Prestige S&A Product Corp. d/b/a Tobacco City, DAB TB10939 (2026)

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

On August 1, 2025, the Center for Tobacco Products (CTP) served a Complaint on Prestige S&A Product Corp., d/b/a Tobacco City (Respondent), at 600 Portion Road, Suite 10, Ronkonkoma, New York 11779.  A copy of the Complaint was also filed with the Food and Drug Administration’s (FDA) Division of Dockets Management on August 1, 2025.  CTP seeks a $709 civil money penalty against Respondent for allegedly violating the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq., and its implementing regulations, 21 C.F.R. pt. 1140, at least three1 times within a 24-month period.  Respondent timely filed an Answer to the Complaint.  Since filing the Answer, however, Respondent has repeatedly disregarded my orders and has been non-responsive to CTP’s discovery requests.  Specifically, Respondent failed to

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respond to CTP’s document requests, failed to respond to CTP’s Motion to Compel Discovery, failed to comply with my Order granting CTP’s Motion to Compel Discovery, and failed to respond to the present Motion to Impose Sanctions.

Currently before me is CTP’s Motion to Impose Sanctions, which seeks sanctions against Respondent for its noncompliance with the rules and orders governing this proceeding.  As a proposed sanction for Respondent’s conduct, CTP asks me to strike Respondent’s Answer and issue a default judgment against Respondent pursuant to 21 C.F.R. § 17.35(c)(3).  For the reasons stated below, I find the requested sanctions are warranted and appropriate under the circumstances.  Therefore, I grant CTP’s Motion to Impose Sanctions, strike Respondent’s Answer, and issue this decision of default judgment imposing the requested civil money penalty against Respondent.

I. Procedural History

On August 1, 2025, CTP served a Complaint on Respondent by United States Postal Service in accordance with 21 C.F.R. §§ 17.5 and 17.7.  See Civil Remedies Division (CRD) Docket (Dkt.) Entry Numbers (Nos.) 1, 1a, 1b.  On August 27, 2025, Respondent timely filed an Answer to the Complaint.2  CRD Dkt. Entry Nos. 3, 4.

On September 3, 2025, I issued an Acknowledgment and Pre-Hearing Order (APHO), which outlined the procedures governing this case and established deadlines for the parties to complete discovery and file pre-hearing exchanges.  CRD Dkt. Entry No. 5.  Among other provisions, the APHO established a deadline of October 3, 2025 for the parties to serve any document requests, and explained that a party must produce any requested documents no later than 30 days after receiving a request for documents from the opposing party.  CRD Dkt. Entry No. 5 ¶ 4; see also 21 C.F.R. § 17.23(a).  The APHO also warned that I may impose sanctions, up to and including dismissal of the Complaint or striking the Answer, for failing to comply with any order in this case, failing to prosecute or defend its case, or engaging in misconduct that “interferes with the speedy, orderly, or fair conduct of the hearing.”  CRD Dkt. Entry No. 5 ¶ 21; see also 21 C.F.R. § 17.35.

On October 2, 2025, CTP filed a Status Report regarding the status of settlement discussions.  CRD Dkt. Entry No. 7.  In the filing, CTP stated that the parties have been unable to reach a settlement in this case.  Id.  CTP also noted that it attempted to contact Respondent to discuss the filing of a Joint Status Report but was unable to reach Respondent.  Id.

On November 10, 2025, CTP filed a Motion to Compel Discovery, stating that it served document requests on Respondent on October 6, 2025, but received no response.  CRD Dkt. Entry No. 8.  Accordingly, CTP requested an order compelling Respondent to comply

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with CTP’s document requests.  Id. at 2.  By a separate filing, CTP also requested a 30-day extension of all outstanding deadlines pending resolution of the Motion to Compel Discovery.  CRD Dkt. Entry No. 9 at 2.

On November 13, 2025, I issued an Order granting CTP’s request for a 30-day extension of the pre-hearing deadlines.  CRD Dkt. Entry No. 10.  I also advised Respondent that it had until December 1, 2025 to respond to CTP’s Motion to Compel Discovery.  Id. at 2.  I warned that if Respondent failed to file a response, “I may grant CTP’s motion in its entirety.”  Id.

Despite my warning, Respondent did not respond to CTP’s Motion to Compel Discovery by the December 1, 2025 deadline.  Accordingly, on December 18, 2025, I issued an Order granting the Motion to Compel Discovery and directed Respondent to fully respond to CTP’s document requests by January 6, 2026.  CRD Dkt. Entry No. 11.  I also extended all deadlines by 30 days to give Respondent time to comply with the Order.  Id. at 2.  I specifically warned Respondent that if it failed to comply, I could impose 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 January 7, 2026, CTP filed the present Motion to Impose Sanctions.  CRD Dkt. Entry No. 12.  In the Motion, CTP states that Respondent failed to comply with my December 18, 2025 Order granting its Motion to Compel Discovery and still has not produced any documents in response to CTP’s discovery requests.  Id. at 1.  As a proposed sanction, CTP asks that I strike Respondent’s Answer and issue a default judgment in favor of CTP.  Id. at 2-3.  By separate filing, CTP also requested a stay of all deadlines pending resolution of its Motion to Impose Sanctions.  CRD Dkt. Entry No. 13.

On January 13, 2026, I issued an Order stating that Respondent had until February 24, 2026 to file a response to CTP’s Motion to Impose Sanctions.  CRD Dkt. Entry No. 14.  I also granted CTP’s request to stay all deadlines pending resolution of the Motion.  Id. at 2.

To date, Respondent has not filed a response to CTP’s Motion for Sanctions, produced any documents in response to CTP’s discovery requests, or otherwise complied with my Order granting CTP’s Motion to Compel Discovery.

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II. Motion to Impose Sanctions

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).

Here, I find that Respondent failed, and continues to fail, to comply with multiple orders and rules in this proceeding, including:

• The requirements in 21 C.F.R. § 17.23(a) and paragraph 4 of the APHO, by failing to respond to CTP’s document requests within 30 days; and
• My December 18, 2025 Order granting CTP’s motion to compel discovery, by failing to respond to CTP’s document requests by January 6, 2026.

In addition, I find that Respondent has failed to defend this action.  Specifically, Respondent did not respond to CTP’s Motion to Compel Discovery or the present Motion to Impose Sanctions.  In fact, Respondent has not taken any action in this case since filing its Answer on August 27, 2025.  Respondent’s noncompliance and lack of responsiveness has interfered with the speedy, orderly, and fair conduct of this proceeding by preventing the case from moving forward to a hearing.  Therefore, I conclude that Respondent’s conduct establishes a basis for sanctions pursuant to 21 C.F.R. § 17.35, and that sanctions are warranted under the circumstances.

The sanctions I impose must relate to the nature and severity of the misconduct or noncompliance.  21 C.F.R. § 17.35(b).  Here, Respondent’s conduct has caused unnecessary delays and disruptions, interfered with CTP’s ability to prosecute its case, and prevented me from conducting a hearing or issuing a decision on the merits.  Respondent’s behavior suggests it has abandoned its defense and is no longer interested in participating in these proceedings.

Based on the severity and ongoing nature of Respondent’s conduct, I find that the appropriate sanction is to strike Respondent’s Answer to the Complaint.  21 C.F.R. § 17.35(b), (c)(3); see also KKNJ, Inc. d/b/a Tobacco Hut 12, DAB No. 2678 at 10-11 (2016) (concluding ALJ did not abuse discretion by striking Respondent’s Answer for failing to comply with discovery order).  While I recognize that this is a harsh remedy, I conclude that a lesser sanction would not effectively address Respondent’s repeated noncompliance and failure to defend its case.  Indeed, Respondent’s conduct has effectively

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brought this proceeding to a standstill without any explanation or justification.  Therefore, CTP’s Motion to Impose Sanctions is GRANTED and Respondent’s Answer to the complaint is hereby STRICKEN from the record.

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).  Accordingly, I must determine whether the allegations in the complaint establish violations of the Act.

For purposes of this decision, I assume the facts alleged in the Complaint to be true, pursuant to the provisions of 21 C.F.R. § 17.11(a).  Specifically, CTP alleges the following facts in its complaint:

• Respondent owns an establishment that does business under the name Tobacco City and is located at 600 Portion Road, Suite 10, Ronkonkoma, New York 11779. Complaint ¶ 11.
• Respondent’s establishment receives tobacco products in interstate commerce, including Black & Mild Original Wood Tip cigars and JUUL Virginia Tobacco e-liquid products, and holds them for sale after shipment in interstate commerce., and holds them for sale after shipment in interstate commerce.  Complaint ¶ 12.
• At approximately 5:04 PM on July 2, 2024, an FDA‑commissioned inspector conducted an inspection at Respondent’s establishment.  During the inspection, a person younger than 21 years of age was able to purchase a JUUL Virginia Tobacco e-liquid product.  Additionally, Respondent’s staff failed to verify, by means of photographic identification containing a date of birth, that the purchaser was 21 years of age or older.  Complaint ¶ 15.
• In a warning letter dated July 25, 2024, CTP informed Respondent of the violations observed during the July 2, 2024 inspection.  CTP warned Respondent that failing to correct the violations could result in civil money penalties or other regulatory action.  Complaint ¶ 16.
• At approximately 4:41 PM on February 17, 2025, an FDA‑commissioned inspector conducted a subsequent inspection at Respondent’s establishment.  During this inspection, a person younger than 21 years of age was able to purchase a Black & Mild Original Wood Tip cigar.  Additionally, Respondent’s staff failed to verify, by

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• means of photographic identification containing a date of birth, that the purchaser was 21 years of age or older.  Complaint ¶ 13.

These facts establish Respondent Tobacco City’s liability under the Act.  The Act prohibits “misbranding” of a regulated tobacco product.  21 U.S.C. § 331(k).  A regulated tobacco product is “misbranded” if sold or distributed in violation of regulations issued under section 906(d) of the Act.  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 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).  Under section 906(d)(5) of the Act, no retailer may sell regulated tobacco products to any person younger than 21 years of age.  Further, under 21 C.F.R. § 1140.14(b)(2)(i), a retailer must verify the age of a person purchasing covered tobacco products by means of photographic identification containing a purchaser’s date of birth.

Accepting the facts alleged in the Complaint as true, I find that Respondent committed at least three violations of the Act during the inspections on July 2, 2024 and February 17, 2025.  Specifically, I find that on both dates, Respondent violated section 906(d)(5) of the Act by selling covered tobacco products to purchasers younger than 21 years of age.  I further find that on the same dates, Respondent violated 21 C.F.R. § 1140.14(b)(2)(i) by failing to verify the purchasers’ age by means of photo identification.  Therefore, I conclude that Respondent committed at least three violations of the Act on July 2, 2024 and February 17, 2025.

CTP has requested a civil money penalty of $709 against Respondent, which is a permissible penalty under 21 C.F.R. § 17.2 for committing three violations of the Act within a 24-month period.  Therefore, I conclude that a civil money penalty of $709 is appropriate and impose a penalty in that amount against Respondent.

ORDER

For the reasons stated above, I enter default judgment and impose a civil money penalty against Respondent, Prestige S&A Product Corp. d/b/a Tobacco City, in the amount of $709.  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.