Vape Central Group, LLC d/b/a Vape Central Group, DAB TB10111 (2025)

SUMMARY DECISION IN FAVOR OF COMPLAINANT

The Center for Tobacco Products (Complainant or CTP) seeks a $21,348 civil money penalty (CMP) against Vape Central Group, LLC d/b/a Vape Central Group (Respondent).  CTP alleges that Respondent, an online retailer of tobacco products, introduced into interstate commerce an electronic nicotine delivery system (ENDS) product that was adulterated or misbranded because it lacked the required premarketing authorization, in violation of the Federal Food, Drug, and Cosmetic Act (Act).  21 U.S.C. §§ 331(a); 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.  For the reasons discussed below, 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 Numbers (Nos.) 1 (Complaint), 1b (Proof of Delivery).  CTP

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alleges that Respondent sells or distributes tobacco products through its online website, and introduced or delivered for introduction into interstate commerce, or caused the introduction or delivery for introduction into interstate commerce, a Cali UL8000 Kiwi Dragon Berry ENDS product that was adulterated and misbranded because it is a new tobacco product that lacked the required FDA premarket authorization, in violation of federal law.  CRD Dkt. Entry No. 1 ¶¶ 1, 4, 13-20.

On November 20, 2024, Respondent timely filed an Answer.  CRD Dkt. Entry No 5.  In its Answer, Respondent admits some of the allegations in CTP’s Complaint, while denying most of the allegations.  Respondent also asserts 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 argues 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. 5.

On December 2, 2024, the Administrative Law Judge (ALJ) previously assigned to this case issued a Pre-Hearing Order establishing procedural deadlines.  CRD Dkt. Entry No. 6.

On January 15, 2025, Respondent filed a Motion to Stay Proceedings pending the resolution of Respondent’s federal litigation.  CRD Dkt. Entry No. 7.  On February 5, 2025, CTP filed its Opposition to Respondent’s Motion to Stay.  CRD Dkt. Entry No. 9.

On March 3, 2025, the ALJ issued an Order Denying Respondent’s Moton to Stay Proceedings.  CRD Dkt. Entry No. 10.  The ALJ determined that there was high likelihood of significant delay if this case was stayed pending the resolution of the federal litigation and that there was a risk of harm to both parties if the case was significantly delayed.  Id. at 2-3.

On April 2, 2025, both parties timely filed their pre-hearing exchanges.  See CRD Dkt. Entry Nos. 11, 12, 12a-12h.  In its pre-hearing exchange, Respondent stated that “it does not plan to present any exhibits or witnesses at the hearing in this case.  Respondent waives its right to submit a pre-hearing brief.  Respondent will cross-examine any witnesses presented by Complainant.”  CRD Dkt. Entry No. 11 at 1.  CTP’s pre-hearing exchange consists of an informal brief, a proposed witness and exhibit list, and seven proposed exhibits.  CRD Dkt. Entry Nos. 12, 12a-12h.  CTP’s exchange includes the written testimony of two witnesses: 1) James Bowling, Deputy Division Director, Office of Compliance and Enforcement, CTP, FDA (CTP Ex. 1); and Dara Hackett, Regulatory Counsel, Office of Compliance and Enforcement, CTP, FDA (CTP Ex. 2).  CRD Dkt. Entry Nos. 12b-12c.

On April 3, 2025, the ALJ issued an Order Scheduling Telephone Hearing in this case.  CRD Dkt. Entry No. 13.  The April 3, 2025 Order established an April 18, 2025 deadline

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for Respondent to file a motion to exclude or objections to CTP’s seven proposed exhibits and a May 5, 2025 deadline for CTP to file a response.  Id. at 2.  The April 3, 2025 Order also scheduled the hearing for June 3, 2025.  Id.

On April 4, 2025, CTP filed a Motion to Extend Deadlines, explaining that a significant reduction in force impacted CTP’s immediate operations.  CRD Dkt. Entry No. 14 at 1.  On April 9, 2025, the ALJ granted CTP’s Motion to Extend Deadlines.  CRD Dkt. Entry No. 15.  The ALJ’s April 9, 2025 Order extended the deadline for Respondent to file a motion to exclude or objections to CTP’s seven proposed exhibits to May 19, 2025, extended the deadline for CTP to file a response to June 4, 2025, and canceled the hearing scheduled for June 3, 2025.  Id. at 1-2.

On June 3, 2025, the ALJ rescheduled the hearing to August 5, 2025.  CRD Dkt. Entry No. 16.  Subsequently, on July 18, 2025, the parties were advised that this case was reassigned to me.  CRD Dkt. Entry No. 21.

On July 29, 2025, CTP filed a Motion for Continuance stating that one of its witnesses would be unavailable for the August 5, 2025 hearing.  CRD Dkt. Entry No. 24.  On July 31, 2025, I granted CTP’s Motion for Continuance and advised the parties that I would schedule a pre-hearing conference for September 4, 2025.  CRD Dkt. Entry No. 25 at 2.

On August 12, 2025, CTP filed a Motion for Summary Decision and a Memorandum in Support of Motion for Summary Decision.  CRD Dkt. Entry Nos. 26, 27.  On August 13, 2025, I issued an Order establishing a September 11, 2025 deadline for Respondent to respond to CTP’s Motion for Summary Decision pursuant to 21 C.F.R. § 17.17(a).  CRD Dkt. Entry No. 28 at 1.  The Order also postponed the prehearing conference pending resolution of CTP’s Motion for Summary Decision.  Id. at 1-2.

On September 11, 2025, Respondent timely filed a Combined Opposition to Complainant’s Motion for Summary Decision and Cross-Motion to Take Official Notice of Facts (Respondent’s Opposition and Cross-Motion).  CRD Dkt. Entry No. 29.

On September 26, 2025, CTP filed an Opposition to Respondent’s Cross-Motion to Take Official Notice of Facts (CTP’s Opposition to Respondent’s Cross-Motion).  CRD Dkt. Entry No. 30.

CTP’s Motion for Summary Decision and Respondent’s Cross-Motion are now ripe for adjudication.

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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).  With its pre-hearing exchange, CTP submitted seven proposed exhibits, including the written direct testimony of two proposed witnesses.  CRD Dkt. Entry Nos. 12a-12h.  Respondent was given an opportunity to file objections regarding the admissibility of CTP’s seven proposed exhibits.  See CRD Dkt. Entry Nos. 13 at 2; 15 at 2.  Respondent did not raise any objections.  See CRD Dkt. Entry No. 16 at 2.  Therefore, I admit CTP Exhibits 1-7 into the administrative record.1   21 C.F.R. § 17.19(b)(11).  Respondent did not submit any proposed exhibits.  See CRD Dkt. Entry No. 11 at 1.

The administrative record contains the exhibits as well as all documents and requests filed in this proceeding.  21 C.F.R. § 17.41(b).  In adjudicating CTP’s Motion for Summary Decision, I will consider the full administrative record 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) (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255; 106 S.Ct. 2505 (1986); 21 C.F.R. §§ 17.17; 17.19(b)(13); 17.39(a)-(e).

III. Issues

The issues for me to decide in considering CTP’s Motion for Summary Decision are:

A. 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(a);

B. Whether any of Respondent’s affirmative defenses are meritorious; and

C. If Respondent is liable, whether the $21,348 civil money penalty sought by CTP is appropriate, considering any mitigating or aggravating factors.

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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 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 the introduction or delivery for introduction into interstate commerce of any tobacco product that is adulterated or misbranded and the delivery or proffered delivery of any tobacco product that is adulterated or misbranded for pay or otherwise.  21 U.S.C. § 331(a).  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 $1,423,220 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 “party opposing the motion may not rest on mere allegations or denials or general

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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 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)).

V. Findings of Undisputed Fact

I find that the following facts are undisputed based on the evidence contained in the administrative record:

• Respondent operates with the business name of Vape Central Group and sells or distributes tobacco products through its online establishment accessible at https://www.vapecentralgroup.com.  CRD Dkt. Entry No. 5 at 1.2 
• On August 17, 2020, CTP sent Respondent a Warning Letter alleging that Respondent sold or distributed new tobacco products that lack the required FDA marketing authorization order.  CRD Dkt. Entry No. 1 ¶¶ 13-14; CRD Dkt. Entry No. 5 at 1; CRD Dkt. Entry No. 12g (CTP Warning Letter).  The letter stated that the sale of such products is prohibited, directed Respondent to come into compliance with the law, and warned that failure to address any violations may result in FDA taking regulatory action.  CRD Dkt. Entry No. 12g at 2.
• On April 10, 2024, an FDA-commissioned inspector conducted an inspection of Respondent’s website at https://www.vapecentralgroup.com and, during this inspection, FDA purchased a Cali UL8000 Kiwi Dragon Berry ENDS product.  CRD Dkt. Entry No. 12c ¶¶ 6-8 (Declaration of Dara D. Hackett); CRD Dkt. Entry No. 12e (Online Order Confirmation); CRD Dkt. Entry No. 12d (Narrative

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Report).  Respondent subsequently shipped the Cali UL8000 Kiwi Dragon Berry ENDS product from Florida to the FDA-commissioned inspector in Maryland.  CRD Dkt. Entry No. 12c ¶¶ 10-11; CRD Dkt. Entry No. 12f (Photographs of Mail Packaging and Product).

• The Cali UL8000 Kiwi Dragon Berry ENDS product that was sold and shipped by Respondent is manufactured by Cali Pods in China.  CRD Dkt. Entry No. 12b ¶ 4 (Declaration of James Bowling); CRD Dkt. Entry No. 12f at 10 (Photograph of Product).  Moreover, the Cali UL8000 Kiwi Dragon Berry 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 the Cali UL8000 Kiwi Dragon Berry ENDS product.  21 U.S.C. § 387c(a)(6).  CRD Dkt. Entry No. 12b ¶¶ 6-8.

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. 27 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.”  Id. at 9.

A. The undisputed material facts establish that Respondent introduced or delivered for introduction into interstate commerce an adulterated and misbranded tobacco product in violation of federal law.

Respondent did not provide arguments or evidence to establish any dispute concerning the facts discussed above.  In its Answer, Respondent claims it lacks sufficient information to admit or dispute certain facts and asserts denials.  See CRD Dkt. Entry No. 5 at 1-2.  However, at this stage of the proceeding, Respondent’s alleged lack of information and its denials alone are not sufficient to create a genuine dispute of material fact.  To defeat CTP’s Motion for Summary Decision, Respondent must present affidavits or other evidence showing that there is a genuine issue of material fact to be decided at a hearing.  21 C.F.R. § 17.17(c); see also Morris View, DAB No. 3149 at 3-4; Norris, 342 F. Supp. 3d at 108.  Respondent did not provide affidavits or evidentiary support for its denials of the factual allegations in CTP’s complaint and has not shown that there is any material fact in dispute which would preclude summary decision in CTP’s favor.

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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 Florida to Maryland 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. 29 at 1, 8-9 (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(a) for which it is liable.

Moreover, the defenses raised by Respondent do not create any dispute of fact that needs to be resolved at a hearing.  The arguments and facts alleged by Respondent in its Opposition to Summary Decision and Cross-Motion are not material to this proceeding and do not affect the outcome of my decision on CTP’s Motion for Summary Decision.

In its Opposition to Summary Decision and Cross-Motion, 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 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. 29 at 1, 8-9.  However, Respondent’s arguments relating to alleged violations by other persons 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. 12b.  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. 12b, 12c), such cross-examination could not alter the outcome of this case.

Respondent also argues that “CTP’s request for a civil money penalty in this case is barred by the doctrines of unclean hands and selective enforcement” because CTP allegedly “has not sought civil money penalties from ‘Big Tobacco’ companies (e.g., R.J. Reynolds, Altria) that market or have marketed unauthorized tobacco products without a marketing granted order.”  CRD Dkt. Entry No. 5 at 2; see also CRD Dkt. Entry No. 29 at 8-9.

Respondent 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 authorizations for other ENDS products.  CRD Dkt. Entry No. 29 at 3-8.  Pursuant to 21 C.F.R. § 17.19(b)(12), the presiding officer has the authority to “take official notice of facts.”  However, I find that none of the alleged facts listed in Respondent’s Opposition to Summary Decision and Cross-Motion are relevant or

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material to the issues in this case.  Therefore, I decline to take official notice of those alleged facts.  21 C.F.R. §§ 17.19(b)(11), (12), 17.39(c).

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 persons who sell ENDS products to adults.”  CRD Dkt. Entry No. 29 at 9.  Respondent also states that, at a September 10, 2025 press conference, the current Secretary of Health and Human Services “falsely stated that Big Tobacco companies put ‘chips’ in their ENDS products which prevent youth usage[]” and the current FDA Commissioner “ridiculously touts anecdotes as his bases for refuting CDC data showing that youth usage of ENDS products is at [a] ten-year low[]” and such “bad faith conduct . . . is evidence of bias.”  CRD Dkt. Entry No. 29 at 7-8.  I find that these arguments lack merit, are not supported by any evidence in the record, or are outside the scope of this proceeding relating to Respondent’s sale of an unauthorized tobacco product on April 10, 2024.

First, a claim of selective enforcement requires a showing that the claimant was similarly situated in material respects to other individuals against whom the law was not enforced.  See Frederick Douglass Found., Inc. v. District of Columbia, 82 F.4th 1122, 1136 (D.C. Cir. 2023); Huff and Puffers, LLC d/b/a Huff and Puffers, DAB No. 3214 at 8-11 (2025).  Here, however, Respondent provided no evidence or testimony that “Big Tobacco” companies are similarly situated to Respondent.  Moreover, Respondent’s claims regarding other companies’ potential violations and alleged “bad faith conduct” with regard to comments made at a September 10, 2025 press conference announcing the seizure of unauthorize ENDS products are based on matters outside the record and are not relevant or material to whether Respondent violated the law as alleged in the Complaint.  See 21 C.F.R. §§ 17.39(c);17.45(a),(b).  Thus, even viewing all evidence presented in the light most favorable to Respondent, Respondent’s filings have not alleged facts or presented evidence which would be necessary to invoke the selective enforcement doctrine, nor has Respondent established any genuine dispute of material fact in this case.

Additionally, the Departmental Appeals Board has 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 Hospital, 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)).

In sum, 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(a).  As a result, I find that Petitioner is liable for a civil money penalty under 21 U.S.C. § 333(f)(9).

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B. 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 impermissibly introduced into interstate commerce an ENDS product that lacked the required premarketing authorization.  21 U.S.C. § 331(a).  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.  CRD Dkt. Entry No. 1 ¶¶ 1, 12; 21 C.F.R. §  17.33(a); 45 C.F.R. § 102.3 (2022); 89 Fed. Reg. 64,815, 64,817 (August 8, 2024).  CTP contends the maximum penalty is appropriate because Respondent introduced and/or delivered “for introduction into interstate commerce an adulterated and misbranded tobacco product.”  CRD Dkt. Entry No. 12 at 10.

In its Answer, Respondent contends that the civil money penalty sought by CTP is excessive as “CTP does not allege that Respondent sells tobacco products to purchasers under the age of 21” and “CTP alleges that Respondent sold a product that is generally considered to be less harmful than combustible cigarettes.”  CRD Dkt. Entry No. 5 at 3.   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 a tobacco vapor 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 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 August 17, 2020,

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that stated that a “review of the website https://www.vapecentralgroup.com revealed that [Respondent] offer[ed] for sale or distribution to customers in the United States the following ENDS products without a marketing authorization order . . .” and that failure to address any violations of the Act “may result in FDA taking regulatory action.”  CRD Dkt. Entry No. 12g at 2.  Although Respondent claims that the 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 its 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.  Moreover, “the mere fact that Respondent did not violate [the Act] in other respects does not mitigate the gravity of repeatedly selling adulterated and misbranded ENDS products through its online store in the United States.”  Huff and Puffers, LLC, DAB No. 3214 at 13.  As discussed above, I found that there is no genuine dispute of material fact in determining that Respondent impermissibly introduced into interstate commerce a Cali UL8000 Kiwi Dragon Berry ENDS product that lacked the required premarketing authorization.  Respondent does not allege facts which diminish the gravity or seriousness of selling this 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.  Respondent admitted that CTP sent a Warning Letter alleging that Respondent sold a new tobacco product that did not have premarket authorization prior to seeking a civil money penalty from Respondent.  See CRD Dkt. Entry No. 5 at 1.  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 are not mitigating factors.

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

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of the proposed civil money penalty and any aggravating or mitigating factors.  As previously discussed, CTP sent Respondent a Warning Letter on August 17, 2020, stating that “review of the website https://www.vapecentralgroup.com revealed that [Respondent] offer[ed] for sale or distribution to customers in the United States the following ENDS products without a marketing authorization order” and that failure to address such violations of the Act “may result in FDA taking regulatory action.”  CRD Dkt. Entry No. 12g at 2.  Thus, I find that given Respondent’s history of prior violations, a civil money penalty of $21,348 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(a).  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.

Although given the opportunity to do so, Respondent did not submit affidavits or other evidence supporting 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.

C. 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

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Appeal Board from adjudicating this case” citing SEC v. Jarkesy, 144 S. Ct. 2117 (2024). CRD Dkt. Entry No. 5 at 2.  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 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).

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, Vape Central Group, LLC d/b/a Vape Central Group, for impermissibly introducing or delivering for introduction into interstate commerce an ENDS product that lacked the required FDA premarketing authorization.

IT IS SO ORDERED.