Lemay Food & Drink, Inc. d/b/a 7-Eleven 19981C, DAB TB9542 (2025)

DECISION

The Center for Tobacco Products (CTP) seeks to impose a civil money penalty (CMP) of $687 against Respondent, Lemay Food & Drink, Inc. d/b/a 7-Eleven 19981C, located at 260 Hoffmeister Avenue, Saint Louis, Missouri 63125, for at least three violations of 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, within a 24-month period.1  Specifically, CTP alleges that Respondent 7-Eleven 19981C violated the Act by impermissibly selling regulated tobacco products to underage purchasers and failing to verify, by means of photo identification containing a date of birth, that a purchaser was 21 years of age or older.

I. Background and Procedural History

As provided in 21 C.F.R. §§ 17.5 and 17.7, on October 18, 2024, CTP served an administrative complaint (Complaint) on Respondent 7-Eleven 19981C by United Parcel Service.  Civil Remedies Division (CRD) Docket (Dkt.) Entry Numbers

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(Nos.) 1, 1b.  On November 15, 2024, Respondent timely filed its Answer. CRD Dkt. Entry No. 4 (Answer).  In its Answer, Respondent admitted the violations alleged on July 9, 2024.  Respondent neither admitted nor denied the violation alleged on April 26, 2024.  Instead, Respondent asserted that it did not "recall this incident and I would like additional evidence .  .  .  ." Id.  However, Respondent admitted receiving the warning letter, which was issued on May 9, 2024.  Id.  On November 25, 2024, I issued a Pre-Hearing Order (PHO), which established procedural directives and deadlines in this case.  CRD Dkt. Entry No. 5.

On February 24, 2025, CTP submitted a pre-hearing exchange, consisting of its informal brief, and 19 proposed exhibits, including the written direct testimony of two witnesses, Deputy Division Director James Bowling and FDA-commissioned inspector Armin Krajina.  CRD Dkt. Entry Nos. 12, 12a-12t.  Respondent did not submit an informal brief or any evidence, including the written direct testimony of any witness, by the February 24, 2025 deadline established in my PHO.  On March 21, 2025, I issued an Order scheduling a hearing in the case for May 2, 2025, at 1:00 PM Eastern Time, and setting a deadline of April 4, 2025 for submission of any objections to exhibits and for Respondent to indicate which of CTP's witnesses it intended to cross-examine at the hearing.  CRD Dkt. Entry No. 17.

On April 4, 2025, CTP filed a Motion to Extend Deadlines advising of a significant reduction in force (RIF) in CTP's Office of Compliance and Enforcement on April 1, 2025, among other FDA divisions, and seeking a 30-day extension to evaluate "the impact the RIF may have on CTP's immediate operations .  .  .  ." CRD Dkt. Entry No. 18.  On April 8, 2025, I issued an Order granting CTP's Motion to Extend Deadlines through May 8, 2025, thereby extending the deadline for Respondent's motion to exclude exhibits and notice indicating which CTP witness(es) would be cross-examined at a hearing.  My Order also cancelled the hearing scheduled for May 2, 2025, noting it would be rescheduled at a later date.  CRD Dkt. Entry No. 19.

On April 9, 2025, Respondent filed a Motion to Dismiss (MTD) seeking dismissal of the instant Complaint alleging CTP's failure to prosecute and unreasonable delays in moving the case forward.  CRD Dkt. Entry No. 20.  On April 10, 2025, I issued an Order staying all outstanding deadlines pending resolution of the Motion to Dismiss, and giving CTP until May 8, 2025 to respond to Respondent's Motion to Dismiss.  CRD Dkt. Entry No. 21 at 2.

On May 7, 2025, CTP filed a Motion for Summary Decision on the grounds that: 1) Respondent has admitted the July 9, 2024 violations; 2) Respondent has not offered any evidence to refute that the April 26, 2024 inspection, and the violation observed during the inspection, occurred; and 3) Respondent disputed the violation count and thus the amount of the civil money penalty sought by CTP.  CTP opines that these factors obviate the need for further proceedings and this matter is ripe for summary decision disposition.  CRD Dkt.

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Entry No. 22 at 4-10.  CTP requested that I enter summary decision and impose a $687 civil money penalty against Respondent.  Id. at 2.

Also on May 7, 2025, CTP filed a response opposing Respondent's Motion to Dismiss. As of the date of this Order, Respondent has not filed a response to CTP's Motion for Summary Decision.

The Motion to Dismiss and the Motion for Summary Decision are now ripe for decision.

II. Respondent's Motion to Dismiss is Denied.

As briefly discussed above, on April 9, 2025, Respondent filed a Motion to Dismiss. CRD Dkt. Entry No. 20.  In its Motion to Dismiss, Respondent argues:

.  .  .  Complainant's delay – including the recent request for additional time [the April 4, 2025 Motion to Extend Deadlines] – reflects a failure to prosecute and violates the principle of administrative efficiency.

The Civil Remedies Division has inherent authority, similar to that recognized under [Federal Rules of Civil Procedure] Fed. R. Civ. P. 41(b), to dismiss actions where a party fails to move its case forward in a reasonable timeframe.

.  .  .  This ongoing delay causes substantial prejudice to Respondent, including:

• Lingering regulatory uncertainty impacting daily business operations;
• Reputational harm stemming from unresolved public allegations;
• Ongoing legal expenses and disruptions to [the] business community.

Eight months is a significant delay in administrative proceedings where swift resolution is essential to both public interest and regulated parties' rights.

.  .  .  Complainant's motion for extension does not demonstrate good cause for continued delay.  No exceptional circumstances have been presented to justify this prolonged inactivity.

Id. at 2.  Respondent seeks dismissal of the Complaint with prejudice for failure to prosecute and unreasonable delay.  Id.

In its response to Respondent's Motion to Dismiss, CTP disputed Respondent's assertion regarding its failure to prosecute this case.  CRD Dkt. Entry No. 22 at 2-4.  CTP argues that Respondent's allegations are "baseless," and it has "diligently prosecuted this case" since its initiation.  Id. at 3.  CTP states that the only extension sought by CTP, filed on

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April 4, 2025, was the result of a significant reduction in force within the Food and Drug Administration.  Id.  CTP notes that, prior to the April 4, 2025 Motion to Extend Deadlines, all deadlines established by this tribunal have been met.  Id.

With regard to Respondent's argument asserting substantial prejudice associated with any alleged delay, CTP argues that the allegations are unsupported by any evidence in the record.  Id. at 4.  CTP contends:

.  .  .  [n]othing about this pending matter prevents Respondent from continuing to do business and sell tobacco and other products at its establishment .  .  .  Respondent['s] claims to have suffered '[o]ngoing legal expenses' and '[r]eputational harm stemming from unresolved public allegations' are unsupported as well .  .  .  First, Respondent is proceeding in this matter pro se .  .  .  There is simply no evidence that Respondent has incurred any legal expenses in conjunction with this matter.  And not only is there no evidence to support Respondent's claims of reputational harm, Respondent cites no cases that would support dismissal of a civil money penalty proceeding because of reputational harm to a respondent .  .  .  .

Id.

In addressing Respondent's Motion to Dismiss, I must first consider whether I have regulatory authority to dismiss a complaint on the basis alleged.  The regulations at 21 C.F.R. § 17.19 identify the general authority of the presiding officer.  A review of that section does not provide any authority to dismiss a complaint under any circumstances. Section 17.19(b)(17) does allow the presiding officer to waive, suspend, or modify any rule in the governing regulations if the presiding officer determines, among other things, that no party would be prejudiced.  However, dismissal of the Complaint filed by CTP would most certainly result in prejudice to that party.  As a result, those provisions do not provide authority to grant Respondent's Motion to Dismiss.

The only provision in the governing regulations which grants the ALJ authority to issue a dismissal is contained in 21 C.F.R § 17.35(e) under the heading "Sanctions."  Section 17.35(e) provides that the presiding officer may "dismiss the action" if a party fails to prosecute or defend an action after service of a notice of hearing.  However, based on the facts presented in the case before me, it is apparent from the consistent participation in this proceeding that the parties fully intended to prosecute/defend their respective cases, both before and after issuance of my March 21, 2025, Order Scheduling Hearing.  CRD Dkt. Entry No. 17.  Therefore, I conclude that this provision does not provide me with authority to grant Respondent's Motion to Dismiss.  See, e.g., T and M United Corporation d/b/a BP Shop, DAB No. 2705 at 8 (2016) ("The regulations .  .  .  list dismissal of an action as a possible sanction '[i]f a party fails to prosecute .  .  .  an action[.]'  21 C.F.R § 17.35(e).  The ALJ found that CTP 'abandoned prosecution of this

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matter' .  .  .  however, he did not identify this provision as authority for dismissing with prejudice.  In any event, we conclude that section 17.35(e) is not applicable since, contrary to what the ALJ found, CTP did not abandon prosecution .  .  . ").  While 21 C.F.R. § 17.35(e) provides a mechanism by which an ALJ may, sua sponte, dismiss a complaint as a sanction if a party "abandons" pursuit of its case, the applicable rules and regulations directly related to these tobacco cases do not address situations where a party files a motion to dismiss.  Therefore, I will rely on the guidance provided by the Federal Rules of Civil Procedure.

Under Federal Rules of Civil Procedure (Fed. R. Civ. P.) 41(b), a claim may be dismissed for failure to prosecute.  Specifically, it states:

(b) Involuntary Dismissal; Effect.  If the plaintiff fails to prosecute or to comply with these rules [Federal Rules of Civil Procedure] or a court order, a defendant may move to dismiss the action or any claim against it.  Unless the dismissal order states otherwise, a dismissal under this subdivision (b) and any dismissal not under this rule – except one for lack of jurisdiction, improper venue, or failure to join a party under Rule 19 – operates as an adjudication on the merits.

Fed. R. Civ. P. 41(b).

While Rule 41(b) does not provide a definition or a standard of review for the term "failure to prosecute," an appellate panel of the Departmental Appeals Board (the Board) has provided guidance regarding the standard of review when considering dismissal of an action for failure of a party to prosecute a case.  In Chateau Nursing and Rehabilitation Center, DAB No. 2427 (2011), the Board explained:

.  .  .  as the Board did first in Osceola and later in Kermit, we look for guidance to cases analyzing dismissals pursuant to Rule 41(b) of the Federal Rules of Civil Procedure, which vests district courts with discretion to dismiss an action "[i]f the plaintiff fails to prosecute .  .  .  ." In Osceola, the Board .  .  .  stated:

"A review of Rule 41(b) cases demonstrates that, while the appellate courts acknowledge the importance of a district court's ability to manage its own docket, they repeatedly declare that dismissal is a remedy to be used with great caution: 'Rule 41(b) dismissals are a "harsh remedy" that are "appropriate only in extreme circumstances."'  Spencer v. Doe, 139 F.3d 107, 112 (2nd Cir. 1998) (citations omitted); 'Dismissal with prejudice is an extreme sanction and should be used only in cases of willful disobedience of a court order or .  .  .  persistent failure to prosecute a complaint.'  Rodgers v. University of Missouri, 135 F.3d 1216, 1219

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(8th Cir. 1998)[2]; '[D]ismissal with prejudice "is a harsh sanction" which runs counter to our "strong policy favoring the disposition of cases on the merits."' Benjamin v. Aroostook Medical Center, Inc., 57 F.3d 101, 107 (lst Cir. 1995) (citations omitted).  Dismissal should be used 'as a weapon of last, rather than first, resort.'  Meade v.Grubbs, 841 F.2d 1512,1520 (10th Cir. 1988)."

Chateau at 8 (citing Osceola Nursing and Rehabilitation Center, DAB No. 1708 at 11-12 (1999)).  The Board further elaborated:

In Kermit, we subsequently relied upon a similar analysis set forth in McNeal v. Papasan, 842 F.2d 787 (5th Cir. 1988), where the court articulated the following considerations in reviewing a Rule 41(b) dismissal for failure to prosecute:

"We have repeatedly recognized, however, that a dismissal with prejudice for failure to prosecute is an extreme sanction which is to be used only when the 'plaintiff's conduct has threatened the integrity of the judicial process [in a way which] leav[es] the court no choice but to deny that plaintiff its benefits.'"  Rogers v. Kroger Co., 669 F.2d 317,321 (5th Cir. 1982).  Therefore, under our abuse of discretion review, we have consistently refused to permit a court to impose this sanction unless the history of a particular case discloses both (1) a clear record of delay or contumacious conduct by the plaintiff, and (2) that a lesser sanction would not better serve the best interests of justice.  Sturgeon v. Airborne Freight Corp., 778 F.2d 1154,1159 (5th Cir. 1985); Rogers, 669 F.2d at 321 (collecting cases); see also Price v. McGlathery, 792 F.2d 472,474 (5th Cir. 1986) .  .  .  ."

Chateau at 8-9 (citing Kermit Healthcare Center, DAB No. 1819 at 8-9 (2002), quoting McNeal, 842 F.2d at 790.

In the case presently before me, Respondent has failed to establish any grounds to support its Motion to Dismiss.  In its Motion to Dismiss, Respondent noted an "unjustifiable delay" in these proceedings of more than seven months.  See CRD Dkt. Entry No. 20 at 1.  However, it is unclear what unjustifiable delay Respondent is referencing.  At the outset, I note that the Complaint was filed with CRD on October 21, 2024, and Respondent filed its Motion to Dismiss on April 9, 2025, which totals approximately five months; not the seven months alleged by Respondent.  Further, except for the 30-day extension granted to CTP in response to the FDA's reduction in force, this case has proceeded in a timely fashion, with each party adhering to the established procedures and deadlines I set for this case.  Nothing in the record indicates any infraction of my directives and orders, nor is there any appearance of

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abandonment of the case by either party.  Respondent has not presented any evidence to sufficiently demonstrate a failure by CTP to prosecute this case.

As to Respondent's argument alleging "substantial prejudice" caused by a presumed procedural delay, I find CTP's contention to be persuasive.  As CTP maintains, Respondent has not presented any evidence to demonstrate any prejudice, whether reputational or financial, suffered by its business during these proceedings.  Therefore, for the reasons discussed above, Respondent's Motion to Dismiss is DENIED.

III. CTP's Motion for Summary Decision Is Granted.

1. Liability

I have the authority to grant a motion for a summary decision if "the pleadings, affidavits, and other material filed in the record, or matters officially noticed, show that there is no genuine issue as to any material fact and that the party is entitled to summary decision as a matter of law."  21 C.F.R. § 17.17(b). Here, the material facts in this case are undisputed.  In its Answer, Respondent admitted the July 9, 2024, violations.  As to the violations alleged on April 26, 2024, Respondent states: "I do not recall this incident and I would like additional evidence of this incident .  .  .  We did receive the warning letter."  Answer.

Further, in my May 7, 2025, Order, I gave Respondent until May 22, 2025 to respond to CTP's Motion for Summary Decision.  CRD Dkt. Entry No. 23.  Respondent failed to file a responsive pleading to CTP's Motion for Summary Decision and my May 7, 2025 Order.  As previously noted, to date, Respondent has not filed a response to CTP's Motion for Summary Decision.

Respondent neither admits nor denies the violation alleged on April 26, 2024.  Its failure to admit or deny this allegation in the Complaint amounts to an admission of the allegation.  See 21 C.F.R. § l 7.9(b)(l) ("[A]llegations not specifically denied in an answer are deemed admitted.").

Upon deeming the allegation which Respondent has failed to deny as an admission, I find Respondent has admitted to both selling regulated tobacco products to underage purchasers and failing to verify, by means of photographic identification containing a date of birth, that the purchaser was 21 years of age or older.  Specifically, I find:

• Respondent owns 7-Eleven 19981C, an establishment that sells tobacco products and is located at 260 Hoffmeister Avenue, Saint Louis, Missouri 63125. Complaint ¶¶ 11-12.

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• At approximately 8:53 AM on April 26, 2024, at Respondent's business establishment, an FDA-commissioned inspector conducted an inspection. During the inspection, a person younger than 21 years of age was able to purchase a package of two Swisher Sweets Classic Grape cigars.  Complaint ¶ 15.
• In a warning letter dated May 9, 2024, CTP informed Respondent of the inspector's April 26, 2024, documented violation, and that such action violates federal law.  The letter further warned that Respondent's failure to correct its violation could result in a civil money penalty or other regulatory action. Complaint ¶ 16.
• At approximately 1:09 PM on July 9, 2024, at Respondent's business establishment, an FDA-commissioned inspector conducted a subsequent inspection.  During this inspection, a person younger than 21 years of age was able to purchase a package of two Swisher Sweets Classic Grape cigars.  Additionally, Respondent's staff failed to verify, by means of photographic identification containing a date of birth, that the purchaser was 21 years of age or older. Complaint ¶ 13.

These facts, as admitted by Respondent, establish its liability under the Act, and that CTP is entitled to summary decision as a matter of law.  21 C.F.R. § l 7.l 7(b).  The Act prohibits misbranding of a tobacco product. 21 U.S.C. § 33 l(k).  A tobacco product is misbranded if sold or distributed 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.l(b).  The Secretary of the U.S. Department of Health and Human Services issued the regulations at 21 C.F.R. pt. 1140 under section 906(d) of the Act. 21 U.S.C. § 387a-l; see 21 U.S.C. § 387f(d)(l); 75 Fed. Reg. 13,225, 13,229 (Mar. 19, 2010); 81 Fed. Reg. 28,974, 28,975-76 (May 10, 2016); 89 Fed. Reg. 70,483, 70,485 (Aug. 30, 2024).  Under section 906(d)(5) of the Act, no retailer may sell regulated tobacco products to any person younger than 21 years of age and retailers must verify, by means of photographic identification containing a purchaser's date of birth, that no tobacco product purchasers are younger than 21 years of age.

The only assertion in the Complaint that Respondent disputes is that three violations took place on April 26, 2024, and July 9, 2024.  See Answer. Respondent asserts that there are only two violations and that the violations alleged on July 9, 2024, are the same incident and should be considered one incident.  Id.  This argument is erroneous as a matter of law, and thus does not require further fact-finding to adjudicate.  CTP's method of counting each regulatory violation separately is based on a reasonable and permissible interpretation of the Federal Food, Drug, and Cosmetic Act ("FDCA") and implementing regulations. The Board has specifically considered the argument

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presented by Respondent (i.e., that CTP may not hold a retailer liable for multiple violations stemming from a single transaction or inspection) and rejected it.  See Orton Motor Company, d/b/a Orton's Bagley, DAB No. 2717 (2016). Specifically, the Board concluded that CTP's method of counting violations is based on a reasonable and permissible interpretation of the Act and regulations and is consistent with FDA's published guidance.  Id. at 1.  The Board's decision was affirmed on appeal before the U.S. Court of Appeals for the D.C. Circuit.  In Orton Motor, Inc., d/b/a Orton's Bagley v. United States Dep't of Health & Human Services, 884 F.3d 1205 (D.C. Cir. 2018), the Court stated: As an initial matter, the statute [TCA] provides plainly for the imposition of civil penalties for violations of the tobacco requirements.  See 21 U.S.C. § 333(f)(9).  Although the statute does not expressly permit the charging of multiple violations from a single inspection or transaction, the law provides the FDA with the authority to impose civil penalties for any violations committed, absent such a restriction.  The FDA's position that its enforcement authority permits it to impose penalties for each violation of the tobacco sale restrictions arising during a single inspection or transaction is a persuasive interpretation of the plain terms of the statute.

*  *  *

The TCA recognizes the adjudication of multiple violations within a single proceeding where it caps civil money penalty liability for tobacco control "for all such violations adjudicated in a single proceeding."  21 U.S.C. § 333(f)(9). The references to "violations" in the plural form demonstrates that a single proceeding may involve the simultaneous adjudication of more than one violation.

Orton, 884 F.3d at 1211-1212, 1213.

I therefore reject Respondent's contention and find, as a matter of law, that CTP's method of counting violations, and subsequent maximum penalty calculation, were appropriate in this case.

The evidence in the record, including the testimony of Deputy Division Director James Bowling and Inspector Armin Krajina (CRD Dkt. Entry Nos. 12d-12e), the contemporaneous Narrative Reports and TIMS Reports from the April 26, 2024 and July 9, 2024 inspections (CRD Dkt. Entry Nos. 12f-12i), the photographs of the tobacco products sold (CRD Dkt. Entry Nos. 12k-12l, 12p-12q), and the May 2024 warning letter (CRD Dkt Entry No. 12c), supports granting CTP's Motion for Summary Decision on the issue of liability.  Therefore, CTP's Motion for Summary Decision is GRANTED on the issue of liability.

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B. Civil Money Penalty

I have found no genuine dispute of material facts on the issue of liability and determined Respondent committed three violations of the Act and its implementing regulations within a 24-month period.  The remaining issue in this case is whether the civil money penalty sought by CTP is appropriate, considering any aggravating and mitigating factors.

Pursuant to 21 U.S.C. § 333(f)(9), Respondent 7-Eleven 19981C is liable for a civil money penalty 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 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), (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).  Respondent must prove any mitigating factors by a preponderance of the evidence.  21 C.F.R. § 17.33(c).

In its Complaint, CTP seeks to impose a CMP of $687, which is the maximum penalty permitted by the regulations during the relevant period.  CRD Dkt. Entry No. 1 ¶¶ 1, 10; see also 21 C.F.R. § 17.33(a); 45 C.F.R. § 102.3 (2023); 88 Fed. Reg. 69,531, 69,534 (October 6, 2023).  CTP contends the maximum amount is appropriate "because of Respondent's repeated violations and unwillingness or inability to correct the violation after the first incident, resulting in a second incident only two and a half months later."  CRD Dkt. Entry No. 22 at 9.

In its Answer, Respondent admitted the July 9, 2024 violation but neither admitted nor denied the violation alleged on April 26, 2024, and did not address the appropriateness of the CMP sought by CTP.  See Answer.  Further, as previously noted, Respondent did not file a pre-hearing exchange in this case nor did Respondent submit a response to CTP's Motion for Summary Decision.  See CRD Dkt. Entry Nos. 5, 23.

For the reasons discussed below, after considering any aggravating or mitigating factors and the underlying facts and circumstances in this case, I conclude that a reduced CMP of $537 is appropriate.

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

The Family Smoking Prevention and Tobacco Control Act was enacted for the purpose of authorizing regulation of tobacco products for the "protection of the public health." 21 U.S.C. § 387f(d).  There is no dispute that Respondent was in the business of selling a

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highly regulated and dangerous product.  See generally 21 U.S.C. § 387 note (Findings and Purpose).  Therefore, Respondent's failure to comply with the law constitutes a serious offense which undermines public health.

I have found that Respondent specifically committed two (2) violations of selling tobacco products to underage purchasers and one (1) violation of failing to verify the photographic identification of a purchaser, totaling three (3) violations of the tobacco regulations.  Respondent's repeated inability to comply with federal tobacco regulations is serious in nature and the civil money penalty amount should be set accordingly.

2. Respondent's Ability to Pay and Effect on Ability to do Business

Respondent has not argued that it does not have the ability to pay the $687 CMP sought. Respondent only states: "that my business is struggling" and "[my] priority is to keep the store open to support my employees and their livelihoods."  CRD Dkt. Entry No. 10. To demonstrate the alleged financial struggle, Respondent submitted, as part of its RFP response, a copy of a financial summary printout for the period ending December 2024. CRD Dkt. Entry No. 9 ¶ 10.  I note that the submitted documentation shows only Respondent's business income and expenses for a limited period – whether it's exclusively for the month of December 2024 or a quarterly report (for example) is unclear.  It does not provide a complete economic snapshot as it pertains to Respondent's inability to pay the CMP sought by CTP.  For an informed deliberation on this issue, documentation of Respondent's assets as well as its liabilities could have been provided for my consideration.  In the absence of any supportive evidence, I do not find Respondent's contention of an inability to pay the penalty amount to be credible. Nor has Respondent presented any evidence that the CMP will have a negative impact on its ability to do business.  Therefore, I find that Respondent has failed to establish mitigating circumstances with respect to its ability to pay the CMP sought by CTP or its ability to continue doing business.

3. History of Prior Violations

The current action is the first civil money penalty action brought against Respondent for violations of the Act and its implementing regulations.  As noted above, Respondent has, three times, violated the prohibition against selling tobacco products to purchasers under 21 years of age and failing to verify that the tobacco product purchaser was of sufficient age.  Act § 906(d)(5); 21 C.F.R. § 1140.14(b)(2)(i).

4. Degree of Culpability

Based on my conclusion that Respondent committed the three violations alleged in the Complaint, I hold it fully culpable for three violations of the Act and its

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implementing regulations.

5. Employer Training Program

As part of its response to CTP's Request for Production, Respondent submitted pictures of warning signs at the establishment, the point-of-sale age verification system, employee successful testing badges, and a screenshot of the log-in page for the online policy handbook.  CRD Dkt. Entry No. 9.  In its RFP response, Respondent also notes "[e]very new employee must signup [sic] and take the online training that covers restricted items multiple times."  Id. at 2.  Also, in a January 30, 2025 email to this office, Respondent also indicated:

.  .  .  I have taken significant steps to ensure this issue never happens again, including:

*  *  *

• Terminating the employee responsible for the sale.
• Implementing a mandatory ID scan for all tobacco purchases, making a repeat occurrence impossible .  .  .  .

CRD Dkt. Entry No. 10.

The Act instructs that I must consider whether the retailer has an "approved training program" when assessing a civil money penalty.  21 U.S.C. § 333 note (Guidance) (quoting TCA § 103(q)(2)(A)-(B)); see also 45 C.F.R. § 102.3.  However, CTP has decided to seek CMPs using the lower schedule for all retailers until FDA promulgates regulations establishing standards for approved retailer training programs.  Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers (Revised): Guidance for Industry (August 2023) at 9-10, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/civil-money-penalties-and-no-tobacco-sale-orders-tobacco-retailers-revised (non-binding recommendations for retailer training programs).

In this case, CTP has not refuted Respondent's assertions regarding its employee training program.  To ensure that justice is served, I find Respondent's assertions on this issue persuasive.

6. State Penalties

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

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7. Other Matters as Justice May Require/Additional Mitigating Factors

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).  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.  See 21 C.F.R. § 17.33(c).

Here, the record reflects Respondent is a small retailer with no history of prior violations resulting in a CMP.  In addition, Respondent has participated in these proceedings, appears to be taking this matter seriously, and has identified steps it has taken to reduce the likelihood of future violations, including the creation and implementation of new policies and practices.  CRD Dkt. Entry Nos. 9, 10. However, as a retailer engaged in the sale of tobacco products, Respondent should have been familiar with the applicable law.

After weighing these factors and evaluating the entire administrative record, I accept Respondent's assertions that attempts were made to put safeguards in place. In light of Respondent's actions to try to prevent future violations, I find evidence to reduce the $687 CMP.  I find that a CMP of $537 is appropriate.

IV. Conclusion

WHEREFORE, the within Motion to Dismiss, Motion for Summary Decision, and all responsive submissions having been read and considered, it be and is hereby ORDERED:

1. Respondent's Motion to Dismiss is hereby DENIED.
2. I find Respondent admitted the violations occurred as alleged in the Complaint.
3. I find Respondent failed to respond to CTP's Motion for Summary Decision.
4. I find the facts as set forth in the Complaint establish liability under the relevant statutes and regulations.
5. CTP's Motion for Summary Decision is hereby GRANTED.
6. I assess a civil money penalty in the amount of $537.