Spring & Summer LLC d/b/a My VPro, DAB TB9477 (2025)

ORDER IMPOSING SANCTIONS AND INITIAL DECISION AND DEFAULT JUDGMENT

The Center for Tobacco Products (CTP) filed an Administrative Complaint (Complaint) against Respondent, Spring & Summer LLC d/b/a My VPro, alleging facts and legal authority sufficient to justify imposing a civil money penalty of $20,678.  The Complaint alleges Respondent introduced into interstate commerce, an electronic nicotine delivery system (ENDS) product lacking the required premarket authorization and offering such product for sale, thereby violating the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq.  CTP seeks a civil money penalty of $20,678.

Respondent filed a timely Answer to CTP's Complaint.  However, during the course of this administrative proceeding, Respondent failed to comply with judicial orders and

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procedures governing this proceeding, 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.

I.  Procedural History

On September 25, 2024, CTP served the Complaint on Respondent, located at 25739 North Hillview Court, Mundelein, Illinois 60060, 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), 1a (Cover letter), and 1b (Proof of Service).  On October 18, 2024, CRD received Respondent's timely filed Request for Extension of Time. CRD Dkt. Entry No. 4.  On October 22, 2024, I issued an Order granting Respondent's Request for Extension.  CRD Dkt. Entry No. 6.  On November 22, 2024, Respondent filled a Notice of Appearance and a second Motion for Extension.  CRD Dkt. Entry No. 7.

On November 25, 2025, I issued a second Order granting Respondent's Request for Extension giving Respondent until December 16, 2024, to file an Answer.  CRD Dkt. Entry No. 9.  On December 16, 2024, Respondent timely filed an Answer.  CRD Dkt. Entry No. 10.

On December 19, 2024, I issued an Acknowledgment and Pre-Hearing Order (APHO), establishing procedural deadlines for this case.  CRD Dkt. Entry No. 11.  The APHO ordered the parties to serve requests for documents no later than January 22, 2025, and ordered the parties receiving the request to provide the requested documents no later than 30 days after the request was made.  Id. ¶ 4.  Further, the APHO 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 the hearing."  Id.  ¶ 21, citing 21 C.F.R. § 17.35.  On January 22, 2025, CTP filed a Joint Status Report stating that the parties "intend to engage in further settlement discussions."  CRD Dkt. Entry No. 12.

On February 27, 2025, CTP contemporaneously filed a Motion to Compel Discovery and a Motion to Extend Deadlines.  CRD Dkt. Entry Nos. 13, 14.  In the Motion to Compel Discovery, CTP stated that it served its Request for Production of Documents (RFP) on January 22, 2025, however Respondent has not responded to the RFP as required by the APHO and the regulations.  CRD Dkt. Entry No. 13 at 1, 2.  In the Motion to Extend, CTP requested that deadlines articulated in the APHO be extended by 30 days, "including the March 14, 2025 due date for CTP's pre-hearing exchange."  CRD Dkt. Entry Nos. 14 at 2.

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On February 28, 2025, Respondent's counsel filed a Motion to Withdraw as counsel.  CRD Dkt. Entry No. 15.  Respondent's counsel asserted that "Professional considerations require the termination of the Firm's representation of Spring & Summer LLC."  Id. at 1.  On March 4, 2025, I issued an Order granting Respondent's Motion to Withdraw, acknowledging that Respondent "will proceed pro se until such time as it obtains alternative counsel, if it so chooses."  CRD Dkt. Entry No. 16.

On March 13, 2025, I issued an Order Granting Motion to Extend, extending the parties' exchange deadlines, and affording Respondent an opportunity to file a response to CTP's Motion to Compel Discovery by March 28, 2025.  CRD Dkt. Entry No. 17.  Respondent was warned "that if it fail[ed] to respond, I may grant CTP's motion in its entirety."  Id. at 2.  Respondent did not file a response to the March 13, 2025 Order.

On April 23, 2025, I issued an Order granting CTP's Motion to Compel Discovery and gave Respondent until May 5, 2025, to comply with CTP's RFP.  CRD Dkt. Entry No. 18 at 2.  Respondent was again warned that:

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.

On May 6, 2025, Respondent filed a document titled "Late Submission – Respondent's Statement Regarding Request for Production of Documents."  CRD Dkt. Entry No. 19.  Respondent contended that "[t]he statement was initially submitted on the deadline date; however, due to a network error, the submission did not go through successfully."  Id.  In addition, Respondent stated that they respectfully declined to produce the documents requested by CTP.  Id.  Lastly, Respondent asserted that they understood their decision to decline CTP's request for documents could "have certain procedural implications under the applicable rules, such as the potential for default judgment or administrative action."  Id.

On May 6, 2025, CTP filed Complainant's Status Report and 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 the April 23, 2025 Order Granting Motion to Compel Discovery.  Id. at 2.  On the same date, CTP also filed a Motion to Stay Deadlines pending the resolution of its Motion to Impose Sanctions.  CRD. Dkt. Entry No. 21.

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On May 7, 2025, I issued an Order giving Respondent until May 22, 2025 to respond to CTP's Motion to Impose Sanctions, and granted CTP's Motion to Stay Deadlines as requested.  CRD Dkt. Entry No. 22.  My May 7, 2025 Order also warned Respondent that if it failed to file a response, "I may grant CTP's motion in its entirety."  Id. at 2.  To date Respondent has not responded to CTP's Motion to Impose Sanctions or my May 7, 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).

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 the December 19, 2024 APHO, when it failed to respond to CTP's Request for Production of Documents within 30 days; and
• Respondent failed to comply with the April 23, 2025 Order Granting Motion to Compel Discovery, requiring Respondent to comply with CTP's Request for Production of Documents by May 5, 2025.1

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

• Respondent did not file a timely response to CTP's Motion to Compel Discovery, as permitted by the regulations, or file a response to the March 13, 2025 Order, giving it an opportunity to respond to CTP's Motion to Compel Discovery; and

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• Respondent did not file a response to CTP's Motion to Impose Sanctions, as permitted by the regulations, or file a response to my May 7, 2025 Order, giving it an opportunity to respond to CTP's Motion to Impose Sanctions.

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 two judicial orders, despite my explicit warnings that its failure to do so could result in sanctions.  See CRD Dkt. Entry Nos. 11 ¶ 21, 18.  Respondent's repeated misconduct interfered with the speedy, orderly, or fair conduct of this proceeding.  In fact, Respondent declined to respond to CTP's RFP as well as the Order Granting Motion to Compel Discovery.  CRD Dkt. Entry No. 19.  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.").

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 owns My VPro, that sells tobacco products through its online establishment, accessible at URL: https://myvpro.com.  The establishment receives tobacco products, including a Lost Mary MO5000 Lemon Sparkling Wine ENDS product, in interstate commerce and delivers or proffers delivery of these products for pay or otherwise.  Complaint ¶¶ 13, 15.

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• In a warning letter dated January 31, 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 order."  Complaint ¶ 14.
• On April 17, 2024, an FDA-commissioned inspector conducted an inspection of Respondent's online establishment at the URL: https://myvpro.com.  During this inspection, the inspector "purchased Respondent's Lost Mary MO5000 Lemon Sparkling Wine ENDS product."  In response to FDA's order and online purchase, "Respondent shipped the Lost Mary MO5000 Lemon Sparkling Wine ENDS product from Illinois to FDA in Maryland."  Complaint ¶¶ 15, 16.
• Respondent's ENDS 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 ENDS product does not have a Marketing Granted Order (MGO) in effect.  Complaint ¶ 18.
• Neither a substantially equivalent (SE) report nor an abbreviated report has been submitted for Respondent's ENDS product.  Complaint ¶ 19.
• Respondent introduced or delivered for introduction into interstate commerce or caused the introduction or delivery for introduction into interstate commerce of, these adulterated and misbranded ENDS products.  Complaint ¶ 20.

These facts establish that Respondent is liable under the Act.  The Act prohibits the introduction or delivery for introduction in interstate commerce of any tobacco product that is adulterated or misbranded and the delivery or proffered delivery of any tobacco product that is adulterated or misbranded for pay or otherwise.  21 U.S.C. § 331(a); see 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

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"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 or delivering for introduction new tobacco products that were adulterated and misbranded.  21 U.S.C. § 331(a).  On April 17, 2024, Respondent offered for sale an ENDS product that was adulterated because it lacked the required FDA marketing authorization and was not exempt from this requirement.  21 U.S.C. §§ 387j(a)(2)(A), 387e(j)(3)(A).  Under 21 U.S.C. § 387c(a)(6), Respondent's ENDS product is also misbranded because it has no substantially equivalent determination as required by 21 U.S.C. § 387e(j).  Therefore, Respondent's actions constitute violations of law that merit 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.  Therefore, I find that a civil money penalty of $20,678 is warranted and so order one imposed.