Warlock Vapes, LLC d/b/a Zuluvape, DAB No. 3226 (2026)

FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

Warlock Vapes, LLC d/b/a Zuluvape (Respondent) appeals an Administrative Law Judge’s (ALJ) Initial Decision and Default Judgment (Initial Decision) and the ALJ’s subsequent Order Denying Respondent’s Motion to Reopen Initial Decision and Default Judgment (Denial Order).  Warlock Vapes, LLC d/b/a Zuluvape, DAB TB9623 (2025); Docket No. T‑25‑2379, Doc. #8a (Nov. 17, 2025) (Denial Order).  We affirm the Initial Decision and the Denial Order for the reasons stated below.

Legal Background

To protect public health, the Federal Food, Drug, and Cosmetic Act (FDCA) restricts the sale, distribution, and use of tobacco products.  21 U.S.C. §§ 301, 331(b), 331(k), 387a(a)-(b), 387c(a)(6), 387f(d).  The FDCA 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.  Id. § 387j(a)(1).  A new tobacco product may not be introduced in interstate commerce without premarket authorization.  21 U.S.C. § 387j(a)(2)(A).  The FDCA prohibits the introduction or delivery for introduction in interstate commerce of any tobacco product that is “adulterated” pursuant to 21 U.S.C. § 387b(6)(A) or “misbranded” pursuant to 21 U.S.C. § 387c(a)(6).  Id. § 331(a).

The FDCA authorizes civil money penalties (CMP) against “any person who violates a requirement of [the FDCA] which relates to tobacco products.”  21 U.S.C. § 333(f)(9)(A).  The implementing regulations establish a schedule of maximum CMP amounts based on the number of violations committed and the period over which they occurred.  See 21 C.F.R. § 17.2 (citing 45 C.F.R. § 102.3 (table)).  To impose a CMP, the Center for Tobacco Products (CTP) must file a complaint and serve a copy on the respondent.  21 C.F.R. § 17.5.1  The respondent may then request a hearing by filing an

Page 2

answer.  Id. § 17.9(a).  The regulations authorize ALJs to enter a default judgment against a respondent that does not file a timely answer.  Id. § 17.11.  If the respondent does not file a timely answer after service of the complaint, the ALJ “shall assume the facts alleged in the complaint to be true, and, if such facts establish liability under the relevant statute . . . shall issue an initial decision” imposing either:  “(1) [t]he maximum amount of penalties provided for by law for the violations alleged; or (2) [t]he amount asked for in the complaint, whichever amount is smaller.”  Id. § 17.11(a).  “[B]y failing to file a timely answer, the respondent waives any right to a hearing and to contest the amount of the penalties and assessments imposed,” and “the initial decision shall become final and binding upon the parties 30 days after it is issued.”  Id. § 17.11(b). 

Within 30 days after issuance of that decision, the respondent may move “to reopen on the grounds that extraordinary circumstances prevented the respondent from filing an answer.”  21 C.F.R. § 17.11(c).  If the respondent demonstrates “extraordinary circumstances excusing the failure to file an answer in a timely manner,” the ALJ may withdraw the initial decision and “grant the respondent an opportunity to answer the complaint.”  Id. § 17.11(d).  However, if the ALJ “decides that the respondent’s failure to file an answer in a timely manner is not excused,” the ALJ “shall affirm the decision.”  Id. § 17.11(e).

A respondent “may appeal an [ALJ’s] initial decision, including a decision not to withdraw a default judgment,” to the Board.  21 C.F.R. § 17.47(a).  The Board may decline to review the case, affirm or reverse the initial decision, “or increase, reduce, reverse, or remand any civil money penalty determined by” the ALJ.  Id. § 17.47(j).

Case Background2

On July 16, 2025, CTP filed an Administrative Complaint (Complaint) alleging that Respondent manufactured, offered for sale, and shipped in interstate commerce a new tobacco product that lacked premarket authorization in violation of 21 U.S.C. § 331(a).  Complaint ¶¶ 1, 16-23.  The Complaint alleged that on August 23, 2024, an FDA-approved inspector purchased for shipment from Respondent’s online store an e‑liquid product that was adulterated and misbranded under 21 U.S.C. §§ 387b(6)(A) and 387c(a)(6).  Id. ¶¶ 14-22.  CTP sought the maximum allowable CMP, $21,348.  Id. ¶ 26; see 45 C.F.R. § 102.3 (eff. Aug. 8, 2024).  The Complaint stated that “Respondent must respond to this Complaint” and “has the right to request a hearing by filing an Answer within 30 days after service of the Complaint.”  Complaint ¶ 24 (citing 21 C.F.R. § 17.9).  The Complaint stated that failure to file an answer within 30 days of service may result in a default order imposing CTP’s proposed CMP.  Id.

Page 3

Respondent does not dispute that it did not timely file an answer or request an extension after being served the Complaint.  Motion to Reopen Default Judgment (Motion to Reopen); R. Br. at 1-2.  Accordingly, on September 12, 2025, the ALJ issued the Initial Decision finding that Respondent “neither filed an answer within the time prescribed, nor requested an extension of time within which to file an answer.”  Initial Decision at 1, 2.  “[P]ursuant to 21 C.F.R. § 17.11,” the ALJ “assume[d] that the facts alleged in the complaint (but not its conclusory statements) are true” and established Respondent’s liability under the FDCA for “introducing or delivering for introduction into interstate commerce a new tobacco product that was adulterated and misbranded.”  Id. at 2-3 (citing 21 U.S.C. § 331(a)).  The ALJ also found that the $21,348 CMP “is permissible under 21 U.S.C. § 333(f)(9)(A) and 21 C.F.R. § 17.2.”  Id. at 3 (citing 45 C.F.R. § 102.3).

On October 9, 2025, Respondent filed the Motion to Reopen, arguing that “[e]xtraordinary circumstances” prevented it from filing a timely answer, and that its oversight was unintentional and “the product of circumstances outside Respondent’s control.”  Motion to Reopen at 1.  Respondent stated that its “sole shareholder and managing member, Orit Deverell, was in New York when the Complaint was delivered to the company’s South Carolina business address,” and that “[a]lthough an employee signed for the delivery, the documents were not provided to Ms. Deverell until after the time to respond had expired.”  Respondent argued that it was “deprived of actual notice and a meaningful opportunity to answer.”  Id.  Respondent attached a supporting sworn declaration from Ms. Deverell.  Id. at 3-5.  CTP opposed the motion.

In the Denial Order, the ALJ held that Respondent did not establish that extraordinary circumstances excused its failure to file a timely answer, stating, “I find that the facts in this case demonstrate that Respondent’s failure to file a timely Answer is due to ordinary negligence.”  Denial Order at 3.  The ALJ reasoned:

Although the regulations do not define the term “extraordinary circumstances,” clearly that term must mean something more than a simple error or omission.  An “extraordinary circumstance” would normally constitute some event or events beyond a Respondent’s ability to control that acted to prevent Respondent from timely filing.  At the very least, the term would preclude reopening where ordinary negligence is the cause of a Respondent’s failure to file an Answer timely.

Id. at 2 (citing Shesh Narayan LLC, DAB No. 3137, at 8 (2024) (stating, “at minimum, the ‘extraordinary circumstances’ test requires proof of circumstances outside of Respondent’s ability to control and an absence of negligence”) (italics substituted for boldface)).  The ALJ found that although Respondent’s managing member stated she was away when the Complaint was properly served, “in this case . . . the inability of Respondent’s staff to comprehend the significance of the Complaint and timely provide the Complaint to its managing member is not an extraordinary circumstance which would

Page 4

excuse Respondent’s failure to file an Answer in a timely manner.”  Id. at 3 (citing 21 C.F.R. § 17.11(d); Shesh Narayan at 8; Joshua Ranjit Inc., DAB No. 2758, at 6 (2017)). 

Respondent appealed the Denial Order to the Board.  Respondent submitted a brief (R. Br.), CTP submitted a memorandum in opposition to Respondent’s appeal (CTP Resp.), and Respondent submitted a reply brief (R. Reply).

Standard of Review

“The standard of review on a disputed issue of fact is whether the initial decision is supported by substantial evidence on the whole record.”  21 C.F.R. § 17.47(k).  “The standard of review on a disputed issue of law is whether the initial decision is erroneous.”  Id.  The Board applies an abuse of discretion standard when reviewing an ALJ’s ruling on a motion seeking to reopen under section 17.11(c).  See Shesh Narayan at 6-7; Vape MD LLC, DAB No. 3204, at 4 (2025).

The Parties’ Arguments to the Board

On appeal, Respondent argues that the ALJ committed legal error in two ways.  First, Respondent argues that the ALJ applied “an unduly rigid interpretation of extraordinary circumstances” that “collapsed the § 17.11(d) inquiry into a categorical rule: where a complaint is received by an employee but not timely conveyed to management, reopening is unavailable.”  R. Br. at 1, 4.  Respondent argues its “single, discrete failure arising from temporary circumstances” was not “intentional avoidance of the proceedings, repeated disregard of agency process, or bad-faith conduct.”  Id. at 1, 5.  Respondent argues the ALJ erred by treating this oversight as “per se disqualifying” without “undertaking the holistic, context-specific inquiry contemplated by” the regulation, and “failed to exercise discretion in a reasoned manner.”  Id. at 2, 4.  Second, Respondent argues that the ALJ erred by imposing the maximum CMP “without proper application of the statutory penalty factors” required by 21 U.S.C. § 333(f)(5)(B).3  Id. at 6.  Respondent insists that a default judgment “does not relieve the agency of its obligation to justify the amount of the [CMP] imposed through a reasoned application of the statutory factors to the record.”  Id.; see also R. Reply at 2 (“If default alone justified the maximum penalty, the statutory factors would serve no purpose.”).  Respondent lists several alleged mitigating factors and argues that the ALJ erred by imposing the maximum CMP without considering them.  R. Br. at 6-7.

Page 5

Respondent asks the Board to reverse the Denial Order “and remand the matter for adjudication on the merits;” or in the alternative, to “vacate the [CMP] determination” and remand to the ALJ to reconsider the CMP consistent with the statutory factors at 21 U.S.C. § 333(f)(5)(B); or in the second alternative, to reduce the CMP “to an amount reflecting a reasoned and proportional application of the statutory penalty factors to the undisputed facts of record.”  R. Br. at 9.  Respondent also raises “constitutional objections solely to ensure that they are preserved for judicial review and reflected in the administrative record.”  Id.

CTP argues that the ALJ did not err in denying the Motion to Reopen.  CTP Resp. at 1, 7.  CTP states that the ALJ did not categorically deny the motion or “treat[] employee receipt of the complaint as dispositive” but “considered every single circumstance and factual assertion raised in [the] Motion to Reopen, considered relevant case law, and made an individualized determination.”  Id. at 8.  Regarding the CMP, CTP argues that Respondent “fails to acknowledge” that when an ALJ establishes liability under the default regulation at section 17.11, the ALJ “shall issue an initial decision within 30 days of the time the answer was due, imposing: (1) [t]he maximum amount of penalties provided for by law for the violations alleged; or (2) [t]he amount asked for in the complaint, whichever amount is smaller.”  Id. at 10 (emphasis omitted); 21 C.F.R. § 17.11(a)(1)-(2).  CTP also states that by not filing an answer, Respondent waived its right to a hearing and to contest the CMP amount, as stated in section 17.11(b).  CTP adds that there is no administrative record to support Respondent’s alleged mitigating factors, as Respondent filed no answer and thus foreclosed the development of any record on which such an ALJ analysis would rely.  Id.   

After reviewing the record and the parties’ arguments, we affirm the Initial Decision and Denial Order because Respondent has shown no error or abuse of discretion by the ALJ.

Analysis

1. The ALJ did not err or abuse discretion in determining that Respondent did not demonstrate “extraordinary circumstances” under 21 C.F.R. § 17.11(d).

An ALJ’s decision to withdraw a default judgment and allow the late filing of an answer is discretionary.  Vape MD at 4.  Under section 17.11(d), an ALJ “may” withdraw a default judgment if the respondent establishes “extraordinary circumstances excusing the failure to file an answer in a timely manner.”  See KKNJ, Inc., DAB No. 2678, at 7 (2016) (stating that the Board has long interpreted use of “may” in regulations as conferring discretion).  

“In reviewing an ALJ’s exercise of discretion, the Board’s role ‘is not to substitute our judgment for that of the ALJ.’”  Romba LLP, DAB No. 3208, at 5 (2025) (quoting Retail LLC, DAB No. 2660, at 14 (2015)).  Instead, the Board will “consider only whether the

Page 6

decision maker has articulated a reasonable basis for the decision under review, not whether it was the only reasonable decision.”  Retail at 10 (emphasis omitted).

The Denial Order was not an abuse of discretion because the ALJ articulated a reasonable basis for finding, pursuant to section 17.11(e), that Respondent did not establish that extraordinary circumstances prevented it from filing a timely answer.  The ALJ correctly explained that the term “extraordinary circumstances” “must mean something more than a simple error or omission” or “ordinary negligence,” and normally indicates “some event or events beyond a Respondent’s ability to control that acted to prevent Respondent from filing timely.”  Denial Order at 2.  This assessment aligns with Board precedent holding that “at minimum, the extraordinary circumstances test requires proof of circumstances outside of Respondent’s ability to control and an absence of negligence.”  Vape MD at 5 (quoting Shesh Narayan at 8); see also Romba at 5.

Respondent does not dispute the ALJ’s finding that Respondent was properly served with the Complaint at its place of business yet did not file an answer.  See Denial Order at 1, 3.  The ALJ considered Respondent’s explanation:  that its “sole shareholder and managing member” was out of town when the Complaint was served, and the employee who “signed for the delivery” did not send the Complaint to the managing member until after the time to respond had expired, thus purportedly depriving Respondent of “actual notice and meaningful opportunity to answer.”  Id. at 2 (citing Motion to Reopen at 1).4  From these asserted facts the ALJ supportably concluded that Respondent’s explanation was insufficient, and “the facts in this case demonstrate that Respondent’s failure to file a timely Answer is due to ordinary negligence.”  Id. at 3. 

We agree with the ALJ that “the inability of Respondent’s staff to comprehend the significance of the Complaint and timely provide the Complaint to its managing member is not an extraordinary circumstance which would excuse Respondent’s failure to file an Answer in a timely manner.”  Id. (citing 21 C.F.R. § 17.11(d)).  It was within the control of Respondent’s employee who signed for delivery of the Complaint to identify the importance of the document and send it to the managing member within 30 days.  It also was within Respondent’s control to have taken any other measures in advance to ensure that important documents such as these were promptly brought to the attention of Respondent’s management so that they could timely act on them.  As the ALJ noted, in a case where non-response to an ALJ’s order to show cause was blamed on an employee’s failure to inform management, the Board reasoned that the respondent “could have appointed an individual to be responsible for monitoring incoming mail or trained its staff to recognize and report important documents received through the mail or could have instituted a system guaranteed to ensure the important documents were brought promptly to the attention of Respondent’s management.”  Joshua Ranjit Inc., DAB No. 2758, at 6

Page 7

(2017); Denial Order at 3.  That reasoning applies with at least equal force here where the regulation required Respondent to show that extraordinary circumstances prevented it from responding timely to the Complaint.  For this reason, we conclude the ALJ rationally found that Respondent’s oversight did not amount to “extraordinary circumstances” that prevented it from filing its answer, and the ALJ committed no abuse of discretion in denying the Motion to Reopen.  

Respondent argues that the ALJ legally erred and “fail[ed] to exercise discretion” in denying the Motion to Reopen.  See R. Br. at 2.  This argument is misplaced and mischaracterizes the Denial Order.  The ALJ did not apply an “unduly narrow” interpretation of “extraordinary circumstances” nor “equate extraordinary circumstances with impossibility,” “treat[] employee receipt of the complaint as dispositive,” “collapse[] the § 17.11(d) inquiry into a categorical rule,” or conclude that oversights by a respondent’s employee are “per se disqualifying.”  See R. Br. at 3, 4.  To the contrary, the ALJ applied the correct legal standard according to the regulation and established Board precedent, and the ALJ exercised her ample discretion to deny Respondent’s motion.  See Denial Order at 2, 3.  At no point did the ALJ state or imply that the occurrence of a so‑called “internal transmission failure” by an employee categorically disqualifies a respondent from consideration for reopening, nor that reopening an initial decision is conditioned on a respondent’s proving that filing a timely answer was impossible, as Respondent claims.

We also reject Respondent’s argument that the ALJ failed to “meaningfully engage” with Respondent’s proffered facts and denied the Motion to Reopen “without undertaking the holistic, context-specific inquiry contemplated by 21 C.F.R. § 17.11(d).”  R. Br. at 1‑2, 4.  As we have shown, the ALJ did review all of the facts asserted by Respondent, which were limited to one paragraph of text.  See Denial Order at 2-3; Motion to Reopen at 1.  The ALJ then appropriately exercised discretion and reached an individualized decision focused on those facts, and did not impose any “per se” rule regarding employee error.  Rather, the ALJ found that “in this case, . . . the inability of Respondent’s staff to comprehend the significance of the Complaint and timely provide the Complaint to its managing member is not an extraordinary circumstance,” and found that “the facts in this case demonstrate that Respondent’s failure to file a timely Answer is due to ordinary negligence.”  Denial Order at 2‑3 (emphasis added).  In this regard, it is also not dispositive whether Respondent’s oversight was not the result of “intentional avoidance of these proceedings, repeated disregard of regulatory obligations, or bad-faith conduct.”  R. Br. at 4.  The “extraordinary circumstances” test does not require satisfying those elements.  As noted, the ALJ correctly stated that “the term would preclude reopening where ordinary negligence,” i.e., unintentional conduct, “is the cause of a Respondent’s failure to file an Answer timely,” and that “at minimum, the . . . test requires proof of circumstances outside of Respondent’s ability to control.”  Denial Order at 2.

Page 8

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

Substantial evidence supports the ALJ’s decision to enter default judgment against Respondent.  Initial Decision at 2-3.  The ALJ found that on July 16, 2025, CTP served on Respondent a Complaint that contained factual allegations supporting Respondent’s liability under the FDCA and warned that failure to file an answer within 30 days could result in a default order imposing the proposed CMP.  Id. at 1-2.  Respondent does not contest this finding and does not contest the ALJ’s determination that the facts alleged by CTP, taken to be true, establish Respondent’s liability for a violation of the FDCA.  Id. at 2-3; see also Complaint ¶¶ 14-23.  Therefore, we summarily affirm the ALJ’s finding that Respondent violated the FDCA, 21 U.S.C. § 331(a), by not obtaining premarket authorization for a tobacco product that it manufactured, causing it to become adulterated and misbranded while offered for sale and shipped in interstate commerce.  See Sana Ventures LLC, DAB No. 3169, at 7 (2025) (summarily affirming ALJ’s findings and conclusions regarding FDCA violation absent specific exceptions in notice of appeal).

3. The ALJ did not commit legal error in imposing a CMP of $21,348.

Respondent argues that the ALJ erred by imposing a CMP of $21,348 “without conducting or explaining an individualized analysis of the factors” set forth at 21 U.S.C. § 333(f)(5)(B).  R. Br. at 6, 7.  The statutory factors at section 333(f)(5)(B) do not apply to the default procedures under which the ALJ issued the Initial Decision, and Respondent cites no authority stating that they do.  When assessing a CMP as a result of a default judgment under 21 C.F.R. § 17.11, ALJs are limited by regulation to choose one of two options.  The ALJ “shall issue an initial decision” imposing either “[t]he maximum amount of penalties provided for by law for the violations alleged” or “[t]he amount asked for in the complaint, whichever amount is smaller.”  21 C.F.R. § 17.11(a)(1)-(2) (emphasis added). 

At the time of the violation, which the ALJ correctly found occurred on August 23, 2024, ALJs were authorized to impose a CMP of up to $21,348 for a single violation.  21 C.F.R. § 17.2; 45 C.F.R. § 102.3.  The Complaint served by CTP sought a CMP in that same amount.  Complaint ¶ 26.  Thus, the ALJ correctly imposed a CMP in the amount of $21,348.  Initial Decision at 3.  The CMP amount the ALJ imposed is legally correct and required by the regulation, as there was no “smaller” CMP amount from which the ALJ could choose.

To the extent that Respondent challenges the validity of section 17.11, ALJs do “not have the authority to find Federal statutes or regulations invalid.”  21 C.F.R. § 17.19(c); accord J. Peaceful, L.C., DAB No. 2742, at 15 (2016) (“Neither the ALJs nor this Board are empowered to ignore or overturn applicable statutes or regulations.”).

Page 9

Further, by failing to timely file an answer, Respondent necessarily forfeited its opportunity for a hearing on the record at which it could have contested the CMP amount, developed an administrative record, and submitted any evidence of alleged mitigating factors for the ALJ to consider.  See 21 C.F.R. § 17.11(b) (“[B]y failing to file a timely answer, the respondent waives any right to a hearing and to contest the amount of the penalties and assessments imposed” pursuant to section 17.11(a).).  For all these reasons, the ALJ’s determination of the CMP amount is not erroneous.

Conclusion

We affirm the Initial Decision and the Denial Order.5