M & A Brothers, Inc. d/b/a Grocery Station, DAB TB9180 (2025)

INITIAL DECISION

Found:

1) Respondent violated 21 U.S.C. § 301 et seq., specifically 21 U.S.C. § 331(c), as charged in the Complaint.
2) Respondent committed at least one violation as set forth hereinafter.
3) Respondent is hereby assessed a civil penalty in the amount of $5,000.

Glossary:

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I. JURISDICTION

I have jurisdiction to hear this case pursuant to my appointment by the Secretary of Health and Human Services (Secretary) and my authority under the Administrative Procedure Act (5 U.S.C. §§ 554-556), 5 U.S.C.A. § 3106, 21 U.S.C. § 333(f)(5), 5 C.F.R. §§ 930.201 et seq. and 21 C.F.R. Part 17.2

II. PROCEDURAL BACKGROUND

The Center for Tobacco Products (CTP or Complainant) filed a complaint on April 8, 2024, against M & A Brothers, Inc. d/b/a Grocery Station (Respondent), located 10810 East Via Linda, Scottsdale, Arizona 85259.  CRD Docket (Dkt.) Entry No. 1 (Complaint).  The Complaint alleges that Respondent received adulterated and misbranded electronic nicotine delivery system (ENDS) products in interstate commerce and delivered or proffered delivery thereof for pay or otherwise, in violation of 21 U.S.C. § 331(c).  Complaint ¶ 1.

Respondent was served with process on April 5, 2024, by United Parcel Service.  CRD Dkt Entry No. 1b.  On April 19, 2024, Respondent filed its Answer.  CRD Dkt. Entry Nos. 3 (Answer), 3a.3  In its Answer, Respondent denied the allegation.  Answer ¶ 1.

As a defense, Respondent stated, that he “was not aware … [he] was selling any illegal product” and that he “went off what the first inspector told [him] to pull off the shelf … apparently she missed one … Selling the product was not only not intentional

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but also I thought I was doing the right thing by discontinuing all vapes.”  Answer ¶ 3.  With regard to the civil money penalty, Respondent indicated that “this civil money penalty would hurt my business.  Id.

On April 24, 2024, the previously assigned Administrative Law Judge,4 Marla Y. Johnson, issued an Acknowledgement and Status Report Order.  CRD Dkt. Entry No. 4.  On June 21, 2024, CTP filed a Joint Status Report advising that the parties had not reached a settlement but intended to continue to engage in settlement discussions.  CRD Dkt. Entry No. 5.  On July 1, 2024, Judge Johnson issued a Pre-Hearing Order (PHO) establishing what the parties must do to present evidence and arguments in this case.  CRD Dkt. Entry No. 6 (PHO).  The PHO directed the CTP to file its pre-hearing exchange by September 20, 2024 and the Respondent to file its pre-hearing exchange by October 11, 2024.  PHO ¶ 5.

On July 31, 2024, Respondent filed a motion to extend all deadlines stating the CTP had recently apprised him of the offered settlement amount and that he “decided to hire an attorney … I am asking for 30 days of extension so I can find an attorney and prepare for my case.”  CRD Dkt. Entry No. 7.  On August 8, 2024, Judge Johnson granted Respondent’s motion for an extension and set the deadline for the parties to serve requests for documents for August 30, 2024, CTP’s pre-hearing exchange deadline was extended to October 21, 2024, and Respondent’s pre-hearing exchange deadline was extended to November 11, 2024.  CRD Dkt. Entry No. 8.

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On October 18, 2024, this case was transferred from to me.  See CRD Dkt. Entry No. 10.

On October 21, 2024, Respondent filed a document entitled “Appeal Letter.”5  CRD Dkt. Entry No. 11.  Also on October 21, 2024, CTP filed its pre-hearing exchange consisting of an informal brief, a list of proposed witnesses and exhibits, and seven proposed exhibits.  CRD Dkt. Nos. 12, 12a-12h.  CTP proposed the written testimony of two proposed witnesses:  Deputy Division Director,  James Bowling, and FDA-Commissioned Officer, Diane H. Burkett.  CRD Dkt. Entry Nos. 12b, 12c.

On October 24, 2024, I issued an Amended Pre-Hearing Order adjusting Respondent’s pre-hearing exchange deadline from November 11, 2024 to November 12, 2024.6  CRD Dkt. Entry No. 13.  On November 11, 2024, Respondent filed a document entitled “Letter of Declaration.”  CRD Dkt. Entry No. 14.

On November 18, 2024, I issued an order scheduling a hearing for January 14, 2025.  CRD Dkt. Entry No. 15.  The November 18, 2024 Order directed the parties to file any motions to exclude or object to the other party’s proposed exhibits by December 30, 2024 and also informed the parties that they had until December 30, 2024 to indicate which witnesses they wished, if any, to cross-examine at the hearing and that if neither party wished to cross-examine an opposing party’s witness that I would cancel the hearing and proceed to a written decision on the record.  Id.

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On November 19, 2024, CTP emailed CRD management stating, “CTP does not wish to proceed to a Hearing in this case and does not object to any of Respondent’s exhibits.”  CRD Dkt. Entry No. 16.  On December 9, 2024, Respondent filed a document stating that he also did not wish to proceed to a hearing.  CRD Dkt. Entry No. 17.

On December 10, 2024, I issued an order cancelling the hearing as both parties had expressed their waiver of a hearing in this case and set deadlines regarding how the parties should address their own and the opposing party exhibits.  CRD Dkt. Entry No. 18.

On December 12, 2024, CTP moved to admit their seven exhibits into evidence.  CRD Dkt. Entry No. 19.

On January 3, 2025, I issued an order setting the final briefing schedule for this case giving the parties until January 23, 20257 to submit final written briefs on the merits of this case.  CRD Dkt. Entry No. 20.  My January 3, 2025 Order also granted CTP’s Motion to Admit Evidence and admitted CTP’s exhibits and as CTP did not object to Respondent’s exhibits, Respondent’s exhibits were also admitted.  Id. at 1-2.

On January 13, 2025, CTP filed Complainant’s Notice of Waiver of Final Brief.  CRD Dkt. Entry No. 21.  Respondent did not file a final brief.  The administrative record is now closed and ready for a decision based on the written record.  21 C.F.R. § 17.45(c).

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III. BURDEN OF PROOF

As the petitioning party, CTP, has the burden to prove, by a preponderance of the evidence, that Respondent is liable and that the proffered penalty is appropriate.  21 C.F.R. § 17.33.

IV. LAW

21 U.S.C. § 301 et seq., specifically 21 U.S.C. § 331(c), 21 U.S.C. § 387b(6)(A), 21 U.S.C. § 387c(a)(6), and 21 U.S.C. § 387j(a)(2)(A).

V. ISSUE

Did Respondent violate 21 U.S.C. § 301 et seq., specifically 21 U.S.C. § 331(c), as alleged in the Complaint and, if so, whether the proffered penalty is appropriate?

VI. ALLEGATIONS

A. Complainant’s recitation of facts

In its complaint, CTP alleged that Respondent owns an establishment, doing business under the name Grocery Station, located at 10810 East Via Linda, Scottsdale, Arizona 85259.  Complaint ¶ 13.  CTP also alleged that Respondent’s establishment received tobacco products, including an Elfbar Kiwi Passion Fruit Guava ENDS product, in interstate commerce and delivered or proffered delivery of such tobacco products for pay or otherwise.  Id. ¶ 14.

CTP’s complaint further alleged that on September 22, 2023, CTP issued a Warning Letter to Respondent, stating that a new tobacco product that Respondent sells and/or distributes is adulterated and misbranded because it lacks the required FDA

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marketing authorization, specifically an Elfbar Cranberry Punch ENDS Product.  Id. ¶ 20; see also CTP Ex. 7 at 1-2.

During a subsequent inspection of Grocery Station on December 19, 2023, an FDA-commissioned inspector observed an Elfbar Kiwi Passion Fruit Guava ENDS product for sale at Respondent’s establishment.  Id. ¶ 15.

Respondent’s ENDS product is a “new tobacco product” because it was not commercially marketed in the United States as of February 15, 2007.  Id. ¶ 16.

Respondent’s ENDS product does not have an order permitting marketing of the new tobacco product under 21 U.S.C. § 387j(c)(1)(A)(i) and is therefore adulterated under 21 U.S.C. § 387b(6)(A).  Id. ¶ 17.

Respondent neither submitted a substantial equivalent report nor an abbreviated report for Respondent’s ENDS product, and the products are therefore, misbranded under 21 U.S.C. § 387c(a)(6).  Id. ¶ 18.

Respondent’s receipt of the adulterated and misbranded ENDS product in interstate commerce and delivered or proffered delivery thereof for pay or otherwise violates of 21 U.S.C. § 331(c).  Id. ¶ 19.

B. Respondent’s recitation of facts

In its Answer, Respondent denies the allegations in the Complaint stating that it did not “intentionally mean to sell any illegal tobacco products. All vapes from the first inspection were thrown in the trash.”  Answer ¶ 1.  In its Answer, Respondent provided the following defense:

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After first inspection I was told what products were illegal.  I immediatly (sic) disposed any illegal vapes. Any vapes that I thought were legal were placed on sale due to the decision to discontinue all vapes in general.

Id. ¶ 2.

Respondent further contends that the penalty is too high and states:

I was not aware that I was selling any illegal product. I went off what the first inpector (sic) told me to pull off the shelf.  Apparently she missed one. This civil money penalty would hurt my business. It would be devastating.  Selling the product was not only not intential (sic) but also I thought I was doing the right thing by distcontinuing (sic) all vapes. Instead I now might be fined over 20k for doing what I thought was the right thing.

Id. ¶ 3.

VII. FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT

The “relevant statute” in this case is actually a combination of statutes and regulations:  The Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111 31, 123 Stat. 1776 (2009) (TCA), amended the Food, Drug, and Cosmetic Act, 21 U.S.C.A. Chap. 9, (FDCA) and created a new subchapter of that Act that dealt exclusively with tobacco products, 21 U.S.C. §§ 387-387u, and it also modified other parts of the FDCA explicitly to include tobacco products among the regulated products whose misbranding can give rise to civil, and in some cases criminal, liability.  The 2009 amendments to the FDCA contained within the TCA also charged the Secretary of Health and Human Services with, among other things, creating regulations to govern tobacco sales.

As of August 8, 2016, pursuant to 21 U.S.C. §§ 387a and 387f(d) (Section 906(d) of the Act), FDA revised the definition of tobacco products to incorporate additional

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products, subject to regulation under the Act.  These products include, but are not limited to, electronic nicotine delivery systems (including e-cigarettes), e-liquids, and pipe tobacco.  See Final Rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 8 Fed. Reg. 28,974 (May 10, 2016), available at https://federalregister.gov/a/2016-10685 (hereafter “Deeming Regulation”).

The TCA prohibits the sale of any “new tobacco product” without authorization from the FDA.  21 U.S.C. § 387(j)(a); 21 U.S.C. § 387a(b) (delegating the FDA the authority to determine what constitutes new tobacco products).  A new tobacco product is any tobacco product that was not commercially marketed in the United States as of February 15, 2007.  21 U.S.C. § 387j(a)(1).  The Secretary’s regulations on tobacco products appear in Part 1140 of Title 21, Code of Federal Regulations (CFR).

The TCA requires new tobacco products to have a premarket authorization in effect.  21 U.S.C. § 387j(a)(2).  To obtain premarket authorization, manufacturers of new tobacco products are required to submit a premarket tobacco application (PMTA) to the FDA for approval to sell their products.  21 U.S.C. § 387j(b)(1).  Alternatively, the product manufacturer may submit a substantial equivalence report, in response to which the FDA may issue an order finding the product is substantially equivalent to a predicate tobacco product.  21 U.S.C. § 387e(j).  Or, the product manufacturer may submit a report, in response to which the Secretary may issue an exemption order.  21 U.S.C. § 387e(j)(3).

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The TCA directs FDA to review PMTAs to determine whether “permitting such tobacco product to be marketed would be appropriate for the protection of the public health.”  21 U.S.C. § 387j(c)(2)(A).  Absent an approval from the FDA, the new tobacco products are considered adulterated and misbranded if they lack the required FDA marketing authorization order, substantial equivalence order, or an exemption order.  21 U.S.C. §§ 387b(6) and 387c(6).

Under the FDCA, “[a] tobacco product shall be deemed to be misbranded if, in the case of any tobacco product sold or offered for sale in any State, it is sold or distributed in violation of regulations prescribed under section 387f(d).”  Under 21 U.S.C. § 387c(a)(6), a new tobacco product is misbranded if a “notice or other information respecting it was not provided as required” under the substantial equivalence or substantial equivalence exemption pathway, including a substantial equivalence report or an abbreviated report.  21 U.S.C. § 387c(a)(6).  Section 387 a-1 directed FDA to re-issue, with some modifications, regulations previously passed in 1996.  21 U.S.C. § 387 a-1(a) (2012).

Under the FDCA, a tobacco product is adulterated if it has not obtained the required premarket authorization.  21 U.S.C. § 387b(6)(A).  Thus, when a retailer does not submit a PMTA for its ENDS products, or when a retailer submits a PMTA for its ENDS products and receives a denial order, the products are being adulterated. 21 U.S.C. § 387b(6)(A).  The adulterated and misbranded ENDS products in turn violates the FDCA.

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The FDCA 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).  The FDA may seek a civil money penalty from “any person who violates a requirement of this chapter which relates to tobacco products.”  21 U.S.C. § 333(f)(9)(A) (2012).  Penalties are set by 21 U.S.C. § 333 note and 21 C.F.R. § 17.2.

VIII. LIABILITY

CTP alleges that Respondent received in interstate commerce and delivered or proffered delivery thereof for pay or otherwise an Elfbar Kiwi Passion Fruit Guava ENDS product that required FDA premarket authorization, in violation of 21 U.S.C. § 331(c), on December 19, 2023.  Complaint ¶¶ 15, 19.

In its Answer, Respondent asserts that it did not intentionally sale illegal products and once notified that products in its inventory were not authorized to be sold in the September 22, 2023 Warning Letter, Respondent alleges that he discarded the products and did not order any other vape products.  Answer at ¶¶ 2,3.  Respondent alleges that he did this after both an August 2023 inspection and the December 19, 2023 inspection.  See CRD Dkt. Entry Nos. 3 at ¶ 2, 11 at 1, 14 at 1.

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 Diane H. Burkett, an FDA-commissioned officer with the state of Arizona.  CTP Exs. 1, 2.

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Regarding the unauthorized product, CTP submitted the sworn declaration Deputy Director James Bowling.  CTP Ex. 1.  In his official capacity, Deputy Director Bowling has personal knowledge of CTP’s tobacco record keeping, registration process, and new tobacco product premarket authorization requirements.  Id. ¶ 3.  Deputy Director Bowling confirmed that a search of the Tobacco Registration and Product Listing Module Next Generation (TRLM NG) did not reveal any registered establishments containing the name “Elfbar” or any listed product named “Elfbar Kiwi Passion Fruit Guava” in Arizona or elsewhere in the United States.  Id. ¶ 6.

Additionally, Deputy Director Bowling confirms that the Elfbar Kiwi Passion Fruit Guava ENDS product observed for sale during the December 19, 2023 inspection, is manufactured in China by iMiracle (Shenzhen) Technology Co., Ltd.  Id. ¶ 7.  Deputy Director Bowling confirmed that iMiracle (Shenzhen) Technology Co., Ltd. does not have any registered tobacco production facilities in the state of Arizona.  Id. ¶ 10.  Further, Deputy Director Bowling confirms that the Elfbar Kiwi Passion Fruit Guava ENDS product was not commercially marketed in the United States as of February 15, 2007.  Id. ¶ 12.  FDA did not have any record of an FDA marketing granted order in effect for the Elfbar Kiwi Passion Fruit Guava ENDS product at issue, a Substantial Equivalence Order or an abbreviated report requesting a Found-Exempt Order.  Id. ¶¶ 13-14.

Respondent did not object to Deputy Director Bowling’s declaration or wish to cross-examine him at a hearing.  Therefore, I find Deputy Director Bowling’s statements about the Elfbar Kiwi Passion Fruit Guava ENDS product and its manufacturer credible

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with respect to the question of whether it had marketing authorization, or if the manufacturer was registered for business in the United States for its new tobacco products.  I also find that the Elfbar Kiwi Passion Fruit Guava ENDS product is adulterated and misbranded as its manufacturer did not obtain FDA’s required premarket authorization.

Deputy Director Bowling’s declaration also supports a finding that the unauthorized product was received via interstate commerce, as the product manufacturer is based in China.  Id. ¶ 7.

As to Respondent’s possession of the unauthorized product, CTP relies on the sworn declaration of Inspector Diane H. Burkett.  CTP Ex. 2.  In the declaration, Inspector Burkett states that, on December 19, 2023, at approximately 2:14 PM, a compliance check inspection was conducted at Respondent’s business establishment.  CTP Ex. 2 ¶ 4.  During the inspection, Inspector Burkett observed that the establishment “sold FDA-regulated tobacco products, and had a sales display containing tobacco products, including an Elfbar Kiwi Passion Fruit Guava product, available for sale.”  Id. ¶ 6.  Photographs were taken by Inspector Burkett of the establishment, as well as the unauthorized product and its placement within the establishment.  Id.; see also CTP Ex. 5.  The inspection was recorded in FDA’s Tobacco Inspection Management System (TIMS) and a Narrative Report was created.  Id. ¶ 7; see also CTP Exs. 3, 4.  Respondent did not object to Inspector Burkett’s declaration or wish to cross-examine her at a hearing.  Therefore, I find Inspector Burkett’s statements regarding what she observed during the December 19, 2023, inspection of Respondent’s establishment, including that

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the establishment had a sales display containing tobacco products, including an Elfbar Kiwi Passion Fruit Guava ENDS product, to be credible.

Based on the uncontroverted testimony of Deputy Director Bowling and Inspector Burkett, as well as the corroborating photographs, reports, and other evidence submitted by CTP, I find and conclude that the Elfbar Kiwi Passion Fruit Guava ENDS product offered for sale at Respondent’s establishment on December 19, 2023, previously traveled in interstate commerce before Respondent’s receipt and delivery or proffered delivery thereof for pay or otherwise.

I find and conclude that the ENDS 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).

Finally, I find and conclude that the ENDS product at issue 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 Respondent’s actions constitute violations of the Act that warrants the imposition of a CMP.

IX. PENALTY

There being liability under the relevant statute, I must now determine the amount of penalty to impose.  Pursuant to 21 U.S.C. § 333(f)(9), Respondent is liable for a civil money penalty not to exceed the amounts listed in FDA’s civil money penalty regulations at 21 C.F.R. § 17.2.  In its complaint, CTP sought to impose the maximum penalty amount of $20,678 against Respondent for violating the Act.  Complaint ¶ 1.

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Since I find that CTP met its burden by a preponderance of the evidence and concluded that Respondent committed violation of the Act, the next step is to determine the amount of the civil money penalty.  When making that determination, 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).

A. The nature, circumstances, extent, and gravity of the violation

The 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 generally 21 U.S.C. § 387 note (Findings and Purpose).

CTP argues in its Pre-Hearing Brief that Respondent’s December 19, 2023 violation is particularly serious because:

they occurred despite earlier warnings from FDA that future violations could result in an enforcement action, and  even after FDA pointed Respondent to information and resources designed to help retailers comply with federal tobacco law.

CRD Dkt. Entry No. 12 at 8; see also CTP Ex. 7.

The warning letter dated September 22, 2023 that CTP references occurred after an August 8, 2023 inspection where an FDA inspector observed Respondent offering for an Elfbar Cranberry Punch ENDS product which lacked premarket authorization.  CTP

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Ex. 7 at 1, 2.  CTP notes that the September 22, 2023 warning letter specifically advised Respondent that future violations could result in enforcement action, “including, but not limited to, civil money penalties, seizure, and/or injunction by FDA.”  CRD Dkt. Entry No. 12 at 8.  CTP also notes the warning letter 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.  CTP contends that Respondent’s “repeated violations, as well as its unwillingness or inability to correct the violations” evidence that Respondent has not grasped “the seriousness and importance of the requirements governing the sales of tobacco products.”  Id. at 9.

Respondent has asserted that each time CTP inspected its establishment and advised of the specific product that was illegal, Respondent immediately removed that product from its shelves and did not purchase any other products similar to what was advised as illegal.  Answer at ¶¶ 2, 3; see also CRD Dkt. Entry Nos. 11 at 1, 14 at 1.

CTP has not disputed Respondent’s assertions and thus, I find that Respondent took measures to attempt to comply with the notice of violations that CTP provided Respondent.  CTP’s September 22, 2023 warning letter cites the specific flavor of Elfbar Cranberry Punch ENDS product.  See CTP Ex. 12h at 1.  In CTP’s subsequent inspection on December 19, 2023, CTP cites a different flavor of Elfbar ENDS product, specifically an Elfbar Kiwi Passion Fruit Guava ENDS Product.  CTP Ex. 5.  There is evidence in the record indicating that Respondent attempted to come into compliance by removing the identified unauthorized product each time he was notified.  Answer at ¶¶ 2, 3; CRD Dkt. Entry Nos. 11 at 1, 14 at 1.  Thus, I find that Respondent’s action of

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removing the identified unauthorized ENDS product after each notice and/or inspection and attempting to come into compliance with the law constitutes a mitigating circumstance.

Lastly, the evidence that CTP provides to support the violation alleged in its Compliant, specifically, the testimony of Deputy Director Bowling and Inspector Burkett, only reference the Elfbar Kiwi Passion Fruit Guava ENDS product as the unauthorized product in this complaint.  See Complaint ¶ 15, CTP Exs. 1 and 2.

B. Respondent’s ability to pay and effect on ability to do business

In evaluating this factor, I have considered Respondent’s arguments in its Answer, Letter of Declaration.  Id.  I understand a penalty of this size could jeopardize Respondent’s ability to do business, however, Respondent has not put forth any evidence of their financial position for me to consider as a mitigating factor.  Thus, while I find Respondent’s evidence on this issue somewhat lacking, I do find that Respondent has established mitigating circumstances which support at least a partial reduction in the penalty amount.

C. History of prior violations

There is no indication in the record of any prior violations of Section 331(c) resulting in a CMP.  Further, I do not agree with CTP that the warning letter also establishes a significant history of prior violations.  Indeed, the 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

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action . . . .”).  Thus, Respondent did not have the opportunity to request a hearing or otherwise dispute the violations alleged in the letter.

In sum, this is Respondent’s first violation resulting in a CMP.  Respondent also appears to be attempting to ensure future compliance with the law.  As a result, I find that Respondent does not have a significant history of prior violations or a substantial likelihood of committing future violations, which is a mitigating factor that supports a reduction in the penalty amount.

D. Degree of culpability

Based on my finding that Respondent committed the violation alleged in the Complaint, I hold the 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 tobacco products because of their highly dangerous and addictive nature.  See 21 U.S.C. § 387 note (Findings and Purpose).  Although I find the Respondent admitted its liability, I find that Respondent took remedial action to rectify its noncompliance whenever it was notified of specific flavors of the Elfbar brand that were not authorized to be sold.  Albeit these actions do not absolve Respondent of its responsibility as a retailer of tobacco products.

E. 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).  Mitigation is an affirmative defense for which Respondent bears the burden of proof.  Respondent must prove any affirmative defenses and any mitigating factors by a preponderance of the evidence.  21

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C.F.R. § 17.33(c).  Respondent has proven, and CTP has not rebutted, Respondent’s defense that it attempted to comply with each warning letter CTP issued and discarded the specific flavor CTP warned was an unauthorized product.

Having considered the evidence in the record and applicable law, I conclude a reduced penalty amount of $5,000 to be appropriate under 21 U.S.C. §§ 333(f)(5)(B) and 333(f)(9).

X. CONCLUSION

Respondent received adulterated and misbranded ENDS products in interstate commerce and delivered or proffered thereof for pay or otherwise, as set forth in the complaint.  Respondent is liable for a civil money penalty of $5,000.  See 21 C.F.R. § 17.2.  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.

WHEREFORE, evidence having been read and considered it be and is hereby ORDERED as follows:

1. I find Respondent was served with process herein and is subject to this forum.
2. I find and conclude that the evidentiary facts, by a preponderance of the evidence standard, support a finding Respondent violated 21 U.S.C. § 331(c) on December 19, 2023.
3. I assess a civil money penalty in the amount of $5,000.