Skip to main content
U.S. flag

An official website of the United States government

Here’s how you know

Dot gov

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

HTTPS

Secure .gov websites use HTTPS
A lock (LockA locked padlock) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Freedom 250 banner logo Join HHS in Celebrating Freedom 250
    • About HHS

      HHS is a U.S. executive department that touches the lives of nearly all Americans by protecting your rights, research, food safety, health care, aging, and much more.

    • Explore About HHS
    • About the Department
      • Leadership
      • HHS Divisions
      • Organizational Chart
      • Priorities
      • Budget in Brief
      • Contact Us
    • Press Room
      • Press Releases
      • Request for Comment
      • Request for Interview
      • Connect on Social Media
      • HHS Live
      • Podcasts
    • Careers
      • Working at HHS
      • Opportunities for Attorneys
      • Join the Health Workforce
      • I am HHS
      • New Employee Orientation
      • Transportation Services
    • Standards and Compliance
      • Gold Standard Science
      • Accessibility
      • Plain Writing
      • Digital Communications Standards
      • Records Management
    • Accountability and Transparency
      • Freedom of Information Act (FOIA)
      • Open Government
      • No Fear Act
      • Privacy at HHS
    • NUTRITION IN AMERICA

      HHS is advancing the Make America Healthy Again agenda by putting nutrition at the center of health. President Trump and Secretary Kennedy flipped the food pyramid to encourage Americans to Eat Real Food.

    • Explore Nutrition in America
    • Advancing Nutrition Education
    • Make Hospital Food Healthy Again
    • Eat Real Food
    • The Real Food Show
  • MAHA
    • Programs & Services

      HHS is responsible for public health, health care, and human/social services for the United States of America. This includes administering over 100 programs and services.

    • Explore Programs & Services
    • Health Care
      • Find a Health Center
      • Find an Indian Health Service Facility
      • Find Support for Mental Health, Drugs, or Alcohol
      • Find a Cancer Center
      • Dental Care Options
      • Telehealth
    • Health Insurance
      • Medicare – 65+ or With Disability
      • Medicaid - Low-Income, With Disability, or Pregnant
      • Children’s Health Insurance Programs (CHIP)
      • Find Health Insurance Coverage
      • Insurance Help for Mental Health and Substance Use
      • No Surprise Medicals Bills
    • Social Services
      • Programs for Children and Families
      • Programs for People with Disabilities
      • Programs for Older Adults
      • Resources for Caregivers
    • Public Health and Prevention
      • Emergency Preparedness and Response
      • Healthy Lifestyle
      • Mental Health and Substance Use
      • Food Safety and Nutrition
      • Drug and Product Safety
    • Health Research and Information
      • National Library of Medicine
      • Surgeon General Reports
      • Health Data
      • National Center for Health Statistics
      • Medline Plus
      • Clinical Research Studies
      • Volunteering to Participate in Research
    • Laws & Regulations

      HHS protects and helps you understand the laws and regulations, also known as "rules," that govern the nation. You also have the power to voice your opinion on these laws and regulations.

    • Explore Laws & Regulations
    • Regulatory Information
      • What is a Rule?
      • Find Rules by Division
      • Comment on Open Rules
      • Suggest Deregulatory Actions
      • Understand Key Federal Laws
    • Civil Rights
      • Your Civil Rights
      • Civil Rights Laws Enforced by HHS
      • Health Information Privacy
      • Substance Use Disorder Patient Confidentiality
      • Conscience and Religious Freedom
    • Laws and Regulations by Topic
      • HIPAA Privacy Rule
      • Health Insurance Protections
      • Health IT Legislation
      • Food and Drug Safety
      • Public Health Emergencies
    • Human Research Protections
      • The Belmont Report
      • Regulations, Policy, and Guidance
      • Human Subjects Regulations (45 CFR 46)
      • Register IRBs and Obtain FWAs
      • Trainings, Tutorials, and Workshops
      • International Research
    • Complaints and Appeals
      • File a Medicare Complaint
      • File a HIPAA Complaint
      • File a Civil Rights Complaint
      • Appeal an Insurance Company Decision
      • Report Fraud, Waste, and Abuse to OIG
      • Report a Problem to the FDA
      • Report a Tip on the Chemical and Surgical Mutilation of Children
    • Grants & Contracts

      HHS gives the most money in grants of any federal agency in the U.S. Find out about our grants and how your organization can apply for them. We also provide information on how you can work with us and our support of small businesses.

    • Explore Grants & Contracts
    • Grants
      • Get Ready for Grants Management
      • Grant Policies and Regulations
      • Research Grants and Funding from NIH
      • Search Grants.gov
      • Avoid Grant Scams
      • Contact HHS Grant Officials
    • Contracts
      • Get Ready to Do Business with HHS
      • Programs for Businesses
      • Contract Policies and Regulations
      • Search Opportunities on SAM.gov
      • Contact HHS Contracting Managers
    • Small Business
      • Contract Opportunities
      • Small Business Programs
      • Small Business Resources
      • Contact Small Business Staff
    • Radical Transparency

      HHS protects and helps you understand the laws and regulations, also known as "rules," that govern the nation. You also have the power to voice your opinion on these laws and regulations.

    • Explore Radical Transparency
    • CDC’s ACIP Conflicts of Interest
    • Ending Anti-Semitism on College Campuses
    • Ending Wasteful Spending
    • Keeping Food Ingredients Safe
    • Chemical Contaminants Transparency Tool
Breadcrumb
  1. Home
  2. About HHS
  3. Agencies
  4. DAB
  5. Decisions
  6. ALJ Decision…
  7. 2026 ALJ Decisions
  8. Broadway Mini Stop LLC d/b/a Broadway Mini Stop, DAB TB11116 (2026)
  • Departmental Appeals Board (DAB)
  • About DAB
    • Organizational Overview
    • Who are the Judges?
    • DAB Divisions
    • Contact DAB
  • Filing an Appeal Online
    • DAB E-File
    • Medicare Operations Division (MOD) E-File
  • Different Appeals at DAB
    • Appeals to DAB Administrative Law Judges (ALJs)
      • Forms
      • Procedures
    • Appeals to Board
      • Practice Manual
      • Guidelines
      • Regulations
      • National Coverage Determination Complaints
    • Appeals to the Medicare Appeals Council (Council)
      • Forms
      • Fully Integrated Duals Advantage (FIDA) Demonstration Project
  • Alternative Dispute Resolution Services
    • Mediation
    • ADR Training
    • Other ADR Services
  • DAB Decisions
    • Board Decisions
    • DAB Administrative Law Judge (ALJ) Decisions
    • Medicare Appeals Council (Council) Decisions
  • Stakeholder Feedback
  • Careers
    • Open Career Opportunities
    • Internships & Externships

Broadway Mini Stop LLC d/b/a Broadway Mini Stop, DAB TB11116 (2026)


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division

Center for Tobacco Products, 
Complainant

v.

Broadway Mini Stop LLC 
d/b/a Broadway Mini Stop, 
Respondent.

Docket No. T-25-2869
FDA Docket No. FDA-2025-H-3118
Decision No. TB11116
June 30, 2026

INITIAL DECISION

The Center for Tobacco Products (CTP) seeks to impose a $709 civil money penalty (CMP) against Respondent, Broadway Mini Stop LLC d/b/a Broadway Mini Stop.  Specifically, CTP alleges that Broadway Mini Stop unlawfully sold regulated tobacco products to underage purchasers and failed to verify, by means of photo identification containing a date of birth, that a purchaser was 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. Part 1140 (Tobacco Regulations), at least three times within a 24-month period.

After initially denying the allegations, Respondent concedes that it violated the Act and Tobacco Regulations but contends that the requested CMP should be reduced.  For the reasons discussed below, I conclude that a CMP of $709 is appropriate.

Page 2

I. Background and Procedural History

  1. Initial Pleadings and Pre-Hearing Orders

CTP began this case by serving an administrative complaint (Complaint) on Respondent at 917 West Broadway Street, Hollis, Oklahoma 73550, 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).  The Complaint alleges that Respondent unlawfully sold regulated tobacco products to underage purchasers and failed to verify a purchaser was 21 years of age or older, thereby violating the Act and Tobacco Regulations.  CTP seeks a CMP of $709 against the Respondent for three violations of the Act and Tobacco Regulations within a 24-month period.1  Complaint ¶ 1.

On September 8, 2025, Respondent registered for the DAB Electronic Filing System (DAB E-File) and timely filed its Answer.  CRD Dkt. Entry No. 3 (Tobacco Appeal).  In its Answer, Respondent denied the allegations of liability, provided defenses, and stated that the CMP was too high.  Id. at 1-2.  Respondent contends that it did not know if the violations were committed by one of its employees, and if so, Respondent “should have been notified immediately.”  Id. at 1.  Respondent further asserts that none of those employees are still employed by Respondent and stated that it had in place “company policies and procedures” that the employees were supposed to read and agreed to follow.  Id. at 1-2.

On September 19, 2025, I issued an Acknowledgment and Pre-Hearing Order (APHO) establishing procedural deadlines for this case.  CRD Dkt. Entry No. 4.

On October 3, 2025, Respondent filed an out-of-order2 pre-hearing exchange consisting of the Pre-Hearing Brief of Respondent and twelve documents.  CRD Dkt. Entry Nos. 5, 5a- 5l.  In its pre-hearing brief, Respondent concedes that it sold tobacco products to persons younger than 21 years of age on July 24, 2024, and March 18, 2025.  CRD Dkt. Entry No. 5 ¶ 4.  Respondent also concedes that it failed to verify the age of the purchasers on March 18, 2025.  Id. ¶ 5.  However, Respondent explained that its basis for conceding to the violations is because it “assume[s] the allegations are true [but] have no proof [as CTP] did not notify [Respondent] at the time of the violation.”  CRD Dkt. Entry

Page 3

No. 5 ¶ 4.  On October 14, 2025, Respondent submitted another out-of-order pre-hearing exchange consisting of documents that it had previously submitted to CTP in response to CTP’s discovery request.  (Document Requests to Respondent) CRD Dkt. Entry No. 7.

On October 20, 2025, CTP filed a Joint Status Report stating that the parties have been unable to reach a settlement in this case and intend to proceed to a hearing.  CRD Dkt. Entry No. 8.

On December 9, 2025, CTP timely filed its pre-hearing exchange consisting of the Informal Brief of Complainant (CTP Br.), Complainant’s List of Proposed Witnesses and Exhibits, and 21 proposed exhibits.  CRD Dkt. Entry Nos. 9, 9a-9v.  CTP’s exchange included the written direct testimony of two proposed witnesses: 1) James Bowling, Deputy Division Director, Office of Compliance and Enforcement, CTP Exhibit (Ex.) 4; and 2) Riley Lynn Williams, FDA-commissioned officer for the state of Oklahoma, CTP Ex. 5.

  1. Pre-Hearing Conference

On February 25, 2026, I held a pre-hearing conference (PHC) in this case.  I explained my role as an impartial Administrative Law Judge, the issues to be decided in this case, and the parties’ respective burdens of proof.  CRD Dkt. Entry No. 12 (Summary of February 25, 2026, Pre-Hearing Conference and Order Establishing Deadlines for Supplemental Briefs (PHC Order)); see 21 C.F.R. §§ 17.19, 17.33.  Specifically, I explained that CTP has the burden of proving Respondent’s liability and the appropriateness of the civil monetary penalty, whereas, the Respondent has the burden of proving any affirmative defenses and mitigating factors.  21 CFR § 17.33.  Id.  I asked the parties whether they understood the issues, and both parties responded affirmatively.

I inquired as to whether the parties reached any stipulations concerning the issues or evidence, and the parties advised that they had not agreed to any stipulations.  I informed the parties that the issues I must decide in the case are whether the Respondent is liable for a CMP for: (1) selling covered tobacco products to an underage purchaser on July 24, 2024, and March 18, 2025; (2) failing to verify the purchaser’s age with photo identification on March 18, 2025; and (3) that if I find Respondent is liable for penalties or assessments, the appropriate CMP amount, considering any mitigating or aggravating factors that I find in this case.

During the PHC, I also discussed the procedural history of the case, the record, and the parties’ prehearing submissions which include the parties’ proposed evidence and witnesses.  With respect to the parties’ evidentiary submissions, CTP submitted a pre-hearing brief; a proposed witness and exhibit list; and 21 proposed exhibits, including written testimony of two proposed witnesses, marked as CTP Exhibits (Exs.) 1 through 21.  See CRD Dkt. Entry Nos. 9, 9a-9v.

Page 4

I also advised that Respondent submitted a pre-hearing brief and 12 unmarked proposed exhibits, submitted as CRD Dkt. Entry Nos. 5a-5l on October 3, 2025, and an unmarked proposed exhibit, in response to CTP’s Document Requests to Respondent, submitted on October 14, 2025.  CRD Dkt. Entry No. 7.  To be consistent with the CRD naming convention for exhibits, I re-marked all of Respondent’s exhibits as Respondent Exhibits 1-13 (R. Exs. 1-13).  Respondent confirmed that it did not propose any witnesses or written testimony.

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 1-21, and I also entered Respondent’s proposed exhibits into the record as Respondent Exhibits 1-13.

I apprised Respondent of CTP’s proposed witnesses, James Bowling, a Deputy Division Director for the Division of Enforcement and Manufacturing in the Office of Compliance and Enforcement (CTP Ex. 4), and Riley Williams, an FDA-commissioned inspector for the state of Oklahoma (CTP Ex. 5).  I asked Respondent co-owner, Adam Bromlow, whether he intended to cross-examine CTP’s witnesses.  He indicated that he did not intend to cross-exam CTP’s witnesses.

I 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 that if a hearing is not needed, I will decide the case based on the arguments and evidence contained in the administrative record.

I then ruled that, given Respondent’s admission of liability and waiver of cross-examination, there was no need for a hearing to cross-examine either of CTP’s witnesses.  Both parties agreed to waive appearance at an oral hearing.  I set a schedule for the submission of the parties’ final briefs and informed the parties that I would issue a decision on the written record after the record was closed.  Id. at 3; see also 21 C.F.R. §§ 17.33, 17.34; 21 C.F.R. § 17.45(a); and 21 U.S.C. § 333(f)(5)(B) (listing the factors to be considered in determining the amount of a civil money penalty).

I issued an order on March 9, 2026, that set March 27, 2026, as the deadline for the parties to file simultaneous final briefs, and April 10, 2026, for the parties to file simultaneous responses to the opposing party’s final brief.  CRD Dkt. Entry No. 12 at 3.

On March 27, 2026, CTP timely filed its Final Brief (Complainant’s Final Brief Opposing Respondent’s Defense to the Age-Verification and Sale to Underage Purchaser Violations).  CRD Dkt. Entry No. 13 (CTP Final Brief).  Respondent did not file a final brief, notice waiving submission of a final brief, or a responsive brief to CTP’s Final Brief.

Page 5

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

As explained above, I previously ADMITTED CTP Exhibits 1 through 21 and Respondent’s Exhibits 1 through 13 into the administrative record at the PHC.

III. Issues

The issues I must decide are:  Whether the Respondent is liable for a CMP for (1) selling covered tobacco products to an underage purchaser on July 24, 2024, and March 18, 2025, in violation of 21 U.S.C. § 331(k) and 21 U.S.C. § 387f(d)(5); (2) failing to verify the purchaser’s age with photo identification on March 18, 2025 in violation of 21 U.S.C. § 331(k) and 21 C.F.R. § 1140.14(b)(2)(i); and (3) If so, the appropriate amount of any CMP, considering any aggravating or mitigating factors.  21 C.F.R. § 17.45.

As explained below, Respondent conceded liability.  Therefore, this decision focuses on the appropriateness of the civil money penalty.

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 the Tobacco Regulations issued 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(b)(2)(i).  All violations observed during an initial failed inspection are counted as a single violation, and each separate violation observed during subsequent failed inspections count as a discrete violation.  See Orton Motor, Inc., 884 F.3d at 1214 (upholding FDA’s methodology of counting tobacco violations).

CTP may 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).  Section 333 (note) of the Act and

Page 6

Section 17.2 of the procedural regulations governing FDA CMP hearings3 establish two parallel CMP schedules, with lower CMPs assessed against a retailer who has an “approved training program.”  21 U.S.C. § 333 note (Guidance); see also 21 C.F.R § 17.2 (Maximum penalty amounts.); 45 C.F.R. § 102.3 (Table 1:  Civil Monetary Penalty Authorities Administered by HHS).  Each schedule establishes progressively increasing maximum CMPs for subsequent tobacco violations that occur within prescribed timeframes.  Id.  The FDA has stated in CMP guidance documents that it will use the lower schedule for all retailers until it has developed regulations establishing standards for retailer training programs.4  Effective August 8, 2024, the lower schedule authorizes a maximum CMP of $709 for three violations of the Act and/or Tobacco Regulations within a 24-month period.5  See 89 Fed. Reg. 64,815, 64,817 (setting the annual civil money penalty inflation adjustment for violations of 21 U.S.C. § 333(f)(9)(A)).

CTP has the burden to prove, by a preponderance of the evidence, Respondent’s liability under the Act and the appropriateness of the proposed CMP assessed against Respondent.  21 C.F.R. § 17.33(b).  Respondent has the burden to prove any affirmative defense and 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 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)).

When determining the appropriate amount of a CMP, I am required to consider any “circumstances that mitigate or aggravate the violation” and “the factors identified in the statute under which the penalty is assessed . . . .”  21 C.F.R. §§ 17.34(a); 17.34(b).  Specifically, I must consider “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).  Also, “for purposes of

Page 7

mitigating a civil penalty . . . [I] shall consider the amount of any penalties paid by the retailer to a State for the same violation” and whether the retailer has an “approved training program.”  21 U.S.C. § 333 note.

V. Findings of Facts, and Conclusions of law

  1. Respondent admitted that it is liable for three violations of the Act and Tobacco Regulations within a 24-month period of time.

The Complaint alleges that Respondent’s establishment receives tobacco products in interstate commerce and holds them for sale after shipment in interstate commerce.  Complaint ¶ 12.  According to CTP, Respondent violated Section 906(d)(5) of the Act (21 U.S.C. § 387f(d)(5)) and/or FDA’s Tobacco Regulations (21 C.F.R. Part 1140) at least three times within a 24-month period.  Id. ¶ 1.  Specifically, CTP alleges that Respondent sold covered tobacco products6 to persons younger than 21 years of age on July 24, 2024, and March 18, 2025, in violation of 21 U.S.C. § 387f(d)(5).  Id. ¶¶ 13, 15.  CTP further alleges that Respondent failed to verify the underage purchaser’s age before the sale on March 18, 2025, in violation of 21 C.F.R. § 1140.14(b)(2)(i).  Id. ¶ 13.

Although Respondent initially denied the allegations of liability in its Answer, Respondent later conceded liability in its Pre-Hearing Brief.  Compare CRD Dkt. Entry No. 3 ¶ 1 (answering that Respondent denies the allegations of liability made in the Complaint and stating that Respondent “do[esn’t] know if one of [its] employees sold to a minor and if they did[, Respondent doesn’t] know which one”) with CRD Dkt. Entry No. 5 ¶¶ 4-5 (answering “Yes” to whether the specific allegations in the Complaint are true and stating “We assume the allegations are true.  We have no proof . . .” and “Again we assume they are telling the truth but we have no proof.”).  Given Respondent’s admissions, I find that Respondent is liable for violating section 906(d)(5) of the Act and section 1140.14(b)(2)(i) of the Tobacco Regulations, as alleged in the Complaint.

Notwithstanding Respondent’s acknowledgment of unlawfully selling covered tobacco products to underage purchasers on July 24, 2024, and March 18, 2025, and failing to verify the purchaser’s age with photo identification on March 18, 2025, I would have found Respondent liable based on the uncontroverted evidence and testimony of Deputy Division Director James Bowling and Inspector Riley Lynn Williams presented by CTP.  See CRD Dkt. Entry No. 1 ¶¶ 13-15; CTP Exs. 4-21.  CTP Ex. 5 ¶¶ 8, 13.  Deputy Division Director Bowling testified that the covered tobacco products at issue were

Page 8

manufactured, prepared, compounded, or processed for commercial distribution in Kentucky, the Dominican Republic, West Virginia, and/or Florida before they were sold by Respondent in Oklahoma on July 24, 2024, and March 18, 2025.  CTP Ex. 4 ¶¶ 6-11.  Inspector Williams testified that he observed Respondent’s employees sell the covered tobacco products at issue to underage purchasers on July 24, 2024, and March 18, 2025.  CTP Ex. 5 ¶¶ 8-9, 13-15.  Inspector Williams also observed that the underage purchaser did not present any identification to Respondent’s employee during the sale on March 18, 2025.  Id. ¶ 15.  Both witnesses referenced contemporaneous, corroborating documentation supporting their testimony.  See CTP Exs. 6-12, 15-16, 20-21.  CTP submitted additional documentation related to the inspections, including a Warning Letter and Compliance Check Inspection Notices.  CTP Ex. 1-3, 13-14, 17-19.  I find that CTP’s sworn testimony and corroborating documentation are credible, unrebutted, and persuasive that Respondent violated the Act and Tobacco Regulations as alleged in the Complaint.

Consequently, the preponderance of evidence in the record establishes that Respondent is liable for three violations of the Act and Tobacco Regulations within a 24-month period and is subject to a CMP.  See 21 U.S.C. §§ 333(f)(5), (f)(9); see also 21 C.F.R. §§ 17.1(j), 17.45(a).

  1. Respondent has not demonstrated by a preponderance of the evidence the existence of mitigating circumstances to support a reduced CMP.

In its Complaint and pre-hearing brief, CTP argues that imposing the maximum penalty amount of $709 against Respondent is appropriate.  CRD Dkt. Entry Nos. 1 (Complaint ¶ 1); 16 (Informal Brief of Complainant (CTP Br.)) at 15.  In its Answer and pre-hearing briefs, Respondent argues that the CMP should be reduced.  CRD Dkt. Entry Nos. 3 (Tobacco Appeal at 3); and 5 (Respondent’s Prehearing Brief (R. Br.)).  For the reasons explained below, I find that a CMP of $709 is appropriate.

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

Respondent committed at least three violations within a 24-month period.  On July 24, 2024, and March 18, 2025, Respondent sold regulated tobacco products to underage purchasers and on March 18, 2025, also failed to verify, by means of photo identification containing a date of birth, that a purchaser was of sufficient legal age to make such a purchase.  CTP seeks the maximum CMP of $709.  Complaint ¶ 1; CTP Br. at 15; see 21 U.S.C. § 387f(d)(5); see also 45 C.F.R. § 102.3 (Table 1 to § 102.3 – Civil Monetary Penalty Authorities Administered by HHS); see also 89 Fed. Reg. 64,815 (eff. Aug. 8, 2024) (final rule establishing the 2024 annual inflation adjustment amounts for Table 1).

Respondent has not shown that the nature, circumstances, extent or gravity of the violations warrants a reduction in the requested CMP.

Page 9

Respondent argues that it has “given the employees the tools they need to make sure they are checking ID’s” requiring compliance with tobacco sales laws, which includes posted signs “everywhere” as a reminder, as well as “a new point of sale system where they have to put in a birthdate.”  R. Br. ¶¶ 4, 6, 7.  In support, Respondent’s has submitted exhibits, including:

  • Photos of the signs posted throughout its business establishment regarding compliance with the tobacco laws (R. Exs. 1-8);
  • A video of Respondent’s Point-of-Sale (POS) system requiring ID checks for tobacco sales (R. Ex. 12);
  • Employee Rules & Expectations documenting Respondent’s policies and requirements for tobacco sales and compliance with all federal laws (R. Ex. 13 at 6);
  • Employee work schedules showing the employees who worked on the dates at issue (R. Ex. 13 at 4-5);
  • Communications with its employees, reminding them of the importance of compliance with the tobacco laws (R. Exs. 9-11); and
  • A chart titled Category Group Sales showing the total amount of sales, profit, margin, and percentage of tobacco sales for one of the dates at issue, March 18, 2025 (R. Ex. 13 at 7).

Respondent also argues that it is up to the employees to follow-through on enforcement of the policies and tobacco laws and insists that to ensure this happens, FDA should “immediately” notify Respondent of a violation so that they can fire the employee, if necessary.  CRD Dkt. Entry No. 3 at 1-3; R. Br. ¶ 4.  Respondent also contends that “we as owners have done everything we can to get them to ask for ID’s [sic],” suggests that CTP “fine[s] the employee immediately when it happens,” and asserts that “we [the owners] should not pay any fine.”  CRD Dkt. Entry No. 3 at 2; see also R. Br. ¶ 6 (“We have given the employees the tools they need to make sure they are checking ID’s [sic] . . the employee needs to be fined not the employer . . . at the time of violation.”).

I find that Respondent’s arguments are not sufficient to reduce the penalty in this case.  Respondent is responsible for its employees’ actions performed within the scope of their employment, even when they fail to follow Respondent’s policies and procedures.  TOH, Inc. d/b/a Ridgeville Service Center, DAB No. 2668, at 16-18 (2015).  As such, its employees’ failure to comply with the federal tobacco laws and regulations is Respondent’s legal responsibility, notwithstanding its efforts.  Tobacco products are highly dangerous and addictive products and, as such, are heavily regulated.  21 U.S.C. § 387 note.  Retailers that choose to sell tobacco products have the burden to ensure their employees understand the regulatory and legal requirements and sell such products in compliance with the law.  I also note that, despite Respondent’s efforts in reminding its

Page 10

employees of the importance of complying with the tobacco laws through posted signage, employee rules and communications, and use of the POS system, these tools did not prevent the violations from occurring.  After considering the underlying facts and circumstances in this case, I find that the requested CMP of $709 is appropriate.

  1. Respondent’s Ability to Pay and Effect on Ability to Do Business

Although Respondent argued that it is unable to pay the requested CMP, Respondent has not submitted sufficient evidence to support its burden of proof.  See R. Ex. 13 at 3 (“We are a small mom and pop store. We cannot afford to the pay [sic] fine.”).  Respondent indicated in its discovery response that it “will attach 2024 taxes.”  See R. Ex. 13 at 3.  However, no tax information was attached to the discovery response filed with the CRD.  The only financial information in the record is a chart titled “Category Group Sales” for March 18, 2025.  R. Ex. 13 at 7.  According to the chart, Respondent’s tobacco sales were the largest category of sales on that day, both in gross revenue and in the total number of items sold.  Id.; see also R. Ex. 10 (stating that Respondent’s tobacco sales account for 35% of its sales).  I also note that Respondent’s total revenue in all categories for March 18, 2025, is greater than the proposed CMP.  R. Ex. 13 at 7.  Thus, I find that the scant financial information that Respondent submitted does not support a reduction in the CMP.  Id.

Respondent has not argued that the CMP would affect Respondent’s ability to do business.  Respondent’s primary argument for seeking a lower CMP is that the employees who were observed committing the violations should have been directly fined, and the CMP should not be passed on to the business.  CRD Dkt. Entry No. 3 ¶ 2; R. Br. ¶¶ 4, 6-7; R. Ex. 13 at 3.  For reasons explained above, Respondent is responsible for paying any penalty related to its employees’ unlawful actions.  Thus, I find that Respondent has the ability to pay the $709 CMP.  Also, given the nominal amount of the requested CMP, I do not find that paying $709 would put Respondent’s business in financial jeopardy.

  1. History of Prior Violations

Respondent admitted to three violations occurring on July 24, 2024, and March 18, 2025.  CRD Dkt. Entry No. 5 ¶¶ 4-5; PHC Order at 1-2.  This is CTP’s first enforcement action against Respondent, and there is no indication in the record of any prior violations of the Act or Tobacco Regulations. 

The evidence of record establishes that Respondent had notice and was aware of the July 24, 2024, initial violation.  CTP submitted the August 24, 2024, Warning Letter informing Respondent about the July 24, 2024, violation, which Respondent has acknowledged receiving.  CTP Ex. 1 at 1.  CTP also submitted Respondent’s August 20, Warning Letter Response to the July 24, 2024, violation.  CTP Ex. 3 ¶¶ 1-2.  Respondent did not contest the Warning Letter or Warning Letter Response or submit any other

Page 11

evidence to refute knowledge of the July 24, 2024, violation.  Although I agree with CTP that the Warning Letter and Warning Letter Response demonstrate a prior violation, I disagree with CTP’s contention that Respondent’s subsequent repeated violation in this case was based on an unwillingness or inability to comply with the law.  Respondent asserts that the employee who sold tobacco products to an underage purchaser on July 24, 2024, has been retrained, and since the subsequent March 18, 2025, violation, Respondent has been more proactive to ensure the tobacco regulation policies are enforced.  CRD. Dkt. Entry No. 3; R. Ex. 7 at 3.

In support, Respondent has submitted exhibits to show it has implemented measures and practices concerning the sale of tobacco products, including a new point of sale system.  See, e.g., R. Exs. 1-4 (signage in front of (including notification of its “We Card” policy) and inside the store)); R. Exs. 5-8 (photos and images showing tobacco products behind the sales counter); R. Ex. 2 at 9-11 (reminders to employees to enforce the tobacco policies, including the FDA CMP charged to the owner for any violations); R. Ex. 12 (video surveillance demonstrating electronic verification using its new point of sale system).  As such, I find that the history of violations in this case is not as significant as CTP contends.  However, I note that the progressive schedule of maximum CMPs already accounts for Respondent’s minimal history of prior violations by setting the penalty at the relatively low amount of $709.

  1. Degree of Culpability

Although Respondent denied the violations in its Answer, in its Pre-Hearing Brief, Respondent acknowledged liability by answering “Yes” to both “Sale or sales of tobacco products to a person younger than 21 years of age,” and “Failure to verify identification of purchaser.”  R. Br. ¶¶ 4-5.  However, Respondent argues that, had it known about the July 24, 2024, initial violation “immediately,” rather than through the subsequent August 20, 2024, Warning Letter, it could have then “correct[ed] the problem.”  CRD. Dkt. Entry No. 3 ¶ 1; R. Br. ¶¶ 4, 6-7.

I do not find Respondent’s arguments that failure to be given “immediate” notice of the violations legally sufficient to reduce Respondent’s culpability because CTP has no legal obligation to do so.  Respondent’s argument is not persuasive or supported by the law.  As previously explained, Respondent has acknowledged that the violations occurred and does not challenge the evidence presented by Inspector Williams and Deputy Division Director James Bowling, in support of these respective July 24, 2024, and March 18, 2025, violations.  PHC Order at 1-2; CTP Ex. 1 at 1; CTP Ex. 2 at 1-2.  Also, as explained above, Respondent is liable and obligated to pay any CMP related to its

employees’ noncompliance with the Act and Tobacco Regulations.  Accordingly, I deem Respondent fully culpable for the three violations on July 24, 2024, and March 18, 2025.

  1. Employee Training Program

Page 12

The Tobacco Control Act establishes two schedules of CMPs, depending on whether retailers have implemented a training program that complies with FDA standards.  21 U.S.C. § 333 note (quoting Tobacco Control Act § 103(q)(2)(A)-(B)); see also 45 C.F.R. § 102.3.  Until FDA promulgates regulations establishing standards for approved retailer training programs, CTP has decided to seek CMPs using the lower schedule for all retailers.  Guidance for Industry, Tobacco Retailer Trainer Programs, at 18 (Rev. Aug. 2018), https://www.fda.gov/media/79013/download, (non-binding guidance document containing various recommendations for retailer training programs).

Respondent lists the proactive measures it had in place at the time of the July 24, 2024, initial violation, and subsequent actions it has taken, including retraining the employee who was on duty that day and implementing a new point-of-sale system.  R. Ex. 13 (Document Requests to Respondent).  Respondent further claims that since the March 18, 2025, subsequent violation, Respondent has put up more signs inside and outside its establishment, constantly reminds its employees to verify purchasers’ identification, and has specifically demonstrated how its new point-of-sale system works.  R. Exs. 5-11.  However, Respondent has not submitted any proof, such as training certificates, to show that its employees are enrolled or have participated in any training program.

Although I find that Respondent’s evidence credibly demonstrates that Respondent has an earnest desire to comply with the Act and Tobacco Regulations and, to that end, has implemented proactive measures, however, I also find that those measures were insufficient, given the three violations committed within a 24-month period.  I also note that CTP seeks a $709 CMP based on the lower penalty schedule, which already accounts for mitigating the CMP based on a retailer’s training program.  Accordingly, I find that this factor does not further mitigate the proposed CMP amount.

  1. State Penalties

Respondent has not presented any evidence that it has paid any penalty to the state of Oklahoma for the same violations.  21 C.F.R. § 17.34(b).  Accordingly, this factor is neither aggravating nor mitigating of the proposed penalty.

  1.    Other Such Matter as Justice May Require

The Act gives me discretion to consider any other evidence or arguments to mitigate the amount of the CMP.  21 U.S.C. § 333(f)(5)(B).  Respondent has not taken full accountability for the three violations, although it has expressed a sincere desire to comply with the Act and Tobacco Regulations, insisting that all the necessary measures are in place to avoid future violations.  CRD Dkt. Entry No. 3 ¶¶ 2-3; R. Br. ¶¶ 4, 6.  Respondent’s proclamations did not prevent the recurrence of violations, and failing to

Page 13

check identification and selling tobacco products to underage purchasers are serious violations.

In summary, Respondent has violated the regulations on two separate occasions, constituting three violations within a 24-month period, and has failed to prove mitigating circumstances.  Thus, I find no basis for reducing the CMP sought by CTP, which I find proportional and appropriate in this case.  Based on the foregoing reasoning, I find the penalty amount of $709 to be appropriate under 21 U.S.C. §§ 333(f)(5)(B) and 333(f)(9).

VI. Conclusion

Pursuant to 21 C.F.R. § 17.45, I enter a judgment in the amount of $709 against Respondent, Broadway Mini Stop LLC d/b/a Broadway Mini Stop for three violations of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., and its implementing regulations, 21 C.F.R. Part 1140, within a 24- month period.  Pursuant to 21 C.F.R. §§ 17.11(b), 17.45(d), this decision becomes final and binding upon both parties after 30 days of the date of its issuance.

/s/

Karen R. Robinson Administrative Law Judge

  • 1

      CTP did not include any prior violations that occurred outside of the relevant timeframe in this Complaint.  Complaint ¶1 n.1.

  • 2

      The September 19, 2025, APHO instructed, “[a]fter reviewing CTP’s exchange, Respondent must file its pre-hearing exchange and serve its pre-hearing exchange on CTP no later than December 30, 2025.  Do not submit your pre-hearing exchange before receiving and reviewing CTP’s pre-hearing exchange.”  CRD Dkt. Entry No. 4 ¶ 6.

  • 3

      21 C.F.R. Part 17 (Civil Money Penalty Hearings).

  • 4

      See, e.g., U.S. Food & Drug Admin., Tobacco Retailer Trainer Programs (Revised): Guidance for Industry (August 2018) at 18, https://www.fda.gov/media/79013/download [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-retailer-training-programs] (non-binding guidance document containing various recommendations for retailer training programs).
     

  • 5

      The CMP amounts were adjusted again, effective January 28, 2026, but CTP filed the current Complaint on August 19, 2025, before those adjustments took effect.  See Annual Civil Monetary Penalties Inflation Adjustment, 91 Fed. Reg. 3,665 (Jan. 28, 2026).

  • 6

      “Covered tobacco products” include cigars, electronic nicotine delivery systems, liquid nicotine, hookah/waterpipe tobacco, pipe tobacco, and dissolvable nicotine products.  The covered tobacco products at issue in this case are a Swisher Sweet Classic Diamonds cigar sold at Respondent’s establishment on July 24, 2024, and a ZYN Wintergreen oral nicotine product sold at Respondent’s establishment on March 18, 2025.

Back to top
Secretary Robert F. Kennedy Jr.

Follow @SecKennedy

HHS icon

Follow @HHSGov

HHS Email updates

Receive email updates from HHS.

Subscribe

HHS Logo

HHS Headquarters

200 Independence Avenue, S.W.
Washington, D.C. 20201
Toll Free Call Center: 1-877-696-6775​

  • Contact HHS
  • Careers
  • HHS FAQs
  • Nondiscrimination Notice
  • Press Room
  • HHS Archive
  • Accessibility Statement
  • Privacy Policy
  • Budget/Performance
  • Inspector General
  • Web Site Disclaimers
  • EEO/No Fear Act
  • FOIA
  • The White House
  • USA.gov
  • Vulnerability Disclosure Policy