Vape NV LLC, d/b/a Vape NV, DAB No. 3216 (2025)

FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

Vape NV LLC (Respondent) is a manufacturer and retailer of new tobacco products.  The Center for Tobacco Products (CTP) filed an administrative complaint against Respondent, seeking a civil money penalty of $20,678 for manufacturing and holding for sale adulterated and misbranded tobacco products in violation of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 331(k).  In its answer, Respondent admitted the factual allegations in the complaint but raised legal defenses, including two constitutional challenges to the authority of the Administrative Law Judge (ALJ) to adjudicate the complaint.  The ALJ granted CTP’s motion for summary decision, concluding that Respondent violated the FDCA by failing to obtain premarket authorization for e-liquid products and finding that a civil money penalty of $20,678 was appropriate.  Vape NV LLC, DAB TB9399 (2025) (ALJ Decision).  The ALJ declined to adjudicate Respondent’s constitutional claims, having concluded that ALJs do not have authority to find federal statutes or regulations invalid.

Before the Board, Respondent does not challenge the ALJ’s determination that it violated the FDCA but argues that the civil money penalty violates its Seventh Amendment right to a jury trial, and that the ALJ is impermissibly protected from removal in violation of the “Appointments and Take Care Clauses.”  We affirm the ALJ Decision because:  (1) Respondent has not shown any error in the ALJ’s legal or factual determinations, and (2) the Board has no authority to find federal statutes or regulations invalid, including the civil money penalty provisions under the FDCA and ALJ removal protections under the Administrative Procedure Act (APA).

Legal Background

In 2009, Congress amended the FDCA, 21 U.S.C. § 301, et seq., through the enactment of the Family Smoking Prevention and Tobacco Control Act (TCA).  See Pub. L. No. 111-31, 123 Stat. 1776 (2009).  The amendments provided the U.S. Food and Drug Administration (FDA) with primary regulatory authority over the manufacture, marketing, and distribution of tobacco products.  Id. § 3(1).  Accordingly, the FDCA

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empowers FDA to set standards for tobacco products (21 U.S.C. § 387g); restrict sales and distribution (id. § 387f(d)(1)); and regulate manufacturing (id. § 387f(e)).  

“Tobacco product” is broadly defined to mean “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product.”  21 U.S.C. § 321(rr).  In 2016, FDA issued a final rule concluding that the statutory definition of “tobacco product,” includes electronic nicotine delivery system (ENDS) products (such as e-cigarettes), as well as their components or parts (such as e-liquids with nicotine).  See Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, 81 Fed. Reg. 28,973, 28,975, 28,982 (May 10, 2016).  As relevant here, the FDCA extends to and imposes additional requirements for “new tobacco products,” that is, tobacco products that were not commercially marketed in the United States as of February 15, 2007.  21 U.S.C. § 387j(a)(1) (defining “new tobacco product”).

A new tobacco product (including e-liquids with nicotine) may not be introduced into interstate commerce without FDA authorization.  See 21 U.S.C. § 387j(a)(2)(A).  FDA may grant such authorization in three ways.  First, based on FDA’s review of a premarket tobacco product application, FDA may issue an order finding that the marketing of the new tobacco product would be “appropriate for the protection of the public health.”  Id. § 387j(c)(1)(A)(i), (2)(A).1  Second, based on FDA’s review of a substantial equivalence report (SE report), FDA may issue an order determining that the new tobacco product is “substantially equivalent” to a tobacco product commercially marketed in the United States as of February 15, 2007, or a tobacco product marketed after that date, but which FDA previously determined to be substantially equivalent.  Id. §§ 387j(a)(2)(A)(i), 387e(j).  Third, based on FDA’s review of an exemption request and “abbreviated report,” FDA may issue an order finding an exemption.  Id. §§ 387j(a)(2)(A)(ii), 387e(j)(1), (3)(A); 21 C.F.R. § 1107.1. 

A new tobacco product is “adulterated” if it is required to have, but does not have, a required premarketing authorization order.  21 U.S.C. § 387b(6)(A).  A new tobacco product is “misbranded” if a report required under section 387e(j) (i.e., an SE report or abbreviated report) for that product was not submitted to FDA.  Id. § 387c(a)(6).  It is a violation of the FDCA to cause a tobacco product to become adulterated or misbranded while it is held for sale after shipment of one or more of its components in interstate commerce.  Id. § 331(k).

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The FDCA authorizes civil money penalties against any person who violates a requirement of the FDCA relating to tobacco products.  21 U.S.C. § 333(f)(9)(A).  At the time of the violation here (April 2024), manufacturers or retailers of tobacco products were subject to a civil money penalty of up to $20,678 for each FDCA violation, not to exceed $1,378,541 for all violations adjudicated in a single proceeding.  21 U.S.C. § 333(f)(9)(A); 21 C.F.R. § 17.2; 45 C.F.R. § 102.3 (eff. Oct. 6, 2023).

To impose a penalty against a tobacco manufacturer or retailer, CTP (the FDA component “with principal jurisdiction over the matter”) must serve an administrative complaint on the respondent and file a copy of the complaint with FDA’s Division of Dockets Management.  21 C.F.R. § 17.5.  The respondent may request a hearing by filing an answer.  Id. § 17.9(a).  Cases are assigned to an ALJ, who conducts the hearing and issues an “initial decision” with findings, conclusions, and any penalty based on the record developed before the ALJ.  Id. §§ 17.5(d), 17.19, 17.45(a).  In determining the appropriate penalty amount, the ALJ must consider factors such as the nature, gravity, and extent of violations, ability to pay, effect on business, prior violations, and culpability.  See 21 U.S.C. § 333(f)(5)(B); 21 C.F.R. § 17.34(a), (b).  ALJs have no authority to declare federal statutes or regulations invalid.  21 C.F.R. § 17.19(c).

A motion for summary decision may be filed by either party at any time after a complaint is filed.  Id. § 17.17(a).  The ALJ may grant a motion for summary decision when there are no genuine issues of material fact, and the moving party is entitled to summary decision as a matter of law.  Id. § 17.17(b), 17.19(b)(13).  “[A] party opposing the motion may not rest on mere allegations or denials or general descriptions of positions and contentions; affidavits or other responses must set forth specific facts showing that there is a genuine issue of material fact for the hearing.”  Id. § 17.17(c).

A party dissatisfied with an initial decision (or summary decision that resolves all issues) may appeal the ALJ’s decision to the Board.  Id. § 17.17(e), 17.47(a).  The Board may decline review, affirm, or reverse the initial decision or decision granting summary decision, and may increase, reduce, reverse, or remand any civil money penalty determined by the ALJ.  Id. § 17.47(j).

Case Background

1. CTP filed an administrative complaint and Respondent requested a hearing.

CTP filed an administrative complaint against Respondent, seeking a civil money penalty in the amount of $20,678 for manufacturing and holding for sale new tobacco products that lack the premarketing authorization required under the FDCA.  Compl. ¶ 1.  The complaint alleged that Respondent manufactures tobacco products (e-liquids) and holds them for sale at its location in Nevada; that at least one component used to manufacture the e-liquids comes from outside of Nevada; and that Respondent’s e-liquid products are

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“new tobacco products” not commercially marketed before February 2007.  Id. ¶¶ 14-15, 18.  The complaint further alleged that in August 2022, CTP issued a warning letter to Respondent, stating that the e-liquid products that Respondent manufactures, sells, and distributes were adulterated and misbranded because they lack the required FDA authorization.  Id. ¶ 16.  Subsequently, in April 2024, an FDA inspector discovered that Respondent was again holding for sale e-liquid products that lack the required FDA marketing authorization order, a substantial equivalence order, or a found-exempt order.  Id. ¶¶ 17, 19-22.  Thus, the complaint alleged, Respondent violated the FDCA, 21 U.S.C. § 331(k), by failing to obtain the required FDA authorization for its e-liquid products, causing them to become adulterated and misbranded while held for sale after shipment of one or more of their components in interstate commerce.  Id. ¶ 23.

Respondent filed an answer conceding the key factual allegations in the complaint but denying the complaint’s legal conclusions.  Answer ¶¶ 3-9.  Respondent asserted that CTP’s enforcement authority did not extend to Respondent because it did not sell its e-liquids across state lines.  Id. ¶¶ 7-9.  Respondent further objected to any civil money penalty, arguing that CTP was required to seek such a penalty in an Article III court and that the administrative proceeding is “unconstitutional and should be stayed immediately.”  Id. ¶ 11.  Respondent also asserted that the civil money penalty requested by CTP was “excessive” given Respondent’s status as a “(very) small business with slim profits overall.”  Id. ¶ 13. 

2. CTP moved for summary decision.

CTP subsequently filed its pre-hearing brief with ten exhibits (CTP Exs. 1‑10), including written direct testimony of the Deputy Division Director for the Division of Enforcement and Manufacturing (CTP Ex. 1) and written direct testimony of the FDA officer who conducted the inspection of Respondent’s establishment in April 2024 (CTP Ex. 2).  CTP separately moved for summary decision, arguing that there is no genuine issue as to any material fact regarding Respondent’s adulteration and misbranding of e-liquid products.  See CTP Motion for Summary Decision (MSD); Mem. of Law in Support of MSD at 4-6.  CTP further argued that there is no factual dispute regarding the appropriate penalty amount based on Respondent’s response to CTP’s document requests.  See Mem. of Law in Support of MSD at 9-10 (citing CTP Ex. A).  Those responses included a statement by Respondent that, with respect to the penalty, it “will not seek to admit any tax returns or other mitigation evidence in this proceeding.”  CTP Ex. A, at ¶¶ 7-8. 

Respondent filed its pre-hearing brief with no exhibits and no witness testimony.  Respondent also filed, without supporting evidence, a one-paragraph response to CTP’s motion for summary decision.  Respondent conceded that it manufactured and held for sale new tobacco products lacking the required FDA marketing authorization order, a substantial equivalence order, or a found-exempt order.  Resp’t Pre-Hr’g Br. at 4-5.  And, while Respondent denied that the penalty requested by CTP was “appropriate,”

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Respondent did not identify any “mitigating circumstances” or any other facts that would warrant a reduction of the penalty.  Id. at 6.  Respondent instead argued that the proceeding violated the Constitution because:  (1) Respondent has a right to a jury trial under the Seventh Amendment (citing SEC v. Jarkesy, 603 U.S. 109 (2024)); and (2) the ALJ is “impermissibly insulated from removal by the President” in violation of the Appointments Clause.  Resp’t Pre-Hr’g Br. at 9 (addendum); see also Response to MSD (“[T]wo constitutional infirmities preclude the maintenance of this action in this venue.”).

3. The ALJ determined that Respondent violated the FDCA and imposed a civil money penalty.

On July 1, 2025, the ALJ granted summary decision in favor of CTP, finding that the undisputed material facts establish that Respondent manufactured and held for sale adulterated and misbranded tobacco products in violation of 21 U.S.C. § 331(k).  ALJ Decision at 6-9.  The ALJ found the uncontroverted record evidence established that Respondent manufactures new tobacco products (e-liquids) and holds them for sale at its location in Nevada; that at least one component used to manufacture the products is from California; and that Respondent’s e-liquid products lack the required FDA marketing authorization order, a substantial equivalence order, or a found-exempt order.  Id. at 6-7.  The ALJ concluded, “as a matter of law and undisputed fact,” that Respondent violated the FDCA by failing to obtain premarket authorization for e-liquid products that it manufactured, causing them to become adulterated and misbranded while held for sale after shipment of one or more components in interstate commerce.  Id. at 7-8.

Having concluded that Respondent violated the FDCA, the ALJ then determined the penalty amount, considering any aggravating and mitigating factors, including the statutory factors under the FDCA.  Id. at 9-10 (citing 21 U.S.C. § 333(f)(5)(B)).  The ALJ determined that a penalty of $20,678 is appropriate because the nature, circumstances, extent, and gravity of the violation are serious; Respondent had a history of violations; and Respondent failed to present evidence disputing the seriousness of the violation or any proof of mitigating circumstances such as inability to pay or lack of culpability.  Id. at 10-12.

Finally, the ALJ declined to adjudicate the merits of Respondent’s constitutional arguments, noting that ALJs are bound by applicable laws and regulations and “‘do not have the authority to find Federal statutes or regulations invalid.’”  Id. at 13 (quoting 21 C.F.R. § 17.19(c)).  Respondent appealed the ALJ Decision to the Board.2

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Standard of Review

The standard of review on a disputed issue of law is whether the initial decision is erroneous.  21 C.F.R. § 17.47(k).  Summary decision is appropriate “if the pleadings, affidavits, and other materials filed in the record, or matters officially noticed, show that there is no genuine issue as to any material fact and that the party is entitled to summary decision as a matter of law.”  Id. § 17.17(b).  An ALJ’s “summary decision” is reviewed de novo because that determination presents only a question of law.  When a motion for summary decision has been properly filed, the party opposing the motion “may not rest on mere allegations or denials or general descriptions of positions and contentions; affidavits or other responses must set forth specific facts showing that there is a genuine issue of material fact for a hearing.”  Id. § 17.17(c); see also ALJ’s Acknowledgment and Pre-Hearing Order ¶ 15 (“A party opposing a motion for summary decision must come forward with evidence of specific facts showing that a dispute exists.” (emphasis added)).  Conclusory or unsupported assertions are insufficient to establish the existence of a genuine issue of material fact.  See Greene v. Dalton, 164 F.3d 671, 675 (D.C. Cir. 1999); Norris v. Wash. Metro. Area Transit Auth., 342 F. Supp. 3d 97, 108 (D.D.C. 2018).3

Analysis

Before the Board, Respondent raises only constitutional arguments.  First, Respondent asserts that the civil money penalty imposed in this administrative proceeding violates the Seventh Amendment.  Respondent’s Brief (Resp’t Br.) at 1 (“The statutory and regulatory scheme that purports to allow the FDA’s claim to be adjudicated in an agency administrative court is unconstitutional.”).  Second, Respondent contends that the ALJ is “insulated from presidential removal by two layers of for cause protection” in violation of the “Appointments and Take Care Clauses” of the Constitution.  Id. at 5-6 (citing cases holding that the APA’s removal provision, 5 U.S.C. § 7521(a), is unconstitutional).  For relief, Respondent requests that the Board dismiss these administrative proceedings or, alternatively, limit the civil money penalty to $20.  Id. at 1, 4. 

1. Respondent violated the FDCA by manufacturing and holding for sale adulterated and misbranded e-liquids.

Respondent does not challenge the ALJ’s determination that the undisputed material facts establish that Respondent manufactured and held for sale adulterated and misbranded tobacco products in violation of 21 U.S.C. § 331(k).  ALJ Decision at 6-9; see also CTP Ex. 1, at 3-5 (¶¶ 7-14); CTP Ex. 2, at 2-3 (¶¶ 5-13); CTP Exs. 3-6 (inspection report and photographs).  Accordingly, we summarily affirm the ALJ’s conclusion that Respondent violated the FDCA by failing to obtain premarket authorization for e-liquid products that

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Respondent manufactured, causing them to become adulterated and misbranded while held for sale after shipment of one or more components in interstate commerce.  ALJ Decision at 7-9; see also Sana Ventures LLC d/b/a Space City Food Mart, DAB No. 3169, at 7 (2025) (summarily affirming ALJ’s findings and conclusions concerning FDCA violation absent specific exceptions in notice of appeal); Smokers Haven 3 LLC d/b/a Smoker’s Haven, DAB No. 3164, at 5 (2024) (same); Leung’s, Inc. d/b/a El Faro Supermarket, DAB No. 3025, at 9 (2020) (same). 

2. There is no basis to disturb the civil money penalty imposed by the ALJ. 

At the time of the FDCA violation here, ALJs were authorized to impose a civil money penalty of up to $20,678 for each violation relating to tobacco products.  21 U.S.C. § 333(f)(9)(A); 21 C.F.R. § 17.2; 45 C.F.R. § 102.3 (eff. Oct. 6, 2023).  In determining the appropriate penalty amount, ALJs must consider factors such as the nature, gravity, and extent of violations, ability to pay, effect on business, prior violations, and culpability.  See 21 U.S.C. § 333(f)(5)(B); 21 C.F.R. § 17.34(a), (b).  After considering circumstances that aggravate or mitigate Respondent’s violation, including each of the relevant statutory factors, and finding no genuine issue of material fact, the ALJ concluded that a civil money penalty in the amount of $20,678 is appropriate.  ALJ Decision at 10-12 (noting that Respondent provided no evidence concerning any of the statutory factors and no evidence of any mitigating circumstances).  In making this determination the ALJ noted:  “Respondent has not submitted any materials in support of its contention that the civil money penalty proposed by CTP is excessive and did not submit any evidence of mitigating circumstances with its Answer, pre-hearing exchange, response to CTP’s Motion for Summary Decision, or at any time during this proceeding.”  Id. at 9-10. 

Respondent argues that it “disputed” the penalty amount before the ALJ and “stated several facts that should support mitigation.”  Resp’t Br. at 5.  While Respondent made certain conclusory factual assertions in its Answer (¶¶ 12-13), none of those assertions were supported by evidence.  Such conclusory and unsupported assertions are insufficient to establish a genuine issue of material fact.  The ALJ directed Respondent, in its brief, to answer certain questions “completely and to the best of its ability.”  Acknowledgment and Pre-Hearing Order ¶ 7.  Those questions included identifying any “fact or situation” that Respondent believed was a basis to “reduce the amount of any penalty imposed,” but Respondent provided no response.  CRD Dkt. 6b (template Pre-Hr’g Br. of Resp’t) § 6; Resp’t Pre-Hrg. Br. at 6.  Moreover, in response to CTP’s discovery requests, Respondent plainly represented that it “will not seek to admit any tax returns or other mitigation evidence in this proceeding.”  CTP Ex. A, at ¶¶ 7-8.

We find no error in the ALJ’s analysis of the statutory factors, all of which weigh in favor of imposing a significant penalty to ensure future compliance with the FDCA.  We affirm the ALJ’s determination that $20,678 is an appropriate penalty amount because it is not

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legally erroneous and Respondent presented no evidence that would warrant a reduction under the relevant factors.

3. The Board has no authority to declare the FDCA’s civil money penalty provisions and related regulations invalid.

Respondent argues that the statutory and regulatory provisions that authorize CTP to pursue a civil money penalty to enforce the FDCA in an administrative proceeding violates Respondent’s right to a jury trial under the Seventh Amendment.  Resp’t Br. at 1-4 (citing SEC v. Jarkesy).4  According to Respondent, “[t]he statutory and regulatory scheme that purports to allow the FDA’s claim to be adjudicated in an agency administrative court is unconstitutional.”  Id. at 1. 

The ALJ declined to declare the FDCA’s enforcement provisions unconstitutional, noting that ALJs are bound by applicable laws and regulations and do not have “‘the authority to find Federal statutes or regulations invalid.’”  ALJ Decision at 13 (quoting 21 C.F.R. § 17.19(c)).  We agree.  Neither ALJs nor the Board have authority to declare a federal statute or regulation invalid on constitutional grounds.  See Drive Thru Vapors, LLC, DAB No. 3168, at 11 (2025) (declining to reverse, based on Jarkesy, an ALJ decision imposing a civil money penalty in connection with tobacco-related FDCA violation); see also Trees Vape Supply, LLC d/b/a Tea Time E-liquid Co., DAB No. 3187, at 6 (2025) (“[T]o the extent Respondent seeks to raise a constitutional challenge to the FDA’s regulatory authority, the Board has no authority to declare federal statutes or regulations invalid or unconstitutional.”); J. Peaceful, L.C. d/b/a Town Market, DAB No. 2742, at 15 (2016) (“Neither the ALJs nor this Board are empowered to ignore or overturn applicable statutes or regulations.”).

We further reject Respondent’s attempt to “equate this case with Jarkesy.”  See Drive Thru Vapors at 11.  As the Board previously explained, Jarkesy did not address the FDCA or its implementing regulations in connection with the enforcement of federal requirements relating to new tobacco products, including ENDS products and e-liquids.  Id.  Rather, Jarkesy arose from “an enforcement action” by the SEC under the Securities Act of 1933, the Securities Exchange Act of 1934, the Investment Advisers Act of 1940, and the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010—none of which apply here.  Jarkesy, 603 U.S. at 115-18.  The SEC sought to impose civil money penalties against an investment advisor and his firm for securities fraud.  Id.  Relying on new authority conferred by the Dodd-Frank Act, the SEC elected to initiate proceedings before an ALJ, rather than in court where the defendants could elect a jury trial.  Id. at 115, 119.  The Supreme Court considered “whether the Seventh Amendment permits the SEC to compel respondents to defend themselves before the agency rather than before a

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jury in federal court,” and concluded that “[t]he Seventh Amendment . . . applies and a jury is required.”  Id. at 115, 120-21.

The Court held that the “SEC’s antifraud provisions replicate common law fraud, and it is well established that common law claims must be heard by a jury.”  Id. at 120.  The Court did not hold that every agency’s attempt to impose a civil money penalty necessarily is, like the SEC’s action, “a common law suit in all but name” that “must be adjudicated in Article III courts.”  Id. at 136.  On the contrary, the Court acknowledged the long-established “public rights exception,” under which “Congress may assign [a] matter for decision to an agency without a jury, consistent with the Seventh Amendment,” and extensively discussed the Court’s precedents applying that exception.  Id. at 127-32. 

We recognize, but do not decide – as the Supreme Court did not decide – the potential applicability of the public rights exception in administrative proceedings for FDCA violations relating to tobacco products.  We cannot and do not predict how the reasoning in Jarkesy might be applied by federal courts in different cases involving different statutory and regulatory contexts; however, it is apparent that not all administrative proceedings involving civil money penalties contravene the Seventh Amendment.  See, e.g., Axalta Coating Sys. LLC v. FAA, 144 F.4th 467, 473-77 (3d Cir. 2025) (holding that the Seventh Amendment did not prohibit adjudication of Federal Aviation Administration’s  action for civil monetary penalties in administrative forum); Butler Amusements, Inc. v. U.S. Dep’t of Labor, Civ. No. 24-1042, 2025 WL 2457687, at *6 (D.D.C. Aug. 26, 2025) (holding that public rights exception applied to DOL’s administrative adjudication and assessment of civil penalty in case involving visa program violation).

We acknowledge that after issuance of the ALJ Decision, one federal district court in a different tobacco product case held that the FDCA’s civil money penalty provisions violate the Seventh Amendment.  See Wulferic, LLC v. FDA, 793 F. Supp. 3d 830 (N.D. Tex. 2025).  FDA has appealed that decision to the Court of Appeals for the Fifth Circuit.  See Wulferic LLC d/b/a Vapor Lab v. FDA, No. 25-11112 (5th Cir. filed Oct. 3, 2025).  The district court’s order enjoining the FDA has no effect on any administrative proceeding other than the one challenged by the plaintiff in that case.  See Wulferic, 793 F. Supp. 3d at 851-52 (rejecting plaintiff’s request for nationwide injunction).  We further note that Respondent’s case and the Wulferic case arise from different federal judicial districts and, in any event, the district court decision is not controlling precedent.  See Camreta v. Greene, 563 U.S. 692, 709 n.7 (2011) (“A decision of a federal district court judge is not binding precedent in either a different judicial district, the same judicial district, or even upon the same [district] judge in a different case.” (internal quotation marks omitted)); William Garner, M.D., DAB No. 3026, at 11 & n.11 (2020) (explaining that the Board is not bound by a federal court decision from a district or circuit different than the one from which the administrative appeal arises).

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Respondent further argues that the regulation prohibiting ALJs from finding federal statutes or regulations invalid, 21 C.F.R. § 17.19(c), is “inconsistent with the oath of office federal employees take.”  Resp’t Br. at 4-5 (“[A]n agency cannot, by regulation or otherwise, lawfully prohibit its employees from acting in accordance with the Constitution, or compel them to continue an unconstitutional course of conduct.”).  Respondent’s argument is misplaced because Jarkesy did not hold that the FDCA’s civil money penalty provisions or their implementing regulations are unconstitutional.  The Board previously considered and rejected this same argument because nothing in the federal employee oath of office “compels or permits federal agency adjudicators to decline to apply or follow” the FDCA and its implementing regulations based on a Court decision that “did not involve, address, or consider” those provisions.  See Drive Thru Vapors at 12. 

Moreover, the jurisdictional limitation under section 17.19(c) is entirely consistent with the well-known principle that regulatory agencies are not free to declare an act of Congress unconstitutional.  See Johnson v. Robison, 415 U.S. 361, 368 (1974); see also Elgin v. Dep’t of the Treasury, 567 U.S. 1, 16-17 (2012) (“[A]djudication of the constitutionality of congressional enactments has generally been thought beyond the jurisdiction of administrative agencies.” (quoting Thunder Basin Coal Co. v. Reich, 510 U.S. 200, 215 (1994) (internal quotation marks and brackets omitted))).  No Article III court has enjoined the Department of Health and Human Services, the FDA, or CTP from implementing the FDCA’s civil money penalty provisions against Respondent, and no court has issued a nationwide injunction generally prohibiting the adjudication of civil money penalties under the FDCA in administrative proceedings.  We find the ALJ acted consistently with her oath of office by not exceeding the limits of her authority and by fulfilling her responsibilities under applicable law. 

In short, the Board has no authority to “ignore or decline to apply any part of the FDCA or its implementing regulations by extrapolation” from the Jarkesy decision.  Drive Thru Vapors at 11.  Neither ALJs nor the Board were granted authority to declare federal statutes or regulations invalid, and the Supreme Court made no such determination with respect to the FDCA’s penalty provisions relating to tobacco products.  Accordingly, we deny Respondent’s request to dismiss these administrative proceedings.   

4. The Board has no authority to declare federal statutory removal protections for ALJs invalid.

Respondent argues that the civil money penalty is unconstitutional because “it was assessed by an ALJ impermissibly protected from control and removal by the President.”  Resp’t Br. at 5.  Respondent asserts that the ALJ is “insulated from presidential removal by two layers of for cause protection” in violation of the “Appointments and Take Care Clauses” of the Constitution.  Id. at 5-6 (citing cases holding that the statutory removal

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protections for ALJs under the Administrative Procedure Act (APA), 5 U.S.C. § 7521(a), violated separation of powers).5

None of the cases cited by Respondent pertain to ALJs at the Departmental Appeals Board, and Respondent provided no evidence or argument as to why those cases should apply to the ALJ in this case.6  Moreover, to the extent that Respondent contends that the Board should declare 5 U.S.C. § 7521(a) to be unconstitutional or invalid, we have no authority to do so.  See supra at pp. 8-10. 

Respondent points to the Fifth Circuit’s decision in Jarkesy v. SEC, 34 F.4th 446, 463-65 (5th Cir. 2022), regarding SEC ALJs, but fails to acknowledge that the Ninth Circuit, the judicial circuit where Respondent maintains its principal place of business, upheld the constitutionality of dual-layer removal protections under 5 U.S.C. § 7521(a).  See Decker Coal Co. v. Pehringer, 8 F.4th 1123, 1136 (9th Cir. 2021) (holding that the removal protections are constitutional as applied to DOL ALJs); Rabadi v. U.S. Drug Enf’t Admin., 122 F.4th 371, 374-76 (9th Cir. 2024) (holding that the removal protections are constitutional as applied to DEA ALJs), cert. denied sub nom., 145 S. Ct. 2846 (2025).  The Supreme Court has not resolved this unsettled area of the law.  See Jarkesy, 603 U.S. at 120-21 (declining to address Fifth Circuit’s conclusion that APA removal protections violated separation of powers); Free Enterprise Fund v. Pub. Co. Accounting Oversight Bd., 561 U.S. 477, 507 n.10 (2010) (declining to address whether dual for-cause limitations on the removal of ALJs are constitutional).

In any event, even if there were a constitutional defect based on the removal protections under section 7521(a), the dismissal of this proceeding or reversal of the ALJ Decision would not be an appropriate remedy.  See Decker Coal, 8 F.4th at 1136 (explaining that even if the court had found the challenged removal provision to be unconstitutional, the remedy would have been to “sever only one level of protection” and not to invalidate the ALJ decision).
 

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Conclusion

We affirm the ALJ Decision.