Y and Z Lunch and Liquor, Inc. d/b/a Lunch and Liquor, DAB TB9228 (2025)

INITIAL DECISION

The Center for Tobacco Products (CTP) seeks to impose a $6,397 civil money penalty against Respondent, Y and Z Lunch and Liquor, Inc. d/b/a Lunch and Liquor.  CTP alleges that Lunch and Liquor impermissibly sold regulated tobacco products to underage purchasers and failed to verify, by means of photo identification containing a date of birth, that the purchasers were 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, at least five times within a 36-month period.

For the reasons discussed below, I find that Respondent violated the Act, as alleged in the Complaint, and conclude that a civil money penalty (CMP) of $6,397 is appropriate.

I. Background

CTP began this matter by serving a Complaint on Respondent at 1424 Ecorse Road, Ypsilanti, Michigan 48198 by United Parcel Service, and by filing a copy of the

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Complaint with the FDA’s Division of Dockets Management.  Civil Remedies Division (CRD) Docket (Dkt.) Entry Nos. 1 (Complaint), 1b (Proof of Service).

On February 20, 2024, Respondent, through counsel, registered for the Departmental Appeals Board (DAB) E-Filing system and filed a timely Answer.  CRD Dkt. Entry No. 6 (Answer).  In its Answer, with regard to the allegations contained in paragraphs 1-10, 12, 15-18, Respondent asserts that it is without sufficient information to either admit or deny the allegations and leaves the Complainant to their proof thereof.  Id. at 1-5.  Respondent admits the allegations contained in paragraph 11.  Id. at 3.  Respondent denies the allegations contained in paragraphs 13-14, stating that the allegations contained therein are untrue in the manner and form alleged, and that they contain incorrect statements and conclusions of facts and/or law.  Id. at 4.  Further, Respondent requests that this matter be dismissed, that Respondent be awarded attorney’s fees for defending this matter or alternatively, that the civil money penalty be reduced to a reasonable amount.  Id. at 5-6.

On February 22, 2024, I issued an Acknowledgment and Pre-Hearing Order acknowledging receipt of Respondent’s Answer and establishing procedural deadlines for this case.  CRD Dkt. Entry No. 8 (APHO).

On March 22, 2024, CTP filed a Joint Status Report indicating that a previous CMP debt action (T-23-2414) had been discharged.  CRD Dkt. Entry No. 10 (JSR).  Additionally, the JSR indicated that the parties intended to engage in further settlement discussions.  Id.

On April 24, 2024, Respondent filed responses to CTP’s request for production of documents, which included photographs of Respondent’s in-store signage regarding tobacco sales, its point-of-sale system which requires the employee to verify a purchaser’s age and tobacco sales instruction literature from the Michigan Department of Health and Human Services, and a congratulatory compliance check letter.  CRD Dkt. Entry Nos. 11-12.

On April 25, 2024, CTP filed an Unopposed Motion to Extend Deadlines, requesting all deadlines set in the APHO be extended 30 days.  CRD Dkt. Entry No. 14.  On April 26, 2024, I issued an Order extending CTP’s pre-hearing exchange to Respondent to June 12, 2024, and Respondent’s pre-hearing exchange to CTP to July 3, 2024.  CRD Dkt. Entry No. 15.

On June 12, 2024, 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 fourteen proposed exhibits.  CRD Dkt. Entry Nos. 16-16o.  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.) 3; and 2. Timothy Shafto, FDA-commissioned inspector for the State of Michigan, CTP Ex. 4. CRD Dkt. Entry Nos. 16d-16e.

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On June 14, 2024, I issued an Order requiring CTP to resubmit its pre-hearing exchange with proper exhibit identifying marks no later than June 21, 2024, and extended Respondent’s pre-hearing exchange to CTP to July 12, 2024.  CRD Dkt. Entry No. 17. On June 17, 2024, CTP timely resubmitted their pre-hearing exchange, with proper identifying exhibit marks, consisting of the Informal Brief of Complainant, Complainant’s List of Proposed Witnesses and Exhibits, and fourteen proposed exhibits. CRD Dkt. Entry Nos. 18-18o.  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.) 3; and 2. Timothy Shafto, FDA-commissioned inspector for the State of Michigan, CTP Ex. 4.  CRD Dkt. Entry Nos. 18d-18e.

On July 12, 2024, Respondent timely filed its pre-hearing exchange consisting of Respondent’s Pre-Hearing Brief (Respondent Br.), Respondent’s Proposed Witness and Exhibit List and Respondent’s Exhibits.  CRD Dkt. Entry Nos. 19-21.

On September 18, 2024, I conducted the pre-hearing conference (PHC) in this case. During the PHC, I explained the issues before me, the parties’ respective burdens of proof, the purpose of conducting a hearing, the administrative record, the procedural history, and we discussed parties’ pre-hearing exchange submissions and proposed witnesses.  CRD Dkt. Entry No. 27 (Order Following PHC).  CTP raised no objections to the admission of Respondent’s proffered twelve exhibits.  Id. at 2.  I asked Respondent’s Counsel if he objected to the admission of CTP’s fourteen proposed exhibits into the record, and counsel stated that he did not object.  Id.  Counsel for Respondent also stated that he did not intend to cross-examine CTP’s proposed witnesses.  Id.  Accordingly, during the PHC, I explained to the parties that I would decide this case based on the written administrative record.  Id.; 21 C.F.R. § 17.45(a).

My September 27, 2024 Order Following PHC established an October 4, 2024 deadline for the parties to file written objections to proposed exhibits, and a November 19, 2024 deadline to file any rebuttal to any objections.  CRD Dkt. Entry No. 27 at 2.  Neither party filed any objections to other parties proposed exhibits.  Additionally, my Order established a December 27, 2024 deadline for the parties to file final briefs.  Id. at 3. Both parties declined to submit final briefs.  CRD Dkt. Entry Nos. 29-30.

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.  21 C.F.R. §§ 17.41(b), 45(a).

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II. Issues

1. Whether Respondent sold regulated tobacco products to an underage purchaser on November 3, 2023, and failed to verify, by photo identification, that the regulated tobacco product purchaser was 21 years of age or older, on that same date, in violation of section 906(d)(5) of the Act; and, if so,
2. Whether the $6,397 CMP is appropriate, considering any mitigating or aggravating factors that I find in this case.  21 C.F.R. § 17.45.

III. Admissions into the Administrative Record

1. CTP’s Exhibits are admitted into the administrative record.

On June 17, 20241 , CTP submitted fourteen proposed exhibits, CTP Exs. 1-14.  See CRD Dkt. Entry Nos. 18b-18o.  Respondent had until November 19, 2024, to file objections to CTP’s exhibits.  CRD Dkt. Entry No. 27 at 2.  Respondent did not file any objections; therefore, absent objection, I admit CTP Exs. 1-14 into the administrative record.

2. Respondent’s submissions are admitted into the administrative record.

On July 12, 2024, Respondent submitted twelve exhibits, Respondent Exs. 1-12.  See CRD Dkt. Entry No. 21.  CTP had until November 29, 2024 to file objections to Respondent’s exhibits.  CRD Dkt. Entry No. 27 at 2.  Respondent did not file any objections to CTP’s exhibits; therefore, absent objection, I admit CTP Exs. 1-14 into the administrative record.

IV. Findings of Fact and Conclusions of Law

In order to prevail, CTP must prove Respondent’s liability by a preponderance of the evidence.  The U.S. Supreme Court 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 not before finding in favor of the party that had the burden to persuade the judge of the fact’s existence.  In re Winship, 397 U.S. 358, 371-72 (1970); Concrete Pipe and Prods. of Cal., Inc. v. Constr. Laborers, 508 U.S. 602, 622 (1993).  CTP has the burden to prove Respondent’s liability and appropriateness of the penalty by a preponderance of the evidence.  21 C.F.R. § 17.33(b).  Respondent has the burden to prove any affirmative defenses and any mitigating factors likewise by a preponderance of the evidence.  21 C.F.R. § 17.33(c).

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CTP seeks to impose a CMP against Respondent pursuant to the authority conferred by the Act and its implementing regulations at Part 21 of the Code of Federal Regulations. Complaint ¶¶ 2-10.  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).  A tobacco product is misbranded if distributed or offered for sale in any state in violation of regulations issued under section 906(d) of the Act.  21 U.S.C. § 387c(a)(7)(B); 21 C.F.R. § 1140.1(b).  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. § 333(f)(9).

The sale of regulated tobacco products to an individual who is under the age of 21 and failure to verify, by means of photo identification containing the bearer’s date of birth, that a regulated tobacco product purchaser is 21 years of age or older are violations of the Act and its implementing regulations.  Act § 906(d)(5); 21 U.S.C. § 387f(d)(5).

A. Violations

1. Prior Violations

This is the second CMP action CTP has brought against Respondent.  CTP Ex. 1; CRD Dkt. Entry No. 1; see CRD Docket Number T-23-2414 (FDA Docket Number FDA‑2023-H-2230).  The prior Complaint alleged: (1) selling regulated tobacco products to purchasers younger than 21 years of age on September 23, 2022, and March 1, 2023, in violation of section 906(d)(5) of the Act; and (2) failing to verify photographic identification of the regulated tobacco product purchasers on those same dates, in violation of 21 C.F.R. § 1140.14(a)(2)(i).  CTP Ex. 1; Complaint ¶ 15.  The previous action concluded when Respondent admitted the allegations contained in the Complaint issued by CTP and paid the agreed upon CMP in settlement of that claim.  Complaint ¶ 16; CTP Ex. 2.

Respondent has not contested these prior violations, and they are administratively final. 21 C.F.R. § 17.15(b) (stating that a “settlement agreement shall be filed in the docket and shall constitute complete or partial resolution of the administrative case as so designated by the settlement agreement.”).  Accordingly, I conclude that Respondent has at least three prior violations2 of the Act and implementing regulations.

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2. Current Violations

In addition to the prior violations, CTP alleges that Respondent committed two additional violations on November 3, 2023.  Complaint ¶ 13.  To support its claims, CTP submitted the signed declarations of James Bowling, Deputy Division Director for the Division of Enforcement and Manufacturing in the Office of Compliance and Enforcement, CTP, FDA, and FDA-commissioned Inspector Timothy Shafto.  CTP Exs. 3-4.  CTP also submitted corroborating evidence, which includes reports, photographs, and other documentation.  CTP Exs. 5-14.  In its Answer, Respondent denies the allegation as untrue in the manner and form alleged because they contain incorrect statements and conclusions of facts and/or law.  See CRD Dkt. Entry No. 6 at 4.

James Bowling (Bowling) testified that, in his official capacity, he gained personal knowledge regarding how CTP enforces certain provisions of the Act and other laws enforced by the FDA, and gained personal knowledge regarding the processes used by the FDA regarding the establishment of registration and product listing requirements. CTP Ex. 3 ¶ 3.  Bowling testified that the Marlboro cigarettes sold on November 3, 2023, at Respondent’s establishment were manufactured by Philip Morris USA.  Id. ¶ 6. Bowling further testified that, according to information provided to the FDA by the manufacturer, the Marlboro cigarettes were manufactured, prepared, compounded, or processed for commercial distribution at Philip Morris USA’s facility in the commonwealth of Virginia, and that Philip Morris USA does not have any registered tobacco production facility in the state of Michigan.  Id. ¶¶ 7-8.

In its Answer, Respondent neither admits nor denies the allegations set forth in paragraph 12 of the Complaint, as it states it is without sufficient knowledge or information upon which to form a belief as to the truth of the allegation.  CRD Dkt. Entry No. 6 at 3-4. Accordingly, I find that Respondent’s establishment received the package of Marlboro cigarettes in interstate commerce, and held them for sale on November 3, 2023, after shipment in interstate commerce.

Inspector Shafto is an FDA-commissioned officer whose duties primarily include determining whether retailers are in compliance with the age and photo identification requirements relating to the sale of regulated tobacco products.  CTP Ex. 4 ¶¶ 2-3. Inspector Shafto’s inspections entail accompanying underage purchasers who attempt to purchase tobacco products from retail establishments, such as the one operated by Respondent.  Id. ¶¶ 2-6.

Inspector Shafto testified that, before the inspection, he confirmed that Underage Purchaser A (UP A) did not have any tobacco products in their possession and possessed an accurate photographic identification of their date of birth.  Id. ¶ 7; see also CTP Ex. 7. Inspector Shafto testified that during the inspection, he parked his car near Respondent’s establishment and that he and UP A exited the vehicle.  Id. ¶ 8.  Inspector Shafto testified

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that from his location he had a clear, unobstructed view of the sales counter and UP A. Id. Inspector Shafto testified that he observed UP A purchase the package of Marlboro cigarettes directly from an employee of Respondent’s establishment, that prior to the purchase UP A did not present any identification to the employees, and the employee did not provide a receipt to UP A after the purchase.  Id.

Inspector Shafto testified that he and UP A exited the establishment and immediately returned to the vehicle and after entering the vehicle, UP A immediately handed him the package of Marlboro cigarettes.  Id. ¶ 9.  Inspector Shafto testified that after driving to a nearby secure location, he processed the evidence in accordance with standard procedures at the time of the inspection, which entailed completing the Tobacco Inspection Management System (TIMS) Form and creating a Narrative Report.  Id. ¶¶ 9-10.  UP A’s redacted identification and Inspector Shafto’s contemporaneous photographs and reports were admitted into evidence and corroborate Inspector Shafto’s testimony.  CTP Exs. 5-9; see also CTP Ex. 10 (Notice of Compliance Check Inspection).

Respondent waived its right to cross-examine or otherwise impeach Inspector Shafto’s testimony concerning the inspection on November 3, 2023.  CRD Dkt. Entry No. 26 at 2. I find Inspector Shafto’s testimony persuasive.  It is supported by corroborating evidence documenting that the November 3, 2023 allegations for selling regulated tobacco products to an underage purchaser and failing to verify the age of the purchaser before the sale actually occurred.

3. Respondent’s Defenses

I find that Respondent has failed to prove any affirmative defenses or to rebut CTP’s evidence regarding the November 3, 2023 violations for selling a regulated tobacco product to an underage purchaser, and failing to verify the purchaser’s age with photographic identification.  In its Answer and pre-hearing brief, Respondent argues, as defenses, that

1. The allegations contained in the complaint as untrue in the manner and form alleged because they contain incorrect statements and conclusions of facts and/or law.  CRD Dkt. Entry No. 6 at 4.
2. CTP has not provided sufficient proof and evidence of Respondent’s alleged sale of tobacco products to an underaged purchaser and many establishments sell Marlboro cigarettes.  CRD Dkt. Entry No. 19 at 7-8.
3. Respondent has imposed rules and procedures to ensure its employees comply with laws and regulations, including training pertaining to the sale of tobacco. CRD Dkt. Entry No. 19 at 3.
4. Respondent’s establishment has signage at the cash register that indicates what a person’s birthdate must be to purchase tobacco products including a “WE I.D.” sign.  CRD Dkt. Entry No. 19 at 3, see also Respondent Exs. 1-2.

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5. Respondent has installed a point-of-sale system that displays an age verification message when tobacco products are purchased.  CRD. Dkt. Entry No. 19 at 3, 7.
6. Respondent provides employees with informational literature in order to keep up to date on laws and regulations governing the sale and purchase of tobacco products.  CRD Dkt. Entry No. 19 at 3-5, see also Respondent Exs. 3-8.
7. Respondent was praised by the Michigan Youth Tobacco Act Non Synar Compliance Check for refusing the sale of tobacco products on April 28, 2016. CRD Dkt. Entry No. 19 at 5, see also Respondent Ex. 9.

I have fully considered all of Respondent’s arguments and find them unpersuasive and lacking in legal support.  Respondent asserts that it has policies and procedures in place and that its employees are sufficiently trained and provided with literature regarding state and federal tobacco laws.  Respondent has submitted affidavits from two employees that attest to the training Respondent provides.  Respondent Exs. 11-12.  Respondent offering training and having rules and procedures is an inadequate defense and fails to prove employee compliance.  Respondent is “obliged to ensure that its policies are enforced and effective.”  TOH, Inc. d/b/a Ridgeville Service Center, DAB No. 2668, at 17-18 (2015). Respondent’s arguments regarding its point-of-sale system and signage fail for similar reasons.  Respondent offers no details regarding when the point-of-sale system was installed or updated nor when the signage was posted in its establishment.  There is insufficient information provided to determine whether these measures were taken before or after the most recent violations.  Thus, I afford this evidence minimal weight.

Additionally, Respondent offers evidence of prior compliance as a defense. Respondent’s alleged compliance during a single compliance check conducted in 2016 is too attenuated in time to have any bearing on Respondent’s compliance seven years later.  Therefore, I afford this evidence minimal weight.

Respondent also argues that CTP has produced insufficient evidence to prove that Respondent sold tobacco products to an underage purchaser.  Specifically, Respondent notes the absence of surveillance videos, photos, and a receipt for the purchase of the tobacco product.  Respondent Br. at 7-8.  Respondent points to no authority that supports that CTP is required to have surveillance videos or photos to meet its burden of proof.  See Atty’s Parti Expo, Inc., d/b/a Parti Expo, DAB No. 2925, at 10 (2019).  Furthermore, CTP is not required to provide a receipt or bill of sale.  Kuma H. Mamie d/b/a 7-Elven Store 22921A, DAB No. 2877 at 7 (2018).  In the instant case, CTP has met its burden of proof with the evidence proffered.  CTP has provided the testimony of Inspector Shafto, which details his personal observations.  CTP has also provided corroborating evidence including photographs and reports, taken contemporaneously.  I find Inspector Shafto’s testimony highly credible, and I give the supporting documentary evidence considerable weight.

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Finally, Respondent claims, because the underage purchaser did not provide testimony, that it has been deprived of its “constitutional right to confront witnesses.”  Respondent Br. at 9-10.  The underaged purchaser’s testimony is not necessary in this case, as CTP has provided the credible testimony of Inspector Shafto, who personally witnessed the sale.  Furthermore, Respondent’s confrontation clause arguments are not applicable to this administrative proceeding.  Three Star Market, Inc. v. U.S. FDA, CTP, No. 18-4257 at 5 (6th Cir. 2020), denied review of Three Star Market, Inc. d/b/a Three Star Market DAB No. 2906 (2018).

In summary, the evidence in the record establishes that the two violations alleged in the Complaint in fact occurred on November 3, 2023, in violation of section 906(d)(5) of the Act.  Additionally, Respondent failed to prove any affirmative defenses to liability. Further, Respondent previously admitted to committing violations of section 906(d)(5) of the Act and 21 C.F.R. § 1140.14(b)(2)(i) on September 23, 2022, and March 1, 2023.

CTP Exs. 1-2.  Accordingly, CTP is entitled to a CMP from Respondent.  21 U.S.C. § 333(f)(9).

B. Civil Money Penalty

I have found that Respondent committed five violations of the Act and its implementing regulations within a 36-month period.  Pursuant to 21 U.S.C. § 333(f)(9), Respondent is liable for a CMP not to exceed the amounts listed in FDA’s civil money penalty regulations at 21 C.F.R. § 17.2.  See also 45 C.F.R. § 102.3.

When determining an appropriate penalty, I am required to evaluate 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), (b).  Under the applicable statute, I must “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).  Also, “for purposes of 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 (Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), Pub. L. 111-31, div. A, title I, § 103(q)(2)(C)).

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).

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In the Complaint, CTP seeks to impose the maximum penalty amount of $6,397 against Respondent.  Complaint ¶ 1.  In its Answer, Respondent asserts that the matter should be dismissed and that Respondent be awarded attorney’s fees or the civil money penalty be reduced to a reasonable amount.  CRD Dkt. Entry No. 6.

For the reasons explained below, I find that a CMP of $6,397 is appropriate.

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

Respondent committed five violations of selling regulated tobacco products to underage purchasers and failing to verify, by means of photo identification containing a date of birth, that the purchasers were of sufficient age.  The most recent violations, on November 3, 2023, are particularly serious because Respondent, for the third time in a 36-month period, sold regulated tobacco products to an underage purchaser, failed to verify the age of the purchaser, and committed these violations despite warnings from FDA that additional violations would result in more serious consequences.  CTP Br. at 13; see also CTP Ex. 12.

Respondent’s repeated inability to comply with federal tobacco regulations is serious in nature and the CMP amount should be set accordingly.

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

Respondent argues that the $6,397 CMP sought by CTP is “unreasonable and beyond comprehension” and “not appropriate in light of the evidence provided by CTP.”  Respondent Br. at 10.  Additionally, Respondent contends that the CMP is not appropriate due to the exhibits and affidavits provided by Respondent.  Id.  However, there is no evidence in the record to show Respondent’s inability to pay the $6,397 CMP. Nor is there any evidence in the record to show that the $6,397 CMP will affect Respondent’s ability to continue to do business. I acknowledge Respondent’s argument that it is a family-owned business and that the COVID 19 pandemic adversely affected its operations.  Respondent Br. at 10.  However, there is no evidence in the record that supports these bald assertions.

3. History of Prior Violations

As noted above, Respondent previously admitted to at least three violations of the prohibitions against selling regulated tobacco products to underage purchasers and failing to verify, by means of photo identification containing a date of birth, that the purchasers were of under 21 years of age.  CTP Exs. 1-2.  Despite previous CMP actions, Respondent committed two additional violations, resulting in five violations within a 36-month period.  Act § 906(d)(5); 21 C.F.R. § 1140.14(a)(2)(i).  Respondent’s history of prior violations warrants a progressively larger CMP.  Respondent’s “repeated violations

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show an unwillingness or inability to sell tobacco products in accordance with federal tobacco laws.”  CTP Br. at 13.  Respondent’s continued inability to comply with FDA tobacco regulations supports the imposition of a CMP.

4. Degree of Culpability

As previously discussed, Respondent failed to prove any affirmative defenses. Respondent previously admitted to violations of the Act and its implementing regulations in the settlement agreements of the prior actions.  See CTP Ex. 2.  In addition, based on the evidence presented, Respondent committed the two most recent violations in the current Complaint.  Therefore, I find Respondent fully culpable for five violations of the Act and its implementing regulations, as alleged in the Complaint.

5. Employer Training Program

The Respondent submitted a proposed witness list of employees who indicated that they would testify that they either provided or received adequate training involving tobacco sales and tobacco-sale related informational literature purportedly used to train employees.  CRD Dkt. Entry Nos. 20-21.  However, no evidence was submitted documenting when this training occurred or whether the training the employees allegedly received complies with standards developed by the Food and Drug Administration.  21 U.S.C. § 333 (quoting Tobacco Control Act § 103(q)(2)(A)-(B)); see also 45 C.F.R. § 102.3.

6. State Penalties

Respondent has not alleged or presented evidence that it has paid any penalty to the State of Michigan for the same violations.  21 C.F.R. § 17.34(b).

7. Other Matters 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).

After reviewing the administrative record, I do not find any evidence to support any additional mitigating circumstances.  Respondent failed to prove that the requested CMP is too high and should be reduced or not assessed.  Respondent did not present any persuasive evidence to support that it is not fully culpable or cannot afford the proposed CMP.

Based on the foregoing, I find a CMP in the amount of $6,397 to be appropriate under 21 U.S.C. §§ 333(f)(5)(B) and 333(f)(9).

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Conclusion

Pursuant to 21 C.F.R. § 17.45, I impose a CMP of $6,397 against Respondent, Y and Z Lunch and Liquor, Inc. d/b/a Lunch and Liquor, for five violations within a 36-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.