Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Center for Tobacco Products,
Complainant,
v.
Market at Fuqua, LLC
d/b/a
One Stop 13 / Exxon
Respondent.
Docket No.T-24-1392
FDA Docket No.FDA-2024-H-0374
Decision No.TB8920
INITIAL DECISION
The Center for Tobacco Products (CTP) seeks to impose a $20,678 civil money penalty (CMP) against Respondent, Market at Fuqua, LLC d/b/a One Stop 13 / Exxon. CTP alleges that Respondent received in interstate commerce an electronic nicotine delivery system (ENDS) product that lacked the premarketing authorization required under the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 387j, and offered such product for sale, in violation of 21 U.S.C. § 331(c). For the reasons discussed below, I find Respondent violated the Act as alleged by CTP and that a reduced CMP of $8,500 is appropriate.
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I. Background
CTP began this matter by serving an Administrative Complaint (Complaint) on Respondent at 7101 West Fuqua Drive1, Missouri City, Texas 77489, by United Parcel Service, 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 Nos. 1, 1b. On February 20, 2024, Respondent, through counsel, timely filed a Notice of Appearance and its Answer. CRD Dkt. Entry Nos. 3, 3a.2 In its Answer, Respondent admitted the allegations in paragraphs 2 through 14 of the Complaint, asserted that it “lack[ed] sufficient knowledge or information to form a belief about the truth of the statements contained in paragraphs 15 through 21 of the Complaint,” asserted some affirmative defenses, and disputed the appropriateness of the CMP. CRD Dkt. Entry No. 3a at 1-2. On February 27, 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. 5. On March 28, 2024, CTP filed a Joint Status Report indicating that the parties intended to engage in further settlement discussions. CRD Dkt. Entry No. 6 at 1.
On April 12, 2024, Respondent filed Respondent’s Responses to Complainant’s Request for Production of Documents (Respondent’s RFP Response), which included, as attachments, a copy of Respondent’s 2022 federal tax return, a copy of Respondent’s S Corporation Form 1120-S Schedule K-1, a copy of Respondent’s 2023 Texas Franchise Tax Report, copies of Respondent’s profit & loss statements for 2022 and 2023, copies of Respondent’s balance sheets for 2022 and 2023, copies of Respondent’s store policy regarding the sale of alcohol, copies of Cigarette, E-cigarette, and Tobacco products Retail Employee Notification Forms for Respondent’s employees, copies of SNAP Training Program confirmation forms for Respondent’s employees, and a copy of an August 15, 2023 FDA 482 form. CRD Dkt. Entry No. 7.
On May 20, 2024, CTP timely filed its pre-hearing exchange, consisting of an Informal Brief of Complainant, Complainant’s List of Proposed Witnesses and Exhibits, and seven proposed exhibits (CTP Exhibits (Exs.) 1-7). CRD Dkt. Entry Nos. 8-8h. CTP’s pre- hearing exchange included the written direct testimony of two proposed witnesses, James Bowling, Deputy Division Director, Division of Enforcement and Manufacturing, Office of Compliance and Enforcement, CTP, FDA (CTP Ex. 1), and Inspector Robert Becker, an FDA-commissioned officer with the state of Texas (CTP Ex. 2). CRD Dkt. Entry Nos. 8b, 8c.
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On June 10, 2024, Respondent timely filed its pre-hearing exchange, consisting of Respondent’s pre-hearing brief, and one exhibit (R. Ex. 1). CRD Dkt. Entry Nos. 9, 9a. Respondent’s exhibit includes: Plaintiff’s Original Petition from a civil litigation case filed by Respondent in the District Court for Harris County Texas on January 10, 2024, against Edgar Gomez and Texas Fuel Solutions, LLC; a copy of a July 17, 2023 statement of work from Texas Fuel Solutions, LLC and billed to Respondent; and copies of eleven business checks written by Respondent to multiple contractors. See CRD Dkt. Entry No. 9a.
On August 28, 2024, I held a telephone pre-hearing conference (PHC) in this case. See CRD Dkt. Entry No. 14. During the PHC, absent objection from Respondent, I admitted CTP’s seven proposed exhibits into the administrative record. Id. at 2. Also, absent objection from CTP, I admitted Respondent’s one proposed exhibit into the administrative record. Id.
At the PHC, Respondent’s counsel confirmed that he did not wish to cross-examine CTP’s proposed witnesses, and Respondent did not propose any witnesses. Id. I therefore found a hearing to be unnecessary in this case, but permitted the parties an opportunity to submit final briefs. Id.
The Order I issued following the PHC established a deadline of October 15, 2024 for the parties to file final briefs, and a deadline of October 22, 2024 for the parties to file a motion for leave to respond to the opposing party’s final brief. Id. at 2. Neither party filed a final brief in this case.
With regard to the documents filed as attachments to Respondent’s RFP Response, Respondent’s counsel has not moved for me to admit those documents as evidence in the administrative record. Furthermore, paragraph 4 of the APHO states:
. . . Neither the request for production of documents, nor the documents provided in response to a request, should be filed with the Civil Remedies Division except if the parties want these documents considered as evidence. If a party would like documents provided during discovery to the other party considered as evidence, the documents must be resubmitted as exhibits with the pre-hearing exchange. See paragraphs 6 and 8 below.
CRD Dkt. Entry No. 5, ¶ 4.
Respondent’s counsel did not resubmit the documents attached to Respondent’s RFP Response as exhibits to its pre-hearing exchange, in accordance with the requirements set forth in the APHO. Id. Accordingly, the documents attached to Respondent’s RFP Response are excluded from evidence. 21 C.F.R. § 17.19(b)(11).
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The administrative record is now complete and closed, and this matter is ready for a decision. 21 C.F.R. §§ 17.41, 45. I will now decide this case based on the evidence in the administrative record. Id.
II. Issues
1. Whether Respondent received in interstate commerce an ENDS product that lacked the premarketing authorization required under the Act, specifically an Esco Bars Lychee Mango ENDS product, and offered such product for sale on August 15, 2023, in violation of 21 U.S.C. § 331(c);
2. Whether the affirmative defenses asserted by Respondent are meritorious; and
3. If Respondent is liable, whether the $20,678 civil money penalty is appropriate, considering any mitigating or aggravating factors that I find in this case. 21 C.F.R. § 17.45(b).
III. Findings of Fact and Conclusions of Law
A. CTP has demonstrated by a preponderance of the evidence that Respondent received an adulterated and misbranded ENDS product in interstate commerce and delivered or proffered such product for sale on August 15, 2023, in violation of the Act.
CTP seeks to impose a CMP against Respondent pursuant to the authority conferred by the Act and implementing regulations at Part 21 of the Code of Federal Regulations. CTP has the burden to prove Respondent’s liability and the 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 by a preponderance of the evidence. 21 C.F.R. § 17.33(c).
The Act prohibits the receipt in interstate commerce of any tobacco product that is adulterated or misbranded and the delivery or proffered delivery of any tobacco product that is adulterated or misbranded for pay or otherwise. 21 U.S.C. § 331(c); see also 21 U.S.C. § 321(b). Premarket authorization from the FDA is required for all “new tobacco products.” 21 U.S.C. § 387j(a)(2)(A).
A “new tobacco product” is defined as any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modification of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007. 21 U.S.C. § 387j(a)(1). A “new tobacco product” is required to have premarket review with a Marketing Granted Order unless it has a substantial
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equivalence or substantial equivalence exemption order (found-exempt order) in effect for such product. 21 U.S.C. §§ 387j(a)(2)(A), 387e(j)(3)(A). A new tobacco product is adulterated if it has not obtained the required premarket authorization. 21 U.S.C. § 387b(6)(A). A new tobacco product for which a “notice or other information respecting it was not provided as required” under the substantial equivalence or substantial equivalence pathway is misbranded. 21 U.S.C. §§ 387c(a)(6).
CTP’s case against Respondent relies on the written direct testimony of Deputy Division Director James Bowling and Inspector Robert Becker. CRD Dkt. Entry Nos. 8b, 8c (CTP Exs. 1, 2). Inspector Becker testified that during the inspection on August 15, 2023, at approximately 1:02 PM, Esco Bars Lychee Mango ENDS products were available for sale at Respondent’s establishment. CTP. Ex. 2 at 2; see also CTP Exs. 3-6 (Inspector Becker’s narrative report, TIMS Assignment Form Inspection Details, photographs and notice of inspection dated August 15, 2023).
Deputy Division Director Bowling testified that the Esco Bars Lychee Mango ENDS product observed for sale during the August 15, 2023, inspection was manufactured in China, which is outside of the state in which Respondent operates. CTP Ex. 1 ¶ 6. Deputy Division Director Bowling further testified that he:
. . . can confirm that the Esco Bars Lychee Mango ENDS products were not commercially marketed in the United States as of February 15, 2007 . . . that on August 15, 2023, the day on which FDA observed the Esco Bars Lychee Mango ENDS product being offered for sale at One Stop 13 / Exxon, there was no record of this product having an FDA marketing granted order in effect under 21 U.S.C. § 387j(c)(1)(A)(i) . . . there was no record of this product having a substantial equivalence order in effect under 21 U.S.C. § 387j(a)(2)(A)(i), and the manufacturer . . . had not submitted a report requesting a substantial equivalence order under 21 U.S.C. §387e(j). . . . the Esco Bars Lychee Mango ENDS product did not have a found- exempt order in effect under 21 U.S.C. § 387e(j)(3)(A) (SE pathway under 21 U.S.C. § 387j(a)(2)(A)(ii)), and that the manufacturer . . . had not submitted an abbreviated report requesting a found-exempt order for such product(s) under 21 U.S.C. § 387e(j)(1).
Id. ¶¶ 10-12.
In its Answer, Respondent initially stated that it “lack[ed] sufficient knowledge or information to form a belief about the truth of the statements contained in paragraphs 15 through 21 of the Complaint.” CRD Dkt. Entry No. 3a at 1. Paragraphs 15 through 21 of the Complaint allege that Respondent offered an ENDS product that lacks the premarketing authorization required under the Act, specifically an Esco Bars Lychee Mango ENDS product, for sale at its establishment on August 15, 2023, in violation of 21
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U.S.C. § 331(c). CRD Dkt. Entry No. 1 ¶¶ 15-21. Subsequently, in its pre-hearing brief, Respondent admitted that it offered an adulterated and misbranded new tobacco product for sale at its establishment on August 15, 2023. See CRD Dkt. Entry No. 9 at 2.
Thus, Respondent has not disputed any of the statements made by Inspector Becker or Deputy Division Director Bowling. Respondent does not specifically deny that the Esco Bars Lychee Mango ENDS product observed by Inspector Becker was at its establishment and being proffered for sale on August 15, 2023. Rather, in its Answer, as an affirmative defense, Respondent argues that “it purchased the products in question from a third party [sic] wholesaler without any knowledge of the lack of approval of the product and thus lacked any intent to violate any law or regulation.” CRD Dkt. Entry No. 3a at 2.
Based on the uncontested testimony of Inspector Becker and Deputy Division Director Bowling, as well as the supporting evidence submitted by CTP, I find that the Esco Bars Lychee Mango ENDS product offered for sale at Respondent’s establishment on August 15, 2023 previously traveled in interstate commerce before Respondent’s receipt and delivery or proffered delivery of such tobacco product for pay or otherwise. See 21 U.S.C. § 331(c); see also United States v. Sullivan, 332 U.S. 689, 696 (1948) (holding that the Act applies “to articles from the moment of their introduction into interstate commerce all the way to the moment of their delivery to the ultimate consumer”). I find that the Esco Bars Lychee Mango ENDS product was adulterated because it lacked the required FDA marketing authorization and was not exempt from this requirement. 21 U.S.C. §§ 387j(a)(2)(A), 387e(j)(3)(A). Under 21 U.S.C. § 387c(a)(6), the products were also misbranded because there was no substantially equivalent determination as required by 21 U.S.C. § 387e(j). Therefore, I find that Respondent’s actions constitute a violation of law.
B. Respondent has not demonstrated by a preponderance of the evidence that purchasing the Esco Bars Lychee Mango ENDS product from a third-party wholesaler without knowledge of the product’s lack of approval, or without the intent to violate any law or regulation, is a meritorious affirmative defense or a factor that should mitigate its liability.
In its Answer, Respondent argues, as an affirmative defense, that “it purchased the products in question from a third party [sic] wholesaler without any knowledge of the lack of approval of the product and thus lacked any intent to violate any law or regulation.” CRD Dkt. Entry No. 3a ¶ 5. However, at a minimum, it is Respondent’s responsibility to ensure compliance with the laws that regulate the tobacco products that it sells to the public. Further, Respondent fails to cite any binding or persuasive legal precedent that would support the claim that when a retailer has purchased unauthorized ENDS products from a third-party wholesaler, the retailer should be absolved of liability
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if the retailer is without knowledge that the ENDS product is unauthorized. With regard to Respondent’s argument that it lacked the intent to violate any law or regulation, when a retailer decides to sale regulated tobacco products, the retailer is obligated to ensure that the products it sells are authorized. The Family Smoking Prevention and Tobacco Control Act (TCA) 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 21 U.S.C. § 387 note. In offering regulated tobacco products to the public, Respondent assumed a duty to know the legal status of the regulated tobacco products that it offered for sale to the public at its establishment. Further, although this is a civil administrative proceeding, it is a well-settled legal principle that ignorance of the law generally is not a defense to liability. See Jerman v. Carlisle, McNellie, Rini, Kramer & Ulrich LPA, 559 U.S. 573, 581 (2010); see also Ratzlaf v. United States, 510 U.S. 135, 149 (1994) (ignorance of the law is generally not a valid criminal defense).
Therefore, I find that Respondent has not met its burden of proving that its purchase of the Esco Bars Lychee Mango ENDS product from a third-party wholesaler without knowing that the product was unauthorized, or without the intent to violate any law or regulation, is a meritorious affirmative defense or a factor that should mitigate Respondent’s liability.
C. Respondent has demonstrated by a preponderance of the evidence mitigating circumstances to support a reduced CMP.
I have determined that Respondent violated the prohibition against receiving in interstate commerce and offering for sale a new tobacco product that was adulterated and misbranded, and that Respondent has not proven by a preponderance of the evidence that the affirmative defense it asserts is meritorious with regard to liability or factors that should mitigate its liability in this case. 21 U.S.C. § 331(c); 21 C.F.R. § 17.33(c). Pursuant to 21 U.S.C. § 333(f)(9), Respondent One Stop 13 / Exxon is liable for a civil money penalty not to exceed the amounts listed in FDA’s CMP regulations at 21 C.F.R. § 17.2; see also 45 C.F.R. § 102.3.
In its Complaint, CTP seeks to impose a CMP amount of $20,678 against Respondent. CRD Dkt. Entry No. 1 ¶ 1. In its Answer, Respondent contests the relief requested by CTP, and asserts that the proposed CMP is “excessive due to Respondent[’]s lack of knowledge that the products were not approved, lack of intent to violate any law or regulation and because of Respondent’s poor financial condition makes such penalty a severe hardship on Respondent.” CRD Dkt. Entry No. 3a ¶ 6. In its pre-hearing brief, Respondent reiterates its argument regarding its purchase of the Esco Bars Lychee Mango ENDS product from a third-party wholesaler, argues that it never received the June 5, 2023 Warning Letter issued by CTP, and that, with the costs that Respondent has
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incurred in 2023 to replace its underground fuel storage tank, imposition of the full CMP would damage its business. CRD Dkt. Entry No. 9 at 3-4.
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).
1. Nature, Circumstances, Extent and Gravity of the Violations
In its Informal Brief of Complainant, CTP asserts that Respondent’s violations are serious in nature as they contravene FDA’s efforts to protect the public health from the multitude of adverse health effects associated with tobacco use. CRD Dkt. Entry No. 8 at 8. CTP specifically refers to the Warning Letter it issued to Respondent on June 5, 2023, citing Respondent for offering for sale tobacco products, specifically an Esco Bars Strawberry Banana ENDS product, that lacked the required marketing authorization order. Id. at 8-9; CTP Ex. 7, at 1-2. CTP states that the Warning Letter notified Respondent that future violations may lead to enforcement action, including, but not limited to, civil money penalties, seizure, and/or injunction by FDA and advised Respondent that “[t]he violation indicated in [the] letter may not be a complete list of violations at the establishment.” Id.; CTP Ex. 7 at 3. Finally, CTP asserts that the Warning Letter referred Respondent to the FDA website, which included information to help tobacco retailers understand and comply with FDA tobacco laws and regulations. Id. at 9; CTP Ex. 7 at 3.
In its pre-hearing brief, Respondent argues that it had not received the June 5, 2023 Warning Letter prior to CTP’s filing of the Complaint. CRD Dkt. Entry No. 9 at 4. Respondent further states that “a copy of [the June 5, 2023 Warning Letter] was sent to [it] by legal counsel for the FDA after this lawsuit was filed. We never received the Warning Letter. If we had received it, we would have removed the Esco Bars products from our store.” Id.
Respondent’s violation of selling an unauthorized ENDS product is indeed serious. In fact, not only was the Esco Bars Lychee Mango ENDS product that was offered for sale by Respondent unauthorized in the United States, it was actually manufactured in a foreign country, namely China. See CTP Ex. 1 ¶ 6.
With regard to Respondent’s argument that it did not receive the Warning Letter prior to CTP filing the Complaint, it should be noted that there is no statutory or regulatory requirement that CTP issue a warning letter to retailers warning them that they are selling
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unauthorized ENDS products. However, Respondent’s assertion that it did not receive the Warning Letter and that, if it had, it would have taken action to remove the Esco Bars ENDS products from its store has merit. Thus, I find that Respondent’s claim that it would have taken remedial measures by removing the Esco Bars ENDS products from its store had it received the Warning Letter has merit and constitutes a mitigating factor.
2. Respondent’s Ability to Pay and Effect on Ability to Do Business
In its pre-hearing brief, Respondent argues that, due to the financial expenses it incurred as a result of replacing its underground fuel storage tank, imposition of the full CMP sought by CTP would “further damage the business.” CRD Dkt. Entry No. 9 at 4. Respondent asserts that in July of 2023 it hired a contractor to remove its old underground fuel storage tank and install a new one for $165,000. Id.; R. Ex. 1 at 2, 7-8. Respondent asserts that the initial contractor dug a large hole in Respondent’s parking lot and removed the old underground fuel storage tank, but never completed the job by installing the new underground fuel storage tank. CRD Dkt. Entry No. 9 at 3-4. Respondent asserts that it paid the initial contractor $125,000, but the work was never completed. Id. at 4. Respondent further asserts that in order to complete the job of replacing its underground fuel storage tank it needed to hire another contractor, and that while the underground fuel storage tank work was incomplete Respondent could not sell gasoline, and the store parking lot had an open hole for months which deterred customers from doing business with Respondent. Id. Respondent asserts that it paid a new contractor $260,000 to complete the underground fuel storage tank job. Id. In support of its argument, Respondent has submitted a copy of its Plaintiff’s Original Petition in a civil case between Respondent and the purported initial contractor for the underground fuel storage tank replacement, filed in the District Court for Harris County Texas. See R. Ex. 1 at 1-6. Respondent also submitted copies of eleven business checks from Respondent and made payable to multiple contractors totaling $266,757.78. See id. at 9- 20.
CTP argues that Respondent’s tax documents alone are insufficient to establish Respondent’s ability to pay the $20,678 CMP. CRD Dkt. Entry No. 8 at 9-10 (citing Joy and Evergreen Petro, Inc. d/b/a Sunoco, DAB No. CR4698, 2016 WL 8650385 at *2 (H.H.S. Sept. 6, 2016). CTP further argues that in order to establish inability to pay the penalty, Respondent should have provided additional evidence as to its business assets, such as, “proof as to its cash reserves, its credit worthiness, or other potential sources of capital, all of which are highly relevant to the issue of ability to pay a penalty.” Id. at 10. If Respondent were simply relying on tax documents to establish its inability to pay the penalty, I would agree with CTP, but Respondent has submitted copies of checks and a copy of a lawsuit, which substantiates its arguments. Despite Respondent not providing evidence of its cash reserves, its credit worthiness, or other potential sources of capital, Respondent has submitted ample evidence to support its assertion that a $20,678 civil money penalty is not appropriate.
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In 2023, Respondent incurred significant expenses related to the cost of replacing its underground fuel storage tank, and those expenses include the costs associated with hiring a new contractor to complete the unfinished work of the initial contractor. CRD Dkt. Entry No. 9 at 4; R. Ex. 1 at 9-20. Respondent has not submitted documentation supporting its assertion that it paid the initial contractor a total of $125,000.00, but Respondent’s Exhibit 1 shows Respondent is suing the original contractor for that amount. The evidence in the record demonstrates that Respondent has paid a total of $266,757.78 in order to complete the unfinished work of the underground fuel storage tank. See R. Ex. 1 at 9-20. Based on the admitted evidence in the administrative record, I determine that the impact of a $20,678 CMP would result in a significantly negative effect on Respondent’s ability to do business and is a mitigating factor.
3. History of Prior Violations
There is no indication in the record of any prior violations of section 331(c) of the Act resulting in a CMP. CTP notes, however, that Respondent received the June 5, 2023 Warning Letter stating that it had previously violated the law and that it nevertheless continued to receive in interstate commerce, and offer for sale, a new tobacco product that lacked the required premarket authorization. According to CTP, these actions show an unwillingness or inability to comply with the law. CRD Dkt. Entry No. 8 at 10. CTP therefore asserts that Respondent’s continued lack of compliance supports a penalty of $20,678. Id.
As discussed previously, I find Respondent’s argument that it did not receive the June 5, 2023 Warning Letter prior to the filing of CTP’s Complaint, and that had Respondent received the Warning Letter it would have taken remedial measures, to be meritorious. See CRD Dkt. Entry No. 9 at 4. Thus, despite the serious nature of the violation, I find Respondent’s claim that it did not receive the Warning Letter, which would have allowed it to remove the selected products, credible and constitutes a mitigating factor. As such, the CMP amount should be reduced accordingly.
4. Degree of Culpability
Based on my finding that Respondent committed the violation alleged in the Complaint, I hold Respondent fully culpable for offering for sale a new tobacco product that was adulterated and misbranded, in violation of the Act. As discussed previously, Respondent’s argument that its purchase of the Esco Bars Lychee Mango ENDS product from a third-party wholesaler without knowing that the product was unauthorized, or without the intent to violate any law or regulation does not mitigate Respondent’s liability nor its culpability. The Act places a heavy burden on retailers who choose to sell tobacco products because of their highly dangerous and addictive nature. See 21 U.S.C. § 387 note (Findings and Purpose).
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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). Based on the evidence in the record, as discussed above, I find the proposed penalty amount of $20,678 will place a significant financial strain on Respondent’s ability to continue to do business. However, having found the Respondent violated the law, to ensure that justice is served, the CMP should ensure 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 reduced penalty amount of $8,500 is appropriate under 21 U.S.C. §§ 333(f)(5)(B), (f)(5)(C), and (f)(9).
IV. Conclusion
For the reasons set forth above, I impose a reduced civil money penalty against Respondent Market at Fuqua, LLC d/b/a One Stop 13 / Exxon in the amount of $8,500 for receiving in interstate commerce ENDS products that lack the premarketing authorization required under the Act, and offering such products for sale. Pursuant to 21 C.F.R. § 17.45(d), this decision becomes final and binding upon both parties after 30 days of the date of its issuance.
The requests set forth in Respondent’s Answer; specifically that: this action be dismissed as to the Respondent; Complainant take nothing by way of this suit; the Court award Respondent its costs and fees incurred herein; and the Court grant such other and further relief, legal or equitable, to which it may be entitled are hereby DENIED.
Jewell J. Reddick Administrative Law Judge
- 1
The Proof of Service filed by CTP shows the Complaint was served at 7101 West Fuqua Drive. See CRD Dkt. Entry No. 1b. The Complaint lists Respondent’s establishment address as 7101 1/2 West Fuqua Drive. See CRD Dkt. Entry No. 1 ¶ 13.
- 2
On February 20, 2024, Respondent’s attorney filed duplicate copies of the Notice of Appearance and Respondent’s Answer. See CRD Dkt. Entry Nos. 4, 4a.