Vape Central Group, LLC v. Food & Drug Administration

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

VAPE CENTRAL GROUP, LLC,

Plaintiff,

v. Civil Action No. 24-3354 (RDM) U.S. FOOD AND DRUG ADMINISTRATION, et al.,

Defendants.

MEMORANDUM OPINION

Vape Central Group, LLC (“Vape Central”) brings this action against the U.S. Food and

Drug Administration (“FDA”), alleging that an administrative civil penalty proceeding that the

FDA has brought against the company for the sale of an adulterated tobacco product violates its

Seventh Amendment right to trial by jury. But before reaching the merits of that claim, however,

the Court must first decide whether it has subject-matter jurisdiction. In answering that question,

the Court begins with the statutory text, which vests exclusive jurisdiction in the courts of

appeals to review FDA civil-penalty orders. See 21 U.S.C. § 333(f)(6). Vape Central does not

dispute that, in most cases, an aggrieved party must wait to bring a challenge to and FDA

enforcement action in the courts of appeals after the agency enters a final order. But it urges the

Court to recognize an exception to that jurisdictional rule in this case, based on the theory that

the company would suffer a “here-and-now injury” if forced to participate in a civil penalty

proceeding without the benefit of a jury—an injury that, on Vape Central’s telling, would stand

separate and apart from the entry of any adverse civil penalty order. For the reasons explained below, Vape Central’s argument fails. Although the Supreme

Court has “recognized a narrow exception to Congress’s prescribed path for judicial review of

agency action” in the courts of appeals in certain extraordinary circumstances—most notably,

where the agency is allegedly “‘wielding authority unconstitutionally in all or a broad swath of

its work,’” Loma Linda-Inland Consortium for Heathcare Educ. v. NLRB, 2023 WL 729839, at

*11 (D.C. Cir. May 25, 2023) (quoting Axon Enterprise, Inc. v. FTC, 598 U.S. 175, 189 (2023)),

this is not, by any measure, such a case. To the contrary, Vape Central’s Seventh Amendment

argument is entirely dependent on what happens in the administrative proceeding, and the harm

that Vape Central claims that it will be forced to ensure if required to participate in the

administrative proceeding may never occur at all. That speculative and fact-dependent harm, in

any event, is both unremarkable and in no way comparable to the type of “here-and-now injury”

that the Supreme Court has held can, at least at times, justify immediate review before a federal

district court.

The Court will, accordingly, GRANT the FDA’s motion for summary judgment, Dkt. 8;

DENY Vape Central’s cross-motion for summary judgment, Dkt. 12; DENY Vape Central’s

motion for a preliminary injunction, Dkt. 3; and DISMISS the case for lack of jurisdiction, all

without reaching the merits of Vape Central’s Seventh Amendment claims.

I. BACKGROUND

A. Regulatory Background

The FDA was given the authority to regulate tobacco products just sixteen years ago. For

many years, the FDA played a minimal role in the regulation of tobacco products. See Philip

Morris USA Inc. v. U.S. Food & Drug Admin., 202 F. Supp. 3d 31, 36 (D.D.C. 2016) (explaining

that “[i]n 1996, the FDA attempted to bring the tobacco industry within its jurisdiction by

asserting that nicotine was a ‘drug’ as defined under the Food, Drug, and Cosmetic Act” but that 2 “endeavor failed . . . when the Supreme Court determined that the FDA had exceeded its

statutory authority and struck down its attempts at regulation” (citing FDA v. Brown &

Williamson Tobacco Corp., 529 U.S. 120, 120 (2000))). That changed in 2009, when Congress

enacted the Family Smoking Prevention and Tobacco Control Act (“TCA” or “the Act”), Pub. L.

No. 111-31, 123 Stat. 1776 (2009).

The TCA makes the FDA the “primary Federal regulatory authority with respect to the

manufacture, marketing, and distribution of tobacco products.” Id. § 3(1). Under the Act, the

FDA is authorized to impose “tobacco product standards” that govern the ingredients or

properties of tobacco products, see 21 U.S.C. § 387g; to restrict the sale and distribution of

tobacco products, see id. § 387f(d)(1); and to prescribe regulations governing the manufacturing

of these products, see id. § 387f(e). See Fontem US, LLC v. U.S. Food & Drug Admin., 82 F.4th

1207, 1212 (D.C. Cir. 2023). “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.” Id. (citing 21 U.S.C. § 387j). This includes

“electronic nicotine delivery systems,” more commonly known as vaping products or e-

cigarettes, which “utilize solutions containing nicotine” that can be vaporized and then inhaled.

Fontem US, LLC v. U.S. Food & Drug Admin., 82 F.4th 1207, 1212 (D.C. Cir. 2023). 1 New

1 The TCA did not immediately regulate e-cigarettes, but it authorized the FDA to subject “any product made or derived from tobacco . . . intended for human consumption” to the provisions of the TCA. 21 U.S.C. § 321(rr)(1). “In 2016, the agency invoked this authority to deem vaping products subject to the Act.” Fontem, 82 F.4th at 1212; see also Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 28,974, 28,975 (May 10, 2016). “As a result of this . . . [r]ule, manufacturers of vaping products were required to secure premarketing approval from the FDA unless the product in question had been marketed prior to 2007.” Fontem, 82 F.4th at 1212.

3 tobacco products, including vaping products, that have not been FDA approved are deemed

“adulterated.” 21 U.S.C. § 387b(6). The “introduction or delivery for introduction into interstate

commerce of any . . . tobacco product . . . that is adulterated” is “prohibited,” and a person who

introduces such a product can face criminal prosecution in district court. Id. § 331(a), 333(a)(1)

(“Any person who violates a provision of section 331 of his title shall be imprisoned for not

more than one year or fined not more than $1,000, or both.”).

Congress also authorized the Secretary of Health and Human Services (“Secretary”) to

enforce the TCA—including the prohibition on introducing adulterated products into interstate

commerce—through the administrative civil penalty scheme established in the Food, Drug, and

Cosmetic Act (“FDCA”). See id. § 333(f)(5). The FDCA authorizes the Secretary to assess civil

penalties in a variety of situations related to the sale or distribution of food, drugs, and tobacco.

See id. § 333(f). As relevant here, Congress provided that “any person who violates a

requirement” of the TCA “shall be liable to the United States for a civil penalty” of up to

“$15,000 for each such violation” (or $250,000 for some specified violations), with a $1,000,000

cap on the penalties that can be levied “in a single proceeding.” Id. § 333(f)(9)(A). 2 Before the

Secretary may impose a penalty, however, he must comply with the procedural requirements set

out in the FDCA: the Secretary must “give written notice to the person to be assessed a civil

penalty” and must “provide such person an opportunity for a hearing on the order.” Id.

§ 333(f)(5)(A). Congress also specified the considerations that the Secretary “shall” take into

account when “determining the amount of a civil penalty,” including “the nature, circumstances,

extent, and gravity of the violation or violations and, with respect to the violator, ability to pay,

2 These penalty amounts are adjusted to keep pace with inflation. As of 2024, when the administrative complaint was filed against Vape Central, the relevant amounts were $21,348, $355,806, and $1,423,220, respectively. See 45 C.F.R. § 102.3.

4 effect on ability to continue to do business, any history of prior such violations, the degree of

culpability, and such other matters as justice may require.” Id. § 333(f)(5)(B).

The Secretary has delegated his civil penalty enforcement authority to the Commissioner

of the FDA and detailed the administrative procedures for imposing these penalties. See 21

C.F.R. Part 17 (2025). First, the “Center with principal jurisdiction”—for tobacco products, the

Center for Tobacco Products or “CTP”—must initiate an “administrative civil money penalty

action[] by serving on the respondent(s) a complaint.” Id. § 17.5(a). The proceeding is then

assigned to an administrative law judge (“ALJ”), who “shall conduct a fair and impartial

hearing” upon request from the respondent. Id. § 17.5(d), 17.19(a). After that hearing, the ALJ

“issue[s] an initial decision” that contains, to the extent necessary, “findings of fact, conclusions

of law, and the amount of any penalties and assessments imposed.” Id. § 17.45(a). Under the

governing regulations, however, the ALJ “does not have the authority to find Federal statutes or

regulations invalid.” Id. § 17.19(c). After receiving the ALJ’s decision, either party can, if

aggrieved, appeal the decision to the Departmental Appeals Board, which can affirm or vacate

the ALJ’s decision. Id. § 17.47.

The road does not end with the Departmental Appeals Board, though, because the statute

provides for judicial review in the courts of appeals, at which stage constitutional arguments can

receive a full presentation. Cf. SEC v. Jarkesy, 603 U.S. 109, 119 (2024) (considering

petitioner’s Seventh Amendment claims on review from an administrative proceeding). Any

person “aggrieved by an order assessing a civil penalty” and who requested a hearing during the

administrative process “may file a petition for judicial review of such order with the United

States Court of Appeals for the District of Columbia Circuit or for any other circuit in which

5 such person resides or transacts business” within 60 days of receiving a decision from the

Departmental Appeals Board. 21 U.S.C. § 333(f)(6); 21 C.F.R. § 17.51.

Notably, an aggrieved party is not required to pay any civil penalties assessed by the

agency until after judicial review is complete. Unpaid civil penalties can be recovered by the

Attorney General in federal district court, but only after the 60-day period for judicial review has

expired or, in the case that judicial review is requested, after the appeals court has “entered a

final judgment in favor of the Secretary.” 21 U.S.C. § 333(f)(7). As a result, an aggrieved party

is guaranteed an Article III forum to raise any constitutional challenges before paying any

penalties.

B. Factual Background

In October 2024, the CTP “filed an administrative complaint for a civil money penalty of

$21,348 against Vape Central.” Dkt. 1 at 9 (Compl. ¶ 44). The factual allegations in the

administrative complaint are straightforward. It alleges (1) that Vape Central “sells and/or

distributes tobacco products through its online establishment,” Dkt. 3-3 at 4 (Admin. Compl.

¶ 13); (2) that “CTP issued a Warning Letter” to Vape Central on August 17, 2020, in which it

warned that Vape Central was selling tobacco products that lacked FDA authorization and were

therefore considered “adulterated,” id. at 4–5 (Admin. Compl. ¶ 14); (3) that an FDA-

commissioned inspector conducted an inspection of Vape Central’s website and purchased from

that website a “Cali UL8000 Kiwi Dragon Berry [electronic nicotine delivery systems] product,”

id. at 5 (Admin. Compl. ¶ 15); (4) that Vape Central fulfilled the inspector’s order by “shipp[ing]

the Cali UL8000 Kiwi Dragon Berry” from Florida to the FDA in Maryland, id. (Admin. Compl.

¶ 16); (5) that this product is a “new tobacco product” because it was not commercially marketed

in the United States as of February 15, 2007, id. (Admin. Compl. ¶ 17); and (6) that the FDA has

not issued either an order approving the marketing of the Cali UL8000 Kiwi Dragon Berry or an 6 order declaring it substantially equivalent to a product already approved, id. (Admin. Compl.

¶¶ 18–19).

Vape Central answered the administrative complaint on November 27, 2024, and, in

doing so, the company admitted most of the factual allegations. It declined to admit or to deny

paragraphs 1–12, 18–20, and 21–22 on the grounds that those paragraphs contained introductory

material, set forth conclusions of law, or merely “set forth CTP’s advice with respect to [Vape

Central’s] procedural rights.” Dkt. 3-4 at 2–3. It admitted the factual allegations contained in

paragraphs 13–14—that is, that Vape Central sells or distributes tobacco products online and that

CTP issued a warning letter to Vape Central in August 2020. See id. at 2; see also Dkt. 3-3 at 4–

5 (Admin. Compl. ¶¶ 13–14). Finally, Vape Central declined to admit or to deny the allegations

contained in paragraphs 15–17 for lack of “sufficient information.” Dkt. 3-4 at 3. As discussed

further below, however, counsel for Vape Central conceded at oral argument in this case that it

has no basis to question the accuracy of even those allegations.

C. Procedural History

Vape Central filed this action on November 27, 2024, alleging that under SEC v. Jarkesy,

603 U.S. 109 (2024), the FDA’s administrative proceeding “violates [the company’s] right to a

jury trial under the Seventh Amendment.” Dkt. 1 at 1–2 (Compl. ¶¶ 1–2). Vape Central asks the

Court to declare that “the FDA’s civil money penalty proceeding against [Vape Central] violates

the Seventh Amendment” and to order that the FDA “dismiss with prejudice the Administrative

Complaint against” Vape Central. Id. at 12 (Compl. ¶ 61). But Vape Central does not confine

its request for relief to the proceedings against it. It also asks the Court to declare that “the

FDCA’s civil money penalty provisions for tobacco products, 21 U.S.C. § 331(f)(9), violate the

Seventh Amendment” and to “prohibit[]” the FDA from “adjudicating civil money penalties in

administrative proceedings” writ large. Id. 7 The same day that Vape Central filed suit it also moved for a preliminary injunction. See

Dkt. 3. That motion asks the Court to “enter an order that stays the [FDA’s] administrative civil

money penalty proceeding against” Vape Central pending resolution of this case. Id. at 1. The

FDA opposed Vape Central’s motion for a preliminary injunction and moved for summary

judgment, arguing both that this Court lacks jurisdiction to entertain a collateral attack on the

administrative proceeding and that, on the merits, no jury trial is required with respect to civil

penalties levied for TCA violations. See Dkt. 8-1 at 6–7. In response, Vape Central cross-

moved for summary judgment and asked the Court to consolidate the hearing on its motion for a

preliminary injunction with proceedings on the merits pursuant to Federal Rule of Civil

Procedure 65(a). See Dkt. 10 at 5. The Court granted Vape Central’s request to consolidate the

proceedings on its motion for a preliminary injunction with the merits, Min. Entry (Feb. 6, 2025),

and held a hearing on the pending motions on February 19, 2025.

Each of these motions is now ripe for decision.

II. ANALYSIS

As a general matter, federal courts “may not rule on the merits of a case without first

determining that [they] have . . . subject matter jurisdiction.” Sinochem Int’l Co. Ltd. v.

Malaysia Int’l Shipping Corp., 549 U.S. 422, 430–31 (2007) (citing Steel Co. v. Citizens for

Better Env’t, 523 U.S. 83, 93–112 (1998)). Here, the FDA argues that 21 U.S.C. § 333(f)(6)

vests challenges to TCA administrative proceedings, including Vape Central’s Seventh

Amendment challenge, exclusively in the courts of appeals. See Dkt. 8-1 at 11. The Court

agrees.

A. Preclusion

Although the default rule generally authorizes federal district courts to consider

challenges to the lawfulness of administrative proceedings, Congress can “preclude district 8 courts from exercising jurisdiction over challenges to federal agency action” by substituting “an

alternative scheme of review.” Axon Enter., 598 U.S. at 185. Sometimes Congress does so

explicitly. Id. Other times, it does so implicitly by “specifying a different method to resolve

claims about agency action,” typically by providing for “review in a court of appeals following

the agency’s own review process.” Id. The statute at issue here follows this latter path. It

provides: “Any person . . . aggrieved by an order assessing a civil penalty . . . may file a petition

for judicial review of such order with the United States Court of Appeals for the District of

Columbia Circuit or for any other circuit in which such person resides or transacts business.” 21

U.S.C. § 333(f)(6).

Even when Congress has implicitly divested the district courts of jurisdiction by

providing for direct review in the courts of appeals, this allocation of jurisdiction “does not

necessarily extend to every claim concerning agency action.” Axon Enter., 598 U.S. at 185. It

extends only to claims “of the type Congress intended to be reviewed within [the] statutory

structure.” Id. at 186 (quoting Thunder Basin Coal Co. v. Reich, 510 U.S. 200, 208 (1994)).

Three considerations, referred to as the Thunder Basin factors, help courts determine whether a

claim is subject to the presumptive “statutory structure” for direct appellate review or whether it

falls outside this scheme.

The first Thunder Basin factor asks whether “precluding district court jurisdiction

[would] ‘foreclose all meaningful judicial review’ of the claim?” Id. (quoting Thunder Basin,

510 U.S. at 212–13). The second factor asks whether “the claim [is] ‘wholly collateral to [the]

statute’s review provisions?’” Id. (quoting Thunder Basin, 510 U.S. at 212). And the third

factor asks whether “the claim [is] ‘outside the agency’s expertise’?” Id. (quoting Thunder

Basin, 510 U.S. at 212). But the Supreme Court has cautioned that “the ultimate question is how

9 best to understand what Congress has done—whether the statutory review scheme, though

exclusive where it applies, reaches the claim in question”—and that the Thunder Basin factors

are meant simply to “aid in th[at] inquiry.” Id.; see also Arch Coal, Inc. v. Acosta, 888 F.3d 493,

500 (D.C. Cir. 2018) (cautioning that these factors are “general guideposts” that should not be

“applied pursuant to any strict mathematical formula”). When each of the Thunder Basin factors

counsels in favor of district court jurisdiction, it is “presume[d] that Congress does not intend to

limit jurisdiction.” Id. (quoting Free Enterprise Fund v. Public Company Accounting Oversight

Bd., 561 U.S. 477, 489 (2010)). But “the same conclusion might follow” even “if the factors

point in different directions.” Id. When that happens, courts must return to the lodestar of

whether Congress intended the type of claim at issue to be swept into the statutory enforcement

scheme.

B. Application of the Thunder Basin factors

Vape Central does not dispute that district courts are typically precluded from

adjudicating challenges to TCA civil penalty proceedings. See Dkt. 12 at 6. It argues, instead,

that its claim falls outside of that scheme because “all three of the Thunder Basin factors come

down on the side of this Court having jurisdiction over Vape Central’s claim.” Dkt. 12 at 10.

The Court is unpersuaded.

1. Factor One: Would precluding district court jurisdiction foreclose all meaningful judicial review?

To start, “all meaningful judicial review” will not be foreclosed if Vape Central’s claims

follow the FDCA’s statutory review procedures. Although the ALJ (and arguably the

Departmental Appeals Board) will lack authority to resolve Vape Central’s Seventh Amendment

defense, if aggrieved by the ALJ’s decision, the company will be able to raise the defense in a

petition for review in the court of appeals. See 21 U.S.C. § 333(f)(6). Using that process, Vape

10 Central can secure “meaningful review” of the agency’s decision, including by arguing that the

administrative process was defective because it deprived the company of its Seventh Amendment

right (if any) to a jury trial. See Thunder Basin, 510 U.S. at 212–13.

In general, review of agency decisions must await finality; that is, in at least most

circumstances, a regulated party has no right to obtain judicial review of the relevant rules and

procedures until after the agency has rendered a decision. That rule applies with particular force,

moreover, where, as here, the regulated party will suffer no adverse consequences—beyond the

cost of participating in the administrative proceeding—until after the decision is final and until

after the regulated party has obtained “meaningful review” of the agency’s decision. As

explained above, the Attorney General is authorized to bring a proceeding to “recover the

amount assessed,” but only “after the order making the assessment becomes final” or, if judicial

review is sought, after the court of appeals “has entered a final judgment in favor of the

Secretary.” 21 U.S.C. § 333(f)(7). If the court of appeals agrees with Vape Central that Seventh

Amendment applies to public health enforcement proceedings, like this one, and agrees that the

administrative process involved the resolution of disputed issues of fact, the company can ask the

court of appeals to vacate the civil penalty order, thereby redressing any harm before it occurs.

Indeed, that is precisely what happened in Jarkesy v. SEC, 34 F.4th 446, 454, 466 (5th Cir.

2022), the case that Vape Central invokes (perhaps mistakenly) in support of its Seventh

Amendment argument, see SEC v. Jarkesy, 603 U.S. 109 (2024). See Dkt. 1 at 1–2 (Compl. ¶ 1).

It is thus unsurprising that every district court that has considered the question post-

Jarkesy has held that the relevant statutory procedures for challenging final administrative orders

provide a sufficient opportunity for “meaningful review” of any Seventh Amendment defense.

See VHS Acquisition Subsidiary No. 7. v. NLRB, 2024 WL 4817175, at *3 (D.D.C. Nov. 17,

11 2024) (holding that “[t]he first Thunder Basin factor . . . points towards a lack of district court

jurisdiction” because the plaintiff “can still receive ‘meaningful review’ of its Seventh

Amendment challenge” in the “circuit court”); Blankenship v. Fin. Indus. Regul. Auth., 2024 WL

4043442, at *2, n.4 (E.D. Pa. Sept. 4, 2024) (noting that “Jarkesy came up on direct review, not

collateral attack” and concluding that “a finding of no jurisdiction in this court will not foreclose

all ‘meaningful’ judicial review” of the plaintiff’s Seventh Amendment claim); Nexstar Media,

Inc. Grp. v. NLRB, 2024 WL 4127090, at *5 (N.D. Ohio Aug. 26, 2024) (determining that the

first “Thunder Basin factor weigh[ed] against jurisdiction” of the plaintiff’s Seventh Amendment

claim because that claim could “be raised in the Court of Appeals which will have authority to

modify” or “set [] aside” the agency’s ruling).

Vape Central nonetheless disagrees, arguing that it needs to obtain judicial review now to

avoid the “irreparable harm” it will suffer if forced “to incur the time and expense of an

unconstitutional proceeding—i.e., a proceeding in which findings of fact will be made by an ALJ

rather than a jury.” Dkt. 10 at 6. According to Vape Central, the cost of participating in such a

constitutionally defective proceeding constitutes the type of “here-and-now injury” that justifies

immediate district court review under Axon Enterprise, Inc. v. Federal Trade Commission, 598

U.S. 175 (2023). Id. at 191. But that contention misunderstands the “narrow exception to

Congress’s prescribed path for judicial review of agency action” that the Supreme Court

recognized in Axon. Loma Linda-Inland Consortium for Healthcare Educ., 2023 WL 7294839,

at *11. The “here-and-now injury” at issue in Axon was not the imposition of a fine that could

have been remedied on judicial review. 598 U.S. at 191. Rather, it was “‘being subjected’ to

‘unconstitutional agency authority’”—that is, being forced to participate in “a ‘proceeding by an

unaccountable ALJ.’” Id. It was being “subject[ed] to an illegitimate proceeding, led by an

12 illegitimate decisionmaker.” Id. “And as to that grievance,” the Supreme Court held, “the court

of appeals [could] do nothing: A proceeding that has already happened cannot be undone.” Id.

The Supreme Court took pains to emphasize, moreover, the limited scope of this

conclusion. It does not represent a “newfound enthusiasm for interlocutory review,” nor does it

call into question the long-settled principle “that ‘the expense and disruption’ of ‘protracted

adjudicatory proceedings’ [does] not justify immediate review.” Id. at 192. What mattered in

Axon was that the challenge had nothing to do with the ultimate result of the administrative

process; rather, the challenge alleged that “the entire proceeding [was] unlawful” and that

subjecting the regulated party to a constitutionally “illegitimate proceeding causes [a] legal

injury” that is wholly “independent of any rulings the ALJ might make.” Id. at 182. In the

words of the Supreme Court, the challenge was “fundamental, even existential,” and it posited

“that the agencies, as currently structured, [were] unconstitutional in much of their work.” Id. at

180.

Here, in contrast, Vape Central does not challenge the legal authority of the ALJ to

perform much of her work, nor does the company contend that its injury consists of being

subjected to the authority of an “illegitimate decisionmaker.” Rather, the company’s principal

complaint focuses on the expense of participating in the administrative proceeding. Unlike the

challenge in Axon, moreover, Vape Central focuses on a narrow slice of the administrative

proceeding, arguing that the ALJ lacks authority to resolve any disputed issues of fact. But, far

from raising a “fundamental” or “even existential” challenge to the administrative process, it is

far from clear that this case (or other, similar cases) will even raise the constitutional issue.

Juries are not necessary at every stage of an action, even when the Seventh Amendment

might otherwise apply. By way of analogy, district courts frequently resolve cases at the motion

13 to dismiss or summary judgment stages, without ever seating a jury. And that process is

consistent with the Seventh Amendment, because the right to a jury trial arises only if “there are

issues of fact to be determined.” In re Peterson, 253 U.S. 300, 310 (1920). The Supreme Court

has also held that “the Seventh Amendment does not require a jury trial” for “determination of a

civil penalty” amount. Tull v. United States, 481 U.S. 412, 427 (1987). Thus, Vape Central’s

Seventh Amendment claim is best characterized, not as a challenge to an “unconstitutional

proceeding,” but as a challenge to the ALJ’s authority—if necessary—to resolve any disputed

issues of fact.

Like federal district courts, FDA ALJs may render “summary decision[s]” on “any issue

in the hearing,” “if the pleadings, affidavits, and other materials filed in the record . . . show that

there is no genuine issue as to any material fact.” 21 C.F.R. § 17.17(a), (b). As a result, the

administrative proceeding against Vape Central could conclude without any Seventh

Amendment right “accru[ing].” Fid. & Deposit Co. of Md. v. United States, 187 U.S. 315, 320

(1902). Indeed, although Vape Central urges the Court to enjoin the FDA from continuing to

pursue the civil money penalties administrative proceeding against it as violative of the Seventh

Amendment, Dkt 1 at 12 (Compl. ¶ 61), the company has yet to identify a single factual issue

that is dispute.

As noted above, when Vape Central answered the administrative complaint, it denied

only three factual allegation—and it did so merely because it lacked “sufficient information upon

which to admit or deny th[ose] allegations.” Dkt. 3-4 at 3. At oral argument, however, Vape

Central’s counsel either admitted the previously contested allegations or conceded that he had no

reason to doubt their accuracy. The first of those allegations simply averred that “an FDA-

commissioned inspector conducted an” online inspection of the Vape Central website and

14 “purchased [Vape Central’s] Cali UL800 Kiwi Dragon Berry ENDS product.” Dkt. 3-3 at 5

(Admin. Compl. ¶ 15). When asked whether Vape Central has any evidence to dispute that

allegation, counsel responded, “I don’t have any reason to believe it is not true . . . at this point.”

Feb. 19, 2025 Hrg. Tr. (Rough at 13). The second allegation averred that “[i]n response to

FDA’s order and purchase, [Vape Central] shipped the Cali UL800 Kiwi Dragon Berry ENDS

product . . . to FDA in Maryland.” Dkt. 3-3 at 5 (Admin. Compl. ¶ 16). When asked about this

allegation, counsel conceded that “the evidence that was . . . produced in discovery probably has

the shipping labels.” Feb. 19, 2025 Hrg. Tr. (Rough at 13). Finally, the third allegation averred

that the “Cali UL800 Kiwi Dragon Berry ENDS product . . . is a ‘new tobacco product’ because

it was not commercially marked in the United States as of February 15, 2007.” Dkt. 3-3 at 5

(Admin. Compl. ¶ 17). And when asked about this one, counsel responded: “That is true.” Feb.

19, 2025 Hrg. Tr. (Rough at 13).

It is thus likely that the administrative proceedings can—and will—be resolved without

the need for any factfinding regarding liability. If the CTP asks the ALJ to render a summary

decision as to liability, Vape Central will not be able to “rest on mere allegations or denials or

general descriptions of positions and contentions” but, instead, will need to “set forth specific

facts showing that there is a genuine issue of material fact for the hearing” and provide support

for those facts. 21 C.F.R. § 17.17(c). Absent such a showing, Vape Central’s Seventh

Amendment defense will never even arise—calling into question not only this Court’s statutory

jurisdiction, but also its Article III jurisdiction. And, in any event, this uncertainty demonstrates

why review “meaningful judicial review” would not be foreclosed by awaiting a final agency

order. Indeed, if anything, “meaningful judicial review” cannot take place until after the

administrative proceeding is completed, so the reviewing court can determine whether any facts

15 were placed in genuine dispute. See Elgin v. Dep’t of Treasury, 567 U.S. at 22–23 (holding that

a constitutional claim was unavailable because “preliminary questions” within the agency’s

wheelhouse “may obviate the need to address the constitutional challenge.”). In short, far from

involving a “here-and-now injury,” the injury alleged here may never occur.

Vape Central makes two arguments in response. Neither is persuasive. First, the

company stresses that the statutory enforcement regime in Axon included summary decision

procedures similar to those at issue here. Dkt. 10 at 10. But that misses the point. The

possibility that the relevant facts will not be disputed matters with respect to a Seventh

Amendment defense; if the facts are undisputed, Vape Central’s Seventh Amendment argument

fails at the outset, without requiring the Court even to consider whether the public rights doctrine

applies in this context. In contrast, the availability of summary decision procedures does nothing

to diminish a challenge, like the challenge raised in Axon, to the constitutional authority of

tenure-protected ALJs to adjudicate disputes.

Second, Vape Central argues that, if the FDA was required to bring civil monetary

penalty proceedings in federal district court, as opposed to in an administrative proceeding, the

regulated party might have the opportunity to take discovery and that discovery might provide a

basis for challenging the FDA’s factual allegations. The company argues, for example that it

would have the opportunity to depose the investigator who completed the undercover purchase.

Feb. 19, 2025 Hrg. Tr. (Rough at 15). But availability of discovery has nothing to do with the

Seventh Amendment. And, to the extent Vape Central’s argument sounds in due process, it may

not, in effect, amend its complaint through an opposition to a motion for summary judgment.

See Sai v. TSA, 326 F.R.D. 31, 33 (D.D.C. 2018). Any such effort, moreover, would likely prove

futile, since the Supreme Court has already held that due process challenges to an agency’s

16 enforcement proceedings are properly raised at the conclusion of the administrative proceeding

through the statutory review mechanism. See Thunder Basin, 510 U.S. at 215.

The Court, accordingly, concludes that the first Thunder Basin factor weighs heavily

against immediate district court review.

2. Factor Two: Is the claim wholly collateral to the statute’s review provisions?

For similar reasons, the Court concludes that Vape Central’s Seventh Amendment

argument is not “wholly collateral” to the statutory review scheme. Axon Enter., 598 U.S. at

184–85. The existence of some genuine dispute of material fact is a necessary prerequisite to

Vape Central’s Seventh Amendment argument. Unlike Axon, this is not a case in which the

asserted injury exists separate and apart from the specifics of the adjudicatory process; it is not a

case in which the plaintiff challenges the ALJ’s “power to proceed at all.” Axon Enter., 598 U.S.

at 192. In other words, Vape Central is objecting not to the ALJ’s “power generally” but to

“how that power [will be] wielded” in the context of the particular proceedings against it. Id. at

193. As a result, the applicability—or inapplicability—of the Seventh Amendment is

inextricably intertwined with administrative process. If no facts relating to liability are

reasonably disputed, Vape Central’s argument fails at the outset. Or, in other words, Vape

Central’s Seventh Amendment argument is wrapped up in “the sorts of procedural or evidentiary

matters an agency often resolves on its way to a merits decision.” Axon Enter., 598 U.S. at 193.

Because Vape Central’s Seventh Amendment argument is not “collateral” to the

proceeding—and, indeed, may well turn on what happens in the administrative proceeding—the

second Thunder Basin factors also weighs heavily against immediate district court review.

17 3. Factor Three: Is the claim outside the agency’s expertise?

This, then, leaves the third factor, which asks whether Vape Central’s challenge lies

“outside the [FDA’s] expertise.” Thunder Basin, 510 U.S. at 212. As Vape Central correctly

observes, the FDA has no expertise regarding the meaning or application of the Seventh

Amendment. That question lies squarely within the judicial ken. But framing the application of

the third Thunder Basin factor in that limited manner risks creating a far more expansive

exception to the statutory review procedures than the Supreme Court has ever embraced; most, if

not all, questions of constitutional law fall outside the expertise of the administrative agencies.

Instead, this factor is better understood to ask whether the challenge raises a pure question of

constitutional law, “detached from ‘considerations of agency policy,’” Axon Enter., 598 U.S. at

194 (quoting Free Enter. Fund, 561 U.S. at 491), or whether it raises a mixed question of law

and fact (or policy), where agency action might shed light on the constitutional question or

“‘obviate the need’” for judicial review, id. at 195 (quoting Elgin, 567 U.S. at 22–23).

Here, the constitutional question—that is, whether Vape Central in entitled to a jury

trial—is intertwined with the question that is before the administrative agency—that is, are any

facts in dispute, and, if so, are those facts necessary to resolving whether Vape Central

introduced “into interstate commerce an electronic nicotine delivery system . . . product that

lacks the premarketing authorization required under the” FDCA, Dkt. 3-3 at 2 (Admin. Compl.

¶ 1). Unlike in Axon, moreover, development of the factual record before the administrative

agency provides an essential component of Vape Central’s claim; it is by no means clear that the

company can prevail even if the administrative process reveals disputed factual questions, but it

is clear that the company cannot prevail without that record. 598 U.S. at 905. And, unlike in

Axon, development of the administrative record may well “‘obviate the need’ to address [the

company’s] constitutional claim[].” Id. at 906 (quoting Elgin, 576 U.S. at 22–23). Either way, 18 the agency’s expertise regarding the factual dispute, if any, may play a central role in the court of

appeals’ ultimate resolution of the constitutional argument.

The Court, accordingly, concludes that the third Thunder Basin factor also weighs against

immediate district court review.

* * *

Considered together, then, the Thunder Basin factors weigh against district court

jurisdiction for Vape Central’s Seventh Amendment claims. Stepping back, moreover, the Court

is convinced that “the statutory review scheme . . . reaches the claim in question,” Axon Enter.,

598 U.S. at 185, and that Congress intended to leave challenges, like the one Vape Central

asserts, to the prescribed statutory review procedure. Vape Central will be able to obtain

meaningful review in the court of appeals at the conclusion of the administrative proceeding; it is

not facing any “here-and-now injury” analogous to the existential challenge at issue in Axon;

and, indeed, it is far from clear that it will even suffer a “there-and-then injury” at some later

time, since the company has yet to identify any genuine dispute of material fact that might, under

any circumstances, support a Seventh Amendment claim. Just like a party who is aggrieved by a

district court order granting partial summary judgment in favor of that party’s opponent—

thereby depriving the aggrieved party of a jury trial on that issue—if the record ultimately shows

that the ALJ resolved a disputed issue of material fact against Vape Central, the company can

raise its Seventh Amendment argument before the court of appeals.

Under these circumstances, the Court is without statutory jurisdiction (and, although the

Court need not reach the question, see U.S. ex rel. Long v. SCS Business & Tech. Inst., Inc., 173

F.3d 890, 893 (D.C. Cir. 1999), might also lack Article III jurisdiction).

19 CONCLUSION

For the foregoing reasons, the Court will GRANT Defendants’ motion for summary

judgment, Dkt. 8; will DENY Plaintiff’s motion for a preliminary injunction, Dkt. 3; will DENY

Plaintiff’s cross-motion for summary judgment, Dkt. 12; and will DISMISS the action without

prejudice for lack of jurisdiction.

A separate order will issue.

/s/ Randolph D. Moss RANDOLPH D. MOSS United States District Judge

Date: February 27, 2025