Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Center for Tobacco Products,
Complainant,
v.
ZJHZ Inc.
d/b/a 24/7 Dorsey Mart Tobacco Outlet / Citgo,
Respondent.
Docket No. T-25-2069
FDA Docket No. No. FDA-2025-H-1750
Decision No. TB10811
ORDER GRANTING COMPLAINANT’S MOTION TO IMPOSE SANCTIONS AND INITIAL DECISION AND DEFAULT JUDGMENT
The Center for Tobacco Products (CTP) began this matter by serving an Administrative Complaint (Complaint) on Respondent, ZJHZ Inc. d/b/a 24/7 Dorsey Mart Tobacco Outlet / Citgo, at 1401 Dorsey Road, Hanover, Maryland 21076, and by filing a copy of the Complaint with the Food and Drug Administration’s (FDA) Division of Dockets Management. The Complaint alleges that Respondent impermissibly sold regulated tobacco products to underage purchasers and failed to verify, by means of photo identification containing a date of birth, that the purchasers were 21 years of age or older, thereby violating the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et
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seq., and its implementing regulations, 21 C.F.R. Part 1140. CTP seeks a civil money penalty of $7,115 against Respondent for at least five1 violations within 36-month period.
Respondent filed an Answer to the Complaint in this matter. However, during the course of this administrative proceeding, Respondent failed to comply with multiple judicial orders and directives and failed to defend its case, which interfered with the speedy, orderly, or fair conduct of this proceeding. 21 C.F.R. § 17.35(a).
Currently, CTP’s Status Report and Motion to Impose Sanctions (Motion to Impose Sanctions) is pending before me. CTP’s Motion to Impose Sanctions requests that I strike Respondent’s Answer as a sanction for failing to respond to CTP’s discovery requests and issue a default judgment against Respondent. After carefully considering the entire record, I hereby GRANT CTP’s Motion to Impose Sanctions, strike Respondent’s Answer, and issue this default decision, pursuant to the provisions of 21 C.F.R. § 17.35(a), (c)(3).
I. Procedural History
As provided for in 21 C.F.R. §§ 17.5 and 17.7, on June 25, 2025, CTP served the Complaint on Respondent by United Parcel Service. Civil Remedies Division (CRD) Docket (Dkt.) Entry Numbers (Nos.) 1 (Complaint), 1b (Proof of Service). On July 22, 2025, Respondent filed a timely Answer to CTP’s Complaint denying the allegations. CRD Dkt. Entry No. 3. On August 1, 2025, I issued an Acknowledgement and Pre‑Hearing Order (APHO) that set deadlines for the parties’ filings and exchanges, including a schedule for discovery. CRD Dkt. Entry No. 4. In the APHO, I directed that a party receiving a discovery request must provide the requested documents within 30 days of the request. APHO ¶ 4; see also 21 C.F.R. § 17.23(a). The APHO warned:
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.
APHO ¶ 21.
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On September 2, 2025, in compliance with paragraph 3 of my APHO, CTP timely filed its status report and a notice of appearance. CRD Dkt. Entry No. 6. The status report indicated that the parties were unable to reach a settlement in this case and CTP remained willing to engage in settlement discussions. Id.
On October 3, 2025, CTP timely filed a Motion to Compel Discovery, asserting that Respondent did not respond to its discovery request as required by my APHO and regulations. CRD Dkt. Entry No. 7. On the same date, CTP also filed a Motion to Extend Deadlines requesting a 30-day extension of “any deadlines, including the October 21, 2025, due date for CTP’s pre-hearing exchange . . . .” CRD Dkt. Entry No. 8 at 2.
On October 8, 2025, I issued an Order advising Respondent that it had until October 22, 2025, to file a response to CTP’s Motion to Compel Discovery. CRD Dkt. Entry No. 9. I also warned that if Respondent failed to respond, “I may grant CTP’s motion in its entirety.” Id. at 1; see also APHO ¶¶ 20-21; 21 C.F.R. § 17.32(c). In my Order, I also extended the pre-hearing exchange deadlines. CRD Dkt. Entry No. 9 at 2.
On November 7, 2025, as Respondent had not responded to CTP’s Motion to Compel Discovery as instructed, I issued an order granting CTP’s Motion to Compel Discovery and gave Respondent until November 20, 2025, to comply with CTP’s Request for Production of Documents. CRD Dkt. Entry No. 10 at 1. Respondent was again warned that:
. . . . [F]ailure to comply with this order may result in sanctions, which may include striking its filings and issuing an Initial Decision and Default Judgment finding Respondent liable for the violations listed in the Complaint and imposing a civil money penalty.
Id. at 2.
On December 2, 2025, CTP filed a Status Report and Motion to Impose Sanctions. CRD Dkt. Entry No. 11. CTP advised that Respondent had not complied with the APHO or my November 7, 2025, Order Granting CTP’s Motion to Compel Discovery. Id. at 1-2. CTP argued that sanctions against Respondent for its repeated non-compliance are an appropriate remedy. Id. at 2. Specifically, CTP asked that I strike Respondent’s Answer as a sanction and issue an Initial Decision and Default Judgment finding Respondent liable for the violations listed in the Complaint and imposing a $7,115 civil money penalty. Id. at 2-3. On December 2, 2025, CTP also filed a Motion to Stay Deadlines. CRD Dkt. Entry No. 12.
On December 4, 2025, I issued an Order staying the pre-hearing exchange deadlines and giving Respondent until December 18, 2025, to file a response to CTP’s Motion to
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Impose Sanctions. CRD Dkt. Entry No. 13. The December 4, 2025, Order also warned Respondent that if it “fails to file a response, I may grant CTP’s Motion to Impose Sanctions and impose in its entirety.” Id. at 2.
II. Striking Respondent’s Answer
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).
Respondent failed to comply with multiple judicial orders and procedures governing this proceeding. 21 C.F.R. § 17.35(a)(1). Specifically:
- Respondent failed to comply with 21 C.F.R. § 17.23(a) and paragraph 4 of my APHO, when Respondent failed to respond to CTP’s Request for Production of Documents within 30 days; and
- Respondent failed to comply with my Order Granting CTP’s Motion to Compel Discovery when it failed to produce documents responsive to CTP’s Request for Production of Documents by November 20, 2025.
I also find that Respondent failed to defend this action. 21 C.F.R. § 17.35(a)(2). Specifically:
- Respondent did not file a response to CTP’s Motion to Compel Discovery, as permitted by the regulations and my October 8, 2025, Order; and
- Respondent did not file a response to CTP’s Motion to Impose Sanctions, as permitted by the regulations and my December 4, 2025, Order.
I find that Respondent failed to comply with multiple orders and procedures governing this proceeding, failed to defend its case, and, as a result, interfered with the speedy, orderly, or fair conduct of this proceeding. I conclude that Respondent’s conduct establishes a basis for sanctions pursuant to 21 C.F.R. § 17.35, and that sanctions are warranted.
Any sanctions I impose must relate reasonably to the nature and severity of Respondent’s misconduct or failure to comply. 21 C.F.R. § 17.35(b). Here, Respondent has ceased participating in this action after initially filing an Answer denying all of the violations
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alleged in CTP’s Complaint. CRD Dkt. Entry No. 3 at 1-2. Specifically, Respondent failed to comply with regulatory requirements and two judicial orders, despite my explicit warnings that its failure to do so could result in sanctions. See APHO ¶ 21; CRD Dkt. Entry No. 10 at 2. Respondent’s repeated misconduct interfered with the speedy, orderly, or fair conduct of this proceeding.
Accordingly, I find that Respondent’s actions are sufficiently egregious to warrant striking its Answer and issuing a decision by default, without further proceedings. 21 C.F.R. § 17.35(b), (c)(3).
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). Pursuant to 21 C.F.R. § 17.11(a), I am required to “assume the facts alleged in the [C]omplaint to be true” and, if those facts establish liability under the Act, issue a default judgment and impose a civil money penalty.
Accordingly, I must determine whether the allegations in the Complaint establish violations of the Act.
Specifically, CTP alleges the following facts in its Complaint:
- Respondent owns 24/7 Dorsey Mart Tobacco Outlet / Citgo located at 1401 Dorsey Road, Hanover, Maryland 21076;
- Respondent’s establishment receives tobacco products in interstate commerce and holds them for sale after shipment in interstate commerce;
- On September 16, 2024, CTP initiated a previous civil money penalty action, CRD Docket Number T-24-4452, FDA Docket Number FDA-2024-H-4338, against Respondent for at least three violations of the Act. CTP alleged those violations to have occurred at Respondent’s business establishment on March 21, 2023, and June 27, 20241F2;
- 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
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right to contest such violations in subsequent actions”;
- An FDA-commissioned inspector conducted a subsequent inspection on January 9, 2025, at approximately 2:46 PM at Respondent’s business establishment. During this inspection, a person younger than 21 years of age was able to purchase a package of Newport cigarettes. Additionally, Respondent’s staff failed to verify, by means of photographic identification containing a date of birth, that the purchaser was 21 years of age or older.
Complaint ¶¶ 11-16.
These facts establish Respondent 24/7 Dorsey Mart Tobacco Outlet / Citgo’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 under section 906(d) of the Act. 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. pt. 1140 under section 906(d) of the Act. 21 U.S.C. § 387a-1; see 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). Pursuant to section 906(d)(5) of the Act, retailers are prohibited from selling regulated tobacco products to any person younger than 21 years of age. Retailers must also 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.
Respondent 24/7 Dorsey Mart Tobacco Outlet / Citgo having failed to file an answer and taking the alleged above facts as true, I find that Respondent violated the prohibition against selling regulated tobacco products to underage purchasers and that it failed to verify that the purchasers were 21 years of age or older. These actions constitute violations of the Act, 21 U.S.C. § 301 et seq., and its implementing regulations, 21 C.F.R. pt. 1140. Accordingly, Respondent’s actions warrant imposing a civil money penalty in the amount of $7,115 pursuant to 21 C.F.R. § 17.2.
ORDER
For these reasons, I enter Default Judgment and impose a civil money penalty in the amount of $7,115 against Respondent ZJHZ Inc. d/b/a 24/7 Dorsey Mart Tobacco Outlet / Citgo. 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.
Rochelle D. Washington Administrative Law Judge
- 1
The Complaint alleges two violations on [Status], two on June 27, 2024, and two on January 9, 2025. In accordance with customary practice, CTP counted the violations at the initial inspection as a single violation, and all subsequent violations as separate individual violations. See Orton Motor, Inc. d/b/a Orton’s Bagley v. U.S. Dep’t of Health & Human Serv., 884 F.3d 1205 (D.C. Cir. 2018).
- 2
In paragraph 15.b of the Complaint, CTP includes a June 26, 2024, violation date from a previous civil money penalty action. However, there is no June 26, 2024, violation in the previous civil money penalty action. Pursuant to 21 C.F.R. § 17.48, this is a typographical error and CTP meant to include June 27, 2024, instead of June 26, 2024.