Lansing Liquors Inc. d/b/a Santori’s Liquors DAB TB9419 (2025)

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

On November 20, 2024, the Center for Tobacco Products (CTP) served an Administrative Complaint (Complaint) on Respondent, Lansing Liquors Inc. d/b/a Santori’s Liquors, 3529 Ridge Road, Lansing, Illinois 60438, and filed a copy of the Complaint with the Food and Drug Administration’s (FDA) Division of Dockets Management.  CTP seeks to impose a $2,757 civil money penalty against Respondent for four 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 24-month period.

Respondent filed an Answer to the Complaint in this matter.  However, during the course of this administrative proceeding, Respondent failed to comply with multiple judicial orders and directives and failed to defend its case, which interfered with the speedy, orderly, or fair conduct of this proceeding.  21 C.F.R. § 17.35(a).

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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.  After carefully considering the entire record, I grant CTP’s Motion to Impose Sanctions, strike Respondent’s Answer, and issue this default decision, pursuant to the provisions of 21 C.F.R. §§ 17.35(a), 17.35(c)(3).

I. Procedural History

As provided for in 21 C.F.R. §§ 17.5 and 17.7, on November 20, 2024, CTP served the Complaint on Respondent by United Parcel Service.  Civil Remedies Division (CRD) Docket (Dkt.) Entry Nos. 1 (Complaint), 1b (Proof of Service).  On December 19, 2024, Respondent filed a timely Answer to CTP’s Complaint denying all of the allegations and stating that the penalty was too high.  CRD Dkt. Entry No. 3.  On December 26, 2024, I issued an Acknowledgement and Pre-Hearing Order (APHO) that set deadlines for the parties’ filings and exchanges, including a schedule for discovery.  CRD Dkt. Entry No. 4.  I directed that a party receiving a discovery request must provide the requested documents within 30 days of the request.  APHO ¶ 4; see also 21 C.F.R. § 17.23(a).  The APHO 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.

APHO ¶ 21.

On January 27, 2025, in compliance with paragraph 3 of the APHO, CTP timely filed its status report.  CRD Dkt. Entry No. 6.  The status report indicated the parties were unable to reach a settlement and that CTP was unable to reach Respondent to file a Joint Status Report.  Id.

On March 6, 2025, CTP filed a Motion to Compel Discovery, asserting that Respondent did not respond to its discovery request as required by my APHO and the regulations. CRD Dkt. Entry No. 7.  On the same date, CTP also filed a Motion to Extend Deadlines requesting a 30-day extension of “any deadlines, including the March 17, 2025, due date for CTP’s pre-hearing exchange .  .  .  .”  CRD Dkt. Entry No. 8 at 2.

On March 11, 2025, I issued an Order advising Respondent that it had until March 26, 2025, to file a response to CTP’s Motion to Compel Discovery.  CRD Dkt. Entry No. 9. I also warned that if Respondent failed to respond, “I may grant CTP’s motion in its 

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entirety.”  Id. at 1; see also APHO ¶¶ 20-21; 21 C.F.R. § 17.32(c).  In my Order, I also extended the pre-hearing exchange deadlines.  Id.

On March 31, 2025, as Respondent had not responded to CTP’s Motion to Compel Discovery as instructed, I issued an order granting CTP’s Motion to Compel Discovery and gave Respondent until April 15, 2025, to comply with CTP’s Request for Production of Documents.  CRD Dkt. Entry No. 10 at 1.  Respondent was again warned that:

• .  .  .  . [F]ailure to comply may result in sanctions, which may include striking its filings and issuing an Initial Decision and Default Judgment finding Respondent liable for the violations listed in the Complaint and imposing a civil money penalty.

Id.

On April 24, 2025, CTP filed a Status Report and Motion to Impose Sanctions.  CRD Dkt. Entry No. 11.  CTP advised that Respondent had not complied with the APHO or my March 31, 2025 Order Granting CTP’s Motion to Compel Discovery.  Id. at 1-2.  CTP argued that sanctions against Respondent for its repeated non-compliance are an appropriate remedy.  Id. at 2.  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 $2,757 civil money penalty.  Id.  On April 24, 2025, CTP also filed a Motion to Stay Deadlines.  CRD Dkt. Entry No. 12.

On April 24, 2025, I issued an Order staying the pre-hearing exchange deadlines and giving Respondent until May 9, 2025, to file a response to CTP’s Motion to Impose Sanctions.  CRD Dkt. Entry No. 13.  The April 24, 2025 Order also warned Respondent that if it “fails to file a response, I may grant CTP’s Motion to Impose Sanctions in its entirety.”  Id. at 1.

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).

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Respondent failed to comply with multiple judicial orders and procedures governing this proceeding.  Specifically:

• Respondent did not file a response to CTP’s Motion to Compel Discovery, as permitted by the regulations and my March 11, 2025 Order; and
• Respondent did not file a response to CTP’s Motion to Impose Sanctions, as permitted by the regulations and my April 24, 2025 Order.

I also find that 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 March 11, 2025 Order; and
• Respondent did not file a response to CTP’s Motion to Impose Sanctions, as permitted by the regulations and my April 24, 2025 Order.

I find that Respondent failed to comply with multiple 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 regulatory requirements and two judicial orders, despite my explicit warnings that its failure to do so could result in sanctions.  See CRD Dkt. Entry No. 9 at 2 and CRD Dkt. Entry No. 13 at 1-2; see also APHO ¶ 21.  Respondent’s repeated misconduct interfered with the speedy, orderly, or fair conduct of this proceeding. In fact, after initially denying all of the violations in its Answer, Respondent has not participated in this action in any meaningful fashion.

Accordingly, 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(a), 17.35(b), (c)(3).

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 

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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 February 16, 2024, CTP initiated a previous civil money penalty action, CRD Docket Number T-24-1762, FDA Docket Number FDA-2024-H-0831, against Respondent for at least two violations1 of the Act. CTP alleged those violations to have occurred at Respondent’s business establishment, 3529 Ridge Road, Lansing, Illinois 60438, on July 24, 2023, and December 5, 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”;
• An FDA-commissioned inspector conducted a subsequent inspection on August 26, 2024, at approximately 1:50 PM at Respondent’s business establishment located at 3529 Ridge Road, Lansing, Illinois 60438.  During this inspection, a person younger than 21 years of age was able to purchase a package of two Swisher Sweets Classic cigars.  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 Santori’s Liquors’ 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. § 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); 89 Fed. Reg. 70,483, 70,485 (Aug. 30, 2024).  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 

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identification containing a purchaser’s date of birth, that no regulated tobacco product purchasers are younger than 21 years of age.

A $2,757 civil money penalty is permissible under 21 C.F.R. § 17.2.

ORDER

For these reasons, I enter default judgment and impose a civil money penalty in the amount of $2,757 against Respondent Lansing Liquors Inc. d/b/a Santori’s Liquors. 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.