D Town Grocery Store LLC d/b/a Downtown Grocery Store, DAB TB8967 (2025)

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

The Center for Tobacco Products (CTP) filed an Administrative Complaint (Complaint) against Respondent, D Town Grocery Store LLC d/b/a Downtown Grocery Store, alleging facts and legal authority sufficient to justify imposing a No-Tobacco-Sale Order (NTSO) against Respondent for a period of 30 consecutive calendar days. 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 impermissibly sold regulated tobacco product to underage purchasers and failed to verify that tobacco product purchasers were of sufficient age, thereby violating the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq., and its implementing regulations, Cigarettes and Smokeless Tobacco, 21 C.F.R. pt. 1140.

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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. During the course of these proceedings, Respondent failed to comply with orders and procedures governing this proceeding and failed to defend this action, 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 19, 2024, CTP served the Complaint on Respondent by United Parcel Service, pursuant to 21 C.F.R. §§ 17.5 and 17.7. In the Complaint and accompanying cover letter, CTP explained that within 30 days, Respondent should file an answer or request an extension of time within which to file an answer. Civil Remedies Division (CRD) Docket (Dkt.) Entry Nos. 1, 1a. CTP warned Respondent that if it failed to take one of these actions within 30 days an Administrative Law Judge could, pursuant to 21 C.F.R. § 17.11, issue an initial decision imposing a No-Tobacco-Sale Order against Respondent. CRD Dkt. Entry No. 1a at 1.

On April 18, 2024, Respondent filed a timely answer. However, the answer was incomplete and missing page 1 of the Answer form. CRD Dkt. Entry Nos. 3, 3a. On April 26, 2024, a by direction letter, issued by the Administrative Law Judge (ALJ) previously assigned to this case, was sent to Respondent giving until May 10, 2024 to file an amended answer. CRD Dkt. Entry No. 5. On May 9, 2024, Respondent submitted the missing page 1 to the answer. CRD Dkt. Entry No. 6.

On May 14, 2024, an Acknowledgment and Status Report Order (ASRO) was issued that gave the parties 60 days from the date of the order to file a Joint Status Report regarding the status of the case. CRD Dkt. Entry No. 7 at 2. On July 3, 2024, CTP filed a Joint Status Report advising of the parties’ inability to reach a settlement in this case, and CTP’s intent to proceed to a hearing. CRD Dkt. Entry No. 8. On July 24, 2024, an Acknowledgment and Pre-Hearing Order (APHO) was issued, which set deadlines for the parties’ filings and exchanges, including a schedule for discovery. CRD Dkt. Entry No. 9 (APHO). The APHO directed that a party receiving a discovery request must provide the requested documentation within 30 days of the request. APHO ¶ 4; see also 21 C.F.R. § 17.23(a). The APHO warned:

. . . [the presiding ALJ] 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

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in misconduct that interferes with the speedy, orderly, or fair conduct of the hearing. 21 C.F.R. § 17.35.

APHO ¶ 21. On August 23, 2024, this case was reassigned to me. CRD Dkt. Entry No. 11.

In accordance with the deadlines set forth in the APHO, CTP served Respondent with its Request for Production of Documents on August 5, 2024. On September 9, 2024, CTP filed a Motion to Compel Discovery asserting that Respondent had not responded to its discovery request. CRD Dkt. Entry No. 12. On that same date, CTP also filed a Motion to Extend Deadlines. CRD Dkt. Entry No. 13. On September 12, 2024, I issued an Order advising Respondent that it had until September 26, 2024, to file a response to CTP’s Motion to Compel Discovery. CRD Dkt. Entry No. 14; see also 21 C.F.R. § 17.32(c); APHO ¶ 20. My September 12, 2024 Order also extended the parties’ pre-exchange deadlines. CRD Dkt. Entry No. 14. Respondent failed to submit a response to CTP’s Motion to Compel Discovery or the September 12, 2024 Order, or otherwise comply with CTP’s Request for Production of Documents.

On September 30, 2024, I issued an Order granting CTP’s Motion to Compel Discovery and ordered Respondent to produce responsive documents to CTP’s Request for Production of Documents by October 16, 2024. I warned:

Failure to [comply] may result in sanctions, including the issuance of an Initial Decision and Default Judgment finding Respondent liable for the violations listed in the Complaint . .

CRD Dkt. Entry No. 15 at 1-2.

On October 17, 2024, CTP filed a Status Report and Motion to Impose Sanctions. CRD Dkt. Entry No. 16. CTP advised that Respondent had not complied with the APHO or my September 30, 2024 Order requiring Respondent to produce documents responsive to CTP’s Request for Production of Documents by October 16, 2024. Id. at 1-2. CTP argued that sanctions against Respondent for its repeated non-compliance are an appropriate remedy. 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 No-Tobacco-Sale Order. Id. at 2. On October 17, 2024, CTP also filed a Motion to Stay Deadlines pending resolution of its Motion to Impose Sanctions. CRD Dkt. Entry No. 17 at 1.

On October 21, 2024, I issued an Order giving Respondent until November 5, 2024, to file a response to CTP’s Motion to Impose Sanctions. CRD Dkt. Entry No. 18. The October 21, 2024 Order also stayed all deadlines pending resolution of CTP’s Motion to

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Impose Sanctions. Id. To date, Respondent has not filed a response to CTP’s Motion to Impose Sanctions or the October 21, 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 multiple judicial orders and directives. Specifically, Respondent has not complied with:

• the regulation at 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 30, 2024 Order, when it failed to submit documents responsive to CTP’s Request for Production of Documents by October 16, 2024.

Additionally, 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 September 12, 2024 Order; and
• Respondent did not file a response to CTP’s Motion to Impose Sanctions, as permitted by the regulations and my October 21, 2024 Order.

Respondent’s failure to respond to CTP’s motions, to comply with multiple orders, and to fulfill its discovery obligations suggests that Respondent has abandoned its defense in this case.

In the absence of any explanation from Respondent, 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. I conclude that Respondent’s conduct establishes a basis for sanctions pursuant to 21 C.F.R. § 17.35, and that sanctions are warranted.

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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 two of my orders, despite my explicit warnings that its failure could result in sanctions. CRD Dkt. Entry Nos. 9 ¶ 21; 15 at 1-2. 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). 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:

• On March 10, 2015, CTP initiated its first civil money penalty action, FDA Docket Number FDA-2015-H-0705, CRD Docket Number C-15-1533, against Respondent for at least three1 violations within a 24-month period. CTP alleged those violations to have occurred at Respondent's business establishment, 116 Winter Street, New Britain, Connecticut 06051, on July 30, 2014, and October 29, 2014. Complaint ¶¶ 7, 11.

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• The first action concluded when an Initial Decision and Default Judgment was entered by the Administrative Law Judge, “finding Respondent liable for the July 30, 2014 and October 29, 2014 violations.” Complaint ¶ 11.
• On December 17, 2019, CTP initiated its second civil money penalty action, FDA Docket Number FDA-2019-H-5880, CRD Docket Number T-20-1063, against Respondent for at least three2 violations on July 30, 2018, and September 18, 2019. Complaint ¶ 12.
• The second action concluded when Respondent “admitted all of the allegations in the Complaint and paid the agreed upon penalty.” Further, “Respondent expressly waived its rights to contest such violations in subsequent actions.” Complaint ¶ 12.
• On December 14, 2022, CTP initiated its third civil money penalty action, FDA Docket Number FDA-2022-H-3175, CRD Docket Number T-23-572, against Respondent for at least three3 violations on October 29, 2021, and September 27, 2022. Complaint ¶ 13.
• The third action concluded when Respondent “admitted all of the allegations in the Complaint and paid the agreed upon penalty.” Further, “Respondent expressly

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waived its rights to contest such violations in subsequent actions.” Complaint ¶ 13.

• At approximately 10:01 AM on July 24, 2023, an FDA-commissioned inspector documented Respondent’s staff selling a package of two Garcia y Vega Game Honey cigars to a person younger than 21 years of age. 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 ¶ 8.

These facts establish that Respondent is liable under the Act. The Act prohibits misbranding of a tobacco product. 21 U.S.C. § 331(k). A 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 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. Prior to December 20, 2019, the regulations prohibited the sale of regulated tobacco products to any person younger than 18 years of age, 21 C.F.R. § 1140.14(a)(1), 21 C.F.R. § 1140.14(b)(1), and required retailers to verify, by means of photographic identification containing the purchaser’s date of birth, that no regulated tobacco product purchasers were younger than 18 years of age, 21 C.F.R. § 1140.14(a)(2)(i), 21 C.F.R. § 1140.14(b)(2)(i).

Under 21 U.S.C. § 333(f)(8), a No-Tobacco-Sale Order is permissible for at least five repeated violations under section 906(d) of the Act and the regulations at 21 C.F.R. pt. 1140 over a 36-month period. The maximum period of time for the first No‑Tobacco‑Sale Order received by a retailer is 30 calendar days. See Food & Drug Admin., Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance with Order at 3-4, available at https://www.fda.gov/media/93328/download (Revised Mar. 2023); Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers at 5‑6, available at http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM252955.pdf(Revised Aug. 2023).

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Taking the above alleged facts as true, Respondent had five repeated violations4 of section § 906(d)(5) of the Act and the regulations found at 21 C.F.R. pt. 1140 within a 36-month period. Respondent violated the prohibition against selling regulated tobacco products to persons younger than 21 years of age, Act § 906(d)(5), on September 27, 2022, and July 24, 2023. On October 29, 2021, September 27, 2022, and July 24, 2023, Respondent also 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. Therefore, Respondent’s actions constitute violations of law that merit a No-Tobacco-Sale Order.

ORDER

For these reasons, I enter default judgment against Respondent D Town Grocery Store LLC d/b/a Downtown Grocery Store, in the form of a No-Tobacco-Sale Order, for a period of 30 consecutive calendar days. See 21 C.F.R. § 17.11(a)(1), (a)(2). During this period of time, Respondent shall stop selling cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and covered tobacco products regulated under the Federal Food, Drug, and Cosmetic Act. 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.