Vape Game LLC d/b/a Vape Game, DAB TB10479 (2026)

ORDER IMPOSING SANCTIONS AND
INITIAL DECISION AND DEFAULT JUDGMENT

On August 15, 2024, the Center for Tobacco Products (CTP) served a Complaint on Vape Game LLC d/b/a Vape Game (Respondent), at 2321 Olympic Street Springfield, Oregon 97477, and filed a copy of the Complaint with the Food and Drug Administration’s (FDA) Division of Dockets Management.  In its Complaint, CTP seeks to impose a $20,678 civil money penalty against Respondent for being a manufacturer and retailer of new tobacco products that lack the premarketing authorization, thereby violating the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq.

Respondent filed an 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).  Accordingly, pursuant to 21 C.F.R. § 17.35(a)(1); 21 C.F.R. § 17.35 (a)(2), I strike Respondent’s Answer and issue this decision of default judgment.

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I. Procedural History

On August 15, 2024, CTP served the Complaint on Respondent, at 2321 Olympic Street Springfield, Oregon 97477, by United Parcel Service (UPS), pursuant to 21 C.F.R. §§ 17.5 and 17.7.  Civil Remedies Division (CRD) Docket (Dkt.) Entry Numbers (Nos.) 1 (Complaint), 1b (UPS Delivery Notification).  On August 21, 2024, the Civil Remedies Division issued an Initial Order Establishing Procedures which instructed Respondent to file an answer or request for extension by September 16, 2024.  CRD Dkt. Entry No. 3.  The order also informed CTP that if Respondent failed to file an answer by September 16, 2024, CTP would have until October 1, 2024, to file a Motion for Default Judgment.  Id. at 1-2.

Respondent did not file an answer by the deadline and on September 19, 2024, CTP filed a Motion for Default Judgment.  CRD Dkt. Entry No. 4.  On September 20, 2024, the previous Administrative Law Judge (ALJ) assigned to this case issued an order instructing Respondent to show cause as to why Judgment of Default should not be entered in favor of CTP.  CRD Dkt. Entry No. 5.  On October 10, 2024, Respondent submitted an explanation for his untimely answer and an answer to the complaint.  CRD Dkt. Entry No. 6a.  On October 23, 2024, by direction of the ALJ, the parties were advised of the deadline for Respondent to demonstrate that extraordinary circumstances prevented Respondent from filing an answer in a timely manner and the deadline for CTP to file an objection.  CRD Dkt. Entry No. 8. 

On November 4, 2024, Respondent’s owner filed documents to support Respondent’s position that a severe car accident on September 6, 2024 and resulting concussion prevented him from filing an answer by the September 16, 2024 deadline.  See CRD Dkt. Entry Nos. 9-9c.  On November 6, 2024, counsel for CTP sent an email to the attorney-advisor assigned to this case stating that CTP did not object to Respondent’s late‑filed answer.  CRD Dkt. Entry No. 10.  Therefore, on January 29, 2025, the ALJ issued a Pre-Hearing Order (PHO) which established a schedule for discovery and deadlines for filings and pre‑hearing exchanges.  CRD Dkt. Entry No. 11.   

On May 28, 2025, CTP submitted its informal brief and 13 proposed exhibits (CTP Exs. 1-13) including the written direct testimony of two proposed witnesses: James Bowling, Deputy Division Director, Office of Compliance and Enforcement, CTP, FDA (CTP Ex. 1); and Shelton L. Stribling, FDA Consumer Safety Officer (CTP Ex. 2).  CRD Dkt. Entry Nos. 14, 14a-14n.  Respondent did not submit an informal brief or any evidence, including the written direct testimony of any witness.

On September 17, 2025, I issued an order informing the parties that the case was reassigned to me for adjudication.  CRD Dkt. Entry No. 15.  Also, I scheduled a pre-hearing conference and instructed the parties to provide my office with their availability during the weeks of October 13, 2025 and October 20, 2025 by September 24, 2025.  Id. 

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at 2.  On September 18, 2025, 2025, CTP emailed the attorney-advisor assigned to this case stating CTP’s availability in mid-late October and indicating that “[c]ounsel for CTP and Respondent [were] cc’d on th[e] email.”  CRD Dkt. Entry No. 16.  Respondent did not respond to my September 17, 2025 order or CTP’s September 18, 2025 email.  On October 2, 2025, I issued an order scheduling a pre-hearing conference for October 23, 2025, at 1:00 P.M. Eastern Time.  CRD Dkt. Entry No. 17.  As a courtesy, on October 22, 2025, the attorney-advisor sent the parties an email reminding them of the scheduled pre-hearing conference.  CRD Dkt. Entry No. 18.

On October 23, 2025, I held the pre-hearing conference call as scheduled.  William H. Rawson, attorney for CTP, appeared at the pre-hearing conference.  However, Respondent failed to appear at the pre-hearing conference call as ordered.  On October 24, 2025, I issued an Order to Show Cause (OSC), giving Respondent until November 12, 2025, to show cause for its failure to comply with my order and failure to defend its case.  CRD Dkt. Entry No. 19.  I warned Respondent that:

• “failure to do so may result in sanctions, including striking Respondent’s Answer 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. at 1. 

To date, Respondent has not responded to the OSC or otherwise communicated with my office.

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. § 17.25(a) and paragraph 4 of the January 29, 2025 PHO by failing to file its pre-hearing exchange by April 28, 2025;

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• Respondent failed to comply with my October 2, 2025 Order Scheduling Pre-Hearing Conference, requiring both parties to appear at the pre-hearing conference; and
• Respondent failed to comply with my October 24, 2025 order requiring Respondent to show cause for its failure to appear at the October 23, 2025 pre-hearing conference. 

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

• Respondent failed to file a pre-hearing exchange as directed by my PHO;
• Respondent failed to appear at the pre-hearing conference; and
• Respondent failed to respond to my OSC.

I find that Respondent failed to comply with 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.

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 three judicial orders, despite my explicit warning that its failure to do so could result in sanctions.  See CRD Dkt. Entry No. 19.  Respondent’s repeated misconduct interfered with the speedy, orderly, or fair conduct of this proceeding.  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), (d); 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 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:

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• Respondent manufactures tobacco products and sells them through its establishment that does business under the name Vape Game, located at 2321 Olympic St, Springfield, Oregon, 97477. Complaint ¶ 14.
• Respondent manufactures tobacco products and sells them through its establishment that does business under the name Vape Game, located at 2321 Olympic St, Springfield, Oregon, 97477.  Complaint ¶ 14.
• On April 10-11, 2024, an FDA-commissioned inspector conducted an inspection of Respondent.  During this inspection, the inspector observed components obtained from California and used to make e-liquid products that Respondent sells at its establishment and Respondent’s DRIP/Killa Vanilla 3mg (60ml) e-liquid product that it sells through its establishment.  Complaint ¶ 15.
• Respondent shipped the product from Oregon to a customer in Florida.  Complaint ¶ 16.
• Respondent’s e-liquid product is a “new tobacco product” because it was not commercially marketed in the United States as of February 15, 2007.  Complaint ¶ 17.
• Respondent’s e-liquid product does not have an SE order or found-exempt order in effect.  Accordingly, it is required by 21 U.S.C. § 387j(a) to have premarket review.  Complaint ¶ 18.
• Respondent submitted a premarket tobacco product application (PMTA) to FDA for certain of its e-liquid products, and on December 12, 2022, FDA issued a Refuse to Accept (RTA) Letter for all its e-liquid products.  Complaint ¶ 19.
• Respondent’s e-liquid product does not have an order permitting marketing of the new tobacco product (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).  Complaint ¶ 20.
• Neither an SE report nor an abbreviated report has been submitted for Respondent’s e-liquid product, and it is, therefore, misbranded under 21 U.S.C. § 387c(a)(6).  Complaint ¶ 21.
• Respondent introduced or delivered for introduction into interstate commerce, or caused the introduction or delivery for introduction into interstate commerce of, this adulterated and misbranded tobacco product, in violation of 21 U.S.C. § 331(a).  Complaint ¶ 22.

These facts establish Respondent Vape Game’s liability under the Act.  The Act prohibits adulterating or misbranding of a regulated tobacco product while it is held for sale after shipment of one or more of its components in interstate commerce.  21 U.S.C. § 331(k).  A tobacco product is adulterated if it has not obtained the required premarket 

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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 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 e-liquid product was not commercially marketed in the United States as of February 15, 2007, and did not have an order permitting marketing of a new tobacco product under 21 U.S.C. § 387j(c)(1)(A)(i).  Thus, Respondent’s e-liquid product lacked the required premarketing authorization and, therefore, is adulterated.  21 U.S.C. § 387b(6)(A). 

A “new tobacco product” is exempt from this premarket authorization requirement only if there is a substantial equivalence or a found exempt order in effect for such product.  21 U.S.C. §§ 387j(a)(2)(A), 387e(j)(3)(A).  Respondent’s e-liquid product does not have an order permitting marketing of a new tobacco product under 21 U.S.C. § 387j(c)(1)(A)(i).  Neither a substantial equivalence (SE) report nor an abbreviated report has been submitted for Respondent’s e-liquid product making it misbranded under 21 U.S.C. § 387c(a)(6).  As a result, Respondent’s e-liquid product is 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 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).  These facts establish Respondent’s liability under the Act. 

Taking the above alleged facts as true, on April 10-11, 2024, Respondent violated the Act’s prohibition against introducing or delivering for introduction into interstate commerce an adulterated and misbranded tobacco product.  21 U.S.C. 331(a); see also 21 U.S.C. § 387b(6)(A), 21 U.S.C. §§ 387j(a)(2)(A), 387e(j)(3)(A).  Therefore, Respondent violated the law which warrants a civil money penalty.    

CTP has requested a civil money penalty of $20,678, which is a permissible penalty under 21 U.S.C. § 333(f)(9)(A) and 21 C.F.R. § 17.2.  See also 45 C.F.R. § 102.3. Therefore, I find that a civil money penalty of $20,678 is warranted and impose a penalty in that amount against Respondent.

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Order

For the reasons stated above, I enter default judgment and impose a civil money penalty against Respondent, Vape Game LLC d/b/a Vape Game in the amount of $20,678. 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.