Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Center for Tobacco Products,
Complainant,
v.
JM Jog LLC
d/b/a Sunoco / Pump and Munch,
Respondent.
Docket No. T-24-2983
FDA Docket No. FDA-2024-H-2420
Decision No. TB10776
INITIAL DECISION
The Center for Tobacco Products (CTP) seeks a $687 civil money penalty against Respondent, JM Jog LLC d/b/a Sunoco / Pump and Munch, located at 3067 South Jog Road, Greenacres, Florida 33467. Specifically, CTP alleges that Respondent sold covered tobacco products to underage purchasers on two separate occasions and failed to verify an underage purchaser’s age by means of photographic identification on one occasion, thereby violating the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq., and its implementing regulations at least three times within a 24-month period. For the reasons discussed below, I find that Respondent committed the violations as alleged and conclude that the requested penalty of $687 is appropriate.
I. Procedural History
CTP initiated this matter by serving an administrative complaint on Respondent at 3067 South Jog Road, Greenacres, Florida 33467 by United Parcel Service and by filing a copy of the complaint with the Food and Drug Administration’s (FDA) Division of Dockets
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Management. Civil Remedies Division (CRD) Docket (Dkt.) Entry (Numbers) Nos. 1, 1b. On June 13, 2024, Respondent, through counsel, requested an extension of time to file its answer, which was granted. CRD Dkt. Entry Nos. 3a, 4.
On July 21, 2024, Respondent timely filed its answer. CRD Dkt. Entry No. 5. In the answer, Respondent denied the allegations in paragraphs 13 through 15 of the complaint and claimed the requested penalty is too high. Id. at 1-2.
On July 29, 2024, the Administrative Law Judge previously assigned to this case1 issued an Acknowledgment and Pre-Hearing Order (APHO). CRD Dkt. Entry No. 6. The APHO outlined the procedures governing the case and established deadlines for completing discovery and for the parties to file pre-hearing exchanges. Id. On August 28, 2024, CTP filed a joint status report stating that the parties intended to engage in further settlement discussions and that CTP would notify my office if the parties reached a settlement. CRD Dkt. Entry No. 9.
On September 5, 2024, in response to Respondent’s document requests, CTP filed a motion for a protective order, seeking to limit the disclosure of certain potentially responsive materials. CRD Dkt. Entry Nos. 10, 10a. Specifically, in a supporting memorandum filed on September 25, 2024, CTP sought to limit the disclosure of identifying information about the underage purchasers (UPs) who participated in the inspections of Respondent’s establishment, including unredacted copies of the UPs’ state-issued identification. CRD Dkt. Entry No. 13. CTP also asserted privilege with respect to certain pre-decisional documents. CRD Dkt. Entry Nos. 13 at 7-12, 13b.
On October 10, 2024, Respondent filed a response to CTP’s motion for protective order. CRD Dkt. Entry No. 14. In the response, Respondent withdrew all pending document requests at issue in the motion for protective order, except that it argued CTP should produce an unredacted copy of the state-issued identification of the UP “that accompanied the FDA-commissioned officer on March 4, 2024.” Id. at 1. Specifically, Respondent argued that the specified UP’s photograph, weight, and height was necessary for its defense because it was disputing the “actual age” of the UP, as well as CTP’s choice to use the UP for tobacco inspections. Id. at 1-2.
On October 16, 2024, CTP requested leave to file a reply in support of its motion for protective order, which I granted. CRD Dkt. Entry Nos. 15, 17. On October 28, 2024, CTP filed a reply in which it argued that, in addition to being protected from disclosure, the UP’s photograph and physical attributes are not relevant to the issues in this case. CRD Dkt. Entry No. 21.
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On October 18, 2024, amid the dispute over CTP’s motion for protective order, CTP filed a motion for leave to amend the complaint. CRD Dkt. Entry Nos. 18-18a, 19. Specifically, CTP sought to amend paragraph 15 of the complaint to correct a regulatory citation and to clarify that the UP was younger than 21 years of age, not younger than 18 as alleged in the original complaint. CRD Dkt. Entry Nos. 18, 19.
Also on October 18, 2024, CTP timely filed its pre-hearing exchange, consisting of a pre-hearing brief (CTP Br.), a list of proposed witnesses and exhibits, and twenty proposed exhibits. CRD Dkt. Entry Nos. 20, 20a-20u. The proposed exhibits included the written direct testimony of two proposed witnesses: James Bowling, Deputy Director, Division of Enforcement and Manufacturing, Office of Compliance and Enforcement, CTP, FDA, and FDA Inspector Marcus Wesker, an FDA-commissioned officer with the state of Florida. CRD Dkt. Entry Nos. 20d, 20e.
On November 7, 2024, Respondent timely filed its pre-hearing exchange, including a prehearing brief and one proposed exhibit. CRD Dkt. Entry Nos. 22, 22a. In its prehearing brief, Respondent asserted various arguments but also claimed it did not have sufficient information to fully assert its defenses without the photograph, weight, and height of the UP that participated in the March 4, 2024 inspection. See CRD Dkt. Entry No. 22 at 4-6.
On December 2, 2024, I issued an Order advising Respondent that it had until December 17, 2024, to file a response to CTP’s motion for leave to amend the complaint. See CRD Dkt. Entry No. 23. On December 17, 2024, Respondent filed a response, arguing that the motion for leave to amend should be denied. CRD Dkt. Entry No. 24. Specifically, Respondent argued that CTP had not shown the amendment was made to “conform with the evidence adduced during the administrative process,” as required by the regulations. Id. at 3. Respondent further argued that allowing the requested amendments at this stage of the proceeding would deprive Respondent of notice and opportunity to adequately respond to the allegations in the complaint. See id. at 3-4.
On April 24, 2025, I issued an Order granting both CTP’s motion for protective order and motion for leave to amend the complaint. CRD Dkt. Entry No. 25. In granting the motion for protective order, I concluded that the UP’s photograph and personally identifiable information is protected under 21 C.F.R. § 20.64(a), is not relevant to any issue in this proceeding, and that Respondent’s stated need for the information (i.e., to prove the UP’s “actual age”) lacked merit. Id. at 4-6. I also noted that Respondent’s discovery requests specifically authorized CTP to redact the UP’s photograph in discovery. Id. at 4. Ultimately, I concluded CTP’s interest in protecting the information outweighed any need Respondent had for the information.
In granting CTP’s motion for leave to amend, I found that the proposed amendments were essentially clerical in nature and were not unfairly prejudicial to Respondent
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because they did not materially alter the substance of any claims, arguments, or defenses. Id. at 6. I also found that the errors were discovered due to “evidence adduced during the administrative process.” Id. at 7. Therefore, I concluded that the amendments were permissible under 21 C.F.R. § 17.5(c), or alternatively, under 21 C.F.R. § 17.19(b)(17). Id. at 7. I also gave Respondent until May 28, 2025 to supplement or amend its answer, prehearing brief, and/or evidentiary submissions, “as needed or wanted,” in response to the amended complaint. Id.
On May 28, 2025, Respondent timely filed an amended answer and an amended pre-hearing exchange. See CRD Dkt. Entry Nos. 26, 26a-c. Respondent’s amended pre-hearing exchange consisted of a pre-hearing brief (R. Br.) and two proposed exhibits, including a digital file that Respondent identified as “video evidence of the alleged sale” from the March 4, 2024 inspection. CRD Dkt. Entry Nos. 26a-c. Respondent’s amended pre-hearing exchange did not include any written direct testimony or otherwise identify any proposed witnesses.
On May 30, 2025, CTP filed a motion to seal the video evidence submitted with Respondent’s amended pre-hearing exchange, claiming it “contains sensitive information” concerning CTP’s covert enforcement operations and should be withheld from public disclosure to “protect the identity of the individual purchasing a tobacco product.” CRD Dkt. Entry No. 27. On June 4, 2025, I granted CTP’s motion and placed the video under seal, finding that public disclosure of a video of the alleged UP could reasonably be expected to constitute an unwarranted invasion of personal privacy and/or interfere with CTP’s ability to conduct future investigations. CRD Dkt. Entry Nos. 28, 26d.
On August 27, 2025, I held a pre-hearing conference (PHC) with the parties to discuss the case and determine whether an oral hearing would be necessary. See CRD Dkt. Entry Nos. 31, 35. During the PHC, both parties stated they had no objections to the opposing party’s proposed exhibits. CRD Dkt. Entry No. 35 at 1-2. As a result, I admitted CTP’s Exhibits (CTP Exs.) 1-20 and Respondent’s Exhibits (R. Exs.) 1-2 into the record. Id. After I explained that a hearing would only be scheduled if Respondent wished to cross-examine one or both of CTP’s witnesses, Respondent stated that it wanted to cross-examine both Deputy Division Director James Bowling and Inspector Marcus Wesker. Id.at 2. Accordingly, after the PHC concluded, I issued an Order summarizing the PHC and scheduling a video hearing for October 15, 2025. Id. The Order also explained that the scope of cross-examination would be limited to the witnesses’ written direct testimony. Id. at 3.
On October 15, 2025, I conducted a video hearing, which was recorded and transcribed for the record. CRD Dkt. Entry No. 36 (Hearing Transcript). During the hearing, I went over the guidelines for the hearing. Hearing Transcript (Hearing Tr.)at 9:23-10:20. Deputy Division Director James Bowling was then sworn in and presented for cross-
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examination. Id. at 11:3. After being reminded that the scope of cross-examination was limited to Mr. Bowling’s written direct testimony, however, counsel for Respondent stated she had no questions for Mr. Bowling and he was excused. Id. at 11:15-12:9. Inspector Marcus Wesker was then sworn in and cross-examined by Respondent’s counsel. Id. at 12:15-18:2. CTP’s counsel also conducted redirect examination of Inspector Wesker. Id. at 18:6-18:15.
On November 13, 2025, the transcript from the hearing was uploaded to the docket. CRD Dkt. Entry Nos. 36, 36a. That same day, I issued an Order making certain non-substantive corrections to the hearing transcript, establishing deadlines for the parties to file additional proposed corrections to the hearing transcript, and establishing a deadline for the parties to file post-hearing briefs. CRD Dkt. Entry No. 37.
On January 8, 2026, CTP timely filed a notice of waiver of final brief, stating it did not intend to file a post-hearing brief. CRD Dkt. Entry No. 38. On the same date, Respondent timely filed a post-hearing brief. CRD Dkt. Entry No. 39.
Both parties have had the opportunity to present evidence and testimony, cross-examine witnesses, and fully argue their respective positions. Accordingly, the administrative record is now closed, and this case is ready for a decision. 21 C.F.R. § 17.41; 21 C.F.R. § 17.45; 21 C.F.R. § 17.19(b)(11).
II. Issues
A. Whether Respondent sold covered tobacco products to underage purchasers on November 2, 2022 and March 4, 2024, and failed to verify, by means of photo identification containing a date of birth, that a purchaser was 21 years of age or older on March 4, 2024, in violation of section 906(d)(5) the Act and 21 C.F.R. § 1140.14(b)(2)(i); and if so,
B. Whether the $687 penalty requested by CTP is appropriate, considering any mitigating or aggravating factors that I find in this case. 21 C.F.R. § 17.45.
III. Findings of Fact and Conclusions of Law
A. CTP has demonstrated by a preponderance of the evidence that the violations occurred as alleged in the amended complaint.
CTP seeks to impose a $687 penalty against Respondent pursuant to the authority conferred by the Act and the implementing regulations at Title 21 of the Code of Federal Regulations. See CRD Dkt. Entry No. 19. The burden is on CTP to prove Respondent’s liability and the appropriateness of the penalty by a preponderance of the evidence.
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21 C.F.R. § 17.33(b). The burden is on Respondent to prove any affirmative defenses or mitigating factors by a preponderance of the evidence. 21 C.F.R. § 17.33(c). The Act prohibits the misbranding of a covered tobacco product while it is held for sale after shipment in interstate commerce, including “covered tobacco products,” such as cigars. 21 U.S.C. § 331(k). A covered tobacco product is defined as “any tobacco product deemed to be subject to the [Act] . . . but excludes any component or part that is not made or derived from tobacco.” 21 C.F.R. § 1140.3. A covered tobacco product is misbranded if it is sold or distributed in violation of section 906(d) of the Act (21 U.S.C. § 387f(d)) or regulations issued under section 906(d) of the Act (21 C.F.R. pt. 1140). 21 U.S.C. § 387c(a)(7)(B); 21 C.F.R. § 1140.1(b). Under section 906(d)(5) of the Act, no retailer may sell covered tobacco products to any person younger than 21 years of age or fail to verify, by means of photographic identification containing a purchaser’s date of birth, that no covered tobacco purchaser is younger than 21 years of age. 21 U.S.C. § 387f(d)(5); 21 C.F.R. § 1140.14(b)(2)(ii).
CTP may seek a civil money penalty against any person who violates any requirement of the Act or regulations concerning the sale of covered tobacco products by filing an administrative complaint. 21 U.S.C. §§ 333(f)(5), (f)(9); see also 21 C.F.R. §§ 17.1(j), 17.5(a). The Act and implementing regulations provide limitations on the amount of the penalty based on the number of violations within a specified timeframe. 21 U.S.C. § 333(f)(9); 21 U.S.C. § 333 note; 21 C.F.R. § 17.2; 45 C.F.R. § 102.3.
In this case, CTP alleges that during two inspections of Respondent’s establishment on November 2, 2022 and March 4, 2024, Respondent committed at least three violations of the Act. CRD Dkt. Entry No. 19 ¶¶ 13-15. Accordingly, CTP requests a civil money penalty against Respondent in the amount of $687 for committing three violations within a twenty-four-month period. Id. ¶ 1. I discuss each inspection and alleged violation below.
1. November 2, 2022 Inspection
CTP alleges that during the initial inspection on November 2, 2022, Respondent violated section 906(d)(5) of the Act by selling a covered tobacco product to a person younger than 21 years of age. CRD Dkt. Entry No. 19 ¶ 15. In support of these allegations, CTP submitted the written direct testimony of Inspector Marcus Wesker and Deputy Division Director James Bowling, as well as documents related to the November 2, 2022 inspection, including reports, photographs, and other materials. See CTP Exs. 3-6, 9-13, 20.
In his written direct testimony, Inspector Wesker testified that on November 2, 2022, at approximately 4:45 PM, he conducted an undercover buy “compliance check inspection” at Respondent’s establishment. CTP Ex. 4 ¶ 8. Inspector Wesker testified that a UP under the age of 21 accompanied him during the inspection and that he personally
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observed the UP purchase a Black & Mild cigar directly from an employee at Respondent’s establishment. Id. ¶¶ 9-10. Inspector Wesker’s testimony is supported by his written reports, photographs of the purchased product, a notice of the inspection that was sent to Respondent, and a redacted copy of the UP’s state-issued identification showing the UP was 18 years old at the time of the sale. See CTP Exs. 5, 6, 9-13.
In his written direct testimony, Deputy Division Director Bowling testified that the FDA maintains a database called the Tobacco Registration and Listing Module Next Generation (TRLM NG), which collects and stores registration information of establishments engaged in the manufacture, preparation, compounding, or processing of tobacco products. CTP Ex. 3 ¶¶ 4-5. Mr. Bowling testified that a review of the TRLM NG database showed that the Black & Mild cigar purchased during the November 2, 2022 inspection is manufactured in the state of Virginia. Id. ¶¶ 4, 6-7. Mr. Bowling further testified that the manufacturer of Black & Mild cigars does not have any registered tobacco production facilities in the state of Florida. Id. ¶ 8. Mr. Bowling’s testimony is supported by a printout from the TRLM NG database showing the registration information for the manufacturer of Black & Mild cigars. CTP Ex. 19.
Although Respondent broadly denied the allegations concerning the November 2, 2022 inspection in its amended answer and amended pre-hearing brief, Respondent does not specifically dispute or challenge any of the testimony or evidence presented by CTP. See CRD Dkt. Entry Nos. 26 at 1, 26a at 4. In fact, besides generically claiming a lack of “sufficient information” to determine if the sale took place as alleged, Respondent has not presented any arguments or evidence concerning the November 2, 2022 inspection. See CRD Dkt. Entry Nos. 26 at 1, 26a at 4. Instead, Respondent’s arguments and evidentiary submissions focus entirely on the March 4, 2024 inspection and the appropriateness of the penalty amount. See CRD Dkt. Entry Nos. 26 at 1, 26a at 4, 39 at 1; see also R. Exs. 1-2. Therefore, I find that Respondent has failed to assert any defense or other basis to overcome a finding of liability with respect to the November 2, 2022 inspection.
In sum, based on the uncontroverted evidence and testimony presented by CTP, I find by a preponderance of the evidence that on November 2, 2022, Respondent sold a covered tobacco product to a person under the age of 21 years in violation of section 906(d)(5) of the Act.
2. March 4, 2024 Inspection
CTP alleges that during a subsequent inspection on March 4, 2024, Respondent committed two additional violations of the Act. CRD Dkt. Entry No. 19 ¶ 13. Specifically, CTP alleges Respondent violated section 906(d)(5) of the Act by selling a covered tobacco product to a person younger than 21 years of age and violated 21 C.F.R. § 1140.14(b)(2)(i) by failing to verify the purchaser’s age by means of photographic identification. Id. In support of these allegations, CTP again relies on the written direct
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testimony of Inspector Wesker and Deputy Division Director Bowling, as well as documents related to the March 4, 2024 inspection, including reports, photographs, and other materials. See CTP Exs. 3, 4, 7, 8, 14-18, 20.
In his written direct testimony, Inspector Wesker testified that on March 4, 2024, at approximately 7:52 PM, he conducted a second “undercover buy compliance check inspection” at Respondent’s establishment. CTP Ex. 4 ¶ 13. Inspector Wesker testified that a UP under the age of 21 accompanied him during the inspection and that he personally observed the UP purchase a Black & Mild Original cigar directly from an employee at Respondent’s establishment. Id. ¶¶ 14-15. Inspector Wesker’s testimony is supported by his written reports, photographs of the purchased product, a notice of the inspection that was sent to Respondent, and a redacted copy of the UP’s state-issued identification showing the UP was 16 years old at the time of the sale. See CTP Exs. 7, 8, 14-18.
In his written direct testimony, Deputy Division Director Bowling testified that based on a review of TLRM NG database, the Black & Mild Original cigar purchased during the March 4, 2024 inspection is manufactured in the state of Virginia. CTP Ex. 3 ¶¶ 4, 6-7. Mr. Bowling further testified that the manufacturer of Black & Mild Original cigars does not have any registered tobacco production facilities in the state of Florida. Id. ¶ 8. Mr. Bowling’s testimony is supported by a printout from the TRLM NG database showing that the product was manufactured in Virginia. CTP Ex. 20.
In its filings, Respondent does not deny selling the cigar to a purchaser, nor does it deny failing to verify the purchaser’s age. See CRD Dkt. Entry Nos. 26, 26a, 39. Instead, Respondent argues that CTP has not proven the individual who purchased the product was under the age of 21. See CRD Dkt. Entry Nos. 26 at 1, 26a at 4-6, 39 at 1-3. Respondent acknowledges that CTP submitted identification into evidence that belongs to someone who was 16 years old at the time of the purchase. See CRD Dkt. Entry No. 39 at 2. Respondent argues, however, that because CTP redacted the photograph, height, and weight from the identification, there is no proof that the submitted identification belongs to the actual purchaser. Id. Respondent further argues that the individual who purchased the tobacco product possessed physical features that raise “significant doubt” and “call into question whether the individual was actually only sixteen years of age.” See id. at 2-3; see also CRD Dkt. Entry Nos. 26 at 1, 26a at 4-6. In other words, Respondent is suggesting CTP may have used an adult purchaser during the inspection and then fraudulently submitted someone else’s identification into evidence.
In connection with these arguments, Respondent submitted an unauthenticated surveillance video which allegedly captured the sale in question. R. Ex. 2. Respondent claims the video supports its claims that the purchaser was “significantly taller” than the inspector and had “facial hair,” which suggest the purchaser was not 16 years old as reflected on the redacted identification. See CRD Dkt. Entry Nos. 26 at 4-6, 39 at 2.
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I am not persuaded by Respondent’s arguments. As a threshold matter, I find that CTP properly redacted the photograph and physical information from the UP’s identification that was admitted into evidence. As I already explained in my order granting CTP’s Motion for a Protective Order, the UP’s photograph and physical features are protected from disclosure and, in any event, are not relevant to any issue in this proceeding. See CRD Dkt. Entry No. 25. Indeed, Respondent is required by the Act’s implementing regulations to verify the age of all tobacco purchasers under the age of 30, regardless of physical appearance, so the UP’s height, weight, and facial hair have no bearing on this case. See 21 C.F.R. § 1140.14(b)(2)(i), (ii).
Moreover, contrary to Respondent’s arguments, I find that CTP has presented sufficient evidence to establish that the UP was under the age of 21 and was the individual who purchased the tobacco product. As noted above, the redacted copy of the UP’s state-issued identification shows the UP was born on December 31, 2007 and was 16 years old at the time of the inspection. CTP Ex. 14. Further, in his sworn written direct testimony, Inspector Wesker testified that he confirmed that the UP was under the age of 21 at the time of the inspection and personally observed the UP purchase the tobacco product from Respondent’s establishment. CTP Ex. 4 ¶¶ 13-14. Inspector Wesker also testified that CTP’s “Exhibit 14 is a true and accurate redacted copy of UP B’s learner’s license.” Id. ¶ 13. On cross-examination, Inspector Wesker further testified that he confirmed the UP’s age and identity prior to the purchase by examining the UP’s state-issued identification and that the birth date on the redacted identification matches the birth date on the UP’s identification that he examined. Hearing Tr.at 12:24-13:10, 14:4-8, 14:22-24.2 Given the totality of this evidence, I find that Respondent’s claim that CTP failed to prove the UP’s age or participation in the inspection is unfounded.
I also note that the video evidence submitted by Respondent does not support its position. Contrary to Respondent’s claims, the person shown in the video is relatively tall but does not possess “unusual” height or stature for a person under the age of 21, nor is any “facial hair” visible other than what might be described as light “peach fuzz,” which in my view is entirely consistent with the UP’s reported age. R. Ex. 2. In fact, I find nothing about the person’s appearance, dress, or demeanor to be atypical or unusual for an individual
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under the age of 21. Id. To the contrary, I find that the video shows what appears to be a teenager purchasing a tobacco product from Respondent’s establishment without being asked to present photographic identification. Id. I also note that the individual in the video matches Inspector Wesker’s description of the UP at the hearing, which contradicts Respondent’s suggestion that someone other than the UP made the purchase. Hearing Tr. 15:18-16:2, 17:11-15. Thus, if anything, Respondent’s video supports CTP’s position and does not help Respondent’s case at all.
Ultimately, CTP is required to prove the elements of its case by a preponderance of the evidence, meaning the violations more likely than not occurred based on the evidence in the record. Based on the documentary and testimonial evidence discussed above, I find that CTP has met this threshold with respect to proving the UP’s age and participation in the inspection, as well as the other elements of its case. I also find the alternative position suggested by Respondent—that CTP and Inspector Wesker potentially falsified evidence and committed perjury to conceal the “real” purchaser’s age—to be implausible and unsupported by the record. Therefore, I find that Respondent has failed to present any convincing defense or other basis to overcome a finding of liability.
In sum, after considering the evidence and arguments presented by the parties, I find by a preponderance of the evidence that on March 4, 2024, Respondent sold a covered tobacco product to a person under the age of 21 years in violation of section 906(d)(5) of the Act, and also failed to verify the age of the purchaser by means of photographic identification in violation of 21 C.F.R. § 1140.14(b)(2)(i). Coupled with my findings above concerning the November 2, 2022 violation, I therefore conclude that Respondent committed at least three violations of the Act within a twenty-four-month period and is subject to a civil money penalty. See 21 U.S.C. §§ 333(f)(5), (f)(9); see also 21 C.F.R. §§ 17.1(j), 17.5(a).
B. The $687 penalty requested by CTP is appropriate.
Having found Respondent liable for the violations alleged in the amended complaint, I now must determine whether the civil money penalty requested by CTP is appropriate. In evaluating the appropriateness of the penalty, 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).
Here, CTP requests a penalty in the amount of $687 for three violations of the Act within a twenty-four-month period, which is the maximum penalty authorized by the regulations. CRD Dkt. Entry No. 19 ¶ 1. For the reasons stated below, after considering
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the factors listed in the statute, I conclude that the requested $687 penalty is reasonable and appropriate. 21 C.F.R. §§ 17.33(a), (c), 17.34(a)-(c).
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 highly regulated and dangerous product. See generally 21 U.S.C. § 387 note (Findings and Purpose).
CTP contends the violations in this case were particularly serious because CTP previously issued a warning letter to Respondent on December 1, 2022 in connection with the November 2, 2022 violation. CTP Br. at 14; see also CTP Ex. 1. In the letter, CTP notified Respondent of the violation and warned that any future violations could result in a civil money penalty action or other action by FDA. CTP Ex. 1 at 2. CTP argues that by committing additional violations after being warned about its conduct, Respondent has demonstrated an unwillingness or inability to correct its violations. CTP Br. at 14.
Respondent, on the other hand, argues that the penalty should be reduced because it has enacted measures to prevent future violations, including “signing up for the WeCard mystery shopper service,” retraining its employees, punishing the employee who conducted the sale, and undergoing “personnel changes in the store.” See R. Br. at 7. In support of these statements, Respondent submitted documentation showing it enrolled in the WeCard program and “passed” three audits (i.e., requested identification from a tobacco purchaser during WeCard “mystery shopper” visits) between May 1, 2024 and July 31, 2024. R. Ex. 1.
After considering the parties’ arguments and submissions, I agree with CTP and find that the nature and circumstances of the violations in this case support imposing the requested penalty. Respondent committed multiple violations of the Act within a relatively short timeframe, including selling a tobacco product to a 16-year-old. Further, the record shows that despite being warned abouts its conduct after the first violation, Respondent committed the exact same type of violation less than eighteen months later. In addition, given Respondent’s repeated emphasis on the second UP’s physical appearance, I am not convinced that Respondent fully understands or accepts its obligations under the Act. Indeed, based on its defense in this case, I have serious concerns about Respondent’s willingness or ability to avoid selling tobacco products to underaged purchasers who Respondent subjectively does not think look like underaged purchasers.
Moreover, while I acknowledge and support Respondent’s stated efforts to prevent future violations, I note that many of the actions identified in Respondent’s filings were also
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identified in Respondent’s written response to the December 1, 2022 warning letter—16 months before the second set of violations occurred. See CTP Ex. 2. I also note that Respondent’s statements about “retraining” and “personnel changes” are not supported by any detail or documentation. See R. Br. at 7. Further, while Respondent’s participation in the WeCard program appears to be a more recent development, I find that it is not adequate to mitigate the violations given the more serious aspects of this case, including the warning letter, the number of violations, and the age of the second UP. For all these reasons, I conclude that the nature, circumstances, extent, and gravity of the violations weigh in favor of imposing the requested penalty amount.
2. Ability to Pay and Effect on Ability to Continue to Do Business
Respondent has not claimed an inability to pay the requested penalty, nor is there any evidence that imposing the requested penalty would negatively impact Respondent’s ability to continue doing business. I also find that the amount of the requested penalty is not prohibitively high or unreasonable, particularly given the circumstances of this case. Accordingly, I find no reason to reduce the requested penalty on this basis.
3. History of Prior Violations
CTP argues that Respondent’s repeated violations demonstrate an “unwillingness or inability to sell tobacco products in accordance with federal tobacco laws.” CTP Br. at 15. By contrast, Respondent claims it does not have an “extensive” history of violations. R. Br. at 7.
While I would not necessarily describe Respondent’s violation history as “extensive,” I do find it significant. Indeed, as discussed above, the record shows Respondent committed at least three violations of the Act during two inspections within a 16-month period, despite being warned about its conduct after the first inspection. Given this history, I conclude that this factor weighs in favor of imposing the requested penalty amount.
4. Degree of Culpability
Based on my finding that Respondent committed the violations as alleged by CTP, I find Respondent fully culpable for its violations of the Act. I find no merit in Respondent’s claims concerning the second UP’s appearance and I find that the preventative measures described in Respondent’s filings do not absolve it of its responsibility to comply with the Act or otherwise mitigate Respondent’s conduct. Therefore, I conclude that this factor weighs in favor of imposing the requested penalty amount.
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5. Other Matters as Justice may Require
As explained above, Respondent bears the burden of proving any mitigating factors by a preponderance of the evidence. 21 C.F.R. § 17.33(c). After reviewing Respondent’s filings, I find that Respondent has not identified or otherwise established any other potentially mitigating factors that warrant consideration in this case.
In sum, after considering the record evidence, the applicable law, and the factors discussed above, I conclude that CTP has proven by a preponderance of the evidence that the requested penalty of $687 is warranted and appropriate under 21 U.S.C. §§ 333(f)(5)(B), (f)(5)(C), and (f)(9).
IV. Conclusion
For the reasons stated above, I impose a civil money penalty against Respondent, JM Jog LLC d/b/a Sunoco / Pump and Munch, in the amount of $687 for committing three violations of the Act within a 24-month period. Pursuant to 21 C.F.R. § 17.45(d), this order becomes final and binding upon both parties after 30 days of the date of its issuance.
Adam R. Gazaille Administrative Law Judge
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This case was reassigned to me on September 12, 2024. CRD Dkt. Entry No. 12.
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In its post-hearing brief, Respondent contends Inspector Wesker was unable to confirm on cross-examination “that the submitted identification was the same as the UP’s identification.” CRD Dkt. Entry No. 39 at 1-2. I disagree and find that this argument misrepresents Inspector Wesker’s testimony. On cross-examination, Inspector Wesker testified that he could not see the biographical information on the identification submitted into evidence because it had been redacted—not that he could not confirm that the redacted identification belonged to the UP. Hearing Tr. 14:18-15:4. In fact, in his written direct testimony and on cross-examination, Inspector Wesker consistently testified that the UP was under the age of 21 and that the redacted identification is a copy of the UP’s state-issued identification. See CTP Ex. 4 ¶ 13; Hearing Tr. at 12:24-14:24.