Muhammed Market 5 Inc. d/b/a Edgmont Deli, DAB TB8100 (2024)

INITIAL DECISION AND DEFAULT JUDGMENT

The Center for Tobacco Products (CTP) filed an Administrative Complaint (Complaint) against Respondent, Muhammed Market 5 Inc. d/b/a Edgmont Deli, alleging facts and legal authority sufficient to justify imposing a civil money penalty of $12,794.  CTP began this case by serving a Complaint on Respondent and filing a copy of the Complaint with the Food and Drug Administration’s (FDA) Division of Dockets Management.  The Complaint alleges that Respondent’s staff sold regulated tobacco products to underage purchasers and failed to verify that purchasers were of sufficient age, thereby 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. 1140.¹  CTP seeks a civil money penalty of $12,794, for six violations of the regulations within a 48-month period.

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During the course of these administrative proceedings, 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 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 6, 2023, CTP served the Complaint and supporting documents on Respondent by United Parcel Service, pursuant to 21 C.F.R. §§ 17.5 and 17.7.  Civil Remedies Division (CRD) Docket (Dkt.) Entry Nos. 1, 1a and 1b.  Respondent timely filed a request for an extension to file an answer.  CRD Dkt. Entry No. 3.  On October 6, 2023, I granted Respondent’s request for an extension and ordered Respondent to file an answer no later than November 6, 2023.  CRD Dkt. Entry No. 4.  On October 24, 2023, Respondent filed a timely answer, offering defenses to the allegations.  CRD Dkt. Entry No. 5.  On November 6, 2023, I issued an Acknowledgment and Pre-Hearing Order (APHO) that set deadlines for the parties’ filings and exchanges, including a schedule for discovery.  I directed that a party receiving a discovery request must provide the requested documents within 30 days of the request.  APHO ¶ 4; see 21 C.F.R. § 17.23(a).  I warned that I may impose sanctions if a party failed to comply with any order, including the APHO.  APHO ¶ 21.

On January 8, 2024, CTP 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. 8.  As an attachment, CTP included its Request for Production of Documents, which showed that Respondent was served with the Request for Production of Documents as part of the discovery process on December 1, 2023.  CRD Dkt. Entry Nos. 9a and 9b.  On January 8, 2024, CTP also filed an Unopposed Motion to Extend Deadlines.  CRD Dkt. Entry No. 10.

On January 17, 2024, I issued an Order informing Respondent of its deadline to file a response to CTP’s Motion to Compel Discovery, and warned that if Respondent failed to respond, “I may grant CTP’s motion in its entirety.”  Order at 1, January 17, 2024 (emphasis in original).  CRD Dkt. Entry No. 11; see also 21 C.F.R. § 17.32(c); APHO ¶ 21.  Respondent did not respond.

On February 14, 2024, I issued an Order to Compel Discovery in which I granted CTP’s motion and ordered Respondent to produce documents responsive to CTP’s discovery request by March 6, 2024.  I warned Respondent that:

[F]ailure to comply may result in sanctions, which may include the issuance of an Initial Decision and Default Judgment finding Respondent

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liable for the violations listed in the Complaint and imposing a civil money penalty.  Order to Compel Discovery.

Order to Compel Discovery at 1 (emphasis in original).  CRD Dkt. Entry No. 12.

On March 13, 2024, CTP filed a Status Report and Motion to Impose Sanctions (Motion to Impose Sanctions).  CRD Dkt. Entry No. 13.  CTP advised that Respondent did not produce responsive documents as ordered.  On that same date, CTP also filed a Motion to Extend Deadlines.  CRD Dkt. Entry No. 14.  On March 20, 2024, I issued an Order informing Respondent of its deadline to file a response to CTP’s motion and warned Respondent that if it failed to file a response, “I may grant CTP’s Motion to Impose Sanctions in its entirety.”  Order at 1, March 20, 2024 (emphasis in original).  CRD Dkt. Entry No. 15.  My March 20, 2024 Order also extended the pre-hearing exchange deadlines.  Respondent did not file a response.

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 to Compel Discovery when it failed to submit the documents responsive to CTP’s Request for Production of Documents by March 6, 2024.

Respondent also failed to defend its action despite my January 17, 2024, and March 20, 2024, orders informing Respondent of such opportunities and warning of consequences.

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,

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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 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 regulation governing this proceeding.  Respondent failed to comply with two of my orders, despite my explicit warnings that its failure could result in sanctions.  I specified that those sanctions may include issuing an Initial Decision and Default Judgment finding Respondent liable for the violations listed in the Complaint and imposing a civil money penalty.  Order to Compel Discovery at 2; Order at 1, March 20, 2024.  Respondent also failed to defend its actions, despite my orders expressly reminding Respondent of the opportunity.  Respondent’s repeated misconduct interfered with the speedy, orderly, or fair conduct of this proceeding.

I find that Respondent’s actions are sufficient to warrant striking its Answer and issuing a decision by default, without further proceedings.  21 C.F.R. § 17.35(b), (c)(3).  Accordingly, I strike Respondent’s Answer, and issue this Initial Decision and Default Judgment, assuming the facts alleged in CTP’s Complaint to be true.  21 C.F.R. §§ 17.35(c)(3), 17.11(a).

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 Edgmont Deli, an establishment that sells tobacco products and is located at 2105 Edgmont Avenue, Chester, Pennsylvania 19013.  Complaint ¶¶ 11-12.
• CTP initiated a previous civil money penalty action on March 14, 2022, CRD Docket Number T-22-96, FDA Docket Number FDA-2022-H-0326, against Respondent for violations of 21 C.F.R. pt. 1140, four² of which occurred during the 48-month period relevant in the current Complaint.  Complaint ¶ 15.

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• 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.”  Complaint ¶ 16.
• An FDA-commissioned inspector conducted a subsequent inspection of Respondent’s establishment on June 4, 2023, at approximately 2:35 PM, during which “a person younger than 21 years of age was able to purchase a package of five Black & Mild Wood Tip cigars . . . .”  Additionally, “the underage purchaser’s age was not verified before the sale . . . .”  Complaint ¶ 13.

These facts establish that Respondent is liable under the Act.  The Act prohibits misbranding of a tobacco product.  21 U.S.C. § 331(k).  A 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 of the U.S. Department of Health and Human Services (Secretary) issued the regulations at 21 C.F.R. pt. 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 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.  Prior to December 20, 2019, the regulations prohibited the sale of regulated tobacco products to any person younger than 18 years of age, 21 C.F.R. § 1140.14(a)(1), 21 C.F.R. § 1140.14(b)(1), and required retailers to verify, by means of photographic identification containing the purchaser’s date of birth, that no regulated tobacco product purchasers were younger than 18 years of age, 21 C.F.R. § 1140.14(a)(2)(i), 21 C.F.R. § 1140.14(b)(2)(i).

Taking the above alleged facts as true, Respondent violated the prohibition against selling regulated tobacco products to underage persons on August 15, 2019, December 1, 2021, and June 4, 2023.  Act § 906(d)(5); 21 C.F.R. § 1140.14(b)(1).  On those same dates, Respondent also violated the requirement that retailers verify, by means of photo identification containing a purchaser’s date of birth, that no regulated tobacco product purchasers are under the legal age.  21 C.F.R. § 1140.14(b)(2)(i).  Therefore, Respondent’s actions constitute violations of law that merit a civil money penalty.

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CTP has requested a civil money penalty of $ 12,794, which is a permissible penalty for six violations of the regulations found at 21 C.F.R. pt. 1140 within a 48-month period.  21 C.F.R. § 17.2.  Therefore, I find that a civil money penalty of $ 12,794 is warranted and so order one imposed.

Endnotes

¹ As of December 20, 2019, the Act was amended to raise the federal minimum age for the sale of tobacco products to 21 years of age or older.  See Act, § 906(d)(5).

² CTP did not include violations that occurred outside the relevant timeframe for this complaint.