Debwany Incorporated d/b/a Let's Stop and Shop / Citgo, DAB TB9499 (2025)

INITIAL DECISION

The Center for Tobacco Products (CTP) seeks to impose a $19,192 civil money penalty (CMP) against Debwany Incorporated d/b/a Let’s Stop and Shop / Citgo (Respondent) for impermissibly receiving in interstate commerce electronic nicotine delivery system (ENDS) products that lack the required premarketing authorization, thereby violating the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. §§ 301 et seq.

For the reasons discussed below, I find Respondent violated the Act as alleged by CTP and that a CMP in the amount $19,192 is appropriate.

I. Background and Procedural History

Respondent does business under the name of Let’s Stop and Shop / Citgo located at 3912 Coliseum Boulevard, Alexandria, Louisiana 71303.  Civil Remedies Division (CRD) Docket (Dkt.) Entry Number (No.) 1 ¶ 14 (Complaint).  On June 13, 2023, CTP issued a Warning Letter to Respondent notifying Respondent that on May 27, 2023, an inspector

Page 2

representing the FDA witnessed electronic nicotine delivery system (ENDS) products that lacked the required marketing authorization offered for sale at Respondent’s establishment.  CRD Dkt. Entry No. 11h at 1.

On August 15, 2023, FDA-Commissioned officer Krystle Johnson inspected Respondent’s business.  CTP Ex. 2 at 1.  During the inspection, Inspector Johnson observed, “that the establishment sold FDA-regulated tobacco products and had a sales display containing tobacco products, including Elfbar Rainbow Cloudz and Elfbar Blueberry Energize” ENDS products for sale.  Id. ¶ 6.  While at the establishment, Inspector Johnson took photographs of the store and its external signage, of the Elfbar ENDS products, and of the products’ placement within the establishment.  Id.

On November 24, 2023, CTP began this matter by serving an Administrative Complaint on Respondent at 3912 Coliseum Boulevard, Alexandria, Louisiana 71303 by United Parcel Service and by filing a copy of the Complaint with the Food and Drug Administration’s (FDA’s) Division of Dockets Management.  Complaint, CRD Dkt. Entry No. 1b (Proof of Service).

On January 25, 2024, Respondent timely filed an Answer.  CRD Dkt. Entry No. 6 (Answer).  In its Answer, Respondent admitted some allegations and denied others.  See Id.  Respondent specifically admitted that it owns the establishment doing business under the name of Let’s Stop and Shop / Citgo located at 3912 Coliseum Boulevard, Alexandria, Louisiana 71303, that it received the tobacco products in interstate commerce, Elfbar Rainbow Cloudz and Elfbar Blueberry Energize ENDS products, that it delivers or proffers delivery of such tobacco products for pay or otherwise, and that on August 15, 2023, an FDA-commissioned inspector conducted an inspection of Respondent’s establishment and observed Elfbar Rainbow Cloudz and Elfbar Blueberry Energize ENDS products for sale at Respondent’s establishment.  Answer at 1-2.

Further, Respondent denied the following allegations in its Answer specifically stating they were “denied for lack of sufficient information upon which to base a belief . . . [a]dmitted but not known at the time displayed and sold”:

(1) Respondent’s ENDS products are new tobacco products because they were not commercially marketed in the United States as of February 15, 2007;

(2)That its ENDS products do not have a Market Granted Order in accordance with 21 U.S.C. § 387j(c)(1)(A)(i) and are thus adulterated per 21 U.S.C. § 387b(6)(A); and

(3 )That neither a substantial equivalent report nor an abbreviated report has been submitted for any of Respondent’s ENDS products, and they are therefore misbranded under 21 U.S.C. § 387c(a)(6)

Id. at 2

Page 3

Respondent further states:

The allegations of Paragraph 21 of the Complaint are denied for lack of sufficient information upon which to base a belief.  Respondent denies any personal knowledge of the receipt of the letter; no employee ever advised of any letter receipt and 2 employees at the time are no longer available.  The allegations of Paragraph 22 of the Complaint are denied for lack of sufficient information upon which to base a belief.  Respondent denies any knowledge of the content of the letter.

Id. at 2-3.

In its Answer, Respondent also raised defenses, including reiterating its denial of Complaint paragraph 21, and that Respondent:

[D]id receive personal delivery of a letter on or about October 1, 2023, from the Louisiana Office of Alcohol and Tobacco Control.  Respondent believed that the letter was advising him that the FDA had prohibited the sale of vapes in Louisiana and all such products must be removed from any sales area within 10 days. Respondent acted immediately and after closing on or about October 1, 2023, did remove all vape products, including the Elf Bar ENDs, and all of the removed products remained boxed in a storage area . . . .  Respondent chose not to replace any of the vape-nicotine products until he gained a full understanding of all F.D.A. issues . . . [and] was actually compliant with the F.D.A. ban on the Elf Bar ENDs products at the time he was served with the complaint.

Id. at 3-4.

On January 26, 2024, I issued an Acknowledgment and Pre-Hearing Order establishing procedural deadlines for this case.  CRD Dkt. Entry No. 7.  On February 28, 2024, the parties filed a Joint Status Report stating that the parties intended to engage in additional settlement discussions.  CRD Dkt. Entry No. 8.  On April 10, 2024, CTP filed an Unopposed Motion to Extend Deadlines requesting that the upcoming deadlines be extended.  CRD Dkt. Entry No. 9.  On April 11, 2024, I granted CTP’s unopposed request to extend the deadlines.  CRD Dkt. Entry No. 10. 

On June 13, 2024, CTP timely filed its pre-hearing exchange consisting of an informal brief (Informal Brief of Complainant), a proposed witness and exhibit list, and eight proposed exhibits.  CRD Dkt. Entry Nos. 11, 11a-i.  CTP’s exchange included the written

Page 4

testimony of two witnesses: 1) James Bowling, Deputy Division Director, Office of Compliance and Enforcement, FDA, CTP (CTP Ex. 1); and 2) Krystle Johnson, FDA-commissioned officer with Computer Evidence Specialists (CTP Ex. 2).  Id. at 11b-11c.

On July 10, 2024, Respondent untimely filed its prehearing exchange consisting of a pre-hearing brief (Pre-Hearing Brief R.).  CRD Dkt. Entry No. 12.  Respondent did not submit any proposed witnesses or exhibits.

On July 11, 2024, the parties sent an electronic mail message to the attorney advisor assisting me with this case advising that they had “met, conferred, and requested that the prehearing conference . . . be scheduled for Tuesday, August 6, 2024 at 1:PM.”  CRD Dkt. Entry No. 13 at 1.  Additionally, in electronic mail messages between CTP and a representative from Respondent Counsel’s office, which included a carbon copy to the attorney advisor assisting me with this case, the parties discussed Respondent filing a “motion” for “leave to file witness and exhibit list and exhibits out of time.”  CRD Dkt. Entry No. 15 at 2-3.  CTP responded to Respondent’s request by stating in an electronic mail message “CTP does not oppose your motion for leave to file out-of-time.”  Id. at 2.

On July 11, 2024, I issued an Order Scheduling Pre-Hearing Conference and Final Deadline for Respondent’s Pre-Hearing Exchange which set a deadline of July 25, 2024 for Respondent’s final pre-hearing exchange filings and set the pre-hearing conference for August 6, 2024.  CRD Dkt. Entry No. 14.

On July 25, 2024, Respondent filed a Witness and Exhibit List and eight proposed exhibits.  CRD Dkt. Entry Nos. 16, 16a-16h.  Respondent’s exchange included the written testimony of three witnesses: 1) Maggey1  Rebecca Turner Winterer, former employee of Respondent (R. Ex. 1.); 2) Caitlin Wells, former employee of Respondent (R. Ex. 2); and 3) Yaser Awawdeh, owner of the business Debwany Incorporated d/b/a Let’s Stop and Shop / Citgo (R. Ex. 8).

I held a pre-hearing conference (PHC) via Microsoft Teams on August 6, 2024.  CRD Dkt. Entry No. 17 at 1.  At the PHC, we discussed the allegations in the Complaint, Respondent’s Answer and its admissions to liability, the issues to be decided in this case, the burdens of proof, the purpose of conducting a hearing in this case, the procedural history, the administrative record, and the parties’ pre-hearing exchanges and proposed witnesses.  Id.  During the PHC, I advised that I would allow the parties to file written objections to the opposing party’s exhibits and that both parties would have time to respond to any written objections.  Id. at 2.

Page 5

During the PHC, it was further explained to the parties that the sole purpose of conducting a hearing is to allow for the cross-examination of any witnesses in which sworn direct testimony was submitted in a party’s pre-hearing exchange.  Id.  Respondent requested to cross-examine CTP’s proposed witness: FDA-commissioned officer Krystle Johnson.  Id.  I reminded Respondent that any cross-examination must be relevant to the remaining issue, which is the appropriateness of any of CMP, as Respondent has admitted the allegations alleged in the Complaint.  Also, I explained that any cross-examination questions are limited to the information in the statements made in the sworn declaration.  Id.

After the conclusion of the pre-hearing conference, I issued an Order Following Pre-Hearing Conference and advised the parties that they had until August 30, 2024 to file any written objections to the opposing party’s proposed exhibits, and that the parties would have until September 16, 2024 to respond to any objections to the opposing party’s proposed exhibits or pre-hearing exchange, and that, thereafter, I would review any objections and responses and issue a ruling on the admission of the parties’ proposed exhibits and pre-hearing exchanges.  Id.  I further advised that the hearing in this case was set for October 8, 2024 at 11:00 AM Eastern Time.  Id.  Neither party filed written objections to the opposing party’s exhibits.

On September 24, 2025, I issued a Notice of Hearing in this case providing the parties the call-in information and instructions for the hearing set for October 8, 2024.  CRD Dkt. Entry No. 18.

On October 1, 2024, Respondent filed an Unopposed Motion to Delay the October 8, 2024 Hearing.  CRD Dkt. Entry No. 19.  On October 7, 2024, I granted the unopposed motion providing instructions for the parties to confer and select a new hearing date.  CRD Dkt. Entry No. 20.  On November 22, 2024, I issued a Notice of Hearing providing the parties with the call-in information and instructions for the hearing set for December 10, 2024 at 11:00 AM Eastern Time.  CRD Dkt. Entry No. 22.

On December 10, 2024, I conducted a hearing in this case.  During the hearing, I admitted all exhibits into the administrative record, including CTP Exhibits (Exs). 1-8 (CRD Dkt. Entry Nos. 11b-11i), and Respondent’s Exs. 1-8 (CRD Dkt. Entry Nos. 16a-16h).  Hearing Transcript (Tr.) at 8-9.  Respondent’s counsel conducted cross-examination of Inspector Krystle Johnson.  Hearing Tr. at 9-23.

On January 16, 2025, the hearing transcript was uploaded to the DAB E-File system.  CRD Dkt Entry No. 24.  On January 29, 2025, I issued an Order establishing deadlines for the parties’ post-hearing brief submissions and transcript corrections.  CRD Docket Entry No. 25.  On March 21, 2025, CTP filed its final brief (CTP Final Br.) and two exhibits, and Respondent filed its Post-Hearing Brief (Post-Hearing Br. R.).  CRD Dkt. Entry Nos. 26, 26a-26b, 27.  On April 4, 2025, CTP filed a Motion to Extend Deadlines

Page 6

requesting a 30-day extension due to a reduction in force within its office that supports all tobacco-related administrative cases.  CRD Dkt. Entry No. 28.  On April 8, 2025, I granted CTP’s motion and extended the remaining post-hearing briefing deadlines in this case.  CRD Dkt. Entry No. 29.  On May 21, 2025, CTP filed Complainant’s Response to Respondent’s Final Brief and one exhibit.  CRD Dkt. Entry No. 30, 30a.  Also on May 21, 2025, Respondent submitted a Reply Brief.  CRD Dkt. Entry No. 32.  Accordingly, the record is now closed, and I will decide this case based on the evidence in the administrative record.  21 C.F.R. §§ 17.41, 17.45(c).

I will consider the full administrative record in deciding this case.  The administrative record contains a transcript of testimony, 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

There are two issues for me to decide in this case:

• Whether Respondent received adulterated and misbranded Elfbar Rainbow Cloudz and Elfbar Blueberry Energize ENDS products in interstate commerce and delivered or proffered delivery thereof for pay or otherwise, in violation of 21 U.S.C. § 331(c) on August 15, 2023; and, if so,
• Whether a $19,192 CMP is appropriate, considering any mitigating or aggravating factors that I find in this case.

III. Analysis

A. CTP has demonstrated by a preponderance of the evidence that Respondent received the adulterated and misbranded Elfbar Rainbow Cloudz and Elfbar Blueberry Energize ENDS products in interstate commerce and delivered or proffered delivery thereof for pay or otherwise on August 15, 2023, in violation of the Act.

The Act prohibits the receipt in interstate commerce of any tobacco product that is adulterated or misbranded and the delivery or proffered delivery thereof 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

Page 7

equivalence order 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 that is required to have premarket review and does not have an MGO permitting marketing of the new tobacco product in effect under 21 U.S.C. § 387j(c)(1)(A)(i), is adulterated.  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 exemption 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 Division Director for the Division of Enforcement and Manufacturing, in CTP’s Office of Compliance and Enforcement, FDA; and Krystle Johnson, FDA-commissioned officer with Computer Evidence Specialists, LLC.  CTP Exs. 1-2.  Inspector Johnson testified that she conducted a compliance inspection of Respondent’s establishment Let’s Stop and Shop / Citgo, located at 3912 Coliseum Boulevard, Alexandria, Louisiana 71303, on August 15, 2023, at approximately 6:21 PM.  CTP. Ex. 2 ¶¶ 4-7; see also CTP Exs. 3-6 (Inspector Johnson’s August 2023 Narrative Report; the August 2023 TIMS Assignment Form; the August 2023 Photographs of Elfbar Rainbow Cloudz and Elfbar Blueberry Energize ENDS products; and the August 2023 Form FDA 482).  Inspector Johnson testified that during the August 15, 2023 inspection, she observed that Respondent’s establishment sold FDA-regulated tobacco products and the establishment had a sales display containing tobacco products, including Elfbar Rainbow Cloudz and Elfbar Blueberry Energize ENDS products available for sale.  CTP. Ex. 2 ¶ 6.  Inspector Johnson recorded the inspection in the FDA’s Tobacco Inspection Management System (TIMS) and created a Narrative Report dated August 15, 2023.  Id. ¶ 7.  Inspector Johnson further testified that CTP exhibits 3 and 4 are true and accurate copies of the Narrative Report and TIMS Form regarding the inspection.  Id.

James Bowling testified that the products “Elfbar Rainbow Cloudz” and “Elfbar Blueberry Energize,” being offered for sale at Respondent’s establishment during the August 15, 2023 inspection, do not have any registered establishments in the state of Louisiana or elsewhere in the United States.  CTP Ex. 1 ¶ 6.  Deputy Division Director Bowling further testified that:

. . . the Elfbar Rainbow Cloudz and Elfbar Blueberry Energize ENDS products are manufactured in China . . . [he] can confirm that Elfbar Rainbow Cloudz and Elfbar Blueberry Energize 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 Elfbar Rainbow Cloudz and Elfbar Blueberry Energize ENDS products being offered for sale at Respondent’s establishment, there was no record of this product having an

Page 8

authorized FDA marketing granted orders 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 of the Elfbar Rainbow Cloudz and Elfbar Blueberry Energize ENDS products had not submitted a report requesting a substantial equivalence order under 21 U.S.C. §387e(j) . . . the Elfbar Rainbow Cloudz and Elfbar Blueberry Energize ENDS products 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 of the Elfbar Rainbow Cloudz and Elfbar Blueberry Energize ENDS products had not submitted an abbreviated report requesting a found-exempt order for such product under 21 U.S.C. § 387e(j)(1).

CTP Ex. 1 ¶¶ 9, 11-13.

Respondent has not disputed any of the statements made in the written direct testimony of CTP’s two witnesses.  Based on the uncontested testimony of James Bowling and Inspector Johnson, as well as the supporting evidence submitted by CTP, I find that the Elfbar Rainbow Cloudz and Elfbar Blueberry Energize ENDS products observed during the August 15, 2023 inspection were received in interstate commerce.  I also find that the Elfbar Rainbow Cloudz and Elfbar Blueberry Energize ENDS products were adulterated because they lacked the required FDA marketing authorization and were not exempt from this requirement.  21 U.S.C. §§ 387j(a)(2)(A), 387e(j)(3)(A).  Finally, under 21 U.S.C. § 387c(a)(6), the Elfbar Rainbow Cloudz and Elfbar Blueberry Energize ENDS products were misbranded because there was no substantially equivalent determination as required by 21 U.S.C. § 387e(j). 

B. Respondent has not demonstrated, by a preponderance of the evidence, the existence of mitigating circumstances to support a reduced CMP.

I determined that Respondent violated the prohibition against receiving in interstate commerce adulterated and misbranded tobacco products and the delivery or proffered delivery thereof for pay or otherwise.  21 U.S.C. § 331(c).  Pursuant to 21 U.S.C. § 333(f)(9)(A) and 21 C.F.R. § 17.2, a CMP of up to $19,192 is permissible for a violation of 21 U.S.C. § 331(c).  See also 45 C.F.R. § 102.3.

In its Complaint, CTP seeks to impose the maximum CMP amount of $19,192 against Respondent.  Complaint ¶ 1.  In its Answer, Respondent contends that the CMP sought by CTP is too high because:

Page 9

Respondent did not actually receive the alleged June 13, 2023 warning letter and in fact has never sold Elf Bar [sic] ENDs to anyone under 21 years of age.  Respondent clearly would have responded, as he did, to the October 1, 2023 warning letter from the State of Louisiana . . . said amount would impose a financial burden and hardship on sustaining the shop now during these economic times and in the future. 

Answer at 4.  

In its Informal Brief of Respondent (Inf. Br. R.), Respondent states it:

[D]oes not believe the maximum penalty of $19,192.00 is appropriate. Respondent did not have any knowledge or intent to violate the law. It took the Federal Government time and effort to discover and prove the problem but [it] did not take additional time to communicate with the States . . .  no such letter was received at the store . . . Mr. Awawdeh had no information until the State letter was received, at which time he acted immediately.” 

Inf. Br. R. at 5.  See also R. Ex. 8.

Further, in its Answer, Respondent offers as a defense:

Respondent has no personal knowledge of any FDA “warning letter.”  Such letter could have been delivered and received by an employee working during the day of delivery. No employee told him of or showed him any such letter. Neither of the two employees working on or about June 13, 2023 are still working for Respondent and have not been located2 . . . .

Respondent’s shop was subsequently inspected by a Louisiana State A.T.C. inspector [on October 1, 2023], who advised that all vapes did not have to be removed, only those identified by the F.D.A.  Respondent chose not to replace any of the vape-nicotine products until he gained a full understanding of all F.D.A. issues.

Answer at 3-4.

Page 10

However, in its Post-Hearing Brief of Respondent (Post Hearing Br. R.), Respondent asserts:

Respondent believes the Court can understand Respondent’s inability to understand the federal/state relationship . . . .  As Respondent sees it, his problem began when he did not receive the FDA Warning Letter and lasted until he got the STATE Warning Letter, when he immediately  complied with both. Then, he received a Complaint for prosecution and a monetary penalty.

Post Hearing Br. R. at 13.

Respondent offers as mitigation the size of his store, the amount of his expenses, the income derived from all sales as shown in R. Ex. 6, and that Respondent is the single and only permanent employee at the store.  Id.

When determining the appropriate amount of a CMP, I must consider any aggravating or mitigating circumstances and the factors listed in the Act.  21 C.F.R. § 17.34(a)-(b).  Specifically, I am required to 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); 21 C.F.R. § 17.45(b)(1)-(3).

 1. Nature, Circumstances, Extent and Gravity of the Violations

The Family Smoking Prevention and Tobacco Control Act (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).

The Act was designed to protect consumers from dangerous products that lack the premarketing authorization required under the Federal Food, Drug, and Cosmetic Act.  Respondent is in the business of receiving and selling highly regulated and dangerous products.  Respondent’s Counsel argues that Respondent was “actually compliant with the F.D.A. ban on the Elf Bar [sic] ENDs products at the time he was served with the complaint” because after the October 1, 2023 State inspection, Respondent removed all Elf Bar ENDS products.  Answer at 4.  Whether Respondent’s establishment had illegal tobacco products on its shelves after the inspection, or at the time Respondent was served with the Complaint, does not absolve Respondent of its violation on August 15, 2023 when Inspector Johnson inspected the establishment.  Further, Respondent’s Counsel asserts that “Respondent believes the Court can understand Respondent’s inability to understand the federal/state relationship.”  Post Hearing Br. R. at 13.  Respondent is

Page 11

solely responsible for ensuring all tobacco products in its possession and offered for sale comply with the federal tobacco regulations.  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).  Respondent has a duty to comply with the federal tobacco laws that are applicable to the products that Respondent chooses to sell.

Furthermore, CTP correctly asserts the well-settled legal principal that ignorance of the law is not a defense to liability, even in the context of civil liability.  See Jerman v. Carlisle, McNellie, Rini, Kramer & Ulrich LPA, 559 U.S. 573, 581 (2010).  I find Respondent’s lack of knowledge regarding federal law does not mitigate Respondent’s liability.

Therefore, the CMP appropriately sought by CTP cannot be waived because Respondent had an inability to understand the state versus federal regulation of tobacco products and how they differ.  Thus, after consideration of the complete administrative record, I find that the nature circumstances, extent, and gravity of the violation does not constitute a mitigating factor.

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

Respondent argues that Respondent’s store size, expenses, income derived from all sales, and that he only “purchased the Elfbar/Ends products 3 times for a total of $1,278” are mitigating factors.  Post Hearing Br. R. at 13; R. Ex. 6; R. Ex. 8 ¶ i.  However, it is unclear from Respondent’s exhibits what Respondent’s assets, cash reserves, credit worthiness, or other potential sources of capital are which, if provided, would be highly relevant factors regarding Respondent’s ability to pay the CMP.  See Joy and Evergreen Petro, Inc. d/b/a Sunoco, DAB No. CR4698 (2016) (finding that business income is inadequate to prove that Respondent is incapable of paying the penalty).  Respondent fails to offer sufficient evidence to support his position that paying the CMP would affect its ability to continue its business.

Respondent acknowledges liability in this case and Respondent has failed to submit evidence of its complete financial situation.  As I am limited to the evidence in the record, I find that Respondent has not established an inability to pay as a mitigating factor.

3. History of Prior Violations

There is no indication in the record of any prior violations of 21 U.S.C. § 331(c) resulting in a CMP.  However, CTP argues that there is a history of prior violations because Respondent was notified in the Warning Letter that it was in violation of the Act by offering for sale tobacco products that lacked the required premarketing authorization. 

Page 12

Informal Brief of Complainant at 11 (citing CTP Ex. 7).  CTP also argues that Respondent continued to offer for sale new tobacco products that lacked the required premarket authorization or exemption and thus demonstrated an unwillingness or inability to comply with federal tobacco laws.  Id. at 11-12.

Respondent asserts that it did not receive the warning letter on June 13, 2024.  R. Ex. 1 at 1-2; R. Ex. 8 at 2-3; Post Hearing Br. R. at 10-11.  However, CTP acknowledges that while the letter was sent on June 13, 2024, it is highly unlikely that it would have been received on the same date it was sent.3  CTP Final Br. at 3.  Nevertheless, 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 history of prior violations.

4. Degree of Culpability

Based on my finding that Respondent committed the violation alleged in the Complaint, I hold the Respondent fully culpable for receiving adulterated and misbranded ENDS products in interstate commerce and delivering or proffering delivery thereof for pay or otherwise, in violation of 21 U.S.C. § 331(c).  Because of the highly dangerous and addictive nature of tobacco products, the Act places restrictions on retailers who choose to sell tobacco products and demands compliance.  See 21 U.S.C. § 387 note (Findings and Purpose).  Even though Respondent may no longer be selling Elfbar tobacco products, Respondent has gone to great lengths to assert his confusion regarding state and federal law; none of which releases Respondent from its responsibility as a retailer of tobacco products and it is therefore fully culpable for the violation on August 15, 2023.

5. Other Such Matters as Justice May Require

Respondent also made other assertions that several unrelated federal cases show that FDA’s process for approving new tobacco products through Premarket Tobacco Product Applications (“PMTAs”) is arbitrary and “replete with acts and omissions that rise to the level of neglect for the nature of the violation put forth herein to protect the public.”  Post Hearing Br. R. at 7, 9.  Respondent’s arguments are irrelevant.  Furthermore, Respondent has admitted liability in this case and the only remaining factor for determination is the appropriateness of a civil money penalty.

Page 13

Respondent also makes several policy arguments that ultimately shift the burden of compliance to CTP and suggest that CTP has not done enough to educate retailers.  Pre-Hearing Br. R at 6; Post Hearing Br. R. at 11-14.  These arguments are also irrelevant and exceed the scope of what is at issue in this case.  Respondent cannot shirk its responsibility to comply with applicable legal requirements.  While I recognize that Respondent may have experienced challenges in trying to comply with the Act, this does not relieve Respondent of its obligation to conduct its business in accordance with federal law.

Additionally, Respondent also cites to its response to a state warning letter and argues that it should be considered a mitigating factor.  Post Hearing Br. R. at 13.  I reject this assertion.  The purported state letter was received by Respondent and Respondent’s actions to comply with state law do not alleviate it of complying with federal law.  Respondent’s failure to comply with federal law is serious and supports a penalty.

Although I have considered all Respondent’s arguments, my decision must be based only on the administrative record and include findings on whether Respondent’s actions identified in the Complaint violated the law; whether any affirmative defenses are meritorious; and the appropriate amount of the penalty considering any mitigating or aggravating factors.  21 C.F.R. § 17.45(a).  I do not have the authority to find federal statutes or regulations invalid.  21 C.F.R. § 17.19(c).

Respondent must prove any mitigating factors by a preponderance of the evidence.  21 C.F.R. § 17.33(c).  These CMPs are in place to ensure retailers comply with the laws that aid in keeping the American people safe.  After considering the entire record, applicable law, 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, I find that a CMP in the amount of $19,192 is appropriate.  21 U.S.C. § 333(f)(5)(B); 21 C.F.R. § 17.45(b)(1)-(3).

Page 14

IV. Conclusion

For these reasons set forth above, I impose a CMP against Respondent Debwany Incorporated d/b/a Let’s Stop and Shop / Citgo in the amount of $19,192 for receiving adulterated and misbranded ENDS products in interstate commerce and delivered or proffered delivery thereof for pay or otherwise.  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.