Polymatrix Systems, Inc. d/b/a Smoke Smart, DAB TB9280 (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 on Respondent, PolyMatrix Systems Inc. d/b/a Smoke Smart, at 4875 Mexico Road, Saint Peters, Missouri 63376, and by filing a copy of the complaint with the Food and Drug Administration’s (FDA) Division of Dockets Management.  The Complaint alleges that Smoke Smart introduced into interstate commerce electronic nicotine delivery system (ENDS) products that lack the required premarketing authorization required under the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq. CTP seeks a civil money penalty of $20,678.

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 

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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 

As provided for in 21 C.F.R. §§ 17.5 and 17.7, on August 5, 2024, 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 August 26, 2024, Respondent filed a timely Answer to CTP’s Complaint denying all of the allegations and stating that the penalty was too high.  CRD Dkt. Entry No. 3.  On September 9, 2024, 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. 4.  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 October 9, 2024, in compliance with the APHO ¶ 3, CTP timely filed its status report.  CRD Dkt. Entry No. 5.  The status report indicated the parties were unable to reach a settlement and that CTP was unable to reach Respondent to file a Joint Status Report.  Id.

On November 14, 2024, CTP timely filed a Motion to Compel Discovery, asserting that Respondent did not respond to its discovery request as required by my APHO and regulations.  CRD Dkt. Entry No. 6.  On the same date, CTP also filed a Motion to Extend Deadlines requesting a 30-day extension of “any deadlines, including the November 29, 2024, due date for CTP’s pre-hearing exchange . . . .”  CRD Dkt. Entry No. 7 at 2. 

On November 19, 2024, I issued an Order advising Respondent that it had until December 4, 2024, to file a response to CTP’s Motion to Compel Discovery.  CRD Dkt. Entry No. 8.  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; 21 C.F.R. § 17.32(c).  In my Order, I also extended the pre-hearing exchange deadlines.  Id. 

Also on November 19, 2024, Respondent filed a Motion to Dismiss challenging the Food and Drug Administration’s (FDA) statutory authority to regulate tobacco products.  CRD 

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Dkt. Entry 9.  On December 4, 2024, CTP filed an Opposition to Respondent’s Motion to Dismiss.  CRD Dkt. Entry No. 10.  On December 6, 2024, Respondent filed an additional document in support of its Motion to Dismiss.  CRD Dkt. Entry No. 11.  On December 30, 2024, 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 January 14, 2025.  CRD Dkt. Entry No. 12.  I warned Respondent that:

• . . . . [F]ailure to comply may result in sanctions, which may include striking its filings 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.

In the order, I also explained that Respondent’s Motion to Dismiss will be addressed in a separate order because Respondent did not specifically respond to CTP’s Motion to Compel Discovery.  Id.  Therefore, Respondent is considered to have failed to file a response to CTP’s Motion to Compel Discovery.

On January 15, 2025, I issued an order denying Respondent’s Motion to Dismiss because Respondent asserted statutory and jurisdictional claims that are beyond the scope of this proceeding and beyond my authority as the presiding officer.  CRD Dkt. Entry No. 13.  On January 16, 2025, CTP filed a Status Report and Motion to Impose Sanctions.  CRD Dkt. Entry No. 14.  CTP advised that Respondent had not complied with the APHO or my December 30, 2024, 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 $20,678 civil money penalty.  Id.  On January 16, 2025, CTP also filed a Motion to Stay Deadlines.  CRD Dkt. Entry No. 15. 

On January 27, 2025, I issued an Order staying the pre-hearing exchange deadlines and giving Respondent until February 7, 2025, to file a response to CTP’s Motion to Impose Sanctions.  CRD Dkt. Entry No. 16.  The January 27, 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. at 1-2.

On January 27, 2025, Respondent filed a second Motion to Dismiss again challenging the FDA’s statutory authority to regulate tobacco products.  CRD Dkt. Entry No. 17.  On February 11, 2025, CTP timely filed an Opposition to Respondent’s Second Motion to Dismiss.  CRD Dkt. Entry No. 18.  On the same day, Respondent filed an additional document in support of its second Motion to Dismiss.  CRD Dkt. Entry No. 19.  On 

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March 7, 2025, I issued an order denying Respondent’s second Motion to Dismiss because Respondent again asserted statutory and jurisdictional claims that are beyond the scope of this proceeding and beyond my authority as the presiding officer.  CRD Dkt. Entry No. 20.  

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 CTP’s Motion to Compel Discovery when it failed to produce documents responsive to CTP’s Request for Production of Documents by January 14, 2025.  

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 November 19, 2024, Order; and
• Respondent did not file a response to CTP’s Motion to Impose Sanctions, as permitted by the regulations and my January 27, 2025, Order. 

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, 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 

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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. 16 at 1-2; see also APHO ¶ 21.  Respondent’s repeated misconduct interfered with the speedy, orderly, or fair conduct of this proceeding.  In fact, after initially admitting all of the violations in its Answer, Respondent has not participated in this action in any meaningful fashion. 

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 Smoke Smart, which is accessible at the URL:
• Respondent sells and/or distributes tobacco products through its online establishment that does business under the name Smoke Smart, which is accessible at the URL: https://smokesmartllc.com;  
• In a Warning Letter dated September 14, 2023, 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;
• On February 9, 2024, an FDA-commissioned inspector conducted an inspection of Smoke Smart at the URL: https://smokesmartllc.com.  During this inspection, FDA purchased Respondent’s Lost Mary Blue Cotton Candy and Funky Lands California Cherry ENDS products;
• In response to FDA’s order and purchase, Respondent shipped the Lost Mary Blue Cotton Candy and Funky Lands California Cherry ENDS products from Missouri to FDA in Maryland;
• Respondent’s ENDS products are “new tobacco products” because they were not commercially marketed in the United States as of February 15, 2007;
• Respondent’s ENDS products do not have a Marketing Granted Order (MGO) in effect;  

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• Neither a substantially equivalent (SE) report nor an abbreviated report has been submitted for Respondent’s ENDS products.  

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(d); 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 ENDS products that lack the premarketing authorization required under the Act.  21 U.S.C. § 331(d).  On February 9, 2024, Respondent offered for sale ENDS products that were adulterated because they lacked the required FDA marketing authorization and were 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 products were also misbranded because they hae 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.

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ORDER 

For these reasons, I enter default judgment and impose a civil money penalty in the amount of $20,678 against Respondent PolyMatrix Systems Inc. d/b/a Smoke Smart.  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.