Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Center for Tobacco Products,
Complainant,
v.
EZ Pass Convenient LLC
d/b/a EZ Pass Convenience,
Respondent.
Docket No. T-25-1464
FDA Docket No. FDA-2025-H-0691
Decision No. TB10381
ORDER GRANTING COMPLAINANT’S MOTION TO IMPOSE SANCTIONS AND INITIAL DECISION AND DEFAULT JUDGMENT
On March 24, 2025, the Center for Tobacco Products (CTP) served a complaint on Respondent, EZ Pass Convenient LLC d/b/a EZ Pass Convenience, at 400 South Payson Street, Baltimore, Maryland 21223. A copy of the complaint was also filed with the Food and Drug Administration’s (FDA) Division of Dockets Management. CTP seeks to impose a $2,846 civil money penalty against Respondent for at least four violations of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq., and its implementing regulations, 21 C.F.R. part 1140, within a 24-month period.
On April 23, 2025, Respondent, through its representative, filed an answer to the complaint. Since filing its answer, however, Respondent has repeatedly disregarded my orders and has been non-responsive to CTP’s requests. Specifically, Respondent failed to respond to CTP’s request for production of documents, failed to respond to CTP’s motion to compel discovery, failed to comply with my order granting CTP’s motion to compel discovery, and failed to respond to the present Motion to Impose Sanctions.
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Currently before me is CTP’s Motion to Impose Sanctions, which requests that I impose sanctions against Respondent for its repeated noncompliance. As a sanction for Respondent’s conduct, CTP asks me to strike Respondent’s answer and issue a default judgment against Respondent pursuant to 21 C.F.R. § 17.35(c)(3). For the reasons stated below, I find that the requested sanctions are warranted and appropriate under the circumstances. Therefore, I grant CTP’s Motion to Impose Sanctions, strike Respondent’s answer, and issue this decision of default judgment imposing the requested civil money penalty against Respondent.
I. Relevant Procedural History
On March 24, 2025, CTP served an administrative complaint on Respondent by United Parcel Service, pursuant to 21 C.F.R. §§ 17.5 and 17.7. Civil Remedies Division (CRD) Docket (Dkt.) Entry Numbers (Nos.) 1, 1b. Respondent’s answer to the complaint was due by April 23, 2025. See 21 C.F.R. § 17.9. On April 23, 2025, Respondent filed a timely answer to the complaint. CRD Dkt. Entry No. 3.
On April 30, 2025, I issued an Acknowledgment and Pre-Hearing Order (APHO). The APHO outlined the procedures governing this case, provided various instructions and directives, and established deadlines for the parties to complete discovery and file pre-hearing exchanges. CRD Dkt. Entry No. 4. With respect to discovery, the APHO stated that a party is required to produce any requested documents no later than 30 days after receiving a request for documents from the opposing party. Id. ¶ 4; see also 21 C.F.R. § 17.23(a). I also warned the parties, as follows:
I may impose sanctions including, but not limited to, dismissal of the complaint or answer, if a party fails to comply with any order (including this order), fails to prosecute or defend its case, or engages in misconduct that interferes with the speedy, orderly, or fair conduct of the hearing. 21 C.F.R. § 17.35.
CRD Dkt. Entry No. 4 ¶ 21.
On June 2, 2025, CTP filed a status report indicating that the parties had been unable to reach a settlement in this case. CRD Dkt. Entry No. 6 at 1. Subsequently, on June 12, 2025, CTP filed a Notice of Unavailability of Declarant and Motion to Extend Deadlines (Notice and Motion), advising of the unavailability of an “essential declarant” to review and execute his declaration. CRD Dkt. Entry No. 7. In the Notice and Motion, CTP “respectfully request[ed] that all deadlines in this case be extended for thirty (30) days, to allow declarant the time to review and sign his declaration upon his return to duty after extended leave.” Id. On June 23, 2025, I issued an Order giving Respondent until July 3, 2025, to respond to CTP’s Notice and Motion. CRD Dkt. Entry No. 8. Respondent did not file a response. On July 9, 2025, I issued an Order granting CTP’s Notice and Motion
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and extended the pre-hearing exchange deadlines by an additional 30 days. CRD Dkt. Entry No. 9.
On August 11, 2025, CTP filed a Motion to Compel Discovery, stating that it served document requests on Respondent on June 4, 2025, but Respondent failed to respond. CRD Dkt. Entry No. 10. On that same date, CTP also filed a motion requesting a 30-day extension of all pre-hearing deadlines. CRD Dkt. Entry No. 11 at 2.
On August 18, 2025, I issued an Order advising Respondent that it had until September 2, 2025, to file a response to CTP’s Motion to Compel Discovery. CRD Dkt. Entry No. 12 at 2; see also CRD Dkt. Entry No. 4 ¶¶ 20-21; 21 C.F.R. § 17.32(c). I also granted CTP’s motion to extend the pre-hearing deadlines. Id.
Respondent did not respond to CTP’s Motion to Compel Discovery. Accordingly, on September 17, 2025, after considering CTP’s statements and arguments, I granted the motion and ordered Respondent to produce all documents responsive to CTP’s document requests by October 2, 2025. CRD Dkt. Entry No. 13. I also extended the parties’ pre-hearing exchange deadlines. Id. at 2. In the order, I specifically warned Respondent:
[F]ailure to comply with this Order may result in sanctions, including the issuance of an Initial Decision and Default Judgment finding Respondent liable for the violations listed in the [c]omplaint and imposing a civil money penalty. 21 C.F.R. § 17.35.
Id.
On October 16, 2025, CTP filed the present Motion to Impose Sanctions. CRD Dkt. Entry No. 14. In the motion, CTP states Respondent failed to comply with my September 17, 2025 Order granting CTP’s Motion to Compel Discovery and has not produced any responsive documents. Id. at 2. CTP asks that I sanction Respondent by striking its answer and issuing an Initial Decision and Default Judgment imposing the requested $2,846 civil money penalty. Id. at 2-3. CTP also filed a separate motion asking me to stay all deadlines pending resolution of its Motion to Impose Sanctions. CRD Dkt. Entry No. 15.
On October 21, 2025, I issued an Order advising Respondent that it had until November 5, 2025, to file a response to CTP’s Motion to Impose Sanctions. CRD Dkt. Entry No. 16 at 2. I also granted CTP’s request to stay all deadlines pending resolution of CTP’s Motion to Impose Sanctions. Id.
To date, Respondent has not filed any response to CTP’s Motion to Impose Sanctions. Further, Respondent has not produced any documents in response to CTP’s discovery
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requests or otherwise complied with my Order granting CTP’s Motion to Compel Discovery.
II. Motion to Impose Sanctions
I may sanction a party for:
(1) Failing to comply with an order, subpoena, rule, or procedure governing the proceeding;
(2) Failing to prosecute or defend an action; or
(3) Engaging in other misconduct that interferes with the speedy, orderly, or fair conduct of the hearing.
21 C.F.R. § 17.35(a).
Here, I find that Respondent failed, and continues to fail, to comply with multiple orders and rules, including:
- The requirements in 21 C.F.R. § 17.23(a) and paragraph 4 of the APHO, by failing to respond to CTP’s Request for Production of Documents within 30 days; and
- My September 17, 2025, Order granting CTP’s Motion to Compel Discovery, by failing to produce documents responsive to CTP’s discovery requests by October 2, 2025.
In addition, I find that Respondent has failed to defend this action. Specifically, Respondent has not filed a response to CTP’s Motion to Compel Discovery or CTP’s Motion to Impose Sanctions, nor has it taken any action in this matter since filing its answer on April 23, 2025. I also find that Respondent has interfered with the speedy, orderly, and fair conduct of this proceeding by preventing the case from moving forward to adjudication. Therefore, I conclude that Respondent’s conduct establishes a basis for sanctions pursuant to 21 C.F.R. § 17.35, and that sanctions are warranted under the circumstances.
The sanctions I impose must relate to the nature and severity of the misconduct or noncompliance. 21 C.F.R. § 17.35(b). Here, Respondent’s conduct has caused unnecessary delays and disruptions, interfered with CTP’s ability to prosecute its case, and prevented me from conducting a hearing or issuing a decision on the merits. Under the circumstances, Respondent’s behavior suggests it has abandoned its defense and is no longer interested in participating in this proceeding.
Based on the severity and ongoing nature of Respondent’s conduct, I find that the appropriate sanction is to strike Respondent’s answer to the complaint. 21 C.F.R.
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§ 17.35(b), (c)(3); see also KKNJ, Inc. d/b/a Tobacco Hut 12, DAB No. 2678 at 10-11 (2016) (concluding administrative law judge did not abuse discretion by striking Respondent’s answer for failure to comply with discovery order). While I recognize that this is a harsh remedy, I conclude that a lesser sanction would not effectively address Respondent’s repeated noncompliance and failure to defend its case. Indeed, Respondent’s conduct has effectively brought this proceeding to a standstill. Therefore, CTP’s Motion to Impose Sanctions is GRANTED and Respondent’s answer to the complaint is hereby STRICKEN from the record.
III. Default Decision
Striking Respondent’s answer leaves the complaint unanswered. Therefore, I am required to issue an initial decision by default, provided that the complaint is sufficient to justify a penalty. 21 C.F.R. § 17.11(a). Accordingly, I must determine whether the allegations in the complaint establish violations of the Act.
For purposes of this decision, I assume the facts alleged in the complaint to be true, pursuant to the provisions of 21 C.F.R. § 17.11(a). Specifically, CTP alleges the following facts in its complaint:
- Respondent owns EZ Pass Convenience, an establishment that sells tobacco products and is located at 400 South Payson Street, Baltimore, Maryland 21223. Complaint ¶¶ 11-12.
- On February 7, 2024, CTP initiated a previous civil money penalty action, CRD Docket Number T-24-1616, FDA Docket Number FDA-2024-H-0652, against Respondent for at least three violations of the Act. CTP alleged those violations to have occurred on February 15, 2023, and November 28, 2023. Complaint ¶ 15.
- The previous action concluded when Respondent admitted the allegations contained in the complaint issued by CTP and paid the agreed upon monetary penalty in settlement of that claim. Further, “Respondent expressly waived its right to contest such violations in subsequent actions.” Complaint ¶ 16.
- An FDA-commissioned inspector conducted a subsequent inspection on November 6, 2024, at approximately 1:37 PM, at Respondent’s business establishment. During the inspection, a person younger than 21 years of age was able to purchase a YME QB XXL Strawberry Lemon Mint electronic nicotine delivery system (ENDS) product. Complaint ¶ 13.
These facts establish Respondent EZ Pass Convenience’s liability under the Act. The Act prohibits misbranding of a regulated tobacco product. 21 U.S.C. § 331(k). A regulated tobacco product is misbranded if sold or distributed in violation of regulations issued
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under section 906(d) of the Act. 21 U.S.C. § 387f(d); see also 21 U.S.C. § 387c(a)(7)(B); 21 C.F.R. § 1140.1(b). The Secretary of the U.S. Department of Health and Human Services issued the regulations at 21 C.F.R. Part 1140 under section 906(d) of the Act. 21 U.S.C. § 387a-1; see also 21 U.S.C. § 387f(d)(1); 75 Fed. Reg. 13,225, 13,229 (Mar. 19, 2010); 81 Fed. Reg. 28,974, 28,975-76 (May 10, 2016); 89 Fed. Reg. 70,483, 70,485 (Aug. 30, 2024). Under section 906(d)(5) of the Act, no retailer may sell regulated tobacco products to any person younger than 21 years of age and retailers must verify, by means of photographic identification containing a purchaser’s date of birth, that no regulated tobacco product purchasers are younger than 21 years of age.
Accepting the allegations in the complaint as true, I find that Respondent violated the prohibition against selling regulated tobacco products to purchasers younger than 21 years of age on February 15, 2023, November 28, 2023, and November 6, 2024. Act § 906(d)(5). I further find that, on November 28, 2023, Respondent violated the requirement that retailers verify, by means of photo identification containing a purchaser’s date of birth, that no regulated tobacco product purchasers are younger than 21 years of age. Id.; 21 C.F.R. § 1140.14(b)(2)(i). Therefore, I conclude that CTP has established that Respondent committed at least four violations of the Act within a 24-month period.
CTP has requested a civil money penalty of $2,846, which is a permissible penalty under 21 C.F.R. § 17.2. Therefore, I conclude that a civil money penalty of $2,846 is appropriate and impose a penalty in that amount against Respondent.
ORDER
For these reasons, I enter default judgment in the amount of $2,846 against Respondent, EZ Pass Convenient LLC d/b/a EZ Pass Convenience. Pursuant to 21 C.F.R. § 17.11(b), this order becomes final and binding upon both parties after 30 days of the date of its issuance.
Pamela S. Levine Administrative Law Judge