Cosme Gomez d/b/a El Paraiso Drive Thru, DAB TB9118 (2025)

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

On July 2, 2024, the Center for Tobacco Products (CTP) served an administrative complaint on Respondent, Cosme Gomez d/b/a El Paraiso Drive Thru, at 7304 North La Homa Road, Mission, Texas 78574.  A copy of the complaint was also filed with the Food and Drug Administration’s (FDA) Division of Dockets Management.  CTP seeks to impose a $13,785 civil money penalty against Respondent El Paraiso Drive Thru, for seven violations of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq., and its implementing regulations, 21 C.F.R. Part 1140, within a 48-month period.

Respondent timely filed an answer to the complaint.  Since filing its answer, however, Respondent has repeatedly disregarded orders and rules, has been non-responsive to CTP’s discovery requests, and has failed to respond to multiple motions.

Currently before me is CTP’s Motion to Impose Sanctions, which requests that I impose sanctions against Respondent for failing to respond to CTP’s discovery requests and for

Page 2

failing to comply with my order granting CTP’s Motion to Compel Discovery.  As a proposed sanction, 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, after considering CTP’s Motion to Impose Sanctions and the record in this case, I find that the sanctions requested by CTP are warranted.  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 July 2, 2024, CTP served an administrative complaint on Respondent by United Parcel Service, in accordance with 21 C.F.R. §§ 17.5 and 17.7.  See Civil Remedies Division (CRD) Docket (Dkt.) Entry Nos. 1, 1a, 1b.  On July 3, 2024, Respondent registered for the Departmental Appeals Board (DAB) E-Filing System and timely filed an answer to the complaint.  CRD Dkt. Entry No. 2.

On August 2, 2024, I issued an Acknowledgment and Pre-Hearing Order (APHO), which established deadlines for the parties to complete discovery and file pre-hearing exchanges.  CRD Dkt. Entry No. 3 (APHO).  With respect to discovery, the APHO stated that a party must produce any requested documents no later than 30 days after receiving a request for the production of documents from the imposing party.  APHO ¶ 4; see also 21 C.F.R. § 17.23(a).  In the APHO, I also warned that I may impose sanctions against a party, up to and including dismissal of the complaint or 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.”  APHO ¶ 21; see also 21 C.F.R. § 17.35.

On October 11, 2024, CTP filed a Motion to Compel Discovery, stating it served a request for documents on Respondent September 4, 2024, but Respondent failed to respond.  CRD Dkt. Entry No. 6, 6a, 6b.  On the same date, CTP also filed an Unopposed Motion to Extend Deadlines, requesting a 30-day extension of all deadlines in this case to account for the discovery issue.  CRD Dkt. Entry No. 7 at 2.

On October 16, 2024, I issued an Order advising Respondent that it had until October 31, 2024, to file a response to CTP’s Motion to Compel Discovery.  CRD Dkt. Entry No. 8.  I also granted CTP’s Motion to Extend Deadlines.  Id.

Respondent did not respond to CTP’s Motion to Compel Discovery or otherwise comply with CTP’s document requests.  Accordingly, on November 5, 2024, I issued an Order 

Page 3

granting CTP’s Motion to Compel Discovery and ordered Respondent to fully comply with CTP’s request for production of documents by November 15, 2024.  CRD Dkt. Entry No. 9.  I also stated:

Respondent is warned that failing to comply with this Order 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. 9. at 2.

On November 20, 2024, CTP filed the present Motion to Impose Sanctions.  CRD Dkt. Entry No. 10.  In the motion, CTP states Respondent has not complied with my November 5, 2024, Order granting CTP’s Motion to Compel Discovery and has not produced any documents in response to CTP’s discovery requests.  Id. at 2.  CTP asks that I strike Respondent’s answer as a sanction for Respondent’s conduct.  Id.  CTP also asks that I issue an Initial Decision and Default Judgment finding Respondent liable for the violations listed in the complaint and impose a $13,785 civil money penalty.  Id.

On December 3, 2024, I issued an Order giving Respondent until December 18, 2024, to file a response to CTP’s Motion to Impose Sanctions.  CRD Dkt. Entry No. 11 at 1.  I also stayed all deadlines in this case pending resolution of the Motion.  Id.

To date, Respondent has not filed a response to CTP’s Motion to Impose Sanctions.  Moreover, Respondent has not produced any documents in response to CTP’s Request for Production of Documents or otherwise complied with my November 5, 2024 Order granting CTP’s Motion to Compel Discovery.

II. Motion to Impose Sanctions

I may sanction a party for:

1. (1)    Failing to comply with an order, subpoena, rule, or procedure governing the proceeding;
2. (2)    Failing to prosecute or defend an action; or
3. (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, Respondent failed, and continues to fail, to comply with multiple orders and rules, including:

Page 4

• The regulation at 21 C.F.R. § 17.23(a) and paragraph 4 of the APHO, by failing to respond to CTP’s Request for Production of Documents within 30 days; and
• My November 5, 2024 Order, by failing to submit documents responsive to CTP’s Request for Production of Documents by November 15, 2024.

Additionally, Respondent has failed to defend this action.  Specifically, Respondent did not file a response to CTP’s Motion to Compel Discovery or CTP’s Motion to Impose Sanctions and has not taken any meaningful action in this case since July 2024.

Based on the foregoing, I find that Respondent failed to comply with orders and procedures governing this proceeding, failed to defend this action, and, as a result, interfered with the speedy, orderly, and fair conduct of this proceeding.  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 failure to comply.  21 C.F.R. § 17.35(b).  Here, Respondent failed to comply with a procedural rule (21 C.F.R. § 17.23(a)), and two of my orders, despite being warned that such conduct may result in sanctions.  See CRD Dkt. Entry No. 9 at 2; see also CRD Dkt. Entry No. 3 ¶ 21.  Further, Respondent failed to respond to multiple motions, including the present motion for sanctions.  In fact, Respondent has not taken any action in this case since filing its answer.  Respondent’s behavior suggests it has abandoned its defense and is not interested in continuing to participate in these proceedings.

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 otherwise deciding this case on the merits.  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 administrative law judge did not abuse discretion by striking Respondent’s answer for failure 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 failure to meaningfully participate in this proceeding.  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.

Page 5

For the 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:

• On June 7, 2023, CTP initiated a previous civil money penalty action, CRD Docket Number T-23-2459, FDA Docket Number FDA-2023-H-2271, against Respondent for six violations1  of the Act2.   CTP alleged those violations occurred at Respondent’s business establishment, located at 7304 North La Homa Road, Mission, Texas 78574, on November 7, 2021, May 7, 2022, and March 5, 2023.
• The previous action concluded when an Initial Decision and Default Judgment was entered by an Administrative Law Judge, “finding that all of the violations alleged in the complaint occurred”;
• At approximately 3:19 PM on April 6, 2024, at Respondent’s business establishment, located at 7304 North La Homa Road, Mission, Texas 78574, an FDA commissioned inspector conducted a subsequent inspection.  During this inspection, a person younger than 21 years of age was able to purchase a package of Camel Crush cigarettes.  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.

These facts establish Respondent El Paraiso Drive Thru’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. § 387f(d); 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); see also 21 U.S.C. § 387f (note) (directing the Secretary to change references to persons younger than 18 to younger than 21, and to change the age verification requirements from individuals under the age of 26 to under the age of 30, in 21 C.F.R. subpart B of part 1140).  Under section 906(d)(5) of the Act, no retailer may sell regulated tobacco products to any person younger than 21 years of age and retailers 

Page 6

must verify, by means of photographic identification containing a purchaser’s date of birth, that no regulated tobacco product purchasers are younger than 21 years of age.

CTP has requested a civil money penalty of $13,785, which is a permissible penalty under 21 C.F.R. § 17.2.  Therefore, I find that a civil money penalty of $13,785 is warranted 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 in the amount of $13,785 against Respondent, Cosme Gomez d/b/a El Paraiso Drive Thru.  Pursuant to 21 C.F.R. § 17.11(b), this order becomes final and binding upon both parties 30 days after the date of its issuance.