Carolina Cigar of Delray, LLC d/b/a Carolina Cigar, DAB No. 3134 (2024)

FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

Carolina Cigar of Delray, LLC d/b/a Carolina Cigar (Respondent) appeals the initial decision and default judgment of an administrative law judge (ALJ) involving an administrative complaint (Complaint) against Respondent by the Center for Tobacco Products (CTP) of the Food and Drug Administration (FDA), Carolina Cigar of Delray, LLC d/b/a Carolina Cigar, DAB TB6991 (2023), issued on September 13, 2023 (ALJ Initial Decision).  The Complaint sought to impose a $638 civil money penalty (CMP) for three alleged violations over a period of 24 months of the Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq., and its implementing regulations, 21 C.F.R. Part 1140.  Specifically, Respondent allegedly impermissibly sold regulated tobacco products to underage purchasers and failed to verify, by means of photo identification containing a date of birth, that the purchasers were of the legal age or older.  The ALJ struck Respondent’s Answer to the Complaint as a sanction, entered a default judgment against Respondent, and concluded a $638 CMP was permissible.  We conclude that the ALJ did not commit an abuse of discretion in striking Respondent’s Answer and entering default judgment and affirm the ALJ Initial Decision because both determinations are supported by substantial evidence and free of legal error.  To the extent Respondent appeals from the ALJ’s denial of Respondent’s request to reopen the case after issuance of the ALJ Initial Decision, we affirm that denial as well.

Legal Background

To protect public health, the Act imposes restrictions on the sale, distribution, and use of tobacco products.  See 21 U.S.C. §§ 301, 331(b), 331(k), 387a(a)-(b), 387c(a)(7)(B), 387f(d).  One such restriction is that “[i]t shall be unlawful for any retailer to sell a tobacco product to any person younger than 21 years of age.”  Id. § 387f(d)(5).  The Act also prohibits any act with respect to a tobacco product held for sale after shipment in interstate commerce that results in the product being “misbranded.”  Id. § 331(k).  A tobacco product is misbranded if, among other things, “it is sold or distributed in violation of section 387f(d)(5)” or “regulations prescribed under section 387f(d).”  Id. § 387c(a)(7)(B).

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The Act directed the Secretary of the U.S. Department of Health and Human Services (Secretary) to establish the CTP within the FDA and authorized the Secretary to issue regulations restricting the sale and distribution of tobacco products.  21 U.S.C. §§ 387a(e), 387f(d).  In accordance with the Act, the Secretary issued regulations codified in 21 C.F.R. Part 1140.  Failure to comply with any of those regulations in the sale or distribution of “covered tobacco products” renders them “misbranded” under the Act.  21 C.F.R. § 1140.1(b); see id. § 1143.1 (defining “Covered tobacco product”).  Regulations prohibiting sale of covered tobacco products to an underage person appear in subpart B of 21 C.F.R. Part 1140.  Those regulations, in relevant part, prohibit a retailer from “sell[ing] covered tobacco products to any person younger than 18 years of age.”  21 C.F.R. § 1140.14(b)(1).  A retailer also must “verify by means of photographic identification containing the bearer’s date of birth that no person purchasing the product is younger than 18 years of age,” except that “[n]o such verification is required for any person over the age of 26.”  Id. § 1140.14(b)(2)(i)-(ii).¹

“FDA conducts inspections of tobacco product retailers to determine a retailer’s compliance with federal laws and regulations,” including the Act and its implementing regulations.  FDA, Advisory and Enforcement Actions Against Industry for Selling Tobacco Products to Underage Purchasers (Nov. 14, 2023), (last visited April 9, 2024), https://www.fda.gov/tobacco-products/compliance-enforcement-training/advisory-and-enforcement-actions-against-industry-selling-tobacco-products-underage-purchasers.  The violations in this case were discovered during undercover buy inspections.  “During Undercover Buy Inspections, the retailer is unaware an inspection is taking place.  The inspector and underage purchaser will not identify themselves.”  Id.

The Act provides for imposition of CMPs against “any person who violates a requirement of [the Act] which relates to tobacco products.”  21 U.S.C. § 333(f)(9)(A).  The implementing regulations concerning CMPs are found in 21 C.F.R. Part 17 and 45 C.F.R. § 102.3.  These regulations establish a schedule of maximum CMP amounts based on the number of violations committed and the time period over which they have occurred.  See 21 C.F.R. § 17.2 (citing 45 C.F.R. § 102.3 (table)).

To impose a CMP, CTP files a complaint with the Departmental Appeals Board’s Civil Remedies Division and serves a copy of the complaint on the “respondent” (the person or entity alleged to have committed the pertinent violation(s)).  See 21 C.F.R. §§ 17.3(b),

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17.5, 17.7.  The respondent may then request a hearing before an ALJ by filing an answer to the complaint.  Id. § 17.9(a).  If the respondent fails to timely answer the complaint, the ALJ “shall assume the facts alleged in the complaint to be true” and issue an initial decision granting a default judgment to CTP if those facts “establish liability” for the remedy sought.  Id. § 17.11(a).

In anticipation of a hearing (and assuming the timely filing of an answer), a party may request discovery by asking the opposing party to produce relevant documents.  21 C.F.R. § 17.23(a).  A party must provide documents “no later than 30 days after the request has been made.”  Id.

An ALJ may sanction a party for “[f]ailing to comply with an order, subpoena, rule, or procedure governing the proceeding,” “[f]ailing to prosecute or defend an action,” or “[e]ngaging in other misconduct that interferes with the speedy, orderly, or fair conduct of the hearing.”  21 C.F.R. § 17.35(a)(1)-(3).  When a party “fails to comply with a discovery order” (e.g., an order to produce documents) or regulations in Part 17 relating to discovery, the ALJ may impose any of the sanctions specified in 21 C.F.R. § 17.35(c), including “[s]trik[ing] any part of the pleadings or other submissions of the party failing to comply[.]”  Id. § 17.35(c)(3).  Any sanction imposed “shall reasonably relate to the severity and nature of the failure or misconduct.”  Id. § 17.35(b).

The ALJ’s “initial decision” must be “based only on the administrative record.”  21 C.F.R. § 17.45(a).  The ALJ Initial Decision must address, among other things, (1) whether the factual allegations in the complaint are true, and, if so, whether they show that the respondent violated the law, and (2) whether the respondent is liable for any penalties or assessments.  Id. § 17.45(b)(1), (3).

A respondent may appeal an ALJ Initial Decision, including “a decision not to withdraw a default judgment,” by filing a notice of appeal with the Board.  21 C.F.R. § 17.47(a).  A notice of appeal “must identify specific exceptions to the initial decision, must support each exception with citations to the record, and must explain the basis for each exception.”  Id. § 17.47(c).

Case Background²

1. The Complaint and Answer

On February 13, 2023, CTP filed a Complaint against Respondent alleging three

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violations of the Act and FDA’s tobacco regulations within a 24-month period.  Complaint ¶¶ 1, 13, 15, 19.  On August 17, 2021, Respondent allegedly sold a covered tobacco product to an individual under the age of 18 and failed to verify the age of a person purchasing covered tobacco products by means of photographic identification containing the bearer’s date of birth.  Id. ¶ 15; see ALJ Initial Decision at 2 n.2 (explaining that “[i]n accordance with customary practice” CTP counted two separate violations on August 17, 2021, as a single violation for penalty calculation purposes).  In October 2021, after that alleged violation, CTP delivered a warning letter to Respondent.  ALJ Initial Decision at 6; Complaint ¶ 16.  On November 13, 2022, Respondent allegedly sold a covered tobacco product to a person under the age of 21 and failed to verify the age of a person purchasing covered tobacco products by means of photographic identification containing the bearer’s date of birth.³  ALJ Initial Decision at 6; Complaint ¶ 13.  CTP sought a CMP of $638, the maximum amount authorized in the applicable penalty schedule for a third violation of section 387f(d)(5) of the tobacco regulations within a 24-month period.  Complaint ¶ 19; see 45 C.F.R. § 102.3 (table) (Mar. 17, 2022).

On March 16, 2023, Respondent timely filed an “Answer” to the Complaint.  See Answer to Complaint (Answer).  In response to the allegations, Respondent placed an “X” in the box indicating “I deny the following allegations in the Complaint,” but listed no allegations.  Id. at 1.  Respondent requested that the ALJ consider Florida Statute § 569.007(4), which provides that “[a] dealer or a dealer’s agent or employee must require proof of age of a purchaser of a tobacco product before selling the product to that person, unless the purchaser appears to be 30 years of age or older.”  Id. at 2.⁴

2. The ALJ Proceedings

On March 17, 2023, the ALJ issued an Acknowledgment and Pre-Hearing Order (APHO) setting deadlines for the parties’ filings and exchanges of evidence and argument.  APHO at 2-5.  The APHO included a schedule for discovery, directing that a party receiving a

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discovery request must provide the requested documents within 30 days of the request.  Id. at 3.  The APHO also stated that a party’s failure to comply with any order by the ALJ (including the APHO), or failure to defend its case, might result in sanctions including dismissal of the answer.  Id. at 10. 

On April 17, 2023, CTP timely served on Respondent a Request for Production of Documents (RFP).  Mot. to Compel Disc. at 1; Ex. A (RFP) at 6 (Certificate of Service) & Ex. B (UPS Delivery Notification).  On May 26, 2023, CTP filed a Motion to Compel Respondent to produce documents because Respondent had not responded to the RFP.  Mot. to Compel Disc.  By order issued on May 30, 2023, the ALJ gave Respondent until June 14, 2023, to file a response to CTP’s motion to compel and extended the pre-hearing exchange deadlines.  Respondent filed no response to the motion to compel.  See Order Granting CTP’s Mot. to Compel Disc. at 2.

On June 21, 2023, the ALJ issued an order granting CTP’s motion to compel, directing Respondent to produce documents responsive to CTP’s RFP by July 5, 2023, and again extended the pre-hearing exchange deadlines.  Id.  at 1-3.  The order warned Respondent that a failure to comply with the RFP might result in 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. at 3.

On July 17, 2023, CTP moved for imposition of sanctions, asserting that Respondent had not complied with the ALJ’s May 30, 2023, order requiring a response to CTP’s motion to compel discovery, and also had failed to comply with the ALJ’s June 21, 2023 order requiring Respondent to produce documents responsive to CTP’s RFP.  CTP’s Status Report and Mot. to Impose Sanctions at 1-2.  CTP asserted that “it [was] unlikely” that giving Respondent more time to respond or additional orders would “change the status quo” and that striking Respondent’s Answer would be a “reasonable sanction” for “non-compliance.”  Id. at 2.  CTP requested the ALJ issue an initial decision and default judgment imposing a $638 CMP.  Id.

By order issued on July 21, 2023, the ALJ gave Respondent until August 7, 2023, to respond to CTP’s motion for sanctions and extended the pre-hearing exchange deadlines.  Order at 2.  The order warned Respondent that “if it fails to timely respond” to CTP’s motion, the ALJ “may grant CTP’s motion in its entirety.”  Id.  Respondent did not respond.  ALJ Initial Decision at 4.

3. The ALJ Initial Decision

The ALJ resolved CTP’s pending motion to impose sanctions within the ALJ Initial Decision.  ALJ Initial Decision at 4-5.  The ALJ found that Respondent had “failed to comply with orders and procedures governing this proceeding” and to defend itself against CTP’s complaint.  Id.  The ALJ further found that Respondent had received

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“explicit warnings” that its failures to comply could result in sanctions, and that its “repeated misconduct interfered with the speedy, orderly, or fair conduct of th[e] proceeding.”  Id. at 5.  Based on those findings, the ALJ determined that the sanction proposed by CTP was warranted and accordingly struck Respondent’s answer to the Complaint.  Id. (citing 21 C.F.R. § 17.35(b), (c)(3)).

Having stricken the Answer, the ALJ was “required to issue an initial decision by default, provided that the Complaint is sufficient to justify a penalty.”  ALJ Initial Decision at 5 (citing 21 C.F.R. § 17.11(a)).  The ALJ then determined that the facts alleged in the Complaint, taken to be true, establish that Respondent is liable under the Act because Respondent committed three violations of the Act and FDA’s tobacco regulations within a 24-month period.  Id. at 5-6.  Those violations were:

• selling covered tobacco products to an underage purchaser and failing to verify the age of persons purchasing tobacco products by means of photographic identification containing the bearer’s date of birth on August 17, 2021;
• selling covered tobacco products to an underage purchaser on November 13, 2022; and
• failing to verify the age of persons purchasing tobacco products by means of photographic identification containing the bearer’s date of birth on November 13, 2022.

Id. at 5-6.  Based on these findings, the ALJ entered a default judgment against Respondent and imposed a CMP in the amount of $638.  Id. at 6.

The Civil Remedies Division transmitted a copy of the ALJ Initial Decision to Respondent by certified mail, together with a copy of the Board’s appellate review guidelines, titled Guidelines – Appellate Review of Decisions of Administrative Law Judges in Food and Drug Administration Cases (“Guidelines”).⁵ 

4. Respondent’s request to “reopen the case” and appeal to the Board

On October 13, 2023, Respondent filed with the Civil Remedies Division an “appeal” of the September 13, 2023 ALJ Initial Decision.  Respondent’s filing asked the ALJ to “reconsider [the] decision” and to “reopen the case so that [Respondent] can do [its] due

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diligence,” and included a copy of a physician’s attestation statement indicating that Respondent’s representative received a full duty medical release to return to work, effective July 25, 2023.  Request for Review (RR) at 1.

On October 17, 2023, the Civil Remedies Division forwarded Respondent’s submissions to the Departmental Appeals Board’s Appellate Division (Board).  The Board determined that October 13, 2023, is the date that Respondent timely filed its appeal even though the Board did not receive the filing on that date, and docketed Respondent’s appeal.  See Board’s October 23, 2023 Letter (citing 21 C.F.R. § 17.47(b)(1) (“A notice of appeal may be filed at any time within 30 days after the presiding officer issues an initial decision or decision granting summary decision.”)).  However, in light of the October 13, 2023 filing asking the ALJ to “reopen the case,” the Presiding Board Member informed the parties by letter dated October 23, 2023, that the Board would refrain from acting on the appeal pending the ALJ’s review of Respondent’s request to reopen.  The Presiding Board Member also instructed Respondent to inform the Board, within 14 days of receipt of notice of the ALJ’s ruling or other determination on Respondent’s October 13, 2023 filing, “whether it wants the Board to review the ALJ Decision and any subsequent ALJ ruling or determination in this case.”

On November 15, 2023, the ALJ issued an order denying Respondent’s motion to reopen the initial decision.  Order Denying Resp’t Mot. to Reopen Initial Decision, at 5.  The ALJ explained that 21 C.F.R. § 17.11 permits withdrawing an initial default decision when extraordinary circumstances “‘excusing the failure to file an answer in a timely manner’ have been established,” but not “under any other circumstances.”  Id. at 4 (citing 21 C.F.R. § 17.11 (c), (d); Minmax Corp. d/b/a Amera, Ruling Dismissing Req. to Appeal, Docket No. A-19-128, at 1 n.1 (2019)⁶ (“The regulations do not afford an [Administrative Law Judge] the authority to reopen or reconsider an initial decision in which an answer was timely filed[]” and the answer was subsequently struck as a sanction.).  The ALJ empathized with Respondent’s representative’s health issues, but determined that, “even assuming there was authority” to find those health issues “were extraordinary circumstances preventing [Respondent] from complying with judicial orders,” Respondent’s evidence “does not support that conclusion.”  Id. at 5.  Specifically, the documentation Respondent submitted indicated that its representative was cleared to work as of July 25, 2023.  Id.  “The record does not reflect any apparent reason,” the ALJ stated, “as to why Respondent could not have filed a response to my July 21, 2023 Order, setting forth any health issues which would have prevented it from complying with judicial orders, by August 7, 2023.”  Id. at 5.

By November 29, 2023, two weeks after the ALJ’s November 15, 2023 Order, the Board had received no communication from Respondent about its intentions, so a Board

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attorney sent an email reminding Respondent that it must state whether it wanted to pursue an appeal by the end of that day.  See Email Correspondence (Nov. 29, 2023).  Respondent informed the Board, by email, that it wanted to pursue an appeal.  Id.  Accordingly, on November 29, 2023, the Board issued a letter acknowledging the appeal, and stating that Respondent must submit within 30 days a brief identifying the parts of the ALJ Initial Decision and November 15, 2023 ALJ Order with which Respondent disagreed and explaining why it disagreed.  Acknowledgment Letter at 2 (citing 21 C.F.R. § 17.47(c)).  Therefore, Respondent’s brief was due no later than December 29, 2023.

Respondent did not file a brief by December 29, 2023.  On January 5, 2024, the Board issued an Order to Show Cause, stating that “unless the Board receives a brief that includes an explanation that shows good cause for Respondent’s failure to timely file its brief, on or before January 19, 2024, the Board may close this case on its docket without further notice.”  Order to Show Cause at 2. 

On January 18, 2024, Respondent filed a brief.  In its brief, Respondent states that its representative “had to have a life saving surgery” on June 19, 2023, which has resulted in a “quite lengthy” recovery period and a difficult time “[m]entally,” “[p]hysically[,] and [f]inancially.”  Resp’t Br. at 3.  Respondent further stated that its representative was admitted to the hospital on November 21, 2023, and has been “overwhelmed with issues since the surgery.”  Id.  In response to CTP’s allegations of three violations within a 24-month period, Respondent contends that the underage purchasers “appeared to be 27 years of age therefore I.D. was not requested and the [covered tobacco] product was sold to them.”  Id. at 2.  Respondent asserts that it “has been in business for 15 years and ha[s] never had an issue.”  Id.  On January 19, 2024, Respondent filed four attachments to its brief that consisted of:

• a medical bill for Respondent’s representative for services rendered on November 21, 2023;
• a typed document with the header “EVIDENCE,” stating that “[t]here w[as] no picture evidence” for the August 17, 2021 sale of the covered tobacco product, even though CTP submitted two pictures of the covered tobacco product that Respondent allegedly sold on November 13, 2022; and
• copies of two photos taken by the FDA-commissioned inspector of the evidence bag containing the tobacco product that CTP alleged that Respondent sold to an underage purchaser on November 13, 2022.⁷

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CTP submitted a memorandum in opposition (CTP Resp. Br.) arguing, among other things, that the Board should decline review in accordance with 21 C.F.R. § 17.47(j) because Respondent’s notice of appeal did not comply with 21 C.F.R. § 17.47(c).  CTP Resp. Br. at 1, 7-8.  More specifically, CTP argues that Respondent’s January 18, 2024 submissions “did not include a written brief and did not identify—let alone explain the basis for—specific exceptions to the Initial Decision and Default Judgment or the subsequent denial of its Motion to Reopen.”  Id. at 8.  CTP further argues that Respondent “failed to demonstrate that good cause prevented it from filing an appeal brief before December 29, 2023.”  Id.  CTP contends that the Board should decline review, but if the Board reviews the case, it should affirm the ALJ Initial Decision because the ALJ “did not abuse her discretion in striking Respondent’s Answer as a sanction” after Respondent failed to comply with CTP’s discovery requests and multiple ALJ orders.  Id. at 7, 10.

We find that Respondent has demonstrated good cause for its failure to timely file a brief by December 29, 2023, and we reject CTP’s invitation to decline review pursuant to 21 C.F.R. § 17.47(j).  It is true that the Board has discretion to decline review of an ALJ’s entry of default judgment for a respondent’s noncompliance with orders to respond to CTP discovery requests, particularly when the respondent’s “submission does not include a brief or allege any error in the ALJ Decision.”  Joe Eideh d/b/a 7-Eleven 34428, DAB No. 2879, at 2 (2018).  Here, however, Respondent has made certain challenges to the ALJ Initial Decision and the ALJ’s order denying reopening that we find appropriate to address briefly.

Standard of Review

The Board’s standard of review on a disputed issue of fact is whether the initial decision is supported by substantial evidence on the whole record.  21 C.F.R. § 17.47(k).  The standard of review on a disputed issue of law is whether the initial decision is erroneous.  Id.  The standard of review on an ALJ’s imposition of a sanction under 21 C.F.R. § 17.35 is whether the ALJ committed an abuse of discretion.  Joshua Ranjit Inc. d/b/a 7-Eleven 10326, DAB No. 2758, at 7 (2017).  “Under an ‘abuse of discretion’ standard, ‘the reviewer may not simply substitute his or her judgment for that of the person exercising discretion.’”  Id. (quoting Vincent Baratta, M.D., DAB 1172, at 9 n.5 (1990)).  “Instead, the reviewing body considers only whether the decision maker has articulated a reasonable basis for the decision under review.”  Id. (citing River East Econ. Revitalization Corp., DAB No. 2087, at 9 (2007)).

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Discussion

1. We affirm the ALJ Initial Decision because Respondent’s appeal identifies no factual or legal error or abuse of discretion by the ALJ.

Pursuant to 21 C.F.R. § 17.47(c), “[a] notice of appeal . . . must identify specific exceptions to the initial decision, must support each exception with citations to the record, and must explain the basis for each exception.”  In addressing these requirements, the Board’s Guidelines unequivocally explain that the Board “expects that the basis for each challenge to a finding or conclusion in the ALJ decision will be set forth in a separate paragraph or section,” and “that the accompanying arguments will be concisely stated” and “be supported by precise citations to the record” and relevant legal authorities.  Guidelines, “Starting the Review Process,” ¶ (d).

Respondent filed an appeal that largely fails to specify clearly which parts of the ALJ Initial Decision Respondent disagrees with and why.  See 21 C.F.R. § 17.47(c).  Respondent raises several contentions, none of which were raised before the ALJ.  Therefore, the Board is not required to consider them.  See 21 C.F.R. § 17.47(g); Cape Tobacco Inc. d/b/a Santa Tobacco, DAB No. 3091, at 8 (2023) (citing 21 C.F.R. § 17.47(g)) (“The Board is not required to consider an issue Respondent could have raised, but failed to raise, before the ALJ.”).  Respondent could have made these arguments and presented its evidence during the ALJ proceeding had it taken an active role and complied with the ALJ’s orders and procedures.  The question before the Board is “not whether Respondent could have prevailed had the case gone to hearing,” but “whether the ALJ abused her discretion in striking Respondent’s answer to the Complaint and entering default judgment against Respondent based on CTP’s allegations.”  KKNJ, Inc. d/b/a Tobacco Hut 12, DAB No. 2678, at 8 (2016).

Respondent has not alleged or attempted to show that the ALJ’s key findings and conclusions are unsupported by substantial evidence or legally erroneous.  Specifically, Respondent does not challenge the ALJ’s finding that Respondent “failed to comply with orders and procedures governing this proceeding” and “interfered with the speedy, orderly, and fair conduct of th[e] proceeding.”  ALJ Initial Decision at 4-5.  Nor does Respondent contend that the ALJ committed any factual or legal error or abuse of discretion by deciding to sanction Respondent by striking its Answer and to enter a default judgment based on the Complaint’s allegations.  In addition, Respondent does not challenge the ALJ’s findings that the Complaint’s allegations establish that it violated 21 U.S.C. § 387f(d)(5) and 21 C.F.R. § 1140.14(b)(2)(i) on August 17, 2021, and November 13, 2022, and committed three violations within a 24-month period.  Respondent also does not dispute that a $638 CMP is an authorized penalty for its three violations. 

Respondent’s arguments are, in effect, a request for equitable relief, which neither the ALJ nor the Board can grant.  Respondent asserts that various health issues rendered its

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representative not “available,” and that allowing Respondent “an opportunity to prove [its] innocence is a more fair decision.”  RR at 1.  We construe these assertions by Respondent as a request for equitable relief from the ALJ’s entry of default judgment; however, “[w]e, like the ALJ, cannot ignore binding regulations on equitable grounds, and, moreover, we find no unfairness in the ALJ Decision in this case.”  Kwik Gas Inc. d/b/a Delta, DAB No. 2852, at 7 (2018).

Having examined the record and applicable law, we find no basis to disturb the ALJ’s decision to sanction Respondent, enter a default judgment in favor of CTP, and impose a CMP in the amount of $638.  We recognize that striking an answer is “a relatively harsh” sanction; however, “[o]ur role . . . is to determine whether the ALJ’s decision to impose that [sanction] was outside the bounds of [the ALJ’s] discretion.”  KKNJ, Inc. at 11.  Respondent deliberately and repeatedly failed to comply with the ALJ’s orders and procedures, despite having received ample time to comply and warnings that noncompliance could result in sanctions and imposition of the remedy sought by CTP.  These failures indisputably “interfered with the speedy, orderly, or fair conduct” of the proceeding, as the ALJ determined.  ALJ Initial Decision at 2, 4-5 (citing 21 C.F.R. § 17.35(a)).  Given these circumstances, 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.  See Joshua Ranjit, Inc. at 1, 8-11 (concluding that the ALJ did not abuse their discretion in striking respondent’s Answer and entering default judgment in favor of CTP as a sanction for respondent’s failure to respond to the ALJ’s orders); KKNJ, Inc. at 8-11 (same); Retail LLC d/b/a Super Buy Rite, DAB No. 2660, at 10-14 (2015) (same); see also Zoom Mini Mart, Inc., DAB No. 2894, at 10 (2018) (“Parties have a responsibility to follow an ALJ’s orders.”); Guardian Care Nursing & Rehab. Ctr., DAB No. 2260, at 21 (2009) (We have an “overarching responsibility to ensure the efficiency and integrity of proceedings before the [DAB] as a whole, which encompasses a concern that the orders of ALJs not be disregarded . . . without consequence.”).

We therefore affirm the ALJ Initial Decision.

2. We affirm the ALJ’s denial of Respondent’s request for reopening of the Initial ALJ Decision because Respondent identifies no factual or legal error or abuse of discretion by the ALJ.

Pursuant to 21 C.F.R. § 17.11(c), a respondent may file a “motion seeking to reopen on the grounds that extraordinary circumstances prevented the respondent from filing an answer.”  21 C.F.R. § 17.11(c).  Section 17.11(d) permits an ALJ to withdraw an initial default decision if a “respondent can demonstrate extraordinary circumstances excusing the failure to file an answer in a timely manner.” 21 C.F.R. § 17.11(d). 

Respondent specifies no error, and we see none, in the ALJ’s determination that

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Respondent presented “no basis for” reopening the ALJ Initial Decision.  As the ALJ correctly observed, Respondent did file a timely answer, and therefore could not demonstrate that extraordinary circumstances prevented it from doing so.  ALJ Initial Decision at 2; Answer; Order Denying Resp’t Mot. to Reopen Initial Decision at 4.  The ALJ also appropriately recognized that the controlling regulations do not afford an ALJ the authority to reopen or reconsider an initial default decision in which an answer was timely filed, when, as here, the answer was subsequently stricken as a sanction.  Order Denying Resp’t Mot. to Reopen Initial Decision at 4; see Minmax at 1 n.1.

The ALJ considered Respondent’s arguments that its representative’s health issues constituted “the extraordinary circumstances preventing it from complying with the judicial orders issued in this case,” but reasonably rejected those arguments.  See Order Denying Resp’t Mot. to Reopen Initial Decision at 4.  As the ALJ observed, Respondent’s own evidence shows that its representative received a physician’s full duty medical release to work, with no functional limitations or restrictions, as of July 25, 2023.  Id.  We also agree with the ALJ’s assessment that the record does not reflect any other apparent reason why Respondent could not have complied timely with its obligations and the ALJ’s orders.

Conclusion

For the foregoing reasons, we affirm the ALJ Initial Decision and ALJ’s Order Denying Respondent’s Motion to Reopen Initial Decision.

Endnotes