Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Center for Tobacco Products,
Complainant,
v.
Yaaja Food & Deli LLC
d/b/a Rich’s Deli,
Respondent.
Docket No. T-24-2662
FDA Docket No. FDA-2024-H-2006
Decision No. TB9094
ORDER GRANTING COMPLAINANT’S MOTION TO IMPOSE SANCTIONS AND INITIAL DECISION AND DEFAULT JUDGMENT
On April 26, 2024, the Center for Tobacco Products (CTP) served a Complaint on Yaaja Food & Deli LLC d/b/a Rich’s Deli (Respondent), at 2826 State Route 23, Stockholm, New Jersey 07460. A copy of the complaint was also filed with the Food and Drug Administration’s (FDA) Division of Dockets Management on April 29, 2024. CTP seeks to impose a $6,892 civil money penalty against Respondent for violating the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq., and its implementing regulations, 21 C.F.R. pt. 1140, at least five times within a 36-month period.
Respondent, through counsel, filed an untimely answer to the complaint. Since filing its answer, however, Respondent has repeatedly disregarded my orders and has been non-responsive to CTP’s requests. Respondent failed to respond to CTP’s request for
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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.
Currently before me is CTP’s Motion to Impose Sanctions, which requests that I impose sanctions against Respondent for failing to respond to CTP’s discovery requests and for ignoring my order granting CTP’s motion to compel discovery. As a proposed sanction, 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. Accordingly, 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 April 26, 2024, 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 No. 1b. Respondent’s answer to the complaint was due by May 28, 2024. See 21 C.F.R. § 17.9.
On May 29, 2024, Respondent, through counsel, registered for the Departmental Appeals Board’s electronic filing system and filed an untimely answer to CTP’s complaint. CRD Dkt. Entry No. 3a. Respondent provided no explanation for its untimely filing. Accordingly, on May 30, 2024, I issued an Order establishing a deadline of June 6, 2024 for Respondent to demonstrate that extraordinary circumstances prevented it from timely filing its answer. CRD Dkt. Entry No. 4. I also established a deadline of June 13, 2024 for CTP to state whether it had any objections to Respondent’s untimely answer. Id. Respondent failed to file any response to my Order. However, on June 10, 2024, CTP informed my office via email that it did not intend to object to Respondent’s untimely answer. CRD Dkt. Entry No. 6.
On June 24, 2024, based on the lack of objections from CTP, I issued an Acknowledgment and Pre-Hearing Order (APHO), accepting Respondent’s untimely answer and establishing deadlines for the parties to complete discovery and file pre-hearing exchanges. CRD Dkt. Entry No. 7. With respect to discovery, the APHO stated that a party must produce any requested documents no later than 30 days after receiving a request for documents from the opposing party. APHO ¶ 4; see also 21 C.F.R. § 17.23(a). In the APHO, I also warned that I may impose sanctions against a party, up to and including dismissal of the Complaint or 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.” APHO ¶ 21; see also 21 C.F.R. § 17.35.
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On August 23, 2024, CTP filed a motion to compel discovery, stating it served document requests on Respondent’s counsel on July 17, 2024, but Respondent failed to respond. CRD Dkt. Entry No. 10 at 1-2. On the same date, CTP also requested a 30-day extension of all deadlines in this case. CRD Dkt. Entry No. 11 at 2.
On August 26, 2024, I issued an Order advising Respondent that it had until September 10, 2024, to respond to CTP’s motion to compel discovery. CRD Dkt. Entry No. 12. I also granted CTP’s motion to extend deadlines. Id. at 2.
Respondent did not file a response to CTP’s motion to compel discovery. Accordingly, on October 2, 2024, based on the representations made in the motion, I granted CTP’s motion to compel discovery and ordered Respondent to comply with CTP’s request for production of documents by October 15, 2024. CRD Dkt. Entry No. 13. I also warned Respondent:
Failure 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 Complaint and imposing a civil money penalty.
Id. at 2.
On October 22, 2024, CTP filed the present Motion to Impose Sanctions. CRD Dkt. Entry No. 14. In the motion, CTP states Respondent failed to comply with my October 2, 2024 Order granting CTP’s motion to compel discovery and has not produced any documents in response to CTP’s discovery requests. Id. at 2. CTP asks that I strike Respondent’s answer as a sanction for Respondent’s repeated non-compliance and non-responsiveness. Id. CTP further asks that I issue an Initial Decision and Default Judgment finding Respondent liable for the violations listed in the complaint and imposing a $6,892 civil money penalty. Id. CTP filed a separate motion asking me to stay all deadlines pending resolution of its Motion for Sanctions. CRD Dkt. Entry No. 15.
On October 30, 2024, I issued an Order giving Respondent until November 13, 2024, 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 the Motion. Id.
To date, Respondent has not produced any documents in response to CTP’s discovery requests or otherwise complied with my Order granting CTP’s motion to compel. In addition, Respondent has not filed a response to CTP’s Motion to Impose.
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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, Respondent failed, and continues to fail, to comply with multiple orders and rules, including:
- the requirements in 21 C.F.R. § 17.9, by failing to answer the complaint within 30 days;
- 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 the Production of Documents within 30 days; and
- my October 2, 2024 Order granting CTP’s motion to compel discovery, by failing to produce documents responsive to CTP’s Request for the Production of Documents by October 15, 2024.
Additionally, Respondent has failed to defend this action. Specifically, Respondent did not file a response to CTP’s Motion to Compel Discovery or CTP’s Motion to Impose Sanctions, and has not taken any action in this case since filing its untimely answer.
Based on the foregoing, I find that Respondent failed to comply with orders and procedures governing this proceeding, failed to defend this action, and, as a result, interfered with the speedy, orderly, and fair conduct of this proceeding. 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 failed to comply with a regulatory requirement and multiple orders, despite being warned that such conduct may result in sanctions. See, e.g., CRD Dkt. Entry No. 13; see also APHO ¶ 21. Further, Respondent failed to respond to multiple motions, including the present motion for sanctions. In fact, Respondent has not taken any action in this case since filing its untimely answer on May 29, 2024. Respondent’s behavior suggests it has abandoned its defense and is not interested in continuing to participate in these proceedings.
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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 otherwise deciding this case on the merits. 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 (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. 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:
- On September 20, 2023, CTP initiated a previous civil money penalty action, CRD Docket Number T-23-3777, FDA Docket Number FDA-2023-H-4027, against Respondent for at least three violations1 of the Act. CTP alleged those violations to have occurred at Respondent’s business establishment, 2826 State Route 23, Stockholm, New Jersey 07460, on May 21, 2022, and July 8, 2023;
- The previous action concluded when an Initial Decision and Default Judgment was entered by an Administrative Law Judge, “finding that all of the violations alleged in the Complaint occurred”;
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- An FDA-commissioned inspector conducted a subsequent inspection on February 16, 2024, at approximately 11:35 AM at Respondent’s business establishment located at 2826 State Route 23, Stockholm, New Jersey 07460. During this inspection, a person younger than 21 years of age was able to purchase a Lava Plus Peach Ice electronic nicotine delivery system (ENDS) product. 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.
These facts establish Respondent Rich’s Deli’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); see also 21 U.S.C. § 387f (note) (directing the Secretary to change references to persons younger than 18 to younger than 21, and to change the age verification requirements from individuals under the age of 26 to under the age of 30, in 21 C.F.R. subpart B of part 1140). 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.
CTP has requested a civil money penalty of $6,892, which is a permissible penalty under 21 C.F.R. § 17.2. Therefore, I find that a civil money penalty of $6,892 is warranted and impose a penalty in that amount against Respondent.
Order
For the reasons stated above, I enter default judgment and impose a civil money penalty against Respondent, Yaaja Food & Deli LLC d/b/a Rich’s Deli, in the amount of $6,892. 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 current complaint alleges two violations were committed on May 21, 2022, two violations on July 8, 2023, and two violations on February 16, 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).