining order given the 21-day waiting
period the parties must endure—notwithstanding a clearly improper
venue. And although the Court resorts to Local Rule 83.1 in this Order
to avert the 21-day stay for the Parties’ interests, it is clear that Local
Rule 83.1 and this Rule are inconsistent. Moreover, the Rule necessarily
infringes on a district court’s charge to manage its own docket. See Link
v. Wabash R.R. Co., 370 U.S. 626 (1962) (holding that trial courts
possess inherent power to “manage their own affairs so as to achieve an
orderly and expeditious disposition of cases”).
Accordingly, 	notwithstanding 	the 	local 	rules, 	the 	Court 	has
determined it is just and expeditious to immediately transfer this case
to the Middle District of North Carolina and directs the clerk to transfer
the case without delay.
CONCLUSION
The most proper venue in this case is the Middle District of North
Carolina. The connection to this District is a mere convenience store and
a few employees that work in this District. In comparison to the
connections that Fontem’s headquarters has to the Middle District of
North Carolina, it is clear that North Carolina is the more convenient
venue. Here, the Court will refrain from taking part in “creative judging”
and is compelled to follow the law laid out by Congress in 28 U.S.C. §
1404(a).2 Thus, having considered the relevant private- and public-
2 "One single object… [will merit] the endless gratitude of the society: that
of restraining the judges from usurping legislation.” Letter from Thomas
Jefferson to Edward Livingston (Mar. 25, 1825), in 16 THE WRITINGS OF
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interest factors, the Court concludes that this case should be and hereby
is TRANSFERRED to the United States District Court for the Middle
District of North Carolina, Greensboro Division.
SO ORDERED on this 23rd day of March 2026.
T HOMAS J EFFERSON 112, 113 (Andrew A. Lipscomb & Albert Ellery Bergh eds.,
1904).
Before the Court is Plaintiff’s Unopposed Motion for Leave to File
Second Amended Complaint. ECF No. 18. Having considered the Motion
and applicable docket entries, the Court GRANTS the Motion.
SO ORDERED on this 18th day of September 2023.
______________________________________________
Mark T. Pittman
UNITED STATES DISTRICT JUDGE
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