David G Patterson d/b/a Quick N Easy, DAB TB9236 (2025)

INITIAL DECISION

The Center for Tobacco Products (CTP) filed an Administrative Complaint (Complaint) against Respondent, David G Patterson d/b/a Quick N Easy, alleging Respondent impermissibly sold regulated tobacco products to an underage purchaser, thereby violating the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq., and its implementing regulations, Cigarettes and Smokeless Tobacco, 21 C.F.R. pt. 1140. The Complaint alleges CTP previously initiated a civil money penalty (CMP) action against Respondent Quick N Easy.  The prior action concluded after Respondent Quick N Easy admitted to at least three violations1 of the Act.  Therefore, CTP seeks a $2,757 CMP against Respondent, for violations of the Act and implementing regulations, at least four times within a 24-month period.  For the reasons discussed below, I find that Respondent violated the Act as alleged by CTP, and that a CMP of $2,757 is appropriate.

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I. Background

CTP began this matter by serving a Complaint on Respondent at 503 East Blue Starr Drive, Claremore, Oklahoma 74017 by United Parcel Service (UPS), and by filing a copy of the Complaint with the Food and Drug Administration’s (FDA) Division of Dockets Management.  Civil Remedies Division (CRD) Docket (Dkt.) Entry Numbers (Nos.) 1 (Complaint), 1b (UPS Tracking Proof of Service). 

On August 14, 2024, Respondent electronically filed, via the Departmental Appeals Board (DAB) E-filing system, its timely Answer.  CRD Dkt. Entry No. 3.  In its Answer, Respondent denied the allegations in the Complaint, asserted defenses, including that it trains its employees and terminated the employee involved, and disputed the appropriateness of the CMP sought by CTP, stating it was “too high” and it had “already paid a penalty on the first 3 incidents.”  Id.  On August 16, 2024, I issued an Acknowledgment and Pre-Hearing Order (APHO) acknowledging receipt of Respondent’s Answer and establishing procedural deadlines for this case.  CRD Dkt. Entry No. 4.

On August 16, 2024, Respondent prematurely filed its Pre-Hearing Brief of Respondent. CRD Dkt. Entry No. 5.  On September 18, 2024, CTP filed a Notice of Entry of Appearance and a Joint Status Report stating that parties were unable to reach a settlement.  CRD Dkt. Entry Nos. 6, 7.  On October 15, 2024, Respondent filed CRD Dkt. Entry Nos. 8 and 8a in response to CTP’s request to produce documents, which included a letter from David G. Patterson in his capacity as “the person responsible for the day to day operations,” a “Cash Register training” guide, and an employee shift schedule for the week of April 21, 2024, to April 27, 2024.  R. Exhibits (Exs.) 1-2.

On November 8, 2024, CTP timely filed its pre-hearing exchange consisting of an Informal Brief of Complainant, Complainant’s List of Proposed Witnesses and Exhibits, and 13 proposed exhibits.  CRD Dkt. Entry Nos. 9, 9a-9m.  CTP’s exchange included the written direct testimony of two proposed witnesses: James Bowling, Deputy Division Director for the Division of Enforcement and Manufacturing in the Office of Compliance and Enforcement, CTP, FDA (CTP Ex. 3), and Inspector Brett R. Martin, FDA-commissioned officer with the state of Oklahoma (CTP Ex. 4).  CRD Dkt. Entry Nos. 9d, 9e.

On November 13, 2024, CTP filed a Motion to Correct and Late-File Exhibit, requesting leave to correct CTP Ex. 7, which was incorrectly redacted, with a simultaneously filed late exhibit.  CRD Dkt. Entry No. 10, 10a.  On November 15, 2024, I issued an Order granting CTP’s motion, removing the unredacted version of proposed CTP Ex. 7 from the record, and allowing CTP’s late-filed amended exhibit (CRD Dkt. Entry No. 10a).  CRD Dkt. Entry No. 11.

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On January 15, 2025, I conducted a telephone pre-hearing conference (PHC) with the parties.  During the PHC, I explained the issues before me and the parties’ respective burdens of proof, discussed the parties’ pre-hearing exchange submissions and explained the purpose of a hearing.  See CRD Dkt. Entry No. 15.  Additionally, I addressed the documents Respondent submitted on October 15, 2024, and Respondent clarified that it wished for those documents to be admitted as exhibits, and, specifically, for CRD Dkt. Entry No. 8a to be admitted as written direct testimony.  Id. at 2.

Therefore, I instructed Respondent that the proposed exhibits would be relabeled as Respondent’s Exhibits 1 and 2 and gave Respondent 10 days to resubmit CRD Dkt. Entry No. 8a with the proper declaration language, after which it would be labeled as Exhibit 3. Id.  CTP did not object to the reclassification of these proposed exhibits or allowing Respondent to resubmit CRD Dkt. Entry No. 8a.  Id.  Respondent also raised no objection to the admission of CTP’s proffered Exhibits 1-13.  There being no objections to either parties’ documentary evidence, I admitted CTP’s Exs. 1-13 and Respondent’s Exs. 1-2 into the record and both parties waived their rights to a hearing.  Id. at 2-3.  Accordingly, having found a hearing to be unnecessary, I explained to the parties that I will decide this case based on the written administrative record.  Id.; 21 C.F.R. § 17.45(a).

On January 15, 2025, after the PHC, Respondent resubmitted CRD Dkt. Entry No. 8a with the proper declaration language.  CRD Dkt. Entry No. 14.  On January 17, 2025, I issued a Summary Order of PHC and Order Establishing Deadlines for Final Briefs, which admitted CRD Dkt. Entry No. 14 into the record as Respondent’s Ex. 3.  CRD Dkt. Entry No. 15.  I also provided a February 14, 2025, deadline for the parties to file simultaneous final briefs.  Id. at 3.

On January 29, 2025, Respondent filed its Final Brief.  CRD Dkt. Entry No. 16 (R. Final Brief).  On February 14, 2025, CTP filed its Notice of Waiver of Final Brief.  CRD Dkt. Entry No. 17.  Therefore, the administrative record is now complete and closed.  I will now decide this case based on the evidence in the full administrative record.  21 C.F.R. §§ 17.41(b), 45(a).

II. Issues

• Whether Respondent impermissibly sold regulated tobacco products to an underage purchaser on April 26, 2024, in violation of the Act;
• Whether any affirmative defenses are meritorious; and
• If Respondent is liable for penalties or assessments, whether the $2,757 CMP is appropriate, considering any mitigating or aggravating factors that I find in this case.  21 C.F.R. § 17.45.

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III. Applicable Law

The Act prohibits misbranding of a regulated tobacco product.  21 U.S.C. § 331(k). A regulated 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. § 1140.1(b).  The Secretary issued the regulations at 21 C.F.R. pt. 1140 under section 906(d) of the Act.  21 U.S.C. § 387a-1; see 21 U.S.C. § 387f(d)(1); 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.

IV. Findings of Fact and Conclusions of Law

A. CTP has demonstrated by a preponderance of the evidence that Respondent impermissibly sold regulated tobacco products to an underage purchaser on April 26, 2024, in violation of the Act.

To prevail, CTP has the burden of proving the Respondent’s liability and the appropriateness of any CMP, whereas the Respondent has the burden of proving any affirmative defenses and mitigating factors.  21 C.F.R. § 17.33 (b)-(c).  In addition to the three violations from a prior CMP action, CTP alleges that Respondent committed an additional violation on April 26, 2024.  Complaint ¶¶ 1, 13, 15-16.

In its case against Respondent, CTP relies on the written direct testimony of James Bowling, Deputy Division Director for the Division of Enforcement and Manufacturing, in CTP’s Office of Compliance and Enforcement, and Inspector Brett R. Martin, FDA-commissioned officer with the state of Oklahoma.  CTP Exs. 3, 4.

Inspector Martin testified that on April 26, 2024, at approximately 4:12 PM, he conducted an undercover buy (UB) compliance check inspection at Quick N Easy, located at 503 East Blue Starr Drive, Claremore, Oklahoma 74017, under Compliance Check Assignment Number 24OK047734B.  CTP Ex. 4 at 2 ¶ 8.  Inspector Martin stated Underage Purchaser (UP) A accompanied him during the compliance check inspection. Id.  Prior to the inspection, Inspector Martin stated that he confirmed that UP A possessed a true and accurate photographic identification showing their actual date of birth and that UP A was under the age of 21 on the date of the inspection.  Id.; see also CTP Ex. 7 (UP A Redacted Driver’s License).2 Inspector Martin also testified that he confirmed that UP A did not possess any tobacco products before the inspection.

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Inspector Martin testified that during the inspection he had an unobstructed view of UP A and the sale counter, and he observed UP A purchase a smokeless tobacco product directly from an employee at the establishment.  CTP Ex. 4 at 3 ¶ 9.  Inspector Martin then stated, after he and UP A exited the store and returned to his vehicle, UP A immediately handed him the smokeless tobacco product.  Id. at 3 ¶ 10.  Inspector Martin testified that he observed the smokeless tobacco product was a Copenhagen Long Cut Wintergreen smokeless tobacco product, and he labeled the smokeless tobacco product as evidence and photographed the top and bottom of the package.  Id.; see also CTP Exs. 8, 9 (April 2024 Photographs of Tobacco Product Sold to UP A, and April 2024 Photographs of Tobacco Product Sold to UP A in Evidence Bag).

Deputy Division Director Bowling testified that the Copenhagen Long Cut Wintergreen smokeless tobacco product observed and sold during the April 26, 2024, inspection at Respondent’s establishment was manufactured in Tennessee, and the manufacturer does not have any registered tobacco production facilities in the state of Oklahoma.  CTP Ex. 3 at 2-3 ¶¶ 6-8.

In its Answer, Respondent denied the allegations set forth in the Complaint, and thus opposed the factual allegations raised therein.  CRD Dkt. Entry No. 3.  Respondent also asserted as a defense that it “spend[s] ample time training new employees,” but maintained that “at some point the employee will be left alone,” and that “[i]t just so happens that this particular employee sold tobacco with out [sic] checking ID during the time of this incident.”  Id.  As part of its defense, Respondent also stated the “employee was terminated,” and that the “employee pool is at the bottom” for convenience stores. Id.  Lastly, Respondent argued the penalty amount is too high.  Id.

In its Pre-Hearing Brief of Respondent, Respondent stated it was “[u]ncertain, according to video evidence [t]he employee did check the ID” in response to CTP’s allegation that Respondent sold tobacco products to a purchaser who was under the age of 21 on April 26, 2024.”  CRD Dkt. Entry No. 5 ¶ 4; see also CRD Dkt. Entry No. 4b ¶ 4.  Further, Respondent provided written direct testimony of David G. Patterson who states that although he is the responsible person for the “day to day” store operations, he was not the person operating the cash register on April 26, 2024, and identified the employee operating the cash register.  R. Ex. 3.  Mr. Patterson claimed the employee did check the underage purchaser’s photo identification but “misread the date.”  See id.

In its Final Brief, Respondent reiterated Mr. Patterson’s testimony who states he did not commit this infraction and identified the employee on duty who had “commented [sic] this infraction.”  R. Final Brief.  Respondent did not dispute any of the evidence offered by CTP, including the statements made in the written direct testimony of CTP’s witnesses Deputy Division Director Bowling and Inspector Martin.  Further, Respondent does not deny that the sale occurred and admits that one of its employees did commit the

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infraction.  See R. Ex. 3; see also R. Final Brief.  Rather, Respondent’s argument relies on shifting liability for the violation to another party.  See R. Final Brief.

Under section 906(d)(5) of the Act, no retailer may sell regulated tobacco products to any person younger than 21 years of age.  Thus, Respondent’s arguments are unpersuasive in its attempt to deny or shift any liability.  Tobacco products are highly dangerous and addictive products and, as such, are heavily regulated.  21 U.S.C. § 387 note.  Retailers that choose to distribute tobacco products have the burden to assure they sell such products in compliance with the law.  Based on the uncontested testimony of Deputy Division Director Bowling, and Inspector Martin, as well as the supporting evidence submitted by CTP, CTP has met its burden to prove Respondent’s liability.

CTP having met its burden, I find Respondent violated the prohibition against selling regulated tobacco products to underage purchasers, thereby violating the Act, 21 U.S.C. § 301 et seq., and its implementing regulations, 21 C.F.R. pt. 1140.  Therefore, Respondent’s actions constitute violations of law that merit a CMP.

This is the second CMP action CTP has brought against Respondent.3   Complaint ¶¶ 15-16 (referencing CRD Number T-24-1228, FDA Number FDA-2024-H-0111). The prior complaint alleged that Respondent committed at least three violations of the Act on August 17, 2022, and October 30, 2023.  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.

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 committed at least four violations of the Act and its implementing regulations within a 24-month period.

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

I have determined that Respondent violated the prohibition against selling regulated tobacco products to an underage purchaser.  I must now consider whether the mitigating circumstances offered by Respondent support a reduction in the CMP.

Pursuant to 21 U.S.C. § 333(f)(9), Respondent Quick N Easy is liable for a CMP not to exceed the amounts listed in the FDA’s CMP regulations at 21 C.F.R. § 17.2; see also 45

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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); 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).

CTP seeks to impose a CMP amount of $2,757 against Respondent.  Complaint ¶ 1. In Respondent’s Answer, Pre-Hearing Brief, written direct testimony, and Final Brief, it maintained that the CMP sought by CTP is too high or should not be imposed against Respondent.  CRD Dkt. Entry Nos. 3, 5; R. Ex. 3; R. Final Brief.  Specifically, in its Pre-Hearing Brief, Respondent stated, “the penalty will have a negative impact on my ability to continue to do business.”  CRD Dkt. Entry No. 5.

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

The Family Smoking Prevention and Tobacco Control Act (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).  CTP contends that Respondent’s violations are serious in nature as they contravene the FDA’s efforts to protect the public health from the multitude of adverse health effects associated with tobacco use.  CRD Dkt. Entry No. 9 at 10 (Informal Brief of Complainant).  CTP specifically states that the “violation on April 26, 2024 is particularly serious because Respondent, for the third time in less than 24 months, directly sold a tobacco product to an underage purchaser.” Id.

Moreover, CTP refers to the September 27, 2022, Warning Letter it issued to Respondent, citing Respondent for violations on August 17, 2022, involving the sale of a covered tobacco product to an individual under the minimum federal age for tobacco sales and failure to verify the age of a person purchasing covered tobacco products by means of a photographic identification containing the bearer’s date of birth.  Id.; CTP Ex. 12 at 1.  CTP asserts that the Warning Letter notified Respondent that future violations may result in a CMP action or other action by FDA.  CRD Dkt. Entry No. 9 at 10; see also CTP Ex. 12 at 2.  Finally, CTP states the Warning Letter referred the Respondent to an FDA website, which included information to help tobacco retailers understand and comply with FDA tobacco laws and regulations.  CRD Dkt. Entry No. 9 at 10-11; CTP Ex. 12 at 3.

Respondent’s explanation as to the nature and circumstances surrounding its most recent violation is not that any of CTP’s allegations are fallible but instead that its employee was responsible for the violation on April 26, 2024.  R. Final Brief.  Respondent argues that holding it responsible is “equivalent to giving me a speeding ticket when I’m only the

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passenger of the vehicle.”  Id.  Respondent’s statements demonstrate its inability to take responsibility for its establishment and avoid future violations.

I considered Respondent’s three previous violations of the Act, CTP’s evidence that Respondent received its Warning Letter, and Respondent’s attempts to shift responsibility to the employee.  The evidence demonstrates that Respondent is repeatedly unsuccessful in its attempts to comply with federal tobacco regulations which is serious in nature and therefore the CMP amount should be set accordingly.

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

In its Answer and Pre-Hearing Brief, Respondent contends that the CMP sought by CTP is too high.  CRD Dkt. Entry Nos. 3, 5.  As noted above, Respondent stated, “the penalty will have a negative impact on my ability to continue to do business.”  CRD Dkt. Entry No. 5.  Further, Respondent’s witness David G. Patterson explained that “[t]ax returns will be available soon,” but that Respondent needed more time to gather those documents.  R. Ex. 3.  However, CTP stated in its Informal Brief of Complainant that, Respondent did not provide any evidence to support its inability to pay the penalty amount and that Respondent can continue to “sell tobacco products and other products at the establishment.”  CRD Dkt. Entry No. 9 at 11.

I agree with CTP that Respondent has failed to substantiate its claims that the penalty will have negative impact on its business by not providing evidence regarding its financial hardship, despite being afforded multiple opportunities to do so.  Accordingly, in the absence of evidence in the administrative record to substantiate the potential financial hardship a CMP would cause Respondent, I have no basis to support a reduction in the amount of the CMP.  Moreover, even if I were to reduce the CMP amount, Respondent’s claim alone that it would affect its ability to continue to do business does not provide me with any information to determine what an appropriate reduction would be.

3. History of Prior Violations

The current Complaint is the second CMP action brought against Respondent for violations of the Act and its implementing regulations.  As noted above, Respondent previously admitted to 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 21 years of age or older. Complaint ¶¶ 15-16.  Respondent’s history of prior violations despite warnings, warrants a progressively larger CMP.  As stated by CTP, Respondent’s “repeated violations show an unwillingness or inability to sell tobacco products in accordance with federal tobacco laws.”  CRD Dkt. Entry No. 9 at 12.  Respondent’s continued inability to comply with FDA tobacco regulations supports the imposition of a CMP.

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4. Degree of Culpability

In its Answer, Respondent explained the circumstances surrounding the violation and asserts that it is the fault of an employee who was provided “about an hour” of training on how to ensure “underage people do not have access to tobacco of any kind” and that these things happen since its “employee pool is at the bottom.”  CRD Dkt. Entry No. 3. As evidence, Respondent offers a document titled “Cash Register training” to demonstrate that training on rules for tobacco sales was included as part of the employee training.  R. Ex. 2 at 1.  Respondent argues, both in its Answer and Pre-Hearing Brief, that the employee was terminated for the incident.  CRD Dkt. Entry Nos. 3, 5. Respondent also states that it has “taken steps to prevent this in the future” but did not explain or identify the steps it has taken.  CRD Dkt. Entry No. 5.  Finally, Respondent relies on the testimony of Mr. Patterson who does not deny that the violation occurred but states, instead, that the penalty should fall on the employee handling the sale and not the Respondent.  R. Ex. 3.  Thus, Respondent repeatedly attempts to absolve itself of its culpability in the April 26, 2024, violation.  See CRD Dkt. Entry Nos. 3, 5; see also R. Ex. 3; R. Final Brief.

I have considered Respondent’s statements that it provides training to its employees regarding tobacco sales, that it terminated the employee once it learned of its violation, and that it has taken preventative measures to avoid future violations.  However, as previously mentioned, under section 906(d)(5) of the Act, no retailer may sell regulated tobacco products to any person younger than 21 years of age.  Respondent’s arguments are unpersuasive in its attempt to deny or shift any liability.  Moreover, Respondent has not offered evidence to demonstrate that it has implemented any policies that would prevent future violations.  Therefore, I find Respondent fully culpable for the additional violation of the Act and its implementing regulations, as alleged in the Complaint which makes the imposition of a CMP appropriate.

5. 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).  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).

After reviewing Respondent’s submissions admitted into the administrative record, I do not find any evidence or legal support for 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, cannot afford the proposed CMP, or would be forced out of business.

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Based on the foregoing, I find a CMP in the amount of $2,757 to be appropriate under 21 U.S.C. §§ 333(f)(5)(B) and 333(f)(9).

V. Conclusion

Pursuant to 21 C.F.R. § 17.45, I impose a civil money penalty of $2,757 against Respondent, David G Patterson d/b/a Quick N Easy, for four violations 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.