Rose Tobacco & Vape LLC d/b/a Rose Tobacco & Vape, DAB TB11104 (2026)

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

The Center for Tobacco Products (CTP) filed an Administrative Complaint (Complaint) against Respondent, Rose Tobacco & Vape LLC d/b/a Rose Tobacco & Vape, alleging facts and legal authority sufficient to justify imposing a civil money penalty of $14,232. CTP began this case by serving a Complaint on Respondent and filing a copy of the Complaint with the Food and Drug Administration’s (FDA) Division of Dockets Management.  The Complaint alleges that Respondent’s staff sold regulated tobacco products to underage purchasers and failed to verify that 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.  CTP seeks a civil money penalty of $14,232 against the Respondent for at least seven violations of the tobacco regulations within a 48-month period.

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Respondent filed a timely Answer to CTP’s Complaint.  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, 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), (c)(3).

I. Procedural History

On October 23, 2025, CTP served the Complaint on Respondent, located at 509 Rosebud Plaza, Clarksburg, West Virginia 26301, 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 (UPS Delivery Notification).

On November 20, 2025, Respondent, through counsel, registered for the DAB E-File system and timely filed a request for a 30-day extension of time within which to file an answer.  CRD Dkt. Entry No. 3a.  On that same date, I issued an Order granting Respondent’s request for an extension.  CRD Dkt. Entry No. 4.  On December 24, 2025, Respondent timely filed an Answer.  CRD Dkt. Entry No. 5.

On January 7, 2026, I issued an Acknowledgment and Pre-Hearing Order (APHO), acknowledging receipt of Respondent’s Answer and establishing procedural deadlines for this case.  CRD Dkt. Entry No. 6.  The APHO set deadlines for the parties’ filings and exchanges, including a schedule for discovery.  Id. ¶¶ 4, 6.  The APHO also stated that a party receiving a discovery request must provide the requested documents within 30 days of the request.  Id. ¶ 4; see also 21 C.F.R. § 17.23(a).  Specifically, the APHO warned:

I may impose sanctions including, but not limited to, dismissal of the [C]omplaint 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.

Id. ¶ 21.

On February 9, 2026, CTP filed a Joint Status Report, stating that the parties intend to engage in further settlement discussions and that CTP would notify my office if the

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parties agreed to a settlement and Respondent fulfilled the terms of the settlement agreement.  See CRD Dkt. Entry No. 8 at 1.

On March 5, 2026, CTP filed a Motion to Compel Discovery (MTC) with two exhibits consisting of its Request for Production of Documents (RFP) and the UPS Delivery Notification.  CRD Dkt. Entry Nos. 9, 9a-9b.  In its MTC, CTP stated that Respondent had not responded to its discovery request, as required by the APHO and the regulations. CRD Dkt. Entry No. 9.  On that same date, CTP also filed a Motion to Extend Deadlines requesting a 30-day extension of “any deadlines, including the March 30, 2026 due date for CTP’s pre-hearing exchange, be extended thirty (30) days .  .  .  .”  CRD Dkt. Entry No. 10 at 2.

On March 10, 2026, I issued an Order advising Respondent that it had until March 20, 2026, to file a response to CTP’s Motion to Compel Discovery.  CRD Dkt. Entry No. 11. I also warned that if Respondent failed to respond, “I may grant CTP’s motion in its entirety.”  Id. at 2; see also APHO ¶¶ 20-21.  In my Order, I also extended the pre-hearing exchange deadlines.  CRD Dkt. Entry No. 11 at 2.  Respondent failed to respond to either CTP’s Motion to Compel Discovery or my March 10, 2026 Order, or otherwise comply with CTP’s Request for Production of Documents.

On March 31, 2026, I issued an Order granting CTP’s Motion to Compel Discovery and ordered Respondent to produce responsive documents to CTP’s Request for Production of Documents by April 9, 2026.  CRD Dkt. Entry No. 12.  Again, I warned:

.  .  .  [F]ailure to comply [.  .  .  .] 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.

Id. at 2.

On April 15, 2026, CTP filed a Status Report and Motion to Impose Sanctions.  CRD Dkt. Entry No. 13.  CTP advised that Respondent had not complied with the APHO or my March 31, 2026 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 $14,232 civil money penalty.  Id. at 2-3.  On April 15, 2026, CTP also filed a Motion to Stay Deadlines.  CRD Dkt. Entry No. 14.

On April 17, 2026, I issued an Order giving Respondent until May 4, 2026, to file a response to CTP’s Motion to Impose Sanctions.  CRD Dkt. Entry No. 15.  My April 17,

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2026 Order also stayed the parties’ pre-hearing exchange deadlines 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.”  Id. at 2.  To date, Respondent has not filed any response.

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 the regulation at 21 C.F.R. § 17.23(a) and paragraph 4 of my January 7, 2026 APHO by failing to respond to CTP’s RFP within 30 days; and
• Respondent failed to comply with my March 31, 2026 Order Granting CTP’s Motion to Compel Discovery by failing to submit documents responsive to CTP’s RFP by April 9, 2026.

Respondent also failed to defend its action.  21 C.F.R. § 17.35(a)(2).  Specifically:

• Respondent did not file a response to CTP’s MTC, as permitted by the regulations, or file a response to my March 10, 2026 Order, giving Respondent until March 20, 2026 to file a response; and
• Respondent did not file a response to CTP’s Motion to Impose Sanctions (MTIS), as permitted by the regulations, or file a response to my April 17, 2026 Order, giving Respondent until May 4, 2026 to respond to CTP’s MTIS.

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, and 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.

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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. 12; see also APHO ¶ 21.  Respondent’s repeated misconduct interfered with the speedy, orderly, or fair conduct of this proceeding.  Further, Respondent has not participated in this action in any meaningful fashion since filing its Answer.  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(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.”); Carolina Cigar of Delray, LLC d/b/a Carolina Cigar, DAB No. 3134, at 11 (2024).

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 the regulations, 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 Rose Tobacco & Vape, an establishment that sells tobacco products and is located at 509 Rosebud Plaza, Clarksburg, West Virginia 26301.  Complaint ¶¶ 11-12.
• On March 19, 2025, CTP initiated a prior civil money penalty action, CRD Docket T-25-1393, FDA Docket FDA-2025-H-0727, against Respondent for violations of the Act, five1 of which occurred during the 48-month period relevant in the current Complaint.  Complaint ¶ 15.
• The previous action concluded when Respondent admitted all of the allegations in the Complaint and paid the agreed upon monetary penalty.  Further,

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• “Respondent expressly waived its right to contest such violations in subsequent actions.”  Complaint ¶ 16.
• An FDA-commissioned inspector conducted a subsequent inspection of Respondent’s establishment on June 1, 2025, at approximately 2:44 PM, during which “a person younger than 21 years of age was able to purchase a Geek Bar Pulse X Blue Razz Ice electronic nicotine delivery system (ENDS) product . . . .”  Additionally, “the underage purchaser’s age was not verified before the sale . . . .”  Complaint ¶ 13.

These facts establish that Respondent Rose Tobacco & Vape 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. 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 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).

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 July 9, 2023, June 10, 2024, November 10, 2024, and June 1, 2025.  Act § 906(d)(5).  On June 10, 2024, November 10, 2024, and June 1, 2025, 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.  Act § 906(d)(5); 21 C.F.R. §1140.14(b)(2)(i).  Therefore, Respondent’s actions constitute violations of law that merit a civil money penalty.

CTP has requested a civil money penalty of $14,232, which is a permissible penalty for at least seven violations of the regulations found at 21 C.F.R. Part 1140 within a 48-month period.  21 C.F.R. § 17.2.  Therefore, I find that a civil money penalty of $14,232 is warranted and so order one imposed.