Star Distribution Inc. d/b/a Vape Star USA, DAB TB9768 (2025)

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

The Center for Tobacco Products (CTP) began this matter by serving an Administrative Complaint (Complaint) on Respondent, Star Distribution Inc. d/b/a Vape Star USA, at 6728 North University Drive, Tamarac, Florida 33321, and by filing a copy of the Complaint with the Food and Drug Administration’s (FDA) Division of Dockets Management.  The Complaint alleges that Vape Star USA introduced into interstate commerce an electronic nicotine delivery system (ENDS) product that lacks the required premarketing authorization, thereby violating the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq. CTP seeks a civil money penalty of $21,348.

During the course of this administrative proceeding, Respondent failed to comply with orders and procedures and failed to defend its actions, which interfered with the speedy, orderly, or fair conduct of this proceeding.  21C.F.R. § 17.35(a).  Accordingly, pursuant

Page 2

to 21 C.F.R. § 17.35(c)(3), I strike Respondent’s Answer and issue this decision of default judgment.

I. Procedural History

As provided for in 21 C.F.R. §§ 17.5 and 17.7, on January 15, 2025, CTP served the Complaint on Respondent by United Parcel Service.  Civil Remedies Division (CRD) Docket (Dkt.) Entry Nos. 1 (Complaint), 1b (Proof of Service).  On February 18, 2025, CTP emailed an Answer from Respondent dated February 14, 2025, to my office.  CRD Dkt. Entry Nos. 3, 4.  In its Answer, Respondent denied all of the allegations in the Complaint and stated that it believed the penalty CTP requests is too high.  CRD Dkt. Entry No. 3.  On March 4, 2025, I issued an Acknowledgement and Pre‑Hearing Order (APHO) that set deadlines for the parties’ filings and exchanges, including a schedule for discovery.  CRD Dkt. Entry No. 7.  I directed that a party receiving a discovery request must provide the requested documents within 30 days of the request.  APHO ¶ 4; see also 21 C.F.R. § 17.23(a).  The APHO warned:

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 the hearing.  21 C.F.R. § 17.35.

APHO ¶ 21.

On March 31, 2025, in compliance with the APHO ¶ 3, CTP timely filed a status report.  CRD Dkt. Entry No. 8.  The status report indicated that the parties were unable to reach a settlement and that CTP was unable to reach Respondent to discuss filing a Joint Status Report.  Id.

On May 6, 2025, CTP filed a Motion to Compel Discovery, asserting that Respondent did not respond to CTP’s discovery request as required by my APHO and applicable regulations.  CRD Dkt. Entry No. 9.

On May 7, 2025, I issued an Order advising Respondent that it had until May 22, 2025, 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.; see also APHO ¶¶ 20-21; 21 C.F.R. § 17.32(c).  Respondent failed to respond to either CTP’s Motion to Compel Discovery or my May 7, 2025 Order.

On May 28, 2025, 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 June 4, 2025.  I warned Respondent that:

Page 3

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.

CRD Dkt. Entry No. 12 at 1-2.

On June 5, 2025, 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 May 28, 2025 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 $21,348 civil money penalty.  Id.

On June 6, 2025, I issued an Order giving Respondent until June 23, 2025, to file a response to CTP’s Motion to Impose Sanctions.  CRD Dkt. Entry No. 15.  The June 6, 2025 Order also warned Respondent that if it “fails to file a response, I may grant CTP’s Motion to Impose Sanctions in its entirety.”  Id.

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 21 C.F.R. § 17.23(a) and paragraph 4 of my APHO, when Respondent failed to respond to CTP’s Request for Production of Documents within 30 days; and
• Respondent failed to comply with my Order Granting Motion to Compel when it failed to produce documents responsive to CTP’s Request for Production of Documents by June 4, 2025.

Page 4

I also find that Respondent failed to defend this action.  21 C.F.R. § 17.35(a)(2).  Specifically:

• Respondent did not file a response to CTP’s Motion to Compel Discovery, as permitted by the regulations and my May 7, 2025 Order; and
• Respondent did not file a response to CTP’s Motion to Impose Sanctions, as permitted by the regulations and my June 6, 2025 Order.

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, or 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 two judicial orders, despite my explicit warnings that its failure to do so could result in sanctions.  See CRD Dkt. Entry No. 12 at 2 and CRD Dkt. Entry No. 15 at 2-3; see also APHO ¶ 21.  Respondent’s repeated misconduct interfered with the speedy, orderly, or fair conduct of this proceeding.  In fact, Respondent has not participated in this action 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).

III. Default Decision

Striking Respondent’s Answer leaves the Complaint unanswered.  Therefore, pursuant to 21 C.F.R. § 17.11(a), I am required to “assume the facts alleged in the Complaint 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 Star USA, which is accessible at the URL: https://vapestarusa.com;
• In a Warning Letter dated April 30, 2024, CTP informed Respondent that the new tobacco products that Respondent sells and/or distributes are adulterated and misbranded because they lack the required FDA marketing authorization;

Page 5

• On May 30, 2024, an FDA-commissioned inspector conducted an inspection of Vape Star USA at the URL: https://vapestarusa.com/.  During this inspection, FDA purchased Respondent’s Smok Spaceman 10K Pro Alphonso Mango ENDS product;
• In response to FDA’s order and purchase, Respondent shipped the Smok Spaceman 10K Pro Alphonso Mango ENDS product from Florida to FDA in Maryland;
• Respondent’s Smok Spaceman 10K Pro Alphonso Mango ENDS product is a “new tobacco product” because it was not commercially marketed in the United States as of February 15, 2007;
• Respondent’s Smok Spaceman 10K Pro Alphonso Mango ENDS product does not have a Marketing Granted Order (MGO) in effect;
• Neither a substantially equivalent (SE) report nor an abbreviated report has been submitted for Respondent’s Smok Spaceman 10K Pro Alphonso Mango ENDS product.

These facts establish that Respondent is liable under the Act.  The Act prohibits introducing into interstate commerce or causing the introduction or delivery for introduction into interstate commerce of any tobacco product that is adulterated or misbranded.  21 U.S.C. § 331(a); see also 21 U.S.C. § 321(b).  Premarket authorization from the FDA is required for all “new tobacco products.”  21 U.S.C. § 387j(a)(2)(A).  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).  A “new tobacco product” is required to have premarket review with a Marketing Granted Order (MGO) unless it has a substantial equivalence or substantial equivalence exemption order (found-exempt order) in effect for such product. 21 U.S.C. §§ 387j(a)(2)(A), 387e(j)(3)(A).  A new tobacco product is adulterated if it has not obtained the required premarket authorization.  21 U.S.C. § 387b(6)(A).  A new tobacco product for which a “notice or other information respecting it was not provided as required” under the substantial equivalence or substantial equivalence pathway is misbranded. 21 U.S.C. § 387c(a)(6).

Taking the above alleged facts as true, Respondent violated the prohibition against introducing into interstate commerce an ENDS product that lacks the premarketing authorization required under the Act.  21 U.S.C. § 331(a).  On May 30, 2024, Respondent offered for sale, sold, and subsequently shipped an Smok Spaceman 10K Pro Alphonso Mango ENDS product that was adulterated because it lacked the required FDA marketing authorization and this ENDS product was not exempt from this requirement.  21 U.S.C.

Page 6

§§ 387b(6)(A); 387j(c)(1)(A)(i); 387j(a)(2)(A), 387e(j)(3)(A).  Under 21 U.S.C. § 387c(a)(6), Respondent’s ENDS product was also misbranded because it had no substantially equivalent determination as required by 21 U.S.C. § 387e(j).  Therefore, I determine that Respondent violated laws regarding the sale and distribution of regulated tobacco products, which merits a civil money penalty.

CTP has requested a civil money penalty of $21,348, which is a permissible penalty under 21 U.S.C. § 333(f)(9)(A) and 21 C.F.R. § 17.2.  I find that a civil money penalty of $21,348 is warranted and order one imposed.

ORDER

For these reasons, I enter default judgment in the amount of $21,348 against Respondent Star Distribution Inc. d/b/a Vape Star USA.  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.