Nasher S. Alsalahi d/b/a American Deli & Grocery, DAB TB9512 (2025)

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

The Food and Drug Administration, Center for Tobacco Products (CTP or Complainant) began this case by serving a Complaint on Respondent, Nasher S. Alsalahi d/b/a American Deli & Grocery, and filing a copy of the Complaint with the Departmental Appeals Board (DAB), Civil Remedies Division (CRD).  The Complaint alleges that Respondent’s staff sold regulated tobacco products to underage purchasers and failed to verify that the purchasers were 21 years of age or older, 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.  CTP seeks a civil money penalty of $13,785 against the Respondent for at least six violations of the tobacco regulations within a 48-month period.1

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Respondent timely requested a hearing by filing an Answer to the Complaint.  I issued an Acknowledgment and Pre-Hearing Order (APHO) establishing procedural guidance and deadlines for this case.

Currently, Complainant’s Status Report and Motion to Impose Sanctions (Motion) is pending before me.  CTP’s Motion requests that I strike Respondent’s Answer as a sanction for failing to comply with CTP’s discovery requests and issue a default judgment against Respondent.  During the course of these administrative proceedings, Respondent failed to comply with multiple judicial orders and procedures governing these proceedings and failed to defend its actions, which interfered with the speedy, orderly, or fair conduct of these proceedings.  21 C.F.R. § 17.35(a).  Therefore, pursuant to 21 C.F.R. § 17.35(c)(3), I grant CTP’s Motion, strike Respondent’s Answer, and issue an Initial Decision and Default Judgment imposing a civil money penalty of $13,785.

I. Procedural History

On December 18, 2024, CTP served the Complaint and supporting documents on Respondent by United Parcel Service, pursuant to 21 C.F.R. §§ 17.5 and 17.7.  CRD Docket (Dkt.) Entry Numbers (Nos.) 1, 1a-1b.  On January 15, 2025, Respondent registered for the DAB Electronic Filing System, and timely filed an Answer to CTP’s Complaint.  CRD Dkt. Entry No. 3.  Respondent also filed a copy of CTP’s Cover Letter.  See CRD Dkt. Entry No. 3a.

On January 23, 2025, Administrative Law Judge (ALJ) Zina D. Ashourian2 issued an Acknowledgment and Pre-Hearing Order (APHO) that set deadlines for the parties’ filings and exchanges, including a schedule for discovery.  CRD Dkt. Entry No. 4.  Specifically, ALJ Ashourian directed that a party receiving a discovery request must provide the requested documents within 30 days of the request.  Id. ¶ 4; see 21 C.F.R. § 17.23(a).  Also, she warned that she may impose sanctions if a party failed to comply with any order, including the APHO.  CRD Dkt. Entry No. 4 ¶ 21.

On February 5, 2025, counsel for CTP filed a Notice of Entry of Appearance, and a Joint Status Report, stating that “[t]he parties intend to engage in further settlement discussions.  CTP will notify the Departmental Appeals Board if the parties agree to a settlement and Respondent fulfills the terms of the settlement agreement.”  CRD Dkt. Entry Nos. 5, 6.

On March 13, 2025, CTP filed a Motion to Compel Discovery with supporting documents and a Motion to Extend Deadlines.  CRD Dkt. Entry Nos. 7, 7a-7b, 8.  In its

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Motion to Compel Discovery, CTP asserted that Respondent did not respond to its discovery requests as required by the APHO and regulations.  CRD Dkt. Entry No. 7.

By Order dated March 18, 2025, ALJ Ashourian informed Respondent of its March 31, 2025, 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.”  CRD Dkt. Entry No. 9 at 1-2; see also 21 C.F.R. § 17.32(c); APHO ¶ 20.  Additionally, she extended the pre-hearing deadlines by 30 days.  CRD Dkt. Entry No. 9 at 2.  CTP’s pre-hearing exchange was extended until May 15, 2025, and Respondent’s pre-hearing exchange was extended until June 5, 2025.  Id.  Respondent did not respond to CTP’s Motion to Compel Discovery or the March 18, 2025, Order.

On April 24, 2025, ALJ Ashourian issued an Order Granting Complainant’s Motion to Compel Discovery.  CRD Dkt. Entry No. 10.  In the Order, she directed Respondent to produce documents responsive to CTP’s discovery requests by May 8, 2025, and warned Respondent that:

Failure to [comply] 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. 10 at 1-2.  ALJ Ashourian also reaffirmed CTP’s and Respondent’s pre-hearing exchange deadlines, due respectively on May 15, 2025, and June 5, 2025.  Id. at 2.

On May 9, 2025, CTP filed Complainant’s Status Report and Motion to Impose Sanctions and a Motion to Stay Deadlines.  CRD Dkt. Entry Nos. 11, 12.  CTP advised that Respondent failed to produce responsive documents in compliance with the April 24, 2025, Order Granting Complainant’s Motion to Compel Discovery.  CRD Dkt. Entry No. 11 at 2.  CTP argued that sanctions against Respondent are an appropriate remedy because “it is unlikely more time or additional orders . . . will change the status quo.”  Id.  Specifically, CTP asked that ALJ Ashourian 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 $13,785 civil money penalty.  Id.

By Order dated May 12, 2025, ALJ Ashourian informed Respondent of its May 27, 2025, deadline to file a response to CTP’s Motion to Impose Sanctions and warned Respondent that if it failed to file a response, “I may grant CTP’s Motion to Impose Sanctions and impose the requested civil money penalty amount of $13,785” against Respondent.  CRD Dkt. Entry No. 13 at 2.  To date, Respondent has not responded to CTP’s Motion to Impose Sanctions or the May 12, 2025, Order.

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On May 22, 2025, both parties were informed that the case has been reassigned to staff attorney June B. King, and that ALJ Zina D. Ashourian would remain as the assigned ALJ.  CRD Dkt. Entry No. 14.

On May 28, 2025, both parties were informed that the case has been reassigned to ALJ Karen R. Robinson, and that June B. King would remain as the assigned staff attorney. CRD Dkt. Entry No. 15.

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).  “When a party fails to comply with a discovery order,” I may draw an inference in favor of the opposing party; may prohibit the non-complying party from introducing or relying on evidence related to the discovery request; and may “[s]trike any part of the pleadings or other submissions of the party failing to comply with [the discovery] request.”  21 C.F.R. § 17.35(c).  Any sanction “shall reasonably relate to the severity and nature of the failure or misconduct.”  21 C.F.R. § 17.35(b).

I conclude that sanctions against Respondent are warranted under 21 C.F.R. § 17.35(a)(1).  Specifically, Respondent failed to comply with:

• the regulations at 21 C.F.R. § 17.23(a) and paragraph 4 of the APHO, when Respondent failed to respond to CTP’s Request for Production of Documents within 30 days; and
• the April 24, 2025, Order Granting Complainant’s Motion to Compel Discovery when it failed to submit (or indicate that it did not have) documents responsive to CTP’s Request for Production of Documents by May 8, 2025.

Additionally, Respondent also failed to defend this action.  21 C.F.R. § 17.35(a)(2).  Specifically, Respondent did not file responses to:

• CTP’s Motion to Compel Discovery and the March 18, 2025, Order; and
   
• CTP’s Motion to Impose Sanctions and the May 12, 2025, Order.

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Respondent’s failure to fulfill its discovery obligations and respond to CTP’s various motions, suggests that Respondent has abandoned its defense of this case.

Further, I find that Respondent’s failure to comply with the orders, regulations governing discovery, and other procedures in this case has delayed the hearing process.  See 21 C.F.R. § 17.35(a)(3).  To provide ample opportunity for Respondent to respond to CTP’s motions and for the parties to prepare their respective pre-hearing exchanges, ALJ Ashourian’s March 18, 2025, Order extended the initial pre-hearing deadlines set in the APHO.  Subsequently, all deadlines were stayed by her May 12, 2025, Order to give Respondent an opportunity to file a response to CTP’s Motion to Impose Sanctions.

In the absence of any explanation from Respondent, I find that Respondent failed to comply with multiple judicial orders and directives governing this proceeding, failed to defend its case, and, as a result, interfered with the speedy, orderly, or fair conduct of this proceeding.  I find no basis to excuse Respondent’s repeated failure to comply with the various orders and regulations in this administrative 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.

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 the regulations governing this proceeding.  Respondent also failed to comply with two Orders, despite ALJ Ashourian’s explicit warnings that its failure could result in sanctions.  See CRD Dkt. Entry Nos. 9 at 2; 10 at 2.  She specified in the April 24, 2025, and May 12, 2025, Orders that those sanctions may include “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. 10 at 2; see also CRD Dkt. Entry No. 13 at 2.  Respondent also failed to defend this action, despite the Orders expressly reminding Respondent of the opportunity to do so.  Respondent’s repeated misconduct interfered with the speedy, orderly, or fair conduct of this proceeding.

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).  Although striking an answer is a harsh sanction, the Departmental Appeals Board has repeatedly held in similar circumstances involving a respondent’s repeated failure to comply with discovery and procedural orders that “the ALJ determination to impose sanctions was not an abuse of discretion, and the sanction imposed was reasonably related to the nature and severity of Respondent’s noncompliance.”  Carolina Cigar of Delray, LLC d/b/a Carolina Cigar, DAB No. 3134, at 11 (2024) (citing Joshua Ranjit, Inc. d/b/a 7-Eleven 10326, DAB No. 2758, at 1, 8-11 (2017); KKNJ, Inc. d/b/a Tobacco Hut 12, DAB No. 2678, at 8-11 (2016); and Retail LLC d/b/a Super Buy Rite, DAB No. 2660, at 10-14 (2015)).  Accordingly, I grant CTP’s Motion to Impose Sanctions and

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strike Respondent’s Answer from the administrative record.  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 the regulations, I must “assume the facts alleged in the [C]omplaint to be true” and, if those facts establish liability under the Act, issue a default judgment imposing the “maximum amount of penalties provided for by law for the violations alleged” or the civil money penalty “amount asked for in the complaint, whichever is smaller.”  Id.  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 American Deli & Grocery, an establishment that sells tobacco products and is located at 1168 Dewey Avenue, Rochester, New York 14613.  Complaint ¶¶ 11-12.
• On October 30, 2023, CTP initiated the most recent civil money penalty action, CRD Docket Number T-24-355, FDA Docket Number FDA-2023-H-4750, against Respondent for violations of the Act and 21 C.F.R. pt. 1140.  Specifically, CTP alleged three violations for selling tobacco products to an underage purchaser on July 12, 2022, March 12, 2023, and August 12, 2023, and two violations for failing to verify the age of a person with photographic identification on July 12, 2022, and August 12, 2023.  Complaint¶ 15.
• The previous action concluded when Respondent “admitted all of the allegations in the Complaint and paid the agreed upon penalty.”  Further, “Respondent expressly waived its right to contest such violations in subsequent actions.”  Complaint ¶ 16.
• During a subsequent inspection of Respondent’s establishment on September 22, 2024, at approximately 11:08 AM, an FDA-commissioned inspector documented that “a person younger than 21 years of age was able to purchase a package of two Dutch Masters Tropical cigars . . . [.]”  The inspector also documented that “the underage purchaser’s identification 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 distributed or offered for sale in any state in violation of regulations issued under

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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 issued the regulations at 21 C.F.R. pt. 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).  Section 906(d)(5) of the Act prohibits the sale of regulated tobacco products to any person younger than 21 years of age, and requires retailers to verify, by means of photographic identification containing a purchaser’s date of birth, that no regulated tobacco product purchaser is younger than 21 years of age.

Taking the above alleged facts as true, Respondent violated the prohibition against selling regulated tobacco products to persons younger than 21 years of age on July 12, 2022, March 12, 2023, and August 12, 2023.  Act § 906(d)(5).  On July 12, 2022, and August 12, 2023, 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 younger than 21 years of age.  Id.; 21 C.F.R. § 1140.14(a)(2)(i); 21 C.F.R. § 1140.14(b)(2)(i).  Subsequently, Respondent violated the prohibition against selling regulated tobacco products to a person younger than 21 years of age on September 22, 2024.  Act § 906(d)(5).  On that same date, 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 purchaser is younger than 21 years of age.  Id.; 21 C.F.R. § 1140.14(b)(2)(i).  All violations observed during the initial failed inspection are counted as a single violation, and each separate violation observed during subsequent failed inspections count as a discrete violation.  Orton Motor, Inc., d/b/a Orton’s Bagley v. U.S. Dep’t of Health & Human Serv., 884 F.3d 1205 (D.C. Cir. 2018).  Accordingly, Respondent had four violations from the previous civil money penalty action and two additional violations on September 22, 2024.  Therefore, Respondent’s actions constitute six violations of law within a 48-month period that merit a civil money penalty.

CTP has requested a civil money penalty of $13,785, which is a permissible penalty under the regulations.  21 C.F.R. §§ 17.2, 17.11; see also 45 C.F.R. § 102.3.  Therefore, I find that a civil money penalty of $13,785 is warranted and so order one imposed.