4 Corner Supermarket LLC d/b/a 4 Corner Super Market, DAB TB9110 (2025)

 INITIAL DECISION

The Center for Tobacco Products (CTP), of the United States Food and Drug Administration (FDA), seeks a civil money penalty (CMP) against Respondent, 4 Corner Supermarket LLC d/b/a 4 Corner Super Market, for violating the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq., and its implementing regulations, 21 C.F.R. pt. 1140, at least seven times within a 48-month period.  Therefore, CTP seeks a $13,785 CMP against Respondent.

For the reasons discussed below, I find that Respondent violated 21 C.F.R. pt. 1140 of the Act, as alleged in the Complaint, and I conclude that a $13,785 CMP against Respondent is appropriate.

I. Background and Procedural History

CTP began this matter by serving an Administrative Complaint (complaint) on Respondent at 271 Hamilton Avenue, Trenton, New Jersey 08609 by United Parcel 

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Service (UPS), and by filing a copy of the complaint with the FDA’s Division of Dockets Management.  Civil Remedies Division (CRD) Docket (Dkt.) Entry Nos. 1-1b.

On May 16, 2024, Respondent filed a timely answer via the Departmental Appeals Board’s (DAB) Electronic Filing System (E-File).  CRD Dkt. Entry No. 3.  In its answer, Respondent admitted to all the allegations alleged in the complaint.  Id.  In addition, Respondent asserted various mitigating measures enforced to prevent future violations including, training for staff on how to serve tobacco products to customers who appear to be under 30 years old, the placement of signage highlighting the requirement of a valid license to purchase tobacco products, and placing signs in high traffic areas.  Id. at 2.

On May 29, 2024, the previous Administrative Law Judge (ALJ) assigned to this case issued an Acknowledgment and Prehearing Order (APHO) acknowledging receipt of Respondent’s Answer and establishing procedural deadlines in this case.  CRD Dkt. Entry Nos. 4-4b.

On June 24, 2024, attorney Jennifer Argabright filed a Notice of Appearance on behalf of CTP.  CRD Dkt. Entry No. 5.  Four days later, on June 28, 2024, CTP filed a Joint Status Report indicating that the parties were unable to reach a settlement in this case. CRD Dkt. Entry No. 6.

On August 13, 2024, CTP timely filed its prehearing exchange.  CRD Dkt. Entry Nos. 7‑7p.  The prehearing exchange consisted of an Informal Brief of Complainant (CTP PH Br.), Complainant’s List of Proposed Witnesses, and fifteen proposed exhibits (CTP Exs. 1-15).  Id.  The Complainant’s Proposed Witnesses were identified as James Bowling, Deputy Division Director, Office of Compliance and Enforcement, and Gloria Achiamaah, FDA-commissioned officer with the state of New Jersey.  CRD Dkt. Entry No. 7a.

On September 2, 2024, Respondent timely filed its pre-hearing brief of Respondent (R. PH Br.) and two proposed exhibits.  CRD Dkt. Entry Nos. 8, 10-11.  In addition, Respondent filed a direct statement from Mia Lopez and a list of employees.  CRD Dkt. Entry Nos. 9-10.  The direct statement identified Ms. Lopez as the employee working on the day of the inspection.  CRD Dkt. Entry No. 9.

On September 24, 2024, I held a Pre-Hearing Conference (PHC) via Microsoft Teams‑Video.  CRD Dkt. Entry No. 14.  Ms. Lopez appeared on behalf of Respondent.  I noted that the direct witness statement of Ms. Lopez was not a declaration signed by the witness under penalty of perjury, as required by the APHO.  CRD Dkt. Entry No. 4 at ¶¶ 8-9; CRD Dkt. Entry No. 9.  In addition, neither Ms. Lopez’s direct statement nor the list of employees were labeled as exhibits, as required by the APHO.  CRD Dkt. Entry No. 4. at ¶¶ 8-9.  I explained to Respondent that for both the direct statement and the proposed exhibits to be properly admitted into the record, Respondent would need to re-

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submit the prior documents filings to comply with the requirements established in the APHO.  CRD Dkt. Entry No. 4.  Respondent agreed to submit a motion to amend its pre-hearing exchange to conform with requirement described in the APHO.  CRD Dkt. Entry No. 15 at 2.  Respondent also indicated it intended to file a motion to submit a tax return to supplement its pre-hearing exchange.  Id.

On September 27, 2024, I issued an Order in which I summarized the prehearing conference and advised Respondent that it must file motions to supplement its pre‑hearing exchange no later than October 18, 2024.  Id.  No such motions or submissions were filed by Respondent by the deadline.

During the PHC, neither party objected to the admission of the other parties’ proposed exhibits.  With there being no objection, I admit CTP Exhibits 1 through 15 and Respondent’s Exhibits 1-2 (R. Exs. 1-2) into the record.  CRD Dkt. Entry Nos. 1-15; CRD. Dkt. Entry Nos. 10-11.  Respondent did not request to cross examine the proposed witnesses of CTP.  CRD Dkt. Entry No. 15.  Since both parties waived their rights to a hearing, I find the hearing to be unnecessary.  Accordingly, I will proceed to decide this case based on the evidence of record.  See APHO ¶ 15.

II. Violations, Parties’ Contentions, and Findings of Fact

1. A. Violations

CTP sought a CMP against Respondent pursuant to the authority conferred by the Act and implementing regulations at Part 21 of the Code of Federal Regulations.  FDA and its agency, CTP, may seek civil money penalties from any person who violates the Act’s requirements as they relate to the sale of tobacco products.  21 U.S.C. § 331(f)(9).

The sale of regulated tobacco products to a person under 21 years of age is a violation of implementing regulations.  21 C.F.R. § 1140.14(a)(1) and 1140.14(b)(1).  The failure to verify, by means of photo identification containing the bearer’s date of birth, that no regulated tobacco product purchaser is under 21 years of age is also a violation of implementing regulations.  21 C.F.R. § 1140.14(a)(2)(i) and 1140.14(b)(2)(i).

1. B. Prior Violations

This is the third CMP action brought by CTP against Respondent.  Complaint ¶ 15; see CRD Docket Number T-23-1228 (FDA Docket Number FDA-2023-H-0716) and CRD Docket Number T-23-3135 (FDA Docket Number FDA-2023-H-3180).  The most recent prior complaint alleged that Respondent: (1) sold regulated tobacco products to a person under 21 years of age on January 22, 2022, November 28, 2022, and May 8, 2023, in violation of 21 C.F.R. § 1140.14(a)(1) and 1140.14(b)(1); and (2) failed to verify photographic identification of the regulated tobacco product purchaser on January 22, 

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2022, November 28, 2022, and May 8, 2023.  Complaint ¶ 15.  The previous action resulted in settlement and concluded after Respondent admitted to five violations of the regulations and paid the agreed upon penalty.  Complaint ¶ 16.

In settling the prior complaint, Respondent expressly waived its right to contest these violations in subsequent actions.  Complaint ¶ 16.  These actions are now administratively final.

1. C. Current Violations

I now turn to whether the remaining allegations in the complaint are true and, if so, whether Respondent’s action constitutes a violation of law.  21 C.F.R. § 17.45(b).

Accordingly, I must determine whether, on February 17, 2024, at approximately 1:59 PM:

• A person under 21 years of age was able to purchase a package of Newport Box 100s cigarettes at Respondent’s business establishment, 271 Hamilton Avenue, Trenton, New Jersey 08609, in violation of 21 C.F.R. § 1140.14(b)(1); and
• Respondent failed to verify the age of a person purchasing cigarettes or smokeless tobacco by means of photographic identification containing the bearer’s date of birth, as required by 21 C.F.R. § 1140.14(a)(2)(i); and, if so
• Whether the CMP sought by CTP is appropriate, considering any aggravating and mitigating factors.
   

1. D. Analysis

As indicated above, CTP alleges that, on February 17, 2024, Respondent sold a tobacco product to a person under 21 years of age and failed to verify the age of that person by means of a photographic identification containing the bearer’s date of birth.  Respondent has provided inconsistent responses to these allegations.  In its answer, Respondent admitted to the allegations and attributed the alleged violations to a newly hired teenaged employee.  CRD Dkt. Entry No. 3 at 1.  However, in its pre-hearing brief, Respondent denied the allegations and indicated that the employee working that day had no recollection of providing a minor with tobacco products without asking for proper identification and would provide written testimony of the events that took place on February 17, 2024.  CRD Dkt. Entry No. 8 at 4.  At the pre-hearing conference, Respondent’s representative indicated she did not contest the sale, but this statement was somewhat inconsistent with her direct statement and the pre-hearing brief.  CRD Dkt. Entry Nos. 8-9.  In the direct statement, Respondent’s representative asserted she did not 

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recall the sale1.  CRD Dkt. Entry No. 9 at 1.  To accord Respondent full due process, I am considering its response to be a denial of the allegations, requiring a full analysis of the evidence in this case.

As support for the allegations in the complaint, CTP has submitted the declaration of Inspector Achiamaah, who conducted the inspection of Respondent’s business on February 17, 2024.  CTP Ex. 6; CRD Dkt. Entry No. 7g.  In her declaration, Inspector Achiamaah stated she accompanied an underage purchaser into the establishment and had a clear view of an employee selling a tobacco product, specifically a package of Newport Box 100s cigarettes, directly to the underage purchaser.  CTP Ex. 6 at 3, ¶ 8; Id.at 3, February 2024 Narrative Report, CTP Ex. 7 at 1, ¶¶ 10, 13; CRD Dkt. Entry No. 7h; February 2024 TIMS Assignment Form, CTP Ex. 8 at 1, ¶¶ 10, 13; CRD Dkt. Entry No. 7i at 1, ¶¶ 10, 13.  CTP also submitted a copy of a birth certificate, establishing that the underage purchaser was 19 years old at the time of the inspection.  CRD Dkt. Entry No. 9.

Inspector Achiamaah also stated she observed that the underage purchaser did not provide identification to the employee before the purchase.  CRD Dkt. Entry No. 7g at 3. Inspector Achiamaah confirmed that the underage purchaser did not possess their government-issued photographic identification reflecting their actual age, and, in fact, did not have any photographic identification.  See Achiamaah Decl., CTP Ex. 6 at 2, ¶ 7; CRD Dkt. Entry No. 7g at 2, ¶ 7; February 2024 Narrative Report, CTP Ex. 7 at 1, ¶¶ 6 7; CRD Dkt. Entry No. 7h at 1, ¶¶ 6-7; February 2024 TIMS Assignment Form, CTP Ex. 8 at 1, ¶¶ 6-7; CRD Dkt. Entry No. 7i at 1, ¶¶ 10, 13.  After the inspection, Inspector Achiamaah stated she and the underaged person immediately returned to the vehicle, at which time the underaged person handed her a package of Newport Box 100s cigarettes, which she processed as evidence, in accordance with standard procedures at the time of the inspection.  CTP Ex. 6 at 3, ¶ 9; CRD Dkt. Entry No. 7g at 3, ¶ 9.

Respondent offered no evidence, filed as a proposed exhibit, to rebut Inspector Achiamaah’s statements regarding the sale of the package of Newport Box 100s cigarettes to the underage purchaser.  It elected not to cross examine the inspector at a hearing and offered no witnesses of its own to counter the inspector’s sworn statement. Moreover, Respondent offered inconsistent statements as to whether or not the sale in question occurred and whether identification was verified, as noted above.  At the pre‑hearing conference, Respondent was given an opportunity to re-file the statement of Ms. Lopez to be in accordance with the APHO.  Respondent was also provided with an explanation of how to properly file the statement of Ms. Lopez.  CRD Dkt. Entry No. 15; 

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CRD Dkt. Entry No. 4.  However, nothing was filed by Respondent within the specified deadline, October 18, 2024.

I find Inspector Achiamaah’s statements, supported by corroborating evidence, to be credible and entitled to great weight.  I find that CTP has provided sufficient evidence to support its allegations that Respondent sold a package of Newport Box 100s to an underage purchaser on February 17, 2024, in violation of 21 C.F.R. § 1140(b)(1), and failed to verify the age of a person purchasing cigarettes or smokeless tobacco by means of photographic identification containing the bearer’s date of birth, as required by 21 C.F.R. § 1140.14(a)(2)(i).  I further find that Respondent failed to provide evidence to rebut CTP’s allegations.  Accordingly, I find that CTP has met its burden to establish Respondent’s liability under the Act for seven violations within a 48-month period.

III. Civil Money Penalty

I have found that Respondent committed seven violations of the Act and its implementing regulations within a 48-month period.  The FDA, and its CTP, may seek civil money penalties from any person who violates the Act’s requirements as they relate to the sale of tobacco products.  21 U.S.C. § 333 (f)(9).  In its complaint, CTP sought the maximum penalty amount of $13,785 against Respondent.  Complaint ¶ 1.  Accordingly, I must now consider whether a $13,785 CMP is appropriate.

When determining the amount of a CMP, I am required to take into account “the nature, circumstances, extent, and gravity of the violation or 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); see also 21 C.F.R. § 17.34.

Nature, Circumstances, Extent and Gravity of the Violations

Respondent has failed to comply with the Act and its implementing regulations on seven occasions.  The repeated inability of Respondent to comply with federal tobacco regulations, even after two previous civil money penalty actions, is serious in nature and the civil money penalty amount should be set accordingly.  The repeated violations are not consistent with a serious attempt to comply with federal tobacco law and require a proportional CMP.

Respondent’s Ability to Pay and Effect on Ability to do Business

Respondent asserts that the $13,785 CMP sought by CTP is too high, explaining that it was a small business that had been heavily impacted by world inflation, sales were reduced yet delivery costs were increased, and it was facing a large rent increase. CRD Dkt. Entry Nos. 3 at 2, 8 at 9.  However, Respondent has provided no evidence to 

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support any of these contentions or any evidence of its current financial situation.  At the PHC, Respondent indicated it intended to file a motion to file a tax return to supplement to its pre-hearing exchange.  CRD Dkt. Entry No. 15 at 2.  However, no such motion was filed within the specified deadline.  Id.  As a result, I cannot find that Respondent has established an inability to pay the CMP.  Moreover, as CTP argued in its Informal Brief, the penalty will not affect Respondent’s ability to do business since it may continue to sell tobacco products and other products in its establishment, as long as it does so in a legal manner.  CRD Dkt. Entry No. 7 at 14.  Absent evidence in the record to the contrary, I conclude that the penalty will not have a substantial effect on Respondent’s ability to do business.

1. A.                History of Prior Violations

As noted, Respondent has violated the prohibition against selling regulated tobacco products to persons younger than 21 years of age, and failed to verify, by means of photo identification containing a purchaser’s date of birth, that no regulated tobacco product purchasers are younger than 21 years of age a total of seven times in the last 48 months. 21 C.F.R. § 1140.14(a)(l); 21 C.F.R § 1140.14(a)(2)(i); 21 C.F.R. § 1140.14(b)(l); 21 C.F.R § 1140.14(b)(2)(i).  Respondent’s continued unwillingness or inability to comply with the federal tobacco regulations calls for a more severe penalty.

1. B.                Degree of Culpability

Respondent previously acknowledged liability after being found liable for five violations of the tobacco regulations within a 36-month period.  Complaint ¶ 16; CTP Exs. 3 and 4; CRD Dkt. Entry Nos. 7d-7e.  On February 17, 2024, it again violated the prohibition against selling a tobacco product to any person younger than 21 years of age and again failed to verify the age of a person purchasing cigarettes or smokeless tobacco by means of photographic identification containing the bearer’s date of birth, despite two prior civil actions detailing violations on January 22, 2022, November 28, 2022, and May 8, 2023. Complaint ¶¶ 15 and 16, CTP Exs. 1-4; CRD Dkt. Entry Nos. 7b-7e.  As a result, the degree of culpability of the business is high, which demands a proportional CMP.

1. C. Other Such Matters as Justice May Require and Additional Mitigating Factors

Mitigation is an affirmative defense for which Respondent bears the burden of proof. Respondent must prove any affirmative defenses and any mitigating factors by a preponderance of the evidence.  21 C.F.R. § 17.33(c).  Respondent asserts that it has taken measures to prevent sales to underage individuals, including purchasing and posting new signage indicating the need to have IDs, both inside and outside the store, and training staff.  CRD Dkt. Nos. 3 at 2, 8 at 5.  It also submitted interior and exterior 

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photographs of that signage.  R. Exs. 1 and 2; CRD Dkt. Entry No. 11.  While commendable, this has not stopped the sale of tobacco products to underage individuals.

Therefore, after considering all statutory and regulatory factors, I find the assessed civil money penalty amount of $13,785 to be appropriate under 21 U.S.C. § 333(f)(5)(B), (f)(5)(C), and (f)(9).

IV. Conclusion

Pursuant to 21 C.F.R. § 17.45, I impose a civil money penalty of $13,785 against Respondent, 4 Corner Supermarket LLC d/b/a 4 Corner Super Market, for selling tobacco products to an underage purchaser and failing to verify the purchaser’s age, therefore violating 21 U.S.C. § 301 et seq., and its implementing regulations, 21 C.F.R. pt. 1140. Pursuant to 21 C.F.R. § 17.45(d), this decision becomes final and binding upon both parties after 30 days of the date of its issuance.