OM Guru, LLC d/b/a Dash In / Shell, DAB TB8980 (2025)

ORDER GRANTING COMPLAINANT’S MOTION TO IMPOSE SANCTIONS AND INITIAL DECISION AND DEFAULT JUDGMENT

The Center for Tobacco Products (CTP) filed an Administrative Complaint (Complaint) against Respondent, OM Guru, LLC d/b/a Dash In / Shell, alleging facts and legal authority sufficient to justify imposing a civil money penalty of $687. CTP began this case by serving a Complaint on Respondent and filing a copy of the Complaint with the Food and Drug Administration’s (FDA) Division of Dockets Management. The Complaint alleges that Respondent’s staff sold regulated tobacco products to underage purchasers and failed to verify 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 seq., and

Page 2

its implementing regulations, 21 C.F.R. pt. 1140. CTP seeks a civil money penalty of $687 for three violations of the regulations within a 24-month period.1

Respondent filed an answer in this matter but failed to comply with multiple judicial orders and procedures governing this proceeding, and also failed to defend its actions, which interfered with the speedy, orderly, or fair conduct of this proceeding. 21 C.F.R. § 17.35(a). Accordingly, pursuant to 21 C.F.R. § 17.35(c)(3), I strike Respondent’s Answer and issue this decision of default judgment.

I. Procedural History

On March 22, 2024, CTP served the Complaint and supporting documents on Respondent by United Parcel Service, pursuant to 21 C.F.R. §§ 17.5 and 17.7. Civil Remedies Division (CRD) Docket (Dkt.) Entry Nos. 1-1b. On April 15, 2024, Respondent registered for the Departmental Appeals Board’s (DAB) e-filing system and timely filed its Answer to CTP’s Complaint. CRD Dkt. Entry No. 3.

On April 18, 2024, the previously assigned Administrative Law Judge, Kourtney LeBlanc, issued an Acknowledgment and Pre-Hearing Order (APHO) that set deadlines for the parties’ filings and exchanges, including a schedule for discovery. CRD Dkt. Entry No. 4. Judge LeBlanc directed that a party receiving a discovery request must provide the requested documents within 30 days of the request. CRD Dkt. Entry No. 4 ¶ 4; see 21 C.F.R. § 17.23(a). Judge LeBlanc warned that sanctions may be imposed if a party failed to comply with any order, including the APHO. CRD Dkt. Entry No. 4 ¶ 21.

On May 17, 2024, CTP filed an Unopposed Motion to Extend Deadlines and Notice of Pending Settlement, requesting that all deadlines in this case be extended for thirty (30) days. CRD Dkt. Entry No. 5. On that same date, Judge LeBlanc granted CTP’s unopposed motion to extend deadlines. CRD Dkt. Entry No. 6.

On June 20, 2024, attorney Tara Ravindra entered an appearance on behalf of CTP. CRD Dkt. Entry No. 7.

On July 3, 2024, this case was reassigned to me for adjudication. CRD Dkt. Entry No. 8.

On July 24, 2024, CTP filed its second Unopposed Motion to Extend Deadlines and Notice of Pending Settlement, requesting that all deadlines in this case be extended for an

Page 3

additional thirty (30) days. CRD Dkt. Entry No. 9. On that same date, I granted CTP’s second unopposed motion to extend deadlines. CRD Dkt. Entry No. 10.

On June 20, 2024, attorney Brian Furlong entered an appearance on behalf of CTP. CRD Dkt. Entry No. 11.

On August 30, 2024, CTP filed a Motion to Compel Discovery asserting that Respondent did not respond to its discovery request as required by the APHO and regulations. CRD Dkt. Entry Nos. 12-12c. CTP also contemporaneously filed a Motion to Extend Deadlines. CRD Dkt. Entry No. 13.

On September 6, 2024, I issued an Order informing Respondent of its September 23, 2024, deadline to file a response to CTP’s Motion to Compel Discovery, and warned that if Respondent failed to respond, “I may grant CTP’s motion in its entirety.” CRD Dkt. Entry No. 15 at 1 (emphasis in original); see also 21 C.F.R. § 17.32(c); CRD Dkt. Entry No. 4 at ¶ 20. Additionally, I held the pre-hearing exchange deadlines in abeyance. CRD Dkt. Entry No. 15 at 2. On September 9, 2024, I issued the First Amendment to September 6, 2024, Order, correcting an error regarding the date that Respondent’s response to CTP’s Request for Production of Documents was due. See CRD Dkt. Entry No. 16 at 1.

Respondent did not respond to the September 6, 2024, Order, nor the September 9, 2024, First Amendment to September 6, 2024, Order.

On September 26, 2024, I issued an Order Granting Complainant’s Motion to Compel Discovery, ordering Respondent to produce documents responsive to CTP’s discovery request, or indicate that Respondent did not have any documents to produce, by October 7, 2024, and warned Respondent that:

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.

CRD Dkt. Entry No. 17 at 2 (emphasis in original).

My September 26, 2024, Order also reestablished the parties pre-hearing exchange deadlines, establishing a November 12, 2024, deadline for CTP’s pre-hearing exchange to Respondent, and a December 2, 2024, deadline for Respondent’s pre-hearing exchange to CTP. See id.

On October 8, 2024, CTP filed Complainant’s Status Report and Motion to Impose Sanctions. CRD Dkt. Entry No. 18. CTP also filed a Motion to Stay Deadlines. CRD

Page 4

Dkt. Entry No. 19. In the former, CTP advised that Respondent did not produce responsive documents in compliance with my Order Granting Complainant’s Motion to Compel Discovery. CRD Dkt. Entry No. 18 at 2.

On October 10, 2024, I issued an Order informing Respondent that it had until October 25, 2024, to file a response to CTP’s Motion to Impose Sanctions. CRD Dkt. Entry No. 20 at 1-2. To date, Respondent has not responded to my October 10, 2024, Order.

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 the following orders and procedures governing this proceeding:

• Respondent failed to comply with 21 C.F.R. § 17.23(a) and paragraph 4 of the APHO, when Respondent failed to respond to CTP’s Request for Production of Documents within 30 days; and
• Respondent failed to comply with my September 26, 2024, Order Granting Complainant’s Motion to Compel Discovery when it failed to submit the documents responsive to CTP’s Request for Production of Documents by October 7, 2024.

Respondent also failed to defend its action despite my September 6, 2024, as amended, and October 10, 2024, Orders informing Respondent of such opportunities and warning of consequences. 21 C.F.R. § 17.35(a)(2). Respondent’s failure to respond to CTP’s motions, to comply with my multiple orders, and to fulfill its discovery obligations suggests that it has abandoned its defense in this case.

Therefore, I find that Respondent failed to comply with multiple judicial 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.

Page 5

The harshness of 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 failed to comply with a regulation governing this proceeding. See 21 C.F.R. § 17.23(a). In addition, Respondent failed to comply with two orders despite explicit warnings that its failure to do so could result in sanctions. Specifically, Judge LeBlanc’s APHO warned the parties of “sanctions including, but not limited to, dismissal of the complaint or answer, if a party fails to comply with any order . . . , fails to prosecute or defend its case, or engages in misconduct that interferes with the speedy, orderly, or fair conduct of the hearing.” CRD Dkt. Entry No. 4 ¶ 21. Further, my Order Granting Complainant’s Motion to Compel Discovery, specified that those sanctions may include “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.” CRD Dkt. Entry No. 17 at 2. Respondent also failed to defend its actions, despite my orders expressly reminding Respondent of the opportunity to do so. Respondent’s repeated misconduct interfered with the speedy, orderly, or fair conduct of this proceeding. I find that Respondent’s actions are sufficient to warrant striking its Answer and issuing a decision by default, without further proceedings. 21 C.F.R. § 17.35(b), (c)(3); see also KKNJ, Inc. d/b/a Tobacco Hut 12, DAB No. 2678 at 8 (2016) (concluding that “the ALJ [Administrative Law Judge] did not abuse her discretion in sanctioning Respondent’s ongoing failure to comply with the ALJ’s directions by striking Respondent’s answer to the Complaint.”).

Accordingly, I strike Respondent’s Answer, and issue this Initial Decision and Default Judgment, assuming the facts alleged in CTP’s Complaint to be true. 21 C.F.R. §§ 17.35(c)(3), 17.11(a).

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:

• At approximately 1:36 PM on July 19, 2023, at Respondent’s business establishment, 1517 South Caton Avenue, Halethorpe, MD 21227,2 an FDA

Page 6

• commissioned inspector conducted an inspection. During this inspection, a person younger than 21 years of age was able to purchase a Black & Mild Wine cigar. 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;
• In a warning letter dated August 17, 2023, CTP informed Respondent of the inspector’s July 19, 2023, documented violations, and that such actions violate federal law. The letter further warned that Respondent’s failure to correct its violations could result in a civil money penalty or other regulatory action;
• At approximately 1:07 PM on January 10, 2024, at Respondent’s business establishment, 1517 South Caton Avenue, Halethorpe, MD 21227, an FDA commissioned inspector conducted a subsequent inspection. During this inspection, a person younger than 21 years of age was able to purchase a Black & Mild Original cigar. 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.

These facts establish Respondent Dash In / Shell’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 issued the regulations at 21 C.F.R. part 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); 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.

Taking the above alleged facts as true, I find that Respondent violated the prohibition against selling regulated tobacco products to underage purchasers and failed to verify that the purchasers were 21 years of age or older, thereby violating the Act, 21 U.S.C. § 301 et seq., and its implementing regulations, 21 C.F.R. pt. 1140. Therefore, Respondent’s actions constitute violations of law that merit a civil money penalty in the amount of $687 as permissible under 21 C.F.R. § 17.2.

Page 7

ORDER

For these reasons, I enter default judgment in the amount of $687 against Respondent, OM Guru, LLC d/b/a Dash In / Shell. 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.