A and K Deli Market LLC d/b/a Sunshine Kitchen and Deli, DAB TB4738 (2020)


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division

Docket No. T-19-2611
FDA Docket No. FDA-2019-H-1958
Decision No. TB4738

INITIAL DECISION AND DEFAULT JUDGMENT

The Center for Tobacco Products (CTP or Complainant) began this matter by serving an administrative complaint on Respondent, A and K Deli Market LLC d/b/a Sunshine Kitchen and Deli, at 999 Maplewood Avenue, Bridgeport, Connecticut 06605, and by filing a copy of the complaint with the Food and Drug Administration’s (FDA) Division of Dockets Management.  The complaint alleges that Respondent impermissibly sold individual cigarettes, sold regulated tobacco products to a minor, and failed to verify, by means of photo identification containing a date of birth, that the purchaser was 18 years of age or older, thereby violating the Act, and its implementing regulations at 21 C.F.R. pt. 1140.  Therefore, CTP seeks a $570 civil money penalty against Respondent Sunshine Kitchen and Deli for three violations within a 24-month period.

Respondent timely answered CTP’s complaint; however during the course of these administrative proceedings, Respondent failed to comply with orders and procedures governing this proceeding and 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.

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I. Procedural History

On April 26, 2019, Complainant served the complaint on Respondent Sunshine Kitchen and Deli by United Parcel Service, pursuant to 21 C.F.R. §§ 17.5 and 17.7.  Respondent timely filed its answer on May 30, 2019, denying the allegations in the complaint.  On June 4, 2019, I issued an Acknowledgment and Pre-hearing Order (APHO) acknowledging receipt of Respondent’s answer and setting forth case procedures and deadlines.  The APHO contained a provision that set out instructions regarding a party's request for production of documents.  That provision states, in part, that a party had until July 5, 2019, to request the opposing party provide copies of documents relevant to this case.  APHO ¶ 12.  The order also stated that a party receiving such a request must provide the requested documents no later than 30 days after the request has been made, pursuant to APHO ¶ 12; see 21 C.F.R. § 17.23(a).  The parties were warned that failure to comply with any order including the APHO may result in sanctions.

On September 12, 2019, Complainant filed a Motion to Compel Discovery stating that it sent its Request for Production of Documents to Respondent on August 6, 2019, but had not received a response from Respondent.  Complainant requested that I issue an order requiring Respondent to comply with Complainant’s Request for Production of Documents.  In a September 19, 2019 letter issued by my direction, Respondent was given until October 4, 2019, to file a response to Complainant’s Motion to Compel Discovery.

Respondent failed to file a response to Complainant’s Motion to Compel Discovery or the September 19, 2019 letter.  Accordingly, in an order dated October 22, 2019, I granted Complainant’s Motion to Compel Discovery and ordered Respondent to comply with Complainant’s Request for Production of Documents by November 6, 2019.  I warned Respondent that:

Failure to do so 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.

October 22, 2019, Order to Compel Discovery (emphasis in original).

On November 13, 2019, Complainant filed a Status Report and Motion to Impose Sanctions indicating that Respondent had not complied with my October 22, 2019 order.  Complainant requested I strike Respondent’s answer and issue an initial decision and default judgment imposing a money penalty against Respondent.  In a November 22, 2019 order, I gave Respondent until November 29, 2019, to file a response to Complainant’s Motion to Impose Sanctions.  The order again warned Respondent that if it failed to file a response, I “may grant CTP’s motion [to impose sanctions] in its

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entirety.”  November 22, 2019, Order.  To date, Respondent has not responded to Complainant’s Motion to Impose Sanctions or the November 22, 2019 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 12 of my APHO, when Respondent failed to respond to CTP’s Request for Production of Documents within 30 days; and
  • Respondent failed to comply with my October 22, 2019 Order to Compel Discovery, when it failed to produce documents responsive to CTP’s Request for Production of Documents by November 6, 2019.

I find that Respondent failed to comply with 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.

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.  I specified that those sanctions “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.”  October 22, 2019, Order to Compel Discovery.  Respondent also failed to defend its actions, despite my orders and directive expressly reminding Respondent of the opportunity.  Respondent’s repeated misconduct interfered with the speedy, orderly, or fair conduct of this proceeding.

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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.  21 C.F.R. § 17.35(c)(3).

I may sanction a party for failing to comply with an order, subpoena, rule, or procedure governing the proceeding; failing to prosecute or defend an action; or 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 to comply with the deadline set forth in the APHO for responding to a discovery request, and the order granting Complainant’s Motion to Compel Discovery issued on October 22, 2019.  Respondent also failed to respond to Complainant’s Motion to Impose Sanctions or the letter sent by my direction on September 19, 2019.  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).  This repeated conduct is sufficiently egregious to warrant striking Respondent’s answer and issuing an initial decision by default.  Therefore, pursuant to 21 C.F.R. § 17.35, I am granting Complainant’s Motion to Impose Sanctions, and striking Respondent’s answer for failing to comply with multiple judicial orders and directives.

III. Default Decision

Striking Respondent’s answer leaves the complaint unanswered.  Pursuant to 21 C.F.R. § 17.11, I assume that the facts alleged in the complaint (but not its conclusory statements) are true.  Specifically:

  • On March 21, 2018, at Respondent’s business establishment, 999 Maplewood Avenue, Bridgeport, Connecticut 06605, an FDA-commissioned inspector observed open packages of Newport Box cigarettes and Marlboro cigarettes intended for the sale of individual cigarettes;
  • In a warning letter dated May 24, 2018, CTP informed Respondent of the inspector’s March 21, 2018 documented violation, and that such action violates federal law.  The letter further warned that Respondent’s failure to correct its violation could result in a civil money penalty or other regulatory action;
  • During a subsequent inspection, at approximately 10:25 AM on January 28, 2019, at Respondent’s business establishment 999 Maplewood Avenue, Bridgeport, Connecticut 06605, an FDA-commissioned inspector documented Respondent’s staff selling a package of two Garcia y Vega Game Green cigars to a person younger than 18 years of age.  The inspector also documented that staff failed to verify, by means of photographic identification containing a date of birth, that the purchaser was 18 years of age or older.

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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 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).  Under 21 C.F.R. § 1140.14(b)(1), no retailer may sell regulated tobacco products to any person younger than 18 years of age.  Under 21 C.F.R. § 1140.14(b)(2)(i), retailers must verify, by means of photographic identification containing a purchaser’s date of birth, that no regulated tobacco product purchasers are younger than 18 years of age.  Additionally, no retailer may break or otherwise open any cigarette package to sell or distribute individual cigarettes.  21 C.F.R. § 1140.14(a)(4).

A $570 civil money penalty is permissible under 21 C.F.R. § 17.2.

Order

For these reasons, I enter default judgment in the amount of $570 against Respondent A and K Deli Market LLC d/b/a Sunshine Kitchen and Deli.  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.