Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Center for Tobacco Products,
Complainant,
v.
G & J Smoke & Vape Shop LLC
d/b/a G & J Smoke Shop,
Respondent.
Docket No. T-25-2832
FDA Docket No. FDA-2025-H-3067
Decision No. TB11035
ORDER GRANTING COMPLAINANT’S MOTION TO IMPOSE SANCTIONS
AND INITIAL DECISION AND DEFAULT JUDGMENT
On August 14, 2025, the Center for Tobacco Products (CTP) served an administrative complaint on Respondent, G & J Smoke & Vape Shop LLC d/b/a G & J Smoke Shop, at 2441 North 48th Street, Lincoln, Nebraska 68504. 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 $14,232 civil money penalty against Respondent G & J Smoke Shop for at least seven 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 48-month period.
While Respondent timely filed an answer to the complaint and a pre-hearing exchange, Respondent has repeatedly disregarded my orders and has not been responsive to CTP’s discovery requests. Specifically, Respondent failed to produce documents responsive to CTP’s document requests, failed to respond to CTP’s Motion to Compel Discovery,
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failed to comply with my Order granting CTP’s Motion to Compel Discovery, and failed to respond to the present Motion to Impose Sanctions.
Currently before me is CTP’s Motion to Impose Sanctions, which requests that I impose sanctions against Respondent for its noncompliance with the rules and orders governing this proceeding. As a proposed 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. Procedural History
On August 14, 2025, CTP served an administrative complaint on Respondent by United Parcel Service in accordance with 21 C.F.R. §§ 17.5 and 17.7. See Civil Remedies Division (CRD) Docket (Dkt.) Entry Numbers (Nos.) 1 (Complaint), 1b (Proof of Service). On September 13, 2025, Respondent’s designated representative timely filed an answer to the complaint. CRD Dkt. Entry No. 3. In its answer, Respondent admitted all of the allegations in the complaint, but argued that the penalty proposed by CTP is not appropriate. See id.
On October 2, 2025, I issued an Acknowledgment and Pre-Hearing Order (APHO). CRD Dkt. Entry No. 4. The APHO outlined the procedures governing this case and established deadlines for the parties to complete discovery and file pre-hearing exchanges. Id. Among other provisions, the APHO directed the parties to serve all discovery requests by November 7, 2025, and explained that a party must 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). The APHO also warned that I may impose sanctions, up to and including dismissal of the Complaint or striking the Answer, for failing to comply with any order in this case, failing to prosecute or defend its case, or engaging in misconduct that “interferes with the speedy, orderly, or fair conduct of the hearing.” CRD Dkt. Entry No. 4 ¶ 21; see also 21 C.F.R. § 17.35.
On October 31, 2025, CTP filed a status report regarding the status of settlement discussions. CRD Dkt. Entry No. 6. In the status report, CTP stated that the parties have been unable to reach a settlement in this case. Id. at 1.
On November 19, 2025, CTP filed a Motion to Compel Discovery, stating that it served a request for production of documents on Respondent on October 15, 2025, but had not received any response. CRD Dkt. Entry No. 7. By separate filing, CTP also requested a 30-day extension of all deadlines in this case due to the discovery delay. CRD Dkt. Entry No. 8.
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On November 24, 2025, I issued an Order advising Respondent that it had until December 9, 2025 to file a response to CTP’s Motion to Compel Discovery. CRD Dkt. Entry No. 9. I also granted CTP’s request to extend the parties’ pre-hearing exchange deadlines by 30 days. Id. at 2. Pursuant to that Order, CTP’s pre-hearing exchange was due by January 21, 2026 and Respondent’s pre-hearing exchange was due by February 11, 2026. Id.
Respondent did not file a response to CTP’s Motion to Compel Discovery or otherwise respond to my November 24, 2025 Order. However, on December 5, 2025, Respondent prematurely filed a pre-hearing exchange, consisting of a pre-hearing brief and one three-page exhibit. See CRD Dkt. Entry Nos. 10, 10a-10b.
On January 12, 2026, I issued an Order granting CTP’s Motion to Compel Discovery and ordered Respondent to produce all documents responsive to CTP’s Request for Production of Documents in its entirety by January 27, 2026. See CRD Dkt. Entry No. 12 at 2. I also extended the parties’ pre-hearing exchange deadlines by an additional 30 days to account for the discovery delay. Id. I specifically warned Respondent that if it failed to comply, I could impose sanctions, “including the issuance of 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 February 2, 2026, CTP filed the present Motion to Impose Sanctions. CRD Dkt. Entry No. 13. In the motion, CTP states that despite filing its pre-hearing exchange, Respondent failed to comply with my January 12, 2026 Order granting its Motion to Compel Discovery and has not produced all documents responsive to CTP’s discovery requests. Id. at 1-2. CTP asks that I sanction Respondent by striking its answer and issuing an Initial Decision and Default Judgment imposing the requested $14,232 civil money penalty. Id. at 3. By separate filing, CTP also asked me to stay all deadlines pending resolution of its Motion to Impose Sanctions. CRD Dkt. Entry No. 14.
On February 4, 2026, I issued an Order advising Respondent that it had until February 19, 2026, to file a response to CTP’s Motion to Impose Sanctions. CRD Dkt. Entry No. 15 at 2. In the Order, I warned Respondent that “if it fails to timely respond, I may grant CTP’s motion in its entirety.” Id. I also granted CTP’s request to stay all deadlines pending resolution of the Motion to Impose Sanctions. Id.
To date, Respondent has not filed a response to CTP’s Motion to Impose Sanctions, fully complied with CTP’s document requests, or otherwise complied with or responded to my Order granting CTP’s Motion to Compel Discovery.
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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 Respondent failed, and continues to fail, to comply with multiple orders and rules in this proceeding, including:
- The requirements in 21 C.F.R. § 17.23(a) and paragraph 4 of the APHO, by failing to respond to CTP’s document requests within 30 days; and
- My January 12, 2026 Order granting CTP’s Motion to Compel Discovery, by failing to produce documents responsive to CTP’s RFP in its entirety by January 27, 2026.
In addition, I find that Respondent has failed to defend this action. Specifically, although Respondent prematurely filed its pre-hearing exchange, it did not file any response to CTP’s Motion to Compel Discovery or respond to my November 24, 2025 Order, nor has it responded to CTP’s Motion to Impose Sanctions. Respondent’s noncompliance and lack of responsiveness 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 failure to comply. 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. Respondent’s conduct is particularly serious given that I warned Respondent on multiple occasions that its noncompliance could result in sanctions. See CRD Dkt. Entry No. 4 ¶ 21; CRD Dkt. Entry No. 12 at 2; CRD Dkt. Entry No. 15 at 2. Under the circumstances, I find that Respondent’s behavior suggests it has abandoned its defense and is no longer interested in participating in these proceedings.
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. § 17.35(b), (c)(3); see also KKNJ, Inc. d/b/a Tobacco Hut 12, DAB No. 2678 at 10-11
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(2016) (concluding ALJ 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 this case. Indeed, Respondent’s conduct has effectively brought this proceeding to a standstill without any explanation or justification. 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 the 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 G & J Smoke Shop, an establishment that sells tobacco products and is located at 2441 North 48th Street, Lincoln, Nebraska 68504. Complaint ¶¶ 11-12.
- On December 6, 2024, CTP initiated a previous civil money penalty action, CRD Docket Number T-25-792, FDA Docket Number FDA-2024-H-5621, against Respondent for at least five1 violations of the Act. CTP alleged those violations to have occurred on October 31, 2022, October 20, 2023, and September 13, 2024. 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 March 14, 2025, at approximately 10:02 AM, at Respondent’s business establishment. During the inspection, a person younger than 21 years of age was able to purchase
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- a package of Marlboro Gold Pack 100’s 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 ¶ 13.
These facts establish Respondent G & J Smoke Shop’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. § 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 October 31, 2022, October 20, 2023, September 13, 2024, and March 14, 2025. Act § 906(d)(5). I further find that, on those same dates, 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(a)(2)(i), 1140.14(b)(2)(i). Therefore, I conclude that CTP has established that Respondent committed at least seven violations of the Act within a 48-month period.
CTP has requested a civil money penalty of $14,232, which is a permissible penalty under 21 C.F.R. § 17.2. Therefore, I conclude that a civil money penalty of $14,232 is appropriate and impose a penalty in that amount against Respondent.
ORDER
For these reasons, I enter default judgment in the amount of $14,232 against Respondent, G & J Smoke & Vape Shop LLC d/b/a G & J Smoke Shop. 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.
Adam R. Gazaille Administrative Law Judge
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The complaint alleges two violations were committed on October 31, 2022, two on October 20, 2023, and two on September 13, 2024. 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).