Best Effort First Time, LLC d/b/a Columbia Auto Care & Wash / Exxon, DAB TB10884 (2026)

INITIAL DECISION

The Center for Tobacco Products (CTP) of the United States Food and Drug Administration (FDA) seeks to impose a No-Tobacco-Sale Order (NTSO) for a period of 30 consecutive days, against Respondent, Best Effort First Time, LLC, d/b/a Columbia Auto Care & Wash / Exxon (Respondent or BEFT).  CTP alleges that Respondent committed five repeated violations of Section 906(d)(5) of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 387(d)(5)) and the regulations codified in 21 C.F.R. Part 1140 (Tobacco Regulations).  Specifically, CTP alleges that Respondent violated the Act when it sold regulated tobacco products to persons under 21 years of age and failed to verify, by means of photo identification containing a date of birth, that such purchasers were 21 years of age or older, and repeated those violations at least five times within a 36-month period.  Respondent acknowledges liability but asks that I deny CTP’s request to impose a 30-day NTSO.  Instead, Respondent argues that a civil monetary penalty (CMP) would be more appropriate, in consideration of several mitigating factors,

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including its specific efforts to prevent any further underage sales of tobacco products and numerous successful county compliance checks.

For the reasons discussed below, I find Respondent liable for five repeated violations of the Act and Tobacco Regulations over a period of 36 months and conclude that a reduced NTSO of 15 consecutive days is appropriate.

I. Background and Procedural History

A. Initial Pleadings and Pre-Hearing Orders

CTP began this case by serving the Complaint on Respondent at 10611 Little Patuxent Parkway, Columbia, Maryland 21044, and filing a copy of the Complaint with the Departmental Appeals Board (DAB), Civil Remedies Division (CRD).  CRD Docket (Dkt.) Entry Numbers (Nos.) 1 (Complaint), 1b (Proof of Service).  CTP seeks an NTSO prohibiting the sale of all tobacco products for a period of 30 consecutive days against Respondent for committing five repeated violations of the Act and Tobacco Regulations within a 36-month period, beginning March 22, 2023, through June 7, 2024.

Specifically, CTP asserts that Respondent admitted to several violations of the Act and Tobacco Regulations in four previous civil money penalty (CMP) actions that are now closed and final.  Complaint ¶¶ 9-13.  In those prior actions, Respondent admitted to one original violation on March 22, 2023, and a repeated violation on December 13, 2023, for selling tobacco products to a person under 21 years of age, pursuant to Section 906(d)(5) of the Act.  Id. ¶ 13; CRD Dkt. Entry No. 17(Informal Brief of Complainant).  CTP also alleges that Respondent previously admitted to one original violation on June 13, 2012, and two repeated violations on March 22, 2023, and December 13, 2023, respectively, for failing to verify the age of the purchasers by means of photographic identification containing the bearer’s date of birth, in violation of 21 C.F.R. § 1140.14(b)(1) and 21 C.F.R. § 1140.14(a)(2)(i). Complaint ¶¶ 10, 13; CRD Dkt. Entry No. 17.In the current NTSO action, CTP alleges that Respondent subsequently sold tobacco products to a person under 21 years of age, in violation of Section 906(d)(5) of the Act, and failed to verify the age of the purchaser by means of photographic identification containing the bearer’s date of birth, in violation of 21 C.F.R. § 1140.14(a)(2)(i), on June 7, 2024.  Complaint ¶ 7.  Accordingly, CTP alleges that Respondent had three repeated violations from the previous CMP actions and two additional repeated violations on June 7, 2024.  Id. ¶¶ 7, 13.  Therefore, CTP contends that Respondent has committed five repeated violations within a 36-month period and is subject to an NTSO.  Id. ¶ 1, 14.

On November 29, 2024, Respondent registered for the Departmental Appeals Board Electronic Filing System (DAB E-File) and timely filed its Answer.  CRD Dkt. Entry No. 3 (Answer).  Without admitting to the allegations, Respondent stated that it had already contacted CTP “to put in a request to resolve this matter outside of a hearing.” Id.

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Based on this representation, on December 6, 2024, I issued an Acknowledgment and Status Report Order (ASRO) acknowledging receipt of Respondent’s Answer and ordering the parties to file a joint status report by January 31, 2025.  CRD Dkt. Entry No. 4 (ASRO).  On January 29, 2025, CTP filed a Joint Status Report, stating that the parties intended to engage in further settlement discussions and that CTP would notify the DAB if the parties agreed to a settlement.  CRD Dkt. Entry No. 5.

As no notification of settlement was filed, on February 6, 2025, I issued a Pre-Hearing Order (PHO) establishing procedural deadlines for this case.  CRD Dkt. Entry No. 6 (PHO).

On March 14, 2025, CTP filed a Status Report, advising that the parties have been unable to reach a settlement in this case, and CTP intends to proceed to a hearing.  CRD Dkt. Entry No. 7.

On April 4, 2025, CTP filed a Motion to Extend Deadlines, stating that “[o]n April 1, 2025, FDA experienced a significant reduction in force (RIF), including in FDA’s Center for Tobacco Product’s Office of Compliance and Enforcement, the office that supports all tobacco-related administrative cases” and CTP “is still evaluating the impact the RIF may have on CTP’s immediate operations .  .  .  [and] is requesting a 30-calendar day extension of all pending deadlines in this matter.”  Given these extraordinary circumstances, I granted CTP’s Motion to Extend Deadlines and all pending deadlines in this matter were extended by 30 days.  CRD Dkt. Entry Nos. 8, 9.

On May 27, 2025, CTP filed a Motion to Compel Discovery (MTC) stating that Respondent failed to respond to CTP’s Request for Production of Documents (RFP), which had been served on March 21, 2025.  CRD Dkt. Entry No. 11; see also CRD Dkt. Entry Nos. 11a, 11b (CTP Exhibit A and Exhibit B).  In its Motion, CTP requested an order be issued compelling “Respondent to respond to CTP’s Request for Production of Documents in its entirety.”  CRD Dkt. Entry No. 11 at 2.  Contemporaneously, CTP filed an Unopposed Motion to Extend Deadlines (UMED), requesting that the deadlines for the parties’ pre-hearing exchanges also be extended by 30 days.  CRD Dkt. Entry No. 12.  On May 29, 2025, I granted CTP’s UMED, pending my ruling on CTP’s MTC, and gave Respondent until June 13, 2025, to respond.

On June 11, 2025, CTP filed a Status Report and Withdrawal of Motion to Compel Discovery, stating “CTP has received documents from the Respondent sufficient to satisfy its Request for Production of Documents. CTP therefore withdraws its Motion to Compel Discovery, filed on May 27, 2025.”  CRD Dkt. Entry No. 14.

On June 12, 2025, CTP filed a Notice of Unavailability of Declarant and Motion to Extend Deadlines, requesting “that all deadlines in this case be extended for sixty (60)

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days, to allow declarant the time to review and sign his declaration upon his return to duty after extended leave.”  CRD Dkt. Entry No. 15.  On June 13, 2025, I granted CTP’s motion to withdraw its Motion to Compel Discovery and further extended the parties’ pre-hearing exchange deadlines to September 5, 2025, for CTP, and September 26, 2025, for Respondent.  CRD Dkt. Entry No. 16.

On September 5, 2025, counsel for CTP timely filed its informal brief (CTP Br.), and 16 proposed exhibits (CTP Exs. 1-16), including the written direct testimony of one witness, Gavin R. Milligan, FDA-commissioned officer with the state of Maryland (CTP Ex. 5). CRD Dkt. Entry Nos. 17, 17a-q.  On September 26, 2025, counsel for Respondent also timely filed its informal brief (R. Br.) and 8 proposed exhibits (R. Exs. A-H), which included the written direct testimony of one witness, Ryan Daggle, Owner and Managing Member of BEFT.  CRD Dkt. Entry Nos. 19-21, 21a-g.

B. Pre-Hearing Conference

On October 30, 2025, I held a telephonic prehearing conference (PHC) in this case with both parties present.  See CRD Dkt. Entry No. 26 (Summary of Order Following October 30, 2025, Pre-Hearing Conference and Order Scheduling a Video Hearing).  During the pre-hearing conference, I explained my role as an impartial Administrative Law Judge, explained the issues before me, and the parties’ respective burdens of proof.  Id. Specifically, I informed the parties that the issues I must decide in the case are:  (1) whether Respondent is liable for 5 repeated violations of the tobacco regulations within a 36-month period; and (2) if so, whether a No-Tobacco-Sale-Order of 30 consecutive days is appropriate, considering any aggravating or mitigating factors.  Id.  I also explained that CTP has the burden of proving the Respondent’s liability and the appropriateness of the NTSO period, whereas Respondent has the burden of proving any affirmative defenses and mitigating factors.  Id.  I asked the parties whether they understood the issues, and counsel for both parties responded affirmatively.  Id.

Based on the pleadings and pre-hearing briefs, I inquired whether Respondent concedes the first issue and, therefore, only the appropriateness of the NTSO remained as an issue for hearing.  Id.  Counsel for Respondent, Mr. Tepe, stated that Respondent agreed to the facts related to the underage sale of tobacco products and primarily challenges the NTSO, but does not formally admit the first issue of liability.  Id. I inquired whether the parties had agreed to any other potential stipulations or admissions that may narrow the issues for a hearing.  Id.  Both parties stated they had not reached any stipulations but were willing to engage in further settlement discussions.  Id.

Next, I discussed the procedural history of the case, the record, and the parties’ prehearing submissions which include the parties’ proposed evidence and witnesses.  I also explained that the purpose of a formal hearing is to allow for the cross-examination of any witnesses who have provided sworn testimony in their exchanges.  I further noted

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that if a hearing is not needed, I will decide the case based on the arguments and evidence contained in the administrative record.  I also encouraged the parties to continue with settlement discussions.  Id.

With respect to the parties’ evidentiary submissions, CTP submitted a pre-hearing brief; a proposed witness and exhibit list; and 16 proposed exhibits, including written testimony of a proposed witness, marked as CTP Exhibits (Exs.) 1 through 16.  CRD  Dkt. Entry Nos. 17, 17a-q.  I apprised Respondent’s counsel of CTP’s proposed witness, FDA-commissioned inspector for the state of Maryland, Inspector Gavin R. Milligan (CTP Ex. 5).

Respondent submitted a pre-hearing brief, a proposed witness and exhibit list; and eight proposed exhibits including written testimony of a proposed witness, marked as Respondent Exhibits (R. Exs.) A through H.  CRD Dkt. Entry Nos. 19- 21, 21a-g.  I also apprised CTP’s counsel of Respondent’s proposed witness, Ryan Daggle, Managing Member of Respondent (R. Ex. B).  To be consistent with CRD’s naming convention for exhibits, I re-marked Respondent’s exhibits as Respondent Exhibits 1-8 (R. Exs. 1-8).  I asked each party if they had any objections to admitting the opposing party’s proposed exhibits into the record.  Both parties stated they had no objections.  Accordingly, I entered CTP’s proposed exhibits into the record as CTP Exhibits 1-16, and I entered Respondent’s proposed exhibits into the record as Respondent Exhibits 1-8. Respondent’s counsel also requested that a Howard County inspection report from an inspection that was just completed on the morning of October 30, 2025, be admitted into the record as Respondent’s Exhibit 9 (R. Ex. 9).  Mr. Tepe advised that he would upload a photograph of the inspection report to the case docket after the prehearing conference.  I asked CTP’s counsel, Mr. Shane, if CTP had any objections to this report or image being entered into the record.  As CTP had no objections, I also admitted Respondent Exhibit 9 into the record.  CRD Dkt. Entry No. 26 at 2-3.

I reiterated that a hearing will be necessary only for cross-examination of witnesses, with the scope limited to statements already in the record, and I asked counsel of their intent to cross-examine each party’s witness.  Counsel for Respondent, Mr. Tepe, stated that he would like to have the opportunity to cross-examine CTP’s witness, Inspector Mulligan. Counsel for CTP, Mr. Shane, also stated that, given this fact, he would also like to cross examine Respondent’s witness, Ryan Daggle.  Id. at 3.

Consequently, I ascertained the mutual availability of the parties and their respective witnesses to schedule a hearing.

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C. Waived Video Hearing and Final Submissions

On December 4, 2025, the parties convened for a hearing in this case.  See CRD Dkt. Entry No. 27 (December 11, 2026, Order Following December 4, 2025, Waived Video Hearing).

At the start of the hearing, counsel for Respondent, Mr. Tepe, informed me that the U.S. Food and Drug Administration (FDA)’s witness, Inspector Gavin R. Milligan, would not be appearing for cross-examination, based on a prior agreement with CTP’s counsel.  Id. Respondent’s counsel also informed me that Respondent does not challenge the alleged violations on June 7, 2024, only the appropriateness of the proposed NTSO and its duration.  Counsel for CTP, Mr. Shane, also advised that he would not be cross-examining Ryan Daggle, Respondent’s witness.  Id.

I advised the parties that since there are no witnesses to be cross-examined, there would be no hearing in this matter.  Instead, I would issue a decision based on the evidence in the administrative record on the only remaining issue, which is whether an NTSO of 30 consecutive days is appropriate, considering any aggravating or mitigating factors.  Id. Both counsel agreed for the hearing to be waived and for me to issue a decision based on the written record.  Both counsel also waived checking the completeness and accuracy of the forthcoming transcript of the video conference wherein the parties waived a hearing. Id.

Further, I confirmed the exhibits admitted into the administrative record, CTP Exhibits 1 through 16 and Respondent Exhibits 1 through 9, and advised that I would issue an order summarizing the matters discussed at the appearance waiving a hearing and establishing a schedule for final briefs.  Mr. Shane informed me that CTP most likely would waive submission of a final brief.  Id.

Finally, I advised counsel that each party may submit final arguments, including any proposed findings of fact and conclusions of law, in simultaneous, post-hearing (or, in this case, supplemental) briefs and responsive briefs.  Id.  I further advised that final briefs by both parties must be filed no later than January 12, 2026, and final responsive briefs must be filed no later than January 27, 2026, specifically noting that no replies or surreplies would be allowed and that submission of a final supplemental or responsive brief is optional and is not required.  Id.

On January 12, 2026, counsel for CTP, Michael Shane, filed a Notice of Waiver of Final Brief, stating that “that it d[id] not intend to file a final brief in the above-captioned case. Consistent with the December 11, 2026, Order, CTP reserve[d] its right to file a responsive brief by January 27, 2026.”  CRD Dkt. Entry No. 28.

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On January 12, 2026, Respondent’s counsel, Jason Tepe, filed its final brief, in which it reasserts its primary argument “that an NTSO is not warranted in this case” and that “the NTSO sought by the CTP in this case is excessive and unnecessary,” citing two CRD cases in support, Kwik Stop 7th Ave., Inc. d/b/a Kwik Stop Food Store, DAB TB5245, and Richard Lorenz d/b/a Rick’s Gas Station, DAB TB5274, where the NTSO period was reduced from 30 days to 15 days.  CRD Dkt. Entry No. 29.  I issued the decision in Lorenz.

On January 26, 2026, CTP filed Complainant’s Response to Respondent’s Final Brief. CTP argues that the supporting cases that Respondent’s counsel cites to are “neither dispositive nor persuasive” and notwithstanding Respondent’s recent efforts to take corrective measures, “do[es] not warrant any reduction in the length of the NTSO sought.”  CRD Dkt. Entry No. 30.

The administrative record is now complete and closed, and this matter is ready for a decision.  I will consider the full administrative record in deciding this case, except for any excluded evidence.  21 C.F.R. §§ 17.41(b), 45(a).

II. Admission of Exhibits

The regulations grant me the authority to “receive, rule on, exclude, or limit evidence.” 21 C.F.R. § 17.19(b)(11).  I also have the authority to “[w]aive, suspend, or modify any rule in this part if the presiding officer determines that no party will be prejudiced, the ends of justice will be served, and the action is in accordance with law .  .  .  . ”  21 C.F.R. § 17.19(b)(17).  As explained above, I previously ADMITTED CTP Exhibits 1 through 16 into the administrative record at the PHC, and previously ADMIITED Respondent’s Exhibits 1 through 9 into the administrative record at the PHC.  I also order that Respondent Exhibit 5, which is a video demonstrating Respondent’s Point-of-Sale system using the unredacted driver’s license of Respondent’s witness, is SEALED for personal privacy concerns.  CRD Dkt. Entry No. 21d; see 21 C.F.R. § 17.28(b).  In accordance with 21 C.F.R. § 20.64, the witness’ driver’s license shall be withheld from public disclosure.

III. Issue

The sole issue in this case is whether an NTSO of 30 consecutive days is appropriate, pursuant to the provisions of 21 C.F.R. § 17.34(a)-(c).

IV. Applicable Law

The Act prohibits the misbranding of tobacco products while they are held for sale after shipment in interstate commerce.  21 U.S.C. § 331(k).  Tobacco products are misbranded if they are sold or distributed in violation of the Act or applicable regulations issued

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under section 906(d) of the Act.  21 U.S.C. § 387c(a)(7)(B); 21 C.F.R. § 1140.1(b). Section 906(d)(5) of the Act prohibits the sale of regulated tobacco products to any person younger than 21 years of age.  21 U.S.C. § 387f(d)(5); see also 21 C.F.R § 1140.14(b)(1).  The Tobacco Regulations, codified at 21 C.F.R. Part 1140, require 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. 21 C.F.R § 1140.14(a)(2)(i).

CTP has authority to seek a CMP from any person who violates a requirement of the Act related to tobacco products, subject to the maximum amounts authorized by the Act, as adjusted for inflation.  21 U.S.C. §§ 333(f)(5)(A), 333(f)(9)(A); see also 21 C.F.R § 17.2; 45 C.F.R. § 102.3.  The Act establishes progressively increasing maximum CMPs for subsequent tobacco violations that occur within prescribed timeframes.  21 U.S.C. § 333 note (Guidance); see also 45 C.F.R. § 102.3 (Table 1:  Civil Monetary Penalty Authorities Administered by HHS).

The Act also authorizes CTP, in the case of “repeated violations,” to impose an NTSO against retailers.  See 21 U.S.C. § 333(f)(8)-(9)(A).  The term “repeated violations” is defined as “at least 5 violations of particular requirements over a 36-month period at a particular retail outlet that constitute a repeated violation .  .  .  .”  See 21 U.S.C. § 333 note at (1)(A).  Thus, each repeated violation represents the second or subsequent violation of a particular requirement within 36 months.  See 21 U.S.C. § 333 note at (1)(A); see also Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers:  Guidance for Industry, at 5-6 (rev. Aug. 2023), https://www.fda.gov/media/80888/download.  The Act also provides that “[p]rior to the entry of a no-sale order under this paragraph, a person shall be entitled to a hearing .  .  .  .”  21 U.S.C. § 333(f)(8); see also 21 U.S.C. § 333(f)(5)(A).

The Act does not establish specific durations for NTSOs, but it does contemplate permanent NTSOs, which may be compromised, modified, or terminated.  See 21 U.S.C. § 333(f)(5)(B) & (D).  Likewise, the applicable regulations do not outline specific durations for NTSOs.  CTP guidance documents, however, establish that the maximum period of time for the first No-Tobacco-Sale Order imposed against a retailer is 30 calendar days.  Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance with an Order (Revised)* at 3-4, available at https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM460155.pdf (last updated March 2023).  Consistently, CTP has requested a No- Tobacco-Sale Order against Respondent for a period of 30 consecutive calendar days.

CTP has the burden to prove, by a preponderance of the evidence, the appropriateness of the proposed CMP assessed against Respondent.  21 C.F.R. § 17.33(b).  Respondent has the burden to prove any mitigating factors, likewise by a preponderance of the evidence. 21 C.F.R. § 17.33(c).  The Supreme Court of the United States has described the

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preponderance of the evidence standard as requiring that the trier-of-fact believe that the existence of a fact is more probable than its nonexistence before finding in favor of the party that had the burden to persuade the judge of the fact’s existence.  Concrete Pipe and Prods. of Cal., Inc. v. Constr. Laborers, 508 U.S. 602, 622 (1993) (citing In re Winship, 397 U.S. 358, 371-72 (1970) (Harlan, J., concurring)).

V. Analysis

A. Violations

Upon consideration of the entire administrative record and applicable law, I find that Respondent committed five repeated violations of the Act and tobacco regulations over a 36-month period, as alleged in the Complaint.  Complaint ¶¶ 7-13.  In four previous administrative proceedings, Respondent admitted to multiple violations of selling cigarettes to underage purchasers and failing to verify the age of the cigarette purchasers, in violation of 21 C.F.R. § 1140.14(a)(1) and 21 C.F.R. § 1140.14(a)(2)(i), respectively.  Id. at 9-13.  Each of the four previous CMP actions concluded by settlement.  Id.; see also CTP Ex. 2 (Acknowledgment Form); CTP Ex. 4 (Acknowledgment Form).  In each settlement agreement, Respondent acknowledged that all of the violations in the respective complaints occurred as alleged, waived the Respondent's ability to contest the violations in the future, and acknowledged that the violations may be counted in determining the total number of violations for purposes of future enforcement actions.  CTP Exs. 2, 4. 

Accordingly, based on these settlement agreements, Respondent previously admitted to selling cigarettes to minors and underage purchasers on June 13, 2012, December 7, 2012, July 15, 2013, April 5, 2018, August 22, 2018, March 22, 2023, and December 13, 2023, in violation of Section 906(d)(5) of the Act and 21 C.F.R. § 1140.14(a)(1).1   See CTP Informal Brief; CRD. Dkt. Entry No. 17.; CTP Exs. 1-6.  Respondent also admitted to committing additional violations on June 13, 2012, December 7, 2012, April 5, 2018, August 22, 2018, March 22, 2023, and December 13, 2023, for failing to verify the age of the cigarette purchasers by means of photographic identification containing the bearer's date of birth, in violation of 21 C.F.R. § 1140.14(a)(2)(i).2   Id.  These prior violations are administratively final and may not be challenged by Respondent.  21 C.F.R. § 17.15(b) (stating that a "settlement agreement shall be filed in the docket and shall constitute

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complete or partial resolution of the administrative case as so designated by the settlement agreement").

In this proceeding, Respondent did not initially admit liability with regards to the two June 7, 2024, violations alleged in the complaint, specifically, that Respondent sold tobacco products to a person under 21 years of age, in violation of Section 906(d)(5) of the Act, and that it failed to verify the age of a person purchasing tobacco products by means of photographic identification containing the bearer’s date of birth in violation of 21 C.F.R. § 1140.14(b)(1) and § 1140.14(a)(2)(i). 

However, in its Informal Brief, Respondent admits to violating the Act’s requirement against selling tobacco product to underage purchasers:  “Yes, Respondent, through its former agent, sold tobacco products to a purchaser under the age of 21 on June 7, 2024, at approximately 11:41 AM.”  R. Brief at 2-3.  Respondent also admits to violating the tobacco regulations by failing to verify the purchaser’s age with photo identification: “Yes, Respondent, through its former agent, failed to verify the identification and age of a tobacco purchaser, not over the age of 30, on June 7, 2024, at approximately 11:41 AM.”  Id. at 3.  Further, Respondent sole argument in its Informal Brief is with regards to the NTSO, stating that “the NTSO sought by the CTP in this case is excessive and unnecessary.”  Id. at 1; see also id. at 6. 

Consistently, during the PHC, Respondent’s counsel stated that “Respondent agreed to the facts related to the underage sale of tobacco products and primarily challenges the NTSO, but does not formally admit the first issue.”  CRD Dkt. Entry No. 26 at 2.  I note that the first issue was “[w]hether Respondent is liable for 5 repeated violations of the federal tobacco regulations within a 36-month period.”  Id. at 1.  More importantly, during the waived hearing on December 4, 2025, Respondent’s counsel agreed that “the only remaining issue, which is whether a No-Tobacco-Sale-Order (NTSO) of 30 consecutive days is appropriate.”  CRD Dkt. Entry No. 27 at 1-2.

Furthermore, based on Inspector Mulligan’s written testimony, he observed Respondent's employee sell underage purchaser A, a package of Newport cigarettes and did not provide a receipt after the purchase.  CTP Ex. 5 ¶ 8.  After the inspection, Inspector Mulligan retrieved the package of Newport cigarettes from underage purchaser A.  Id. ¶ 9. Inspector Mulligan then labeled the cigarettes as evidence, photographed the evidence, and processed the evidence according to standard procedures, which entailed completing several contemporaneous reports.  Id. ¶¶ 9-10.  These photographs and reports document the inspection and corroborate Inspector Mulligan’s testimony.  See CTP Ex. 6 (Narrative Report); CTP Ex. 7 (Tobacco Inspection Management System (TIMS) Assignment Form); CTP Ex. 8 (underage purchaser A’s redacted identification); CTP Ex. 9 (Photographs of the cigarettes sold by Respondent to underage purchaser A); and CTP Ex. 10 (Photographs of the cigarettes sold by Respondent to underage purchaser A). Respondent has not challenged Inspector Mulligan’s testimony or any of this

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documentary evidence, and subsequently decided not to cross examination Inspector Milligan, as both parties waived the scheduled video hearing.

In addition, Respondent has acknowledged liability by specifying corrective actions taken since the June 7, 2024, violation, including, “terminat[ing] the offending employee (there was one BEFT employee responsible for the two offending tobacco sales under consideration) and registered its employees for formal tobacco sales training modules to ensure ongoing compliance.”  R. Br., Exs. B, F, G, & H.

Accordingly, I conclude that on June 7, 2024, Respondent violated the law by selling cigarettes to an underage purchaser and failing to verify, by means of photo identification containing a date of birth, that the purchaser was 21 years of age or older, as alleged in the Complaint.  Further, the unrebutted record evidence compels me to find by a preponderance of evidence that the violations occurred as alleged in the Complaint. 

Given Respondent’s admissions in prior settlement agreements, admissions in this proceeding, and the evidence of record, I conclude that Respondent committed five repeated violations of the Act and its implementing regulations over a 36-month period, as alleged in the Complaint.  See Complaint ¶ 1 n.1; see also id. ¶ 1 (table).  When determining the number of repeated violations for an NTSO, each regulatory requirement at 21 C.F.R. Part 1140 is viewed separately and each “repeated violation” represents the second or subsequent violation of a particular requirement over a 36-month period.  See 21 U.S.C. § 333 note at (1)(A); see also Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers:  Guidance for Industry, at 5-6 (rev. Dec. 2016), https://www.fda.gov/media/80888/download.  Thus, for purposes of imposing an NTSO under 21 U.S.C. § 333(f)(8), the original violations are not included when determining whether a Respondent has committed at least five “repeated violations” over a 36-month period.  Id.  Accordingly, I conclude that Respondent originally violated Section 906(d)(5) of the Act by selling cigarettes or smokeless tobacco to a person under 21 years of age on March 22, 2023, and committed two repeated violations on December 13, 2023, and June 7, 2024.  I also conclude that Respondent originally violated the tobacco regulations (21 C.F.R. § 1140.14(b)(1) /§ 1140.14(a)(2)(i)) by failing to verify the cigarette or smokeless tobacco purchasers’ age by means of photographic identification on June 13, 2012, and committed three repeated violations on March 22, 2023, December 13, 2023, and June 7, 2024.  Therefore, Respondent committed a total of five repeated violations on March 22, 2023, December 13, 2023, and June 7, 2024.  These repeated violations fall within a 36-month period beginning March 22, 2023.

B. No-Tobacco-Sale Order

Having determined that Respondent is liable for committing five repeated violations over a 36-month period, I conclude that I have the authority to impose an NTSO, under

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21 U.S.C. § 333(f)(8).  However, the primary issue before me is whether the requested NTSO for a period of 30 consecutive days is appropriate.  21 C.F.R. § 17.34.

As previously noted, the Act and regulations do not establish specific durations for NTSOs.  However, CTP’s non-binding guidance document states that the maximum period of time that FDA would seek for a first NTSO is 30 calendar days.  See Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance with an Order:  Guidance for Tobacco Retailers, at 4-5 (March 2023), http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM460155.pdf.  While the CTP guidance documents are not regulations, and, thus, are not binding, as a matter of law, I find that CTP has provided a reasonable explanation for its policy determinations and find them persuasive, particularly with respect to the need to protect the public health and gradually increasing the NTSO’s duration when imposing subsequent NTSOs.  Id. at 3-5.  I may, however, "compromise, modify, or terminate, with or without conditions, any no-tobacco-sale order."  21 U.S.C. § 333(f)(5)(D).  

When determining the appropriate period to be covered by an NTSO, I am required to take into account "the nature, circumstances, extent and gravity of the violations and, with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, the degree of culpability, and such other matters as justice may require.”  21 U.S.C. § 333(f)(5)(B).

Consistent with its guidance document, CTP seeks to impose the maximum NTSO for the first NTSO for a period of 30 consecutive days against Respondent.  Complaint ¶ 1.  In its Informal Brief, CTP asserts that “[d]ue to Respondent’s multiple repeated violations of federal tobacco law, as well as its unwillingness or inability to stop violating the law, an NTSO is necessary and appropriate to protect the public health.”  CTP Br. at 14.  CTP notes that this is the fifth administrative action that it has brought against Respondent for violating the FDA’s tobacco regulations, despite previous warnings and directing Respondent to information on the FDA’s website to help tobacco retailers understand and comply with Part 1140 regulations.  Id. at 2, 12 (citing the April 18, 2023 Warning Letter to Respondent, CTP Ex. 15).

However, Respondent argues that a 30-day NTSO is excessive.  Respondent cites to Richard Lorenz d/b/a Rick’s Gas Station, DAB TB5274 (2021) and Kwik Stop 7th Ave., Inc. d/b/a Kwik Stop Food Store, DAB TB-5245 (2020), both of which the Administrative Law Judges respectively found (in the case of Lorenz, I made that finding) that a reduced 15-day NTSO was more appropriate. 

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Respondent specifically argues:

In both Richard Lorenz and Kwik Stop, the CRD found that a 30-day NTSO was inappropriate and ordered a 15-day NTSO.  In the case sub judice, Respondent BEFT took even more corrective action than both of the respondents in Richard Lorenz and Kwik Stop. Notably, BEFT:  (a) installed mandatory ID-scanners for tobacco sales (see Resp. Informal Br. Ex. E); (b) retrained all its employees on tobacco policies (Resp. Informal Br. Exs. F, G, & H); (c) terminated the offending employee (Resp. Informal Br. Ex. B); (d) published its written tobacco policy and required employees to sign-off, confirming receipt and review (Resp. Informal Br. Ex. D); and (e) all employees were registered and required to complete a vetted tobacco control training program (Resp. Informal Br. Ex. H). Respondent took all actions that both respondents took in Richard Lorenz and Kwik Stop.  Unlike the respondent in Richard Lorenz, BEFT already had signage in its facility and installed a mandatory ID-scanner for any tobacco sales.  Unlike the respondent in Kwik Stop, BEFT terminated the offending employee (there was one BEFT employee responsible for the two offending tobacco sales under consideration) and registered its employees for formal tobacco sales training modules to ensure ongoing compliance. 

R. Final Br. at 3 (CRD. Dkt. Entry No. 29). 

Furthermore, Respondent argues that, unlike the Respondent in Kwik Shop which had an additional violation following CTP’s notification, “[n]ot only has BEFT had no violations from CTP since June 2024 (19 months), BEFT has actually had numerous unannounced inspections by Maryland tobacco control investigators and has passed each one.”  See R. Final Br. at 4; see also R. Ex. 1 at 1-3; R. Ex. 9 (demonstrating four successful tobacco compliance checks by the Howard County Health Department).  According to Respondent, “[u]nlike Richard Lorenz, BEFT is not relying simply on the fact that no one has found additional violations.  Here, BEFT has been checked through 4 unannounced inspections and was found to be in compliance with tobacco sales laws.”  R. Final Br. at 4.  For this reason and BEFT’s efforts “to correct any gaps in compliance,” Respondent further argues that “even a 15-day NTSO seems excessive in light of the circumstances.” Id.  Respondent is requesting that I “issue an order that this Board determines is reasonable and appropriate under the circumstances.”  Id. 

For the following reasons, I reject CTP’s proposed duration of the 30 consecutive day NTSO and conclude that an NTSO for 15 days is more appropriate, based upon the evidence of record, applicable law, and aggravating and mitigating circumstances in this case.  I also reject Respondent’s argument that “even a 15-day NTSO seems excessive in light of the circumstances.”  R. Final Br. at 4.

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1. Nature, Circumstances, Extent and Gravity of the Violations

I have found that Respondent committed two repeated violations of selling cigarettes or smokeless tobacco products to underage purchasers and three repeated violations for failing to verify, by means of photo identification containing a purchaser’s date of birth, that no cigarette or smokeless tobacco purchasers are younger than 21 years of age, totaling five repeated violations of the tobacco regulations within a 36-month period.  The repeated inability of Respondent to comply with federal tobacco regulations is serious in nature and the penalty should be set accordingly. 

However, contrary to CTP’s arguments, I conclude that the totality of circumstances warrants a reduction in the NTSO period.  See CTP Response to R. Final Br. at 2.  The repeated violations occurred within a relatively isolated 15-month period of time (March 22, 2023, through June 7, 2024) and were committed primarily by a single employee, whom Respondent eventually terminated.  R. Br. at 3-5; R. Ex. 2 at 1-2.  As explained in detail below, Respondent had numerous successful inspections by the Howard County Tobacco Enforcement Division before, during, and after the relevant period.  See History of Prior Violations; see also Act (stating that the “Secretary shall coordinate with the States in enforcing the provisions of this Act .  .  .    and, for purposes of mitigating a civil penalty to be applied for a violation by a retailer .  .  .  ,  shall consider the amount of any penalties paid by the retailer to a State for the same violation.”).  Respondent also took several corrective actions to prevent future violations.  See infra, Other Matters as Justice May Require and Additional Mitigating Factors.  Thus, the circumstances of the violations demonstrate that Respondent’s violations were isolated and its remedial measures were effective.

2. Respondent’s Ability to Pay

CTP seeks a 30-day NTSO, while Respondent argues that a civil money penalty is more appropriate.  Respondent does not suggest an appropriate, alternate civil money penalty amount, but the regulations provide guidance on the appropriate amount of a civil money penalty in similar circumstances.  Specifically, the regulations provide for a maximum penalty of $7,115 for five violations of the Act or tobacco regulations within a 36-month period.  See 45 C.F.R. § 102.3 (Table 1:  Civil Monetary Penalty Authorities Administered by HHS).  Counting the original violation of the Act on March 22, 2023, and the repeated violations on March 22, 2023, December 13, 2023, and June 7, 2024, would yield six violations within a 48-month period, for which the regulations authorize a maximum civil money penalty of $14,232.  See id. 

I also acknowledge that an order prohibiting the sale of tobacco products will have a financial impact on a retailer, such as Respondent, but Respondent has not presented any financial evidence of its tobacco sales to prove the existence or extent of any financial hardship.  In particular, Respondent has not argued or presented any evidence

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demonstrating that it cannot forgo tobacco sales for 30 consecutive days or to support an alternate civil money penalty. 

Respondent relies on the cases of Richard Lorenz and Kwik Stop to support a reduced NTSO period, but, unlike Respondent, the respondents in those cases submitted credible and persuasive evidence that their respective tobacco sales constituted a significant percentage of the businesses’ overall sales.  See Richard Lorenz at 14-16; Kwik Stop at 8. Additionally, both respondents were heavily impacted financially by the COVID-19 pandemic.  See Richard Lorenz at 16-17; Kwik Stop at 9-10.  In the absence of evidence concerning Respondent’s financial condition, this factor neither aggravates nor mitigates the NTSO.

3. Effect on Respondent’s Ability to Continue to Do Business

Respondent argues that “the NTSO sought by the CTP in this case is excessive and unnecessary” (R. Final Brief at 1), but does not present any evidence of its financial condition or specifically address how that would affect Respondent’s ability to continue to conduct its business.  See CTP Br. at 14-15; see also CTP Response to R. Final Br. at 2-3. 

However, I am mindful that Respondent committed five repeated violations and the purpose of an NTSO is to promote compliance with the Act and regulations by penalizing retailers for non-compliance and deterring future violations.  I also consider Respondent’s corrective actions since its current June 7, 2024, violation.  Specifically, the business costs it incurred to implement numerous revisions to its policies, operations, and employee training.  R. Informal Br. at 4-6; see also infra, Other Matters as Justice May Require and Additional Mitigating Factors. 

Balancing the objectives of the Act and this statutory factor for imposing an NTSO, I conclude that, even though an NTSO is warranted and the duration of the NTSO should sting, it should not be so punitive that it puts a retailer out of business or threatens its viability.  See 21 U.S.C. § 387 note (explaining that one of the purposes of the Act is “to continue to permit the sale of tobacco products to adults in conjunction with measures to ensure that they are not sold or accessible to underage purchasers”).  Consequently, I conclude that the proposed duration of the NTSO should be fewer than 30 consecutive days.  21 U.S.C. § 333(f)(5)(B), (D); 21 C.F.R. § 17.33(a).

4. History of Prior Violations

The current action is the first NTSO action against Respondent.  

The first $500 CMP action, CRD Docket Number C-13-817, FDA Docket Number FDA-2013-H-0634, was brought against Respondent for at least three violations of 21 C.F.R.

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§§ 1140.14(a) and (b)(1) on June 13, 2012, and December 7, 2012.  See CTP Ex. 1.  Respondent settled the first complaint with CTP for an undisclosed penalty amount.  See CTP Ex. 2.

The second $2,000 CMP action, CRD Docket Number C-14-821, FDA Docket Number FDA-2014-H-0340, was brought against Respondent for an additional violation of 21 C.F.R. § 1140.14(a) committed on July 15, 2013.  See Complaint ¶ 11.  Respondent settled the fourth complaint with CTP for an undisclosed penalty amount.  Id.

The third $559 CMP action, CRD Docket Number T-19-444, FDA Docket Number FDA-2018-H-4241, was brought against Respondent for at least three violations of 21 C.F.R. §§ 1140.14(a)(1) and (a)(2)(i) on April 5, 2018, and August 22, 2018.  See Complaint ¶ 12.  Respondent settled the third complaint with CTP for an undisclosed penalty amount.  Id.

The fourth $687 CMP action, CRD Docket Number T-24-1836, FDA Docket Number FDA-2024-H-0923, was brought against Respondent for at least three violations of Section 906(d)(5) of the Act and 21 C.F.R. § 1140.14(a)(2)(i) committed on March 22, 2023, and December 13, 2023.  See CTP Ex. 3.  Respondent settled the fourth complaint with CTP for an undisclosed penalty amount.  See CTP Ex. 4.

This NTSO action was brought against Respondent for two additional violations on June 7, 2024 - one violation of Section 906(d)(5) of the Act and one violation of 21 C.F.R. § 1140.14(a)(2)(i).  I agree with CTP that “[b]ut for Respondent’s recidivism, the present NTSO case would not have been necessary.”  CTP Response to R. Final Br. at 2. Respondent’s continued inability to comply with the federal tobacco regulations calls for a proportionate NTSO.

However, I conclude that Respondent’s history of prior violations and successful compliance checks warrants a reduction in the proposed NTSO period.  According to Respondent, four of its five repeated violations were committed by a single employee on December 13, 2023, and June 7, 2024, and that employee was terminated as a result. R. Br. at 4.  Notwithstanding the five repeated violations between March 22, 2023, and June 7, 2024, “Respondent has had at least nineteen (19) successful compliance checks from the Howard County Tobacco Enforcement Division, dating back to February 2014.” Id. at 5 (citing R. Ex. 1).  I also find that between the third and fourth civil money penalty actions, Respondent had a period of nearly 5 years without any violations of the Act or Tobacco Regulations, from August 22, 2018, until March 22, 2023.  R. Br. at 3.  During this period, Respondent also had eight successful tobacco sales compliance checks conducted by the Howard County Tobacco Enforcement Division on March 23, 2019, September 7, 2019, October 4, 2019, February 27, 2020, December 22, 2020, May 4, 2021, December 15, 2021, and December 11, 2022.  R. Ex. 1 at 7-14. 

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Moreover, I find that during the relevant time period wherein Respondent committed five repeated violations of the Act and Tobacco Regulations, from March 22, 2023, through June 7, 2024, Respondent had three successful tobacco sales compliance checks by the Howard County Tobacco Enforcement Division (specifically, on April 29, 2023, January 16, 2024, and April 8, 2024).  Id. at 4-6.  After committing its fifth repeated violation on June 7, 2024, Respondent had four successful tobacco sales compliance checks conducted by the Howard County Tobacco Enforcement Division on November 5, 2024, March 21, 2025, June 14, 2025, and October 30, 2025.  Id. at 1-3; R. Ex. 9. 
CTP has not challenged Respondent’s evidence of successful compliance checks by the Howard County Tobacco Enforcement Division.  Therefore, I agree with Respondent that it has an overall history of substantial compliance with the Act and tobacco regulations that mitigates the proposed NTSO.

5. Degree of Culpability

Respondent admitted to five repeated violations of the Act and the tobacco regulations in previous civil money penalty settlement agreements and this NTSO action.  Therefore, I hold Respondent fully culpable for five repeated violations of the Act and its implementing regulations.

6. Other Matters as Justice May Require and Additional Mitigating Factors

The Act gives me discretion to consider any other evidence or arguments to mitigate the NTSO period.  21 U.S.C. § 333(f)(5)(B).  Additionally, “in determining whether to impose a no-tobacco-sale order . . . [I must] consider whether the retailer has taken effective steps to prevent violations of the minimum age requirements for the sale of tobacco products . . .”  21 U.S.C. § 333 note (Guidance § (1)(G)).  Such steps include:

(i) adopting and enforcing a written policy against sales to minors;

(ii) informing its employees of all applicable laws;

(iii) establishing disciplinary sanctions for employee noncompliance; and

(iv) requiring its employees to verify age by way of photographic identification or electronic scanning device.

21 U.S.C. § 333 note (Guidance § (1)(F)).  Finally, I “shall consider the amount of any penalties paid by the retailer to a State for the same violation.”  21 U.S.C. § 333 note (Guidance § (2)(C)). 
Despite CTP’s opposing arguments, I find that Respondent has presented credible, unrebutted mitigation evidence justifying a reduction in the NTSO period.  See CTP Response to R. Final Br. at 2 (stating that Respondent’s recent efforts to come into

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compliance by revising its policies, operations, and staff training do not warrant any reduction in the length of the NSTO sought) and R. Final Br. at 4 (stating “BEFT made numerous revisions to its policies, operations, and staff training, and those have clearly been successful.  .  .  BEFT’s actions have been proven, on 4 separate occasions, to have ensured compliance with tobacco sales laws.”).  Specifically, Respondent submitted unrebutted evidence of the following efforts:

• photographs of updated signage at the facility’s entrance and point of sale;
• updated tobacco sales policy with employee signatures acknowledging receipt;
• revisions to its point-of-sale system requiring scans of identification before tobacco sales;
• updated employee training materials, including employee test results; and
• termination of the employee responsible for violating tobacco sales and age verification laws.

R. Exs. 3-8; see also R. Ex. 2 at 1-2.  Notably, Respondent has presented evidence that since its latest violation on June 7, 2024, its facility has successfully complied with and passed tobacco sales compliance checks conducted by the Howard County Tobacco Enforcement Division.  See R. Exs. 1 at 1-3, 9.

CTP argues that “[a]lthough Respondent has submitted evidence concerning recent corrective actions, the evidence does not support a reduction of the NTSO period.” See CTP Response to R. Final Br. at 5.  I disagree, as it shows that Respondent is putting in a concerted effort to ensure it is complaint with the county (and state) policies, which reflect tangible efforts to prevent tobacco sales to underage purchasers, in accordance with the Act and federal tobacco regulations. 

Therefore, I also conclude that Respondent’s efforts have been effective to some degree.  Accordingly, I find that this factor weighs in favor of a reduced NTSO.  See Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance with an Order:  Guidance for Tobacco Retailers, at 3-4 (Aug. 2015), http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM460155.pdf (stating that the FDA may reduce the duration of an NTSO if the "retailer has taken effective steps to prevent selling tobacco products to minors").

In sum, I find persuasive Respondent’s arguments and evidence that an NTSO of 30 consecutive days is excessive in this case, based on the facts.  To ensure that justice is served, I have considered the statutory factors and evidence of record and conclude that an NTSO of 15 consecutive days is appropriate under 21 U.S.C. § 333(f)(5)(B) and (f)(5)(D).   

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VI. Conclusion

For the reasons detailed above, I impose a No-Tobacco-Sale Order against Respondent, Best Effort First Time, LLC d/b/a Columbia Auto Care and Wash / Exxon, for a period of 15 consecutive days.  During this period of time, Respondent shall stop selling cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and covered tobacco products regulated under the Federal Food, Drug, and Cosmetic Act.  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.