Vapor Boss LLC d/b/a Vapor Boss, DAB TB9353 (2025)

INITIAL DECISION

The Center for Tobacco Products (CTP) seeks a $19,192 civil money penalty (CMP) against Respondent Vapor Boss LLC d/b/a Vapor Boss.  Specifically, CTP alleges that Respondent Vapor Boss introduced or delivered for introduction into interstate commerce an adulterated and misbranded tobacco product, thereby violating the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 331(a).  For the reasons discussed below, I find Respondent violated the provisions of 21 U.S.C. § 331(a) and conclude that a civil money penalty in the amount of $9,596 is appropriate.

I.     Background and Procedural History

CTP began this matter by serving an administrative complaint (Complaint) on Respondent at 969 Dalton Road, Riverside, California 92501, by United Parcel Service, and by filing a copy of the Complaint with the FDA’s Division of Dockets Management.  Civil Remedies Division (CRD) Docket (Dkt.) Entry (Numbers) Nos. 1, 1b.

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On January 22, 2024, Respondent timely filed its Answer to the Complaint.  CRD Dkt. Entry No. 6.  On January 24, 2024, Administrative Law Judge Debbie K. Nobleman issued an Acknowledgment and Pre-Hearing Order (APHO) establishing deadlines for discovery and the parties’ pre-hearing exchanges.  CRD Dkt. Entry No. 7.

On June 18, 2024, the parties were advised that this case had been reassigned to me for adjudication.  See CRD Dkt. Entry No. 12.

On June 28, 2024, CTP filed a Motion to Compel Discovery, asserting that Respondent had not responded to its Request for Production of Documents (RFP) as required by the APHO and the regulations.  CRD Dkt. Entry No. 13, 13a-13b; see also APHO ¶ 4; 21 C.F.R. § 17.23(a).  On July 2, 2024, I issued an Order advising Respondent that it had until July 15, 2024 to file a response to CTP’s Motion to Compel Discovery.  I also warned that if Respondent failed to respond, “I may grant CTP’s motion in its entirety.”  CRD Dkt. Entry No. 15 at 2; see also APHO ¶¶ 20-21; 21 C.F.R. § 17.32(c).  On July 12, 2024, Respondent filed a document titled “Respondent’s response to request for production of documents” (Respondent’s July 12, 2024 Response).  CRD Dkt. Entry No. 16.  In Respondent’s July 12, 2024 Response, Respondent asserted that it was in the process of dissolving the company, argued the merits of the case, asserted that CTP’s request for production of documents was irrelevant, and requested that the case be dismissed.  See CRD Dkt. Entry No. 16 at 1-2.

On August 1, 2024, I issued an Order Granting Complainant’s Motion to Compel Discovery, concluding that the document requests in CTP’s RFP were relevant to the issues in the case, and that Respondent had not produced documents responsive to CTP’s RFP in compliance with the APHO and the regulations regarding discovery as set forth at 21 C.F.R. § 17.23(a).  CRD Dkt. Entry No. 18 at 2.  I ordered Respondent to produce responsive documents to CTP’s RFP by August 15, 2024, or submit a written response to CTP stating that it did not have responsive documents to produce by that same date.  Id. at 3.  I also warned:

Failure to comply with this Order may result in sanctions, including the issuance of an Initial Decision and Default Judgment finding Respondent liable for the violations listed in the Complaint and imposing a civil money penalty.

Id.

On August 12, 2024, Respondent filed a letter and supporting documentation asserting that Respondent’s business had been dissolved.  CRD Dkt. Entry No. 19.

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On August 29, 2024, CTP filed a Status Report and Motion to Impose Sanctions (Motion to Impose Sanctions) asserting that Respondent failed to produce documents responsive to CTP’s RFP by August 15, 2024, as ordered by my August 1, 2024 Order Granting Complainant’s Motion to Compel Discovery.  CRD Dkt. Entry No. 20 at 1-2.  In its Motion to Impose Sanctions, CTP also requested that, pursuant to 21 C.F.R.§ 17.35(c)(3), I strike Respondent’s Answer as a sanction for its non-compliance and issue an initial decision and default judgment imposing the full proposed civil money penalty of $19,192 against Respondent.  Id.  On August 30, 2024, I issued an Order advising Respondent that it had until September 16, 2024 to file a response to CTP’s Motion to Impose Sanctions.  CRD Dkt. Entry No. 22 at 2.  I also warned that if Respondent failed to respond, “I may grant CTP’s motion in its entirety.”  Id.; see also APHO ¶¶ 20-21; 21 C.F.R. §§ 17.32(c), 17.35.  In the Order, I also stayed the parties’ pre-hearing exchange deadlines pending resolution of CTP’s Motion to Impose Sanctions.  CRD Dkt. Entry No. 22 at 2.  On September 16, 2024, Respondent timely filed its response to CTP’s Motion to Impose Sanctions.  CRD Dkt. Entry No. 23.  In its response, Respondent asserted that it did not have responsive documents to produce to CTP, argued the merits of the case, and requested that the proposed penalty be dismissed, or that these proceedings be delayed pending a Supreme Court decision in Food and Drug Administration v. Wages and White Lion Investments, L.L.C., dba Triton Distribution, et al.  Id.

On October 21, 2024, I issued an Order denying CTP’s Motion to Impose Sanctions.  CRD Dkt. Entry No. 24.  In the Order, I concluded that sanctions against Respondent were not appropriate given that, pursuant to 21 C.F.R.§ 17.35(a), the imposition of sanctions against a party is a discretionary power within the authority of the presiding officer, and Respondent, though unrepresented by counsel, has filed timely responses to all of my Orders in these proceedings, has actively participated, and stated in its September 16, 2024 response to CTP’s Motion to Impose Sanctions that it had nothing else to submit in response to CTP’s RFP.  Id. at 3-4.  In the Order denying CTP’s Motion to Impose Sanctions, I also denied Respondent’s requests to dismiss the CMP and to delay proceedings pending a Supreme Court decision in Food and Drug Administration v. Wages and White Lion Investments, L.L.C., dba Triton Distribution, et al.  Id. at 4.  I then vacated the stay previously imposed and reestablished the parties’ pre-hearing exchange deadlines.  Id.

On November 26, 2024, CTP timely filed its pre-hearing exchange, consisting of a pre-hearing brief, a list of proposed witnesses and exhibits, and seven proposed exhibits.  CRD Dkt. Entry Nos. 25, 25a-25h.  CTP’s pre-hearing exchange included the written direct testimony of three proposed witnesses: James Bowling, Deputy Division Director, Division of Enforcement and Manufacturing, Office of Compliance and Enforcement, CTP, FDA; Eric Harvey, Regulatory Counsel, Division of Promotion, Advertising, and

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Labeling (DPAL), Office of Compliance and Enforcement, CTP, FDA;1 and Dara D. Hackett, Regulatory Counsel, DPAL, Office of Compliance and Enforcement, CTP, FDA.  CRD Dkt. Entry Nos. 25b, 25c, 25d (CTP Exhibits (Exs.) 1, 2, 3).  On December 17, 2024, Respondent timely filed its pre-hearing exchange, consisting of a pre-hearing brief, a list of proposed exhibits, and seven unmarked proposed exhibits.2  CRD Dkt. Entry Nos. 26, 27, 28, 28a-28f.

On February 6, 2025, I held a pre-hearing conference (PHC) with both parties participating.  See CRD Dkt. Entry No. 39 (Order Following PHC).  During the PHC, I discussed various procedural matters, including the parties’ pre-hearing submissions and proposed exhibits (CTP Exs. 1-7; R. Exs. 1-7).3  I asked Respondent’s authorized representatives if Respondent objected to the admission of CTP’s seven proposed exhibits into the record, and Respondent did not.  Id. at 1-2.  Thus, I admitted CTP’s seven proposed exhibits into the record.  Id. at 2.  CTP, through counsel, raised an objection to the admission of Respondent’s seven proposed exhibits.  CRD Dkt. Entry No. 39 at 2.  Specifically, CTP asserted that Respondent’s exhibits should be excluded, because Respondent failed to produce the documents in accordance with the discovery requirements of these proceedings and CTP did not have an opportunity to respond to Respondent’s proposed exhibits in its informal brief.  Id.  I instructed CTP to file any objections to Respondent’s proposed exhibits in writing by February 20, 2025 and set a deadline of March 10, 2025 for Respondent to respond to CTP’s objections.  Id.

At the PHC, I also discussed the purpose of an oral hearing and asked the parties whether a hearing was necessary in this case.  Id. at 2.  Respondent stated that it did not wish to cross-examine any of CTP’s proposed witnesses.  Id.  Since Respondent did not submit any testimony or identify witnesses that could be cross-examined by CTP, I advised the parties that no hearing would be held and that I would decide the case based on the administrative record.  Id.  I also stated that the parties would have an opportunity to file final briefs before I made my decision.  Id.

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On February 10, 2025, I issued an Order memorializing the issues discussed at the PHC and establishing deadlines for final briefs.  Id.  The parties were given until March 10, 2025, to file final written briefs and until March 25, 2025, to file response briefs.  Id.

Counsel for CTP did not file an objection to Respondent’s proposed exhibits in writing, as instructed during the PHC and in the February 10, 2025 Order.  See id.  On March 10, 2025, CTP timely filed its final brief and one exhibit, a copy of a prior decision by a Departmental Appeals Board Administrative Law Judge.  CRD Dkt. Entry Nos. 40, 40a.  On that same date, Respondent timely filed its final brief and one exhibit, a copy of a screenshot from the California Secretary of State’s website, indicating that Vapor Boss LLC’s business status is “terminated” and “inactive,” as of August 15, 2024.  CRD Dkt. Entry Nos. 41, 41a.

The record is now closed and this matter is ready for a decision based on the administrative record.  See 21 C.F.R. §§ 17.19(b)(11), 17.19(b)(17), 17.41, 17.45(c).

II.     Evidence

1. CTP’s Exhibits 1-7

During the PHC, CTP’s seven proposed exhibits were admitted into the record without objection as CTP Exs. 1-7.  See CRD Dkt. Entry No. 39 at 2.  Specifically, CTP submitted the following seven exhibits:

• CTP Ex. 1: Declaration of James Bowling (CRD Dkt. Entry No. 25b);
• CTP Ex. 2: Declaration of Eric Harvey (CRD Dkt. Entry No. 25c);
• CTP Ex. 3: Declaration of Dara D. Hackett (CRD Dkt. Entry No. 25d);
• CTP Ex. 4: March 2023 Investigator Controlled Purchase Redacted Narrative Report (CRD Dkt. Entry No. 25e);
• CTP Ex. 5: March 2023 Redacted Screenshot of Vapor Boss Online Purchase (CRD Dkt. Entry No. 25f);
• CTP Ex. 6: March 2023 Photographs of Vapor Boss Bubble Gum 60 ML - 8MG e-liquid product (CRD Dkt. Entry No. 25g); and
• CTP Ex. 7: September 2021 Warning Letter (CRD Dkt. Entry No. 25h).

2. Respondent’s Exhibits 1-7

Respondent submitted seven proposed exhibits with its pre-hearing exchange (R. Exs. 1-7).  CRD Dkt. Entry Nos. 28, 28a-28f.  Specifically, Respondent submitted the following seven exhibits:

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• R. Ex. 1: October 2024 John Deere Financial default letter (CRD Dkt. Entry No. 28);
• R. Ex. 2: 2024-2025 Riverside County Annual Secured Property Tax Bill (CRD Dkt. Entry No. 28a);
• R. Ex. 3: December 2024 IRS tax bill (CRD Dkt. Entry No. 28b);
• R. Ex. 4: September 2024 UWM mortgage loan statement (CRD Dkt. Entry No. 28c);
• R. Ex. 5: undated De Lage Landen payment collections letter (CRD Dkt. Entry No. 28d);
• R. Ex. 6: undated Insufficient Funds Notice from HOA (CRD Dkt. Entry No. 28e); and
• R. Ex. 7: automobile insurance notice of cancellation (CRD Dkt. Entry No. 28e).

As stated above, during the PHC, counsel for CTP raised an objection to the admission of Respondent’s proposed exhibits into the record.  See CRD Dkt. Entry No. 39 at 2.  CTP objected on grounds that Respondent did not produce the documents during discovery, thus CTP did not have an opportunity to respond to the proposed documentary evidence in CTP’s informal brief.  Id.  However, CTP did not subsequently file its objection in writing by February 20, 2025, as I instructed during the PHC and in the February 10, 2025 Order memorializing the PHC.  See id.  In addition, in CTP’s final brief, CTP did in fact respond to Respondent’s seven proposed exhibits and the arguments that Respondent submitted the exhibits in support of.  See CRD Dkt. Entry No. 40 at 2-4.  In CTP’s final brief, it did not renew or reiterate its objection to the admission of Respondent’s seven proposed exhibits.  See id. generally.  I find that Respondent’s seven proposed exhibits are relevant and material to the issue of whether the CMP sought by CTP is appropriate.  21 C.F.R. § 17.39(a), (c).  Moreover, given that CTP has had an opportunity to respond to Respondent’s proposed exhibits, CTP will not be unfairly prejudiced by the admission of Respondent’s Exs. 1-7.  Thus, I admit Respondent’s exhibit’s R. Exs. 1-7 into the record.  21 C.F.R. §§ 17.11, 17.39(a). 

3. Respondent’s August 12, 2024 Documentary Evidence and March 10, 2025 Exhibit

On August 12, 2024, Respondent submitted a letter asserting that Respondent’s business had been dissolved, and a copy of a completed Secretary of State Certificate of Cancellation form from the California Secretary of State, undated and signed by Robert M. Garcia.  CRD Dkt. Entry No. 19.  On March 10, 2025, with Respondent’s final brief, Respondent submitted new documentary evidence as an unmarked exhibit.  CRD Dkt. Entry No. 41a.  Respondent’s March 10, 2025 exhibit is a copy of a screenshot from the California Secretary of State’s website, indicating that Vapor Boss LLC’s business status is “terminated” and “inactive,” as of August 15, 2024.  Id.

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I find that Respondent’s August 12, 2024 documentary evidence is relevant and material to the issue of whether the CMP sought by CTP is appropriate.  21 C.F.R. §§ 17.39(a), (c).  Further, I find that the admission of Respondent’s August 12, 2024 documentary evidence will not unfairly prejudice CTP, given CTP had an opportunity to respond to Respondent’s August 12, 2024 documentary evidence, and did so in its final brief.  See CRD Dkt. Entry No. 40 at 2-4.  Thus, I admit Respondent’s August 12, 2024 documentary evidence into the record.  21 C.F.R. §§ 17.11, 17.39(a), (c).

With regard to Respondent’s March 10, 2025 Exhibit, although Respondent, which is unrepresented by counsel, filed the exhibit after the deadline for Respondent to file its pre-hearing exchange, counsel for CTP has not filed an objection, nor a motion for leave to file an objection, to Respondent’s March 10, 2025 exhibit.  I find that Respondent’s  March 10, 2025 exhibit is relevant and material to the issue of whether the CMP sought by CTP is appropriate.  21 C.F.R. § 17.39(c).  Thus, in the absence of objection from CTP, I also admit Respondent’s March 10, 2025 exhibit into the record.  21 C.F.R. §§ 17.11, 17.39(a), (c). 

III.     Issues

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

1. Whether Respondent introduced or delivered for introduction into interstate commerce an adulterated and misbranded tobacco product, specifically Respondent’s Vapor Boss Bubble Gum 60ML/8MG e-liquid product, on March 13, 2023, in violation of 21 U.S.C. § 331(a); and, if so,
2. Whether the $19,192 CMP proposed by CTP is appropriate, considering any mitigating or aggravating factors I find in this case.  21 C.F.R. § 17.45.

IV.     Applicable Law

To prevail, CTP must prove Respondent’s liability by a preponderance of the evidence.  The United States Supreme Court has described the preponderance of the evidence standard as requiring that the trier-of-fact believe that the existence of a fact is more probable than not before finding in favor of the party that had the burden to persuade the judge of the fact’s existence.  In re Winship, 397 U.S. 358, 371-72 (1970); Concrete Pipe and Prods. of Cal., Inc. v. Constr. Laborers, 508 U.S. 602, 622 (1993).  CTP has the burden to prove Respondent’s liability and appropriateness of the penalty by a preponderance of the evidence.  21 C.F.R. § 17.33(b).  Respondent has the burden to prove any affirmative defenses and any mitigating factors by a preponderance of the evidence.  21 C.F.R. § 17.33(c).

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

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

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

Under the Act, a tobacco product is adulterated if it has not obtained the required premarket authorization.  21 U.S.C. § 387b(6)(A).  Thus, when a manufacturer does not submit a PMTA for its e-liquid products, or when a manufacturer submits a PMTA for its e-liquid products and receives a denial order or a Refuse to Accept letter, the products are adulterated.  Id.

Under the Act, “[a] tobacco product shall be deemed to be misbranded . . . if, in the case of any tobacco product distributed or offered for sale in any State . . . it is sold or distributed” in violation of regulations prescribed under section 387f(d).  See 21 U.S.C. §§  387c(a), c(a)(7), c(a)(7)(B).  Under 21 U.S.C. § 387c(a)(6), a new tobacco product is misbranded if a “notice or other information respecting it was not provided as required” under the substantial equivalence or substantial equivalence exemption pathway, including a substantial equivalence report or an abbreviated report.  21 U.S.C. § 387c(a)(6); see also 21 U.S.C. § 387e(j).

Adulterated and misbranded e-liquid products violate the Act.  The Act prohibits the introduction or delivery for introduction into interstate commerce of any tobacco product that is adulterated or misbranded.  21 U.S.C. § 331(a).  FDA may seek a civil money penalty from “any person who violates a requirement of this chapter which relates to

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tobacco products.”  21 U.S.C. § 333(f)(9)(A) (2012).  Penalties are set by 21 U.S.C. § 333 and 21 C.F.R. § 17.2.

V.     Analysis

CTP alleges that Respondent introduced or delivered for introduction into interstate commerce its Vapor Boss Bubble Gum 60ML/8MG e-liquid product that required FDA premarket authorization, in violation of 21 U.S.C. § 331(a), on March 13, 2023.  CRD Dkt. Entry No. 1 ¶¶ 16, 23.

CTP’s case against Respondent relies on the written direct testimony of: James Bowling, Deputy Division Director, Division of Enforcement and Manufacturing, Office of Compliance and Enforcement, CTP, FDA; Eric Harvey, Regulatory Counsel, DPAL, Office of Compliance and Enforcement, CTP, FDA; and Dara D. Hackett, Regulatory Counsel, DPAL, Office of Compliance and Enforcement, CTP, FDA.  CTP Exs. 1, 2, 3.

Regarding Respondent’s e-liquid product, CTP submitted the sworn declaration of Deputy Division Director James Bowling.  CTP Ex. 1.  In his official capacity, Deputy Division Director Bowling has personal knowledge of FDA’s tobacco record keeping, registration process, and new tobacco product premarket authorization requirements.  Id. ¶ 3.  Deputy Division Director Bowling confirmed that, according to the label, the Vapor Boss Bubble Gum 60ML/8MG e-liquid product, the tobacco product observed and being offered for sale during the March 13, 2023 investigation of Vapor Boss at URL: https://vaporboss.com/, is manufactured by Vapor Boss in California.  Id. ¶ 6.  Additionally, Deputy Division Director Bowling confirmed that Vapor Boss does not have any registered tobacco production facilities in the state of Maryland.  Id. ¶ 7.  Further, Deputy Division Director Bowling confirmed that the Vapor Boss Bubble Gum 60ML/8MG e-liquid product was not commercially marketed in the United States as of February 15, 2007.  Id. ¶ 9.  FDA did not have any record of an FDA marketing granted order in effect for the Vapor Boss Bubble Gum 60ML/8MG e-liquid product, a Substantial Equivalence Order, or an abbreviated report requesting a Found-Exempt Order.  Id. ¶¶ 10, 11.

Regarding the purchasing of Respondent’s e-liquid product by FDA, CTP relies on the sworn declaration of Regulatory Counsel Eric Harvey.  CTP Ex. 2.  In the declaration, Regulatory Counsel Harvey testifies that on March 13, 2023, at approximately 11:41 AM, he conducted a controlled online purchase investigation of Vapor Boss at URL: https://vaporboss.com under Controlled Purchase Assignment Number 15.  Id. ¶ 5.  Regulatory Counsel Harvey testified that he directly observed and supervised Undercover Purchaser (UP) A during the controlled online purchase investigation.  Id.  Regulatory Counsel Harvey testified that he observed UP A purchase a Vapor Boss Bubble Gum 60ML/8MG e-liquid product directly from the establishment’s website and that the website generated a receipt to the purchaser after the purchase.  Id. ¶ 6.  Regulatory

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Counsel Harvey recorded the investigation as it was occurring and created an Investigator Controlled Purchase Narrative Report.  Id. ¶ 7; see CTP Exs. 4, 5.

Regarding FDA’s processing of Respondent’s e-liquid product after purchase and delivery to FDA’s Headquarters in Silver Spring, Maryland, CTP relies on the sworn declaration of Regulatory Counsel Dara D. Hackett.  CTP Ex. 3.  In the declaration, Regulatory Counsel Hackett testifies that, on March 22, 2023, she processed evidence from a controlled online purchase from Vapor Boss.  Id. ¶ 6.  Regulatory Counsel Hackett testified that she opened the Controlled Purchase Assignment Number 15 package, mailed by Respondent Vapor Boss at URL: https://vaporboss.com to an address in Maryland, and observed that the tobacco product inside the package was a Vapor Boss Bubble Gum 60ML/8MG e-liquid product.  Id. ¶ 7.  Regulatory Counsel Hackett testified that she labeled the Vapor Boss Bubble Gum 60ML/8MG e-liquid product as evidence, photographed the e-liquid product, then placed the e-liquid product, a signed copy of the CTP Inventory Sheet of Evidence and the outer mail packaging, into an FDA evidence bag and sealed the evidence bag.  Id.  Regulatory Counsel Hackett testified that the evidence bag was then placed into a locked cabinet, which is designated for controlled online purchase investigation evidence storage at FDA Headquarters in Silver Spring, Maryland, where it remained as of the date of Regulatory Counsel Hackett’s declaration.  Id.  Regulatory Counsel Hackett took photographs during the evidence collection process for Controlled Purchase Assignment Number 15.  Id. ¶ 8; see CTP Ex. 6.

In its Answer, Respondent admits the allegations in the Complaint, asserts defenses, and disputes the proposed CMP as too high.  CRD Dkt. Entry No. 6 at 1-2.  During the PHC, Respondent reiterated its admission of the allegations in the Complaint and disputed the appropriateness of the proposed CMP.  See CRD Dkt. Entry No. 39 at 2.

Given Respondent admits the allegations in the Complaint, does not dispute the evidence and testimony submitted by CTP with regard to liability, and did not wish to cross-examine CTP’s witnesses, I find that the uncontroverted testimony of Deputy Division Director James Bowling, Regulatory Counsel Eric Harvey, and Regulatory Counsel Hackett, as well as the corroborating evidence submitted by CTP, establishes that Respondent introduced or delivered for introduction into interstate commerce an adulterated and misbranded tobacco product, thereby violating the Act.  21 U.S.C.           § 331(a).  Specifically, the evidence shows that Respondent, which operated an online establishment on March 13, 2023 in California at URL: https://vaporboss.com, introduced or delivered for introduction into interstate commerce its Vapor Boss Bubble Gum 60ML/8MG e-liquid product when Respondent processed FDA’s undercover inspection purchase and shipped the e-liquid product from California to FDA in Maryland on March 13, 2023.  21 U.S.C. § 331(a); see CTP Exs. 2-6.  I find that the Vapor Boss Bubble Gum 60ML/8MG e-liquid product manufactured and sold by Respondent was adulterated because it lacked the FDA premarketing authorization and was not exempt from this requirement.  21 U.S.C. §§ 387j(a)(2)(A), 387e(j)(3)(A); see

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CTP Ex. 1.  I also find Respondent’s e-liquid product was misbranded under 21 U.S.C.   § 387c(a)(6) because there was no substantially equivalent determination as required by 21 U.S.C. § 387e(j).  See CTP Ex. 1.

In its Answer and subsequent filings, Respondent asserts a number of defenses.  See CRD Dkt. Entry Nos. 6 at 2, 16 at 1-2, 19 at 1, 23, 26 at 1-2, 41.  Specifically,  Respondent “[requests] the [CMP] be waived . . . [because Respondent is] no longer selling [its] manufactured e-liquids.”  CRD Dkt. Entry No. 6 at 2.  Respondent also asserts that it “attempt[ed] to comply with FDA regulations . . . quite early in the process by submitting [its] premarket application as soon as it was available but[,] [was] denied with no explanations as to why.”  Id.  In its Answer, Respondent concedes that it “did at some point receive an uncertified letter stating that [its] application had been denied . . . .”  CRD Dkt. Entry No. 6 at 2.  The evaluation of Respondent’s PMTA by FDA is not within my jurisdiction for adjudication, nor does Respondent’s argument present a defense to its liability under the Act.  Finally, Respondent argues that in Wages and White Lion Investments, L.L.C. v. Food & Drug Administration, the U.S. Circuit Court of Appeals for the Fifth Circuit held that “the FDA had been arbitrary and capricious, in violation of a federal law . . . by denying the applications without considering plans by the companies to prevent underage access and use.”  CRD Dkt. Entry No. 6 at 2; see also CRD Dkt. Entry Nos. 16 at 1, 23 at 1.  In Wages and White Lion Investments, L.L.C. v. Food & Drug Administration, the Fifth Circuit held that FDA acted arbitrarily and capriciously by applying application standards different from those articulated in its predecisional guidance documents regarding scientific evidence, cross-flavor comparisons, and device type.  Wages and White Lion Investments, L.L.C. v. Food & Drug Administration, 21-60800 (5th Cir. 2022).  Although the primary issue in Wages and White Lion Investments, L.L.C. v. Food & Drug Administration was the legality of FDA’s PMTA evaluation process, and not relevant to the issue of Respondent’s liability under the Act in this case, it is worth noting that on April 2, 2025, the United States Supreme Court unanimously held in favor of FDA, and remanded the case back to Fifth Circuit.  See FDA v. Wages and White Lion Investments, LLC, 145 S.Ct. 898 (2025).

I conclude that Respondent violated the Act by selling its unauthorized e-liquid product and shipping it to FDA’s offices in Maryland from California, Respondent’s arguments do not present a meritorious defense to its liability, and the imposition of a civil money penalty against Respondent is warranted. 

VI.     Civil Money Penalty

Having determined that Respondent is liable under the Act, I conclude that I have the authority to impose a civil money penalty under 21 U.S.C. 333(f)(9)(A).  In its Complaint, CTP sought to impose a penalty amount of $19,192 against Respondent.  CRD Dkt. Entry No. 1 ¶ 1.  In its pre-hearing brief and final brief, CTP continued to assert that a $19,192 civil money penalty is appropriate.  CRD Dkt. Entry Nos. 25 at 9-

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12; 40 at 1-4.  With regard to the CMP sought by CTP, in its final brief, Respondent “ask[s] that the CMP be waived.”  CRD Dkt. Entry No. 41.

In determining whether a $19,192 civil money penalty is appropriate, I must consider any aggravating or mitigating circumstances and the factors listed in the Act.  21 C.F.R. § 17.34(a)-(b).  Specifically, I am required to consider “the nature, circumstances, extent and gravity of the violation or violations and, with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, the degree of culpability, and such other matters as justice may require.”  21 U.S.C. § 333(f)(5)(B); 21 C.F.R. § 17.45(b)(1)-(3).  Respondent must prove any mitigating factors by a preponderance of the evidence.  21 C.F.R. § 17.33(c).  For the following reasons, I conclude that a $9,596 civil money penalty is appropriate based upon the record evidence, applicable law, and aggravating and mitigating circumstances in this case.

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).

CTP argues Respondent’s violation is particularly serious because CTP previously issued a warning letter to Respondent on September 1, 2021, citing Respondent for offering for sale new tobacco products that lacked the required marketing authorization.  CRD Dkt. Entry No. 25 at 10; see also CTP Ex. 7.  The September 1, 2021 warning letter notified Respondent that a review of the website https://vaporboss.com revealed that Respondent manufactured and offered for sale or distribution to customers in the United States electronic nicotine delivery system products under the Vapor Boss brand, including Boss Bar I Love Licorice and Boss Bar Mango, without marketing authorization.  CTP Ex. 7 at 2.  The warning letter explained the sale of unauthorized new tobacco products is prohibited and warned Respondent to take action to correct the violations.  Id. at 1-3.

In its pre-hearing brief, CTP notes that the warning letter specifically advised Respondent that future violations could result in enforcement action, “including, but not limited to, civil money penalties, seizure, and/or injunction by FDA.”  CRD Dkt. Entry No. 25 at 10.  CTP also notes the warning letter stated that “all new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA’s discretion.”  Id.  CTP contends that based on Respondent’s “unwillingness or inability to correct the violations, a penalty is necessary in order for Respondent to grasp the seriousness and importance of the requirements governing the sale of tobacco products.”  Id. at 11.

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In its pre-hearing brief, Respondent argues that “the [C]omplainant states they are trying to [‘]protect the public health from the multitude of adverse health effects associated with tobacco use[.][’][] However if this were true then there would be a complete ban on all tobacco products just as there is on drugs like cocaine and fentanyl. Vapor Boss has complied to the best of its ability to cease sales entirely.”  CRD Dkt. Entry No. 26 at 2.  Given that Respondent continued to sell unauthorized new tobacco products on its website after receiving CTP’s September 1, 2021 warning letter, I find Respondent’s argument unpersuasive.  Further, the continued marketing and selling of unauthorized new tobacco products during the time period between the issuance of CTP’s September 1, 2021 warning letter and March 13, 2023, the date of the allegation in the Complaint, demonstrates that Respondent did not comply with federal tobacco law, which is serious in nature and demands a proportional civil money penalty amount.

2. Ability to Pay and Effect on Ability to Continue to Do Business

Respondent asserts that it cannot afford to pay the proposed CMP, and that the impact of paying the $19,192 CMP “would ultimately bankrupt [Respondent] and possibly foreclose homes etc.”  CRD Dkt. Entry No. 6 at 2.  As evidence in support of its claim that it is unable to pay the proposed CMP, Respondent submitted documentary evidence demonstrating the owner’s financial hardship.  See R. Exs. 1-7, CRD Dkt. Entry Nos. 28, 28a-28f.

In its pre-hearing brief, CTP asserts “Respondent has not provided sufficient evidence that shows an inability to pay the $19,192 civil money penalty.”  CRD Dkt. Entry No. 25 at 11.  In its final brief, CTP further argues that the evidence submitted by Respondent “do[es] not establish an inability to pay the civil money penalty.  Failing to pay one’s personal bills is not the same thing as being unable to pay a civil money penalty.”  CRD Dkt. Entry No. 40 at 2-3.  CTP further argues, “Respondent has provided no evidence as to its past income, assets, or any other potential sources of revenue.  Therefore, Respondent has failed to meet its burden of establishing an inability to pay the requested penalty.”  Id. at 3.  In its final brief, Respondent responds by arguing that “[i]t is absurd of CTP to think that anyone with funds on reserve would willingly allow their personal credit to plummet by failing to make payments on things that they once could.”  CRD Dkt. Entry No. 41 at 1.

In the absence of recent bank statements, federal tax returns, and other evidence that would more accurately reflect a comprehensive picture of Respondent’s financial situation and inability to pay the proposed CMP, Respondent’s argument that it is unable to pay the CMP is less compelling.  However, the evidence in the record does demonstrate that the owner of Respondent’s establishment has recently defaulted on multiple personal loans and other payment obligations, implying a significant financial strain on personal finances, and providing a basis for determining that Respondent is unable to pay the full $19,192.  Specifically, Respondent submitted a letter dated October

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5, 2024 stating that the owner defaulted on a John Deere Financial equipment loan with an amount due of $3,576.14, and a county tax bill dated September 16, 2024 stating that the owner defaulted on his fiscal year 2024 through 2025 Riverside County, California Annual Secured Property taxes with two payments of $4,391.06 due: one on December 10, 2024; and a second on April 10, 2025, for a total amount due of $8,782.12.  See R. Exs. 1, 2.  In addition, Respondent submitted an IRS tax bill for tax year 2023 with an outstanding amount due of $2,162.15, a September 30, 2024 mortgage loan statement with an overdue amount of $4,749.25 and a total amount due of $9,167.22, an undated De Lage Landen payment collections letter with a past due amount of $1,691.88, an undated Insufficient Funds Notice from HOA requesting a replacement check in the amount of $211.00, and an automobile insurance notice of cancellation for non-payment of premium with a balance due of $2,560.29.  See R. Exs. 3-7.  Importantly, Respondent asserts, and has provided documentary evidence to support its claim, that it has closed its business selling tobacco products online and that it is no longer operating.  See CRD Dkt. Entry Nos. 16 at 1, 19, 23, 41, 41a.  Based on the evidence in the record, I find Respondent’s arguments regarding its ability to pay the CMP proposed by CTP and its ability to continue to do business to be credible and in the absence of any conflicting documentary evidence or argument regarding Respondent’s ability to pay the proposed CMP and ability to continue to do business, these mitigating circumstances warrant a reduction in the civil money penalty sought by CTP.

3. History of Prior Violations

There is no indication in the record of any prior violations of section 331(a) of the Act resulting in a CMP.  However, CTP argues that Respondent “has a history of violating the Act’s requirements” based on the September 1, 2021, warning letter.  CRD Dkt. Entry No. 25 at 11.  CTP contends a CMP of $19,192 is appropriate in this case because Respondent’s history demonstrates an “unwillingness or inability” to comply with the law.  Id.

As discussed above, I have already found that the warning letter helps to establish the nature, circumstances, extent, and gravity of the violation.  However, I do not agree with CTP that the warning letter also establishes a significant history of prior violations.  Respondent did not have the opportunity to request a hearing or otherwise dispute the violations alleged in the September 1, 2021 warning letter.

In sum, this is Respondent’s first violation resulting in a CMP.  Further, Respondent asserts that Vapor Boss, LLC is no longer in business.  Specifically, in its final brief, Respondent states “[i]f you were to search for ‘Vapor Boss’ in California’s Secretary of State online portal . . . , you would see that the status of the business is terminated which is further proof from our original filing document of dissolution.”  CRD Dkt. Entry No. 41; see also CRD Dkt. Entry Nos. 19, 41a.  As a result, I find that Respondent does not have a significant history of prior violations or a substantial likelihood of committing

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future violations, which is a mitigating factor that supports a reduction in the penalty amount.

4. Degree of Culpability

Based on my finding that Respondent committed the violation alleged in the Complaint, I
find Respondent fully culpable for offering for sale new tobacco products that were adulterated and misbranded, in violation of the Act.  The Act places a heavy burden on retailers who choose to sell prohibited tobacco products because of their highly dangerous and addictive nature.  See 21 U.S.C. § 387 note.  Although Respondent asserts that is has dissolved Vapor Boss, LLC and is no longer in the business of selling unauthorized e-liquid products, I find that dissolution of the company after its violation does not absolve Respondent of its culpability in violating the Act.  CRD Dkt. Entry No. 41; see also CRD Dkt. Entry Nos. 19, 41a. 

5. Other Matters as Justice May Require

The Act gives me discretion to consider any other evidence or arguments to mitigate the amount of the CMP.  See 21 U.S.C. § 333(f)(5)(B).  As noted above, CTP is requesting the maximum penalty amount permitted by the regulations.  See 45 C.F.R. § 102.3 (2022); 87 Fed. Reg. 15,100, 15,103 (March 17, 2022).  In assessing the appropriateness of CTP’s request, I find that justice requires me to consider the full range of available penalties in light of the specific facts and circumstances of the case, separate and apart from the factors discussed above.  In doing so, I note that the overall purpose of a CMP is to promote compliance with the law and deter future violations.  Therefore, a CMP should be significant, but not overly punitive.

Here, the record reflects Respondent is a relatively small manufacturer and retailer of tobacco products with no history of prior violations resulting in a CMP.  In addition, Respondent has participated in these proceedings, appears to be taking this matter very seriously, dissolved Vapor Boss, LLC, and is no longer in the business of selling unauthorized e-liquid products.  See CRD Dkt. Entry No. 41; see also CRD Dkt. Entry Nos. 19, 41a.  However, as a manufacturer and retailer engaged in the sale of tobacco products, Respondent should have fully complied with FDA’s January 8, 2021 Refuse to Accept letter.  Further, CTP previously warned Respondent about the potential consequences of continuing to offer unauthorized new tobacco products.  See CTP Ex. 7.

After weighing these factors and evaluating the entire administrative record, I find that imposing the maximum penalty would be overly punitive and would not serve the interests of justice.  However, I also find that Respondent’s conduct was serious and warrants a proportional penalty.  Therefore, I conclude that reducing the amount by fifty percent, but still imposing a substantial CMP of $9,596 is appropriate in this case under 21 U.S.C. §§ 333(f)(5)(B), (f)(5)(C), and (f)(9). 

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VII.     Conclusion

For the reasons stated above, I impose a civil money penalty against Respondent, Vapor Boss LLC d/b/a Vapor Boss, in the amount of $9,596 introducing or delivering for introduction into interstate commerce an adulterated and misbranded tobacco product.  Pursuant to 21 C.F.R. § 17.45(d), this Initial Decision becomes final and binding upon both parties after 30 days of the date of its issuance.