Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Center for Tobacco Products,
Complainant,
v.
Shell Park City Ltd.
d/b/a Shell / Food Mart,
Respondent.
Docket No. T-24-1366
FDA Docket No. FDA-2024-H-0355
Decision No. TB9049
INITIAL DECISION
The Center for Tobacco Products (“CTP”), of the United States Food and Drug Administration (FDA) seeks to impose a $638 civil money penalty (CMP) against Shell Park City Ltd. d/b/a Shell / Food Mart (Respondent) for 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. CTP alleges that Respondent impermissibly sold regulated tobacco products to underage purchasers and failed to verify that the purchasers were 21 years of age or older. Therefore, CTP seeks a $638 civil money penalty against Respondent for three violations of the Act within a 24-month period.
For the reasons discussed below, I find Respondent violated the Act as alleged by CTP and that a CMP in the amount $638 is appropriate.
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I. Background and Procedural History
CTP began this matter by serving an Administrative Complaint on Respondent at 3211 Belvidere Road, Park City, Illinois 60085, by United Parcel Service (UPS), and by filing a copy of the complaint with the FDA’s Division of Dockets Management. Civil Remedies Division (CRD) Docket (Dkt.) Entry Nos. 1 (Complaint), 1b (Proof of Service).
On February 14, 2024, Respondent timely filed an Answer to CTP’s complaint. CRD Dkt. Entry No. 4 (Answer). In its Answer, Respondent denies the allegations in the Complaint and states as a defense that it “always implement measures to ensure that any item subject to age restrictions under 21 is sold only to customers who can demonstrate their legal age with valid identification.” Answer at 2. Respondent further states as a defense that “. . . as part of our commitment to quality and customer service, we provide every customer with a purchase receipt, facilitating any potential returns in case of defective products. These practices reflect our strong commitment to legal compliance and customer satisfaction.” Id. at 2.
On February 27, 2024, Administrative Law Judge Zeitlin1 issued an Acknowledgement and Pre-Hearing Order (APHO) establishing procedural deadlines for this case. CRD Dkt. Entry No. 5 (APHO). On March 18, 2024, Respondent filed its pre-hearing exchange, which consisted of its informal brief, a second informal brief that includes photographs, and the written direct testimony of two witnesses: Antonio D’Amado, and Gabriel Sierra, which were submitted in Spanish, and subsequently translated to English. CRD Dkt. Entry Nos. 6, 7, 8, 8a‑8c.
On April 26, 2024, CTP filed a Motion to Compel Discovery asserting that Respondent had not responded to its discovery request. CRD Dkt. Entry Nos. 12, 12a, 12b (Motion to Compel). On that same date, CTP also file an Unopposed Motion to Extend Deadlines, requesting that the pre-hearing exchange deadlines be extended by 30 days. CRD Dkt. Entry No. 13. Also on April 26, 2024, Judge Zeitlin issued an order which granted CTP’s request for an extension of pre-hearing exchange deadlines, and Judge Zeitlin also advised Respondent that it had until May 13, 2024, to file a response to CTP’s Motion to Compel Discovery. CRD Dkt. Entry No. 14.
On May 2, 2024, Respondent filed a response to CTP’s Motion to Compel Discovery. CRD Dkt. Entry No. 15. In its response, Respondent affirms that it submitted the requested information through the DAB E-file system in March and April. Id. On the same date, Respondent also re-filed supporting documents and declarations. CRD Dkt.
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Entry Nos. 16-16c. Respondent further stated, “that I have responded to all requests made to me and have complied with the deadlines to the best of my ability.” CRD Dkt. Entry No. 15. On June 4, 2024, a letter was issued at Judge Zeitlin’s direction giving CTP until June 18, 2024, to file a status report on whether Respondent satisfied its discovery request and withdraws its Motion to Compel Discovery, or if CTP still seeks to compel additional discovery. CTP Dkt. Entry No. 17.
On June 17, 2024, CTP filed a status report indicating that its discovery request was not fulfilled in its entirety. CRD Dkt. Entry No. 18 at 2-3. CTP also stated that it is willing to withdraw its April 26 Motion and proceed to a hearing, but requested that Respondent be estopped from presenting new evidence at the hearing without a showing of extraordinary circumstances. Id. at 3. On July 3, 2024, Judge Zeitlin issued an order denying CTP’s Motion to Compel Discovery as moot. CRD Dkt. Entry No. 19. Judge Zeitlin also advised that the order did not preclude either party from objecting to any proposed evidence or exhibits.
On July 15, 2024, CTP timely submitted its pre-hearing exchange, consisting of its informal brief, list of proposed witnesses, and 20 proposed exhibits (CTP Exs. 1-20) including the written direct testimony of two witnesses, Deputy Division Director for the Division of Enforcement and Manufacturing, Office of Compliance and Enforcement, James Bowling (CTP Ex. 4) and FDA-commissioned officer in the state of Illinois, Karin T. Buck (CTP Ex. 5). CRD Dkt. Entry Nos. 20, 20a-20u.
On September 6, 2024, Judge Zeitlin conducted a pre-hearing conference (PHC). During the PHC, Judge Zeitlin discussed the allegations in the complaint, Respondent’s Answer, the issues to be decided in this case, the burdens of proof, the purpose of conducting a hearing, the procedural history, the administrative record, the parties’ pre‑hearing exchanges and proposed witnesses, and the parties’ efforts to engage in settlement negotiations. CRD Dkt. Entry No. 23 (Order Following PHC). During the pre-hearing conference, Antonio D’Amado appeared on behalf of Respondent and denied that Respondent sold tobacco products to persons under 21 years of age and failed to verify the age of persons purchasing covered tobacco products. Id. at 2. Neither party raised any objections concerning the admission or exclusion of evidence. Id. However, Judge Zeitlin advised that Respondent would be provided an opportunity to submit any objections in writing, and CTP may respond to any objections in writing. Id. Judge Zeitlin further advised that if no objections were filed, he would admit all exhibits into evidence without further discussion. Id.
Mr. D’Amado stated Respondent did not intend to cross-examine CTP’s proposed witnesses. Id. at 3. CTP also stated that it did not intend to cross-examine Respondent’s proposed witnesses. Id. Since neither party wished to cross-examine the opposing party’s witnesses, Judge Zeitlin found a hearing to be unnecessary and established deadlines for objections and final briefing. Id.
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On September 27, 2024, Respondent filed a document labeled as “Objection” written entirely in Spanish. CRD Dkt. Entry No. 24. On October 2, 2024, CTP’s counsel emailed the Attorney‑Advisor assisting me with this case and indicated that “since Respondent did not object to the admission of any of CTP’s exhibits or witnesses, CTP neither plans to file a response to Respondent’s September 27, 2024 filing, nor file a final brief.” CRD Dkt. Entry No. 27. On October 25, 2024, my office received a translated version of Respondent’s September 27, 2024 filing and uploaded the English translation to the administrative record. CRD Dkt. Entry No. 26. After reviewing Respondent’s translated filing, it appears to be Respondent’s final brief in this matter. As neither party filed any objections concerning the admission or exclusion of documentary evidence, CTP Exs. 1‑20 were admitted to the administrative record. CRD Dkt. Entry No. 28.
As previously discussed, the parties waived the right to a hearing in this case and agreed that the matter could be decided based on the written record. Accordingly, the record is now closed, and I will consider the full administrative record in deciding this case. The administrative record contains the exhibits and other evidence admitted as well as all documents and requests filed in this proceeding. 21 C.F.R. § 17.41(b).
II. Issues
- Whether Respondent sold regulated tobacco products to underage purchasers and failed to verify, by photo identification, that regulated tobacco product purchasers were of sufficient age on July 18, 2022, and November 10, 2023, in violation of Section 906(d)(5) of the Act and 21 C.F.R. § 1140.14(b)(2)(i) as charged in the Complaint; and, if so,
- Whether the civil money penalty amount of $638 that CTP seeks is an appropriate penalty.
III. Findings of Facts and Conclusion of Law
To prevail, CTP must prove Respondent’s liability by a preponderance of the evidence. The U.S. Supreme Court has described the preponderance of the evidence standard as requiring that the trier-of-fact believe that the existence of a fact is more probable than not before finding in favor of the party that had the burden to persuade the judge of the fact’s existence. In re Winship, 397 U.S. 358, 371-72 (1970); Concrete Pipe and Prods. of Cal., Inc. v. Constr. Laborers, 508 U.S. 602, 622 (1993).
CTP has the burden to prove Respondent’s liability and appropriateness of the penalty by a preponderance of the evidence. 21 C.F.R. § 17.33(b). Respondent has the burden to prove any affirmative defenses and any mitigating factors likewise by a preponderance of the evidence. 21 C.F.R. § 17.33(c).
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- Violations
CTP determined to impose a civil money penalty against Respondent pursuant to the authority conferred by the Act and implementing regulations at Part 21 of the Code of Federal Regulations. The Act prohibits the misbranding of tobacco products while they are held for sale after shipment in interstate commerce. 21 U.S.C. § 331(k). A tobacco product is misbranded if distributed or offered for sale in any state in violation of regulations issued under Section 906(d) of the Act. 21 U.S.C. § 387c(a)(7)(B); 21 C.F.R. § 1140.1(b). FDA and its agency, CTP, may seek civil money penalties from any person who violates the Act’s requirements as they relate to the sale of tobacco products. 21 U.S.C. § 333(f)(9).
The sale of regulated tobacco products to an individual who is under the age of 21 and failure to verify, by means of photo identification containing the bearer's date of birth, that a regulated tobacco product purchaser is of sufficient age are violations of implementing regulations. Act, Section 906(d)(5); 21 U.S.C. § 387f(d)(5).
- July 18, 2022 Allegations
CTP’s Complaint alleges that Respondent committed two violations:
1) At approximately 7:11 PM on July 18, 2022, at Respondent’s business establishment, 3211 Belvidere Road, Park City, Illinois 60085, Respondent sold a JUUL Virginia Tobacco e-liquid product to a person younger than 21 years of age.
2) Respondent failed to verify, the purchaser’s age, by means of photographic identification containing the purchaser’s date of birth, prior to the sale of the JUUL Virginia Tobacco e-liquid product.
CTP’s case against Respondent rests on the testimony of James Bowling and Inspector Buck, who conducted the inspection at issue and is supported by corroborating evidence including a narrative report, Tobacco Inspection Management System (TIMS) Assignment Form, and photographs. CRD Dkt. Entry Nos. 20e-h, 20k-o, 20u. James Bowling is the Deputy Division Director for the Division of Enforcement and Manufacturing in the Office of Compliance and Enforcement, CTP, FDA. CRD Dkt. Entry No. 20e. Mr. Bowling testified that the JUUL Virginia Tobacco e-liquid product purchased at Respondent’s establishment on July 18, 2022 was manufactured, prepared, compounded, or processed for commercial distribution at JUUL Labs, Inc.’s facility in Wisconsin. CRD Dkt. Entry No. 20e at ¶ 7.
Inspector Buck is an FDA-commissioned officer with the state of Illinois. CRD Dkt. Entry No. 20f at ¶¶ 1-4 (Inspector Buck’s Declaration). Her duties include using undercover buy (UB) inspections with an Underage Purchaser (UP) to determine whether
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a retailer complies with the age and photo identification requirements when selling tobacco products. Id. Inspector Buck testified that she conducted such an inspection of Respondent’s establishment on July 18, 2022, at approximately 7:11 PM, while accompanied by UP A. Id. at ¶ 7. During the inspection, she observed UP A purchase an e-liquid product from Respondent. Id. at ¶ 8.
Inspector Buck testified that, prior to the inspection at issue, she verified that UP A carried photographic identification that included UP A’s true age. Id. at ¶ 7. Inspector Buck also verified that UP A did not have any tobacco products in their possession. Id. Inspector Buck testified that, during the inspection, her car was parked in the parking lot of Shell / Food Mart (Respondent’s establishment) and Inspector Buck and UP A exited the vehicle. Id. at ¶ 8. Inspector Buck entered the establishment first, and UP A entered the establishment moments after her. Id. The inspector testified that she entered the establishment and positioned herself in a location that had a clear, unobstructed view of the sales counter and UP A. Id. The inspector testified that she observed UP A purchase an e-liquid product directly from an employee at the establishment. Id. Inspector Buck further testified that prior to the purchase, she observed that UP A did not present any identification to the employee, and the employee did not provide UP A with a receipt after the purchase. Id.
Inspector Buck testified that, after UP A completed the purchase, UP A and Inspector Buck returned to the vehicle, where UP A immediately handed Inspector Buck the e‑liquid product. Id. at ¶ 9. Inspector Buck testified that she observed that the product was a JUUL Virginia Tobacco e-liquid product. Id. After driving to a nearby secure location, Inspector Buck labeled the package of JUUL Virginia Tobacco e-liquid product as evidence and photographed all of the panels of the package. Id. Inspector Buck then processed the evidence in accordance with standard procedures at the time of the inspection, which entailed completing the TIMS Form and creating a Narrative Report. Id. at ¶¶ 9-11.
UP A’s redacted identification and Inspector Buck’s contemporaneous photographs and reports were admitted into evidence and corroborate Inspector Buck’s testimony. CRD Dkt. Entry Nos. 20f-h, 20k-o.
Respondent did not specifically acknowledge the July 18, 2022 violations in its Answer. In Respondent’s brief, Respondent marked the line stating the July 18, 2022 sale to a person younger than 21 years of age and the failure to verify the identification of the purchaser was untrue. In its brief, Respondent’s sole argument was “That respondent did no[t] sell tobacco products to an individual or individuals under the age of 21 on any of the dates and times specified by CTP.” CRD Dkt. Entry No. 6 (R’s Br.) at 4. In Respondent’s second pre-hearing brief, it includes photographs which shows a warning sign stating that “You must be 21 or older to purchase tobacco products” with the date on which someone would need to be born to purchase a tobacco product. CRD Dkt. Entry
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No. 7 at 10. Another photo looks to show the back of the warning sign stating that “You must ensure that customers are 21 or older before selling a tobacco product.” Id. at 11. There are two additional photographs which appear to be ID card scanners. Id. at 12, 13.
Respondent submitted the declaration of Antonio D’Amado. CRD Dkt. Entry No. 8b. In the declaration, Mr. D’Amado states that:
“I am there every day from 9 AM to 7 PM supervising the staff, and especially the cashiers, so that they respect the regulations and comply with the law, also their assignments, and especially the critical task of selling tobacco and alcohol exclusively to customers of legal age. It should be mentioned that for better control and security all products are scanned and a receipt is issued at the time of payment, whether cash or credit. We take our work very seriously, especially in the sale of tobacco and alcohol, where a document is required to comply with legal regulations and prevent sales to minors. As the law indicates, it can be sold only to persons over 21 years old.”
Id. at 1.
Respondent also submitted the declaration of Gabriel Sierra. CRD Dkt. Entry No. 8c. The declaration states that:
“I, as an employee and cashier when selling tobacco, scan and we verify that the ID is of legal age to be able to sell it and make sure that the customer is of legal age and they are allowed to purchase tobacco, after that they are charged and given a receipt whether they have paid in cash or with a card.”
Id. at 1.
In Respondent’s final brief, it argues that “The only evidence submitted by the FDA is a device in a bag and photos of the outside of the gas stations, which is not sufficient to link us definitively to the alleged sale to a minor.” CRD Dkt. Entry No. 26 (R’s Final Br.) at 1. Respondent asserts that “At our establishment we have multiple notices prohibiting the sale of these products to minors. Additionally, we have a system that requires our employees to verify the identification of the customer by manually entering their date of birth or by scanning their ID before making any sale.” Id. at 1-2. Respondent further asserts that “Although in the past we committed some involuntary errors, since then we have implemented all the necessary measures to ensure that incidents like those will not be repeated.” Id. at 2.
I have considered Respondent’s arguments but find them to be unpersuasive. Respondent did not challenge, nor specifically deny selling JUUL Virginia Tobacco e‑liquid products,
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which Mr. Bowling confirmed were manufactured in Wisconsin, and traveled in interstate commerce prior to being held for sale by Respondent. Respondent did not present any evidence to support its assertions other than photographs of warning signs and ID scanners in addition to the declarations of the store owner and an employee. While Respondent did submit declarations of the owner and an employee, there is not enough evidence to support the claims made in each of the declarations. Therefore, I rely on Inspector Buck’s persuasive testimony based on corroborating evidence documenting the July 18, 2022 violation for selling a regulated tobacco product to a UP and failing to verify the age of the UP prior to the purchase.
- November 10, 2023 Allegations
CTP’s Complaint alleges that Respondent committed two additional violations:
1) At approximately 11:05 AM on November 10, 2023, at Respondent’s business establishment, 3211 Belvidere Road, Park City, Illinois 60085, Respondent sold a Posh Plus Grape electronic nicotine delivery system (ENDS) product to a person younger than 21 years of age.
2) Respondent failed to verify, the purchaser’s age, by means of photographic identification containing the purchaser’s date of birth, prior to the sale of the ENDS product.
CTP’s case against Respondent rests on the testimony of James Bowling and Inspector Buck, who conducted the inspection at issue and is supported by corroborating evidence including a narrative report, Tobacco Inspection Management System (TIMS) Assignment Form, and photographs. CRD Dkt. Entry Nos. 20e, 20f, 20i, 20j, 20p-t. James Bowling testified that the Posh Plus Grape ENDS product purchased at Respondent’s establishment on November 10, 2023 was manufactured by Shenzhen Hiyue Technology in China. CRD Dkt. Entry No. 20e at ¶ 9, 12; see CTP Ex. 16.
Inspector Buck testified that she conducted such an inspection of Respondent’s establishment on November 10, 2023, at approximately 11:05 AM, while accompanied by UP B. CRD Dkt. Entry No. 20f at ¶ 12. During the inspection, she observed UP B purchase an e-liquid product from Respondent. Id. at ¶ 13.
Inspector Buck testified that, prior to the inspection at issue, she verified that UP B carried photographic identification that included UP A’s true age. Id. at ¶ 12. Inspector Buck also verified that UP B did not have any tobacco products in their possession. Id. Inspector Buck testified that, during the inspection, her vehicle was parked in the parking lot of Shell / Food Mart (Respondent’s establishment) and Inspector Buck and UP B exited the vehicle. Id. Inspector Buck entered the establishment first, and UP B entered the establishment moments after her. Id. The inspector testified that she entered the
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establishment and positioned herself in a location that had a clear, unobstructed view of the sales counter and UP B. Id. The inspector testified that she observed UP B purchase an ENDS product directly from an employee at the establishment. Id. Inspector Buck further testified that prior to the purchase, she observed that UP B did not present any identification to the employee, and the employee did not provide UP B with a receipt after the purchase. Id.
Inspector Buck testified that, after UP B completed the purchase, UP B and Inspector Buck returned to the vehicle, where UP B immediately handed Inspector Buck the ENDS product. Id. at ¶ 14. Inspector Buck testified that she observed that the product was a Posh Plus Grape ENDS product. Id. After driving to a nearby secure location, Inspector Buck labeled the package of Posh Plus Grape ENDS product as evidence and photographed all of the panels of the package. Id. Inspector Buck then processed the evidence in accordance with standard procedures at the time of the inspection, which entailed completing the TIMS Form and creating a Narrative Report. Id. at ¶¶ 14, 15.
UP B’s redacted identification and Inspector Buck’s contemporaneous photographs and reports were admitted into evidence and corroborate Inspector Buck’s testimony. CRD Dkt. Entry Nos. 20f, 20i, 20j, 20p-t.
Similar to the violations on July 18, 2022, Respondent did not specifically acknowledge the November 10, 2023 violations in its Answer. In Respondent’s brief, Respondent marked the line stating the November 10, 2023 sale to a person younger than 21 years of age and the failure to verify the identification of the purchaser was untrue. In its brief, Respondent’s sole argument was “That respondent did not sell tobacco products to an individual or individuals under the age of 21 on any of the dates and times specified by CTP.” R’s Br. at 4. In Respondent’s second pre-hearing brief, it includes photographs which shows a warning sign stating that “You must be 21 or older to purchase tobacco products” with the date on which someone would need to be born to purchase a tobacco product under the warning. CRD Dkt. Entry No. 7 at 10. Another photo looks to show the back of the warning sign stating that “You must ensure that customers are 21 or older before selling a tobacco product.” Id. at 11. There are two additional photographs which look to be ID card scanners. Id. at 12, 13.
Respondent submitted the declaration of Antonio D’Amado. CRD Dkt. Entry No. 8b. In the declaration, Mr. D’Amado states that:
“I am there every day from 9 AM to 7 PM supervising the staff, and especially the cashiers, so that they respect the regulations and comply with the law, also their assignments, and especially the critical task of selling tobacco and alcohol exclusively to customers of legal age. It should be mentioned that for better control and security all products are scanned and a receipt is issued at the time of payment, whether cash or credit. We take our
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work very seriously, especially in the sale of tobacco and alcohol, where a document is required to comply with legal regulations and prevent sales to minors. As the law indicates, it can be sold only to persons over 21 years old.”
Id. at 1.
Respondent also submitted the declaration of Gabriel Sierra. CRD Dkt. Entry No. 8c. The declaration states that:
“I, as an employee and cashier when selling tobacco, scan and we verify that the ID is of legal age to be able to sell it and make sure that the customer is of legal age and they are allowed to purchase tobacco, after that they are charged and given a receipt whether they have paid in cash or with a card.”
Id. at 1.
In Respondent’s final brief, it argues that “The only evidence submitted by the FDA is a device in a bag and photos of the outside of the gas stations, which is not sufficient to link us definitively to the alleged sale to a minor.” CRD Dkt. Entry No. 26 (R’s Final Br.) at 1. Respondent asserts that “At our establishment we have multiple notices prohibiting the sale of these products to minors. Additionally, we have a system that requires our employees to verify the identification of the customer by manually entering their date of birth or by scanning their ID before making any sale.” Id. at 1-2. Respondent further asserts that “Although in the past we committed some involuntary errors, since then we have implemented all the necessary measures to ensure that incidents like those will not be repeated.” Id. at 2.
Respondent does not differentiate its defenses between the July 18, 2022 violations and the November 10, 2023 violations. Thus, I have considered Respondent’s arguments and find them to be unpersuasive. Respondent did not challenge, nor specifically deny selling Posh Plus Grape ENDS products, which James Bowling confirmed were manufactured by Shenzhen Hiyue Technology in China and traveled in interstate commerce prior to being held for sale by Respondent. Respondent did not present any evidence to support its assertions other than photographs of warning signs and ID scanners in addition to the declarations of the store owner and employee. Therefore, I rely on Inspector Buck’s testimony that is supported by corroborating evidence documenting the November 10, 2023 violation for selling a regulated tobacco product to a UP and failing to verify the age of the UP prior to the purchase.
The evidence of record establishes to my satisfaction that the violations charged in this case in fact took place on the dates in question and I conclude that Respondent is liable
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under the Act. Accordingly, CTP is entitled to a civil money penalty from Respondent. 21 U.S.C. § 333(f)(9).
IV. Civil Money Penalty
I find that Respondent committed three2 violations of the Act and its implementing regulations within a 24-month period. The FDA, and CTP, may seek civil money penalties from any person who violates the Act’s requirements as they relate to the sale of regulated tobacco products. 21 U.S.C. § 333(f)(9). In its complaint, CTP sought to impose the maximum penalty amount of $638 against Respondent. See CRD Dkt. Entry No. 1 at ¶ 1. When determining an appropriate penalty, the presiding officer must evaluate any circumstances that mitigate or aggravate the violation. 21 C.F.R. § 17.34(a). Under the applicable statute, I must “take into account the nature, circumstances, extent, and gravity of the violation or violations and, with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, the degree of culpability, and such other matters as justice may require.” 21 U.S.C. § 333(f)(5)(B); see also 21 C.F.R. § 17.34.
- Nature, Circumstances, Extent and Gravity of the Violations
I find that Respondent committed three violations of selling regulated tobacco products to underage purchasers and failing to verify, by photographic identification, that the purchasers were of legal age. The repeated inability of Respondent to comply with federal tobacco regulations is serious in nature and the civil money penalty amount should be set accordingly.
- Respondent’s Ability to Pay and Effect on Ability to Do Business
Respondent did not argue that it does not have the ability to pay a $638 CMP. Respondent did not present any evidence that the penalty will affect its ability to continue to do business. In Respondent’s brief, Respondent asserts that the CMP is not appropriate because “no violation has occurred, and thus, no penalty is warranted.” R’s Br. at 7. Beyond simply denying that a violation occurred, Respondent does not explain or provide evidence to prove mitigating circumstances. Therefore, Respondent has provided no reason as to why it cannot continue to sell tobacco products or operate its establishment if a $638 CMP is imposed.
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- History of Prior Violations
The current action for three violations of the Act and its implementing regulations is the first CMP action brought against Respondent.
- Degree of Culpability
It is Respondent’s responsibility to ensure its staff complies with the regulations. Therefore, I find Respondent fully culpable for all violations of the Act and its implementing regulations.
- Additional Mitigating Factors and 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).
While Respondent has asserted that it has taken measures to prevent future violations of the act, this is not sufficient to prove any mitigating circumstances. Based on the findings above, I find the proposed penalty amount of $638 is appropriate. Having found that Respondent violated the law, a CMP of $638 should ensure Respondent’s future compliance with the Act and tobacco regulations.
For these reasons, after considering the record evidence, applicable law, and aggravating and mitigating circumstances in this case, I find that a penalty amount of $638 is appropriate under 21 U.S.C. §§ 333(f)(5)(B), (f)(5)(C), and (f)(9).
V. Conclusion
Pursuant to 21 C.F.R. § 17.45, I impose a civil money penalty against Respondent Shell Park City Ltd. d/b/a Shell / Food Mart in the amount of $638 for impermissibly selling regulated tobacco products to underage purchasers and failing to verify that the purchasers were 21 years of age or older. 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.
Endnotes
1 Administrative Law Judge Zeitlin was previously assigned to this case. The case has since been transferred to me, as referenced in the letter dated October 21, 2024 sent to both parties. CRD Dkt. Entry No. 25.
2 Two violations were committed on July 18, 2022, and two on November 10, 2023. In accordance with customary practice, CTP counted the violations identified during the initial inspection as a single violation, and violations identified during subsequent inspections individually.
Meredith Montgomery Administrative Law Judge