Samee Crown, Inc. d/b/a Marathon, DAB TB9003 (2025)

INITIAL DECISION

The Center for Tobacco Products (CTP) seeks a $20,678 civil money penalty (CMP) against Respondent, Samee Crown, Inc. d/b/a Marathon, at 510 North Franklintown Road, Baltimore, Maryland 21223. Specifically, CTP alleges that Respondent Marathon received in interstate commerce an electronic nicotine delivery system (ENDS) product that lacks the required premarketing authorization and offered such product for sale, thereby violating the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 331(c). For the reasons discussed below, I find Respondent violated the provisions of 21 U.S.C. § 331(c) and conclude that a CMP in the amount of $13,441 is appropriate.

I. Background and Procedural History

CTP began this matter by serving an administrative complaint on Respondent at 510 North Franklintown Road, Baltimore, Maryland 21223, by United Parcel Service, 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, 1b. On April 9, 2024,

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Respondent, through counsel, timely filed an answer to the complaint, admitting certain allegations, denying certain allegations, and disputing the amount of the CMP. Id. CRD Dkt. Entry No. 4.1

On April 11, 2024, I issued an Acknowledgment and Pre-Hearing Order (APHO) establishing deadlines for discovery and the parties’ pre-hearing exchanges. CRD Dkt. Entry No. 5. On May 13, 2024, CTP filed a Joint Status Report stating that the parties intended to engage in further settlement discussions and would notify my office if they reached a settlement. CRD Dkt. Entry No. 6.

On July 1, 2024, CTP timely filed its pre-hearing exchange, consisting of a pre-hearing brief (CTP Br.), a list of proposed witnesses and exhibits, and seven proposed exhibits. CRD Dkt. Entry Nos. 7, 7a-7h. CTP’s pre-hearing exchange 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 Gavin R. Mulligan, an FDA-commissioned officer with the state of Maryland. CTP Exs. 1, 2.

On July 15, 2024, Respondent timely filed its pre-hearing exchange consisting of a pre-hearing brief (R. Br.) and three unmarked exhibits, including the written direct testimony of Abdul Khokhar, Respondent’s president. CRD Dkt. Entry Nos. 8, 8a-8c. In its pre-hearing brief and written direct testimony, Respondent admitted it committed the violation on December 7, 2023, but argued that the penalty proposed by CTP is not appropriate. R. Br. at 3-4.

On September 25, 2024, I held a telephonic pre-hearing conference (PHC) with both parties present. See CRD Dkt. Entry No. 12 (Order Following PHC). During the PHC, I went over various procedural matters, including the parties’ pre-hearing submissions and proposed exhibits. Both parties stated they had no objections to the opposing party’s proposed exhibits. Id. at 2. Therefore, I admitted CTP’s proposed exhibits 1-7 into the record as CTP Exhibits (CTP Exs.) 1-7. Id. I also verbally marked Respondent’s proposed exhibits and admitted them into the record as Respondent’s Exhibits (R. Exs.) 1-3. Id.

At the PHC, I explained the purpose of an oral hearing and asked the parties whether a hearing was necessary in this case. CRD Dkt. Entry No. 12 at 2. Both parties stated they did not intend to cross-examine the opposing parties’ proposed witnesses. Id. Therefore, I advised the parties that no hearing would be held, and I would decide the case based on the administrative record. Id. I also stated that the parties would have an opportunity to file final briefs before I issued a decision. Id.

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On September 27, 2024, I issued an Order memorializing the issues discussed at the PHC. CRD Dkt. Entry No. 12. I also set a deadline of October 30, 2024 for the parties to file final briefs. Id. at 2.

On October 18, 2024, Respondent timely filed a final brief (R. Final Br.), which restates and expands upon the arguments made in its pre-hearing brief. CRD Dkt. Entry No. 13. On October 30, 2024, CTP also filed a final brief, labeled a “supplemental brief” (CTP Final Br.), which responds to the arguments asserted in Respondent’s briefs. CRD Dkt. Entry No. 14. As the final briefing deadline has passed, the administrative record is now closed, and this matter is ready for a decision based on the written record. See 21 C.F.R. §§ 17.41, 17.45(c), 17.19(b)(11), 17.19(b)(17).

II. Evidence

CTP submitted the following exhibits with its pre-hearing exchange, which were admitted into the record at the PHC without objection:

• CTP Ex. 1: Declaration of James Bowling
• CTP Ex. 2: Declaration of Gavin R. Milligan
• CTP Ex. 3: December 2023 Narrative Report
• CTP Ex. 4: December 2023 TIMS Assignment Form
• CTP Ex. 5: December 2023 Photographs of Elbar Triple Melon ENDS Product
• CTP Ex. 6: December 2023 Form FDA 482
• CTP Ex. 7: September 2023 Warning Letter

Respondent submitted the following exhibits with its pre-hearing exchange, which were verbally marked and admitted into the record at the PHC without objection:

• R. Ex. 1: Declaration of Abdul S. Khokhar (CRD Dkt. Entry No. 8a)
• R. Ex. 2: 2022 Tax Return (CRD Dkt. Entry No. 8b)
• R. Ex. 3: 2023 Tax Return (CRD Dkt. Entry No. 8c)

III. Issues

1. Whether Respondent received in interstate commerce an ENDS product that lacks the premarketing authorization required under the Act, specifically an Elfbar Triple Melon ENDS product, and offered such product for sale on December 7, 2023, in violation of 21 U.S.C. § 331(c); and, if so,
2. Whether the $20,678 CMP proposed by CTP is appropriate, considering any mitigating or aggravating factors I find in this case. 21 C.F.R. § 17.45.

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IV. Findings of Fact and Conclusions of Law

1. CTP has demonstrated by a preponderance of the evidence that Respondent received an adulterated and misbranded ENDS product in interstate commerce and delivered or offered such product for sale 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. The burden is on CTP to prove Respondent’s liability and the appropriateness of any civil money penalty, including any aggravating circumstances, by a preponderance of the evidence. 21 C.F.R. § 17.33(b). On the other hand, the burden is on Respondent to prove any affirmative defenses and 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 (MGO) 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 James Bowling, Deputy Director, Division of Enforcement and Manufacturing, Office of Compliance and Enforcement, CTP, FDA, and Inspector Gavin R. Milligan, an FDA-commissioned officer with the state of Maryland. CTP Exs. 1, 2. Inspector Milligan testified that during an inspection on December 7, 2023, at approximately 2:31 PM, Inspector Milligan observed an Elfbar Triple Melon ENDS product offered for sale at Respondent’s establishment. CTP Ex. at 2, ¶¶ 4-6; see also CTP Exs. 3-6 (Inspector Milligan’s narrative report, inspection results, photographs and notice of inspection dated December 7, 2023).

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Deputy Director Bowling testified that the Elfbar Triple Melon ENDS product observed during the December 7, 2023, inspection was manufactured in China, which is outside the state in which Respondent operates. CTP Ex. 1 at 3, ¶ 7. Deputy Director Bowling further testified that Elfbar Triple Melon ENDS products were not commercially marketed in the United States as of February 15, 2007, and that at the time of inspection on December 7, 2023, 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). Id. at 4, ¶¶ 12-13. Finally, Deputy Director Bowling testified that there was no record of Elfbar Triple Melon ENDS products having a substantial equivalence order in effect under 21 U.S.C. § 387j(a)(2)(A)(i) nor had a report requesting a substantial equivalence order under 21 U.S.C. § 387e(j) been submitted; and that the products did not have a found-exempt order in effect under 21 U.S.C. § 387e(j)(3)(A) nor had an abbreviated report requesting a found-exempt order been submitted. Id. at 4, ¶ 14.

Respondent does not challenge the evidence or testimony submitted by CTP, nor does it offer any defenses to a finding of liability. In fact, Respondent admits it offered the subject ENDS product for sale on December 7, 2023 in violation of the Act, and instead focuses its arguments on the appropriateness of the proposed CMP. See R. Br. at 1-2, R. Final Br. at 2. As a result, I find that the testimony and evidence presented by CTP is undisputed with respect to liability.

Based on the uncontroverted testimony of Deputy Director Bowling and Inspector Milligan, as well as the corroborating evidence and Respondent’s admission of liability, I find that Respondent received an Elfbar Triple Melon ENDS product in interstate commerce and delivered, or proffered delivery of, that product for pay or otherwise within the meaning of 21 U.S.C. § 331(c). See also United States v. Sullivan, 332 U.S. 689, 696 (1948) (holding 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 the product was adulterated because it lacked the FDA premarketing authorization and was not exempt from this requirement. 21 U.S.C. §§ 387j(a)(2)(A), 387e(j)(3)(A). I also find the product was misbranded under 21 U.S.C. § 387c(a)(6) because there was no substantially equivalent determination as required by 21 U.S.C. § 387e(j). Therefore, I conclude that Respondent violated 21 U.S.C. § 331(c) and is liable for a CMP under 21 U.S.C. § 333(f)(9).

2. Based on the aggravating and mitigating circumstances established by the parties, I find that a reduced CMP of $13,441 is appropriate.

I have determined 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). Under 21 U.S.C. § 333(f)(9), Respondent is liable for a CMP 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

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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 is proposing a CMP in the amount of $20,678, which is the maximum penalty permitted by the regulations. CRD Dkt. Entry No. 1, ¶ 1; 21 C.F.R. § 17.33(a); 45 C.F.R. § 102.3 (2022); 87 Fed. Reg. 15,100, 15,103 (March 17, 2022). For the reasons discussed below, after considering aggravating and mitigating factors and the underlying facts and circumstances in this case, I conclude that a reduced CMP of $13,441 is 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 engaged in the sale of a highly regulated and dangerous product. See generally 21 U.S.C. § 387 note (Findings and Purpose).

CTP argues the violation in this case is particularly serious because CTP previously issued a warning letter to Respondent on September 22, 2023 for selling an ENDS product that lacked the required marketing authorization. CTP Br. at 8; see also CTP Ex. 7. Specifically, the warning letter stated that during an inspection on August 5, 2023, an FDA inspector observed Respondent offering for sale an “Elfbar Honeydew Pineapple Orange ENDS product” which lacked the premarket authorization under the Act. CTP Ex. 7 at 1. The letter explained the sale of such products was prohibited and warned Respondent to take action to correct the violation. Id. at 1-3. The warning letter further stated that “all new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA’s discretion.” Id. at 3. The letter explained that future violations could result in enforcement action, “including, but not limited to, civil money penalties, seizure, and/or injunction by FDA.” Id. CTP contends that by continuing to sell prohibited ENDS products after receiving the letter, Respondent demonstrated an “unwillingness or inability to correct the violations .  .  .  ” CTP Br. at 9.

In its answer to the complaint, Respondent admitted to receiving the September 22, 2023 warning letter and stated it “notified the supplier to remove such products from the premises in an effort to comply with the Warning Letter.” CRD Dkt. Entry No. 4 at 1, ¶ 6. In its pre-hearing and final briefs, however, Respondent now denies receiving the warning letter and argues “there is absolutely no proof” it received the warning letter.

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R. Br. at 3-4; R. Final Br. at 3. In a sworn declaration, Respondent’s president, Abdul S. Khokar, also states he was not aware of the warning letter and that Respondent never received notice of any violation prior to the December 7, 2023 inspection. R. Ex. 1 at ¶¶ 6, 12. Relying on these arguments, Respondent contends the penalty should be reduced because it “was not made aware by Complainant, or from any other source, that the sale of the adulterated and misbranded tobacco product was prohibited.” R. Final Br. at 3. Respondent makes no attempt to reconcile the admission in its answer with its post- pleading arguments.

Given the prior admission in Respondent’s answer, I am not convinced by Respondent’s current argument that it never received the warning letter. As a general rule, admissions in the pleadings are conclusively binding on the parties. See Amgen Inc. v. Connecticut Ret. Plans & Tr. Funds, 568 U.S. 455, 470 n.6 (2013) (declining to consider argument inconsistent with facts admitted in answer). Such an admission becomes an established fact for the duration of the proceedings and eliminates the need for evidence or argument on that issue. See State Farm Mut. Auto. Ins. Co. v. Worthington, 405 F.2d 683, 686 (8th Cir. 1968). Moreover, “[i]t is well established that even if the post-pleading evidence conflicts with the evidence in the pleadings, admissions in the pleadings are binding on the parties.  .  .  .” Bright v. QSP, Inc., 20 F.3d 1300, 1305 (4th Cir. 1994) (citations and quotations omitted).

Here, Respondent’s answer, which was filed through counsel, clearly and unambiguously admitted the point it now tries to dispute—that Respondent received the warning letter. CRD Dkt. Entry No. 4 at 1, ¶ 7. Respondent’s answer even contained unsolicited details concerning the actions it took to comply with the warning letter. Id. As a result, I find that Respondent’s receipt of the warning letter is an established fact for purposes of this proceeding. See State Farm Mut. Auto. Ins. Co., 405 F.2d at 686. Any other outcome would be unfairly prejudicial to CTP, which presumably relied on the admission in deciding which evidence to submit with its pre-hearing exchange. Therefore, I conclude that Respondent is bound by its prior admission that it received the warning letter and decline to consider its post-pleading arguments to the contrary. See Amgen Inc., 568 U.S. at 470 n.6.

Further, while Respondent’s president states in a sworn declaration that Respondent never received notice of a prior violation, I find that this testimony, on its own, is insufficient to overcome the binding nature of Respondent’s prior admission. See Bright, 20 F.3d at 1305. In addition, I find that the declaration is not credible as it pertains to the warning letter because Respondent’s president has an interest in these proceedings and his testimony directly conflicts with the affirmative statements contained in Respondent’s answer. I also note that the warning letter was addressed to the same address used to serve the complaint. See CTP Ex. 7 at 1. For these additional reasons, I find no merit in Respondent’s claim that it never received the warning letter.

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Finally, I find that even if Respondent could demonstrate that it never received the warning letter, Respondent’s claim that it was not “made aware” of its obligations under the Act would not excuse or mitigate the violation in this case. As a retailer that has chosen to sell tobacco products, the burden is on Respondent to ensure it understands and complies with the applicable legal and regulatory requirements. Respondent cannot shift that burden to CTP or minimize its responsibility by claiming CTP failed to tell it what to do. Indeed, nothing in the Act requires CTP to provide individual guidance to a retailer prior to imposing a CMP. Thus, regardless of whether Respondent received the warning letter, I find that Respondent’s purported ignorance of its legal obligations does not constitute a mitigating circumstance.

In sum, after considering the parties’ arguments and submissions, I find that Respondent continued marketing and selling unauthorized ENDs products in violation of the Act even after receiving a warning from CTP about similar conduct and the potential consequences. Therefore, I conclude that CTP has demonstrated aggravating circumstances in this case which support the imposition of a significant penalty.

2. Ability to Pay and Effect on Ability to Continue to Do Business

Respondent contends it is unable to pay the proposed CMP and that the penalty would have a negative impact on its ability to continue doing business. R. Br. at 3; R. Final Br. at 3. In support of these arguments, Respondent relies on the declaration of its president, which states that the proposed CMP “would be a financial hardship for the Respondent.” R. Ex. 1 at 2. Respondent also submits its 2022 and 2023 corporate income tax returns. R. Exs. 2, 3. For 2022, the tax returns show Respondent reported gross profits of $233,173 and a taxable income of negative $21,021. R. Ex. 2. For 2023, the tax returns show Respondent reported gross profits of $257,270 with a taxable income of negative $17,464. R. Ex. 3.

I find that Respondent’s submissions do not demonstrate an inability to pay the proposed CMP, nor do they establish how much Respondent is able to pay. Indeed, the tax returns only show Respondent’s reported annual income after credits and deductions. R. Ex. 2, 3. As such, they do not provide a complete picture of Respondent’s financial position. Further, the statements by Respondent’s president are wholly conclusory and lack any degree of specificity. See R. Ex. 1 at 2. Respondent has not provided profit and loss statements, bank statements, sales reports, reports of assets and liabilities, or any similar documentation to support its position. Such evidence would have enabled me to fully assess Respondent’s arguments, potentially resulting in a greater reduction in the penalty amount.

Still, considering that Respondent’s tax returns show a negative taxable income for both 2022 and 2023, I am persuaded that imposing the full CMP would likely have a negative impact Respondent’s ability to continue doing business. While Respondent has failed to

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establish the extent of that impact, I acknowledge that the maximum penalty of $20,678 is a substantial sum of money, particularly for a business with a negative taxable income. Thus, while I find Respondent’s evidence lacking, I do find that Respondent has established mitigating circumstances on this basis which support at least a partial reduction in the penalty amount.

3. History of Prior Violations

There is no indication in the record of any prior violations of the Act resulting in a CMP. However, CTP argues that Respondent “has a history of violating the Act’s requirements” based on the previously discussed September 22, 2023, warning letter. CTP Br. at 10. CTP contends the maximum penalty of $20,678 is appropriate because Respondent’s history demonstrates an “unwillingness or inability” to comply with the law. Id.

As discussed above, I have already found that the warning letter constitutes an aggravating factor. However, the warning letter was not a final agency determination and did not result in any penalties imposed against Respondent. See CTP Ex. 7 at 3 (“Please note that this warning letter does not constitute final agency action….”). Further, Respondent did not have the opportunity to request a hearing or otherwise dispute the violations alleged in the letter. Id. Therefore, I disagree with CTP that the warning letter, on its own, demonstrates a significant history of prior violations.

I also note that Respondent’s president testified that Respondent removed the subject ENDS product from its store upon learning it was prohibited. R. Ex. 1 at 2. CTP attempts to argue that this testimony shows Respondent continues to violate the law because it only states Respondent removed “the product” at issue in this case as opposed to all unauthorized ENDS products. However, as CTP has not presented any evidence showing Respondent continues selling unauthorized ENDS products, its argument is too speculative to support any conclusions.2 Instead, I find that Respondent, by attempting to remedy the violation in the complaint, has at least demonstrated a willingness to comply with the law.

In sum, the record shows that this is Respondent’s first violation of the Act resulting in a CMP. In addition, Respondent submitted evidence which suggests it is attempting to comply with the law and avoid future violations. As a result, I conclude that Respondent does not have a significant history of prior violations or a substantial likelihood of committing future violations, which is mitigating factor that supports a reduction in the penalty amount.

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4. Degree of Culpability

Based on my finding that Respondent committed the violation alleged in the Complaint, I find Respondent fully culpable for offering for sale new tobacco products that were adulterated and misbranded, in violation of the Act. The Act places a heavy burden on retailers who choose to sell prohibited tobacco products because of their highly dangerous and addictive nature. See 21 U.S.C. § 387 note (Findings and Purpose). While Respondent states it has taken steps to avoid future violations, I find that those actions do not absolve Respondent of its responsibility to comply with the law in the first place.

5. Other Considerations

The Act gives me discretion to consider “other matters as justice may require” in determining whether a CMP is appropriate. See 21 U.S.C. § 333(f)(5)(B). As noted above, CTP is requesting the maximum penalty amount permitted by the regulations. See 45 C.F.R. § 102.3 (2022); 87 Fed. Reg. 15,100, 15,103 (March 17, 2022). In assessing this request, I find that justice requires me to consider the range of available penalties in light of the specific facts and circumstances of the case, separate and apart from the factors discussed above. In doing so, I note that the purpose of a CMP under the Act is to promote compliance with the law and deter future violations to protect public health. Therefore, a CMP should be sufficient to achieve this purpose, but not overly punitive.

Here, the record shows Respondent operates primarily as a gas station—not as a “vape shop” or a commercial distributor—and has no history of prior violations of the Act resulting in a CMP. See R. Exs. 1-3. Further, Respondent did not manufacture the subject ENDS product, but instead appears to have been selling it for individual use. In addition, Respondent claims it only sold a small number of the prohibited ENDS products over a three-month period and its revenue from the sales was minimal. See R. R. Br. at 3; R. Ex. 1 at 2.3 I also note that Respondent has actively participated in these proceedings, appears to be taking the violation seriously, and claims to have taken steps to reduce the likelihood of future violations.

On the other hand, as a retailer that has chosen to sell tobacco products for profit, Respondent should have been familiar with the applicable law and known which products it was permitted to sell. Further, Respondent continued selling prohibited ENDS products even after being warned about similar conduct and the potential consequences. In addition, by claiming the violation was, at least in part, due to CTP’s supposed failure

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to make it aware of the applicable law, Respondent has failed to take full accountability for its actions.

After weighing these competing factors, I find that imposing the maximum penalty would be overly punitive and would not serve the interests of justice. However, I also find that Respondent’s conduct was serious in nature and warrants a proportional penalty.Therefore, based on these additional factors, I conclude that a reduced, but still substantial, CMP is appropriate in this case.

6. Penalty Determination

Respondent asks me to impose a penalty in the amount of $1,000. R. Br. at 4; R. Final Br. at 4. However, the amount proposed by Respondent is less than one-twentieth of what CTP is seeking and is not supported by any methodology or rationale. Further, the Act contemplates substantially higher penalties to disincentive the sale of unauthorized tobacco products. Based on these factors, as well as the circumstances of the violation and the overriding public health interests at stake, I find that imposing a $1,000 penalty in this case would not sufficiently promote compliance with the Act or deter future violations. Instead, I find that the CMP proposed by CTP, which is more consistent with the penalties authorized by the Act, provides a reasonable starting point for determining an appropriate reduction.

Based on the record evidence, the applicable law, and the aggravating and mitigating factors outlined in this decision, I find that a thirty-five percent reduction in the penalty proposed by CTP is warranted. Therefore, I conclude that a reduced penalty of $13,441 is appropriate under 21 U.S.C. §§ 333(f)(5)(B), (f)(5)(C), and (f)(9).

V. Conclusion

For the reasons stated above, I impose a civil money penalty against Respondent, Samee Crown, Inc. d/b/a Marathon in the amount of $13,441 for receiving in interstate commerce an ENDS product that lacks the premarketing authorization required under the Act and offering such product for sale. 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.