Empire Imports, LLC d/b/a Vape.com, DAB TB10765 (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, Empire Imports, LLC d/b/a Vape.com, alleging facts and legal authority sufficient to justify imposing a civil money penalty of $21,348.  The Complaint alleges that Respondent impermissibly introduced into interstate commerce an electronic nicotine delivery system (ENDS) product that lacks the premarketing authorization required under the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq., and its implementing regulations, Cigarettes and Smokeless Tobacco, 21 U.S.C. § 387 et seq.  CTP seeks a civil money penalty of $21,348.

During the course of these administrative proceedings, Respondent failed to comply with judicial orders and procedures governing this proceeding and failed to defend its action, 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 July 9, 2025, CTP served the Complaint on Respondent’s counsel located at 4 Franklin Place, Suite 104, Woodmere, New York 11598, by United Parcel Service, pursuant to 21 C.F.R. §§ 17.5 and 17.7.  Civil Remedies Division (CRD) Docket (Dkt.) Entry Numbers (Nos.) 1 (Complaint), 1b (Proof of Service).  On August 7, 2025, Respondent timely filed a request for an extension of time to file its answer.  CRD Dkt. Entry No. 3.  On August 8, 2025, I issued an Order granting Respondent’s request and ordered Respondent to file its answer by September 8, 2025.  CRD Dkt. Entry No. 4.  On September 8, 2025, Respondent timely filed its Answer.  CRD Dkt. Entry No. 5.   In its Answer, Respondent argued that Respondent was not the owner of the establishment at the time of the alleged violation and stated that the penalty was too high.  Id.

On September 11, 2025, I issued an Acknowledgment and Pre-Hearing Order (APHO) which established the procedures for presenting evidence and arguments in this case including a deadline of October 14, 2025, for the parties to serve requests for documents.  CRD Dkt. Entry No. 6.

My APHO directed the party receiving a request to provide the requested documents no later than 30 days after the request was made.  Id. ¶ 4.  I also warned the parties that:

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 this hearing.

Id. ¶ 21; 21 C.F.R. § 17.35.

My APHO further instructed the parties to file and serve Notices of Appearance by October 2, 2025.  Id. ¶ 1.  On September 30, 2025, Respondent’s counsel timely filed its Notice of Appearance.  CRD Dkt. Entry No. 7.  On October 14, 2025, CTP timely filed a Status Report stating that the parties were unable to reach a settlement in this case and that CTP attempted to contact Respondent to discuss the filing of a Joint Status Report but was unable to obtain consent.  CRD Dkt. Entry No. 8; see also APHO ¶ 3.

On October 31, 2025, CTP filed a Motion to Compel Discovery (Motion to Compel) with two attachments, and a Motion to Extend Deadlines.  CRD Dkt. Entry Nos. 9, 9a-9b, 10.  CTP stated that it served its Request for Production of Documents (RFP) on Respondent’s counsel on September 26, 2025, but CTP had not received a response from Respondent.  CRD Dkt. Entry No. 9 at 1-2.  On November 5, 2025, I issued an Order instructing Respondent to file a response to CTP’s Motion to Compel Discovery by November 17,

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2025, and extended the parties’ pre-hearing exchange deadlines as requested.  CRD Dkt. Entry No. 11 at 1-2.  Respondent was warned “that if it fail[ed] to respond, I may grant CTP’s motion in its entirety.”  Id. at 1.

On November 17, 2025, Respondent timely filed a response to CTP’s Motion to Compel stating that ownership of the website referenced in the allegations of this case had “already transitioned to a third party” prior to the dates at issue and asked that I “deny the Motion to Compel” and permit Respondent additional time to gather and produce the necessary documentation.  CRD Dkt. Entry No. 12 at 1.

On December 5, 2025, I issued an Order denying CTP’s Motion to Compel and granting Respondent’s request for an extension.  CRD Dkt. Entry No. 13 at 1-2.  I gave Respondent until December 17, 2025, to comply with CTP’s discovery request.  Id. at 1.

On December 15, 2025, Respondent filed an Unopposed Motion to Extend All Deadlines requesting a second 30-day extension of time to respond to CTP’s RFP and stated that Respondent was “currently working with [CTP] to address and finalize the remaining [discovery] items” and that CTP’s Counsel did “not oppose” the request.  CRD Dkt. Entry No. 14.

On December 17, 2025, Respondent filed a Corrected Unopposed Motion to Extend clarifying that CTP’s Counsel does not oppose the request “as long as all timelines” were extended.  CRD Dkt. Entry No. 15 at 1.

On December 18, 2025, I issued a second Order granting Respondent’s third request to extend deadlines in its Unopposed Motion to Extend All Deadlines, and giving Respondent until January 20, 2026, to respond to CTP’s Request for Production of Documents, ordered the parties to file a Joint Status Report by January 26, 2026, and stayed all deadlines.  CRD Dkt. Entry No. 16.

On January 26, 2026, CTP filed a Status Report stating that Respondent had not sufficiently responded to CTP’s RFP, the parties were unable to reach a settlement in this case, and CTP attempted to contact Respondent to discuss the filing of a Joint Status Report but was unable to reach Respondent.  CRD Dkt. Entry No. 17.  Also on January 26, 2026, CTP renewed its Motion to Compel as Respondent had not entirely responded to CTP’s Request for Production of Documents.  CRD Dkt. Entry No. 18 at 1-2.

On January 27, 2026, I issued an Order Granting CTP’s Motion to Compel1 stating that

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Respondent was given three opportunities to comply and respond to CTP’s Motion to Compel including two opportunities where I granted Respondent’s extension requests providing an additional 30 days to comply.  CRD Dkt. Entry No. 19.  My Order gave Respondent until February 10, 2026, to comply with CTP’s Request for Production of Documents in its entirety and warned:

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.

Id. at 2 (emphasis in original).

On February 18, 2026, CTP filed Complainant’s Status Report and Motion to Impose Sanctions (Motion to Impose Sanctions).  CRD Dkt. Entry No. 20.  In its Motion to Impose Sanctions, CTP advised that Respondent did not produce responsive documents in compliance with my January 27, 2026, Order Granting its Motion to Compel Discovery.  Id. at 1-2.  CTP requested that I strike Respondent’s Answer and issue a default judgment imposing the $21,348 civil money penalty sought.  Id.

On February 20, 2026, I issued an Order giving Respondent until March 5, 2026, to respond to CTP’s Motion to Impose Sanctions.  CRD Dkt. Entry No. 21.  My February 20, 2026, Order again warned Respondent that if it failed to file a response, “I may grant CTP’s motion in its entirety.”  Id. at 3 (original emphasis omitted).  To date, Respondent has not responded to CTP’s Motion to Impose Sanctions.  Further, Respondent has not produced documents in entirety in response to CTP’s discovery requests or otherwise complied with my Order Granting CTP’s Motion to Compel Discovery.

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 the following orders and procedures governing this proceeding:

• Respondent failed to comply with paragraph 4 of my September 11, 2025, APHO, when it failed to respond to CTP’s Request for Production of Documents within 30 days; and
• Respondent failed to comply with my January 27, 2026, Order Granting Motion to Compel Discovery, requiring Respondent to comply with CTP’s Request for Production of Documents.

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

• My January 20, 2026, Order giving Respondent an opportunity to file a response to CTP’s Motion to Impose Sanctions.

This leads me to conclude that Respondent has abandoned its defense of this case.

In the absence of any sufficient explanation from Respondent, I find no basis to excuse Respondent’s continued failure to comply with various orders in this administrative proceeding even after affording Respondent numerous extensions providing Respondent with additional time to participate in this case and comply with CTP’s RFP.  See CRD Dkt. Entry Nos. 4, 13, 16.  Despite explicit warnings that failure to comply with my Orders could result in sanctions, Respondent did not comply with my Orders.  See CRD Dkt. Entry Nos. 6 ¶ 4, 19 at 2, 21 at 3.

Accordingly, I find that Respondent failed to comply with judicial orders and procedures governing this proceeding, failed to defend its case, and, as a result, engaged in a pattern of misconduct that interfered with the speedy, orderly, and fair conduct of the hearing.  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).

I find that Respondent’s actions are sufficiently egregious and 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.”).  Therefore, CTP’s Motion to Impose Sanctions is GRANTED and Respondent’s Answer to the Complaint is hereby STRICKEN from the record.

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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 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:

• Respondent sells and/or distributes tobacco products through its online establishment that does business under the name Vape.com, which is accessible at the URL: https://vape.com;
• On August 16, 2024, an FDA-commissioned inspector conducted an inspection of Vape.com at the URL: https://vape.com.  During this inspection, FDA purchased Respondent’s Funky Republic Ti7000 Pomelo Pearl Grape ENDS product;
• In response to FDA’s order and purchase, Respondent shipped the Funky Republic Ti7000 Pomelo Pearl Grape ENDS product from California to FDA in Maryland;
• Respondent’s Funky Republic Ti7000 Pomelo Pearl Grape ENDS product (hereinafter Respondent’s ENDS product) is a “new tobacco product” because it was not commercially marketed in the United States as of February 15, 2007;
• Respondent’s ENDS product does not have an MGO in effect under 21 U.S.C. § 387j(c)(1)(A)(i) and it is, therefore, adulterated under 21 U.S.C. § 387b(6)(A);
• Neither an SE report nor an abbreviated report has been submitted for Respondent’s ENDS product, and it is, therefore, misbranded under 21 U.S.C. § 387c(a)(6).

Complaint ¶¶ 13-19.

The Act prohibits the introduction or delivery for introduction into interstate commerce any tobacco product that is adulterated or misbranded.  21 U.S.C. § 331(a).  A tobacco product is adulterated if it has not obtained the required premarket authorization.  21 U.S.C. § 387b(6)(A).  Under 21 U.S.C. § 387j(a)(2)(A), premarket authorization is required for a “new tobacco product.”  A “new tobacco product” is defined as any tobacco product that was not commercially marketed in the United States as of

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February 15, 2007, or any modification of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.  21 U.S.C. § 387j(a)(1).  Respondent’s failure to obtain the required premarket authorization for its new tobacco products while such products are held for sale after shipment in interstate commerce results in such products being adulterated.  21 U.S.C. § 387b(6)(A).  A “new tobacco product” is exempt from this premarket authorization requirement only if the Secretary has issued a substantial equivalence report or a found exempt order for such product.  21 U.S.C. §§ 387j(a)(2)(A), 387e(j)(3)(A).  Neither a substantial equivalence report nor an exempt order report has been submitted for Respondent’s new e-liquid products.  As a result, Respondent’s tobacco products are misbranded, under the provisions of 21 U.S.C. § 387c(a)(6); see also 21 U.S.C. § 387c(a)(7)(B); 21 C.F.R. § 1140.1(b).  The Secretary of the 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).  These facts establish Respondent’s liability under the Act.

Respondent Empire Imports, LLC d/b/a Vape.com having failed to file an answer and taking the alleged above facts as true, I find that Respondent violated the prohibition against introducing into interstate commerce an electronic nicotine delivery system (ENDS) product without the premarketing authorization required under the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq., and its implementing regulations, Cigarettes and Smokeless Tobacco, 21 U.S.C. § 387 et seq.  Accordingly, I conclude Respondent’s actions warrant a civil money penalty in the amount of $21,348 under 21 U.S.C. § 333(f)(9)(A) and 21 C.F.R. § 17.2.

ORDER

For these reasons, I enter Default Judgment in the amount of $21,348 against Respondent, Empire Imports, LLC d/b/a Vape.com.  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.