Route 291 Fuel Stop Inc. d/b/a 291 Fuel Stop, DAB TB10130 (2025)

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

The Food and Drug Administration (FDA), Center for Tobacco Products’ (CTP or Complainant) 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 Route 291 Fuel Stop Inc. d/b/a 291 Fuel Stop’s (Respondent) Answer as a sanction for failing to comply with CTP’s discovery requests and issue a default judgment against Respondent.  During the course of this administrative proceeding, Respondent failed to comply with multiple judicial 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).  Therefore, 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 $6,892.

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I. Background and Procedural History

On November 13, 2024, CTP served an Administrative Complaint for Civil Money Penalty (Initial Complaint) and supporting documents on Respondent by United Parcel Service (UPS), pursuant to 21 C.F.R. §§ 17.5 and 17.7.1  Civil Remedies Division (CRD) Docket (Dkt.) Entry Numbers (Nos.) 1, 1a-1b.  The Initial Complaint alleged 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. Part 1140.  The Initial Complaint sought a civil money penalty of $6,892 against Respondent for committing at least five violations of the tobacco regulations within a 36-month period.2 

On December 10, 2024, Respondent registered for the Departmental Appeals Board’s Electronic Filing System (DAB E-File), using email address bbhatti112@gmail.com, and timely filed an Answer to CTP’s Initial Complaint.  CRD Dkt. Entry No. 4.  Respondent also filed a copy of CTP’s Initial Complaint.  See CRD Dkt. Entry No. 4a.  Respondent’s Answer denied the allegations and argued that the proposed penalty is too high.  CRD Dkt. Entry No. 4 (Answer ¶¶ 1, 3).

On January 2, 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. 5.

On January 17, 2025, CTP filed a Notice of Entry of Appearance, Motion for Leave to Amend Complaint (Motion to Amend), and the proposed First Amended Complaint for Civil Money Penalty (Amended Complaint).  CRD Dkt. Entry Nos. 7, 7a.  CTP sought leave to file and serve an Amended Complaint that accurately describes Respondent’s

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prior violation history and cites the correct corresponding regulation.3   CRD Dkt. Entry No. 7 at 2.  The Amended Complaint also seeks a civil money penalty of $6,892 against Respondent for committing at least five violations of the tobacco regulations within a 36-month period.

On February 3, 2025, CTP filed a Joint Status Report stating that the parties intended to continue settlement negotiations.  CRD Dkt. Entry No. 8.  CTP stated that Respondent authorized CTP to file the joint status report.  Id. at 1.

On February 10, 2025, I issued an Order establishing a February 24, 2025, deadline for Respondent to file a response to CTP’s Motion to Amend.  CRD Dkt. Entry No. 9 at 2.  The February 10, 2025, Order also stayed the discovery deadline, and the deadlines for the parties to file their respective pre-hearing exchanges, pending resolution of CTP’s Motion to Amend.  Id. at 3.

On March 10, 2025, after Respondent failed to file a response to CTP’s Motion to Amend or my February 10, 2025, Order, I granted CTP’s Motion to Amend.  CRD Dkt. Entry No. 10.  My March 10, 2025, Order also instructed CTP to file proof of service of the Amended Complaint by no later than March 17, 2025, and informed Respondent that it may file an amended Answer to CTP’s Amended Complaint by April 16, 2025, if desired.  Id. at 3.  I informed the parties that I would consider Respondent’s December 10, 2024, Answer as Respondent’s Answer to CTP’s Amended Complaint if Respondent did not file an amended Answer to CTP’s Amended Complaint.  Id.  Lastly, my March 10, 2025, Order vacated the stay imposed on these proceedings.  Id. at 3-4.

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On March 13, 2025, CTP timely filed the Amended Complaint, Amended Cover Letter, Amended UPS Proof of Service, and Notice of Filing.  CRD Dkt. Entry Nos. 11, 12, 12a- 12b.  Respondent did not file an amended Answer.

On April 17, 2025, I issued an Amended APHO.  CRD Dkt. Entry No. 13.  Given Respondent did not file an amended Answer to CTP’s Amended Complaint, in accordance with my March 10, 2025, Order, I considered Respondent’s Answer, dated December 10, 2024, as its Answer to CTP’s Amended Complaint.  See id. at 2.  My Amended APHO set new deadlines for the parties’ filings and exchanges, including the schedule for discovery.  Id. ¶¶ 4, 6.  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).  I also warned that I may impose sanctions if a party failed to comply with any order, including the Amended APHO.  CRD Dkt. Entry No. 13 ¶ 21.

On May 6, 2025, CTP filed a second Joint 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 No. 14.  CTP indicated that Respondent authorized CTP to file the joint status report.  Id. at 1.

On May 15, 2025, CTP filed a Motion to Serve Discovery Electronically, and three exhibits including CTP’s Request for Production of Documents (RFP), email correspondence between CTP and UPS, and a copy of the returned envelope.  CRD Dkt. Entry Nos. 15, 15a-15c.  CTP asserted that it attempted to serve its discovery request on Respondent by UPS, but Respondent refused to accept the UPS delivery.  CRD Dkt. Entry No. 15 at 1.  Consequently, CTP requested leave to serve its discovery request on Respondent by DAB E-File.  Id. at 1-2.

On May 20, 2025, I issued an Order giving Respondent until June 5, 2025, to file a response to CTP’s Motion to Serve Discovery Electronically.  CRD Dkt. Entry No. 16 at 2.  My May 20, 2025, Order also stayed the parties’ discovery request and pre-hearing exchange deadlines pending resolution of CTP’s Motion to Serve Discovery Electronically.  Id.

On June 13, 2025, after Respondent failed to file a response to CTP’s Motion to Serve Discovery Electronically or my May 20, 2025, Order, I issued an Order Granting [CTP’s] Motion to Serve Discovery Electronically.  CRD Dkt. Entry No. 17.  My June 13, 2025, Order established a June 19, 2025, deadline for CTP to serve its RFP on Respondent via DAB E-File.  See id. at 2.  My June 13, 2025, Order also lifted the stay previously imposed and reestablished the parties’ pre-hearing exchange deadlines.  Id.

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On June 17, 2025, CTP timely served its RFP on Respondent via DAB E-File.  CRD Dkt. Entry No. 18.

On July 17, 2025, CTP filed a Motion to Compel Discovery, and a Motion to Extend Deadlines.  CRD Dkt. Entry Nos. 19, 20.  In its Motion to Compel Discovery, CTP asserted that Respondent did not respond to its discovery requests as required by the Amended APHO and regulations.  CRD Dkt. Entry No. 19 at 1.

By Order dated July 30, 2025, I informed Respondent of its August 8, 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. 21 at 2; see also 21 C.F.R. § 17.32(c); Amended APHO ¶ 20.  Additionally, I extended the pre-hearing deadlines by 30 days.  CRD Dkt. Entry No. 21 at 3.  CTP’s pre-hearing exchange deadline was extended until September 10, 2025, and Respondent’s pre-hearing exchange deadline was extended until October 1, 2025.  Id.  Respondent did not respond to CTP’s Motion to Compel Discovery or my July 30, 2025, Order.

On August 14, 2025, I issued an Order Granting Complainant’s Motion to Compel Discovery.  CRD Dkt. Entry No. 22.  In the Order, I directed Respondent to produce documents responsive to CTP’s discovery requests by August 22, 2025, and warned Respondent that:

Failure 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 [Amended] Complaint and imposing a civil money penalty.  21 C.F.R. § 17.35.

CRD Dkt. Entry No. 22 at 2.  I also extended the parties’ pre-hearing exchange deadlines by thirty days.  Id.  Thus, the deadline for CTP to file its pre-hearing exchange was extended to October 10, 2025, and Respondent’s deadline to file its pre-hearing exchange was extended to October 31, 2025.  Id.

On August 25, 2025, CTP filed Complainant’s Status Report and Motion to Impose Sanctions and a Motion to Stay Deadlines.  CRD Dkt. Entry Nos. 23, 24.  CTP advised that Respondent failed to produce documents in compliance with the August 14, 2025, Order Granting Complainant’s Motion to Compel Discovery.  CRD Dkt. Entry No. 23 at 2.  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.  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 [Amended] Complaint and imposing a $6,892 civil money penalty.  Id.

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By Order dated September 4, 2025, I informed Respondent of its September 19, 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 and impose the requested civil money penalty against Respondent.”  CRD Dkt. Entry No. 25 at 2.  To date, Respondent has not responded to CTP’s Motion to Impose Sanctions or the September 4, 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).  Specifically, Respondent failed to comply with:

• the regulations at 21 C.F.R. § 17.23(a) and paragraph 4 of the Amended APHO, when Respondent failed to respond to CTP’s RFP within 30 days; and  
• my August 14, 2025, Order Granting Complainant’s Motion to Compel Discovery when it failed to submit (or indicate that it did not have) documents responsive to CTP’s RFP by August 22, 2025.

Additionally, Respondent also failed to defend this action.  21 C.F.R. § 17.35(a)(2).  Specifically, Respondent did not file responses to:

• CTP’s Motion to Serve Discovery Electronically and my May 20, 2025, Order;  
• CTP’s Motion to Compel Discovery and my July 30, 2025, Order; and  
• CTP’s Motion to Impose Sanctions and my September 4, 2025, Order.

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

Further, I find that Respondent has engaged in misconduct that interferes with the speedy, orderly, or fair conduct of the hearing when it refused to accept UPS delivery of CTP’s discovery request.  See 21 C.F.R. § 17.35(a)(3). On May 6, 2025, CTP attempted to serve its RFP at Respondent’s retail location – at the same address and by the same mail delivery service where Respondent was served copies of the Initial Complaint and Amended Complaint.  CRD Dkt. Entry No. 15b at 3-4; see also CRD Dkt. Entry Nos. 1b, 12b.  I also note that Respondent previously confirmed the accuracy of its address in the signature line of its December 10, 2024, Answer.  CRD Dkt. Entry No. 4 at 2.  Yet, the RFP was returned to CTP because the “RECEIVER REFUSED, CANCELLED ORDER.”  CRD Dkt. Entry No. 15c (CTP Ex. C) at 11; see also CRD Dkt. Entry No. 15b at 2 (email correspondence between CTP Regulatory Counsel and UPS confirming that “the driver attempted to deliver the package, but the consignee refused the delivery”).  According to the UPS tracking information, the RFP package was refused on May 8, 2025, only two days after CTP filed (with Respondent’s approval) the May 6, 2025, Joint Status Report stating that the parties intended to proceed to a hearing.  CRD Dkt. Entry No. 15b at 3-4; see also CRD Dkt. Entry No. 14 at 1.  Given the parties’ intention to proceed to a hearing, I find that Respondent was fully aware of its pre-hearing deadlines and obligations and intentionally obstructed the proceedings by refusing delivery of CTP’s discovery request.

Finally, I note that Respondent’s obstructive behavior and 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 20, 2025, Order, July 30, 2025, Order, and September 4, 2025, Order stayed or extended the discovery and pre-hearing exchange deadlines set in the Amended APHO.

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, intentionally obstructed the hearing process, 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 obstructed the hearing process by refusing to accept delivery of CTP’s RFP.  Respondent also failed to comply with the Amended APHO, my August 14, 2025, Order Granting Complainant’s

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Motion to Compel Discovery, and the discovery regulation governing this proceeding when it failed to respond to CTP’s RFP by August 22, 2025.  Amended APHO ¶ 4; CRD Dkt. Entry No. 22 at 2; 21 C.F.R. § 17.23(a).  Moreover, Respondent failed to defend this action by failing to respond to CTP’s Motion to Serve Discovery Electronically, Motion to Compel Discovery, and Motion to Impose Sanctions, despite several Orders reminding Respondent of the opportunity to do so.  Notably, Respondent failed to comply with two Orders, despite my explicit warnings that its failure could result in sanctions.  See CRD Dkt. Entry Nos. 22 at 2; 25 at 2.  I specified in my August 14, 2025, and September 4, 2025, Orders that those sanctions may include “the issuance of an Initial Decision and Default Judgment finding Respondent liable for the violations listed in the [Amended] Complaint and imposing a civil money penalty.”  CRD Dkt. Entry No. 22 at 2; see also CRD Dkt. Entry No. 25 at 2.  Respondent’s repeated misconduct interfered with the speedy, orderly, or fair conduct of this proceeding.

Upon consideration of the totality of facts and circumstances, 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 (2017); KKNJ, Inc. d/b/a Tobacco Hut 12, DAB No. 2678, at 8-11 (2016); and 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(a)(1)-(3), (b), (c)(3).

III. Default Decision

Striking Respondent’s Answer leaves the Amended Complaint unanswered.  Therefore, I am required to issue an initial decision by default, provided that the Amended Complaint is sufficient to justify a penalty.  Pursuant to 21 C.F.R. § 17.11(a), I must “assume the facts alleged in the [Amended] [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.

A. Liability

First, I must determine whether the allegations in the Amended Complaint establish violations of the Act.  Specifically, CTP alleges the following facts in its Amended

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Complaint:

• Respondent owns 291 Fuel Stop, an establishment that receives and sells tobacco products in interstate commerce and is located at 1398 Industrial Highway, Eddystone, Pennsylvania 19022.  Amended Complaint ¶¶ 11-12.
• On August 24, 2023, CTP initiated the most recent civil money penalty action, CRD Docket Number T-23-3459, FDA Docket Number FDA-2023-H-3604, against Respondent for violations of the Act and 21 C.F.R. Part 1140.  Specifically, CTP alleged two violations for selling tobacco products to underage purchasers on November 8, 2021, and June 10, 2023, and two violations for failing to verify the age of a person with photographic identification on those same dates.  Amended Complaint¶ 15.
• The most recent 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.”  Amended Complaint ¶ 16.
• During a subsequent inspection of Respondent’s establishment on August 24, 2024, at approximately 11:30 AM, an FDA-commissioned inspector documented that “a person younger than 21 years of age was able to purchase a package of Newport Box cigarettes . . . [.]”  The inspector also documented that “the underage purchaser’s identification was not verified before the sale . . . .”  Amended 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. Part 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 and 21 C.F.R. Part 1140 prohibit 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 November 8, 2021, and June 10, 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

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21 years of age.  Id.; 21 C.F.R. § 1140.14(a)(2)(i); 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 August 24, 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(a)(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 November 8, 2021, which counted as a single violation, and the violations on June 10, 2023, counted as two separate violations.  Accordingly, Respondent had three violations from the most recent civil money penalty action and two additional violations on August 24, 2024, from the current civil money penalty action.  Therefore, Respondent’s actions constitute five violations of law within a 36-month4  period that merit a civil money penalty.

B. Penalties

The Act establishes two schedules of civil money penalties, depending on whether retailers have implemented a training program that complies with FDA standards.  21 U.S.C. § 333 note (Guidance) (quoting Tobacco Control Act § 103(q)(2)(A)-(B)); see also 45 C.F.R. § 102.3 (Table 1 to § 102.3—Civil Monetary Penalty Authorities Administered by HHS).  Until FDA promulgates regulations establishing standards for approved retailer training programs, CTP has decided to seek penalties using the lower schedule for all retailers.  U.S. Food & Drug Admin., Tobacco Retailer Trainer Programs (Revised): Guidance for Industry (August 2018) at 18, https://www.fda.gov/media/79013/download [https://www.fda.gov/regulatory-information/search-fda-guidance-document…] (non-binding guidance document containing various recommendations for retailer training programs).  The civil money penalty schedules are adjusted annually for inflation.

When issuing a default judgment and initial decision, I must impose the smaller amount of either the maximum civil money penalty provided for by law for the violations alleged or the amount asked for in the Amended Complaint.  21 C.F.R. § 17.11(a)(1)-(2).  For penalties assessed on or after August 8, 2024, the maximum civil money penalty for a fifth violation of Section 906(d)(5) of the Act or of the 21 C.F.R. Part 1140 regulations within a 36-month period is $7,115.  89 Fed. Reg. 64,815, 64,818 (Aug. 8, 2024); see also 21 C.F.R. § 17.2, 45 C.F.R. § 102.3.  CTP has requested a civil money penalty of $6,892 in its Amended Complaint.  Accordingly, awarding the smaller amount of $6,892

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requested in the Amended Complaint is appropriate.  Therefore, I find that a civil money penalty of $6,892 is warranted and so order one imposed.

IV. Conclusion

Pursuant to 21 C.F.R. § 17.35(a)(1)-(3), (b) and (c)(3), I grant Complainant’s Motion to Impose Sanctions, strike Respondent’s Answer, and enter a default judgment and initial decision imposing a civil money penalty of $6,892 against Respondent for committing five violations of the Act and 21 C.F.R. Part 1140 regulations within a 36-month period.  Pursuant to 21 C.F.R. §§ 17.11(b), 17.45(d), this decision becomes final and binding upon both parties after 30 days of the date of its issuance.