Huff and Puffers, LLC d/b/a Huff and Puffers, DAB TB8770 (2025)

SUMMARY DECISION IN FAVOR OF COMPLAINANT

Complainant the Center for Tobacco Products (CTP) seeks a $20,678 civil money penalty (CMP) against Huff and Puffers, LLC d/b/a Huff and Puffers (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.  I grant summary decision in favor of CTP and find a civil money penalty in the amount of $20,678 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 sells or distributes tobacco products through its online website

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and introduced or delivered for introduction into interstate commerce or caused the introduction or delivery for introduction into interstate commerce, an EB Create BC5000 Sakura Grape electronic nicotine delivery system (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 July 5, 2024, Respondent timely filed an Answer, which admitted many of 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. 3a (Answer).

On July 8, 2024, the Administrative Law Judge (ALJ) assigned to this case issued an Acknowledgement and Pre-Hearing Order establishing procedural deadlines for this case.  CRD Dkt. Entry No. 5 at 2-4.  On August 12, 2024, CTP filed Complainant’s Motion for a Protective Order.  CRD Dkt. Entry No. 7.  On August 20, 2024, Respondent filed Respondent’s Motion for Protective Order.  CRD Dkt. Entry No. 8.  Both parties subsequently filed Memoranda in Support of their Motions and Oppositions to the opposing party’s Motion for Protective Order and on September 25, 2025, the ALJ issued an Order staying this case pending resolution of the motions.  See CRD Dkt. Entry Nos. 10, 11-13, 15.

On September 30, 2024, Respondent filed a Motion to Stay [Departmental Appeals Board] DAB Proceeding Pending the Resolution of an Ongoing Federal Court Challenge to the Constitutionality of the FDCA’s Civil Money Penalty Provisions.  CRD Dkt. Entry No. 16.  On October 15, 2024, CTP filed its Opposition to Respondent’s Motion to Stay.  CRD Dkt. Entry No. 18.  On October 16, 2024, Respondent filed a Reply in Support of its Motion to Stay.  CRD Dkt. Entry No. 19.

On October 29, 2024, the ALJ assigned to this case issued an Order Denying Respondent’s Moton to Stay Proceedings Pending Resolution of an Ongoing Federal Court Challenge.  CRD Dkt. Entry No. 20.  The ALJ determined that there would be a likelihood of significant delay if this case was stayed pending the resolution of the federal litigation, the denial of a stay would not affect Respondent’s ability to pursue any constitutional challenges in a separate forum, and that there was a risk of harm to both parties if the case was significantly delayed.  CRD Dkt. Entry No. 20 at 3-4.

On November 18, 2024, the ALJ denied Respondent’s Motion for Protective Order as moot after CTP withdrew its request for the specific documents that were the subject of the motion.  CRD Dkt. Entry No. 23 at 2-3.  The ALJ granted Complainant’s Motion for a Protective Order for the documents identified in Complainant’s Privileged Document Log

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and for Respondent production numbers 8-11 as “requir[ing] a party to compile and produce documents that are not relevant to the issues [in this case] would be unduly costly, burdensome, and would unduly delay the proceedings here.”  CRD Dkt. Entry No. 23 at 5.

On February 3, 2025, CTP timely filed its pre-hearing exchange consisting of an informal brief, a proposed witness and exhibit list, and seven proposed exhibits.  CRD Dkt. Entry Nos. 25, 25a-h.  CTP’s exchange included 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. 25b-c, respectively.

On February 21, 2025, this case was reassigned to me.  CRD Dkt. Entry No. 26.  On February 25, 2025, Respondent timely filed its pre-hearing exchange consisting of a pre-hearing brief, a proposed exhibit and witness list, and one proposed exhibit (R. Ex. 1).  CRD Dkt. Entry Nos. 27, 27a, and 28.  Respondent indicated it did not plan to call any witnesses.  CRD Dkt. Entry No. 28 at 1.

On March 31, 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. 36.  At the prehearing conference, Respondent requested to cross-examine CTP’s two proposed witnesses.  CTP then advised that it anticipated filing a Motion for Summary Decision in the coming days which could obviate the need for a hearing.  Id. at 2.  I advised the parties that I would address deadlines regarding dispositive motions after receipt of CTP’s motion.  Id.

On April 4, 2025, CTP filed a Motion for Summary Decision and its Memorandum in Support of Motion for Summary Decision.  CRD Dkt. Entry Nos. 34, 34a.  On April 10, 2025, I issued an Order establishing deadlines for filing objections to proposed exhibits and rebutting any objections.  CRD Dkt. Entry No. 36.  I established a deadline of May 5, 2025, for Respondent to respond to CTP’s Motion for Summary Decision and serve opposing affidavits or countermove for summary decisions pursuant to 21 C.F.R. § 17.17(a).  Id. at 2.  I also set a hearing date for the purpose of cross-examination of CTP’s two witnesses, should a hearing be necessary.  Id. at 2.

On April 23, 2025, CTP timely filed Complainant’s Motion to Exclude Proposed Exhibit requesting that proposed exhibit R. Ex. 1 be excluded as it has no relevance in determining Respondent’s liability or the appropriateness of the civil money penalty in this matter.  CRD Dkt. Entry No. 38.  On May 8, 2025, Respondent timely filed Respondent’s Opposition to Complainant’s Motion in Limine.  CRD Dkt. Entry No. 39.

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On June 3, 2025, Respondent filed a Combined Opposition to Complainant’s Motion for Summary Decision and Cross-Motion to Take Official Notice of Facts.  CRD Dkt. Entry No. 40.  This filing was untimely, as Respondent had to respond to CTP’s Motion for Summary Decision by May 5, 2025, pursuant to 21 C.F.R. § 17.17(a) and my April 10, 2025 Order.  CRD Dkt. Entry No. 36 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 CTP’s Motion for Summary Decision 29 days after the established deadline.1  On June 4, 2025, I issued an Order noting Respondent’s untimely filing and establishing a deadline for CTP to file any response.  CRD Dkt. Entry No. 41.  I also stayed the hearing in this matter pending resolution of the parties’ pending motions.  CRD Dkt. Entry No. 41.  On June 11, 2025 CTP timely filed an Objection to Respondent’s Late-Filed Opposition and Cross-Motion.  CRD Dkt. Entry No. 42.  Thus, CTP’s Motion for Summary Decision 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 and for the following reasons, I admit CTP Exhibits 1-7 and R Ex. 1 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).

With its pre-hearing exchange, CTP submitted seven proposed exhibits, including the written direct testimony of two proposed witnesses.  CRD Dkt. Entry Nos. 25a-h.  Respondent did not raise any objections to CTP Exhibits 1-7 during the prehearing conference or when given the opportunity to submit written objections.  See CRD Dkt. Entry No. 36 at 2.  Therefore, I admit CTP Exhibits 1-7.

Respondent timely filed its pre-hearing exchange and did not submit direct testimony of any proposed witnesses.  Respondent’s proposed exhibit (R. Ex. 1) 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. 27a, 28.

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CTP timely filed Complainant’s Motion to Exclude Proposed Exhibit requesting that proposed R. Ex. 1 be excluded.  CRD Dkt. Entry No. 38.  CTP argues the exhibit has no relevance in determining Respondent’s liability or the appropriateness of the civil money penalty in this matter.  Id. at 6.  CTP states that proposed R. Ex. 1:

[C]ontains a description of electronic nicotine delivery system (ENDS) and nicotine pouch use rates among middle and high school students in the United States and describes the frequency of use by these students of particular brands of ENDS and nicotine pouches . . . [s]uch information is irrelevant to the question of whether Respondent introduced or delivered for introduction or caused the introduction or delivery for introduction into interstate commerce a new tobacco product that does not have an FDA marking authorization in effect.

CRD Dkt. Entry No. 38 at 4.

Respondent timely filed Respondent’s Opposition to Complainant’s Motion in Limine arguing that CTP “asks the ALJ to exclude HHS’s own data showing drastically declining youth usage of vapor products . . . the data that CTP seeks to exclude is relevant to the amount of the CMP should the ALJ find that Respondent violated the [Act].”  CRD Dkt. Entry No. 39 at 1.

I have reviewed the parties’ arguments and agree with CTP that R. Ex.1 is not relevant or material to the issues present in this proceeding.  Nevertheless, I decline to exclude R. Ex. 1 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. Ex. 1, 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(a); and if so,
2. Whether the $20,678 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 $20,678 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 “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)); see also Acknowledgement and Pre-Hearing Order ¶ 15 (“A party opposing a motion for 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 in the pleadings and briefs, as well as the evidence contained in the administrative record:

• Respondent operates with the business name of Huff and Puffers and sells or distributes tobacco products through its online establishment at https://www.huffandpuffers.com.  Answer at 1;2 CRD Dkt. Entry No. 27 at 1-2 (Respondent’s Pre-hearing Brief).
• On May 31, 2023, CTP sent Respondent a Warning Letter alleging that Respondent sold or distributed a new tobacco product that did not have the required FDA marketing authorization order in effect.  Complaint at ¶¶ 13, 14; Answer at 1-2; CRD Dkt. Entry No. 25g (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 future violations may be subject to enforcement actions by CTP.  CRD Dkt. Entry No. 25g at 2.

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• On December 13, 2023, an FDA-commissioned inspector conducted an inspection of Respondent’s website at https://www.huffandpuffers.com and, during this inspection, FDA purchased an EB Design BC5000 Disposable Vape 4% Nicotine Sakura Grape ENDS product.  CRD Dkt. Entry No. 25c ¶¶ 6-8 (Declaration of Dara D. Hackett); CRD Dkt. Entry No. 25e (Online Order Confirmation); CRD Dkt. Entry No. 25d (Narrative Report).  Respondent subsequently shipped an EB Create BC5000 Sakura Grape ENDS product, a different ENDS product than the one ordered, from California to the FDA-commissioned inspector in Virginia.  CRD Dkt. Entry No. 25c ¶ 10; CRD Dkt. Entry No. 25f (Photographs of Mail Packaging and Product).
• The EB Create BC5000 Sakura Grape ENDS product that was sold and shipped by Respondent is manufactured by Fewo Intelligent Manufacturing Limited in China.  CRD Dkt. Entry No. 25b ¶ 7 (Declaration of James Bowling); CRD Dkt. Entry No. 25f at 6 (Photograph of Product).  Moreover, the EB Create BC5000 Sakura Grape 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 EB Create BC5000 Sakura Grape ENDS product.  21 U.S.C. § 387c(a)(6).  Complaint ¶¶ 17-19; Answer at 2; see also CRD Dkt. Entry No. 25b ¶¶ 10-12.

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. 34a at 5-6.  Regarding the proposed civil money penalty, CTP asserts that “[a]lthough the parties may disagree on the appropriate penalty amount, there is no factual dispute between the parties necessitating a hearing” and “the penalty amount, too, is appropriate for resolution on summary decision.”  CRD Dkt. Entry No. 34a at 10.

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 has not provided any arguments or evidence establishing any dispute concerning the facts discussed above.  In its Answer and Pre-hearing brief, Respondent claims it lacks sufficient information to admit or dispute certain facts.  See Answer at 2; Respondent Pre-hearing Brief at 2.  However, at this stage of the proceeding, Respondent’s supposed lack of knowledge and denials alone are not sufficient to create a genuine dispute of material fact.  To defeat CTP’s Motion for Summary Decision,

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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 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 allegation 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.

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. 40at 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(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.  First, as stated above, Respondent’s Opposition to Complainant’s Motion for Summary Decision was filed several weeks late with no explanation or excuse, and Respondent did not request an extension pursuant to 21 C.F.R. § 17.17(a).  I may refuse to consider any response that is not filed in a timely manner or in compliance with the rules of 21 C.F.R. Part 17.  See 21 C.F.R. § 17.35(f).  As Respondent did not request an extension for good cause and Respondent’s Opposition was received 29 days after the deadline, I decline to consider Respondent’s filing.  21 C.F.R. § 17.35(a), (b), (f).  However, even if I were to consider Respondent’s untimely filing, the arguments and facts alleged therein are not material to this proceeding and do not affect the outcome of my decision on CTP’s Motion for Summary Decision.3

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Specifically, Respondent 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., Reynolds, Altria) that market ENDS products without an MGO.”  Answer at 3; see also CRD Dkt. Entry No. 40 at 3-5, 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. 40 at 3-7.4  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 sells ENDS products to adults.”  CRD Dkt. Entry No. 40 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 on whether the unclean hands doctrine may ever be applied to 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).  Similarly, 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 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, however, Respondent provided no evidence or testimony that “Big Tobacco” companies are similarly situated to Respondent.  In addition, Respondent has not shown, or even argued, that the alleged selective enforcement infringed on a constitutional right.  Moreover, Respondent’s claims regarding other companies’ potential violations 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 unclean hands or selective enforcement doctrines, nor have they established any genuine dispute of material fact in this case.

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,

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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 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)).

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 under21 U.S.C. § 333(f)(9).

B. A $20,678 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 $20,678, which is the maximum penalty permitted by the regulations.  Complaint ¶¶ 1, 12; 21 C.F.R. § 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 sold a product that is generally considered to be less harmful than combustible cigarettes.”  Answer 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 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).

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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 May 31, 2023, that stated, “FDA has determined that your firm markets new tobacco products lacking premarket authorization in the United States.  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.”  CRD Dkt. Entry No. 25g 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.  Respondent admitted that its ENDS products are new tobacco products that are adulterated and misbranded and that CTP sent Respondent 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 Answer at 3.  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.

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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 May 31, 2023, stating “FDA has determined that your firm markets new tobacco products lacking premarket authorization in the United States.  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.”  CRD Dkt. Entry No. 25g at 2.  Thus, I find that given Respondent’s history of prior violations, a civil money penalty of $20,678 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 $20,678 is appropriate.

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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 Appeal Board from adjudicating this case.”   Answer at 3 (citing SEC v. Jarkesy, 144 S. Ct. 2117 (2024)).  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 and regulatory authority.  Further, I reject Respondent’s attempt to conflate this case with Jarkesy.  In a recent case, the Board held that:

The [Supreme] 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).

Although it is outside of the scope of my authority to determine the validity of statutes or regulations, I note that no court has declared the Federal Food, Drug and Cosmetic Act’s  civil money penalty provisions unconstitutional, nor has a court declared unconstitutional the execution of an Administrative Law Judge’s duties pursuant to the Tobacco Control Act and the applicable federal regulations in proceedings where the imposition of a civil money penalty is at issue.  See Vape Cent. Grp., LLC v. FDA, No. CV 24-3354 (RDM), 2025 WL 637416 (D.D.C. Feb. 27, 2025); Drive Thru Vapors LLC, DAB No. 3168 (2025).

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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 $20,678 civil money penalty against Respondent Huff and Puffers, LLC d/b/a Huff and Puffers for impermissibly introducing or delivering for introduction into interstate commerce an ENDS product that lacked the required FDA premarketing authorization.

IT IS SO ORDERED.