Guras LLC d/b/a S and J Food Mart, DAB TB8465 (2024)

INITIAL DECISION

The Center for Tobacco Products (CTP) seeks to impose a $19,192 civil money penalty (CMP) against Respondent, Guras LLC d/b/a S and J Food Mart. CTP alleges that Respondent received in interstate commerce electronic nicotine delivery system (ENDS) products that lack the premarketing authorization required under the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 387j, and offered such products 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 $6,700 is appropriate.

I.  Background

CTP began this matter by serving an Administrative Complaint on Respondent at 6533 Meridian Road, Lone Grove, Oklahoma 73443, 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. Respondent timely filed its Answer, denying the allegations, raising defenses, and

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disputing the appropriateness of the CMP. CRD Dkt. Entry No. 3. On November 29, 2023, I issued an Acknowledgment and Pre-Hearing Order acknowledging receipt of Respondent's Answer and establishing procedural deadlines for this case. CRD Dkt. Entry No. 4. On January 3, 2024, CTP filed a Joint Status Report indicating that the parties intended to engage in further settlement discussions and that CTP would notify the Departmental Appeals Board if the parties agreed to a settlement and the Respondent fulfilled the terms of the settlement agreement. CRD Dkt. Entry No. 6 at 1.

On February 23, 2024, CTP timely filed its pre-hearing exchange, consisting of an Informal Brief of Complainant, Complainant's List of Proposed Witnesses and Exhibits, and eight proposed exhibits (CTP Exhibits (Exs.) 1-8). CRD Dkt. Entry Nos. 10-10i. CTP's pre-hearing exchange included the written direct testimony of two proposed witnesses, James Bowling, Deputy Division Director, Office of Compliance and Enforcement, CTP, FDA (CTP Ex. 1), and Brett R. Martin, an FDA-commissioned officer with the state of Oklahoma (CTP Ex. 2). CRD Dkt. Entry Nos. 10b-10c.

Respondent did not file a pre-hearing exchange. However, Respondent was corresponding with the Attorney-Advisor assisting me with this case via email. On December 7, 2023, the Respondent repeated the statements made in its Answer and requested the CMP be dismissed. The Attorney-Advisor advised Respondent that it should contact CTP to discuss settlement options. See CRD Dkt. Entry Nos. 5, 5a. Subsequently, on January 3, 2024, Respondent advised the Attorney-Advisor that the business had been locked by the landlord due to the non-payment of mortgage and updated the mailing address for case correspondence. CRD Dkt. Entry No. 7. Respondent also noted issues with accessing its DAB e-file account to upload documents. CRD Dkt. Entry No. 8.

On April 22, 2024, I held a telephone pre-hearing conference (PHC) in this case. See CRD Dkt. Entry No. 13. During the PHC, I explained the issues before me, and the parties' respective burdens of proof. Id. at 1-2. I also explained to Respondent that CTP timely submitted its pre-hearing exchange, which consisted of CTP's Informal Brief, List of Proposed Witnesses and Exhibits, and eight exhibits. Id. at 2. I asked Respondent if it objected to the admission of CTP's exhibits into the record. Respondent requested more time to review CTP's submission because it had not reviewed the submission. Id. I granted the Respondent's request. Id. at 4. Respondent did however confirm that it did not wish to cross-examine CTP's proposed witnesses. Id. at 3.

During the PHC, in response to my inquiry about its lack of filing a pre-hearing exchange or any evidence to support its Answer, Respondent stated it misunderstood that the information and documentation that was submitted to CTP during settlement negotiations was also provided to me. Id. at 2. I asked CTP if it objected to Respondent's untimely submission of evidence given Respondent's misunderstanding. CTP stated that it did not

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if it was provided an opportunity to review the submission and object if necessary. Id. at 2-3.

The Order I issued following the PHC established a deadline of May 3, 2024, for Respondent to submit its documentary evidence, and any objections to the admission of CTP's eight exhibits. Id. at 3. CTP was ordered to file any objections to the Respondent's submissions by May 17, 2024. Id. Finally, the Order stated that final briefs were due on June 17, 2024. Id.

On April 29, 2024, Respondent filed an "Explanation Letter," and eight bank statements. CRD Dkt. Entry Nos. 14, 15-15g. Respondent did not submit any objections to CTP's proposed exhibits. On May 8, 2024, CTP emailed the Attorney-Advisor assisting me with this case stating that CTP did not have any objections to Respondent's submissions. CRD Dkt. Entry No. 16.

On June 17, 2024, CTP timely filed Complainant's Final Brief. CRD Dkt. Entry No. 17. On June 20, 2024, Respondent filed an "Appeal Letter" and documentary evidence in the form of a bank statement showing unemployment benefits from January 12, 2024, through June 5, 2024. See CRD Dkt. Entry Nos. 18-19. CTP did not file a response to Respondent's untimely submissions.

As previously discussed, Respondent waived its right to cross-examine CTP's proposed witnesses and Respondent has not proposed any witnesses. Therefore, a hearing in this matter is not necessary. The administrative record is now complete and closed, and this matter is ready for a decision. I will now decide this case based on the evidence in the administrative record. 21 C.F.R. § 17.45(a).

II.   Admissions into the Administrative Record

1. CTP's Exhibits 1-8 are admitted into the administrative record.

On February 23, 2024, CTP submitted eight proposed exhibits, CTP Exs. 1-8. See CRD Dkt. Entry Nos. 10b-10i. Respondent had until May 3, 2024, to file objections to the admission of CTP's eight exhibits. CRD Dkt. Entry No. 13 at 3. Respondent did not file any objections; therefore, absent objection, I admit CTP Exs. 1-8 into the administrative record.

2. Respondent's April 29, 2024, submissions are admitted into the administrative record.

On April 29, 2024, in accordance with my Order, Respondent filed an "Explanation Letter," and eight bank statements ranging from August 2023, through March 2024. See CRD Dkt. Entry Nos. 14, 15-15g. On May 8, 2024, by email, counsel for CTP advised

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the Attorney-Advisor assisting me with this case that it did not object to Respondent's submissions. CRD Dkt. Entry No. 16. Therefore, absent objection, I admit Respondent's submissions into the administrative record as Respondent (R.) Exs. 1-8.

3. Respondent's June 20, 2024, submissions are admitted into the administrative record.

On June 20, 2024, Respondent submitted an appeal letter and supporting evidence. See CRD Dkt. Entry Nos. 18, 19. Respondent's appeal letter, which I consider to be its final brief because it reiterates and expands on the contentions made in the Respondent's Answer and other correspondence, is untimely because it was filed after the deadline established in my Order following the PHC. CRD Dkt. Entry No. 13 at 3. However, because the brief repeats contentions the Respondent has made throughout this case and CTP has formulated arguments against them, CTP is not prejudiced by the untimely submission of Respondent's final brief.

On the other hand, the supporting evidence submitted is new evidence that goes to Respondent's contentions regarding its ability to pay the CMP sought. The evidence is relevant and material. See 21 C.F.R. § 17.39. More specifically, Respondent submitted a bank statement showing monthly unemployment benefits deposits from January 2024 to June 2024. CRD Dkt. Entry No. 18. Although Respondent has repeatedly stated that it was on the verge of going out of business, Respondent has not provided this evidence at any previous point in these proceedings. And while CTP has made its arguments against the Respondent's statements, it has not had the opportunity to respond to this specific evidence. Despite this situation, CTP did not object to Respondent's untimely submission. CTP, represented by counsel, is aware that the regulations require me to exclude Respondent's untimely evidence if a party objects and I determine that the failure to comply with my scheduling order should result in such evidence's exclusion. See 21 C.F.R. § 17.25(b)(1).

I have considered the history of this case, especially Respondent's self-represented status, and its unfamiliarity with the administrative appeals process. See CRD Dkt. Entry No. 13 at 2 (memorializing Respondent's misunderstanding of the prehearing exchange process). Absent objection from CTP, I find the ends of justice will be served to accept Respondent's untimely submissions so that Respondent may support the contentions it has consistently made throughout these proceedings. See 21 C.F.R. § 17.19(b)(17). Accordingly, I consider the Respondent's June 20, 2024, submission in its entirety and admit the Respondent's supporting evidence into the administrative record as R. Ex. 9.

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III.  Issues

1. Whether Respondent received in interstate commerce ENDS products that lack the premarketing authorization required under the Act, specifically Elfbar Gumi and Elfbar Malaysian Mango ENDS products, and offered such products for sale on August 15, 2023, in violation of 21 U.S.C. § 331(c); and, if so
2. Whether the $19,192 civil money penalty is appropriate, considering any mitigating or aggravating factors that I find in this case. 21 C.F.R. § 17.45.

IV.  Findings of Fact and Conclusions of Law

1. CTP has demonstrated by a preponderance of the evidence that Respondent received adulterated and misbranded ENDS products in interstate commerce and delivered or proffered those products 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 the Respondent's liability and the appropriateness of the penalty by a preponderance of the evidence. 21 C.F.R. § 17.33(b).

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 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 Director James Bowling, Office of Compliance and Enforcement, CTP, FDA, and Inspector Brett

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R. Martin, an FDA-commissioned officer with the state of Oklahoma. CRD Dkt. Entry Nos. 10b-10c (CTP Exs. 1-2). Inspector Martin testified that during the inspection on August 15, 2023, at approximately 4:14 PM, Inspector Martin observed Elfbar Gumi and Elfbar Malysian Mango ENDS products available for sale at Respondent's establishment. CTP. Ex. 2 ¶¶ 4-6; see also CTP Exs. 3-6 (Narrative Report, TIMS Report, product photographs, and Form FDA 482 (Notice of Inspection dated August 15, 2023)).

Deputy Director Bowling testified that the ENDS products observed for sale during the August 15, 2023, inspection were manufactured in China, which is outside of the state in which Respondent operates. CTP Ex. 1 at 3, ¶ 9; see also CTP Ex. 8 at 2 (Premarket Tobacco Product Application Submission for Elfbar products showing manufacturer located in China). Deputy Director Bowling further testified that he confirmed that the Elfbar Gumi and Elfbar Malysian Mango ENDS products were not commercially marketed in the United States as of February 15, 2007, and that on August 15, 2023, the day on which FDA observed the products at issue being offered for sale at S and J Food Mart, there were no records of these products having an authorized FDA premarket authorization order in effect under 21 U.S.C. § 387j(1)(A)(i). CTP Ex. 1 at 4, ¶¶ 11-12. Finally, Deputy Director Bowling testified that there was no record of these products having a substantial equivalence order in effect under 21 U.S.C. § 387j(a)(2)(A)(i); a report requesting a substantial equivalence order under 21 U.S.C. §387e(j) had not been requested; and that the products did not have a found-exempt order in effect under 21 U.S.C. § 387e(j)(3)(A), nor an abbreviated report requesting a found-exempt order submitted. CTP Ex. 1 at 4 ¶ 13.

Respondent has not disputed any of the statements made by Inspector Martin or Deputy Director Bowling. While Respondent has denied the allegations, its contentions regarding liability have consistently been that it removed the flavor that was mentioned in the warning letter, that it did not bring any new products of the brand, and it was unaware of the flavors for which it was being penalized. See, e.g., CRD Dkt. Entry No. 3 at 4-5. In other words, Respondent does not specifically deny that the ENDS products observed by Inspector Martin were not at its establishment and being proffered for sale, but only that they were not new products, and it did not know that these were also unlawful products. However, tobacco products are highly dangerous and addictive and, as such, are heavily regulated. 21 U.S.C. § 387 note. Retailers that choose to distribute tobacco products have the burden to assure that they make their sales in compliance with the law. Thus, not knowing that the products were unlawful is not an affirmative defense that can relieve Respondent of its liability.

Based on the uncontroverted testimony of Inspector Martin and Deputy Director Bowling, as well as the supporting evidence submitted by CTP, the ENDS products 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 products for pay or otherwise. See 21 U.S.C. § 331(c); see also United

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States v. Sullivan, 332 U.S. 689, 696 (1948), 92 L. Ed. 297, 303 (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"). The ENDS products were adulterated because they 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, Respondent's actions constitute violations of law that merit a CMP.

2. Respondent has demonstrated by a preponderance of the evidence mitigating circumstances to support a reduced CMP of $6,700.

I have determined that Respondent violated the prohibition against receiving and offering for sale a new tobacco product that was adulterated and misbranded. 21 U.S.C. § 331(c). Pursuant to 21 U.S.C. § 333(f)(9), Respondent S and J Food Mart 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. When determining the appropriate amount of a CMP, I am required to consider any "circumstances that mitigate or aggravate the violation" and "the factors identified in the statute under which the penalty is assessed . . . ." 21 C.F.R. §§ 17.34(a); 17.34(b). Specifically, I must consider "the nature, circumstances, extent and gravity of the violations and, with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, the degree of culpability, and such other matters as justice may require." 21 U.S.C. § 333(f)(5)(B).

In its Complaint, CTP seeks to impose a CMP amount of $19,192 against Respondent. CRD Dkt. Entry No. 1, ¶ 1. In its Answer, Respondent contends that the CMP sought by CTP is too high because it removed the flavors as instructed in the warning letter and that it was unaware the flavors for which it is being penalized. CRD Dkt. Entry No. 3, at 4. In addition, the Respondent states that due to its business condition it is unable to pay monthly rent, which could result in losing the business. Id.; see also CRD Dkt. Entry Nos. 14 and 19.
For the reasons explained below, I find that Respondent has established mitigating factors by a preponderance of the evidence and conclude that a reduced CMP of $6,700 is appropriate. 21 C.F.R. §§ 17.33(a), (c); 17.34.

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 the Respondent was in the business of selling a highly regulated and dangerous product. See 21 U.S.C. § 387 note.

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CTP further contends that Respondent's violations are particularly serious because they occurred despite earlier warnings that future violations could result in an enforcement action, and after providing Respondent with information and resources designed to help retailers to comply with federal tobacco law. CRD Dkt. Entry No. 10 at 8-9. CTP specifically refers to a warning letter it issued to Respondent on June 13, 2023, citing Respondent for offering for sale an ENDS product that lacked the required marketing authorization order. Id. at 9; see also 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 this letter may not be a complete list of violations at the establishment." CRD Dkt. Entry No. 10 at 9. Finally, CTP states the warning letter referred the Respondent the FDA website, which included information to help tobacco retailers understand and comply with FDA tobacco laws and regulations. Id. CTP concludes that Respondent's repeated violation demonstrates its unwillingness or inability to correct the violations. Id.

In its Answer, Respondent states that it removed the flavor identified in the warning letter, and that it did not bring in any new flavors. See CRD Dkt. Entry No. 3, at 4. In other words, rather than disregarding the warning letter as CTP proffers, Respondent is arguing that it attempted to come into compliance upon receiving the warning letter by removing the identified product and not bringing in additional products.

I have reviewed the warning letter issued to Respondent in this case and find that, rather than disregarding the warning letter as CTP proffers, Respondent attempted to remedy the violation identified in the warning letter. The warning letter begins by notifying Respondent that it was observed to be in violation of the federal tobacco laws and regulations and states: "[f]ailure to address this violation may result in FDA initiating regulatory or legal action, including monetary penalties." CTP Ex. 7 at 1 (underline in original, italics added for emphasis). The warning letter then states that "the establishment offered for sale an Elfbar Blueberry Ice ENDS product," and instructed Respondent to correct the identified violation. Id. at 1, 3. The warning letter does not identify the product as an example or otherwise signal that other flavors of the brand may also lack the premarket authorization required under the Act. See id.

While CTP is correct that the warning letter states that the "violation indicated in [the] letter may not be a complete list of violations at the establishment," it does so midway through the letter on page 3 of 5. Id. at 3. Had this indication been more prominently placed or plainly written, I would give more consideration to CTP's argument Respondent's violations are particularly serious because they occurred despite being previously warned.

Instead, the administrative record supports Respondent's contentions that it took remedial action upon receipt of the warning letter. The photographs from the August 15, 2023,

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inspection do not show the Elfbar Blueberry Ice product identified in the warning letter, which supports Respondent's contentions that it attempted to remedy the violation specified in the warning letter. CTP Ex. 5. Therefore, despite the serious nature of the violations, I find the Respondent's attempt to comply with law, although insufficient to relieve it of liability, is a mitigating factor and the CMP amount should be accordingly reduced.

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

Respondent's principal argument against the appropriateness of the CMP amount is its inability to pay. Respondent has stated since its Answer that it was at risk of losing its business due to an inability to pay monthly rent. CRD Dkt. Entry No. 3 at 2. In its Explanation Letter, Respondent explained that, in fact, by December 31, 2023, its landlord locked the establishment's door due to its inability to pay rent and that it lost its investment in the business. CRD Dkt. Entry No. 14; see also CRD Dkt. Entry No. 7 (January 3, 2024, email correspondence from Respondent updating mailing address stating that the business has been locked by the landlord due to non-payment of mortgage). CTP does not dispute Respondent's statements, but only asserts that Respondent has not provided sufficient evidence that shows an inability to pay the $19,192 CMP. See CRD Dkt. Entry Nos. 10 at 9-10, and 17 at 2-3. I disagree.

Respondent has provided bank statements from August 2023 to March 2024. R. Exs. 1-8. Respondent's August 2023 bank statement shows an ending balance of just over $2,300, and just over $1.00 in March 2024. R. Exs 1, 8. Almost all the bank statements show multiple returned item fees and overdrawn fees, as well as personal deposits from the Respondent. See, e.g., R. Ex. 1 at 3, 4; R. Ex. 3 at 3,4; R. Ex. 4 at 3-4; R. Ex. 7 at 3. Finally, Respondent's personal checking account statement shows that Respondent began receiving unemployment benefits beginning January 2024. R. Ex. 9.

CTP argues that bank statements alone are insufficient to establish Respondent's ability pay the $19,192 penalty. See CRD Dkt. Entry Nos. 10 at 9-10 (citing Joy and Evergreen Petro, Inc. d/b/a Sunoco, DAB No. CR 4698, 2016 WL 8650385 at *2 (H.H.S. Sept. 6, 2016)) and17 at 2-3. However, as explained, the bank statements in this case support the Respondent's statements of its grim financial condition. Indeed, the multiple returned item fees and personal deposits and unemployment deposits are evidence of its lack of assets and potential sources of capital to pay the penalty amount. See CRD Dkt. Entry No. 10 at 10 (stating Respondent is required to show proof of its cash reserve, credit worthiness, or other potential sources of capital). Finally, the near zero balance of the Respondent's business bank account and the Respondent's unemployment benefits are evidence of its contentions that the establishment is no longer in business. Therefore, I find Respondent's contentions regarding its inability to repay the sought after CMP due to its financial condition to be sincere and credible, and the evidence persuasive on this issue.

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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 a warning letter that it had previously violated the law and that it nevertheless continued to receive in interstate commerce and offer for sale new tobacco products that lacked the required premarket authorization, which shows an unwillingness or inability to comply with the law. CRD Dkt. Entry No. 10 at 10. CTP therefore proffers Respondent's repeated violation supports a penalty of $19,192.

I agree with CTP that the warning letter demonstrates a prior violation. However, I disagree with CTP's contentions that this Respondent's repeated violation in this case was based on an unwillingness or inability to comply with the law. As explained previously, Respondent acted upon receipt of CTP's warning letter to remedy the violation identified in the letter. Therefore, I find that the history of violations in this case is not significant as CTP contends, and accordingly should not favor towards a larger CMP amount.

4. Degree of Culpability

Based on my finding that Respondent committed the violation alleged in the Complaint, I hold Respondent culpable for offering for sale new tobacco products that were adulterated and misbranded, in violation of the Act. I acknowledge Respondent's statements that it was unaware of the different flavors for which the CMP is being sought. CRD Dkt. Entry No. 3 at 4. However, 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. As such, although I have no basis to doubt Respondent's statements that it was unaware that the specific products at issue violated the law, Respondent's unawareness does not absolve it of its responsibility as a retailer of tobacco products to sell tobacco products in compliance with the law.

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). In this case, I cannot ignore the evidence that demonstrates that this Respondent's establishment is already closed. In its explanation letter, the Respondent states that its landlord locked the establishment's door at the end of 2023 and that Respondent lost all its investment that it had put in its store. CRD Dkt. Entry No. 14; see also CRD Dkt. Entry No. 7. As previously discussed, CTP does not dispute these statements. Coupled with the evidence that demonstrates Respondent's dire financial condition, I find the proposed penalty amount of $19,192 will place a significant financial strain personally on Respondent. I acknowledge that even a

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reduced penalty will place a heavy financial burden on the Respondent. However, having found Respondent violated the law, the CMP should be meaningful to ensure future compliance with the Act and tobacco regulations.

In summary, Respondent has violated the law. And while the violations are serious, the record does not support a significant history of violations nor that the violations at issue in this case occurred in complete disregard of CTP's warning letter. As described, Respondent has demonstrated its attempt to remedy the violation identified in the warning letter. I find that Respondent's remedial actions are insufficient to relieve it of liability, but they do demonstrate that Respondent was serious about correcting its violations of the law.

I have also carefully considered the remaining statutory factors, most of which support the imposition of a reduced penalty. In particular, based on the financial evidence, I find Respondent has shown that it cannot afford to pay the proposed penalty.

In determining an appropriate penalty for the violation in this case, I have considered again the purpose of the Tobacco Control Act, which was stated to be the protection of public health. 21 U.S.C. § 387f(d). The CMP should not then be so punitive as to damage any future viability, but instead be sufficient to penalize Respondent for violating the Act and to deter it from doing so again in the future.

For these reasons, after considering the statutory factors and record evidence, I find that a reduced penalty amount of $6,700 is appropriate under 21 U.S.C. § 333(f)(5)(B), (f)(5)(C), and (f)(9)(A).

V.  Conclusion

For the reasons set forth above, I impose a reduced civil money penalty against Respondent Guras LLC d/b/a S and J Food Mart in the amount of $6,700 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.