The Vaping Dragon, LLC d/b/a The Vaping Dragon, DAB TB9895 (2025)

SUMMARY DECISION IN FAVOR OF COMPLAINANT

Complainant the Center for Tobacco Products (CTP) seeks a $21,348 civil money penalty (CMP) against The Vaping Dragon, LLC d/b/a The Vaping Dragon (Respondent).  CTP alleges that Respondent, a retailer of tobacco products, received in interstate commerce an electronic nicotine delivery system (ENDS) product that lacked the required premarketing authorization, in violation of the Federal Food, Drug, and Cosmetic Act (Act).  21 U.S.C. §§ 331(c); 387j.  CTP now moves for summary decision and asserts that no genuine issues of material fact exist as to Respondent's violation of the Act and Respondent is liable for a civil money penalty as a matter of law.  I grant summary decision in favor of CTP and find a civil money penalty in the amount of $21,348 is appropriate.

I.  Background and Procedural History

CTP began this matter by serving a Complaint on Respondent.  Civil Remedies Division (CRD) Docket (Dkt.) Entry Nos. (Numbers) 1 (Complaint), 1b (Proof of Delivery).  CTP alleges that Respondent receives tobacco products in interstate commerce, including a

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Geek Bar Pulse Berry Bliss 50mg/ml ENDS product and delivers or proffers delivery of such tobacco for pay or otherwise, in violation of federal law.  CRD Dkt. Entry No. 1 ¶¶  1, 4, 13-21.

On January 27, 2025, Respondent timely filed an Answer, which denied the allegations in CTP's Complaint, asserted defenses based on the Seventh Amendment to the United States Constitution and the U.S. Supreme Court's decision in SEC v. Jarkesy, 144 S. Ct. 2114 (2024), and argued that CTP's request for a civil money penalty is excessive and barred by the doctrines of unclean hands and selective enforcement.  CRD Dkt. Entry No. 4 (Answer).

On January 28, 2025, I issued an Acknowledgement and Pre-Hearing Order (APHO) establishing procedural deadlines for this case.  See CRD Dkt. Entry No. 5.

On May 21, 2025, CTP timely filed its pre-hearing exchange consisting of an informal brief, a proposed witness and exhibit list, and six proposed exhibits.  CRD Dkt. Entry Nos. 10, 10a-g.  CTP's exchange included the written testimony of two witnesses: James Bowling, Deputy Division Director, Office of Compliance and Enforcement, CTP, FDA (CTP Ex. 1); and Aimee Rockhill-Carpenter, FDA-commissioned officer in the state of Texas (CTP Ex. 2).  CRD Dkt. Entry Nos. 10b-10c, respectively.

On June 11, 2025, Respondent timely filed its pre-hearing exchange consisting of a pre-hearing brief, a proposed witness and exhibit list, and four proposed exhibits (R. Exs. 1-4).1  CRD Dkt. Entry Nos. 11, 11a-11e.  Respondent indicated it did not plan to call any witnesses.  CRD Dkt. Entry No. 11 at 1.

On June 26, 2025, I issued an Order Scheduling the Pre-Hearing Conference for July 16, 2025, at 1:00 PM Eastern Time.  CRD Dkt. 16.  On July 11, 2025, CTP filed a Motion for Summary Decision and its Memorandum in Support of Motion for Summary Decision.  CRD Dkt. Entry Nos. 17, 17a.

On July 16, 2025, I conducted a pre-hearing conference at which we discussed the issues to be decided, the purpose of conducting a hearing, the procedural history, and the parties' pre-hearing exchanges and proposed witnesses.  See CRD Dkt. Entry No. 19.  At the prehearing conference, Respondent requested to cross-examine CTP's two proposed witnesses.  Further, Respondent raised no objection to the admission of CTP's proffered exhibits 1-6.  Id. at 2.  There being no objection, I admitted CTP's exhibits (Exs.) 1-6 into the record.  CTP raised objections to Respondent's four proposed exhibits.  Id.  I advised

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that CTP would have until August 11, 2025, to file written objections to Respondent's proposed exhibits or pre-hearing exchange.  Id.  I gave Respondent until August 21, 2025, to respond to any written objections filed by CTP.  Id.; see also 21 C.F.R § 17.32(c).  I further advised that thereafter, I would review any objections and responses filed and would issue a ruling on the admission of Respondent's proposed exhibits and the parties' pre-hearing exchanges.  Id.

On July 29, 2025, I issued an Order summarizing the pre-hearing conference and details  regarding the final submissions of the parties and final procedures.  See CRD Dkt. Entry No. 19.

On August 11, 2025, CTP timely filed Complainant's Motion to Exclude Respondent's Exhibits along with a Memorandum of Law in Support of Complainant's Motion to Exclude Respondent's Exhibits requesting that Respondent's exhibits be excluded as they have no relevance in determining Respondent's liability or the appropriateness of the civil money penalty in this matter.  CRD Dkt. Entry Nos. 20, 21.  Also on August 11, 2025, Respondent timely filed a Respondent's Opposition to Complainant's Motion for Summary Decision and Cross-Motion to Take Official Notice of Facts.  CRD Dkt. Entry No. 22.

On August 25, 2025, Respondent filed Respondent's Opposition to Complainant's Motion in Limine.  CRD Dkt. Entry No. 23.  This filing was untimely, as Respondent was instructed to respond to CTP's Motion to Exclude Respondent's Exhibits by August 21, 2025, pursuant to my July 29, 2025 Order.2  CRD Dkt. Entry No. 19 at 2.  Respondent did not request an extension or attempt to notify my office that its response would be delayed before filing Respondent's Opposition to Complainant's Motion in Limine.3

On August 28, 2025, CTP timely filed an Objection to Respondent's Late-Filed Opposition to Complainant's Motion to Exclude Respondent's Exhibits.  CRD Dkt. Entry No. 24.  Also on August 28, 2025, Respondent filed Respondent's Response to Complainant's Objection to Respondent's Late-Filed Opposition.  CRD Dkt. Entry No. 25.

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Thus, CTP's Motion for Summary Decision, CTP's Motion to Exclude Respondent's Exhibits, and Respondent's Cross-Motion are now ripe for adjudication.

II.  Admission of Exhibits

As the presiding officer, I have the authority to receive, rule on, exclude, or limit evidence.  21 C.F.R. § 17.19(b)(11).  I provided the parties the opportunity to submit written objections and rebuttals regarding the admissibility of the proposed exhibits.  I have now reviewed the parties' filings.  As stated, CTP exhibits were admitted at the pre-hearing conference without objection from Respondent.  CRD Dkt. Entry No. 19 at 2.  For the following reasons, I also admit R Exs. 1-4 (Corrected) into the administrative record.  The administrative record contains the exhibits as well as all documents and requests filed in this proceeding.  21 C.F.R. § 17.41(b).

Respondent timely filed its pre-hearing exchange and did not submit direct testimony of any proposed witnesses.  Respondent's first proposed exhibit (R. Ex. 1 corrected) contains inspection photographs of Respondent's establishment which were produced by CTP during discovery.  See CRD Dkt. Entry Nos. 11 at 1, 12.  Respondent's second proposed exhibit (R. Ex. 2 corrected) is an article entitled "Eunice Park-Lee, et al., [Notes from the Field:] E-Cigarette and Nicotine Pouch Use Among Middle and High School Students – United States, 2024, 73 Morbidity and Mortality Weekly Report 774 (Sept. 5, 2024)."  See CRD Dkt. Entry Nos. 11 at 1, 13.  Respondent's third proposed exhibit (R. Ex. 3 corrected) is an article entitled " Haider J. Warraich, et al., Opportunities for Innovation in Smoking Cessation Therapies: A Perspective from the National Institutes of Health and U.S. Food and Drug Administration, Annals of Internal Medicine (Oct. 15, 2024)."  See CRD Dkt. Entry Nos. 11 at 1, 13.  Respondent's fourth  proposed exhibit (R. Ex. 4 corrected) is an FDA press release entitled "Youth E-Cigarette Use Drops to Lowest Level in a Decade (Sept. 5, 2024)."  See CRD Dkt. Entry Nos. 11 at 1, 14.

CTP timely filed Complainant's Motion to Exclude Exhibits requesting that Respondent's proposed exhibits be excluded.  CRD Dkt. Entry Nos. 20, 21.  CTP argues that Respondent's exhibits have no relevance in determining Respondent's liability or the appropriateness of the civil money penalty in this matter.  Id. at 7-8.  CTP states that proposed R. Exs. 2 and 4:

[D]iscuss the state of youth e-cigarette use.  Putting aside the fact that they contradict Respondent's take-away that "the so-called ‘youth vaping epidemic' has long been over," Respondent was not charged with selling tobacco products to underage purchasers; it was charged with selling unauthorized ENDS products, a separate and distinct violation.  And none of the exhibits offer anything that is relevant or material to the

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comparative seriousness of such violations … [n]either the FDCA nor FDA's implementing regulations allows for reduction in penalty based on violations not alleged.

CRD Dkt. Entry No. 21 at 7.

CTP argues that proposed R. Ex. 1 is irrelevant and immaterial as it explicitly points to a sign advising "NO ID NO SALE!" Id.  CTP offers no further arguments regarding this exhibit.

CTP further argues that proposed R. Exs. 2-4:

[H]ave no conceivable bearing on Respondent's affirmative defenses of "unclean hands" or "selective prosecution."  Indeed, they are silent on either subject, including the  accuracy of Respondent's assertion that "CTP has not sought CMPs from ‘Big Tobacco' companies (e.g., Reynolds, Altria) that have marketed unauthorized electronic cigarettes," or that "Reynold's unauthorized Vuse Menthol products are among those most popular e-cigarettes among underage users."  Respondent has offered no reason for its puzzling inclusion of Exhibit 3, which discusses innovation in smoking cessation therapies and the regulation of such products.

Id. at 8.

Lastly, CTP argues that Respondent should be "disallowed pursuant to 21 C.F.R. § 17.35(f), because Respondent failed to identify them in its response to CTP's document request."

Id. at 7.

Respondent timely filed Respondent's Opposition to Complainant's Motion in Limine arguing that CTP "asks the ALJ to exclude:

(1) CTP's own inspection photographs showing that Respondent does not sell its products to people under 21, (2) HHS's own published data showing that youth usage of vaping is declining, (3) an article published by HHS officials acknowledging that, "Many adults who smoke have used e-cigarettes to quit smoking," and (4) an FDA press release titled, "Youth E-Cigarette Use Drops to Lowest Level in a Decade."

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CRD Dkt. Entry No. 23 at 1.  Respondent challenges CTP's argument that it failed to identify its exhibits in response to CTP's document request by arguing that CTP fails to demonstrate any harm caused by Respondent's failure to properly turn over documents during discovery.  Id. at 2.

I have reviewed the parties' arguments and agree with CTP that R. Exs. 2-4 are not relevant or material to the issues present in this proceeding, however, the information submitted could be considered for mitigating factors.  Thus, I decline to exclude R. Exs. 2-4 at this stage of the proceeding.  Instead, for purposes of CTP's Motion for Summary Decision, I will consider the full administrative record, including R. Exs. 1-4 (Corrected), and analyze the evidence presented in this case in the light most favorable to the nonmoving party.  See Norris v. Wash. Metro. Area Transit Auth., 342 F. Supp. 3d 97, 108 (D.D.C. 2018); 21 C.F.R. §§ 17.17; 17.19(b); 17.39.

III.  Issues

There are two issues for me to decide in considering CTP's Motion for Summary Decision:

1. Whether the undisputed material facts establish that Respondent introduced or delivered for introduction into interstate commerce or caused the introduction or delivery for introduction into interstate commerce of an adulterated and misbranded tobacco product in violation of 21 U.S.C. § 331(c); and if so,
2. Whether the $21,348 civil money penalty sought by CTP is appropriate, considering any mitigating or aggravating factors.

IV.  Applicable Law

In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act to regulate tobacco products.  21 U.S.C. §§ 387 et seq.  The law prohibits selling any "new tobacco product" without authorization from the Food and Drug Administration (FDA).  21 U.S.C. §§ 387j(a); 387a(b) (delegating to 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).

New tobacco products are required to have an FDA 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

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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).

FDA must 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 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(a)(6).

The Act prohibits receiving adulterated or misbranded tobacco products in interstate commerce 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).  The FDA has the authority to seek civil money penalties from any person who violates any Act requirement that relates to tobacco products.  21 U.S.C. § 333(f)(9).  The term "person" is defined to include individuals, partnerships, corporations, and associations.  21 U.S.C. § 321(e).  Retailers who violate a requirement of the Act that relates to tobacco products shall be liable for a civil money penalty up to the maximum amounts provided for by law, which was $21,348 during the relevant period, for each such violation, not to exceed $1,378,541 for all violations adjudicated in a single proceeding.  21 U.S.C. § 333(f)(9)(A); 21 C.F.R. § 17.2; 45 C.F.R. § 102.3.

I may grant summary decision "if the pleadings, affidavits, and other materials filed in the record, or matters officially noticed, show that there is no genuine issue as to any material fact and that the party is entitled to summary decision as a matter of law."  21 C.F.R. § 17.17(b).  When a motion for summary decision is properly submitted, the opposing party "may not rest on mere allegations or denials or general descriptions of positions and contentions; affidavits or other responses must set forth specific facts showing that there is a genuine issue of material fact for a hearing."  21 C.F.R. § 17.17(c).  "[C]onclusory assertions offered without any evidentiary support at the summary judgment stage do not establish a genuine issue for trial."  See Norris v. Wash. Metro. Area Transit Auth., 342 F. Supp. 3d 97, 108 (D.D.C. 2018) (citing Greene v. Dalton, 164 F.3d 671, 675 (D.C. Cir. 1999)).  Further, in examining the evidence for purposes of deciding whether summary decision is appropriate, I must draw all reasonable inferences in the light that is most favorable to the party that opposes the motion.  See The Oaks, DAB No. 3160 at 9 (2024).

"To defeat an adequately supported summary judgment motion, the nonmoving party may not rely on the denials in its pleadings or briefs but must furnish evidence of a dispute concerning a material fact – a fact that, if proven, would affect the outcome of the case under governing law."  Morris View Healthcare Center, DAB No. 3149 at 3-4 (2024) (citing Senior Rehab & Skilled Nursing Ctr., DAB No. 2300 at 3 (2010), aff'd, 405 F. App'x 820 (5th Cir. 2010)); see also APHO ¶ 15 ("A party opposing a motion for

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summary decision must come forward with evidence of specific facts showing that a dispute exists.  It is never sufficient for a party opposing a motion to aver only that it ‘disputes' alleged facts or that it demands an in-person hearing.").

V.  Findings of Undisputed Fact

I find that the following facts are undisputed based on the admissions contained the briefs and the evidence contained within the administrative record:

• Respondent owns an establishment that does business under the name The Vaping Dragon and is located at 1465 South Danville Drive, Abilene, Texas 79605.  Complaint ¶ 13; CRD Dkt. Entry No. 11e at 1 (Respondent's Pre-hearing Brief).4
• Respondent's establishment received tobacco products in interstate commerce, including a Geek Bar Pulse Berry Bliss 50mg/ml ENDS product and delivers or proffers delivery of such tobacco product for pay or otherwise.  Complaint ¶ 14; CRD Dkt. Entry 10b ¶ 7 (Declaration of James Bowling); Respondent's Pre-hearing Brief at 1.
• On September 29, 2024, an FDA-commissioned inspector conducted an inspection of The Vaping Dragon.  CTP Exhibit 2 ¶ 4.  During this inspection, the inspector observed a Geek Bar Pulse Berry Bliss 50mg/ml  ENDS product for sale at Respondent's establishment.  Complaint CRD Dkt. Entry No. 10c ¶¶ 4-6 (Declaration of Inspector Aimee Rockhill-Carpenter); CRD Dkt. Entry No. 10e (Photographs of Geek Bar Pulse Berry Bliss 50 mg/ml ENDS Product and Establishment); Complaint ¶ 15.
• The Geek Bar Pulse Berry Bliss 50mg/ml ENDS product that was sold by Respondent on September 29, 2024 is manufactured by Zhuhai Qisitech Co., LTD, in China.  Declaration of James Bowling ¶ 7; CRD Dkt. Entry No. 10e at 3 (Photograph of Product).  Moreover, the Geek Bar Pulse Berry Bliss 50mg/ml ENDS product is a new tobacco product which is adulterated and misbranded because it was not commercially marketed in the United States as of February 15, 2007, it did not have a Marketing Granted Order in effect under 21 U.S.C. § 387b(a)(6)(A), and neither a substantial equivalence nor an abbreviated report was submitted for Geek Bar Pulse Berry Bliss 50mg/ml ENDS product.  21 U.S.C. § 387c(a)(6).  Complaint ¶¶ 16-19; Declaration of James Bowling ¶¶ 9-14.

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VI.  Analysis

In its Memorandum in Support of Summary Decision, CTP asserts that it is entitled to summary decision as a matter of law and undisputed fact regarding Respondent's liability for the allegations in the Complaint.  See CRD Dkt. Entry No. 17a at 5-6.  Regarding the proposed civil money penalty, CTP asserts that "[a]lthough the parties may disagree on the appropriate penalty amount, their disagreement is not a genuine dispute of material facts necessitating a hearing" and "the penalty amount, too, is appropriate for resolution on summary decision."  CRD Dkt. Entry No. 17a at 9-11.

1. The undisputed material facts establish that Respondent received an adulterated and misbranded tobacco product and delivered or proffered delivery thereof for pay or otherwise in violation of federal law.

Respondent has not presented any arguments or evidence establishing a genuine dispute regarding the facts set forth above.  In its Pre-hearing brief, Respondent asserts it lacks sufficient information to admit or deny certain facts.  Respondent Pre-hearing Brief at 2.  However, at this stage of the proceeding, mere claims of insufficient knowledge or blanket denials are inadequate to create a genuine dispute of material fact.  To defeat CTP's Motion for Summary Decision, Respondent must submit affidavits or other competent evidence demonstrating that a genuine issue of material fact exist for resolution at a hearing.  21 C.F.R. § 17.17(c); see also Morris View Healthcare Center, DAB No. 3149 at 3-4 (2024), Norris v. Wash. Metro. Area Transit Auth., 342 F. Supp. 3d 97, 108 (D.D.C. 2018).  Respondent failed to provide affidavits or evidentiary support for its denials of the factual allegations in CTP's complaint and thus, has not shown that there is any material fact in dispute which would preclude summary decision in CTP's favor.

Specifically, Respondent argues that there are "genuine issues of material fact in this case on (1) Respondent's affirmative defense of selective enforcement, and (2) the appropriate amount of any civil money penalty issued against Respondent" because CTP allegedly has not "issued a Warning Letter or Civil Money Penalty in which the charge included selling an unauthorized NJOY or R.J. Reynolds ENDS product to an adult."  See CRD Dkt. Entry No. 22 at 1, 7.  Respondent also asks me to take official notice of facts related to companies other than Respondent who Respondent claims submitted premarket tobacco applications and were granted marketing authorization for other ENDS products.  CRD Dkt. Entry No. 22 at 3-7.5  Respondent further contends that there is an issue of material fact on what civil money penalty is appropriate because "combustible cigarettes present greater health risks than ENDS products [and] FDA issues much lower civil money penalties to persons who sell combustible cigarettes to children than it does to

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persons who sell ENDS products to adults."  CRD Dkt. Entry No. 22 at 7-8.  I find that these defenses lack merit, are not supported by any evidence in the record, or are outside the scope of this proceeding.

First, the courts have cast doubt as to whether the unclean hands doctrine may be invoked against the government in analogous contexts.  See Heckler v. Cmt. Health Servs., 467 U.S. 51, 60 (1984); Bartko v. SEC, 845 F.3d 1217, 1227 (D.C. Cir. 2017).  Likewise, a selective enforcement claim requires proof that the claimant was similarly situated in material respects to other individuals against whom the law was not enforced, and that the selective enforcement infringed a constitutional right.  See Frederick Douglass Found., Inc. v. District of Columbia, 82 F.4th 1122, 1136 (D.C. Cir. 2023).  Here, Respondent provided no evidence or testimony that "Big Tobacco" companies are similarly situated to Respondent nor has Respondent shown, or even argued, that the alleged selective enforcement infringed on a constitutional right.  Furthermore, Respondent's references to other companies' alleged violations rely on matters outside the record and are not relevant or material to the issue of whether Respondent violated the law as alleged in the Complaint.  See 21 C.F.R. §§ 17.39(c);17.45(a),(b).  Accordingly, even when viewing the evidence presented in the light most favorable to Respondent, its filings fail to allege facts or present evidence sufficient to invoke the unclean hands or selective enforcement doctrines, or to establish any genuine dispute of material fact.

Further, the Departmental Appeals Board has consistently held that it lacks the power to grant equitable relief because it is bound by all applicable laws and regulations.  See, e.g., Commonwealth of Virginia, DAB No. 2876 at 22 (2018) (citing Kan. Dep't of Admin., DAB No. 2845 at 12 (2018) (equitable defenses of unclean hands, stale claims, laches, waiver and estoppel are "not cognizable in this forum")), appeal dismissed, C.A. No. 6:18-cv-01104 (D. Kan. 2018).  Lastly, the Board has also consistently held that "the alleged failure to take equally harsh steps against other similarly noncompliant [entities] may not itself be made to constitute a defense or a bar to future enforcement."  See Arizona Surgical Health, LLC, DAB No. 1890 n. 7 (2003) (citing Beverly Health and Rehabilitation - Spring Hill, DAB No. 1696 (1999), aff'd Beverly Health & Rehabilitation Servs. v. Thompson, 223 F.Supp.2d 73 (D.D.C. 2002)).

2. Cross examination of witnesses in a hearing is not necessary to determine Respondent's liability in this case.

Respondent requested the opportunity to cross-examine CTP's witnesses.  The purpose of conducting a hearing is "to determine whether the respondent is liable for a civil money penalty and, if so, the appropriate amount of any such civil money penalty."  21 C.F.R. § 17.33(a).  Respondent asserts it "should be afforded its right to cross-examine Complainant's witnesses" and specifically states that it would cross examine James Bowling "on what, if any rational basis CTP has for its differential treatment of

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Respondent" and "why CTP believes the ‘gravity' of Respondent's alleged violation warrants a much higher penalty than that issued to persons who sell combustible cigarettes to children."  CRD Dkt. Entry No. 22 at 1, 7-8.  However, Respondent's arguments relating to alleged violations by other companies or businesses are not relevant or material to whether Respondent violated the law as alleged in this case.  Moreover, these matters are not addressed in James Bowling's Declaration and are outside the scope of any direct testimony CTP has provided.  See CRD Dkt. Entry No. 10b.  I am to permit the parties to conduct such cross-examination as may be required for a full disclosure of the facts.  21 C.F.R. § 17.37(d).  Thus, if I were to allow Respondent to cross-examine either of CTP's witnesses on their direct testimony provided by declaration (CRD Dkt. Entry Nos. 10b and 10c), such cross examination could not alter the outcome of this case.

Even considering the facts and all possible inferences in the light most favorable to Respondent, I find that the record demonstrates that Respondent introduced or delivered for introduction into interstate commerce an adulterated and misbranded tobacco product.  The evidence shows that Respondent sold and shipped an ENDS product from California to Virginia without an FDA marketing granted order in effect.  Respondent does not challenge these findings and, in fact, appears to concede that it violated the Act as alleged.  See CRD Dkt. Entry No. 22 at 1, 7 (claiming disputes of material fact only with respect to its "selective enforcement" defense and the penalty amount).  Therefore, I conclude that as a matter of law and undisputed fact, Respondent committed a violation of 21 U.S.C. § 331(c) for which it is liable.

Respondent's arguments in its Opposition to Complainant's Motion for Summary Decision are not material to this proceeding and do not affect the outcome of my decision on CTP's Motion for Summary Decision.  After considering Respondent's arguments, the admissions in the pleadings, and all the evidence of record, I conclude that as a matter of law and undisputed fact, Respondent violated 21 U.S.C. § 331(c).  As a result, I find this matter does not necessitate a hearing and that Respondent is liable for a civil money penalty under 21 U.S.C. § 333(f)(9).

3. A $21,348 civil money penalty is appropriate, considering any aggravating and mitigating factors.

I found no genuine dispute of material facts and determined that Respondent received tobacco products in interstate commerce, including a Geek Bar Pulse Berry Bliss 50mg/ml ENDS product and delivers or proffers delivery of such tobacco product for pay or otherwise in violation of federal law.  21 U.S.C. § 331(c).  The remaining issue in this case is whether the civil money penalty sought by CTP is appropriate, considering any aggravating and mitigating factors.

Here, CTP is proposing a civil money penalty in the amount of $21,348, which is the maximum penalty permitted by the regulations.  Complaint ¶¶ 1, 12; 21 C.F.R.

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§ 17.33(a); 45 C.F.R. § 102.3 (2022); 87 Fed. Reg. 15,100, 15,103 (March 17, 2022).  In its Answer, Respondent contends that the CMP sought by CTP is excessive as "CTP does not allege that Respondent sold a tobacco product to a purchaser under the age of 21" and "CTP alleges that Respondent sells a product, an e-cigarette, that is generally considered to be less harmful than combustible cigarettes."  Answer at 2.  Additionally, "Respondent notes that CTP requests much lower civil money penalties in cases where a retailer is alleged to have sold combustible cigarettes to an underage purchaser" which Respondent asserts "is a much more serious violation than selling an ENDS product to an adult."  Id.

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; see also 45 C.F.R. § 102.3.  When determining the appropriate amount of a civil money penalty, I am required to consider any "circumstances that mitigate or aggravate the violation" and "the factors identified in the statute under which the penalty is assessed . . . ."  21 C.F.R. § 17.34(a), (b).  Specifically, I must consider "the nature, circumstances, extent and gravity of the violations and, with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, the degree of culpability, and such other matters as justice may require."  21 U.S.C. § 333(f)(5)(B).

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

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).  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).  Also, Respondent received a written warning letter dated September 28, 2023, that stated, "FDA has determined that you manufacture, sell, and/or distribute to customers in the United States e-liquid products without a marketing authorization order."  CRD Dkt. Entry No. 11g at 2.  Although Respondent claims that civil money penalty is "excessive" because Respondent is not alleged to have sold a tobacco product to a purchaser under the age of 21 and contends ENDS products are "generally considered to be less harmful than combustible cigarettes," whether respondent sold products that are less dangerous than combustible cigarettes is not material to the violations at issue in this case or whether CTP assessed an appropriate penalty amount.  As discussed above, Respondent does not dispute that it sold ENDS products lacking the required FDA premarket authorization, and Respondent does not allege facts which diminish the gravity or seriousness of selling an ENDS product, manufactured in China, without FDA premarketing authorization.  Respondent has not presented any evidence demonstrating that there is a genuine issue as to any material fact regarding the serious nature of its violation.

As explained above, Respondent has not provided any defenses that this forum can consider nor has Respondent provided evidence of relevant mitigating circumstances.

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Respondent is responsible for complying with the laws governing the products it sells online.  Thus, I find that the nature circumstances, extent, and gravity of the violation in this case are serious and warrant a substantial civil money penalty.

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

Respondent has not provided any evidence to show its inability to pay the civil money penalty CTP seeks or relating to Respondent's inability to continue to do business.  Additionally, Respondent did not submit any mitigating evidence to support its claim that the amount of proposed civil money penalty is excessive.  Therefore, I find that Respondent's ability to pay the proposed civil money penalty and its ability to continue to do business is not a mitigating factor.

3. History of Prior Violations

Respondent has not asserted any argument nor submitted any evidence pertaining to Respondent's history of prior violations, or lack thereof, in relation to the appropriateness of the proposed civil money penalty and any aggravating or mitigating factors.  As previously discussed, CTP sent Respondent a Warning Letter on September 28, 2023, stating "FDA has determined that you manufacture, sell, and/or distribute to customers in the United States e-liquid products without a marketing authorization order" and advised Respondent that "while such article is held for sale after shipment in interstate commerce which results in such product being adulterated or misbranded is a prohibited."  CRD Dkt. Entry No. 11g at 2.  Thus, I find that given Respondent's history of prior violations, a civil money penalty is appropriate.

4. Degree of Culpability

Based on my finding that Respondent committed the violation alleged in the Complaint, I hold Respondent fully culpable for introducing or delivering for introduction into interstate commerce an adulterated and misbranded ENDS product in violation of 21 U.S.C. § 331(c).  The law 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).

5. Other Such Matters as Justice May Require

I have discretion to consider any other evidence or arguments to mitigate the amount of the civil money penalty.  21 U.S.C. § 333(f)(5)(B).  The purpose of a civil money penalty is to ensure retailers and manufactures comply with the Food, Drug and Cosmetic Act and its implementing regulations with the overarching goal of protecting the health of the American people.

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Although given the opportunity to do so, Respondent did not present any mitigating factors in this case.  21 C.F.R. § 17.17(c).  Instead, Respondent argues the proposed civil money penalty is excessive because it is not alleged to have sold a tobacco product to a purchaser under the age of 21 and that it believes ENDS products are less harmful than combustible cigarettes.  Respondent failed to submit supporting materials demonstrating a factual dispute between the parties on the issue of the appropriateness of the civil money penalty and there are no questions of fact for me to resolve on this issue.

Therefore, after considering the circumstances that mitigate or aggravate Respondent's violation and the factors identified in 21 U.S.C. § 333(f)(5)(B), I conclude that a civil money penalty in the amount of $21,348 is appropriate.

4. Respondent's constitutional arguments are unavailing.

In this proceeding, Respondent asserted that it "has a right to a jury trial on CTP's request for a civil money penalty" and the "Seventh Amendment prohibits the Departmental Appeal Board from adjudicating this case" citing SEC v. Jarkesy, 144 S. Ct. 2117 (2024). Answer at 3.  Regarding Respondent's constitutional arguments, I refer to the regulation at 21 C.F.R. § 17.19(c), which expressly provides that presiding officers "do not have the authority to find Federal statutes or regulations invalid."  Further, an appellate panel of the Departmental Appeals Board (the Board) held "[n]either the ALJs nor this Board are empowered to ignore or overturn applicable statutes or regulations."  J. Peaceful, L.C. d/b/a Town Market, DAB No. 2742 at 15 (2016); see also Zoom Mini Mart, Inc., DAB No. 2894 at 15 (2018) ("In sum, the ALJ came to his conclusion that a 30-day NTSO was appropriate by following the applicable authority found in the Act and Tobacco Control Act (TCA) authority which we are not allowed to ignore or overturn . . . .").  Therefore, I am bound to make any determination in these tobacco cases based on the applicable statutory authority.  Further, I reject Respondent's attempt to conflate this case with Jarkesy.  In a recent case, the Board held that:

The Court did not hold that every agency's attempt to impose and enforce CMPs necessarily is, like the SEC's action, "a common law suit in all but name" that "must be adjudicated in Article III courts."  Jarkesy, 144 S. Ct.  at 2136.  On the contrary, the Court acknowledged the long-established "public rights exception," under which "Congress may assign [a] matter for decision to an agency without a jury, consistent with the Seventh Amendment," and extensively discussed the Court's precedents applying that exception.  Id. at 2131-34.

The Oaks, DAB No. 3160 at 27 (2024).

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VII.  Conclusion

For the reasons discussed above, no genuine issue of material fact exists as to Respondent's liability for allegations in CTP's Complaint and Respondent is liable for a civil money penalty as a matter of law.  CTP's Motion for Summary Decision is hereby GRANTED and I impose a $21,348 civil money penalty against Respondent The Vaping Dragon, LLC d/b/a The Vaping Dragon for impermissibly introducing or delivering for introduction into interstate commerce an ENDS product that lacked the required FDA premarketing authorization.

IT IS SO ORDERED.