Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Center for Tobacco Products,
Complainant,
v.
Matra LLC
d/b/a Willett Farms Convenience Store,
Respondent.
Docket No. T-24-3188
FDA Docket No. FDA-2024-H-2667
Decision No. TB9073
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, Matra LLC d/b/a Willett Farms Convenience Store, at 185 Willett Avenue, Riverside, Rhode Island 02915, and by filing a copy of the Complaint with the Food and Drug Administration’s (FDA) Division of Dockets Management. CTP seeks to impose a $6,892 civil money penalty against Respondent for at least five 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 36-month period.
The Complaint alleges CTP previously initiated a civil money penalty against Respondent Willett Farms Convenience Store. The prior action concluded when a
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default judgment was entered against Respondent for at least three1 violations of the Act. Specifically, Respondent was found to have sold a regulated tobacco product 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. The Complaint further alleges that Respondent Willett Farms Convenience Store subsequently committed two additional violations of the Act. Specifically, that Respondent sold a regulated tobacco product to an underage purchaser and failed to verify, by means of photo identification containing a date of birth, that the purchaser was 21 years of age or older, thereby violating the Act. Therefore, CTP seeks a $6,892 civil money penalty against Respondent Willett Farms Convenience Store for a total of at least five violations within a 36-month period.
Respondent’s representative filed a timely Answer to the Complaint. However, during the course of this administrative proceeding, 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).
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. Accordingly, pursuant to 21 C.F.R. § 17.35(c)(3), I strike Respondent’s Answer and issue this decision of default judgment.
Procedural History
On June 6, 2024, CTP served the Complaint 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 (Complaint), 1b (Proof of Service). On July 5, 2024, Respondent’s representative registered for DAB E-File. On that same date, Respondent’s representative filed a narrative statement and, subsequently on July 8, 2024, filed its timely answer to CTP’s Complaint. CRD Dkt. Entry Nos. 4a, 5.
On July 10, 2024, Administrative Law Judge (ALJ) Richard Goodwin, the ALJ previously assigned to preside in this case, issued a Pre-Hearing Order (PHO) setting deadlines for the parties’ filings and exchanges, including a schedule for discovery. CRD
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Dkt. Entry No. 6. In the PHO, among other things, Judge Goodwin directed that a party receiving a discovery request must provide the requested documents within 30 days of the request. PHO ¶ 3; see also 21 C.F.R. § 17.23(a). The PHO further 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.
PHO ¶ 12.
On September 4, 2024, CTP filed a Motion to Compel Discovery, asserting that Respondent had not responded to its discovery request as required by the PHO and the regulations. CRD Dkt. Entry No. 8 (Motion to Compel Discovery). In the Motion to Compel Discovery, CTP noted Judge Goodwin’s directive that “. . . if the requesting party does not receive the documents within 30 days, the remaining deadlines in this Pre-Hearing Order shall be automatically stayed pending resolution of the discovery dispute.” Id. at 2; see also PHO ¶ 3. On October 10, 2024, Judge Goodwin issued an Order to Compel Discovery and Order to Show Cause to Respondent (Order to Show Cause) advising Respondent that it had until October 25, 2024, to 1) comply with CTP’s Request for Production of Documents; and 2) show cause why default judgment should not be entered for failure to comply with directives and procedural rules. CRD Dkt. Entry No. 9 at 2. Judge Goodwin warned “[f]ailure to comply will result in sanctions, which may include issuance of an Initial Decision and Default Judgment finding Respondent liable for the violations listed in the Complaint and imposing a civil money penalty. 21 C.F.R. § 17.35.” Id. at 1-2. Judge Goodwin’s Order to Show Cause also continued the stay of these proceedings previously addressed in his PHO. Id. at 2.
On October 29, 2024, CTP filed a Status Report and Motion to Impose Sanctions. CRD Dkt. Entry No. 10. CTP advised that Respondent had not complied with the PHO or Judge Goodwin’s October 10, 2024, Order to Show Cause. Id. at 2. CTP argued that sanctions against Respondent are an appropriate remedy, “as it is unlikely that more time or additional orders . . . will change the status quo.” Id. Specifically, CTP asked the ALJ to 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 $6,892 civil money penalty. Id.
On November 8, 2024, Judge Goodwin issued a second Order to Show Cause to Respondent (November 8, 2024, Order) giving Respondent until November 25, 2024, to show cause “why default judgment should not be entered . . . .” CRD Dkt. Entry No. 11 at 2. The Second Order to Show Cause also continued the stay on all remaining deadlines pending resolution of the discovery dispute. Id. To date, Respondent has not
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filed a response to CTP’s Motion to Impose Sanctions or the November 8, 2024, Order. On November 12, 2024, this case was transferred to me for a decision.
I. 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 3 of the PHO, when Respondent failed to respond to CTP’s Request for Production of Documents within 30 days; and
- The October 10, 2024, Order, when it failed to submit documents responsive to CTP’s Request for Production of Documents by October 25, 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, or file a response to the ALJ’s October 10, 2024, Order; and
- Respondent did not file a response to CTP’s Motion to Impose Sanctions, as permitted by the regulations, or file a response to the ALJ’s November 8, 2024, Order.
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.
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
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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.
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 the ALJ’s orders, despite the explicit warnings that its failure could result in sanctions. See CRD Dkt. Entry Nos. 9 at 1-2; 11 at 1; see also PHO ¶ 12. Additionally, Respondent failed to respond to any of CTP’s motions. See CRD Dkt. Entry Nos. 9 at 2; 11 at 2. Respondent’s repeated misconduct interfered with the speedy, orderly, or fair conduct of this proceeding. 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); 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.”).
II. 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. Id. Specifically:
- On February 28, 2023, CTP initiated a previous civil money penalty action, CRD Docket Number T-23-1192, FDA Docket Number FDA-2023-H-0649, against Respondent for at least three violations of the Act. CTP alleged those violations to have occurred at Respondent’s business establishment, 185 Willett Avenue, Riverside, Rhode Island 02915, on November 19, 2021, and November 22, 2022;
- 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”;
- An FDA-commissioned inspector conduced a subsequent inspection on March 6, 2024, at approximately 11:10 AM, at Respondent’s business establishment located at 185 Willett Avenue, Riverside, Rhode Island 02915. During the inspection, a person younger than 21 years of age was able to purchase a Crave+ Max Mango Ice electronic nicotine delivery system (ENDS) product. 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.
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These facts establish Respondent Willett Farms Convenience Store’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. 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); 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.
Respondent having failed to file an answer and taking the alleged above facts as true, a $6,892 civil money penalty is permissible under 21 C.F.R. § 17.2.
ORDER
For these reasons, I enter default judgment in the amount of $6,892 against Respondent Matra LLC d/b/a Willett Farms Convenience Store. 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.
Zina D. Ashourian Administrative Law Judge
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The Complaint alleges two violations on November 19, 2021, and two violations on November 22, 2022. 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).