Jarnail Singh Mann d/b/a Kingpin Smoke and Vape, DAB TB9750 (2025)

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

The Food and Drug Administration, Center for Tobacco Products (CTP or Complainant) began this case by serving a Complaint on Respondent, Jarnail Singh Mann d/b/a Kingpin Smoke and Vape, and filing a copy of the Complaint with the Departmental Appeals Board (DAB), Civil Remedies Division (CRD).  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 its implementing regulations, 21 C.F.R. pt. 1140.  CTP seeks a civil money penalty of $13,785 against the Respondent for at least seven violations of the tobacco regulations within a 48-month period.1  Respondent timely requested a hearing by filing an Answer to the Complaint.

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However, during the course of this administrative proceeding, 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).

Currently, Complainant'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 comply with CTP's discovery requests and issue a default judgment against Respondent.  After careful consideration of the entire record, pursuant to 21 C.F.R. § 17.35(c)(3), I grant CTP's Motion to Impose Sanctions, strike Respondent's Answer, and issue an Initial Decision and Default Judgment imposing a civil money penalty of $13,785.

I.  Procedural History

On December 19, 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.  CRD Docket (Dkt.) Entry Numbers (Nos.) 1, 1a-1b.  On January 25, 2025, Respondent registered for the DAB Electronic Filing System (DAB E-File), and timely filed an Answer to CTP's Complaint.  CRD Dkt. Entry No. 3.

On February 4, 2025, I 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.  Specifically, I directed that a party receiving a discovery request must provide the requested documents within 30 days of the request.  Id. ¶ 4; see 21 C.F.R. § 17.23(a).  Also, I warned that I may impose sanctions if a party failed to comply with any order, including the APHO.  CRD Dkt. Entry No. 4 ¶ 21.

On March 6, 2025, counsel for CTP filed a Notice of Entry of Appearance, and a Status Report, stating that "[t]he parties have been unable to reach a settlement in this case.  CTP remains willing to engage in settlement discussions but, absent an executed settlement agreement, intends to proceed to a hearing."  CRD Dkt. Entry Nos. 5, 6.

On April 4, 2025, CTP filed a Motion to Extend Deadlines, stating that "[o]n April 1, 2025, FDA experienced a significant reduction in force (RIF), including in FDA's Center for Tobacco Product's [CTP's] Office of Compliance and Enforcement, the office that supports all tobacco-related administrative cases[,]" Complainant "is still evaluating the impact the RIF may have on CTP's immediate operations[,] . . . [and Complainant] is requesting a 30-calendar day extension of all pending deadlines in this matter."  CRD Dkt. Entry No. 7.

On April 8, 2025, I granted CTP's Motion to Extend Deadlines, and all pending deadlines were extended by 30 days.  CRD Dkt. Entry No. 8.

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On May 12, 2025, CTP filed a Motion to Compel Discovery with supporting documents, and a Motion to Extend Deadlines.  CRD Dkt. Entry Nos. 9, 9a-9b, 10.  In its Motion to Compel Discovery, CTP asserted that Respondent did not respond to its discovery request as required by the APHO and regulations.  CRD Dkt. Entry No. 9.  In its Motion to Extend Deadlines, CTP asserted that Respondent's response to its discovery request was necessary before CTP could prepare its pre-hearing exchange and, thus, requested a 30-day extension of the pre-hearing exchange deadlines.  CRD Dkt. Entry No. 10.

By Order dated May 16, 2025, I informed Respondent of its May 28, 2025, 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. 11 at 1-2; see also 21 C.F.R. § 17.32(c); CRD Dkt. Entry No. 4 ¶ 20.  Additionally, I extended the pre-hearing deadlines by 30 days.  CRD Dkt. Entry No. 11 at 2.  CTP's pre-hearing exchange deadline was extended until June 27, 2025, and Respondent's pre-hearing exchange deadline was extended until July 18, 2025.  Id.  Respondent did not respond to my May 16, 2025, Order.

On June 2, 2025, I issued an Order Granting Complainant's Motion to Compel Discovery.  CRD Dkt. Entry No. 12.  Additionally, I ordered Respondent to produce documents responsive to CTP's discovery requests by June 16, 2025, and warned Respondent that:

. . . [F]ailure 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. 12 at 2.  I also extended CTP's and Respondent's pre-hearing exchange deadlines by an additional fourteen days, to July 11, 2025, and August 1, 2025, respectively.  Id. at 3.

On June 24, 2025, CTP filed Complainant's Motion to Impose Sanctions and a Motion to Stay Deadlines.  CRD Dkt. Entry Nos. 13, 14.  CTP's Motion to Impose Sanctions advised that Respondent failed to produce responsive documents in compliance with my June 2, 2025, Order Granting Complainant's Motion to Compel Discovery.  CRD Dkt. Entry No. 13 at 1.  CTP argued that sanctions against Respondent are an appropriate remedy because "it is unlikely more time or additional orders . . . will change the status quo."  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 $13,785 civil money penalty.  Id.  CTP's Motion to Stay Deadlines "requests that any deadlines . . . be stayed until resolution of CTP's Motion to Impose Sanctions."  CRD Dkt. Entry No. 14 at 1.

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By Order of June 27, 2025, I informed Respondent of its July 11, 2025, deadline to file a response to CTP's Motion to Impose Sanctions and warned Respondent that if it failed to file a response, "I may grant CTP's motion in its entirety."  CRD Dkt. Entry No. 15 at 3.  I also stayed the parties' respective pre-hearing exchange deadlines pending my ruling on CTP's Motion to Impose Sanctions.  Id.  To date, Respondent has not responded to CTP's Motion to Impose Sanctions or my June 27, 2025, 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).  "When a party fails to comply with a discovery order," I may draw an inference in favor of the opposing party; may prohibit the non-complying party from introducing or relying on evidence related to the discovery request; and may "[s]trike any part of the pleadings or other submissions of the party failing to comply with [the discovery] request."  21 C.F.R. § 17.35(c).  Any sanction "shall reasonably relate to the severity and nature of the failure or misconduct."  21 C.F.R. § 17.35(b).

I conclude that sanctions against Respondent are warranted under 21 C.F.R. § 17.35(a)(1).  Respondent repeatedly failed to comply with the following orders and directives governing these proceedings:

• paragraph 4 of the APHO and the regulation at 21 C.F.R. § 17.23(a) when Respondent failed to respond to CTP's Request for Production of Documents within 30 days; and
• the June 2, 2025, Order Granting Complainant's Motion to Compel Discovery when Respondent failed to submit (or indicate that it did not have) documents responsive to CTP's Request for Production of Documents by June 16, 2025.

Additionally, I conclude that sanctions against Respondent are warranted under 21 C.F.R. § 17.35(a)(2) because Respondent also failed to defend this action.  Not only did Respondent fail to respond to CTP's discovery request, but it also failed to respond to the ensuing motions and orders necessitated by its initial failure to respond to CTP's discovery request.  21 C.F.R. § 17.32(c); see also CRD Dkt. Entry No. 4 ¶ 20 (ordering that "a party must answer a motion within 15 days from the date of receipt unless I provide otherwise").  Specifically, Respondent did not file responses to:

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• CTP's Motion to Compel Discovery and the May 16, 2025, Order; and
• CTP's Motion to Impose Sanctions and the June 27, 2025, Order.

Respondent's failure to fulfill its discovery obligations and to respond to CTP's various motions suggests that Respondent has abandoned its defense of this case.

Further, I find that Respondent's failure to comply with the orders, regulations governing discovery, and other procedures in this case has delayed the hearing process.  See 21 C.F.R. § 17.35(a)(3).  To provide ample opportunity for Respondent to respond to CTP's motions and for the parties to prepare their respective pre-hearing exchanges, my May 16, 2025, Order extended the pre-hearing deadlines set in the April 8, 2025, Order Granting Complainant's Motion to Extend Deadlines.  Subsequently, all deadlines were stayed by my June 27, 2025, Order to give Respondent an opportunity to file a response to CTP's Motion to Impose Sanctions.

In the absence of any explanation from Respondent, I find that Respondent failed to comply with multiple judicial orders and directives governing this proceeding, failed to defend its case, and, as a result, interfered with the speedy, orderly, or fair conduct of this proceeding.  I find no basis to excuse Respondent's repeated failure to comply with the various orders and regulations in this administrative proceeding.  Therefore, 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 the discovery regulations governing this proceeding.  See 21 C.F.R. § 17.23(a).  Respondent also failed to comply with multiple Orders regarding discovery and other administrative procedures, despite my explicit warnings that its failure could result in sanctions.  See CRD Dkt. Entry Nos. 4 (APHO) at ¶¶ 4, 20; 11 (May 16, 2025, Order) at 2; 12 (June 2, 2025, Order Granting Complainant's Motion to Compel Discovery) at 2; 15 (June 27, 2025, Order Granting Motion to Stay Deadlines Pending a Ruling on CTP's Motion to Impose Sanctions) at 3.  For example, I specified in my May 16, 2025, Order that "I may grant CTP's motion [to compel discovery] in its entirety" and in my June 2, 2025, Order Granting Complainant's Motion to Compel Discovery that Respondent's "failure to comply with [the] 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. No. 11 at 2; see also CRD Dkt. No. 12 at 2.  Respondent also failed to defend this action, despite my Orders expressly informing Respondent of the opportunity to request a protective order for CTP's discovery requests and to file responses to CTP's Motion to Compel Discovery and Motion to Impose Sanctions.  See CRD Dkt. Entry Nos. 4 ¶¶ 4,

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20; 11 at 2; 15 at 3.  As explained above, 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).  Although striking an answer is a harsh sanction, the Departmental Appeals Board has repeatedly held in similar circumstances involving a respondent's repeated failure to comply with discovery and procedural orders that "the ALJ determination to impose sanctions was not an abuse of discretion, and the sanction imposed was reasonably related to the nature and severity of Respondent's noncompliance."  Carolina Cigar of Delray, LLC d/b/a Carolina Cigar, DAB No. 3134, at 11 (2024) (citing Joshua Ranjit, Inc. d/b/a 7-Eleven 10326, DAB No. 2758, at 1, 8-11; KKNJ, Inc. d/b/a Tobacco Hut 12, DAB No. 2678, at 8-11 (2016); Retail LLC d/b/a Super Buy Rite, DAB No. 2660, at 10-14 (2015)).  Accordingly, I grant CTP's Motion to Impose Sanctions and strike Respondent's Answer from the administrative record.  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 must "assume the facts alleged in the [C]omplaint to be true" and, if those facts establish liability under the Act, issue a default judgment imposing the "maximum amount of penalties provided for by law for the violations alleged" or the civil money penalty "amount asked for in the complaint, whichever is smaller."  Id.  Accordingly, I must determine whether the allegations in the Complaint establish violations of the Act.

Specifically, CTP alleges the following facts in its Complaint:

• Respondent owns Kingpin Smoke and Vape, an establishment that sells tobacco products and is located at 3210 Pacific Avenue, Stockton, California 95204.  Complaint ¶¶ 11-12.
• On March 1, 2024, CTP initiated the most recent civil money penalty action, CRD Docket Number T-24-1929, FDA Docket Number FDA-2024-H-1019, against Respondent for violations of the Act and 21 C.F.R. pt. 1140.  Specifically, CTP alleged three violations for selling tobacco products to an underage purchaser on June 15, 2022, December 21, 2022, and December 19, 2023, and three violations for failing to verify the age of a person purchasing tobacco products with photographic identification on those same dates.  Complaint¶ 15.

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• The previous action concluded when Respondent "admitted all of the allegations in the Complaint and paid the agreed upon penalty."  Further, "Respondent expressly waived its right to contest such violations in subsequent actions."  Complaint ¶ 16.
• During a subsequent inspection of Respondent's establishment on September 11, 2024, at approximately 1:50 PM, an FDA-commissioned inspector documented that "a person younger than 21 years of age was able to purchase a FLUM Aloe Watermelon Splash electronic nicotine delivery system (ENDS) product . . . [.]"  The inspector also documented that "the underage purchaser's age was not verified before the sale . . . ."  Complaint ¶ 13.

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 distributed or offered for sale in any state 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); 89 Fed. Reg. 70,483, 70,485 (Aug. 30, 2024).  Section 906(d)(5) of the Act prohibits the sale of regulated tobacco products to any person younger than 21 years of age, and requires retailers to verify, by means of photographic identification containing a purchaser's date of birth, that no regulated tobacco product purchaser is younger than 21 years of age.

Taking the above alleged facts as true, Respondent violated the prohibition against selling regulated tobacco products to persons younger than 21 years of age on June 15, 2022, December 21, 2022, and December 19, 2023.  Act § 906(d)(5).  On those same dates, 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.; 21 C.F.R. § 1140.14(b)(2)(i).  Subsequently, Respondent violated the prohibition against selling regulated tobacco products to a person younger than 21 years of age on September 11, 2024.  Act § 906(d)(5).  On that same date, 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 purchaser is younger than 21 years of age.  Id.; 21 C.F.R. § 1140.14(b)(2)(i).  All violations observed during the initial failed inspection are counted as a single violation, and each separate violation observed during subsequent failed inspections count as a discrete violation.  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).  Respondent had an initial failed inspection on June 15, 2022, which counted as a single violation.   Accordingly, Respondent had five violations from the previous civil money penalty action and two additional violations on September 11, 2024.  Therefore, Respondent's

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actions constitute seven violations of law within a 48-month period that merit a civil money penalty.

CTP has requested a civil money penalty of $13,785, which is a permissible penalty under the regulations.2  21 C.F.R. §§ 17.2, 17.11; see also 45 C.F.R. § 102.3.  Therefore, I find that a civil money penalty of $13,785 is warranted and so order one imposed.